Idaho Medicaid Drug Utilization Review Program

1. Idaho Medicaid Drug Utilization Review Program 19 April 2012

2. Follow-up to Previous Reviews • Citalopram High Dose • Transdermal Testosterone Intervention • Colchicine DUR • Ketorolac DUR

3. Citalopram High Dose DUR • FDA 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. • A review of Idaho Medicaid Recipients showed that during the previous 3 months 234 recipients had received doses greater than 40 mg per day.

4. Citalopram High Dose DUR • Letters were sent out about 235 patients on 10/6/2011 to 186 prescribers with a list of their patients along with the FDA Safety Announcement and Survey Response Form. (see Letter and Announcement in Packet) • As of 4/11/2012, 60 responses have been received (32% response rate) • 1 additional response since last DUR Meeting

5. Citalopram High Dose DUR: Response Detail as of 4/11/2012 • Note that providers may choose more than one selection per response. • Will use this information for care of future patients 29 • Reviewed info and have modified or plan to modify treatment 28 • Found Info clinically useful and plan to monitor patients 22 • Reviewed info and do not believe adjustment is necessary 19 • Will change dose 19 • Very useful to my practice 18 • Extremely useful to my practice 15 • Somewhat useful to my practice 10 • Not useful to my practice 6

6. Citalopram High Dose DUR: Response Detail as of 4/11/2012 • Note that providers may choose more than one selection per response. • Previously saw this patient, but no longer in my care 5 • Attempted to modify the therapy, but the patient response was not favorable 5 • Will discontinue medication 3 • Patient is under my care, but I am not prescriber for this med 2 • I am not the provider for this patient 1

7. Citalopram High Dose DUR:Response Detail as of 4/11/2012 (one additional comment from last meeting) • “Pt is no longer on this. It was changed to Effexor when she was hospitalized, thanks.”

8. Citalopram High Dose DUR • Recommendations • Decrease the maximum daily dose to the FDA recommended 40mg. • Require a quantity override Prior Authorization for any claims with a dose greater than 40mg per day.

9. Citalopram High Dose DUR • 2 patients currently receiving 60mg daily • Both times pharmacy overrode with: • TD – Therapeutic Duplication • M0 – Prescriber consulted • 1G – Filled, prescriber approval • Idaho Medicaid Pharmacy Clinical Call Center has been receiving PA requests for 60mg stating patient is stable on current regimen with no mention of awareness of the new FDA Safety announcement. These requests are being denied. • Example of recent PA request (see packet)

10. Citalopram High Dose DUR • On 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.

11. Citalopram High Dose DUR • Report ran looking at data from 1/1/2012 to 3/25/2012 and there were 76 recipients receiving 40mg of citalopram daily who were over the age of 60. • Should a new RetroDur activity be done on this patient population?

12. Transdermal Testosterone Intervention • The Idaho Medicaid Pharmacy and Therapeutics Committee recommended that therapeutic criteria be set up on this class of medication including testosterone levels as part of the criteria. • RetroDur activity was completed and new criteria was implemented based on these recommendations.

13. Transdermal Testosterone Intervention • 48 prescribers with 52 recipients were identified and letters along with the educational handout and PA form were sent out to the prescribers. (see packet) • As of 4/11/2012, 24 completed PA forms (46%) were sent in and 1 returned saying they were not the prescriber. • As of 4/11/2012, 3 new PA requests have come in which were not part of the DUR Intervention. • 18 out of the 27 PA requests (67%) were approved. • 5 recipients are no longer on therapy • 22 recipients will have claim deny on next fill at pharmacy.

14. Colchicine DUR • Historical Perspective • In June 2006, the FDA announced a new drug safety initiative to remove unapproved drugs from the market, including a final guidance entitled “Marketed Unapproved Drugs-Compliance Policy Guide (CPG)”. • Notice that any illegally marketed product is subject to FDA enforcement at any time • Clarified that the FDA intends to use a risk-based approach to enforcement • July 29, 2009: Colcrys® approved for Familial Mediterranean Fever (FMF) • July 30, 2009: Colcrys® approved for Acute Gout Flares • October 16, 2009: Colcrys® approved for Chronic Gout

15. Colchicine DUR • October 1, 2010: FDA sent out a notice that it intends to initiate enforcement action against any marketed and listed unapproved single-ingredient oral colchicine product that is manufactured on or after November 15, 2010, or that is shipped on or after December 30, 2010.

