mandated benefit review of h.b. 800 th general court: … · mandated benefit review of h.b. 800 an...
TRANSCRIPT
CENTER FOR HEALTH INFORMATION AND ANALYSIS
OCTOBER 2016
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MANDATED BENEFIT REVIEW OF H.B. 800 SUBMITTED TO THE 189TH GENERAL COURT: AN ACT PROMOTING CONTINUITY OF CARE
FOR MULTIPLE SCLEROSIS TREATMENT
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TABLE OF CONTENTSBenefit Mandate Overview: ..........................................................................................1
History of the bill ......................................................................................................................1
What does the bill propose? ....................................................................................................1
Medical efficacy of H.B. 800 ....................................................................................................1
Current coverage .....................................................................................................................1
Cost of implementing the bill ...................................................................................................2
Plans affected by the proposed benefit mandate ....................................................................2
Plans not affected by the proposed benefit mandate .............................................................2
Medical Efficacy Assessment ......................................................................................3
Multiple sclerosis .....................................................................................................................3
Multiple sclerosis symptoms and diagnosis ............................................................................3
Disease-modifying therapy for MS ..........................................................................................4
Continuity of treatment ............................................................................................................4
Conclusion ...............................................................................................................................5
Appendix A: Route of Administration and Common Side Effects of MS Disease-Modifying Therapies ............................................................................................6
Appendix B: Clinical Efficacy and Safety Issues for MS Disease-Modifying Therapy ..........................................................................................7
Endnotes ......................................................................................................................8
Actuarial Assesment
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BENEFIT MANDATE OVERVIEW:
H.B. 800: AN ACT PROMOTING CONTINUITY OF CARE FOR MULTIPLE SCLEROSIS TREATMENT
HISTORY OF THE BILLThe Committee on Financial Services referred House Bill (H.B.) 800, “An Act promoting continuity of care for multiple sclerosis treatment,” sponsored by Rep. Bradley of Hingham in the 189th General Court, to the Center for Health Information and Analysis (CHIA) for review.1 Massachusetts General Laws, Chapter 3, Section 38C requires CHIA to review and evaluate the potential fiscal impact of a mandated benefit bill referred to the agency by a legislative committee.
WHAT DOES THE BILL PROPOSE?The bill provides for continuity of coverage for treatment of multiple sclerosis:
■ It requires carriers to cover a disease-modifying prescription drug for treatment of multiple sclerosis (MS) that the patient has already been prescribed and has been taking; it would apply to an MS patient entering or already in the carrier’s membership.
■ It provides that these benefits shall not be subject to any greater deductible, coinsurance, copayments, or out-of-pocket limits than any other disease-modifying prescription drug for multiple sclerosis provided by the insurer.
MEDICAL EFFICACY OF H.B. 800Multiple sclerosis (MS) is an unpredictable, frequently disabling disease of the central nervous system in which the immune system attacks the protective sheath (myelin) that surrounds, insulates, and protects nerve fibers. There is no cure for MS, but treatments can expedite recovery from attacks, modify the course of the disease, and manage symptoms. Disease-modifying drug therapy (DMT) is at the core of MS treatment, and is administered with the goals of reducing the frequency and severity of relapses and slowing the progression of disability. Research supports initiation of DMT early in the course of the disease, and patients who adhere to DMT experience better quality of life and lower risk of relapse.
Once a patient is managed effectively on a DMT, clinical literature supports continuing that DMT, except in prescribed circumstances. To the extent enactment of H.B. 800 would reduce the risk that patients would not be able to continue using an effective treatment, it would promote the health of the relevant population.
CURRENT COVERAGENo current Massachusetts law requires coverage, or comparable cost-sharing, for continued treatment with a given DMT for current or new members. However, in a survey of carriers conducted for this analysis, carriers reported covering most available DMT. All surveyed carriers reported using both a tiered system to manage pharmacy benefits and “step therapy” i before covering non-preferred drugs. Carriers reported that their policies allow members to waive step therapy if the prescribing provider requests it as medically necessary, and carriers would consider covering a DMT drug not on their formularies on a case-by-case basis if the member’s healthcare provider requested an exception for medical necessity. When such an exception is granted, the member pays the highest tier cost-sharing.
i Most carriers use a three-tier formulary system where Tier 1, the tier with the lowest patient cost sharing, includes generic drugs, Tier 2 includes the carrier’s “preferred” brands, and Tier 3, the tier with the highest patient cost sharing, includes the carrier’s “non-preferred” brands.
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COST OF IMPLEMENTING THE BILLRequiring coverage for this benefit by fully-insured health plans would result in an average annual increase, over five years, to the typical member’s monthly health premiums of between $0.02 (0.004%) and $0.10 (0.021%), with the most likely value at approximately $0.04 (0.008%). This increase is driven by the requirement that carriers must immediately cover any DMT drug for MS a new member had already been taking, regardless of the drug’s status with respect to its formulary. The carrier would no longer have discretion to require new members who have already been taking a particular DMT drug to change to an alternative that is less expensive to the carrier.
The Massachusetts Division of Insurance and the Commonwealth Health Insurance Connector Authority are responsible for determining any potential state liability associated with the proposed mandate under Section 1311 of the Affordable Care Act (ACA).
PLANS AFFECTED BY THE PROPOSED BENEFIT MANDATEH.B. 800 provides for continued coverage of medications for multiple sclerosis for all commercially fully-insured health plans offered pursuant to Massachusetts General Laws, including general indemnity, Blue Cross Blue Shield, HMO coverage, as well as plans, both fully- and self-insured, sponsored by the Group Insurance Commission (GIC) for the benefit of public employees and their dependents. The proposed mandate would apply to members covered under the relevant plans issued in Massachusetts by the relevant Massachusetts-licensed carriers.
PLANS NOT AFFECTED BY THE PROPOSED BENEFIT MANDATESelf-insured plans (i.e., where the employer or policyholder retains the risk for medical expenses and uses a third-party administrator or insurer only to provide administrative functions), except for those provided by the GIC, are not subject to state-level health insurance mandates. State benefit plan mandates do not apply to Medicare and Medicare Advantage plans, the benefits of which are qualified by Medicare. State mandates also do not apply to federally-funded plans including TRICARE (covering military personnel and dependents), the Veterans Administration, and the Federal Employee’s Health Benefit Plan. In addition, Massachusetts benefit plan mandates do not apply to Massachusetts residents covered by plans governed by other states. The bill as drafted does not address Medicaid/MassHealth.
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MEDICAL EFFICACY ASSESSMENTMassachusetts House Bill (H.B.) 800,2 as submitted in the 189th General Court, requires commercial fully-insured health plans and plans sponsored by the Group Insurance Commission (GIC), to provide “coverage for a disease-modifying prescription drug for treatment of multiple sclerosis that the individual has already been prescribed and has already been taking.” It also requires that the benefits for the disease-modifying prescription drug “shall not be subject to any greater deductible, coinsurance, copayments or out-of-pocket limits than any other disease-modifying prescription drug for multiple sclerosis provided by the insurer.”
M.G.L. c. 3 §38C charges the Massachusetts Center for Health Information and Analysis (CHIA) with reviewing the medical efficacy of proposed mandated health insurance benefits. Medical efficacy reviews summarize current literature on the effectiveness and use of the mandated treatment or service, and describe the potential impact of a mandated benefit on the quality of patient care and the health status of the population.
MULTIPLE SCLEROSISMultiple sclerosis (MS) is an unpredictable and frequently disabling disease of the central nervous system—the brain and spinal cord—in which the immune system attacks the fatty protective sheath (myelin sheath) that surrounds, insulates, and protects nerve fibers.3,4 When any part of the myelin sheath or nerve fiber is damaged or destroyed, nerve pulses traveling to and from the spinal cord are slowed or blocked.5 This causes a wide variety of symptoms, depending on the amount of nerve damage and on which nerves are affected.6 The “multiple” in MS refers to the many places in which myelin is lost, and “sclerosis” refers to the scars that form in the areas without myelin.7 There is no cure for MS, but treatments can expedite recovery from attacks, modify the course of the disease, and manage symptoms.8
MULTIPLE SCLEROSIS SYMPTOMS AND DIAGNOSISMost people who develop MS experience their first symptoms between the ages of 20 and 40.9 Typical initial presentations include blurred or double vision, red-green color distortion, or even blindness in one eye.10 Most MS patients develop muscle weakness in their extremities, which can lead to difficulty with coordination and balance.11 MS symptoms can be severe, producing partial or complete paralysis.12 Other symptoms may include transitory abnormal sensory feelings such as numbness, prickling, or complaints of “pins and needles”.13 Some individuals may experience pain, speech impediments, tremors, and dizziness.14 Hearing loss is an occasional symptom.15 Approximately half of all patients with MS experience cognitive symptoms.16 These symptoms include difficulties with concentration, attention, or memory, and poor judgment.17 Depression is a common feature of MS.18
Although patients experience a wide variety of symptoms, the disease may take one of four courses (“types” or “phenotypes”).19 The name of each course describes how the disease presents:20
■ Relapsing-Remitting Multiple Sclerosis (RRMS) is the phenotype diagnosed in most people with MS (80 percent). Individuals with RRMS go through periods of symptoms (relapse) followed by absence of symptoms (remission).21
■ Secondary Progressive Multiple Sclerosis (SPMS) is characterized by initial RRMS that suddenly begins to worsen without periods of remission.
■ Progressive-Relapsing Multiple Sclerosis (PRMS) is the rarest type of MS, and it is characterized by a steady worsening of the disease with superimposed attacks.
■ Primary Progressive Multiple Sclerosis (PPMS) is characterized by a steady increase in disability without attacks. The U.S. Food and Drug Administration (FDA) has approved no medications for the treatment of PPMS. This is because PPMS is characterized by nerve degeneration rather than inflammation, and disease-modifying treatments work primarily by reducing inflammation in the central nervous system.22
MS affects approximately 400,000 people in the United States;23 an estimated 90 per 100,000 people have the disease.24 However, the Centers for Disease Control and Prevention (CDC) does not require U.S. physicians to report new cases, and the symptoms of MS can be completely invisible.25 Therefore, the prevalence of MS can only be estimated and may not be accurate.26
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When considering MS as a potential diagnosis, the clinician must rule out other potential causes of the patient’s symptoms.27 An MS diagnosis requires a neurological exam and an extensive patient history, with detailed probing into any past neurological events. No single biological marker can diagnose MS.28 A diagnostic workup typically begins with an MRI of the brain, with additional MRI studies related to specific symptoms.29 A diagnosis of MS requires evidence of damage in two separate areas of the central nervous system which occurred at least one month apart.30 A lumbar puncture or spinal tap is used to rule out other disease processes and help confirm an MS diagnosis.31
DISEASE-MODIFYING THERAPY FOR MSWhile no cure for MS exists, disease-modifying therapies (DMTs) have been shown to be effective in limiting the number of relapses, preventing new inflammatory lesions, and reducing the progression of disability.32,33 Additionally, clinical trials have demonstrated that starting a DMT within three months of a first event decreases the risk of conversion to clinically-definite MS.34 Currently the FDA has approved 13 disease-modifying agents. (See Appendix A.) Interferon injectibles and glatiramar acetate have long-established efficacy and have served as the primary DMTs since the 1990’s, and they are the first-line treatments for RRMS, the most common phenotype.35
Since early 2010, many new drug therapies have been introduced, expanding treatment options for a disease that previously had very few.36 Appendix B summarizes the efficacy findings and safety issues for approved DMTs; highlights of recent efficacy evaluations of the newer products follow.
