high-cost medications in workers’ compensation and auto no- fault · • treats a complex or rare...

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High-cost medications in workers’ compensation and auto no-fault

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Presenters

Tron Emptage, BS Pharm, MA, RPhChief Clinical OfficerClinical Services

Susan Martin, BS Pharm, RPh Clinical PharmacistClinical Services

Learning objectives

• Delineate the top areas of medication spend in workers’ compensation and auto no-fault

• Understand the general scope of high-cost and specialty medications in workers’ compensation

• Define and identify specialty medication and their impact on the industry

• Define and identify compounded medications and their impact on the industry

• Define and identify opioid analgesics and their impact on the industry

• Understand what to look for and ask when managing claimants who are prescribed specialty medications, opioid analgesics and/or compounded medications

Top 10 medication classes by total spend

31.5%

13.1%

9.6%

7.0%

6.4%

6.5%

1.9%

2.4%

2.2%

2.1%

30.3%

14.8%

8.8%

7.5%

6.4%

6.3%

2.2%

2.2%

2.1%

2.0%

0% 5% 10% 15% 20% 25% 30% 35%

Opioid analgesics

Anticonvulsants

Anti-inflammatories

Dermatologicals

Skeletal muscle relaxants

Antidepressants

Antiasthmatics

Ulcer medications

Antipsychotics

Hypnotics

2015

Top 10 medication classes by total spend

31.5%

13.1%

9.6%

7.0%

6.4%

6.5%

1.9%

2.4%

2.2%

2.1%

30.3%

14.8%

8.8%

7.5%

6.4%

6.3%

2.2%

2.2%

2.1%

2.0%

0% 5% 10% 15% 20% 25% 30% 35%

Opioid analgesics

Anticonvulsants

Anti-inflammatories

Dermatologicals

Skeletal muscle relaxants

Antidepressants

Antiasthmatics

Ulcer medications

Antipsychotics

Hypnotics

2015 2016

Top 10 medications by total spend

2016Rank

2015Rank

TotalSpend

Common Brand Name Generic Name Therapeutic Class

1 1 8.5% Lyrica capsule pregabalin Anticonvulsants

2 2 7.0% OxyContin tablet oxycodone ER Opioid Analgesics

3 3 5.6% Percocet tablet oxycodone-acetaminophen Opioid Analgesics

4 6 3.2% Lidoderm Patch lidocaine Dermatologicals

5 5 3.1% Cymbalta capsule duloxetine Antidepressants

6 4 3.1% Vicodin, Norco tablet hydrocodone-acetaminophen Opioid Analgesics

7 7 2.7% Celebrex capsule celecoxib Anti-inflammatories

8 10 2.0% Neurontin tablet gabapentin Anticonvulsants

9 8 1.9% Duragesic patch fentanyl Opioid Analgesics

10 11 1.8% Neurontin capsule gabapentin Anticonvulsants

Top 10 medications by spend category

32%

45%

8%

7%8%

Anticonvulsants

Opioid analgesics

Dermatologicals

Anti-inflammatories

Antidepressants

Breakdown of opioid analgesics, compounded medications, specialty medications and all other medications

64.8%

3.3%1.6%

30.3%

All other medicationsSpecialty medicationsCompounded medicationsOpioid analgesics

Specialty medication utilization with inflation

Year Claims % Spend % Rx %

2015 1.3% 3.2% 0.3%

2016 1.3% 3.3% 0.4%

Specialty medications

Source: Pharmacist’s Letter: Specialty Drugs: A primer for Pharmacists and Technicians, Volume 2014, Course No. 306 Rosato EA, Letter to Peter Hammen regarding HB 736, Feb 2013

According to industry experts

• Spending expected to increase from $55 billion in 2005 to $1.7 trillion in 2030

• Expenditures growing about twice as fast as spending on traditional medications

• Lack of adherence results in expensive and life-threatening complications

• Specialized pharmacies and PBMs focus on helping claimants improve adherence

Source: Pharmacist’s Letter: Specialty Drugs: A primer for Pharmacists and Technicians, Volume 2014, Course No. 306 Rosato EA, Letter to Peter Hammen regarding HB 736, Feb 2013

