Idaho Medicaid Drug Utilization Review Program

23 August 2012

Follow-up to Previous ReviewsCitalopram High Dose DUR

2

Citalopram High Dose DURFDA Drug Safety Communication: Abnormal

heart rhythms associated with high doses of Celexa (citalopram hydrobromide)On August 24, 2011, the Food and Drug

Administration (FDA) released a Safety Announcement addressing the high dose of citalopram and potential adverse effects it can have on the heart. The maximum daily dose is now recommended to be 40 mg per day when it was previously 60 mg per day.

3

Citalopram High Dose DUROn March 28, 2012 the FDA sent out a revised

Drug Safety Communication with updated recommendations: Recognition that although citalopram use should be avoided, if

possible, in patients with certain conditions because of the risk of QT prolongation, ECG monitoring and/or electrolyte monitoring is recommended if citalopram must be used in such patients.

Patients with congenital long QT syndrome are at particular risk of Torsade de Pointes, ventricular tachycardia, and sudden death when given drugs that prolong the QT interval.  Nevertheless, the labeling recommendation for patients with congenital long QT syndrome has been changed from “contraindicated” to “not recommended,” because it is recognized that there may be some patients with this condition who could benefit from a low dose of citalopram and who lack viable alternatives.

The maximum recommended dose of citalopram is 20 mg per day for patients over the age of 60.

Citalopram is recommended to be discontinued in patients who are found to have persistent QTc measurements greater than 500 ms. 4

Citalopram High Dose DURIt was decided at the last DUR Board

Meeting that we would look at the numbers again once a little time had past after the FDA Safety Announcement.

5

Citalopram High Dose DUR

Series10

20406080

7751

10

40mg citalopram use in recipients 60 years and older

Distinct recipients with a paid claim 1/1/2012-3/31/2012Same recipients with a paid claim in June 2012Recipients with a new claim in June 2012

6

Citalopram High Dose DURNext steps ???

7

Current Interventions/Outcomes StudiesP&T Committee Narcotic Analgesic StudiesAliskiren DURLupron DURCiprofloxacin DURSynagis DUR – Medical Claims DataGrowth Hormone DURPsychotropic Medications in Foster Children

UpdateFive (5) or more psychotropic medications prescribed

concomitantly

8

Narcotic Patterns of Use in Chronic Non-Malignant Pain

Complete Report

9

Profile ReviewGenerated profiles for the top 150 recipients

by total narcotic claim count from the recipients who had at least one narcotic claim in each of the 24 months of the period ending December 2011

Time Period: May 1, 2011 through December 31, 2011

Evaluated 144 Cancer Diagnosis found in 6All profiles were hand reviewed by Idaho

Medicaid Pharmacists

10

Review FocusYears of opioid use Number of different opioids usedDaily morphine equivalentsNumber of different prescribersOther concurrent potentially addictive drugsDiagnosis or indication for chronic opioid useAverage days between refillsHistory of abuse diagnosisCurrently in lock-in program?Additional opioid use outside of Medicaid

Length of Time for Continuous Opioid Use

12

1 2 3 4 5 6 7 8 9 10 11 12 13 140

2

4

6

8

10

12

14

16

18

20

22

24

26Number of Years on Opioids -Through 2011

Number of Years

Number of Participants

Records only back to 1998

Average = 8.2 years

Number of Different Opioids

13

Includes different drugs or dosage formsMay or may not be concurrent, but over course of therapy

1 2 3 4 5 6 7 8 9 100

5

10

15

20

25

30

35

40

45

50Number of Different Opioids

Number of Opioids

Number of Participants

Average = 2.9

Daily Morphine Equivalents

14

Lowest = 10 mgHighest = 2421 mg

0-99100 - 199200-299300-399400-499500-599600-699700-799800-899900-999

1000-10991100-11991200-12991300-1399

2000 or More

0 5 10 15 20 25 30 35 40 45

Daily Morphine Equivalents

Number of participants

Daily Morphine Equivalents (mg)

Average = 256 mg equivalents

Number of Prescribers for Opioids

1 2 3 4 5 6 7 8 9 10 11 120

510

15

20

25

30

35

4045

50

55

6065

70

Number of Prescribers for Opioids

Number of Prescribers

Number of Partic-ipants

Average number of prescribers per participant is 2

15

16

19%

27%

10%

6%

13%

13%

1%3%

1%

9%

Percent of Other Concurrent Potentially Addictive Drugs

None

Benzodiazepines Only (up to 3)

Muscle relaxants only

Sedative Hypnotics Only

Benzodiazepines plus muscle re-laxants

Benzodiazepines plus sedative hypnotics

Sedative Hypnotics plus muscle re-laxants

Benzodiazepines plus a stimulant

Benzodiazapines plus a stimulant plus a sedative hypnotic

Benzodiazepines plus muscle re-laxants plus sedative hypnotics

Diagnosis/IndicationsDiagnosis Number of Participants

(incidence)

lumbago: unspecified disorder of back; back pain 114

chronic pain; chronic pain syndrome; other chronic pain 90

intervertebral disc disorder; lumbar disc degeneration; cervical disc degeneration; cervicalgia; sciatica; disc degeneration; spondylosis

84

knee injury; shoulder injury; pain in limb; lower leg pain; neck injury; hip and thigh injury; wrist injury 38

hand joint pain; osteoarthritis; rheumatoid arthritis; pain in joint of ankle and foot; ankylosing spondylitis; other disorders of synovium tendon and bursa

