Connecticut Medical Assistance Pharmacy Program Drug Utilization Review (DUR) Program DUR Board Meeting

Transcription

1 December 2012 Minutes ATTENDEES Board Members Present: Kenneth Fisher, R.Ph. (Chair), Keith Lyke R.Ph., Dennis Chapron, M.S., Bhupesh Mangla, M.D., Charles Caley, Pharm.D., Ram Illindala, M.D., Richard Gannon, Pharm.D., Carol Drufva R.Ph. Ex-Officio Non-Voting Member Present: Heather Kissinger, Pharm. D. (HID), James Zakszewski, R.Ph. (DSS), Mark Synol, R.Ph. (HP) Guests: Robert Gallagher (Amgen), James Kolcooyna (Allergan), Terry Lee (Gilead), Tom Radice (ViiV Healthcare) INTRODUCTORY BUSINESS Heather Kissinger called the meeting to order at 6:42 p.m. A. Previous Meeting Minutes Minutes to the September 13, 2012 meeting were approved with no changes. B. Follow-Up from Previous Meeting The Board reviewed section 3 titled Follow-up from the September Follow-up 1, a request was made to know the extent of overlap and different prescribers involved in follow up question #3 from the September DUR meeting (the number of instances of therapeutic duplication of long acting injectable antipsychotics. 10 recipients were found to be receiving Invega Sustenna and Risperdal Consta concurrently from 1/1/2012 through 5/18/2012). Heather reviewed the 10 patient profiles with the Board. Follow-up 2, a request was made to know the numbers of Lidoderm patches per day patients were receiving during the July 2012 cycle when the Lidoderm intervention took place. Heather stated 1297 patients were prescribed 1 patch per day, 273 patients were prescribed 2 patches per day, 163 patients were prescribed 3 patches per day, 4 patients were prescribed 4 patches per day, and 1 patient was prescribed more than 4 patched per day. Carol Drufva stated that the max dose per day is 3 patches per package insert and suggested a hard edit be placed in order to reject claims that exceed 3 patches per day. Heather stated a new criteria would be developed in order to flag patients receiving more than 3 patches per day but the intervention would be retrospective. HP would need the approval of the Department of Social Services to implement a hard edit for Lidoderm quantity limits. Jim Zakszewski stated monitoring could be performed with the retrospective criteria and if the amount of patients receiving more than the recommended dose grew a hard edit would then be considered. 1

2 December 2012 Minutes Follow-up 3, a request was made to look at the Anticholinergic burden formula; look at top patients within the polypharmacy group. Heather stated more clarification was needed in order to build the query being requested. The Board suggested taking the list of drugs found at :// and compile the top 25 patients receiving the most number of drugs on that list during a 3 month period. Once the top 25 patients are pulled, manually review their profiles and calculate their anticholinergic burden over 3 months time. Heather stated she would have this information for the March 2013 meeting. Follow-up 4, a request was made to know that HID s Retrospective DUR criteria reflect the most recent and up to date Beers criteria. Heather stated that yes, HID started out with the original Beers then the updated Fick s review and now the AGS Beers update. Follow-up 5, a request was made to know if a diagnosis comes later to explain the kids with ADHD who are receiving antipsychotics. (Question stemmed from the review of the Pediatric Criteria Trend Summary 2011, criteria 3235 Alert Message: The patient is under the age of 18 with a diagnosis of ADHD and is receiving an atypical antipsychotic with no evidence, in their diagnostic history, of a FDA approved indication for use. Atypical antipsychotics have not been shown to be safe and effective for the treatment of ADHD. These agents have significant adverse effects which can be more prevalent and severe in pediatric patients.) Heather stated that another review would have to be performed to know if the appropriate diagnosis comes later to explain why children with ADHD are receiving antipsychotics, but if this same criteria were run to determine if these patients are continuing to hit on this criteria it could mean two things if the patient is no longer being flagged by criteria 3235: 1. The patient is no longer receiving the antipsychotic or 2. The patient does have a valid diagnosis for use of the antipsychotic Jim questioned if the alert message should include information regarding the Federal push to review mental health drugs in the foster care children and pediatrics in general. Heather stated that criteria can be customized by the Board. The Board requested to review follow-up 5 during the March 2013 meeting to have Angela s input. Follow-up 6, a request was made to know the specifics regarding criteria 899 and muscle ache/fatigue. (Alert Message: The simvastatin-containing agent may be over-utilized. The recommended dosing range for simvastatin is 5 to 40 mg per day. Exceeding the recommended range may increase the risk of adverse effects, including the occurrence of myopathy and/or rhabdomyolysis. The use of an 80 mg dose of simvastatin should be restricted to 2

