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.
- Review of Requests for Drug Exemptions from the Mandatory Generic Program
- Discussion of Draft Individual Prior Authorization Format
|10:30 - 10:40||Welcome and Introductions|
|10:40 - 11:40||Public Comment Session (up to 1hr.)*|
|11:40 - 4:00||Committee Discussion Session (non-public session)|
A. Summary of Public Comment Session:
The following scheduled speakers made presentations:
- 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.
- 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.
- 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 Recommendation||P&T Vote||Final 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.||Consensus||Approved|
|To revise the Brand Name Prior Authorization Prescriber Worksheet as follows:
|To revise the Brand Name Prior Authorization Prescriber Instructions as follows:|
-Add "For requesting drug exemptions, please refer to the Department Website for details".
*The P&T Committee did not receive any new brand name drug exemtion requests