16. Therapeutic Criteria for Colcrys® • Acute Gout • Contra-indication and/or failure to NSAIDS or corticosteroids • Chronic Gout • Adjunct to allopurinol AND contra-indication or failure to NSAIDS

17. Colcrys’® Utilization • Utilization Overview

18. Therapeutic Criteria for Colcrys® • The Idaho Medicaid Pharmacy & Therapeutics Committee has recommended that no PA be required for acute cases. • Pharmacies do have the ability to use a 3 day emergency override if the prescription falls under the appropriate criteria.

19. Ketorolac DUR • Historical Perspective: • Discovered that in the drug profiles the Maximum Quantity was set at 10 tablets per day. • The Maximum Quantity was immediately changed to 4 tablets per day as recommended by the package insert. • Report was generated to see how many patients have actually received doses higher than the recommended amount and based on this report it was felt that a Retrospective DUR would be appropriate.

20. Ketorolac DUR • Maximum quantity per day reduced from 10 to 4 tablets on 5/24/2011 • Utilization Overview: • DUR letter sent on 6/20/2011 to 9 prescribers • 3 patient profiles provided in packet to review

21. Current Interventions/Outcomes Studies • P&T Committee Narcotic Analgesic Studies • Ophthalmic Antibiotic/Steroid Combinations • Atopic Dermatitis • Senator Grassley Letter • Protease inhibitors and statins • Synagis 2010-2011 Season

22. Narcotic Patterns of Use in Chronic Non-Malignant Pain Intermittent Report

23. Profile Review • Generated 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 thus far 90. Cancer Diagnosis found in 3. • All profiles were hand reviewed by Idaho Medicaid Pharmacists • Diagnoses were hand searched from electronic records since medical diagnosis codes were unavailable in RetroDUR database

24. Review Focus • Years of opioid use • Number of different opioids used • Daily morphine equivalents • Number of different prescribers • Other concurrent potentially addictive drugs • Diagnosis or indication for chronic opioid use • Average days between refills • History of abuse diagnosis • Currently in lock-in program? • Additional opioid use outside of Medicaid

25. Length of Time for Continuous Opioid Use

26. Number of Different Opioids Average = 2.6 Includes different drugs or dosage forms May or may not be concurrent, but over course of therapy

27. Daily Morphine Equivalents Lowest = 10 mg Highest = 1080 mg Average= 202 mg equivalents

28. Number of Prescribers per Participant

30. Diagnosis/Indications Most patients had multiples diagnoses

31. Average Days Prior to Refill

32. Other Information Gathered • Number on Medicaid Pharmacy Lock-In • 3 currently on lock-in • 1 previously on lock-in, released 1/2011 • Non-Medicaid Opioid Fills • From Board of Pharmacy Reports • 30 of the 87 patients had fills not paid for by Medicaid • Extra number of doses ranged from 2 to 1719

33. Summary of Narcotic Study- 1 • 87 of the top 150 were evaluated for time period of 5/2011 through 12/2011 • The average patient evaluated had been receiving narcotic analgesics f0r 9.8 years • Each patient was on an average of 2.6 different narcotic analgesics • Daily total morphine equivalents ranged from 10 mg to 1080 mg with average being 202 mg • The patients saw an average of 2 different prescribers for their narcotic prescriptions

34. Summary - 2 • Most patients were on concurrent potentially addictive drugs • Most common were benzodiazepines with or without muscle relaxants or sedative hypnotics • The most common diagnoses were lumbago/back pain and chronic pain syndrome • Three patients were currently on pharmacy lock-in • 34 % of the patients had opioid prescriptions paid outside of Medicaid pharmacy benefit with extra doses up to 1719 for the 8 month period

35. Next Steps

36. Ophthalmic Antibiotic/Steroid Combinations • The P&T Committee requested a DUR to evaluate whether the prescribing physicians were specialists (ophthalmologists), primary care, or ER prescribers. Also included in the review will be the age of the recipients.

