Idaho Medicaid Drug Utilization Review Program

1. Idaho Medicaid Drug Utilization Review Program 23 August 2012

2. Follow-up to Previous Reviews • Citalopram High Dose 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.

4. 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.

5. Citalopram High Dose DUR • It 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.

6. Citalopram High Dose DUR

7. Citalopram High Dose DUR • Next steps ???

8. Current Interventions/Outcomes Studies • P&T Committee Narcotic Analgesic Studies • Aliskiren DUR • Lupron DUR • Ciprofloxacin DUR • Synagis DUR – Medical Claims Data • Growth Hormone DUR • Psychotropic Medications in Foster Children • Update • Five (5) or more psychotropic medications prescribed concomitantly

9. Narcotic Patterns of Use in Chronic Non-Malignant Pain Complete Report

10. 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 144 Cancer Diagnosis found in 6 • All profiles were hand reviewed by Idaho Medicaid Pharmacists

11. 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

12. Length of Time for Continuous Opioid Use

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

14. Daily Morphine Equivalents Lowest = 10 mg Highest = 2421 mg

15. Number of Prescribers for Opioids

17. Diagnosis/Indications Most patients had multiples diagnoses

18. Average Days Prior to Refill

19. Other Information Gathered • Number on Medicaid Pharmacy Lock-In • 4 currently on lock-in • 1 previously on lock-in, released 1/2011 • Non-Medicaid Opioid Fills • From Board of Pharmacy Reports • 43 of the 144 patients ( 30%) had fills not paid for by Medicaid • Extra number of doses ranged from 2 to 4275 • Concurrent Drug Abuse Diagnosis 56 (39%)

20. Comparison of Intermittent and Complete Review

21. Narcotic Analgesics • DUR Board Recommendations April 2012 • Complete Review for the rest of top 150 patients • Research other state restrictions and initiatives • P&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

22. Review of External Programs and Recommendations

23. PROP – Physicians for Responsible Opioid Prescribing • www.responsibleopioidprescribing.org • Mission 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 Statement PROP 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

24. 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 prescribers • Updated Medication Guide and patient counseling document • Assessment/Auditing

25. Training for Prescribers • Training 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.

26. Updated Medication Guide • Consumer friendly information on the safe use, storage, and disposal of long acting opioids • Signs of potential overdose • Specific advice on safe storage to prevent accidental exposure to family members and household visitors.

27. Assessment/Auditing • Companies 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.

28. PROP Response to FDA Letter sent by PROP to the Food and Drug Administration on July 25, 2012 • Recommendations •  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.

29. PROP Future Activities • National Summit on Opioid Safety • October 31 – November 1, 2012 • Seattle, WA • Keynote Speakers • Roger Chou MD, MPH • Oregon Health & Science University • Jane Ballantyne, MD, MPH • University of Washington

30. Current Activities • Revision 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 Programs • Alaska therapeutic duplication edit • Washington second opinion by pain specialist • Montana case management • Oregon back pain management program

31. Possible Intervention • Education on patients receiving > 500 morphine equivalents per day • From review n = 17 • Content ?

32. Aliskiren DUR • The 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.

33. Aliskiren DUR • Letters 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.

34. Aliskiren DUR response detail as of 8/10/2012 • Note that providers may choose more than one selection per response. • Reviewed and have or will modify the treatment 1 • I will use this information in the care of future pts 1 • My patient, but I did not prescribe this 2 • Not useful to my practice 1 • Info regarding this pt appears to be correct 1

35. 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

36. Aliskiren DUR • Utilization 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

37. Aliskiren DUR • Comments/Suggestions ???

38. Lupron DUR • Reason 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.

39. Lupron DUR • Previously 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

40. Lupron DUR • FDA 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)

41. Lupron DUR • Profiles reviewed for patients with paid Lupron claims between 9/01/2011 and 3/31/2012 (n=25)

42. Lupron DUR • 15 children with precocious puberty – age as of 3/31/2012 • Minimum age: 3 years, 4 months • Maximum age: 14 years, 8 months • Mean age: 9 years, 4 months • 10 women with endometriosis – age as of 3/31/2012 • Minimum age: 17 years • Maximum age: 35 years • Mean age: 23 years • Entered prior authorization approvals for all current patients who are still receiving Lupron therapy (grandfathering).

43. Lupron DUR • Cost 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

44. Lupron DUR • Will 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.

45. Lupron DUR • Approve 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)

46. Lupron DUR • References • Abbott Laboratories. Lupron Depot-PED prescribing information. • Cigna Medical Coverage Policy – Effective date 1/15/2011. • Texas Medicaid Policy.

47. Ciprofloxacin DUR • Rationale 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.

48. Ciprofloxacin DUR • Ciprofloxacin 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.

49. Ciprofloxacin DUR • Retrospective 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.

50. Ciprofloxacin DUR