Drug Utilization Review (DUR) Board Meeting Summary - March 23, 2009
Agenda and Introduction
The Drug Utilization Review Board Meeting scheduled on Monday, March 23, 2009 from 9:00 A.M. to 5:00 P.M., was held in the Empire State Plaza Concourse, Meeting Room 3, Albany, New York.
A. Background Materials Provided:
The Board was provided copies of the meeting agenda and timetable.
B. Public Comment Period:
The following speaker provided comment to the board:
Christine Dubé, PharmD, PAHM, MedImmune, Gaithersburg, MD.
C. Key issues raised by interested parties and the Drug Utilization Review Board during the public comment period:
The Board was asked to consider information presented by Dr. Dubé related to palivizumab utilization, especially with regard to preterm infants in the Medicaid population, including the high risk for RSV disease and RSV related hospitalization.
D. Presentations and Discussion:
The following speakers presented to the Board:
- Jones, Linda, RN, Director, Medicaid Pharmacy Program, Office of Health Insurance Programs, New York State Department of Health (NYSDOH)
- Lehmann, David, MD, PharmD, Professor of Medicine and Pharmacology, SUNY Upstate Medical University
- Finnerty, Molly, MD, Director, Bureau of Evidence Based Services & Implementation Science, NYS Psychiatric Institute, Office of Mental Health
- McNamara, Daniel, RPh, Pharmacy Consultant, Medicaid Pharmacy Program, Office of Health Insurance Programs, New York State Department of Health (NYSDOH)
- Doloresco, Fred, PharmD, MS, Clinical Assistant Professor, State University of New York, Buffalo
- Wenzel, Marie, PharmD, Associate Director of Clinical Services, University of Massachusetts Medical School
- Naioti, John, RPh, DUR Manager, Medicaid Pharmacy Program, Office of Health Insurance Programs, New York State Department of Health (NYSDOH)
Medication Therapy Management Program
A Medicaid Medication Therapy Management (MTM) Program status report was presented to the Board by Linda Jones. The purpose of the program is to improve compliance with drug therapy and improve clinical outcomes. The Board was advised of the following:
- Patient consent forms, evaluation plan, and training outline were finalized.
- Reimbursement fees were approved and would be announced shortly.
- The MTM Program was presented to the NYS Board of Pharmacy and was well received.
- The MTM software was approved and would be available at no cost to MTM pharmacists during the pilot.
- System implementation was being assessed.
- Enrollment forms, letters, and process were developed for both the MTM pharmacy and pharmacists.
- Enrollee, practitioner, and pharmacist survey development was completed.
- Outreach to interested parties was being conducted.
- State plan amendment, federal public notice and federal waiver for submission to the federal Medicaid agency, Centers for Medicare and Medicaid Services (CMS), were being prepared.
The Prescriber Education Program
The Prescriber Education Program (PEP) update was presented by Dr. Lehmann. The purpose of PEP is to provide prescribers with evidence based, non-commercial sources of the latest objective information about pharmaceuticals. Dr. Lehmann updated the Board on the PEP modules planned for 2009.
Psychiatric Services and Clinical Knowledge Enhancement System (PSYCKES)
PSYCKES update was presented by Dr. Finnerty. The program focuses on improving the safety and quality of psychotropic medication management in New York State. Information pertaining to implementation, field validation of indicator sets, and data analysis on the continuous quality improvement process was provided to the Board. Discussion from the Board addressed the support and synergy PSYCKES will give to the Retrospective DUR (RetroDUR) and Prospective DUR (ProDUR) Programs in the future.
American Drug Utilization Review Society (ADURS) Conference
Mr. McNamara presented an overview of the annual ADURS Symposium that was held from February 26 - March 1, 2009. The symposium is a forum of leadership and support for drug utilization review programs involving all the states to obtain information, develop skills, and receive training to efficiently and effectively perform their duties. Subjects of interest from the symposium include; complexities of bipolar disorder and management of the disease, new drugs and potential off label use, and the role of specialty pharmacies in the application of DUR clinical and utilization techniques. Also discussed were the more prevalent DUR related initiatives that other states are pursuing.