In a review of the safety and efficacy of five new agents and one new dosage formulation, peginterferon beta 1a and high-dose glatiramer acetate were found to be effective, while reducing the burden (frequency) of administration.37 Three new oral agents were found to have varying efficacy in reducing annualized relapse rates, compared with a placebo, of 48 to 55 percent (Fingolimod), 22 to 36 percent (teriflunomide), and 44 to 53 percent (dimethyl fumarate). Alemtuzumab, a biologic agent given over a 2-year span, reduced annualized relapse rates by 55 percent in previously-untreated patients and by 49 percent in patients relapsing on prior DMTs.38 Adverse effects emerging during treatment were common with all drug treatments, including liver toxicity, infections, and neuropathy (see Appendix B for more detail).39 In one recent large drug class review of disease-modifying drugs for MS,ii evidence was presented that interferon beta-1a IM (Avonex®) was less effective than interferon beta-1a SC (Rebif®) and interferon beta-1b (Betaseron®) for preventing relapse in RRMS.40 However, in other outcomes and other populations, direct evidence was lacking or little difference was observed in the safety and effectiveness among the disease-modifying drugs.41
DMTs vary in routes and frequency of administration, tolerability and likelihood of treatment adherence, common adverse effects, risk of major toxicity, and pregnancy-related risks.42 To establish a logical and safe treatment plan for each individual patient, these variables, as well as the benefit-risk profiles of each drug, must be carefully considered by the clinician and patient.43
CONTINUITY OF TREATMENTNumerous studies document the importance of taking MS disease-modifying agents regularly to achieve optimal outcomes.44,45,46 In a large multicenter observational study in patients with RRMS, MS patients who adhered to their treatment with disease-modifying agents reported better quality of life and fewer neuropsychological issues than non-adherent patients.47 In a systematic literature review, researchers found a greater risk of MS relapse or progression among patients who did not adhere to DMT compared to those who adhered.48 In a retrospective study of patients taking interferon-beta therapy for MS, patients who adhered to treatment tended to have a lower risk of relapse over three years than did non-adherent patients.49 In a study of 114 subjects with RRMS, researchers found that subjects who missed an injection had a fourfold chance of having a relapse.50 Study authors have cited better quality of life, lower risk of relapse, and fewer hospitalizations and emergency room visits as benefits of adherence.51
ii DrugsstudiedforsafetyandefficacyincludedGlatirameracetate(Copaxone®),interferonbeta-1a(Avonex®,Rebif®),interferonbeta-1(Betaseron®,Extavia®),mitoxantrone(Novantrone®),andnatalizumab(Tysabri®).
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In a review of current treatment strategies for MS, the authors advise that changes in disease-modifying therapy should be considered in specific situations, such as a suboptimal response to treatment, intolerable side effects, laboratory tests indicating reduced effectiveness of treatment, or the presence of certain antibodies under special circumstances.52
With the introduction of new DMTs, treatment decisions have become more complex. In a review of DMT selection and use for patients with MS, the author noted that the major goal of DMT therapy is to “balance perceived efficacy and tolerability in a specific patient with the relative impact of the disease activity and adverse events of quality of life.”53 These factors are specific to each patient and how that patient’s characteristics and preferences interact with the benefits and risks of each drug.
By requiring coverage for members transitioning from one insurance plan to another, and prohibiting a carrier from discontinuing coverage, for an MS DMT when the member is actively using it, H.B. 800 reduces the risk that a member will experience a gap in treatment due to coverage or other non-clinical reasons.
CONCLUSIONDisease-modifying therapy is at the core of MS treatment and is administered with the goals of reducing the frequency and severity of relapses, reducing the rate of nerve damage, and slowing the progression of disability. Research supports initiation of DMT early in the course of the disease, and patients who adhere to their DMT experience better quality of life and lower risk of relapse. Since 2010, the number and use of disease-modifying therapies has grown, with new mechanisms of action and expanded options for route and frequency of administration, and therapeutic approaches to MS are expected to continue to grow and evolve as researchers gain a better understanding of the pathogenesis of MS and the influence of environmental factors.54 DMTs have numerous common side effects and carry many warnings. Choosing the right DMT for an individual depends on balancing many factors, including chances of adherence based on lifestyle. Once a patient is being managed effectively on a DMT, clinical literature supports continuation of that DMT except in prescribed circumstances. To the extent enactment of H.B. 800 would reduce the risk that patients would not be able to continue using an effective treatment, it would promote the health of the relevant population.
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APPENDIX A: ROUTE OF ADMINISTRATION AND COMMON SIDE EFFECTS OF MS DISEASE-MODIFYING THERAPIES55,56
Treatment (Chemical Name) Route of Administration Most Common Side Effectsiii
Lemtrada® (alemtuzumab)
Intravenous infusion Rash, headache, fever, nasal congestion, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infections, hives, itching, thyroid gland disorders, fungal infection, pain in joints, extremities and back, diarrhea, vomiting, flushing. Infusion reactions (including nausea, hives, itching, insomnia, chills, flushing, fatigue, shortness of breath, changes in the sense of taste, indigestion, dizziness, pain) also common while the medication is being administered and for 24 hours after infusion.
Tecfidera® (dimethyl fumarate)
Orally twice a day Flushing (sensation of heat or itching and a blush on the skin), gastrointestinal issues (nausea, diarrhea, abdominal pain).
Gilenya® (fingolimod)
Orally once a day Headache, flu, diarrhea, back pain, liver enzyme elevations, sinusitis, abdominal pain, pain in extremities and cough.
Glatopa® (glatiramer acetate)
Subcutaneously (under the skin) once a day
Injection site reactions (redness, pain, swelling).
Copaxone® (glatiramer acetate)
Subcutaneously once a day, three times a week
Injection site reactions (redness, pain, swelling), flushing, shortness of breath, rash, chest pain.
Avonex® (interferon beta-1a)
Intramuscularly (into a large muscle) once a week
Headache, flu-like symptoms (chills, fever, muscle pain, fatigue, weakness), injection site pain and inflammation.
Rebif® (Interferon beta-1a)
Subcutaneously three times per week
Flu-like symptoms (chills, fever, muscle pain, fatigue, weakness, headache), injection site reactions (redness, pain, swelling).
Betaseron® (interferon beta-1b)
Subcutaneously every other day
Flu-like symptoms (chills, fever, muscle pain, fatigue, weakness) following injection, headache, injection site reactions (swelling, redness, pain), injection site skin breakdown, low white blood count.
Extavia® (Interferon beta-1b)
Subcutaneously every other day
Flu-like symptoms (chills, fever, muscle pain, fatigue, weakness) following injection, headache.
Novantrone® (mitoxantrone)
Intravenous infusion Nausea, hair loss, menstrual change, upper respiratory infection, urinary tract infection, mouth sours, irregular heartbeat, diarrhea, constipation, back pain, sinusitis, headache, blue-green urine.
Tysabri® (natalizumab)
Intravenous infusion Headache, fatigue, joint pain, chest discomfort, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea, rash.
Plegridy® (peginterferon beta-1a)
Subcutaneously every 14 days
Flu-like symptoms (chills, fever, muscle pain, fatigue, weakness, headache, itching). Injection site reactions (swelling, redness, pain).
Aubagio® (teriflunomide)
Orally once a day Headache, hair thinning, diarrhea, nausea, abnormal liver tests.
iii Inadditiontocommonsideeffects,eachdiseasemodifyingtherapyhasadditionalwarnings.SeeAppendixB.
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APPENDIX B: CLINICAL EFFICACY AND SAFETY ISSUES FOR MS DISEASE-MODIFYING THERAPY57
TreatmentClinical efficacy in placebo-controlled phase III trialsiv Safety issues
Alemtuzumab 12 mg/d intravenously for five days followed by 12 mg/d intravenously for three days one year after the first course
49%-55% reduction of ARR over two years compared to subcutaneous interferon beta 1a 42% reduction of progression of disability at two years compared to subcutaneous interferon beta 1a
Infusion associated reactions; cytokine release syndrome; lymphopenia; infections; autoimmune thyroiditis; thrombocytopenic purpura; glomerulonephritis
Dimethyl fumarate 240 mg orally twice a day
44%-53% reduction of ARR over two years 38% reduction of progression of disability at two years
Lymphopenia; progressive multifocal leukoencephalopathy
Fingolimod 0.5 mg orally every day
48%-54% reduction of ARR over two years 30% reduction of progression of disability at two years
Bradyarrhythmias after first dose; lymphopenia; viral infections (VZV); macular edema; hepatotoxicity; hypertension
Glatiramer acetate 20 mg subcutaneously every day
29% reduction of ARR over two years (RRMS) 45% risk reduction of conversion to CDMS at three years (CIS) No statistically significant effect on disability progression
Cutaneous necrosis; anaphylaxis (rare)
Interferon beta 1b 250 mcg subcutaneously every other day
34% reduction of annualized relapse rate (ARR) over two years (RRMS) 50% risk reduction of conversion to CD MS at two years (CIS) No statistically significant effect on disability progression
Hepatotoxicity; myelotoxicity; autoimmune thyroiditis; microangiopathy; epileptic seizures (rare)
Interferon beta 1a 30 mcg intramuscularly once a week
18% reduction of ARR over two years (RRMS) 44% risk reduction of conversion to CD MS at two years (CIS) No statistically significant effect on disability progression
Same as above
Interferon beta 1a 44 mcg subcutaneously three times a week.
32% reduction of ARR over two years (RRMS) 45% risk reduction of conversion to CD MS at two years (CIS) 30% reduction of progression of disability at two years (RRMS)
Same as above
Mitoxantrone 12 mg/m2 intravenously every three months or 8 mg/m2 intravenously every month
65% reduction of relapse risk over two years (mostly in RRMS) 66% reduction of risk of disability progression at two years (mostly in RRMS)
Infusion site tissue necrosis; myelotoxicity; infections; cardiotoxicity; acute leukemia
Peginterferon beta 1a 125 mcg subcutaneously every two weeks
36% reduction of ARR over one year Same as above
Natalizumab 300 mg intravenously every four weeks
68% reduction of ARR over two years 42% reduction of progression of disability at two years
Infusion associated reactions; anaphylaxis; infections; hepatotoxicity; progressive multifocal leukoencephalopathy
Teriflunomide 14 mg orally every day
31%-36% reduction of ARR over one year or more 26%-32% reduction of progression of disability at one year or more
Myelotoxicity; hepatotoxicity; infections; peripheral neuropathy; pancreatic fibrosis; teratogenicity (requires accelerated elimination procedure)
iv CDMS:ClinicallyDefiniteMS;CIS:Clinicallyisolatedsyndrome;RRMS:Relapsing-remittingMS;ARR:Annualizedrelapserate.
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ENDNOTES1 The 189thGeneralCourtoftheCommonwealthofMassachusetts,HouseBill800,“AnActpromotingcontinuityofcarefor
multiplesclerosistreatment.”Accessed24May2016:https://malegislature.gov/Bills/189/House/H800.2 The 189thGeneralCourtoftheCommonwealthofMassachusetts,HouseBill800,“AnActpromotingcontinuityofcarefor
multiplesclerosistreatment.”Accessed24May2016:https://malegislature.gov/Bills/189/House/H800.3 NIHNationalInstituteofNeurologicalDisordersandStroke.NINDSMultipleSclerosisInformationPage.UpdatedNovember
19,2015.Accessed24May2016:http://www.ninds.nih.gov/disorders/multiple_sclerosis/multiple_sclerosis.htm.4 NIHNationalLibraryofMedicine.MedlinePlus.MultipleSclerosis.Accessed24May2016:https://www.nlm.nih.gov/
medlineplus/multiplesclerosis.html.5 Op. cit. NIHNationalLibraryofMedicine,MedlinePlus.MultipleSclerosis.6 MayoClinic.MultipleSclerosis.Accessed24May2016:http://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/
home/ovc-20131882?p=1. 7 LitzingerM,LitzingerM.MultipleSclerosis:ATherapeuticOverview.USPharmacist.2009;34(1):HS3-HS9.Accessed24May
2016:http://www.medscape.com/viewarticle/588913_2.8 Op cit. MayoClinic,MultipleSclerosis.9 Op. cit. NIHNationalInstituteofNeurologicalDisordersandStroke,NINDSMultipleSclerosisInformationPage.10 Op. cit. NIHNationalInstituteofNeurologicalDisordersandStroke,NINDSMultipleSclerosisInformationPage.11 Op. cit. NIHNationalInstituteofNeurologicalDisordersandStroke,NINDSMultipleSclerosisInformationPage.12 Op. cit. NIHNationalInstituteofNeurologicalDisordersandStroke,NINDSMultipleSclerosisInformationPage.13 Op. cit. NIHNationalInstituteofNeurologicalDisordersandStroke,NINDSMultipleSclerosisInformationPage.14 Op. cit. NIHNationalInstituteofNeurologicalDisordersandStroke,NINDSMultipleSclerosisInformationPage.15 Op. cit. NIHNationalInstituteofNeurologicalDisordersandStroke,NINDSMultipleSclerosisInformationPage.16 Op. cit. NIHNationalInstituteofNeurologicalDisordersandStroke,NINDSMultipleSclerosisInformationPage.17 Op. cit. NIHNationalInstituteofNeurologicalDisordersandStroke,NINDSMultipleSclerosisInformationPage.18 Op. cit. NIHNationalInstituteofNeurologicalDisordersandStroke,NINDSMultipleSclerosisInformationPage.19 NationalMultipleSclerosisSociety.TypesofMS.Accessed24May2016:http://www.nationalmssociety.org/What-is-MS/Types-
of-MS.20 Op. cit. LitzingerM,LitzingerM,MultipleSclerosis:ATherapeuticOverview.21 Op. cit. LitzingerM,LitzingerM,MultipleSclerosis:ATherapeuticOverview.22 NationalMultipleSclerosisSociety.TreatingPPMS.Accessed26May2016:http://www.nationalmssociety.org/What-is-MS/
Types-of-MS/Primary-progressive-MS/Treating-Primary-Progressive-MS.23 ClevelandClinicCenterforContinuingEducation.MultipleSclerosis.DiseaseManagement.PublishedJune2014.Accessed24
May2016:http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/neurology/multiple_sclerosis/. 24 Op. cit. ClevelandClinicCenterforContinuingEducation,DiseaseManagement.MultipleSclerosis.25 NationalMultipleSclerosisSociety.MSPrevalence.Accessed24May2016:http://www.nationalmssociety.org/About-the-
Society/MS-Prevalence. 26 Op. cit. NationalMultipleSclerosisSociety,MSPrevalence.27 MarcusJ,WaubantE.UpdatesonClinicallyIsolatedSyndromeandDiagnosticCriteriaforMultipleSclerosis.Neurohospitalist.
