Medicaid Pharmacy and Therapeutics Committee

New York State Office Of Medicaid Management
Pharmacy and Therapeutics Meeting Summary - June 6, 2002

The Medicaid Pharmacy and Therapeutics Committee met on June 6, 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

  • Mandatory Generic Drug Exemption Process
  • Mandatory Generic Drug Exemption Form
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 comments received on the exemption process and form
  • Discussion of proposed revisions to the exemption process and form
  • Development of recommendations for the Commissioner
  • Motion and vote on the final recommendations
  • Submission of final recommendations
  • Collection of travel vouchers
  • Adjournment

Recommendations

The following chart provides a summary of the recommendations, which were made by the Medicaid Pharmacy and Therapeutics Committee on June 6, 2002. Final decisions are made by the Commissioner after review of the recommendations.

Description of RecommendationP&T Vote Final Decision Dept. of Health
To revise the Committee's Operating Procedures regarding potential conflict of interest when a specific drug product is under review by the Committee. The members will recuse themselves from voting when:
  • the member is a paid consultant for a manufacturer on a particular drug;
  • the member speaks on behalf of a manufacturer's drug;
  • the member is working on a grant paid by the drug manufacturer:
  • the member sits on an advisory board that renders advice and decisions on a particular drug; and
  • the member participates in a particular drug's clinical trials.

If approached, or pressured by any entity regarding a specific issue before the Committee, a member will report such an occurrence to the other committee members, and the SDOH.		 Passed 9 to 0Approved
To revise the draft drug exemption process and form as follows:
  • Question 1. Remove "reference the citation of statistically" and change to: "Please provide valid...."
  • Question 5. Amend the proposed language so that it now reads: "Describe any adverse medical outcomes anticipated for specific patient populations which may result from the use of a bio equivalent GENERIC agent."

The Committee agreed that valid clinical studies, while not required in an exemption request, would add considerable merit to the recommendation for an exemption.

 Passed 9 to 0Approved