Specialty medications

• There is no standard industry-wide definition for specialty drugs

• They are considered “special” because they’re high cost and “high touch” due to their complex and unique requirements

• The Food and Drug Administration (FDA) doesn’t decide which medications are considered “specialty”

• Drug companies and insurers may have their own designations

• Some states are working on legislation that will give a clearer definition of specialty medications

Typical characteristics of specialty medications

• Treats a complex or rare condition, often chronic

• May involve unique administration including injection, infusion, inhalation as well as oral

• Requires close claimant assessment, monitoring, education, follow-up

• Manufacturing process is complex resulting in higher costs

• Specialty pharmacies with trained staff dedicated to dispensing specialty medications

• May need to comply with Risk Evaluation and Mitigation Strategy (REMS)

*as defined by Centers for Medicare and Medicaid Services

Factors driving specialty medication spend

• High research and development costs

• Fewer generic (biosimilar) substitutes

• Specialty handling, education, and administration by medical professionals

• Growing efforts surround targeted and personalized medicine

Top 10 specialty medications by spend

Rank Medication Therapeutic class Average AWP Cost/unit*

1 Truvada® tablet Antiretrovirals $63

2 Isentress® tablet Antiretrovirals $28

3 Harvoni® tablet Antivirals $1,350

4 Xolair ® solution Antiasthmatics $1,227

5 Synvisc-One® injection Skeletal muscle relaxants $250

6 Euflexxa® injection Skeletal muscle relaxants $204

7 Orthovisc® injection Skeletal muscle relaxants $242

8 Forteo® solution Misc Endocrine $3,598

9 Lovenox® injection Anticoagulants $90

10 Humira® injection Anti-rheumatics $5,329

Human Immunodeficiency Virus (HIV) infection

Examples

Truvada®, Isentress®

Indicated for/General information

• Prevention and treatment of human immunodeficiency virus (HIV) infection

• Truvada + Isentress = preferred regimen for HIV Postexposure Prophylaxis (PEP)

How it works

• Inhibit ability of HIV to replicate via combination therapy, targeting multiple mechanisms of virus reproduction.

• Initially administered post exposure to prevent conversion to HIV infection, and as lifelong treatment in seroconverted claimants to prevent progression to AIDS.

Alternatives Appropriateness in workers’ compensation

Depending on testing and resistance pattern, other combinations of HIV antiretrovirals may be prescribed

HIV exposure and/or infection may occur following a contaminated needle stick in health care workers or emergency responders; used for PEP. If exposed, treatment should begin immediately and preferably within 72 hours after exposure.

Hepatitis C Virus (HCV) infection

Examples

Harvoni®, Sovaldi®, Daklinza®


• A “cure” for some forms of hepatitis C virus infection

• Multiple treatment regimens available

How it works

• Inhibits the ability of hepatitis C virus to multiply.

• Length of treatment typically 12 weeks, depending on specific genetic typing of the Hepatitis virus, presence of liver damage, and treatment history.


• Interferon injection

• Other Hepatitis C antivirals

• Liver Transplant

Hepatitis C infection may occur following a contaminated needle stick in health care workers or emergency responders.

Asthma

Examples

Xolair® (omalizumab)


• Moderate to severe persistent asthma not controlled by inhaled corticosteroids

• Chronic idiopathic urticaria (chronic hives without known cause) not controlled by antihistamines

How it works

• Binds to human IgE's high affinity Fc receptor, preventing the binding of IgE to a variety of cells associated with the allergic response and lowering free serum IgE concentrations.

• Avoiding the bridging between IgE and cells associated with allergic response prevents degranulation of such cells and, thereby, the release of inflammatory mediators.


• Inhaled corticosteroids + long-acting beta2-agonists or other medications (asthma)

• Antihistamines (hives)

Use in workers’ compensation should be limited to claimants who have not been well controlled on first-line medications for asthma. Verify why medication is being prescribed for claimants.

Osteoarthritis of the knee

Examples

Synvisc-One®, Euflexxa®, Orthovisc®


Treatment of pain in osteoarthritis (OA) of the knee in claimants who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e.g., acetaminophen.