2013Apr;3(2):65–80.Accessed26May2016:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3726117/. 28 Op. cit. MarcusJ,WaubantE,UpdatesonClinicallyIsolatedSyndromeandDiagnosticCriteriaforMultipleSclerosis.29 Op. cit. MarcusJ,WaubantE,UpdatesonClinicallyIsolatedSyndromeandDiagnosticCriteriaforMultipleSclerosis.30 NationalMultipleSclerosisSociety.TipSheet:2010RevisedMcDonaldDiagnosticCriteriaforMS.Accessed27May2016:
http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Paper-TipSheet_-2010-Revisions-to-the-McDonald-Criteria-for-the-Diagnosis-of-MS.pdf.
31 MedscapeMultispecialty.MultipleSclerosis:ATherapeuticOverview.Accessed27May2016:http://www.medscape.com/viewarticle/588913_3.
32 BergamaschiR,QuagliniS,TavazziE,et.al.Immunomodulatorytherapiesdelaydiseaseprogressioninmultiplesclerosis.MultScler.2012May31.Accessed25May2016:http://www.ncbi.nlm.nih.gov/pubmed/22653657.
33 TrojanoM,PaolicelliD,TortorellaC.et.al.Naturalhistoryofmultiplesclerosis:haveavailabletherapiesimpactedlong-termprognosis?NeurolClin.2011May;29(2):309-21.Accessed25May2016:http://www.ncbi.nlm.nih.gov/pubmed/21439443.
34 Op. cit. MarcusJ,WaubantE,UpdatesonClinicallyIsolatedSyndromeandDiagnosticCriteriaforMultipleSclerosis.35 EnglishC,AloiJJ.NewFDA-ApprovedDisease-ModifyingTherapiesforMultipleSclerosis.ClinTher.2015Apr1;37(4):691-
715.Accessed25May2016:https://www.ncbi.nlm.nih.gov/pubmed/25846320.
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36 Op. cit. EnglishC,AloiJJ,NewFDA-ApprovedDisease-ModifyingTherapiesforMultipleSclerosis.37 Op. cit. EnglishC,AloiJJ,NewFDA-ApprovedDisease-ModifyingTherapiesforMultipleSclerosis.38 Op. cit. EnglishC,AloiJJ,NewFDA-ApprovedDisease-ModifyingTherapiesforMultipleSclerosis.39 Op. cit. EnglishC,AloiJJ,NewFDA-ApprovedDisease-ModifyingTherapiesforMultipleSclerosis.40 SmithB,CarsonS,FuR,et.al.DrugClassReview:Disease-modifyingDrugsforMultipleSclerosisFinalUpdate1Report.
OregonHealth&ScienceUniversity:2010Aug.Accessed26May2016:http://www.ncbi.nlm.nih.gov/books/NBK50570/. 41 Op. cit. SmithB,CarsonS,FuR,et.al.,DrugClassReview:Disease-modifyingDrugsforMultipleSclerosis42 WingerchukDM,CarterJL.Multiplesclerosis:currentandemergingdisease-modifyingtherapiesandtreatmentstrategies.Mayo
ClinProc.2014Feb;89(2):225-40.Accessed26May2016:https://www.ncbi.nlm.nih.gov/pubmed/24485135.43 Op. cit. WingerchukDM,CarterJL,Multiplesclerosis:currentandemergingdisease-modifyingtherapiesandtreatment
strategies.44 SteinbergSC,FarisRJ,ChangCF,et.al.Impactofadherencetointerferonsinthetreatmentofmultiplesclerosis:anon-
experimental,retrospective,cohortstudy.ClinDrugInvestig.2010;30(2):89-100.Accessed25May2016:http://www.ncbi.nlm.nih.gov/pubmed/20067327.
45 DevonshireV,LapieereY,MacdonellR,et.al.TheGlobalAdherenceProject(GAP):amulticenterobservationalstudyonadherencetodisease-modifyingtherapiesinpatientswithrelapsing-remittingmultiplesclerosis.EurJNeurol.2011Jan;18(1):69-77.Accessed25May2016:https://www.ncbi.nlm.nih.gov/pubmed/20561039/.
46 MenzinJ,CaonC,NicholsC,et.al.NarrativeReviewoftheLiteratureonAdherencetoDiseaseModifying TherapiesAmongPatientswithMultipleSclerosis.JManagCarePharm.2013;19(1-a):S24-S40.Accessed5June2016:
http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=16102.47 Op. cit. DevonshireV,LapieereY,MacdonellR,et.al.TheGlobalAdherenceProject(GAP):amulticenterobservationalstudyon
adherence to disease-modifying therapies in patients with relapsing-remitting multiple sclerosis.48 Op. cit. MenzinJ,CaonC,NicholsC,et.al.,NarrativeReviewoftheLiteratureonAdherencetoDiseaseModifyingTherapies
AmongPatientswithMultipleSclerosis.49 Op. cit. SteinbergSC,FarisRJ,ChangCF,et.al.,Impactofadherencetointerferonsinthetreatmentofmultiplesclerosis:anon-
experimental,retrospective,cohortstudy.50 MocciaM,PalladinoR,RussoC,et.al.Howmanyinjectionsdidyoumisslastmonth?Asimplequestiontopredictinterferon
β-1aadherenceinmultiplesclerosis.ExpertOpinDrugDeliv.2015;12(12):1829-35.Accessed25May2016:http://www.ncbi.nlm.nih.gov/pubmed/26371561.
51 HalpemR,AgarwalS,DembekC.Comparisonofadherenceandpersistenceamongmultiplesclerosispatientstreatedwithdisease-modifyingtherapies:aretrospectiveadministrativeclaimsanalysis.PatientPreferAdherence.2011Jan20;5:73-84.Accessed26May2016: https://www.ncbi.nlm.nih.gov/pubmed/21423591/.
52 GajofattoA,BenedettiM.Treatmentstrategiesformultiplesclerosis:Whentostart,whentochange,whentostop?WorldJClinCases.2015Jul16;3(7):545–555.Accessed25May2016:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4517331/.
53 CarrithersMD.Updateondisease-modifyingtreatmentsformultiplesclerosis.ClinTher.2014Dec1;36(12):1938-45.Accessed27May2016:https://www.ncbi.nlm.nih.gov/pubmed/25218310.
54 YadavSK,MindurJE,ItoK,et.al.Advancesintheimmunopathogenesisofmultiplesclerosis.CurrOpinNeurol.2015Jun;28(3):206-19.Accessed25May2016:https://www.ncbi.nlm.nih.gov/pubmed/25887768.
55 NationalMultipleSclerosisSociety.Medications.Accessed27May2016:http://www.nationalmssociety.org/Treating-MS/Medications.56 NationalMultipleSclerosisSociety.Disease-ModifyingTherapiesforMS.UpdatedFebruary2016.Accessed27May2016:
http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-The-MS-Disease-Modifying-Medications.pdf.
57 AdaptedfromOp cit. GajofattoA,BenedettiM,Treatmentstrategiesformultiplesclerosis:Whentostart,whentochange,whentostop?
For more information, please contact:
CENTER FOR HEALTH INFORMATION AND ANALYSIS501 Boylston Street Boston, MA 02116617.701.8100
www.chiamass.govPublication Number: 16 -302 -CHIA -01
CHIAcenter
for healthinformation
and analysis
centerfor health
information and analysis
ActuarialAssessmentofHouseBill800
Submittedtothe189thGeneralCourt:“AnActpromotingcontinuityofcarefor
multiplesclerosistreatment”
PreparedforCommonwealthofMassachusetts
CenterforHealthInformationandAnalysis
October2016
PreparedbyCompassHealthAnalytics,Inc.
compass Health Analytics October 2016
ActuarialAssessmentofHouseBill800:“AnActpromotingcontinuityofcareformultiplesclerosistreatment”
TableofContents
ExecutiveSummary.......................................................................................................................................i
1.Introduction..............................................................................................................................................1
2.InterpretationofH.B.800........................................................................................................................1
2.1.Plansaffectedbytheproposedmandate.........................................................................................1
2.2.Coveredservices................................................................................................................................2
2.3.Currentcoverage...............................................................................................................................2
2.4.Expandedcoverage...........................................................................................................................3
3.Methodology............................................................................................................................................4
3.1.Overview............................................................................................................................................4
3.2.Datasources......................................................................................................................................4
3.3.Stepsintheanalysis..........................................................................................................................5
3.4.Limitations.........................................................................................................................................6
4.Analysis.....................................................................................................................................................6
4.1.Estimatemembersaffectedbythemandate....................................................................................7
4.2.MonthlycostperuserofcontinuedDMTdrugtreatmentforMS....................................................8
4.3.AnnualincrementalmedicalexpenseofcontinuedDMTdrugsforMS............................................9
4.4.IncrementalPMPMmedicalexpense..............................................................................................10
4.5.Carrierretentionandincreaseinpremium.....................................................................................10
4.6.Projectedfully-insuredpopulationinMassachusetts.....................................................................10
4.7.Projectionoftotalmarginalmedicalexpense.................................................................................11
4.8.Carrierretentionandincreaseinpremium.....................................................................................11
5.Results....................................................................................................................................................11
5.1.Five-yearestimatedimpact.............................................................................................................12
5.2.ImpactontheGIC............................................................................................................................13
AppendixA:Disease-ModifyingTherapyDrugsforMultipleSclerosis,,.....................................................14
AppendixB:MembershipAffectedbytheProposedMandate.................................................................18
Endnotes....................................................................................................................................................19
compass Health Analytics October 2016
ThisreportwaspreparedbyJeffreyStock,FSA,MAAA,ValerieHamilton,RN,MHA,JD,AndreaClark,MS,JenniferElwood,FSA,MAAA,LarryHart,JamesHighland,PhD,andLarsLoren,JD.
compass Health Analytics i October 2016
ActuarialAssessmentofHouseBill800:“AnActpromotingcontinuityofcareformultiplesclerosistreatment”
ExecutiveSummaryMassachusettsHouseBill(H.B.)800,assubmittedinthe189thGeneralCourt,requireshealthinsurancecarrierstoprovidecontinuedcoverageofa“disease-modifyingprescriptiondrugtotreatmultiplesclerosis(MS)thattheindividualhasalreadybeenprescribedandhasalreadybeentaking.”Thiscoverage“shallnotbesubjecttoanygreaterdeductible,coinsurance,copayments,orout-of-pocketlimitsthananyotherdisease-modifyingprescriptiondrugformultiplesclerosisprovidedbytheinsurer.”1
MassachusettsGeneralLaws(M.G.L.)c.3§38CchargestheMassachusettsCenterforHealthInformationandAnalysis(CHIA)withreviewingthepotentialimpactofproposedmandatedhealthcareinsurancebenefitsonthepremiumspaidbybusinessesandconsumers.CHIAhasengagedCompassHealthAnalytics,Inc.(Compass)toprovideanactuarialestimateoftheeffectenactmentofthebillwouldhaveonthecostofinsuredhealthplansinMassachusetts.
Background
H.B.800requireshealthinsurancecarrierstoprovidecontinuedcoverageofadisease-modifyingtreatment(DMT)drugtotreatMSthattheindividualhasalreadybeenprescribedandhasalreadybeentaking,andthatincreasingcostsharingforsuchcoverageisnotallowed.Therearethirteen2DMTdrugsforMScurrentlyonthemarket.Thetreatmentsaredistinctandnotallaresafeoreffectiveforeverypatient.3AppendixAliststhesedrugs,theirroutesofadministration,clinicaleffectiveness,commonsideeffects,andsafetyissues.
