Iowa Medicaid Drug Utilization Review Commission Meeting Minutes August 1, 2007
Attendees Commission members Bruce Alexander Staff Janalyn Phillips Guests Alyssa Franklin, PharmD Student
Chuck Wadle, Magellan Observers Sandy Dirks, Ortho McNeil Janssen
Larson called the meeting to order at 9:35 a.m. at the Iowa Foundation for Medical Care offices. Commission members, guests, and observers were welcomed and introduced. The minutes from the June 6, 2007 meeting were approved as amended. (Motion by Alexander, second by Murphy, unanimous approvalby voice vote.)
Program Statistics/Evaluations Phillips presented four intervention case studies. Recommendations by Commissioners from these four examples resulted in annualized total savings of $5,939.86 before rebate. Larson presented detailed data in regards to the 6 patients from the Duplicate Anticonvulsants Focus Study who had complete discontinuation of anticonvulsants. Savings before rebate, increased from $13,300.00 to $14,202.60 after the additional factors were taken into consideration. Larson presented management reports highlighting the fact that with the implementation of NPI, dummy code use dropped significantly. Discussion ensued over the Number of Selected Medications By Age Group report. Alexander requested a report that showed utilization of antipsychotics by age group in 10-year increments. Larson presented data for the smoking cessation program. Questions arouse in regards to the data from the exception to policy for Chantix, which were explained by Parker. It was noted that only $80,730.04 had been spent on smoking cessation products, year to date. Prospective DUR The Commission discussed the off-label use of Provigil® in children less than 16 years old. Data was shared regarding the specialties writing the prescriptions and the breakdown of ages of the children less than 16 years old. The Commission voted to place a proDUR edit restricting Provigil® to those 16 years of age and older to match FDA approved indications. (Motion by Schutte-Schenck, second by Griffith, unanimous approvalby voice vote) The Commission did not want to discuss age edits for the new product Nuvigil® since it was not on the market yet. The Commission voted to increase the quantity limits for Seroquel 25mg, 100mg, and 200mg from 62/31days to 93/31days to be consistent with package labeling. (Motion by Alexander, second by Murphy, unanimous approval by voice vote). The Commission discussed concurrent IM/PO antipsychotic use and duplicative therapy. Larson shared data on duplicative therapy for both typicals and atypicals. Alexander requested that this report be run yearly in order to track trends. The Commission asked Larson to develop language for PA criteria preventing the concurrent use of long-acting IM and oral dosage forms with the same chemical entity for the September meeting. New Trends Larson shared that carisoprodol tablets contained 350mg of the active ingredient, while carisoprodol/ASA and carisoprodol ASA/codeine contained 200mg. Therefore the quantity limits for the latter two products should be increased from 124 to 248 tablets for
a 31-day supply. The Commission approved this change (Motion by Griffith, second by Logemann, unanimous approval by voice vote). Focus Studies
Concurrent Benzodiazepine and Hypnotic Focus Study Larson asked whether the Commission wanted to exclude patients with cancer from this study. The Commission agreed that these individuals should be included, because concurrent therapy is not indicated for any patient. The Commission agreed that this study should target patients on at least 60-90 days of therapy. Underutilization of Inhaled Corticosteroids The Commission approved the intervention letter and response form with minor changes for this focus study. Larson shared that DUR was planning on collaborating further with the case managers on asthma, diabetes, and heart failure. Open Comment Joseph Ineck from Purdue Pharma spoke regarding the indications, safety, and abuse potential of Oxycontin. Dr. Kline asked the Commission for feedback regarding barriers to the Iowa Medicaid Electronic Record System (IMERS). He also updated the Commission on the Case Management, Clinical Advisory Committee happenings, various disease state programming, and the Medical Value Management Program. Prior Authorization Tretinoin Products Larson clarified that the title for this PA should have been Tretinoin products, not Anti- Acne, as voted upon at the last meeting. Prior authorization is required for all tretinoin prescription products. Payment for non- preferred tretinoin products will be authorized only for cases in which there is documentation of previous trial and therapy failure with a preferred agent. Alternatives such as topical benzoyl peroxide (OTC), and topical or oral antibiotics must first be tried (unless evidence is provided that use of these agents would be medically contraindicated) for the following conditions: endocrinopathy, mild to moderate acne (non-inflammatory and inflammatory), and drug-induced acne. Trials and therapy failure will not be required for those patients presenting with a preponderance of comedonal acneUpon treatment failure with the above-mentioned products or if medically contraindicated, tretinoin products will be approved for three months. If tretinoin therapy is effective after the three-month period, approval will be granted for a one-year period. Skin cancer, lamellar ichthyosis, and Darier’s disease diagnoses will receive automatic approval for lifetime use of tretinoin products. . Requests for the combination products will only be considered after the member has documented unsuccessful, separate trials with tretinoin and topical benzoyl peroxide (OTC), and topical or oral antibiotics.
