Minutes Drug Utilization Review Board Meeting June 11, 2008 Meeting Purpose: Quarterly Open Board Meeting 6:00 P.M. - 8:00 P.M. Meeting opened at 6:10 P.M. by Amy Levy, Drug Utilization Review (DUR) Program Director. Agenda Items: I. Welcome and Introductory Remarks II. Acceptance of March 2008 DUR Board minutes III. Suboxone/Subutex Initiative IV. Zetia Quality Assurance Analysis V. DUR Annual Clinical Report VI. MassHealth Drug List VII. DUR Operational Update VIII. MassHealth Update IX. Guest speakers Agenda Item Discussion Conclusions/Follow Up Review of Minutes The Board reviewed and accepted the minutes to the March 12, 2008 DUR Board meeting with no changes noted. Follow Up Action Minutes accepted as written. Agenda Item Discussion Conclusions/Follow Up Suboxone/ Subutex Initiative DUR staff presented a brief and early review of the January 2, 2008, initiative. A discussion took place about how often Suboxone prescriptions are filled for pain control and other non-FDA indications. Dr. Jeffrey noted that Suboxone is now ranked seventh on the MassHealth list of most expensive drugs. There was a brief discussion about illegal use of Suboxone. Conclusions MassHealth Prior Authorization (PA) policy appears to be appropriate. There is no well-documented clinical evidence of improved efficacy or retention in treatment for those patients taking greater than 32mg/day. The duration timeframe and dosage reflects SAMSHA guidelines There is still no conclusive evidence that Suboxone therapy is lifelong, but DUR will keep reviewing the literature and best practice models for potential changes to MassHealth policy. Action DUR will continue to monitor this initiative within the next six to 12 months and make any changes as needed. Agenda Item Discussion Conclusions/Follow Up Zetia Quality Assurance Review Ezetimibe (Zetia) background and recent literature, current approval criteria inclusive of diagnosis, review of utilization and recommendations were presented. ENHANCE trial results were noted. Approvals and denials were presented along with rationale for decisions made. Conclusions Ezetimibe is LDL lowering. Current MassHealth approval and denial procedures are within established guidelines. It was concluded due to newly published concerns about the FDA approval for ezetimibe, as well as high cost, that stricter criteria are needed. Action Clinical criteria for approval will be adjusted to reflect new diagnosis criteria and information from the ENHANCE trial. Agenda Item Discussion Conclusions/Follow Up DUR Annual Clinical Report This new item provides an overview of DUR clinical accomplishments and projects from July 2007 to June 2008. Highlighted were new drug reviews, new clinical guidelines and updates, QA analyses, therapeutic class reviews and finally, initiatives. Currently 19 guidelines are posted online, 10 are in the review process, and 10 are in development. The goal is to post as many clinical guidelines online as possible. Conclusions Currently, DUR manages over140 guidelines. The goal is to consolidate where appropriate and publish them. Action New clinical guidelines will continue to be added to the DUR website. Follow Ups Check the Web site for updates. Agenda Item Discussion Conclusions/Follow Up MassHealth Drug List There are 13 new additions to the MassHealth Drug List effective July 1, 2008. Changes in Prior Authorization status effective July 1, 2008, and July 15, 2008 were noted. Conclusions Follow Ups Action Agenda Item Discussion Conclusions/Follow Up DUR Operational Update DUR Program staff reported that prior authorizations, handling times, queue times, abandonment rates and appeals, all remained fairly consistent. Conclusions Action DUR will continue to monitor the above mentioned areas. Agenda Item Discussion Conclusions/Follow Up MassHealth Update Dr. Paul Jeffrey Dr. Jeffrey reported that the MassHealth fiscal 2009 budget is complete. He’ll present a graphic at the September meeting. The FY09 MassHealth Pharmacy budget accounts for 1.16 million members. Some highlights: 31% of members are in our” in house” managed care plan, 32% of members are in our fee for service plan, and 220,000 have Medicare as their primary insurance coverage. The amount of claims with MassHealth as the secondary payer increased dramatically and continues to do so due to Medicare Part D. Claims paid in January 2007 were 270,000 compared to 470,000 in March 08. On April 1, 2008, we complied with Federal Regulations regarding tamper proof prescription pads. On October 1, 2008, another level of security will be added regarding tamper proof pads. National Provider Identifier (NPI) for physicians went into effect May 20, 2008. Physicians appear to be adapting well. Pharmacy providers have already achieved 100% compliance. There have been media requests about what MassHealth is doing to prevent misuse of behavioral medications in children. DMH, MBHP and the MCOs have partnered to establish a workgroup. Together they will collect data and begin developing strategies that will address this issue. They’ll also try to design interventions for further review. There will be new changes to the pharmacy regulations for August 1, 2008. A new non-drug section will be created and the definition of “electronic prescriptions” will be redefined. 90-day supplies will be allowed when MassHealth is the secondary payer. The MassHealth Drug list will now have regulatory authority to set refill limits on medications and the 340 B provider enrollment forms are being simplified. Conclusions Follow Ups Agenda Item Discussion Conclusions/Follow Up Guest speakers: Nathan Capone of Shire spoke about Vyvanse and presented new data from recent studies regarding it’s usage in children ages six-12 years with ADHD. On April 23, 2008 Vyvanse was approved to treat adults with ADHD. Theresa Cerulli, M.D., shared some patient experiences. She noted that Vyvanse does not get abused and patients claim no associated high with the product. She expressed her professional trust in the drug, that’s why she wanted to express her feelings independently from Shire. Meeting adjourned at 7:40 P.M. Respectfully Submitted, Amy Levy, R.Ph, MHP DUR Program Director