How it works

Hyaluronic acid derivatives are injected into the joint space of the knee and work as lubricants to reduce friction during movement to allow smooth joint movement.


• Acetaminophen

• Non-steroidal anti-inflammatory drugs (NSAIDs)

OA of the knee may develop following a workplace knee injury. Verify that claimant has tried and failed conservative non-pharmacologic therapy and simple analgesics prior to authorizing these agents. May prolong knee replacement surgery in some claimants.

Osteoporosis

Examples

Forteo® (teriparatide)


• Treatment of glucocorticoid-induced osteoporosis, osteoporosis in men and post-menopausal women

• Off-label use: Stress fracture healing

How it works

• Parathyroid hormone analog that stimulates new bone growth and bone resorption; increases bonemass and strength.

• Regulates calcium (increases levels) and phosphorus (decreases levels) metabolism in the bone and kidney.


• None for stress fracture healing

• Rest and refrain from activity

• Bisphosphonates (osteoporosis)

As stress fractures are most common in athletes, use in workers’ compensation should be limited. Verify why this medication is being prescribed for claimants. Look for prior history of corticosteroid use or treatment failure with other medications.

Blood clots

Examples

Lovenox® (enoxaparin)


• Prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) after orthopedic or abdominal surgery

• Acute treatment of DVTs

• Prevent complications in patients with unstable angina or heart attacks

How it works

• Low molecular-weight heparin (LMWH) binds to and accelerates the activity of antithrombin III.

• Strongly inhibits coagulation factor Xa and IIa (thrombin) thereby preventing formation of clots.


• Warfarin (vitamin K antagonist)

• Fragmin (dalteparin sodium)

Use in workers’ compensation should be limited to claimants who have undergone orthopedic or abdominal surgery. Verify why medication is being prescribed for claimants.

Rheumatologic disease

Examples

Humira® (adalimumab)


• Reduce the signs and symptoms of rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, plaque psoriasis, Crohn’s disease, ulcerative colitis

• Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

How it works

• Large complex molecules derived from living organisms

• Targets specific areas of the immune system - anti-tumor necrosis factor (anti-TNF) alpha agents

• TNF-blocker: fully human monoclonal antibody that binds to TNF blocking its interaction with both p55 and p75 cell surface receptor


• Nonpharmacologic therapy

• NSAIDs

• Corticosteroids

• Non-biologic DMARDs (methotrexate, leflunomide, sulfasalazine, hydroxychloroquine

Use in workers’ compensation should be limited to when arthritic condition has been deemed as related to injury. Verify why medication is being prescribed for claimants.

Compounded medication utilization


2015 1.2% 3.4% 0.5%

2016 0.7% 1.6% 0.3%

Compounded medications

Compounded medications are combined, mixed or altered for specific needs of one claimant

• Serve as alternatives to FDA-approved commercially prepared drugs

• Require a prescription

• Typically used to avoid allergies and other claimant sensitivities

• Largely experimental in use with few randomized controlled trials to determine efficacy or safety

Types of compounded medications

Topical Preparations Oral Preparations

• Skin application

• Local use

• No commercially available strength

• Unique combination of agents

• Capsules, solutions, suspensions, lozenges, troches

• Must ensure no impurities

Ophthalmic Agents Injectable Agents

• Absence of commercial preparation

• Avoid adverse reactions

• Sterility of high importance

• Absence of commercial preparation

• Sterility of high importance

Compounded medications in therapy

• When a commercial product is unavailable from the manufacturer

• When treatment of the injury requires a specialty mix of medications

• When typical administration of the medication therapy is unsuitable or ineffective

– Side effects

– Allergies

– Difficulty swallowing

– Absorption issues

• Outside of workers’ compensation, compounded medications are most often used for hormone replacement, dermatology, children’s formulations and anti-cancer treatment

Compounded medications

Examples

Topical medications, multiple ingredients


• Used for a variety of pain related conditions

• Typical ingredients: anti-inflammatory (ketoprofen, ibuprofen), anticonvulsants (gabapentin), muscle relaxants (cyclobenzaprine, baclofen)

How it works

Provides one or more medications in a topically applied medication, with the goal of treating pain/inflammation directly at the site of injury.