3 December 2012 Minutes patients who have been taking simvastatin chronically (e.g., 12 months or more) without evidence of muscle toxicity. Heather stated that patients must get at least a 21 day supply in the most current 90 days (with claim in the most recent claims data) and the dose per day exceeds the dose limit value. The reviewer determines if the patient has been receiving the drug for > 12 months or if they have any diagnoses to indicate muscle toxicity. There are no negating and inclusive diagnoses built into the criteria. Follow-up 7, a request was made to review short-acting opiates > = 90 days (negating with a long-acting opioid) with 120 morphine equivalents as a cutoff. Heather stated that the query was requested to flag patients receiving any short acting opiate for >= 90 days during 2012 at or above the following doses, negate patients who are receiving any long acting opiate. Codeine 800mg per 24hrs Hydrocodone 120mg per 24hrs Hydromorphone 30mg per 24hrs Morphine 120mg per 24hrs Oxycodone 80mg per 24hrs Oxymorphone 40mg per 24hrs The query results would be released during the March 2013 meeting. HID does have a criteria that flags patients receiving short acting opiates without a long acting opiate but does not take into account specific doses. C. Criteria Trend Summary Heather discussed the criteria trend analyses tables included in the DUR Board meeting packet. The tables list the number of criteria exceptions found before and after DUR intervention letters are mailed. Criteria are suppressed for patients who are selected for intervention for 6 months after letters are mailed so that prescribers do not receive the same letter for the same patient month after month. In almost all cases the number of criteria exceptions noted 6 months after DUR letters were mailed was reduced as compared to the number of exceptions prior to letters being mailed. Charles Caley noted that the intervention reviewed during April 2012, Additive Anticholinergic Effects (problem code 030), did not fully describe what type of intervention was performed. Heather stated she would provide a specific list of criteria that make up problem code 030. D. Program Summary Review The Board reviewed the program summary for 2 nd and 3 rd quarter Heather stated that during 2 nd quarter 2012 prescription claims cost was approximately $190 million, the number of prescriptions in the 2 nd QTR were approximately 2.1 million, the number of unique recipients receiving a prescription was approximately 330,000 and the average paid per prescription was $

4 December 2012 Minutes During 3 rd quarter 2012 prescription claims cost was approximately $175 million, the number of prescriptions in were approximately 2 million, the number of unique recipients receiving a prescription was approximately 326,000 and the average paid per prescription was $84.36 D. Intervention Activity Report Heather reviewed the Intervention Activity Report included in the DUR Board packet. It was stated that the Intervention Activity Report is a monthly summary of the distribution of letters mailed to prescribers and also summarizes the main criteria that were reviewed each month. In July 2012, 2,899 profiles were reviewed and 2,237 letters were sent. The main interventions reviewed for the adult population were: Lidoderm (transdermal lidocaine) is FDA approved only for the relief of pain associated with postherpetic neuralgia. Our records do not indicate a supporting diagnosis for the use of this medication. The long-term safety and\efficacy of this agent in treating other disease states is unknown. (848 letters) Lock-in criteria (323 letters) The main intervention reviewed for the pediatric population was: The effects of prolonged use of atypical antipsychotics in pediatric patients are unknown. Preliminary evidence suggests that pediatric patients experience more prevalent and severe adverse effects than those reported in adults (e.g., weight gain, extrapyramidal side effects, and insulin resistance). If therapy with these agents is clinically necessary use the lowest effective dose and observe patients closely for adverse events. If adverse effects cannot be controlled consider switching, if clinically possible, to a Second Generation Antipsychotic with a more favorable adverse effect profile. (55 letters) In August 2012, 2,852 profiles were reviewed and 2,187 letters were sent. The main interventions reviewed for the adult population were: Underutilization of Diabetic Medications. (706 letters) Lock-in criteria (662 letters) The main intervention reviewed for the pediatric population was: The effects of prolonged use of atypical antipsychotics in pediatric patients are unknown. Preliminary evidence suggests that pediatric patients experience more prevalent and severe adverse effects than those reported in adults (e.g., weight gain, extrapyramidal side effects, and insulin resistance). If therapy with these agents is clinically necessary use the lowest effective dose and observe patients closely for adverse events. If adverse effects cannot be controlled consider switching, if clinically possible, to a Second Generation Antipsychotic with a more favorable adverse effect profile. (300 letters) 4