42

headache; migraine 14

disorders of muscle ligament and fascia; other disease of bone and cartilage; myalgia 6

abdominal pain, generalized pain 7

multiple sclerosis 4

peripheral neuropathy; diabetic peripheral neuropathy 4

Unknown 2

Most patients had multiples diagnoses

17

Average Days Prior to Refill

1 2 3 4 5 6 7 8 9 101112131415161718192021222324252627282930313233343536370

10

20

30

40

50

60

70

80

Average Days

Number of Partic-ipants

Average = 27 days

18

Other Information GatheredNumber on Medicaid Pharmacy Lock-In

4 currently on lock-in1 previously on lock-in, released 1/2011

Non-Medicaid Opioid FillsFrom Board of Pharmacy Reports 43 of the 144 patients ( 30%) had fills not paid

for by MedicaidExtra number of doses ranged from 2 to 4275

Concurrent Drug Abuse Diagnosis 56 (39%)

19

Comparison of Intermittent and Complete Review

Intermittent (90 pts)

Total (150 pts)

Number with Cancer DX

3 6

Average # of Years on Opioids

9.8 (Range 3-14) 8.2 (Range 3-14)

Average # of Different Opioids

2.6 (Range 1-9) 2.9 ( Range 1-10)

Average Daily Morphine Equivalents

202 (Range 10 mg-1080 mg)

256 (Range 10 mg -2421mg)

Average # of Prescribers/Participant

2 (Range 1-12) 2 ( Range 1-12)

Average Days Prior to Refill

30 27

Lock-in Patients 3 4Patients with Prescriptions Paid Outside of Medicaid

34% 30% 20

Narcotic AnalgesicsDUR Board Recommendations April 2012

Complete Review for the rest of top 150 patients

Research other state restrictions and initiativesP&T Recommendations May 2012

Long- Acting Narcotic Analgesics Tighten up definition of “failure of a preferred

agent” beyond just a prior fill of preferred agent Removal of history of preferred oral agent for

fentanyl transdermal

21

Review of External Programs and Recommendations

22

PROP – Physicians for Responsible Opioid Prescribingwww.responsibleopioidprescribing.orgMission Statement

Our mission is to reduce morbidity and mortality resulting from prescribing of opioids and to promote cautious, safe and responsible opioid prescribing practices.

Disclosure StatementPROP does not accept financial support from pharmaceutical companies, medical device companies, urine toxicology laboratories or any other entities that could be perceived as a potential conflict of interest.

Cautious Evidence Based Opioid Prescribing Four page handout included in your packet.

Video: Effectiveness for Chronic Pain: http://www.supportprop.org/educational/index.html

 

23

FDA Recommendations July 9, 2012 FDA introduced new safety measures for

extended release and long acting opioid medications as part of a federal initiative to address the prescription drug abuse, misuse, and overdose epidemic.

Key components to REMS (risk evaluation and mitigation strategies):Training for prescribersUpdated Medication Guide and patient counseling

documentAssessment/Auditing

24

Training for PrescribersTraining for prescribers is OPTIONAL at this time.  The Obama Administration is pursuing legislative changes

to link mandatory training on responsible opioid prescribing to DEA registration.

Companies will be required to make education programs available to prescribers based on an FDA blueprint at no or a nominal cost.

Companies will be required to perform periodic assessments of the implementation of the REMS and the success of the program in meeting its goals.

FDA will review these assessments and may require additional elements to achieve the goals of the program.

25

Updated Medication GuideConsumer friendly information on the safe

use, storage, and disposal of long acting opioids

Signs of potential overdoseSpecific advice on safe storage to prevent

accidental exposure to family members and household visitors.

26

Assessment/AuditingCompanies will be expected to achieve certain

FDA-established goals for the percentage of prescribers of ER/LA opioids who complete the training (25% at the end of the first year, 50% after two years, 60% after four years).

 Assess prescriber’s understanding of important risk information.

 Assess whether the REMS is adversely affecting patient access to necessary pain medications.

27

PROP Response to FDALetter sent by PROP to the Food and Drug Administration on July 25, 2012Recommendations

 Strike the term “moderate” from the indication for non-cancer pain.

Add a maximum daily dose, equivalent to 100mg of morphine, for non-cancer pain.

Add a maximum duration of 90 days for continuous (daily) use for non-cancer pain.

28

PROP Future ActivitiesNational Summit on Opioid Safety

October 31 – November 1, 2012Seattle, WAKeynote Speakers

Roger Chou MD, MPH Oregon Health & Science University

Jane Ballantyne, MD, MPH University of Washington

29

Current ActivitiesRevision of long-acting opioid criteria

Manual Review (automatic POS denial) for all new patients with prescriptions for the following Oxycodone ER Fentanyl transdermal Butrans

Review of Other State ProgramsAlaska therapeutic duplication editWashington second opinion by pain specialistMontana case managementOregon back pain management program

30

Possible InterventionEducation on patients receiving > 500

morphine equivalents per dayFrom review n = 17Content ?

31

Aliskiren DURThe U.S. Food and Drug Administration (FDA)

came out with a safety announcement on April 20, 2012 warning of the possible risks when using aliskiren containing products with ACEIs or ARBs in patients with diabetes or kidney impairment. (see packet for safety announcement)

A report was run to identify patients who had received an aliskiren containing product within the past 90 days.

32

Aliskiren DURLetters were sent to 17 prescribers about 13

patients on 4/30/2012.As of 8/10/2012, 4 responses have been

received (24% response rate.)See packet for a copy of the letters.