ConsiderableevidencesupportstheimportanceofearlyinitiationofaDMTinthecourseofMS.4,5OnceapatientisbeingmanagedeffectivelyonaDMT,theliteraturesupportscontinuingthatspecificDMTdrugindefinitelyunlesstherearecontraindicationssuchassub-optimaltreatmentresponseorintolerablesideeffects.6
CurrentCoverage
AllcarriersrespondingtoaCompasssurveyregardingH.B.800icoveredmostavailableDMTdrugsforMSthroughouttheretrospectiveanalysisperiodofcalendaryear2014.iiThemainexceptionisExtavia®,whichisnotcoveredbyasetofcarrierscomprisingthemajorityoffully-insuredcommercialmembership.However,Betaseron®,whichiscoveredbyallsurveyedcarriers,hasthesameactivecompound,dosage,androuteofadministrationasExtavia®.
iElevenmajorMassachusettscommercialcarriers,withacombinedmembershipcomprisingapproximately90%oftheMassachusettscommercialfully-insuredpopulation,respondedtothesurvey.iiPlegridy®receivedFDAapprovalinAugust2014,Lemtrada®inNovember2014,andGlatopa®inApril2015.
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Allrespondingcarriersuseatieredsystemtomanagepharmacybenefits.Mostuseaclosedthree-tierformulary(whereTier1,thetierwiththelowestpatientcostsharing,includesgenericdrugs,Tier2includesthecarrier’s“preferred”brands,andTier3,thetierwiththehighestpatientcostsharing,includesthecarrier’s“non-preferred”brands)system.Allcarriersrequire“steptherapy”beforetheywillcoveranon-preferreddrug.Insteptherapy,amembermusttryothermedicationsfirstandhavedocumentedtherapeuticfailureorseveresideeffectsbeforeasimilarhigher-tierdrugwillbecovered.
CarriersstatedintheirsteptherapypoliciesthattheseprogramsmayallowmemberswithachronicconditionsuchasMStowaivesteptherapyandcontinueonanon-preferredmedicationiftheprescribingproviderrequestsitasmedicallynecessary.
Inaclosed-formularysystem,drugsnotontheformularyarenotcovered.Allcarriersreportingaclosed-formularysystemreportedthattheywouldconsidercoveringnon-formularyDMTdrugsforMSonacase-by-casebasisifthemember’shealthcareproviderrequestedanexceptionformedicalnecessity.Whensuchexceptionsaregranted,thememberpaysthehighest-tiercostsharing.
ExpandedCoverage
IfH.B.800wereenacted,carrierswouldimmediatelycoveranyDMTdrugforMSanewmemberhadalreadybeentaking,regardlessofthedrug’sstatuswithrespecttoitsformulary.Thisprovisionistheonlyportionofthelawthatwouldhaveamaterialcostimpact.InthecasewhereacarrierremovesaDMTdrugforMSfromitsformulary,acurrentmemberalreadytakingthatdrugwouldhavecontinuedcoverage,aprovisionwhichdatareviewedforthisstudysuggestswouldnothaveamaterialcostimpact.Inbothcases,thedrugwouldbecoveredwithmembercostsharingnogreaterthanthehighestcostsharingofaDMTdrugforMSonthecarrier’sformulary.Basedondatacollectedforthisstudy,thiscost-sharingprovisionwouldalsonothaveasignificantcostimpact.
Inaddition,thetextofthebillmightbereadtosuggestthat,ifadrugweremovedtoatierhigherthanthatofanyotherDMTdrugforMSonthecarrier’sformulary(e.g.,acarriermovedaDMTdrugtoTier3,whenpriortothemoveallcoveredDMTdrugshadbeenonlowertiers),thosemembersalreadytakingthedrugwouldbecoveredunderthetermsofthehighesttierforaDMTdrugpriortothechange.Intheexampleabove,thedrugmovedtoTier3wouldhavetobecoveredasaTier2drugforcurrentmemberswhohadalreadybeentakingitatthetimeofthechange.Currentcarriercoverageindicatesthisinterpretationwouldnothaveamaterialcostimpact.
Analysis
EstimatingH.B.800’simpactonpremiumsrequiresestimatingthenumberofcommercialfully-insuredMassachusettsresidentsusingDMTdrugsforMSwhomaybeaffectedbythebill,andtheaverageannualcostperaffecteduserofcontinuouscoverageforDMTdrugsforMSwhenmembersswitchcarriers.
Compassthenmultipliedtheseestimatestogetherandprojectedthemforwardoverthenextfiveyears(2017to2021)forindividualsunderage65withMassachusetts-regulated,fully-insured
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commercialcoverage,forecastingprescriptiondruginflationandaddingcarrierretention(administrativecostandprofit)toarriveatanestimateofthebill’seffectonpremiums.
Thisanalysisreliesonestimatesofthenumberoffully-insuredMassachusettsresidentstakingDMTdrugswhowouldbeaffectedbytheproposedmandate,theannualcosttocarriersofcontinuingthecoverage,andtherateofinflationofprescriptiondrugprices.Theuncertaintiesinherentinsuchestimatesareaddressedbymodelingarangeofassumptionswithinreasonablejudgment-basedlimits,andproducingarangeofincrementalimpactestimatesbasedonvaryingtheseparameters.
Summaryresults
TableES-1summarizestheestimatedeffectofH.B.800onpremiumsforfully-insuredplansoverfiveyears.Thisanalysisestimatesthattheproposedmandate,ifenactedasdrafted,wouldincreasefully-insuredpremiumsbyasmuchas0.021percentonaverageoverthenextfiveyears;amorelikelyincreaseisintherangeof0.008percent,equivalenttoanaverageannualexpenditureof$879thousandovertheperiod2017to2021.
Theimpactofthebillonanyoneindividual,employer-group,orcarriermayvaryfromtheoverallresultsdependingonthecurrentlevelofbenefitseachreceivesorprovidesandonhowthosebenefitswouldchangeundertheproposedmandate.
TableES1:SummaryResults
2017 2018 2019 2020 2021WeightedAverage 5YrTotal
Members(000s) 2,020 2,018 2,015 2,011 2,007 MedicalExpenseLow($000s)
$245 $365 $387 $411 $436 $391 $1,843MedicalExpenseMid($000s)
$490 $729 $774 $821 $871 $782 $3,685MedicalExpenseHigh($000s)
$1,198 $1,909 $2,167 $2,460 $2,791 $2,234 $10,525PremiumLow($000s)
$275 $410 $435 $461 $489 $439 $2,070PremiumMid($000s)
$550 $819 $870 $923 $979 $879 $4,140PremiumHigh($000s)
$1,346 $2,144 $2,435 $2,763 $3,136 $2,509 $11,824PMPMLow $0.02 $0.02 $0.02 $0.02 $0.02 $0.02 $0.02PMPMMid $0.03 $0.03 $0.04 $0.04 $0.04 $0.04 $0.04PMPMHigh $0.08 $0.09 $0.10 $0.11 $0.13 $0.10 $0.10EstimatedMonthlyPremium
$463 $473 $483 $493 $503 $483 $483Premium%RiseLow
0.003% 0.004% 0.004% 0.004% 0.004% 0.004% 0.004%Premium%RiseMid
0.007% 0.007% 0.007% 0.008% 0.008% 0.008% 0.008%Premium%RiseHigh
0.017% 0.019% 0.021% 0.023% 0.026% 0.021% 0.021%
compass Health Analytics 1 October 2016
ActuarialAssessmentofHouseBill800:“AnActpromotingcontinuityofcareformultiplesclerosistreatment”
1.IntroductionMassachusettsHouseBill(H.B.)800,assubmittedinthe189thGeneralCourt,requireshealthinsurancecarrierstoprovidecontinuedcoverageofa“disease-modifyingprescriptiondrugtotreatmultiplesclerosis(MS)thattheindividualhasalreadybeenprescribedandhasalreadybeentaking.”Thiscoverage“shallnotbesubjecttoanygreaterdeductible,coinsurance,copayments,orout-of-pocketlimitsthananyotherdisease-modifyingprescriptiondrugformultiplesclerosisprovidedbytheinsurer.”7
MassachusettsGeneralLaws(M.G.L.)c.3§38CchargestheMassachusettsCenterforHealthInformationandAnalysis(CHIA)withreviewingthepotentialimpactofproposedmandatedhealthcareinsurancebenefitsonthepremiumspaidbybusinessesandconsumers.CHIAhasengagedCompassHealthAnalytics,Inc.(Compass)toprovideanactuarialestimateoftheeffectenactmentofthebillwouldhaveonthecostofhealthinsuranceinMassachusetts.
Assessingtheimpactoftheproposedmandateonpremiumsentailsanalyzingitsincrementaleffectonspendingbyinsuranceplans.Thisinturnrequirescomparingspendingundertheprovisionsofthebilltospendingundercurrentstatutesandcurrentbenefitplansfortherelevantservices.
Section2ofthisreportoutlinestheprovisionsofthebill.Section3summarizesthemethodologyusedfortheestimate.Section4discussesimportantconsiderationsintranslatingthebill’slanguageintoestimatesofitsincrementalimpactonhealthcarecostsandstepsthroughthecalculations.Section5summarizestheresults.
2.InterpretationofH.B.800H.B.800requirescarrierstoprovidecontinuedcoverageofadisease-modifyingtherapy(DMT)drugtotreatMSthatthepatienthasalreadybeenprescribedandhasalreadybeentaking.Thiscoverageshallnotbesubjecttoanycost-sharingtermsorout-of-pocketlimitsgreaterthanthoseforanyotherdisease-modifyingprescriptiondrugformultiplesclerosisprovidedbythecarrier.
2.1.PlansaffectedbytheproposedmandateThebillamendsstatutesthatregulatehealthinsurancecarriersinMassachusetts.Itincludesfivesections,eachofwhichaddressesstatutesdealingwithaparticulartypeofhealthinsurancepolicy:
• Section1:GroupInsuranceCommission(GIC)(amendingM.G.L.c.32Abyadding§28)
• Section2:Accidentandsicknessinsurancepolicies(amendingM.G.L.c.175byinserting§47EEafter§47DD)
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• Section3:Contractswithnon-profithospitalservicecorporations(amendingM.G.L.c.176Abyinserting§8GGafter§8FF)
• Section4:Certificatesundermedicalserviceagreements(amendingM.G.L.c.176Bbyinserting§4GGafter§4FF)
• Section5:Healthmaintenancecontracts(amendingM.G.L.176Gbyinserting§4Yafter§4X)
ThisbillrequirescoverageforMassachusettsresidentsinsuredunderthelicensetypeslistedabove,withtheexceptionofindividualsinsuredunderGIC,whoarecoveredregardlessofstateofresidence.Self-insuredplans,exceptforthosemanagedbytheGIC,arenotsubjecttostate-levelhealthinsurancebenefitmandates.StatemandatesdonotapplytoMedicareorMedicareAdvantageplans,thebenefitsofwhicharequalifiedbyMedicare;thisanalysisexcludesmembersoffully-insuredcommercialplansover64yearsofageanddoesnotaddressanypotentialeffectonMedicaresupplementplanseventotheextenttheyareregulatedbystatelaw.ThisanalysisdoesnotapplytoMedicaid/MassHealth.
2.2.CoveredservicesH.B.800requireshealthinsurancecarrierstoprovidecontinuedcoverageofaDMTdrugtotreatMSthatthepatienthasalreadybeenprescribedandhasalreadybeentaking.ConsiderableevidencesupportstheimportanceofearlyinitiationofaDMTinthecourseofMS.8,9
OnceapatientismanagedeffectivelyonaDMT,theliteraturesupportscontinuingthatspecificDMTdrugindefinitelyunlesscontraindicationssuchassub-optimaltreatmentresponseorintolerablesideeffectsappear.10ThirteeniiiDMTdrugsforMSarecurrentlyonthemarket.Thetreatmentsaredistinctandnotallaresafeoreffectiveforeverypatient.11AppendixAliststhesedrugs,theirroutesofadministration,clinicaleffectiveness,commonsideeffects,andsafetyissues.
2.3.CurrentcoverageAllcarriersrespondingtoaCompasssurveyregardingH.B.800ivcoveredmostavailableDMTdrugsforMSthroughouttheretrospectiveanalysisperiodofcalendaryear2014.vThemainexceptionisExtavia®,whichisnotcoveredbyasetofcarrierscomprisingthemajorityoffully-insuredcommercialmembership.However,Betaseron®,whichiscoveredbyallsurveyedcarriers,hasthesameactivecompound,dosage,androuteofadministrationasExtavia®.
Allrespondingcarriersuseatieredformularysystemtomanagepharmacybenefits.Mostuseaclosedthree-tierformularysystem(whereTier1,thetierwiththelowestpatientcostsharing,includesgenericdrugs,Tier2includesthecarrier’s“preferred”brands,andTier3,thetierwiththehighestpatientcostsharing,includesthecarrier’s“non-preferred”brands).OnlyoneDMTdrugfor iiiThisanalysistreatsCopaxone®20mgandCopaxone®40mgasdistinctdrugs.ivElevenmajorMassachusettscommercialcarriers,withacombinedmembershipcomprisingapproximately90%oftheMassachusettscommercialfully-insuredpopulation,respondedtothesurvey.vPlegridy®receivedFDAapprovalinAugust2014,Lemtrada®inNovember2014,andGlatopa®inApril2015.