37. Ophthalmic Antibiotic/Steroid Combinations • Ophthalmic Antibiotic/Steroid Combinations by Provider Type (see packet)

38. Ophthalmic Antibiotic/Steroid Combinations

39. Next Steps

40. Atopic Dermatitis • The P&T Committee requested a DUR on this drug class to include patterns of use, presence or absence of step up therapy from steroids, specialty of prescribers and geographic region differences of prescribing patterns. The DUR should include an educational piece on risks of these agents compared to risks from steroids since many practitioners seem to be using these agents to spare patients from steroid exposure.

41. Atopic Dermatitis • Atopic Dermatitis (AD) is a chronic relapsing, pruritic, inflammatory skin condition that most commonly affects children. • 60-65% of patients develop AD before age 1 • 85-90% of patients have developed signs of their disease by age 5. • Lifetime prevalence is estimated between 10-20% in children and 1-3% in adults. • It is estimated that close to $2.6 billion is spent yearly on the disease in the United States.

42. Atopic Dermatitis • The cause of AD appears to be a result of interactions between genetics, environment, skin barrier defects, and the immune system. • AD persists on average 4.4 years in children and 18.2 years in adults. • The disease typically improves as children get older; however, up to 40% does not and recurs into adulthood. • Triggers may include aeroallergens, climate, emotional stress, hormones, food, irritants, and microbes.

43. Atopic Dermatitis • Treatment • Emollients are considered mainstay of maintenance therapy • Topical corticosteroids are the standard of care which other treatments are compared and are considered first-line treatments for flare-ups. • Local side effects include striae, atrophy, and telangiectasia. • Systemic side effects including hypothalamic-pituitary-adrenal axis suppression, reduced linear growth in children, and bone density changes in adults are the most worrisome. There is no conclusive evidence that appropriately used topical steroids cause significant systemic adverse effects. • Topical corticosteroids should be used for the shortest duration possible to control the flare-up.

44. Atopic Dermatitis • Treatment • Sedating antihistamines are useful when patients have sleep disturbances and concomitant allergic conditions. • Antibiotics should be reserved for patients with acutely infected lesions. • Topical calcineurin inhibitors should be second-line treatments for flare-ups and maintenance. • Local side effects include skin burning and irritation. Patients should also be counseled on proper sun protection. • Black Box Warning – discussed on next slide

45. Atopic Dermatitis

46. Atopic Dermatitis • In March 2010, the FDA issued a public health advisory about the potential cancer risk associated with the use of Elidel (pimecrolimus) and Protopic (tacrolimus) products applied to the skin. • This was based off of information from animal studies, case reports in a small amount of patients, and how the drugs work. • The FDA recommends that healthcare providers, patients, and caregivers consider the following: • Use these products only as second-line agents as short term and intermittent treatment. • Avoid the use in children under the age of 2. • Use for a short period of time, not continuously. • Children and adults with a weakened or compromised immune system should not use these products. • Use the minimum amount of the products needed to control the patient’s symptoms.

47. Atopic Dermatitis • References • http://www.aad.org/skin-conditions/dermatology-a-to-z/atopic-dermatitis. Retrieved March 22, 2012. • Hanifin, J.M., Cooper, K.D., Ho, V.C., Kang, S., et al. Guidelines of care for atopic dermatitis. Journal of the American Academy of Dermatology. 2004;50:391-404. • Peterson, J.D., Chan, L.S., A Comprehensive Management Guide for Atopic Dermatitis. Dermatology Nursing. 2006;18(6):531-542. • Buys, L.M., Treatment Options for Atopic Dermatitis. Am Fam Physician. 2007;Feb 15;75(4):523-528. • http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm153525.htm. Retrieved March 16, 2012. • http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm153941.htm. Retrieved March 16, 2012. • Elidel [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corp.; July 2010. • Protopic [package insert]. Deerfield, IL; Astellas Pharma US, Inc.; November 2011.

48. Atopic Dermatitis • Topical Immunomodulators 2011 Table (see packet) • Topical Immunomodulators 2011 Sorted by City Table (see packet)

49. Atopic Dermatitis Region Map

50. Atopic Dermatitis