33

Aliskiren DUR response detail as of 8/10/2012Note that providers may choose more than one

selection per response.

Reviewed and have or will modify the treatment1

I will use this information in the care of future pts1

My patient, but I did not prescribe this2

Not useful to my practice1

Info regarding this pt appears to be correct1 34

Aliskiren DUR response detail as of 8/10/2012 “I am recipient’s PCP. Dr Rahim from Idaho Kidney Institute

manages her BP medications because of her nephrotic syndrome. There are frequent changes made and he was the one who started her on aliskiren. He did decrease her lisinopril to 20mg. She is being monitored closely with frequent lab and f/u with the specialist. Thank you for the information.”

“She is no longer on aliskiren.” “no longer on this combo. Also original rx was by the patient’s

nephrologist Dr Davidson.” “before sending information please do appropriate research. Pt

has stage 5 CKD and is no longer approved for ACE or ARB therapy.” Please refer to packet for recipient’s profile

35

Aliskiren DURUtilization Data

Letters were sent to the prescriber of the Tekturna HCT and two of the Tekturna July 2012 claims and one of the claims for Tekturna elicited the first response on the previous slide.

5 other recipients have started Tekturna since January 2012

36

Product January 2012 Claims

July 2012 Claims

Tekturna 12 7Tekturna HCT

1 1

Valturna 2 0

Aliskiren DUR

Comments/Suggestions ???

37

Lupron DURReason for DUR Project – Received prior authorization

request for Lupron for a 14 year old genetically male patient who is in the process of becoming a girl. Currently lives in another state – “he” and his mother are planning on moving to Idaho so this prior authorization request was submitted as “he” is now eligible for Idaho Medicaid.

Nothing specific in Idaho Medicaid’s rules about paying or not paying for transgender procedures. Would fall under “medical necessity” review. Chart note was submitted with prior authorization request – nothing written in endocrinologist’s chart note about chromosomal mosaicism or genetic abnormality. Request was denied as not medically necessary.

38

Lupron DURPreviously Lupron claims would pay at pharmacy

with prior authorization not needed. Have since instituted prior authorization requirements.

FDA approved indications Precocious Puberty

Girls less than 8 years old; boys less than 9 years old Monthly dose 7.5mg – 15mg; Can switch to every 3 month

depot formulation Uterine leiomyomata associated with anemia, in

conjunction with iron supplementation 3.75mg monthly x 3 months or 11.25mg depot single

injection

39

Lupron DURFDA approved indications continued

Endometriosis 3.75mg monthly x 3 months or 11.25mg depot single

injection Premenstrual syndrome

3.75mg monthly x 3 months Prostate cancer, advanced (palliative treatment)

7.5mg monthly (indefinitely) or 22.5mg depot every 3 months or 30mg depot every 4 months or 45mg depot every 6 months

In vitro fertilization Not a diagnosis covered by Idaho Medicaid (do not cover

fertility treatment)

40

Lupron DURProfiles reviewed for patients with paid Lupron

claims between 9/01/2011 and 3/31/2012 (n=25)

41

15

10

Patients

Children with sexual precocity (ICD-9 259.1)Women with endometrio-sis

Lupron DUR15 children with precocious puberty – age as of 3/31/2012

Minimum age: 3 years, 4 monthsMaximum age: 14 years, 8 monthsMean age: 9 years, 4 months

10 women with endometriosis – age as of 3/31/2012Minimum age: 17 yearsMaximum age: 35 yearsMean age: 23 years

Entered prior authorization approvals for all current patients who are still receiving Lupron therapy (grandfathering).

42

Lupron DURCost of Lupron therapy (all strengths) from 4/1/2011

– 3/31/2012 through outpatient prescription drug program: $289,971.77 (49 patients total)

Cost of Lupron therapy (all strengths) from 4/1/2011 – 3/31/2012 through J-code billing on medical side: $12,179.79 (24 patients total)

Cost of Lupron therapy for requested patient (7.5mg monthly): ~$880 per month - $10,560 per year

43

Lupron DURWill be instituting auto-PA rule so that claims for

children with precocious puberty and women with endometriosis would still pay at Point of Sale with no prior authorization paperwork required IF the applicable diagnosis is in the patient’s electronic profile at the time that the pharmacy claim is run.

44

Lupron DURApprove within age and dosage limits for the following FDA

approved diagnoses: ICD-9 259.1 Sexual precocity ICD-9 617.x Endometriosis ICD-9 174.x Malignant neoplasm of female breast ICD-9 175.x Malignant neoplasm of male breast ICD-9 183.x Malignant neoplasm of ovary ICD-9 185.x Malignant neoplasm of prostate ICD-9 218.x Uterine leiomyoma

Parameters in Rx POS System Age set at 0-999 Quantity set at 0.04 (1 syringe/30 days = 0.033) Both (male and female)

45

Lupron DURReferences

Abbott Laboratories. Lupron Depot-PED prescribing information.

Cigna Medical Coverage Policy – Effective date 1/15/2011.

Texas Medicaid Policy.

46

Ciprofloxacin DURRationale for study: Idaho Medicaid was

requested to look at why ciprofloxacin was prescribed for pediatric patients less than 16 years old. Currently ciprofloxacin will pay at the pharmacy with no age limitations while levofloxacin currently requires an age override prior authorization for pediatric patients less than 16 years old.