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MS,Glatopa®,isgeneric.AllothercoveredDMTdrugsforMSfallinthepreferredornon-preferredbrandtiers.vi
Allcarriersrequire“steptherapy”beforetheywillcoveranon-preferreddrug.Insteptherapy,amembermusttryandhavedocumentedtherapeuticfailureorsideeffectssosevereastoprecludeuseofsimilarlower-tierdrugs(e.g.,thegenericandthepreferredbrand),ifalternativesexist.CarriersstatedthattheirsteptherapypoliciesallowmemberswithachronicconditionsuchasMStowaivesteptherapyandcontinueonanon-preferredmedicationiftheprescribingproviderrequestsitasmedicallynecessary.
Inaclosed-formularysystem,drugsnotontheformularyarenotcovered.Allcarriersreportingaclosed-formularysystemreportedthattheywouldconsidercoveringnon-formularyDMTdrugsforMSonacase-by-casebasisifthemember’shealthcareproviderrequestedanexceptionwithadequatedocumentationofsteptherapyand/orthatthemember’sconditionwasstableonthenon-formularydrugandthatdiscontinuingthenon-formularydrugwouldthreatenthatstability.Whensuchexceptionsaregranted,thememberpaysthehighest-tiercostsharing.
2.4.ExpandedcoverageH.B.800containstwomainprovisionsrelatedtoDMTsformultiplesclerosis:
1. ContinuityofCoverage.Carrierswouldberequiredtoprovidecontinuedcoverageofa“disease-modifyingprescriptiondrugtotreatmultiplesclerosis(MS)thattheindividualhasalreadybeenprescribedandhasalreadybeentaking.”12Thisprovisionrequiresthat:
a. AcarriermustimmediatelycoveranyDMTdrugforMSthatanewmemberhadalreadybeentaking,regardlessofthedrug’sstatusinthecarrier’sformulary.
b. IfacarrierremovedaDMTdrugforMSfromitsformulary,thecarrierwouldcontinuetocoverthatdrugforcurrentmembersalreadytakingit.
2. Comparablecostsharing.Thiscoverage“shallnotbesubjecttoanygreaterdeductible,coinsurance,copayments,orout-of-pocketlimitsthananyotherdisease-modifyingprescriptiondrugformultiplesclerosisprovidedbytheinsurer.”13
Underthefirstcontinuityofcoveragerequirement,carrierswouldimmediatelycoveranyDMTdrugforMSthatanewmemberhadalreadybeentaking,whetherornotthedrugisincludedinthemember’snewpharmacybenefitplanandregardlessofthenewplan’ssteptherapyrequirements.Thisprovisiondrivesthecostoftheproposedmandate,asitremovescarriers’discretiontorequirenewmemberswhohavealreadybeentakingaparticularDMTdrugtochangetoanalternativethatislessexpensivetothecarrier.
viSomecarriersofferafour-tierformularyinsomeplans.Typically,thehighestcost-sharingfourthtierwillconsistofexpensive“specialtydrugs.”DMTdrugsforMSarelikelytobeplacedinthisspecialtytieronsuchformularies.
compass Health Analytics 4 October 2016
Inthesecondcontinuityofcoveragerequirement,underwhichacarrierremovesaDMTdrugforMSfromitsformulary,acurrentmemberwhohasalreadybeentakingthatparticulardrugwouldhavecontinuedcoverage.Formularychangesareinfrequent,andlikelytooccuronlyinthecaseoftherapeuticequivalencebetweentwodrugs,theremovalofadrugfromthemarket,orsignificantadversereactions.OnemajorcarriernotedthatthelasttimeaDMTdrugforMSwasremovedfromtheirformularywasin2011;thenon-covereddrugisoneoftwothataretherapeuticallyequivalent.Also,asnotedabove,allcarriershaveexceptionprocessesinplaceallowingcoverageofnon-formularydrugsasmedicallynecessary.Giventhesefacts,thecostofthisrequirementofthemandate,ifany,islikelytobeimmaterial.
Theprovisionofthebillrequiringcomparablecostsharingmightbereadtosuggestthat,ifadrugweremovedtoatierhigherthanthatofanyotherDMTdrugforMSonthecarrier’sformulary(e.g.,acarriermovedaDMTdrugtoTier3,whenpriortothemoveallcoveredDMTdrugshadbeenonlowertiers),thosemembersalreadytakingthedrugwouldbecoveredunderthetermsofthehighesttierforaDMTdrugpriortothatchange.Intheexampleabove,thedrugmovedtoTier3wouldhavetobecoveredasaTier2drugforcurrentmembersalreadytakingitatthetimeofthechange.GiventhatallcarriersrespondingtotheCompasssurveyalreadycoveratleastoneDMTdrugforMSatthehighesttier,thisanalysisestimatesthecostofthisprovisiontobezero.
3.Methodology
3.1.OverviewBasedontheinterpretationofH.B.800’sprovisionsinSection2,theanalysisfocusedontheeffectofthecontinuityofcoverageprovisiononmembersmovingfromonecarriertoanother.Estimatingthebill’simpactonpremiumsrequiresestimatingthenumberofcommercialfully-insuredMassachusettsresidentsaffectedbythebill,andtheaverageannualcostperaffecteduserofcontinuouscoverageforDMTdrugsforMS.Combiningthesecomponents,andaccountingforcarrierretention,resultsinabaselineestimateoftheproposedmandate’sincrementaleffectonpremiums,whichisthenprojectedoverthefiveyearsfollowingtheassumedJanuary1,2017implementationdateofthelaw.
3.2.DatasourcesTheprimarydatasourcesusedintheanalysiswere:
• Information,includingdescriptionsofcurrentcoverage,fromresponsestoasurveyofcommercialhealthinsurancecarriersinMassachusetts
• Academicliterature,publishedreports,andpopulationdata,citedasappropriate
• AninterviewwithapanelofexpertsonMSincludingtheauthorofthebilltextandaneurologistwhotreatsMSpatients
compass Health Analytics 5 October 2016
• MassachusettscarrierclaimdatafromCHIA’sMassachusettsAllPayerClaimDatabase(MA-APCD)forcalendaryear2014,forplanscoveringthemajorityoftheunder-65fully-insuredpopulationsubjecttothemandate
3.3.StepsintheanalysisTheanalysiswasexecutedinthefollowingsteps.
Estimatethenumberofmembersaffectedbythebill
• Estimatethenumberofcommercialfully-insuredMassachusettsresidentstakingaDMTdrugforMS.
• IdentifyallcommercialDMTdrugclaimsduringthestudyperiodintheMA-APCD.
• Calculatethepercentoffully-insuredDMTdrugusersduringthestudyperiodwhoskippeddosesatthetimeofthecarrierswitch,definedasagapofgreaterthanonemonth’ssupply,butwholaterhadclaimsforthedrugunderthenewcarrier.
• CalculatetheaveragenumberofdosesmissedperuserwhoskippeddosesbutlaterhadDMTclaimsunderthenewcarrier.
• Calculatethepercentoffully-insuredDMTdruguserswhodiscontinueduseofaDMTfortheremainderofthestudyperiodatthetimeofthecarrierswitch.
• Multiplytheestimatednumberofcommercialfully-insuredMassachusettsresidentstakingDMTdrugsforMSbytheratesofcoveragediscontinuitiestoestimatethenumberofmembersaffectedbythemandateineachgroup.
EstimatetheannualmedicalexpenseofcontinuedDMTcoverage
• UsingtheMA-APCD,calculatetheaveragepaidcostperuserpermonthforallDMTdrugs.
• EstimatetheaveragecostperuserperyearformemberswithmisseddosesastheaveragecostpermonthofDMTdrugsmultipliedbytheaveragenumberofdosesskippedandthenbytheestimatednumberofaffectedfully-insuredindividuals.
• EstimatetheaveragecostperuserperyearformembersdroppingDMTutilizationwhenswitchingcarriersastheaveragecostpermonthofDMTdrugsmultipliedbytwelveandthenbytheestimatednumberofaffectedfully-insuredindividuals.
• Sumthecostestimatesforthetwotypesofaffectedindividuals.
CalculateinsurancepremiumimpactofcontinuedDMTcoverageoverthenextfiveyears
• Dividetheannualincrementalcostbythecorrespondingmembershiptocalculateabaselineper-memberper-month(PMPM)cost.
• Estimatetheimpactofcarrierretention(administrativecostsandprofit)onpremiums.
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• CalculatetheannualizedrateofpriceinflationofDMTdrugsforMSforcommercialfully-insuredusersintheMA-APCDovertheperiod2011to2014.
• ProjectthePMPMcostforwardoverthefive-yearanalysisperiodusingannualizedratesofpharmaceuticalpriceinflationfrompublishedstudies.
• Estimatethefully-insuredMassachusettspopulationunderage65,projectedforthenextfiveyears(2017to2021).
• MultiplythePMPMcostsbythecorrespondingmembershiptocalculateannualincrementalcost.
Section4describesthesestepsinmoredetail.
3.4.LimitationsChallengesandlimitationsinestimatingthecostofthismandateinclude:
• Datalimitations:CompassreviewedMA-APCDclaimrecordsforDMTdrugsformemberswhoswitchedcarriersduringtheperiodNovember15,2013toNovember14,2014toidentifymemberspossiblyaffectedbythemandate.Thesegapsmayhaveindicatedabreakintreatmentwhileseekinganexceptionforcoveragewiththenewcarrier,failuretoobtaincoverageunderanewcarrier,oravoluntarybreakinadherence.Itisimpossibletodiscernfromclaimdataifamemberdiscontinuedadrugforcoveragereasonsorbecausethemembervoluntarilydiscontinuedthedrugcoincidentallywithacoveragechange.
• Lackofinformationoncarrierpharmacyrebates:Manycarriersreceiverebatesfromthemakersofcertainpharmaceuticalproducts,likelyincludingsomeDMTdrugsforMS.Theserebatescanmateriallychangethecarriers’costsfortherebatedproducts.However,rebatedataareproprietarytothecarriersandarenotsubmittedtotheMA-APCD,norarethereanysecondarypublicsourcesavailableforthisinformation.
Theseuncertaintiesareaddressedbymodelingarangeofassumptionswithinreasonablejudgment-basedlimits,andproducingarangeofestimatesofincrementalcostbyvaryingthemodeledparameters.Themoredetailedstep-by-stepdescriptionoftheestimationprocessoutlinedinthenextsectionsaddressestheseuncertaintiesfurther.
4.AnalysisThissectiondescribesthecalculationsoutlinedintheprevioussectioninmoredetail.Theanalysisincludesdevelopmentofa“middle-cost”scenario,aswellasalow-costscenariousingassumptionsthatproducedalowerestimate,andahigh-costscenariousingmoreconservativeassumptionsthatproducedahigherestimatedimpact.
Sections4.1and4.2belowdescribethestepsusedtocalculatethenumberoffully-insuredcommercialmembersaffectedbythemandateandtheassociatedcostperuserperyear.Sections
compass Health Analytics 7 October 2016
4.3to4.8discusstheincrementalcostcalculationandtheprojectionoverthe2017to2021reportingperiod.
4.1.EstimatemembersaffectedbythemandateEstimatingthecostofthemandaterequiresfirstestimatingthenumberofcommercialfully-insuredMassachusettsresidentsaffectedbythemandateinoneyear.
ContinuoususeofDMTforMSisextremelyimportanttothetreatment’sefficacy;evenshortlapsesinadherencecanallowrelapsesresultinginpermanentneurologicalconsequencestothepatient.However,studiesofDMTdrugadherenceinMSpatientshavefoundadherenceratesrangingfrom61to87percent.14Compass’sreviewofMA-APCDclaimdataandanecdotalevidencefromaneurologistspecializinginMSinterviewedbyCompassstaffareconsistentwiththeseresults.
CompassreviewedallMA-APCDclaimrecordsformemberswithconsistentDMTdrugutilizationwhoswitchedcarriersduringtheperiodNovember15,2013toNovember14,2014toidentifymembersexperiencingcoveragediscontinuities.Thesemisseddosesmayhaveindicatedabreakintreatmentwhileseekinganexceptionforcoveragewiththenewcarrier,failuretoobtaincoverageunderanewcarrier,oravoluntarybreakinadherence.Itisimpossibletodiscernfromclaimdataifamemberdiscontinuedadrugforcoveragereasonsorbecausethemembervoluntarilydiscontinuedthedrugcoincidentallywithacoveragechange.Toaccountforthisuncertainty,Compassestimatedarangeofestimatesofincrementalcostfortheproposedmandateinthefollowingsteps.
