Medicaid Pharmacy and Therapeutics Committee

New York State Office Of Medicaid Management
Pharmacy and Therapeutics Meeting Summary - July 26, 2002

The Medicaid Pharmacy and Therapeutics Committee met on July 26, 2002 from 10:30 a.m. to 4:00 p.m. in in the 7th Floor Conference Room (#725) located at 99 Washington Avenue, Albany, New York 12210.

Agenda Items

  • Review of Requests for Drug Exemptions from the Mandatory Generic Program
  • Discussion of Draft Individual Prior Authorization Format
TimeAgenda
10:30 - 10:40Welcome and Introductions
10:40 - 11:40Public Comment Session (up to 1hr.)*
11:40 - 4:00Committee Discussion Session (non-public session)
  • Review of requests received for exemption of Drugs
  • Development of recommendations for the Commissioner
  • Motion and vote on the final recommendations
  • Discussion of Draft Prior Authorization Format
  • Collection of travel vouchers
  • Adjournment

A. Summary of Public Comment Session:

The following scheduled speakers made presentations:

  1. James Sherry, M.D., Ph.D., Bertek Pharmaceuticals presented information on Mylan's Extended Phenytoin Sodium, U.S.P. 100 mg capsules on how it is bioequivalent and therapeutically equivalent to the innovator drug, Dilantin Kapseal 100 mg. The speaker recommended that this product not be exempted from the mandatory generic program.
  2. Eric Davis, M.D., Bertek Pharmaceuticals presented information on Mylan's Clozapine Tablets, 25 mg & 100 mg on how it is bioequivalent and therapeutically equivalent to the innovator drug, Clozaril Tablets 25 mg & 100 mg. Dr. Davis also presented information on Mylan's Digitek 0.125 mg & 0.25 mg tablets on how it is bioequivalent and therapeutically equivalent to Lanoxin Tablets 0.125 mg & 0.25 mg. The speaker recommended that this product not be exempted from the mandatory generic program.
  3. William Cieri, Bertek Pharmaceuticals presented an overview of the use of generic drugs Clozapine, Digitek and Extended Phenytoin Sodium by the federal government's pharmaceutical procurement processes. The speaker recommended that that Dilantin, Clozaril and Lanoxin should not be exempted from the mandatory generic requirement, based on the experience of the federal government.

A summary of other public comments, which were received by the P&T Committee, from interested parties, was provided. Written copies of these materials were also distributed.

P&T Committee Meeting Recommendations*

Description of RecommendationP&T VoteFinal Decision Dept. of Health
To support the Commissioner's list of exempted drugs, but clarify that the exempted drugs do not preclude the prescribing of their generic equivalent and an exemption is not an opinion on bioequivalency of the generic versions. ConsensusApproved
To revise the Brand Name Prior Authorization Prescriber Worksheet as follows:
  • Revise name of worksheet to read "Brand Name Prior Authorization for Individual Patients - Prescriber Work Sheet".
  • Add "For drug exemptions, see Prescriber Instructions".
  • Add "Reminder: write DAW, Brand Medically Necessary on the face of the prescription when prescribing brand named drugs".
  • the member sits on an advisory board that renders advice and decisions on a particular drug; and
  • Revise text to read "For technical assistance, policy questions or clinical concerns, contact the Pharmacy Policy and Operations Unit at (518-486-3209)."
 ConsensusApproved
To revise the Brand Name Prior Authorization Prescriber Instructions as follows:
-Add "For requesting drug exemptions, please refer to the Department Website for details".		ConsensusApproved

*The P&T Committee did not receive any new brand name drug exemtion requests