47

Ciprofloxacin DURCiprofloxacin Package Insert:

FDA approved for pediatric patients 1-17 years of age with complicated urinary tract infections and pyelonephritis due to E coli and for pediatric patients (age not specified) with inhalational anthrax.

Levaquin Package Insert:FDA approved for pediatric patients (6 months

of age and older) only for the prevention of inhalational anthrax (post-exposure) and for plague.

48

Ciprofloxacin DURRetrospective DUR was done on patients less

than 16 years of age with at least one paid claim between 2-1-12 and 4-30-12.N=77, mean age 10.3, std deviation 4.0 years.

49

Ciprofloxacin DUROral Antibiotic Utilization 2-1-2012 through 4-30-2012 < 16

years of ageProduct Distinct

Recipients

Total Claims

Total Reimbursement to

Pharmacy

Average cost per claim

Levofloxacin 8 9 $827.62 $91.96Ciprofloxacin*

79 86 $2,772.86 $32.24

Amoxicillin 14,159 15,380 $194,848.07 $12.67Augmentin 3,326 3,620 $119,378.31 $32.98Azithromycin

6,620 7,157 $140,062.90 $19.57

Bactrim 1,883 2,240 $26,755.37 $11.94* Report ran after original run to identify 77 recipients so 2 new recipients showed up on this report

50

Ciprofloxacin DURSummary

Diagnosis Total # of recipientsUTI or cystitis or pyelonephritis with at least one antibiotic tried before ciprofloxacin

18

UTI or cystitis or pyelonephritis with no other antibiotic tried before ciprofloxacin

7

CF Patients 4

Oncology Patients 2

Asthma/Respiratory Distress 11

Pneumonia/URI/bronchitis 6

Other 16

No Diagnosis Listed 1351

Ciprofloxacin DURUTI or cystitis or pyelonephritis with at least one antibiotic tried before ciprofloxacinn=18, mean age (standard deviation) 10.5 yrs (3.8), min=3, max=1513/18 filled ciprofloxacin once; three (2 fills), one (3 fills), one (4 fills)

Series10

1

2

3

4

5

6

amox

azit

h Augm

enti

n

Bac

trim

ceph

alex

in

cefd

inir

nitr

ofu-

rant

oin

amox

+Au

gm

enti

n

52

Ciprofloxacin DUR

Emergency Medicine

NP Family Practice

PA Midwife (pt. is 14 years old)

Urology Peds Unknown0

1

2

3

4

5

6

2

4

5

2

1 1

2

1

Prescriber taxonomy for patients treated for UTI/cystitis/pyelonephritis with previous antibi-

otic usage

53

Ciprofloxacin DURUTI or cystitis or pyelonephritis with no other antibiotic tried before ciprofloxacinn=7, mean age (standard deviation) 11.7 yrs (3.7), min=6, max=15All had only single fill of ciprofloxacin

Series10

1

2

3

4

5

6

7

87

# o

f rec

ipie

nts

54

Ciprofloxacin DUR

Emergency Medicine

General Practice NP Family Practice Peds0

1

2

3

2

1

2

1 1

Prescriber taxonomy for patients treated for UTI/cystitis/pyelonephritis without previous an-

tibiotic usage

55

Ciprofloxacin DURCF Patientsn=4, mean age (standard deviation) 9 yrs (4.6), min=4, max=14

prior antibioticsCiprofloxacin

fills

02468

101214

Patient 1

Patient 2

Patient 3

Patient 4

21

7

5

8

3

12 13

56

Ciprofloxacin DUROncology Patients

Both were 6 years oldKidney cancer with cellulitis of legBone cancer with infection of amputation

stumpBoth had single fills of ciprofloxacin

57

Ciprofloxacin DURAsthma/Respiratory Distressn=11, mean age (standard deviation) 9.6 yrs (5.0), min=1, max=154 had no prior antibiotics, 7 had prior antibiotics ranging from 1-155 patients had 1 fill only of ciprofloxacin, 3 fills (2 patients), 8 fills (1 patient), 11 fills (1 patient), 12 fills (1 patient)

no prior antibiotics prior antibiotics0

1

2

3

4

5

6

7

8

4

7

# o

f rec

ipie

nts

58

Ciprofloxacin DURPneumonia/URI/bronchitisn=6, mean age (standard deviation) 8.8 yrs (5.1), min=2, max=14All had single fills of ciprofloxacin

no prior antibiotics Augmentin/azithromycin previously

0

1

2

3

4

5

65

1# o

f rec

ipie

nts

59

Ciprofloxacin DUROthern=16, mean age (standard deviation) 9.9 yrs (4.0), min=3, max=159 had prior antibiotics (Bactrim x 3, amox x 2, Augmentin x 1, cephalexin x 1, minocycline x 1, Bactrim/Augmentin x 1)13 had one fill of ciprofloxacin only; two had two fills and one had 5 fills (s/p liver transplant)

Series10

1

2

3

4ot

itis

med

ia phar

yngi

tis

abdo

min

al

pain

cellu

litis

/ski

n in

fect

ion

1 ea

ch -

foot

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ound

infe

c-tio

n, s

/p li

ver

tran

spla

nt,

s/p

kidn

ey

tran

spla

nt,

peri

tone

al

absc

ess,

ski

n in

fect

ion,

ap

pend

iciti

s

# o

f rec

ipie

nts

60

Ciprofloxacin DURNo Diagnosis Listedn=13, mean age (standard deviation) 11.8 yrs (2.6), min=7, max=1511 had one fill of ciprofloxacin; one had two fills and one had 3 fills

no prior an-tibiotics

amoxicillin Augmentin Augmentin/azithromycin

0

2

4

6

8

10

1210

1 1 1# o

f rec

ipie

nts

61

Ciprofloxacin DURAmerican Academy of Pediatrics: The Use of

Systemic and Topical Fluoroquinolones. John S. Bradley, Mary Anne Jackson and the Committee on Infectious Diseases. Pediatrics 2011;128;e1034-e1045.Quotes from the article: Use of fluoroquinolones in children should continue to be

limited to treatment of infections for which no safe and effective alternative exists.