• Commercially available preparations

• Oral medication therapy

Unlikely; compounded medications are not first line therapy according to multiple state and national treatment guidelines

Opioid analgesic utilization


2015 57.6% 31.5% 32.6%

2016 54.0% 30.3% 31.2%

Opioid analgesics

Define opioid analgesics

• Useful in management of moderate to severe pain due to trauma, surgery, or nerve damage

• May be considered in select claimants if pain is not adequately relieved by non-opioid analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs)

• Not recommended as first-line treatment of chronic noncancer pain, neuropathic pain, or in claimants at high risk of misuse, diversion or abuse

• Classified according to duration of their effects － Short-acting (immediate-release) – treats acute and/or breakthrough pain

－ Long-acting (extended-release) – treats baseline or around-the-clock pain

Opioid analgesic treatment guidelines

Centers for Disease Control and Prevention (CDC) Chronic Pain Guidelines

Limits on Morphine Equivalent Dose (MED) vary based on guideline and type of pain

• Encourage the use of Prescription Drug Monitoring Programs (PDMPs)

• Recommend the use of opioid analgesic risk assessment tools

• Establish treatment goals, expectations and a plan for discontinuing opioid analgesics

• Use urine drug testing at baseline and at least annually

• Official Disability Guidelines (ODG): 100 MED/day

• American College of Occupational & Environmental Medicine (ACOEM): 50 MED/day

• CDC Chronic Pain Guidelines: 50 MED/day (acute); 90 MED/day (chronic)

Industry controls

• FDA requested Endo voluntarily remove reformulated Opana ER tablets from U.S. market

－ Abuse-deterrent properties – not supporting original claims

－ Post-marketing data identified shift in route of abuse from nasal to injection

－ Increased cases of HIV, hepatitis C and serious blood disorders in certain populations

• This FDA request does NOT affect:

－Original formulation generic oxymorphone ER tablets (no abuse-deterrent properties)

－Opana (oxymorphone) immediate-release tablets, brand or generic

• July 6, 2017: Endo agreed to work with FDA to remove Opana ER from the market

• Not officially removed from the U.S. market

• Until recalled…..assess claims and ongoing need for opioid analgesics; prescribers should be talking to patients and making plans to modify medication therapy

Opioid analgesics - Fentanyl products

Examples

Actiq®, Abstral®, Fentora®


• Management of breakthrough cancer pain that also take other routine opioid analgesic medications to manage cancer pain.

• Off-label use: Non-cancer breakthrough pain

How it works

• Short-acting opioid analgesic gets absorbed through the mucous lining of the mouth. Often referred to as Transmucosal Immediate-Release Fentanyl (TIRFs)


• Morphine immediate-release

• Oxycodone immediate-release

• Hydromorphone immediate-release

As these medications are intended to ease cancer pain in claimants that may have difficulty or inability to swallow, use in workers’ compensation should be limited.

Questions to ask for high-cost medications

1. Is it directly or indirectly related to the treatment of an injury covered under workers’ compensation?

2. Have other equally effective, low-cost medications been trialed?

3. Is the medication FDA approved for the treatment of the condition?

4. How long is therapy expected to last?

5. Does the claimant and/or physician need to complete a registration or REMS program before using the medication?

6. Does the claimant understand the risks and benefits of the planned therapy?

7. Can the claimant comply with any special storage, administration or disposal instructions of the particular medication?

8. How will the claimant realize success of the treatment?

9. Does the claimant understand the need for adherence to the therapy?

10. Are there benefits on the overall medical spend and outcomes related to these high cost medications?

Thank you!Questions?

CE credits for this course are administered by the CEU Institute. If you have any issues or questions regarding your

credits, please contact [email protected].

Register for additional Continuing Education Opportunities www.HeliosComp.com/Resources/Continuing-Education

You will receive an email from the CEU Institute on our behalf approximately 24 hours after the webinar. This email will contain a link that you will use to submit for your CE credits. You must complete this task within 72 hours.

PHM14-17711

high-cost medications in workers’ compensation and auto no- fault · • treats a complex or rare...

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