ADD/ADHD/Narcolepsy Agents Larson shared an additional indication (Other FDA approved indications) had been added to the ADD/ADHD/Narcolepsy Agents PA criteria. This allows for the use of Provigil® for obstructive sleep apnea and shift work disorder. These indications were currently accepted by the PA unit on the Request for Prior Authorization form, but were not listed in the PA criteria. Biologicals The Commission discussed changes to the PA criteria that were previously developed. Murphy expressed his concern that the Commission should obtain an expert opinion on the guidelines developed to ensure completeness. Larson will forward the language to experts in rheumatology, gastroenterology, and dermatology for their opinion. Suboxone®/Subutex® Larson presented data on the use of Suboxone® and Subutex®. Currently there were 18 recipients on these medications. Of that, one patient was taking several narcotic agents concurrently. Since their was only one recipient receiving inappropriate therapy, the Commission declined to implement a PA and requested that a letter be sent to the provider of that individual patient. Oxycontin® The Commission discussed the Iowa Medicaid Pharmacy and Therapeutics recommendation to keep OxyContin® as a nonpreferred product on the PDL except for members being treated for cancer related pain or Hospice enrolled members. The Commission approved the following changes in bold print to the Oxycodone CR/ER (Oxycontin®) PA criteria to incorporate these recommendations: (Motion by Griffith, second by Rinehart, unanimous approval by voice vote) OxyContin® is non-preferred except for members being treated for cancer related pain or Hospice enrolled members. For all other diagnoses, a previous trial with a preferred long-acting narcotic will be required prior to consideration. Oxycodone CR/ER should be dosed every 12 hours. Prior authorization is required for Oxycodone CR/ER for: 1. doses exceeding two tablets per day of the same strength or 2. for more than two strengths per month. Prior authorization for Oxycodone CR/ER at any dose twice daily for cancer pain will be approved. In order to receive approval for quantities or strengths of Oxycodone CR/ER that require prior authorization, the prescriber must provide information to document the need for the medication at the prescribed dosage or quantity. Strategies, Challenges, and Initiatives From Other States
Protopic® Larson shared further data regarding the off-label usage of Protopic® in children. Schutte-Schenck noted that most of the recipients receive Protopic® only once. Larson shared that almost all of the providers were pediatricians and family practice. The Commission voted to restrict Protopic® with the following proDUR edits:(Motion by Schutte-Schenck, second by Griffith, unanimous approval by voice vote)
Elidel® Larson shared further data on the off-label usage of Elidel®. Larson shared that almost all of the providers were pediatricians and family practice. As with Protopic®, most recipients only received one fill of this product. The Commission voted to restrict Elidel® as follows: (Motion by Schutte-Schenck, second by Logemann, unanimous approval by voice vote.)
Elidel (pimecrolimus) Open Comment No comments were made. Retrospective Criteria Review The Commission reviewed Benzodiazepines 28:24.08. Questions arouse as to what the accurate maximum doses should be for alprazolam. Larson said that she would research this issue for the next meeting. Fluoroquinolones and Quinolone 08:12:18 was also reviewed and accepted. . Miscellaneous
• MedWatch – Safety alerts were provided.
• DUR Digest – The Fall, 2007 Digest was approved with the insert from
Articles of interest distributed included:
• Vildagliptin: A novel oral therapy for type 2 diabetes mellitus.
• Varenicline: The newest agent for smoking cessation
Larson adjourned the meeting at 12:25 p.m. The next meeting will be held at 9:30 a.m. on Wednesday, September 5, 2007 at the Iowa Foundation for Medical Care in West Des Moines.
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