Animal toxicology data available with the first quinolones compounds documented their propensity to create inflammation and subsequent destruction of weight-bearing joints in juvenile animals.

No published reports exist of physician-diagnosed cartilage damage in children in the United States, either from controlled clinical trials of fluoroquinolones or from unsolicited reporting to the FDA or drug manufacturers.

No reports of tendon rupture in pediatric patients exposed to any quinolone.

62

Ciprofloxacin DURStudy 1 – Prospective safety study performed at

the request of the FDA by Bayer for ciprofloxacin.Studied rate of arthropathy 6 weeks after treatment with

ciprofloxacin (n=335) or comparator antibiotic (n=349) in eight countries including the US.

A difference was only detected in the US with a rate of arthropathy 21.0% (n=62) with ciprofloxacin vs. 11.3% (n=71) with comparator antibiotic.

Mexico had a zero incidence of arthropathy in both ciprofloxacin and comparator antibiotic.

The study used a non inferiority design to assess musculoskeletal complaints across all countries, and as analyzed, the groups were sufficiently different to suggest potential musculoskeletal toxicity with ciprofloxacin (9.3%) vs. comparator (6.0%).

63

Ciprofloxacin DURStudy 2 - Prospective and randomized but not

blinded study performed by Johnson & Johnson for levofloxacin as part of their FDA-coordinated program of pediatric drug development.N=2523 from 3 large multicenter efficacy trials

including a community-acquired pneumonia trial in children aged 6 months to 16 years and acute otitis media in children 6 months to 5 years.

An analysis of weight-bearing joint disorders had a statistically greater rate between the levofloxacin and comparator treated groups at 2 months (1.9% vs. 0.7%, p=0.025) and at 12 months (2.9% vs. 1.6%, p=0.047).

A history of joint pain accounted for 85% of all events, but there were no findings of joint abnormality when assessed by physical examination (all patients) or CT scan/MRI (selected patients). 64

Ciprofloxacin DURWorld Health Organization: What is the

evidence of safety of quinolones use in children?  International Child Health Review Collaboration.  September 2, 2008. Summary Statement:Fluoroquinolones are efficacious antimicrobial agents

with an important role in the treatment of a variety of pediatric infections.  Ciprofloxacin is a particularly useful fluoroquinolone for dysentery and typhoid.

There is grade A evidence to support both the overall safety of ciprofloxacin use in children and lack of joint toxicity.

65

Ciprofloxacin DURRecommendations for prior authorization for

age override for pediatric patients receiving ciprofloxacin and levofloxacin?Add age criteria to cipro and/or remove age

criteria from levofloxacin?

66

Synagis DUR

Medical claims for 2011-2012 season: $274,881.27

Pharmacy claims for 2011-2012 season: $1,362,626.70

67

Synagis DUR – Medical Claims Data from 10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)40 patients identified – ALL had prior

authorization approvals.PA Request Marked as:

Billing using CPT Code: 11Pharmacy billing for drug: 7Nothing specific marked on form: 22

Future Question: Should we inform Idaho medical unit of all prior authorizations for Synagis as the doctors’ offices are not doing a good job of informing Medicaid if claim will be paid as a medical claim or as a pharmacy claim? 68

Synagis DUR – Medical Claims Data from 10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)Four patients identified with claims that

should NOT have paid:Patient 1

SEVEN doses paid for: 3 as medical claims and 4 as pharmacy claims. Also kept switching between 50mg and 100mg vial sizes. 12/5/11 – 50mg (pharmacy claim) 1/9/12 – 100mg (pharmacy claim) 1/13/12 – 50mg (medical claim) 2/6/12 – 100mg (pharmacy claim) 2/16/12 – 50mg (medical claim) 3/5/12 – 100mg (pharmacy claim) 4/26/12 – 50mg (medical claim)

69

Synagis DUR – Medical Claims Data from 10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)

Patient 2 A total of 5 doses paid but two paid in same month

(one as pharmacy claim and one as medical claim) plus four claims paid as 100mg but third paid as 50mg. 12/12/11 – 100mg (pharmacy claim) 1/9/12 – 100mg (pharmacy claim) 1/20/12 – 50mg (medical claim) 2/6/12 – 100mg (pharmacy claim) 3/5/12 – 100mg (pharmacy claim)

70

Synagis DUR – Medical Claims Data from 10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)

Patient 3 PA was approved through 4/30/12 but second dose

paid on 6/1/12 and second dose paid for 50mg when first dose was for 100mg. 4/5/12 – 100mg (medical claim) 6/1/12 – 50mg (medical claim)

Patient 4 Only approved for four doses as one dose was

already given in hospital. Five doses were paid for as pharmacy claims and an additional claim was submitted on the medical side that was not paid.