Estimatethenumberofcommercialfully-insuredMassachusettsresidentstakingDMTforMS
TheGreaterNewEnglandChapteroftheNationalMSSocietystatesthat“morethan12,000”MassachusettsresidentshaveMS.15Approximately85percentofpeoplewithMShavearelapsingformofthedisease,forwhomtheliteraturesupportsinitiatingDMTassoonaspossiblefollowingdiagnosis,16,17withtreatmenttocontinueindefinitelyunlesscontraindicated.18Approximately15percentofindividualswithMShavePrimaryProgressiveMS(PPMS),forwhichtherearenoFDA-approvedtreatments.19AssumingtotalMSincidenceof12,000inthepopulation,Compassestimatedapproximately3,000fully-insuredcommercialmembersusingDMTdrugsforMSresidedintheCommonwealthin2014,usingthefollowingcalculationandroundingtheresulttothenearesthundred:
12,000 MassachusettsresidentswithMSX 85.0% MSpatientswitharelapsingformofMSX 84.9% ProportionofMassachusettsresidentsaged0-6420X 34.2% Massachusettsresidentswithfullyinsuredcommercialinsurance21
2,963 Commercialfully-insuredMassachusettsresidentsusingDMTin2014
compass Health Analytics 8 October 2016
CalculateanestimateofDMTdrugusersmissingdosesduetocoveragegaps
BetweenNovember15,2013andNovember15,2014,viiapproximately1.7percentofcommercialfully-insuredDMTdrugusersthatshowedconsistentmonthlyprescriptionfillsforMSreportedintheMA-APCDshowedagapofatleastonemonthinDMTdrugclaimsafterswitchingcarriers.Applyingthisratetotheestimated3,000fully-insuredcommercialMassachusettsresidentsusingDMTdrugsforMSyieldsanestimateof51affectedusers:
3,000 Massachusetts-residentFIusersofDMTDrugsforMSX 1.7% ofFIMA-APCDDMTuserswithgapsincoverage
51 FIMassachusettsresidentspotentiallyaffectedbythemandateTheaveragegapincoverage(basedonprescriptionfilldatesorservicedates)wasapproximately6.5weeks(1.52months).Assumingthatmembersswitchingcarrierswouldcontinuetoexperienceshortadministrativedelaysinobtainingcoverageinthepresenceoftheproposedmandate(timewouldstillberequiredfordocumentationoftheongoingprescriptiontobeprovidedtothenewcarrier,andfortheauthorizationtobeprocessedinordertobegincoverage),Compassassumedahalf-monthcoveragegapwouldremainundertheproposedmandateduetoadministrativedelays,yieldingareductioninaveragelengthofcoveragegapsperuserofapproximatelyonemonth(1.52monthsless0.5months)tocalculatetheincrementalcosttocarriersofH.B.800,resultinginanestimated52incrementalmonthsofcoverageforthesemembers:
51 Massachusetts-residentFIuserswithgapsincoverageX 1.02 Averageincrementalincreaseincoverage(inmonths)
52 IncrementalmonthsofcoverageunderH.B.800
CalculateanestimateofDMTdrugusersdiscontinuinguse
BetweenNovember15,2013andNovember15,2014,approximately0.4percentofcommercialfully-insuredDMTdrugusersreportedintheMA-APCDdiscontinueduseoftheirDMTdrugafterswitchingcarriers.Applyingthisdiscontinuationratetotheestimated3,000fully-insuredcommercialMassachusettsresidentsusingDMTdrugsforMSyieldsanupperboundestimateofelevenaffectedusers:
3,000 Massachusetts-residentFIusersofDMTDrugsforMSX 0.4% ofMA-APCDDMTusersdiscontinuingatthetimeofcarrierswitch
12 Incrementalusers
4.2.MonthlycostperuserofcontinuedDMTdrugtreatmentforMSCompasscalculatedanupperboundaverageannualcostperuserofcontinuedDMTforMSof$68,000,representinga$5,667costpermonth.Thismonthlyamountisthe2014weightedaveragecommercialcarrierpaidcostperuserpermonthbeforerebatesforDMTdrugsforMS.
viiThistimespanwaschoseninordertoobserveJanuary1stcoveragechanges.
compass Health Analytics 9 October 2016
4.3.AnnualincrementalmedicalexpenseofcontinuedDMTdrugsforMSCompasscalculatedthehigh-costscenarioincrementalcostfortheadditionalmonthsofcoverageformemberswithmisseddosesbymultiplyingtheestimated52monthsofadditionalcoverageby$5,667.
Thehigh-costscenarioincrementalcostfortheelevenuserswhodiscontinueduseuponswitchingcarrierswascalculatedbymultiplyingtheelevenincrementalusersby$68,000,theaveragemonthlydrugcostmultipliedbytwelve.Thisestimatereflectstwoconservativeassumptions:(i)thataffectedmembersarediscontinuinguseofDMTdrugsforMSduetoachangeincarriersatthebeginningoftheyearwithnoadministrativegapincoverageand(ii)thataffectedmemberswouldhave100percenttreatmentadherencethroughouttheyearinthepresenceoftheproposedmandate.
Bothhigh-costscenarioestimatesreflecttheconservativeassumptionthatallobserveddiscontinuitiesinDMTdrugclaimsweretheresultofcarriercoverageissues,notmedicaldecisionsorvoluntarygapsinadherence.
Usingassumptionsmoreconservativethancanbedirectlysupportedbydatareflectstheuncertaintyintroducedbythelackofcarrierpharmaceuticalrebatedata.Theresultingupperboundcostestimate,althoughlargerthanobservableevidencesupports,reflectsthefactthatcarriersmayexperiencecostsinthepresenceoftheproposedmandate(duetolostrebates)thatarenotmeasurablewithinthescopeofthisstudy.
Themid-levelcostscenarioisassumedtobehalfofthehighscenariocost(e.g.aslightlylongeradministrativegapandanaveragemid-yearcarrierchange).Intheabsenceofevidenceonwhichtobasethelow-costcostscenario,thelow-levelcostisassumedtobehalfofthemid-levelcost.Table1displaystheseresults.
Table1:Estimated2014AnnualMarginalCostofContinuousCoverageofDMTDrugsforMS
IncrementalCostofMissedDoses
IncrementalCostofDiscontinuingUsers
TotalIncrementalCostofH.B.800
LowScenario $74,000 $204,000 $278,000MidScenario $147,000 $408,000 $555,000HighScenario $295,000 $816,000 $1,111,000
H.B.800maybeinterpretedtorequireeachcarriertocoverallDMTdrugsforMSonthesamecost-sharingtermsasthelowest-tierDMTdrugforMSonitsformulary.Thisinterpretation,whilenotusedinthiscostanalysis,wouldlikelyhaveaminimalincrementalimpactontheestimatedcostofthemandategiventhelownumberofclaimsimpacted.viii
viiiWhilethisamountisnotmaterialfromthecarrierormarket-wideperspective,suchaco-paydifferentialmaybeamaterialbenefittotheindividualmembers,especiallyconsideringMSpatientsoftentakemultipleexpensivedrugstomanagesymptomsinadditiontoDMT.
compass Health Analytics 10 October 2016
4.4.IncrementalPMPMmedicalexpenseTheannualcostisthendividedbyestimatedcommercialfully-insured2014membermonthsforMassachusettsresidentstoderivetheestimatedbaselinePMPMincrementalmedicalexpenseattributabletotheproposedmandate.Table2showstheseresults.
Table2:EstimateofIncreaseinCarrier2014ClaimCost
TotalIncrementalCostofH.B.800
LowScenario $0.01MidScenario $0.02HighScenario $0.05
4.5.CarrierretentionandincreaseinpremiumAssuminganaverageannualretentionrateof11.0percentbasedonCHIA’sanalysisofhealthinsurancecarrieradministrativecostsandprofitinMassachusetts,22theincreaseinmedicalexpensewasadjustedupwardtoapproximatethetotalimpactonpremiums.Table3showstheresult.
Table3:EstimateofIncreaseinCarrier2014PremiumExpense
LowScenario $0.01MidScenario $0.03HighScenario $0.05
4.6.Projectedfully-insuredpopulationinMassachusettsTable4showsthefully-insuredpopulationinMassachusettsage0to64projectedforthenextfiveyears.AppendixBdescribesthesourcesofthesevalues.
Table4:ProjectedFully-InsuredPopulationinMassachusetts,Age0-64
Year Total(0-64)2017 2,019,6902018 2,017,5262019 2,014,9192020 2,011,1092021 2,007,384
compass Health Analytics 11 October 2016
4.7.ProjectionoftotalmarginalmedicalexpenseThelowandmiddlescenarioincrementalmedicalexpensescalculatedinsection4.4wereprojectedfortheperiodJanuary1,2017toDecember31,2021usinga6.3percentperyearestimateofinflationforallprescriptiondrugsfortheperiod2014to2024.23Thehighscenarioincrementalmedicalexpensewasprojectedforwardusinga13.7percentperyearestimateofinflationforMSdrugsfortheperiod2010to2014.24ThetrendedincrementalPMPMmedicalexpensesweremultipliedbythemembermonthsdisplayedinTable4androundedtothenearestthousanddollarstocalculatethetotalprojectedincrementalmedicalexpensesshowninTable5.
Thisanalysisassumesthebill,ifenacted,wouldbeeffectiveJanuary1,2017.25
Table5:ProjectedMarginalMedicalExpense
ofContinuousCoverageofDMTDrugstotreatMS,2017to2021
2017 2018 2019 2020 2021LowScenario $245,000 $365,000 $387,000 $411,000 $436,000MidScenario $490,000 $729,000 $774,000 $821,000 $871,000HighScenario $1,198,000 $1,909,000 $2,167,000 $2,460,000 $2,791,000
4.8.CarrierretentionandincreaseinpremiumAdjustingtheprojectedincrementalmedicalexpenseshowninTable5byan11percentretentionfactor26androundingtothenearestthousanddollarsresultsintheestimatedincrementalincreaseinpremiumsrelatedtoH.B.800asshowninTable6.
Table6:ProjectedIncreaseinPremium
ofContinuousCoverageofDMTDrugstotreatMS,2017to2021
2017 2018 2019 2020 2021LowScenario $275,000 $410,000 $435,000 $461,000 $489,000MidScenario $550,000 $819,000 $870,000 $923,000 $979,000HighScenario $1,346,000 $2,144,000 $2,435,000 $2,763,000 $3,136,000
5.ResultsTheestimatedimpactoftheproposedmandateonmedicalexpenseandpremiumsappearsbelow.Theanalysisincludesdevelopmentofa“mid-level”scenario,aswellasalow-levelscenariousingassumptionsthatproducedalowerestimate,andahigh-levelscenariousingmoreconservativeassumptionsthatproducedahigherestimatedimpact.
Theimpactonpremiumsisbasedprimarilyonestimatesofthenumberofcommercialfully-insuredMassachusettsresidentsusingDMTdrugsforMSwhomaybeaffectedbythebill,andtheaverageannualcostperaffecteduserofcontinuouscoverageforDMTdrugsforMS.
compass Health Analytics 12 October 2016
Startingin2020,thefederalAffordableCareActwillimposeanexcisetax,commonlyknownasthe“CadillacTax”,onexpendituresonhealthinsurancepremiumsandotherrelevantitems(healthsavingsaccountcontributions,etc.)thatexceedspecifiedthresholds.Totheextentrelevantexpendituresexceedthosethresholds(in2020),H.B.800,byincreasingpremiums,hasthepotentialofcreatingliabilityforadditionalamountsunderthetax.Estimatingtheamountofpotentialtaxliabilityrequiresinformationontheextenttowhichpremiums,notwithstandingtheeffectofH.B.800,willexceedorapproachthethresholdsandisbeyondthescopeofthisanalysis.
5.1.Five-yearestimatedimpactForeachyearinthefive-yearanalysisperiod,Table7displaystheprojectednetimpactofthemandateonmedicalexpenseandpremiumsusingaprojectionofMassachusetts-residentfully-insuredmembership.NotethattherelevantprovisionsofH.B.800areassumedeffectiveJanuary1,2017.27
Thehighscenarioassumesplanscoveredbythemandatewillcover196additionalmonthlysuppliesofDMTdrugsforMSatanaveragepriceof$5,666.67inthebaseyearandthatMSdrugswillexperienceannualinflationmorethantwiceashighasthatofprescriptiondrugsoverallthroughouttheprojectionperiod.Theseassumptionsresultinanaveragecostof$2.5millionperyear.Themiddlescenariohalvesthebase-yearupperboundestimateandassumesMSdruginflationwillbethesameasthatofprescriptiondrugsoverall,resultinginanaverageannualcostof$879thousand,oranaverageof0.008percentofpremium.
Finally,theimpactoftheproposedlawonanyoneindividual,employer-group,orcarriermayvaryfromtheoverallresultsdependingonthecurrentlevelofbenefitseachreceivesorprovides,andonhowthebenefitswillchangeunderthemandate.