These topics included:
- Antipsychotic utilization controls using step therapy.
- Dose optimizers and quantity limits, clinical and quantity edits for sedatives and short and long acting opioids.
- Launching Medication Therapy Management and Prescriber Education programs to reach prescriber outliers.
- The integration of e-prescribing and electronic health records with prospective drug utilization intelligence.
Dr. Doloresco presented a review of topical immunomodulators pimecrolimus and tacrolimus to the Board. The review included utilization data specific to the NYS Medicaid program. He noted that malignancies related to topical immunomodulator therapy have been reported and have resulted in the addition of a black box warning to the product labeling by the Food and Drug Administration (FDA) in January 2006. He also noted that retrospective review of NY Medicaid claims data showed utilization outside of FDA approved indications and indications supported in the drug compendia. He discussed previous efforts by DUR to reduce inappropriate topical immunomodulator therapy. He concluded that the data suggests there are prescriptions being filled for topical immunomodulators without the presence of a claim for a medically accepted indication, and that these agents, in some cases, are being prescribed as first line therapy rather than second line therapy when other topical therapies are inadvisable or ineffective as recommended by product labeling.
Dr. Wenzel presented a clinical review of palivizumab to the Board. Her presentation also included data specific to the NY Medicaid program and focused on utilization outside of the RSV season and in patients greater than two (2) years of age at onset of the RSV season. She noted Palivizumab is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk. Discussion focused on the guidelines for the use of palivizumab as published by the American Academy of Pediatrics.
Anti-Psychotic Medication RetroDUR Criteria
Mr. Naioti presented the RetroDUR criteria for anti-psychotic medication utilization. The criteria are applied to paid claims retroactively and are used to indicate whether use is appropriate, medically necessary and not likely to result in adverse medical outcomes. The criteria were discussed by the DURB.
E. Executive Session:
The Board recessed the public session at 11:20 A.M. to go into executive session for review of confidential Medicaid beneficiary cases. No official action was taken in the executive session. The executive session was recessed at 12:45 P.M.
F. Additional Discussion:
The Board discussed the changes in information technology and how the changes relate to the delivery of information to and from the DUR Board in the future. The Board was challenged to suggest ideas on how to enhance the DUR program.
G. DUR Board Action:
The DUR Board took the following actions regarding palivizumab:
- Recommended that the Medicaid program implement edits that restrict use of palivizumab to the period of October 16 to March 31 and to children less than two (2) years of age at the onset of the RSV season.
- Agreed that palivizumab met the criteria for inclusion into the Clinical Drug Review Program (CDRP).
- Recommended that the Medicaid Pharmacy & Therapeutics Committee (P&TC) consider palivizumab for inclusion into the CDRP.
The DUR Board took the following actions regarding topical immunomodulators:
- Agreed that topical immunomodulators met the criteria for inclusion into the Clinical Drug Review Program (CDRP).
- Recommended that the Medicaid P&TC consider topical immunomodulators for inclusion into the CDRP
- Recommended that the P&TC consider the following questions be asked of the prescriber when prior authorization is requested for topical immunomodulators:
- Is the patient diagnosed with atopic dermatitis?
- Did the patient attempt using a high potency topical corticosteroid for four (4) weeks before being prescribed topical pimecrolimus or tacrolimus?
- Has the patient experienced a treatment failure or a clinically significant adverse reaction to a high potency corticosteroid?
- Does the patient have any contraindications to high potency topical corticosteroids?
- Is topical tacrolimus being used for moderate to severe atopic dermatitis?
- Is the patient immunocompromised?
Review of Anti-psychotic Medication RetroDur Criteria
The Board reviewed, commented on and voted on the anti-psychotic medication related RetroDUR criteria.
The meeting adjourned at 2:30 P.M.
Meeting Summary Posted 5/19/09