71

Synagis DUR – Medical Claims Data from 10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)Other Dosing Issues per each individual

patientClaims paid on pharmacy side not medical side

First dose paid for 150mg but second through fifth doses paid for 100mg

Claims paid on medical side Doses 1, 2, 3, 5 – 150mg but Dose 4 - 200mg

Claims paid on medical side Doses 1, 3, 4, 5 – 150mg but Dose 2 - 100mg

Claims paid on pharmacy side Dose 1 – 150mg but Dose 2 100mg

Claims paid on medical side Doses 1, 2, 4, 5 – 150mg but Dose 3 100mg 72

Synagis DUR – Medical Claims Data from 10-1-2011 through 6-20-2012 (RSV 2011-2012 Season)

Comments/suggestions ???

73

Synagis - July 2012 AAP Red Book Updates for Synagis ProphylaxisGestational Age 32 weeks, 0 days through 34

weeks, 6 days AND chronological age less than 90 daysSynagis prophylaxis (maximum of 3 monthly

doses) may be considered for infants who have at least 1 of 2 risk factors:1. Infant attends child care, defined as home or

facility where care is provided for any number of infants or young toddlers.

2. One or more older siblings younger than 5 years of age or other children younger than 5 years of age lives permanently in the same household. Multiple births younger than 1 year of age do not qualify as fulfilling this risk factor.

74

Synagis - July 2012 AAP Red Book Updates for Synagis ProphylaxisInfants with congenital abnormalities of the

airway or neuromuscular diseaseImmunoprophylaxis may be considered for

infants who have either congenital abnormalities of the airway or a neuromuscular condition that compromises handling of respiratory secretions. Infants and young children in this category should receive a maximum of 5 doses of palivizumab during the first year of life.

75

Growth Hormone DURIdaho Medicaid’s Pharmacy & Therapeutics

(P&T) Committee requested that the DUR Board look at the utilization numbers of the Growth Hormone class.

The potential exists to save the State money should patients be switched from a non-preferred to a preferred agent. Previously patients have been grandfathered to allow them to remain on their current therapy.

76

Growth Hormone DURDrug Utilization HIC3 = P1A (Growth Hormones) 1/1/2012 –

6/24/2012Product Unique Recipients Total claimsGenotropin 16 65Humatrope 4 15Norditropin Flexpro* 29 112Norditropin Nordiflex*

1 2

Nutropin* 2 5Nutropin AQ* 2 10Nutropin AQ Nuspin* 10 41Saizen 1 4Serostim 1 2Summary of All 66 256* Currently preferred agents

77

Growth Hormone DUR

Comments/Suggestions ???

78

Foster ChildrenPreliminary Idaho Medicaid Data

8/2012

79

80

Use of Psychotropic Medications in Foster Children

Percentage of children (0-17 years old) prescribed psychotropic Medications in named State and year

Foster Children Nonfoster children Ratio of foster to nonfoster children

Florida 2008 22.0% 8.2% 2.7

Massachusetts 2008 39.1% 10.2% 3.8

Michigan 2008 21.0% 7.9% 2.7

Oregon 2008 19.7% 4.8% 4.1

Texas 2008 32.2% 7.1% 4.5

Idaho 2008 38.8% 14.8% 2.6

Idaho 2011 42.9% 14.8% 2.9

Comparison of Idaho Medicaid to Five States in GAO Study

81

Foster Children and Non-Foster Children Population Basis

Year Total # of Foster childrenTotal # of Non-Foster

children

2007 2,384 85,894

2008 2,516 86,419

2009 2,658 96,979

2010 2,718 103,199

2011 2,785 106,024

82

Percentage of Children Receiving Psychotropic Medications Over Time

2007 2008 2009 2010 20110%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Perc

enta

ge o

f Chi

ldre

n

Focus on Calendar Year 2011

83

ADHD Drugs Anti-depressants Mood Stabilizers Atypical Antipsychotics0%

5%

10%

15%

20%

25%

30%

35%

40%

36%

23%

13%

21%

9%

6%

0%

4%

Percent of Foster and Non-Foster Children Psychotropics by Drug Class

Calendar Year 2011

% Foster Children% Non-foster Children

Total foster =2785Total Non-Foster = 106,024

84

ADHD Drugs in Foster Children

0-6 F 0-6 M 7-12 F 7-12 M 13-17 F 13-17 M0.0%

2.0%

4.0%

6.0%

8.0%

10.0%

12.0%

14.0%

Foster Children Receiving ADHD DrugsPercent by Age and Gender

Foster Non-Foster

85

Antidepressants in Foster Children

0-6 F 0-6 M 7-12 F 7-12 M 13-17 F 13-17 M0%

1%

2%

3%

4%

5%

6%

7%

8%

Foster Children Receiving Antidepressants Percent by Age and Gender

Foster Non-Foster

86

Atypical Antipsychotics in Foster Children

0-6 F 0-6 M 7-12 F 7-12 M 13-17 F 13-17 M0.0%

1.0%

2.0%

3.0%

4.0%

5.0%

6.0%

7.0%

Foster Children Receiving Atypical An-tipsychotics

Percent by Age and Gender

Foster Non-Foster

87

Who is Prescribing These Drugs?