Table7:SummaryResults
2017 2018 2019 2020 2021WeightedAverage 5YrTotal
Members(000s) 2,020 2,018 2,015 2,011 2,007 MedicalExpenseLow($000s)
$245 $365 $387 $411 $436 $391 $1,843MedicalExpenseMid($000s)
$490 $729 $774 $821 $871 $782 $3,685MedicalExpenseHigh($000s)
$1,198 $1,909 $2,167 $2,460 $2,791 $2,234 $10,525PremiumLow($000s)
$275 $410 $435 $461 $489 $439 $2,070PremiumMid($000s)
$550 $819 $870 $923 $979 $879 $4,140PremiumHigh($000s)
$1,346 $2,144 $2,435 $2,763 $3,136 $2,509 $11,824PMPMLow $0.02 $0.02 $0.02 $0.02 $0.02 $0.02 $0.02PMPMMid $0.03 $0.03 $0.04 $0.04 $0.04 $0.04 $0.04PMPMHigh $0.08 $0.09 $0.10 $0.11 $0.13 $0.10 $0.10EstimatedMonthlyPremium
$463 $473 $483 $493 $503 $483 $483Premium%RiseLow
0.003% 0.004% 0.004% 0.004% 0.004% 0.004% 0.004%Premium%RiseMid
0.007% 0.007% 0.007% 0.008% 0.008% 0.008% 0.008%Premium%RiseHigh
0.017% 0.019% 0.021% 0.023% 0.026% 0.021% 0.021%
compass Health Analytics 13 October 2016
5.2.ImpactontheGICTheproposedmandateisassumedtoapplytobothfully-insuredandself-insuredplansoperatedforstateandlocalemployeesbytheGIC,withaneffectivedateforallGICpoliciesonJuly1,2017.
BecausethebenefitofferingsofGICplansaresimilartothoseofmostothercommercialplansinMassachusetts,theestimatedPMPMeffectoftheproposedmandateonGICmedicalexpenseisnotexpectedtodifferfromthatcalculatedfortheotherfully-insuredplansinMassachusetts.Thisisconsistentwithcarriersurveyresponseswhich,ingeneral,didnotindicatedifferencesincoveragefortheGIC.
ToestimatethemedicalexpenseseparatelyfortheGIC,thePMPMmedicalexpenseforthegeneralfully-insuredpopulationwasappliedtotheGICmembershipstartinginJulyof2017.
Table8breaksouttheGIC-onlyfully-insuredmembershipandtheGICself-insuredmembership,andthecorrespondingincrementalmedicalexpenseandpremium.Notethatthetotalmedicalexpenseandpremiumvaluesforthegeneralfully-insuredmembershipdisplayedinTable7alsoincludetheGICfully-insuredmembership.Finally,theproposedmandateisassumedtorequiretheGICtoimplementtheprovisionsonJuly1,2017;therefore,theresultsin2017areapproximatelyone-halfofanannualvalue.
Table8:GICSummaryResults
2017 2018 2019 2020 2021WeightedAverage 5YrTotal
GICFully-Insured Members(000s) 54 54 54 54 54 MedicalExpenseLow($000s) $5 $10 $10 $11 $12 $11 $47MedicalExpenseMid($000s) $9 $19 $21 $22 $23 $21 $95MedicalExpenseHigh($000s) $22 $51 $58 $66 $75 $60 $272PremiumExpenseLow($000s) $5 $11 $12 $12 $13 $12 $53PremiumExpenseMid($000s) $10 $22 $23 $25 $26 $24 $106PremiumExpenseHigh($000s) $25 $57 $65 $74 $84 $68 $305GICSelf-Insured Members(000s) 270 270 269 268 268 MedicalExpenseLow($000s) $23 $49 $52 $55 $58 $53 $236MedicalExpenseMid($000s) $46 $97 $103 $110 $116 $105 $472MedicalExpenseHigh($000s) $112 $255 $289 $328 $372 $302 $1,357
compass Health Analytics 14 October 2016
AppendixA:Disease-ModifyingTherapyDrugsforMultipleSclerosis28,29,30
DMTDrug Treatment
Clinicalefficacyinplacebo-controlled
PhaseIIItrials MostCommonSideEffects OtherSafetyIssues
CurrentCoverageperSurvey
AlemtuzumabLemtrada® 12mg/d
intravenouslyforfivedaysfollowedby12mg/dintravenouslyforthreedaysoneyearafterthefirstcourse
49%-55%reductionofARRovertwoyearscomparedtosubcutaneousinterferonbeta1a42%reductionofprogressionofdisabilityattwoyearscomparedtosubcutaneousinterferonbeta1a
Rash,headache,fever,nasalcongestion,nausea,urinarytractinfection,fatigue,insomnia,upperrespiratorytractinfection,herpesviralinfections,hives,itching,thyroidglanddisorders,fungalinfection,paininjoints,extremitiesandback,diarrhea,vomiting,flushing.Infusionreactions(includingnausea,hives,itching,insomnia,chills,flushing,fatigue,shortnessofbreath,changesinthesenseoftaste,indigestion,dizziness,pain)alsocommonwhilethemedicationisbeingadministeredandfor24hoursafterinfusion.
Infusionassociatedreactions;cytokinereleasesyndrome;lymphopenia;infections;autoimmunethyroiditis;thrombocytopenicpurpura;glomerulonephritis
ApprovedbytheFDAfortreatmentofrelapsingMSinNovember2014.
DimethylFumarateTecfidera® 240mgorallytwicea
day44%-53%reductionofARRovertwoyears38%reductionofprogressionofdisabilityattwoyears
Flushing(sensationofheatoritchingandablushontheskin),gastrointestinalissues(nausea,diarrhea,abdominalpain).
Lymphopenia;progressivemultifocalleukoencephalopathy
Coveredbyallrespondingcarriers;Tier2formost,Tier3forothers.
FingolimodGilenya® 0.5mgorallyevery
day48%-54%reductionofARRovertwoyears30%reductionofprogressionofdisabilityattwoyears
Headache,flu,diarrhea,backpain,liverenzymeelevations,sinusitis,abdominalpain,paininextremitiesandcough.
Bradyarrhythmiasafterfirstdose;lymphopenia;viralinfections(VZV);macularedema;hepatotoxicity;hypertension
Coveredbyallrespondingcarriers,abouthalfTier2andhalfTier3.
compass Health Analytics 15 October 2016
DMTDrug Treatment
Clinicalefficacyinplacebo-controlled
PhaseIIItrials MostCommonSideEffects OtherSafetyIssues
CurrentCoverageperSurvey
GlatirameracetateCopaxone20® 20mgsubcutaneously
everyday29%reductionofARRovertwoyears(RRMS)45%riskreductionofconversiontoCDMSatthreeyears(CIS)Nostatisticallysignificanteffectondisabilityprogression
Injectionsitereactions(redness,pain,swelling),flushing,shortnessofbreath,rash,chestpain.
Cutaneousnecrosis;anaphylaxis(rare)
Coveredbyallrespondingcarriers,generallyonTier2.
Copaxone40® 40mgsubcutaneouslythreetimesaweek
33%reductioninARRover12months(RRMS),significantreductionincumulativenumberofgadolinium-enhancingT1(44.8)andnewornewlyenlargingT2lesions(34.7%)atmonths6and12.31
Injectionsitereactions(redness,pain,swelling),flushing,shortnessofbreath,rash,chestpain.
Cutaneousnecrosis;anaphylaxis(rare)
Coveredbyallrespondingcarriers,generallyonTier2.
Glatopa® 20mgsubcutaneouslyeveryday
29%reductionofARRovertwoyears(RRMS)45%riskreductionofconversiontoCDMSatthreeyears(CIS)Nostatisticallysignificanteffectondisabilityprogression
Injectionsitereactions(redness,pain,swelling).
Cutaneousnecrosis;anaphylaxis(rare)
Generic;didnotlaunchuntil2015.
Interferonbeta1aAvonex® 30mcg
Intramuscularly(intoalargemuscle)onceaweekintramuscularly
18%reductionofARRovertwoyears(RRMS)44%riskreductionofconversiontoCDMSattwoyears(CIS)Nostatisticallysignificanteffectondisabilityprogression
Headache,flu-likesymptoms(chills,fever,musclepain,fatigue,weakness),injectionsitepainandinflammation.
Hepatotoxicity;myelotoxicity;autoimmunethyroiditis;microangiopathy;epilepticseizures(rare)
Coveredbyallrespondingcarriers,usuallyonTier2.
compass Health Analytics 16 October 2016
DMTDrug Treatment
Clinicalefficacyinplacebo-controlled
PhaseIIItrials MostCommonSideEffects OtherSafetyIssues
CurrentCoverageperSurvey
Rebif® 44mcgsubcutaneouslythreetimesaweek
32%reductionofARRovertwoyears(RRMS)45%riskreductionofconversiontoCDMSattwoyears(CIS)30%reductionofprogressionofdisabilityattwoyears(RRMS)
Flu-likesymptoms(chills,fever,musclepain,fatigue,weakness,headache),injectionsitereactions(redness,pain,swelling).
Hepatotoxicity;myelotoxicity;autoimmunethyroiditis;microangiopathy;epilepticseizures(rare)
Coveredbyallrespondingcarriers,usuallyonTier2.
Interferonbeta1bBetaseron® 250mcg
subcutaneouslyeveryotherday
34%reductionofannualizedrelapserate(ARR)overtwoyears(RRMS)50%riskreductionofconversiontoCDMSattwoyears(CIS)Nostatisticallysignificanteffectondisabilityprogression
Flu-likesymptoms(chills,fever,musclepain,fatigue,weakness)followinginjection,headache,injectionsitereactions(swelling,redness,pain),injectionsiteskinbreakdown,lowwhitebloodcount.
Hepatotoxicity;myelotoxicity;autoimmunethyroiditis;microangiopathy;epilepticseizures(rare)
Coveredbyallrespondingcarriers,generallyonTier3.
Extavia® 250mcgsubcutaneouslyeveryotherday
34%reductionofannualizedrelapserate(ARR)overtwoyears(RRMS)50%riskreductionofconversiontoCDMSattwoyears(CIS)Nostatisticallysignificanteffectondisabilityprogression
Flu-likesymptoms(chills,fever,musclepain,fatigue,weakness)followinginjection,headache.
Hepatotoxicity;myelotoxicity;autoimmunethyroiditis;microangiopathy;epilepticseizures(rare)
Notcoveredbyseveralcarriers,allofwhomcoverBetaseron®.Ifcovered,coveredonTier3.
MitoxantroneNovantrone® 12mg/m2
intravenouslyeverythreemonthsor8mg/m2intravenouslyeverymonth
65%reductionofrelapseriskovertwoyears(mostlyinRRMS)66%reductionofriskofdisabilityprogressionattwoyears(mostlyinRRMS)
Nausea,hairloss,menstrualchange,upperrespiratoryinfection,urinarytractinfection,mouthsours,irregularheartbeat,diarrhea,constipation,backpain,sinusitis,headache,blue-greenurine.
Infusionsitetissuenecrosis;myelotoxicity;infections;cardiotoxicity;acuteleukemia
Coveredasamedicalbenefit.
compass Health Analytics 17 October 2016
DMTDrug Treatment
Clinicalefficacyinplacebo-controlled
PhaseIIItrials MostCommonSideEffects OtherSafetyIssues
CurrentCoverageperSurvey
NatalizumabTysabri® 300mgintravenously
everyfourweeks68%reductionofARRovertwoyears42%reductionofprogressionofdisabilityattwoyears
Headache,fatigue,jointpain,chestdiscomfort,urinarytractinfection,lowerrespiratorytractinfection,gastroenteritis,vaginitis,depression,paininextremity,abdominaldiscomfort,diarrhea,rash.
Infusionassociatedreactions;anaphylaxis;infections;hepatotoxicity;progressivemultifocalleukoencephalopathy
Coveredasamedicalbenefit.
Peginterferonbeta1aPlegridy® 125mcg
subcutaneouslyeverytwoweeks
36%reductionofARRoveroneyear
Flu-likesymptoms(chills,fever,musclepain,fatigue,weakness,headache,itching).Injectionsitereactions(swelling,redness,pain).
Hepatotoxicity;myelotoxicity;autoimmunethyroiditis;microangiopathy;epilepticseizures(rare)
LaunchedinAugust2014.
TeriflunomideAubagio® 14mgorallyeveryday 31%-36%reductionofARR
overoneyearormore26%-32%reductionofprogressionofdisabilityatoneyearormore
Headache,hairthinning,diarrhea,nausea,abnormallivertests.