5 December 2012 Minutes In September 2012, 2,853 profiles were reviewed and 2,400 letters were sent. The main interventions reviewed for the adult population were: Inappropriate Therapy for the Elderly. (683 letters) Lock-in criteria (937 letters) The main intervention reviewed for the pediatric population was: The effects of prolonged use of atypical antipsychotics in pediatric patients are unknown. Preliminary evidence suggests that pediatric patients experience more prevalent and severe adverse effects than those reported in adults (e.g., weight gain, extrapyramidal side effects, and insulin resistance). If therapy with these agents is clinically necessary use the lowest effective dose and observe patients closely for adverse events. If adverse effects cannot be controlled consider switching, if clinically possible, to a Second Generation Antipsychotic with a more favorable adverse effect profile. (373 letters) E. RetroDUR Criteria New Criteria Following criteria as written in the DUR Board packet were approved by the DUR Board 1. Omega-3-Acid Ethyl Esters / Therapeutic Appropriateness 2. Omega-3-Acid Ethyl Esters / Overuse 3. Omega-3-Acid Ethyl Esters / Therapeutic Duplication 4. Omega-3-Acid Ethyl Esters / Anticoagulants **The Board requested to know the specific anticoagulants that are in util B in criteria 4 5. Omega-3-Acid Ethyl Esters / Pregnancy / Pregnancy Negating 6. Omega-3-Acid Ethyl Esters / Hepatic Impairment 8. Omega-3-Acid Ethyl Esters / Non-adherence 9. Dronedarone / Therapeutic Appropriateness 11. Mirabegron / High Dose 12. Mirabegron / Severe Renal Impairment or Mod. Hepatic Impairment 14. Mirabegron / Bladder Outlet Obstruction 15. Mirabegron / Antimuscarinic Medications 16. Mirabegron / Digoxin 17. Mirabegron / Pediatric Patients 18. Mirabegron / Drugs Metabolized by CYP2D6 19. Stribild / Other Antiretroviral Therapy 20. Fosamprenavir / Delavirdine 21. Revatio / Children 1-17 years of Age 22. Didanosine / Ribavirin 23. Stribild / Non-adherence 24. Complera / Non-adherence 25. Complera / All Other Antiretroviral Agents 26. Forfivo XL / Overutilization 27. Forfivo XL / Therapeutic Appropriateness (0-18 yoa) 28. Bupropion / Ticlopidine & Clopidogrel 5

6 December 2012 Minutes Charlie requested to know if an additional criteria should be developed to address the possible drug drug interaction between bupropion and methadone and bupropion and methotrexate since both methadone and methotrexate are mild 2B6 inhibitors. Heather stated she would research this and follow-up during the March 2013 meeting. The following criteria were approved as amended by the DUR Board 10. Dronedarone / Pulmonary Toxicity, removal of dyspnea from util B The following criteria were tabled by the DUR Board 13. Mirabegron / Hypertension & Antihypertensive Medications The Board requested to know if there is a diagnosis of malignant hypertension that could be used in Util B instead of the hypertension ICD9s and antihypertensive medications. The following criteria were rejected by the DUR Board: 7. Omega-3-Acid Ethyl Esters / Atrial Fibrillation or Flutter The following criteria that were tabled during the September 2012 meeting were approved: 12. Darunavir / Kaletra 13. Darunavir / Saquinavir F. Newsletter Mark Synol reminded HID to obtain an updated provider address file from HP for the newsletter mailings. The Board approved the December 2012 DUR Newsletter with the following modifications: o Remove or bacterial from the last sentence in the first paragraph. o Unjustify of ABRS in the last sentence on the first page. The Board requested the March 2013 Newsletter cover anticholinergic burden information. NEW BUSINESS The 2013 meeting dates were selected: o March 28, 2013 o June 13, 2013 o September 12, 2013 o December 12, 2013 The meeting was adjourned at 8:00pm. 6