Child/Adolescent Psychi-atrist18%

Psychiatrist19%

Behavioral/Develop-mental Pediatrician

7%

Neurologist2%

Pediatrician15%

Family Medicine/Gen-eral Practice

17%

Internal Medicine1%

Nurse Practitioner15%

Physican Assistant6%

Other0%

Prescriber Type by Claims Volume Statewide

88

Regional Prescriber Variation

Specialist Generalist - MD Midlevel 0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Prescriber Type by Region By Percentage of Psychotropic Prescriptions

for Foster Children

Region 1Region 2Region 3Region 4Region 5Region 6Region 7

89

90

Age Distribution

0-6 7-12 13-170%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

Percent of Prescription Volume by Age

Foster Children Psychotropic Drugs Red Flags

8/21/2012

91

Red FlagsFive (5) or more psychotropic medications

prescribed concomitantlyTwo (2) or more concomitant antidepressantsTwo (2) or more concomitant antipsychotic

medicationsTwo(2) or more concomitant stimulant

medications long-acting plus short-acting ok

Three (3) or more concomitant mood stabilizer medications

Psychotropic polypharmacy (2 or more agents) for a given mental disorder prescribed before utilizing psychotropic monotherapy

92

93

Implementation of Red Flags

Retroacti

ve Evaluatio

n

Identify outliers

Profile

Review

DUR Board Intervention• Targ

eted education

Re-evaluation• indi

viduals

• overall

Further

Action

Point of service edits• Informa

tional (soft) – pharmacist override

• Hard Stop

Foster Children with Five or More Psychotropic Medications

August 2012

94

Study ParametersFoster Children with 5 or more distinct

behavioral health drugsService Dates between 11/1/2011 and

4/30/2012 (6 months)N = 5

95

Mental Health Drug List: Stimulants

Stimulantsamphetamine mixed salts generic, Adderall, Adderall XRdextroamphetamine generic, Dexedrine, Dexedrine

Spansulelisdexamfetamine Vyvansemethylphenidate generic, Ritalin, Metadate ER,

Metadate CD, Methylin, Methylin ER, Concerta, Daytrana TD

dexmethlyphenidate generic, Focalin, Focalin XR

96

Mental Health Drug List: Other ADHD Treatments

Other ADHD Treatmentsatomoxetine Stratteraclonidine generic, Catapresguanfacine generic, Tenex, Intunivbupropion generic, Wellbutrin, Wellbutrin

SR, Wellbutrin XRimipramine generic, Tofranil, Tofranil-PMnortriptyline generic, Aventyl, Pamelor

97

Mental Health Drug List: AntidepressantsSSRIcitalopram generic, Celexaescitalopram generic, Lexaprofluoxetine generic, Prozacparoxetine generic, Paxil, Paxil CRfluvoxamine generic, Luvox, Luvox CRsertraline generic, ZoloftSNRIvelafaxine generic, Effexor, Effexor XRduloxetine Cymbaltadesevenlafaxine Pritiq

98

Mental Health Drug List: Mood Stabilizers

Mood Stabilizerscarbamazepine generic, Carbatol, Tegretol,

Tegretol XRdivalproex generic, Depakotelithium generic, Eskalith, Eskalith CR,

Lithobidlamotrigine generic, Lamictal

99

Mental Health Drug List: Second Generation (atypical) AntipsychoticsSecond Generation Antipsychoticsaripiprizole Abilifyasenapine Saphrisclozapine generic, Clozarililoperidone Fanaptlurasidone Latudaolanzapine generic, Zyprexapaliperidone Invegaquetiapine generic, Seroquel, Seroquel XRrisperidone generic, Risperdalziprasidone generic, Geodon

100

Mental Health Drug List: First Generation (Typical) AntipsychoticsFirst Generation Antipsychoticschlorpromazine generic, Thorazinehaloperidol generic, Haldolperphenazine generic, Trilafonpimozide Orap

101

Patient 10115 year old femaleMental Health Diagnoses

Pervasive Developmental DisorderEncephalopathy, otherOppositional Defiant DisorderAttention Deficit with HyperactivityPosttraumatic Stress Disorder

Drug DurationVyvanse 70 mg #30 2 years 5 monthsAmphetamine Salt Combo 10 mg #60 3 years 3 monthsClonidine 0.1 mg #30 10 monthsFluoxetine 10 mg #30 6 monthsGeodon 80 mg #60 1 year 3 monthsGeodon 60 mg #30 1 year 7 months

102

Patient 10516 year old femaleMental Health Diagnoses

Reactive Attachment DisorderPosttraumatic Stress DisorderBipolar Disorder, Unspecified

Drug DurationAmphetamine Salt Combo 20 mg #62

2 years

Sertraline 100 mg #30 1 year 5 monthsOxcarbazepine 600 mg #60 4 yearsLithium 300 mg #120 4 yearsRisperidone 0.5 mg #60 1 year 11 monthsQuetiapine 400 mg #30 6 years

103

Patient 1138 year old femaleMental Health Diagnoses

Bipolar I Disorder, UnspecifiedBipolar I Disorder, Mixed SevereAttention Deficit Disorder with HyperactivityReactive Attachment DisorderUnspecified Delay in Development

104

Patient 113Drug DurationAdderall XR 20 mg #30 3 years 8 monthsAmphetamine Salt Combo 10 mg #30 1 year 7 monthsVyvanse 70 mg #30 1 year 8 monthsClonidine 0.1 mg #120 1 year 11 monthsGeodon 40 mg 1 monthAbilify 30 mg #30 1 year 7 monthsQuetiapine 100 mg #60Quetiapine 200 mg #60Quetiapine 300 mg #30Quetiapine 400 mg #30

Quetiapine was started 5/20/2011. Dose during the evaluated 6 month period 700 mg daily.