Myelotoxicity;hepatotoxicity;infections;peripheralneuropathy;pancreaticfibrosis;teratogenicity(requiresacceleratedeliminationprocedure)
Coveredbyallrespondingcarriers,abouthalfTier2andhalfTier3.
compass Health Analytics 18 October 2016
AppendixB:MembershipAffectedbytheProposedMandateThisappendixdescribesthecalculationsusedtoestimatethenumberofmemberswhosecoverageispotentiallyaffectedbyaproposedmandate.Itaddressesseveraldifferentaggregationsofmembersandanalysisoftheimpactofagivenproposedmandatemaydrawonsomeoralloftheseaggregations.Sourcesusedtodevelopthesepopulationestimatesandprojectionsareprovidedbelow.
MembershippotentiallyaffectedbyaproposedmandatemayincludeMassachusettsresidentswithfully-insuredemployer-sponsoredhealthinsuranceissuedbyaMassachusetts-licensedcompany(includingthroughtheGIC),non-residentswithfully-insuredemployer-sponsoredinsuranceissuedinMassachusetts,Massachusettsresidentswithindividual(direct)healthinsurancecoverage,and,insomecases,livescoveredbyGICself-insuredcoverage.Membershipprojectionsfor2017to2021arederivedfromthefollowingsources.
TotalMassachusettspopulationestimatesfor2013,2014,and2015fromU.S.CensusBureaudata32formthebasefortheprojections.Distributionsbygenderandage,alsofromtheCensusBureau,33wereappliedtothesetotals.Projectedgrowthratesforeachgender/agecategorywereestimatedfromCensusBureaupopulationprojectionsto2030.34TheresultinggrowthrateswerethenappliedtothebaseamountstoprojectthetotalMassachusettspopulationfor2017to2021.
ThenumberofMassachusettsresidentswithemployer-sponsoredorindividual(direct)healthinsurancecoveragewasestimatedusingCensusBureaudataonhealthinsurancecoveragestatusandtypeofcoverage35appliedtothepopulationprojections.
ToestimatethenumberofMassachusettsresidentswithfully-insuredemployer-sponsoredcoverage,projectedestimatesofthepercentageofemployer-basedcoveragethatisfully-insuredweredevelopedusinghistoricaldatafromtheMedicalExpenditurePanelSurveyInsuranceComponentTables.36
Toestimatethenumberofnon-residentscoveredbyaMassachusettspolicy–typicallycasesinwhichanon-residentworksforaMassachusettsemployerofferingemployer-sponsoredcoverage–thenumberofliveswithfully-insuredemployer-sponsoredcoveragewasincreasedbytheratioofthetotalnumberofindividualtaxreturnsfiledinMassachusettsbyresidents37andnon-residents38tothetotalnumberofindividualtaxreturnsfiledinMassachusettsbyresidents.
ProjectionsfortheGICself-insuredlivesweredevelopedusingGICbasedatafor2013,392014,40and2015,41andthesameprojectedgrowthratesfromtheCensusBureauthatwereusedfortheMassachusettspopulation.BreakdownsoftheGICself-insuredlivesbygenderandagewerebasedontheCensusBureaudistributions.
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Endnotes 1The189thGeneralCourtoftheCommonwealthofMassachusetts,HouseBill,“AnActpromotingcontinuityofcareformultiplesclerosistreatment.”Accessed24May2016:https://malegislature.gov/Bills/189/House/H800.2ThisanalysistreatsCopaxone®20mgandCopaxone®40mgasdistinctdrugs.3GajofattoA,BenedettiM.Treatmentstrategiesformultiplesclerosis:Whentostart,whentochange,whentostop?WorldJClinCases.2015Jul16;3(7):545–555.Accessed25May2016:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4517331/.4MarcusJ,WaubantE.UpdatesonClinicallyIsolatedSyndromeandDiagnosticCriteriaforMultipleSclerosis.Neurohospitalist.2013Apr;3(2):65–80.Accessed26May2016:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3726117/.5NoyesK,Weinstock-GuttmanB.Impactofdiagnosisandearlytreatmentonthecourseofmultiplesclerosis.AmJManagCare.2013Nov;19(17Suppl):s321-31.Accessed22June2016:https://www.ncbi.nlm.nih.gov/pubmed/24494633.6Op.cit.GajofattoA,BenedettiM,Treatmentstrategiesformultiplesclerosis:Whentostart,whentochange,whentostop?7The189thGeneralCourtoftheCommonwealthofMassachusetts,HouseBill,“AnActpromotingcontinuityofcareformultiplesclerosistreatment.”Accessed24May2016:https://malegislature.gov/Bills/189/House/H800.8Op.cit.MarcusJ,WaubantE,UpdatesonClinicallyIsolatedSyndromeandDiagnosticCriteriaforMultipleSclerosis.9Op.cit.NoyesK,Weinstock-GuttmanB,Impactofdiagnosisandearlytreatmentonthecourseofmultiplesclerosis.10Op.cit.GajofattoA,BenedettiM,Treatmentstrategiesformultiplesclerosis:Whentostart,whentochange,whentostop?11Op.cit.GajofattoA,BenedettiM,Treatmentstrategiesformultiplesclerosis:Whentostart,whentochange,whentostop?12The189thGeneralCourtoftheCommonwealthofMassachusetts,HouseBill,“AnActpromotingcontinuityofcareformultiplesclerosistreatment.”Accessed24May2016:https://malegislature.gov/Bills/189/House/H800.13Op.cit.The189thGeneralCourtoftheCommonwealthofMassachusetts,HouseBill,“AnActpromotingcontinuityofcareformultiplesclerosistreatment.”14RemingtonG,RodriguezY,LoganD,et.al.FacilitatingMedicationAdherenceinPatientswithMultipleSclerosis.InternationalJournalofMSCare.2013Spring;15(1):36–45.Accessed20June2016:http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3883032/.15Dickson,Michelle.TestimonysubmittedonOctober20th,2015totheJointCommitteeonFinancialServicesinsupportofHB800AnActpromotingcontinuityofcareformultiplesclerosistreatment.20October2015.16Op.cit.NoyesK,Weinstock-GuttmanB,Impactofdiagnosisandearlytreatmentonthecourseofmultiplesclerosis.17Op.cit.MarcusJ,WaubantE,UpdatesonClinicallyIsolatedSyndromeandDiagnosticCriteriaforMultipleSclerosis.18Op.cit.GajofattoA,BenedettiM.Treatmentstrategiesformultiplesclerosis:Whentostart,whentochange,whentostop?19NationalMultipleSclerosisSociety.PrimaryProgressiveMultipleSclerosis(PPMS).Accessed8June2016:http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Primary-progressive-MS.20U.S.CensusBureau.PEPSYASEX-Geography-Massachusetts:AnnualEstimatesoftheResidentPopulationbySingleYearofAgeandSexfortheUnitedStates,States,andPuertoRicoCommonwealth:April1,2010toJuly1,
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2014Accessed28April2016:http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=bkmk.21U.S.CensusBureau.HealthInsuranceCoverageintheUnitedStates:2014.Report.Accessed8June2016:http://www.census.gov/hhes/www/hlthins/hlthins.html.hi05_acs.xls.22Op.cit.U.S.CensusBureau,HealthInsuranceCoverageintheUnitedStates:2014.23CentersforMedicareandMedicaidServices(CMS),OfficeoftheActuary.NationalHealthExpenditureData,NHEProjections2014-2024-ForecastSummary.Accessed8June2016:https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/NationalHealthAccountsProjected.html.24Optum.MultipleSclerosisCostDrivers.PostedSeptember9th,2014.Accessed11June2016:https://www.optum.com/resources/library/ms-spending-cost-drivers.html.25TheanalysisassumesthemandatewouldbeeffectiveforpoliciesissuedandrenewedonorafterJanuary1,2017.Theimpactofthemandateoncostin2017wasestimatedat71.3percentoftheannualcost,usinganassumedrenewaldistributionbymonth,bymarketsegment,andbytheMassachusettsmarketsegmentcomposition.26MassachusettsCenterforHealthInformationandAnalysis.PerformanceoftheMassachusettsHealthCareSystem,AnnualReportSeptember2015.Accessed19January2016:http://www.chiamass.gov/assets/2015-annual-report/2015-Annual-Report.pdf.27TheanalysisassumesthemandatewouldbeeffectiveforpoliciesissuedandrenewedonorafterJanuary1,2017.Theimpactofthemandateoncostin2017wasestimatedat71.3percentoftheannualcost,usinganassumedrenewaldistributionbymonth,bymarketsegment,andbytheMassachusettsmarketsegmentcomposition.28NationalMultipleSclerosisSociety.Medications.Accessed27May2016:http://www.nationalmssociety.org/Treating-MS/Medications.29NationalMultipleSclerosisSociety.Disease-ModifyingTherapiesforMS.UpdatedFebruary2016.Accessed27May2016:http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Brochures/Brochure-The-MS-Disease-Modifying-Medications.pdf.30AdaptedfromOp.cit.GajofattoA,BenedettiM,Treatmentstrategiesformultiplesclerosis:Whentostart,whentochange,whentostop?31KhanO,RieckmannP,BoykoA,et.al.Threetimesweeklyglatirameracetateinrelapsing-remittingmultiplesclerosis.AnnNeurol.2013June;73(6):705-13.Accessed8June2016:http://www.ncbi.nlm.nih.gov/pubmed/23686821.32U.S.CensusBureau.AnnualEstimatesoftheResidentPopulationfortheUnitedStates,Regions,States,andPuertoRico:April1,2010toJuly1,2015.Accessed28April2016:http://www.census.gov/popest/data/state/totals/2015/index.html.33U.S.CensusBureau.PEPSYASEX-Geography-Massachusetts:AnnualEstimatesoftheResidentPopulationbySingleYearofAgeandSexfortheUnitedStates,States,andPuertoRicoCommonwealth:April1,2010toJuly1,2014.Accessed28April2016:http://factfinder.census.gov/faces/tableservices/jsf/pages/productview.xhtml?src=bkmk.34U.S.CensusBureau.File4.InterimStateProjectionsofPopulationbySingleYearofAgeandSex:July1,2004to2030.U.S.CensusBureau,PopulationDivision,InterimStatePopulationProjections,2005.Accessed28April2016:http://www.census.gov/population/projections/data/state/projectionsagesex.html.35U.S.CensusBureau.TableHIB-4.HealthInsuranceCoverageStatusandTypeofCoveragebyStateAllPersons:1999to2012.Accessed28April2016:https://www.census.gov/data/tables/time-series/demo/health-insurance/historical-series/hib.html.Wheresourceiandivareslightlydifferentprojections,weuseivbecausethesamplingismorecurrent.Samplingmethodsandmarginforerrordescribedatthelink:http://www2.census.gov/programs-surveys/acs/tech_docs/accuracy/ACS_Accuracy_of_Data_2014.pdf.
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36AgencyforHealthcareResearchandQuality.Percentofprivate-sectorenrolleesthatareenrolledinself-insuredplansatestablishmentsthatofferhealthinsurancebyfirmsizeandState(TableII.B.2.b.1),years1996-2012:1996(RevisedMarch2000),1997(March2000),1998(August2000),1999(August2001),2000(August2002),2001(August2003),2002(July2004),2003(July2005),2004(July2006),2005(July2007),2006(July2008),2008(July2009),2009(July2010),2010(July2011),2011(July2012),2012(July2013),2013(July2014),2014(July2015).MedicalExpenditurePanelSurveyInsuranceComponentTables.GeneratedusingMEPSnet/IC.Accessed25January2016:https://meps.ahrq.gov/mepsweb/data_stats/quick_tables_results.jsp?component=2&prfricon=yes&searchText=insured&subcomponent=2&tableSeries=2&year=-1.37IRS.HistoricalTable2.IndividualIncomeandTaxData,byStateandSizeofAdjustedGrossIncome,TaxYear2010.Accessed6March2014:https://www.irs.gov/uac/SOI-Tax-Stats-Historic-Table-2.38MassachusettsDepartmentofRevenue.MassachusettsNonresidentPersonalIncomeTaxafterCreditbyStateforTaxYear2010.Accessed23January2014:http://www.mass.gov/dor/tax-professionals/news-and-reports/statistical-reports/.39GroupInsuranceCommission.GICHealthPlanMembershipbyInsuredStatusFY2013.Accessed28March2016:http://www.mass.gov/anf/docs/gic/annual-report/annualreportfy2013.pdf.40GroupInsuranceCommission.GICHealthPlanMembershipbyInsuredStatusFY2014.Accessed28March2016:http://www.mass.gov/anf/docs/gic/annual-report/fy2014annual-report.pdf.41GroupInsuranceCommission,GroupInsuranceCommissionFiscalYear2015AnnualReport.Accessed25January2016:http://www.mass.gov/anf/docs/gic/annual-report/gic-annual-reportfy15.pdf.