Minutes Drug Utilization Review Board Meeting DATE: September 15, 2010  Meeting Purpose: Quarterly Open Board Meeting Meeting opened at 6:10PM by Chair, Patrick Reilly. Agenda Items: I. Welcome and Introductory Remarks II. Acceptance of June 2010 DUR Board Minutes III. Pulmonary Arterial Hypertension Initiative IV. Antidiabetic Initiative V. Palivizumab Initiative VI. MassHealth Drug List VII. DUR Operational Update VIII. MassHealth Update: Dr. Paul Jeffrey Agenda Item Review of June 2010 Minutes Discussion Motion to approve June 2010 Minutes as written. Motion seconded. Conclusions/Follow Up Follow Up Action The Chair welcomed and introduced the two new board members. Conclusions: Minutes approved as written. Agenda Item Pulmonary Arterial Hypertension Discussion Pulmonary Arterial Hypertension (PAH) was discussed, reviewed, summarized and medication costs were highlighted. Background information was provided in regard to World Health Organization (WHO) and New York Heart Association (NYHA) guidelines. Contraindications/ precautions were noted. Ambrisentan and bosentan are contraindicated in women who are or may become pregnant. The respective black box warning and restricted distribution program was also mentioned. A brief discussion ensued regarding the high cost of Revatio and Viagra. A question was also raised regarding the cost effectiveness of Viagra versus Revatio. Letairus and Tracleer’s unique utilizers were reviewed. The majority of members with paid claims for these agents had previously been denied claims for Revatio and Adcirca. Although significantly lower-priced, the current PA restriction on Viagra and Revatio may have lead to the use of more expensive, non-PA agents. Conclusions/Follow Up Follow Up A follow up on whether Viagra might be more cost effective than Revatio will be provided. Action Conclusions: It was recommended that all oral PAH agents be placed on PA with a look back for diagnosis and preferred PDE5 agents. No changes were recommended for epoprostenol which will remain on the MHDL without PA. Prior authorization will be required for the remaining agents with rationale for bypassing epoprostenol. All members currently stable on an agent will continue with lifetime approvals. A POS rule will be developed to look back for epoprostenol in addition to prescriber specialty. It was also recommended that quantity limits are developed due to level pricing on Ambrisentan (30 tablets/30days), Bosentan 62.5 mg and 125 mg: 60 tablets/30 days, and Iloprost: 90 vials/30 days. Agenda Item Antidiabetics Discussion The current MassHealth guidelines were reviewed. Current utilization of Antidiabetic agents that require PA was assessed. A sampling of prior authorization requests was highlighted. A discussion took place regarding the current treatment guidelines for the management of type 2 diabetes along with current safety concerns. Utilization data for single entity agents and combination agents was presented. A summary of approvals and denials followed. Of 297 prior authorizations, there were 151 approvals, 146 denials, 34 recertifications and initial denial rate of 49%. Januvia and all other agents combined were reviewed along with PA requests by agent between December 1, 2009 and May 31, 2010. Diabetes treatment guidelines were covered. There was a discussion following the presentation of this initiative. It was noted that placing Actos and Avandia on PA would ensure appropriate use. Conclusions/Follow Up Follow Up Action Moving forward Actos/Avandia will require prior authorization effective January 1, 2011. The approval criteria for all agents requiring PA will be adjusted. The prior authorization requirement for generic combination agents will be removed effective November 1, 2010. POS rules for stability will be added for Januvia and Onglyza. Additional POS rules will be formulated based on newly developed criteria currently in process. Conclusions: Regarding safety concerns: On August 24, 2010, a study published in the AHA journal Circulation found no difference in risk of heart disease/death between Actos and Avandia. Approximately 4% of patients taking either drug suffered a heart attack, heart failure, both, or died over a 33 month period. Agenda Item Synagis Initiative Discussion Background was provided regarding the prevalence of Respiratory syncytial virus (RSV), its impact on high risk infants, goal of prophylaxis, the RSV season and recommendations from the American Academy of Pediatrics. Dosing: five doses for most infants. During the 2009-2010 season, October 1, 2009 to March 31, 2010, there were 295 unique utilizers and 1,157 claims. Total amount paid was $1,857.957. Trends from 2006-2010 were highlighted. Prior authorization requests from October 1, 2009 to March 31, 2010 were 614. There were 402 approvals, 212 denials, with a 34.5% denial rate. It was pointed out that the West and Northwest regions of Massachusetts had no claims for Synagis. Prophylaxis can cost $10,000 per infant in a single season. Conclusions/Follow Up Follow Up Suggestion arose regarding the need for a prescriber outreach program. There are a number of PA approvals that are not associated with a subsequent paid claim. There were 402 approvals yet only 295 unique utilizers. Possible reasons could stem from third party payer involvement and/or hospitalization. Perhaps remote locations could also be a factor. Action No changes were recommended to the approval criteria for the 2010-2011 season. Training sessions for consultants will occur in September. DUR will begin reviewing requests on October 1, 2010. Conclusions: Palivizumab is indicated for the prevention of serious lower respiratory tract disease caused by RSV. Certain groups of children are at a higher risk of hospitalization. This drug is effective yet costly. DUR relies on the recommendations developed by the AAP. A yearly quality assurance analysis is conducted to review utilization and trends. Agenda Item MHDL Update Discussion There will be 25 new drugs added to the MassHealth Drug List, effective November 1, 2010. Drugs requiring prior authorization effective January 1, 2011, were listed as well as changes to the over the counter drug list. Conclusions/Follow Up Follow Up Action The following new therapeutic class tables will be added to the MHDL with evaluation criteria and cost data on November 1, 2010: Table 50- Modafinil products Table 51- Glaucoma agents Prior authorization forms for Modafinil products (November 1, 2010) and Antidiabetic agents (January 1, 2011) will be added to the MHDL. Conclusions: Agenda Item DUR Operational Update Discussion Prior authorization requests peaked in March, 2010 with 7,593 requests DUR call volume also peaked in March, 2010 with 9,077 calls. It was noted that March had five weeks. DUR call statistics noted abandonment rates, average time of abandoned calls, average queue time and average handling times. Provider outreach (outbound calls) numbers peaked in June, 2010 with 624 calls. Appeal numbers ranged from 6 to 24 per month. Conclusions/Follow Up Follow Up Action Conclusions: Agenda Item MassHealth Update: Dr. Paul Jeffrey Discussion Budgetary concerns continue for Massachusetts. The MassHealth budget was estimated to have a projected shortfall of hundreds of millions of dollars. On a positive note the state received an influx of $750M in enhanced federal matching funds. The Pharmacy Program has a projected $550M expense but the budget was cut to $510M. There has been much going on regarding technology with the newest generation, POPS III claims processor. The SMART TPL module could generate between 12 and 20M dollars. The CHIPRA program is underway due to a grant that the state received to improve the quality of health of our children. The MassHealth Program continues to broaden. The Medical Home Project will grow in participation with an additional 36 practices. Program integrity is being emphasized and the prevention of fraud is ever important. Desk and field audits are occurring more often. The use of antipsychotics in foster children is a concern and audits will be taking place. Behavioral health advisory groups have been established to look at the data. Pharmacists will be administering flu shots again. A work group has been formed to look into the possibility of pharmacists administering other vaccines if needed. Conclusions/Follow Up Follow Up Action Conclusions: Meeting adjourned at 7:40 PM. Respectfully submitted by: Vincent Palumbo, Director of DUR Date: _________________