105

Patient 11717 year old femaleMental Health Diagnoses

Moderate Intellectual DisabilityUnspecified Developmental DelayBipolar Disorder, Unspecified

106

Patient 117Drug DurationGuanfacine 1 mg #30 2 monthsCitalopram 20 mg #30 1 monthCitalopram 40 mg #30 2 years 4 monthsQuetiapine 200 mg #30 2 years 4 monthsQuetiapine 400 mg #30 2 years 4 monthsRisperidone 1 mg #60 4 years 3 months

107

Patient 12011 year old maleMental Health Diagnoses

Attention Deficit Disorder with HyperactivityUnspecified Episodic Mood DisorderUnspecified Emotional Disturbance of

Childhood or Adolescence

108

Patient 120Drug DurationConcerta 54 mg #30 3 years 8 monthsStrattera 60 mg # 30 10 monthsClonidine 0.1 mg #90 2 years 7 monthsAbilify 5 mg #30 2 monthsQuetiapine * 50 mg #90 1 monthQuetiapine * 200 mg #60 4 monthsQuetiapine * 300 mg #60 2 years 8 months

Patient has been on varying doses of quetiapine since 9/16/2008

109

Proposed Studies for Next Quarter:P&T Committee Narcotic Analgesic Studies –

Next StepsLeukotrienes vs. inhaled corticosteroids in

children with asthmaUse of Psychotropic Medications in Foster

ChildrenTwo (2) or more concomitant antidepressants

Migraine PreventionProphylaxis Utilization in Chronic Triptan UtilizersTopiramate

PA, Medical Claim and Triptan Use MismatchIVIG

110

Leukotrienes vs. inhaled corticosteroids in children with asthmaNumber of recipients < 18 years of age with

paid claim for leukotriene:

Number of recipients < 18 years of age with paid claim for inhaled corticosteroid:

Date # of recipients7/1/2011 – 9/30/2011 3,3691/1/2012 – 3/31/2012 3,059

Date # of recipients7/1/2011 – 9/30/2011 1,5951/1/2012 – 3/31/2012 2,156

111

Use of Psychotropic Medications in Foster Children The U.S. Government Accountability Office

released the results from a study that they performed examining the rates of psychotropic medications for foster and nonfoster children in 2008.

It was determined that HHS Guidance Could Help States Improve Oversight of Psychotropic Prescriptions.

112

Use of Psychotropic Medications in Foster ChildrenMedication Classes included in the report

ADHD drugsAnti-anxietyAnticonvulsantAntidepressantsAnti-enuretic (just desmopressin acetate) Antiparkinson Antipsychotics Combination anti-anxiety and antidepressant Hypnotic Mood stabilizer (just lithium)Sleep aid (just melatonin) 

113

Use of Psychotropic Medications in Foster Children: Next StepsTwo (2) or more concomitant antidepressants

114

Migraine PreventionProphylaxis Utilization in Chronic Triptan

UtilizersSee packet for summary handout

115

Migraine PreventionTopiramate use other than Seizure

Disorder/Migraine HeadacheEvaluate the use of topiramate for non-FDA labeled

indications. Off label use for weight loss Off label use as a mood stabilizer for Bipolar symptoms

All patients on topiramate were evaluated from 1/1/2012 thru 6/30/2012. 1,223 patients on topiramate 949 patients with approved criteria (ICD-9 code in Medical

Profile) of Seizure Disorder/Migraine Headache 274 (22.4%) of patients without approved criteria

Review patients to determine topiramate use other than FDA approved indications

116

IVIG – Intravenous Immune Globulin

Currently prior authorization is not needed for either an outpatient prescription (as long as cost per claim is less than $7500) or for a claim on the medical side.

117

IVIG – Intravenous Immune GlobulinReviewing outpatient prescription claims

between 8/01/2011 and 7/31/2012$279,52779 claims14 patientsAverage cost per prescription: $3538

Claims paid on medical side between 1/01/2011 and 12/31/2011$106,414136 claims37 patientsAverage cost per prescription: $783

118

IVIG – Intravenous Immune GlobulinIn the process of sending out letters to gather

medical information:DiagnosisDosing regimenResponse to therapy

Will review information at October 2012 DUR meeting. Future question to answer: Should IVIG require prior authorization?

119

Prospective DUR ReportHistory Errors:

• DD – drug-to-drug• PG – drug to pregnancy• TD – therapeutic

duplication• ER – early refill• MC – drug-to-disease

Non-History Errors:• PA – drug-to-age• HD – high dose• LD – low dose• SX – drug-to-gender

120

Prospective DUR ReportIdaho Medicaid ProgramProDUR Message Report

July-12 

ProDUR ProDUR Message MessageMessage Severity Count Amount

Drug To Drug 1 1,810 $436,467.09  2 14,750 $2,464,369.13  3 67,726 $11,376,540.02

9 4 $58.07Drug To Gender 1 189 $42,290.26  2 68 $3,956.14Drug To Known Disease 1 63,676 $8,404,657.29  2 239,425 $46,436,371.98  3 290,817 $50,899,774,.57Drug To Pregnancy 1 100 $1,065.85  2 11 $542.34  A 4 $109.25  B 83 $19,811.01  C 224 $22,883.60  D 29 $3,143.66  X 14 $259.81Duplicate Therapy 0 114,360 $24,014,747.46Min Max 0 33,293 $5,183,695.34Too Soon Clinical 0 21,690 $3,721,624.57ALL   848,273 $153,032,367.44               Total Number of Claims with Messages 210,213              Average ProDUR Message Per Claim            4.04 

121

DUR Summer NewsletterCopy of Spring Newsletter in packetBrainstorm for new topics

122

Medicaid Update

123