Minutes Drug Utilization Review Board Meeting March 11, 2009 Meeting Purpose: Quarterly Open Board Meeting 6:00 P.M.-8:00 P.M. Meeting opened at 6:07 P.M. by Chair, Brian O’Neil. Agenda Items: I. Welcome and Introductory Remarks II. Acceptance of December 2008 DUR Board Minutes III. Antiemetic Initiative IV. Aldara Initiative V. Xifaxan Initiative VI. MassHealth Drug List VII. DUR Operational Update VIII. MassHealth Update: Paul Jeffrey Agenda Item Discussion Conclusions/Follow Up Review of Minutes Conclusions Minutes were approved as written. Action A motion to approve the December 2008 minutes was made and seconded. Follow up Agenda Item Discussion Conclusions/Follow Up Antiemetic Initiative A 5-HT3 receptor antagonists QA analysis was presented. A brief background, review of the current MassHealth quantity limits, analysis of recent utilization data and PA requests and discussion of the recommendations was given. Utilization data from July 1, 2008, through December 31, 2008, was reviewed. The number of MassHealth PAs for the same time period was reviewed along with the number of denials and approvals. Action There were no questions or comments. Conclusions It was concluded that the vast majority of requests were for ondansetron. The addition to Sancuso to the MassHealth Drug List requiring authorization is not reflected due to the rollout being February 2009. It was further concluded that the majority of patients with hyperemesis gravidarum are approved; however there are some noteworthy findings in the approvals and denials. Main issues revolve around whether the member had documented weight loss and the number of alternatives tried. Several recommendations were made. It was recommended that clarification be added to the guideline regarding approval in hyperemesis gravidarum, that MassHealth select a preferred agent, due to cost differential, that ondansetron HCL tablets (excluding ODT) and solution be selected as the preferred agents in this class and that current quantity limits for ondansetron products would remain in effect and the other agents would require prior authorization for all quantities. Other conclusions regarded indications in the guideline, that would remain the same with a requirement of two non-5-HT3 receptor antagonists before approval of ondansetron. Lastly, due to the new black box warning on metoclopramide, it was recommended that it is not suggested as an alternative agent, however it is counted as a trial towards approval in this class. Follow Up Aldara Initiative The objectives of this initiative were to review the FDA-approved indication for imiquimod, to compare it with alternative agents with similar indications, to analyze the prior authorization procedures for it, to provide an overview of utilization among MassHealth patients, and to discuss results of placing it on prior authorization. A background and cost comparison was presented. The drug is used for the treatment of external genital and perianal warts. Backgrounds, treatments and cost comparisons for actinic keratosis (AK), superficial basal cell carcinoma (sBCC) and external warts (GW) were presented. Action Conclusions: - The clinical benefit of imiquimod over less costly alternative options was not established. - Current practice guidelines do not designate imiquimod as first line for any indication. - Utilization reports indicate that placing the drug on prior authorization has been associated with a decrease in cost for this medicine. - Paid claims for less costly alternatives including podofilox and fluorouracil have increased in response. - Total unique utilizers of agents for the treatment of AK, sBCC and GW has decreased. Agenda Item Discussion Conclusions/Follow Up Xifaxan Initiative Xifaxan received FDA approval on May 25, 2004, for treatment for patients aged 12 years old and older with traveler’s diarrhea caused by noninvasive strains of E. coli with a recommended duration of treatment for three days. Currently there is no MassHealth prior authorization for the drug. The purpose of this QA analysis was to assess utilization to inform potential revisions of the prior authorization status. Utilization data from February 1, 2008, to January 31, 2009, was reviewed. Standard dosing and coverage by other payers was presented. There were 814 paid claims for 215 unique utilizers of rifaximin during the 12 month period. The average cost per claim equaled $513 and the average quantity per claim was 124. Why are doses so high? There are several possible factors (the treatment of Crohn’s is one possibility); this is why quantity limits are recommended. It was suggested that perhaps the number of prescribers along with the number of utilizers be looked at. Conclusions It was concluded, looking at the presented data, that current utilization as measured by average quantities per claim suggests that this product is being prescribed to a significant extent for off labeling indications. Change the MassHealth Drug List status of this drug to require prior authorization for quantities greater than nine tables every 30 days after documenting alternatives. Action Follow up In the event that rifaximin is approved for additional indications, the guidelines could be further modified to adjust the quantity limits (but retain the requirement of documented failed trials of less costly alternatives). Agenda Item Discussion Conclusions/Follow Up MassHealth Drug List There will be 13 new additions to the drug list effective May 4, 2009. Eurax and Ovide will no longer requiring prior authorization. There will be changes in prior authorization status with prostaglandin analogs (Lumigan, Travatan and Xalatan), intranasal corticosteroids (Nasacort ZQ) and oral antibiotics (Xifaxan). Tables 1, 4, 25, 41, 42, and 43 will be added to the MassHealth Drug List. Conslusions With the addition of the new six therapeutic class tables, the Drug List continues to evolve. Please see www.mass.gov/pharmacy for the most current changes to the MassHealth Drug List. Action Follow up Agenda Item Discussion Conclusions/Follow Up DUR Operational Update The number of PA requests as well as call volume remains consistent. The abandonment rate is almost 2% or less. Regarding appeals, the number of no shows was greater in January with no specific drug classes noted. Conclusions Follow up Continue to monitor the DUR metrics. MassHealth Update Dr. Paul Jeffrey MassHealth has been extremely busy with the progress of the NewMMIS communication/information system which has a projected “live” date on May 26, 2009. Dr. Jeffrey expressed how impressed he has been with the scope of this project and he noted that we are well prepared for what will follow. Providers will be able to access much Web-based information. He also noted that providers should pay special attention to any MassHealth mailings they may get, due to all the changes that are and will be taking place. One such change is that MassHealth is about to select the next generation of managed care partners. The process has begun and it’s a huge effort. The PCC plan is undergoing transformation as well; new elements regarding primary care are being added. Some will be “in house” and some will be contracted. The MassHealth initiative entitled “medical homeness” and care management was discussed. Utilization management in Dr. Jeffrey’s office is changing as well. There is much communication and strategy taking place regarding atypical antipsychotic use. An educational campaign to encourage prescribers to use these drugs optimally is underway. How the campaign will roll out to primary care provider groups is undetermined, but MassHealth will try to engage as many folks as possible. Our first effort will be in collaboration with the Office of Medicaid and Department of Mental Health. Regarding the Pharmacy Program, we are about to re-procure claims processing and will be going out to bid for a new pharmacy processing program. The budget crisis continues to make things difficult; the President’s economic stimulus package ($1.2 B) has gone through but we are not sure how those funds will be dispersed. Governor Patrick will make those decisions. We previously cut over $1B from the fiscal year so we may have the opportunity to restore some of those cuts. Dr. Jeffrey noted that the FY10 pharmacy budget is light: $20M. Another initiative is regarding the special pharmacy program. It was asked how long it would take for this initiative to occur and Dr. Jeffrey replied that it will depend on when it gets into regulation (if necessary). Alternative strategies will also be considered. Conclusions Follow up Dr. Jeffrey will continue to keep this group apprised of future changes. Before the meeting closed Brian O’Neil was presented with a commemorative desk clock in thanks and appreciation for his service to the DUR Board as Chairperson. Meeting adjourned at 7: 15 pm. Respectfully Submitted, Vincent Palumbo, R.Ph. DUR Program Director