Medicaid Pharmacy and Therapeutics Committee

New York State Office Of Medicaid Management
Pharmacy and Therapeutics Meeting Summary - February 28, 2003


The Medicaid Pharmacy and Therapeutics Committee met on February 28, 2003 from 10:30 a.m. to 3:30 p.m. in in the 7th Floor Conference Room (#725) located at 99 Washington Avenue, Albany, New York 12210.

A. Background Materials Provided:

The Committee was provided copies of emails from interested parties, and written materials submitted by interested parties in advance of the meeting, including materials from the American Academy of Allergy, Asthma and Immunology, pharmaceutical manufacturers and the Medical Society of the State of NY (MSSNY). In addition, a detailed clinical evaluation of current research outcomes regarding the use of second-generation antihistamines was provided to the Committee.

B. Public Comment Period:

The following speakers addressed the Committee:

  1. Sudershan Dang, MD,(Utica), representing the Association of Physicians of India.
  2. Hewlett, Jr., MD, FACP, FIDSA, Medical Director for the Allergy Disease Management Team - introduced by Anna Maria Maritato, Manager, Pfizer Government Relations.
  3. George Georges, MD, Aventis Pharmaceuticals.
  4. Thomas Achtyl, MD, Amsterdam NY.
  5. Mike Burgess, NY Statewide Senior Action Council.

C. Key Issues Raised by Interested Parties and Pharmacy and Therapeutics Committee Response:

Issues RaisedP&T Committee Response
The Medicaid program is forcing prescribers to use first-generation antihistamines instead of the newer, more effective second-generation products. The Committee does not recommend requiring the patient to try a first-generation product, and be approved for a second-generation only on treatment failure. Instead, they recommend encouraging the use of less expensive over-the-counter, rather than prescription, versions of second-generation antihistamines.
Recipients won't be able to afford to buy over-the-counter prescriptions; they will have to go without. Unlike many insurers, the Medicaid program covers selected over-the-counter products. The recipient is only responsible for a small co-payment of 50 cents.
Prior authorization will deny the prescriber the ability to use a specific product. The current Medicaid prior authorization process does not deny a request to prescribe any drug. It is an easy-to-use review process that reminds the prescribers that there are alternatives available.
Only one prescription product is approved for children age six months to two years. The over-the-counter product is only approved for children age two and over. Approval criteria were included which allows the prescriber to use a prescription product in the limited circumstances where it is needed for children age six months to two years.

D. Findings:

As a result of their discussions, the Committee had the following findings:

  • Prior authorization of second-generation antihistamines should be undertaken for Medicaid recipients to promote the use of less expensive, comparable over-the-counter antihistamines. Over-the-counter versions of second-generation antihistamines can be considered comparable to the prescription versions of these products.
  • Failure of a first-generation antihistamine was not recommended as a condition of approval for use of a second-generation antihistamine.
  • There are a variety of patient-specific clinical situations where the prescribing physician may consider a specific prescription product more appropriate than the over-the-counter version. Consideration should be given to this array of potential situations as part of the criteria for approval of the prior authorization.
  • Only one product, Zyrtec, has been approved for use in children ages six (6) months to two (2) years. All other prescription versions as well as the over-the-counter version of second-generation antihistamines, are approved for age 24 months and older. Consideration should be given to this issue as part of the criteria for approval of a prior authorization.
  • The purpose of the prior authorization should be included in educational efforts to assure the cooperation of prescribers in the Medicaid program.
  • Some manufacturers have begun to actively promote their asthma prescription products, which are also approved for allergy treatment, when current second-generation prescription products are put on prior authorization by insurers. These products are considerably more expensive than either the over-the-counter or prescription versions of second-generation antihistamines. It would not be appropriate to place these asthma products on prior authorization together with the second-generation antihistamines initially; should such utilization be measured, however, the Committee may reconsider the issue.

E. Recommendations of the Pharmacy and Therapeutics Committee:

The following recommendations developed by the P&T Committee were submitted to the Commissioner of Health for final determination:

Description of RecommendationsP&T VoteFinal Decision DOH
Prior authorization of second-generation antihistamines should be undertaken by Medicaid, given the availability of less expensive, comparable over-the-counter, second-generation antihistamines. UnanimousApproved
Approval for use of a prescription, rather than an over-the-counter (OTC), second-generation antihistamine should be given when one or more of the following criteria are met:
  1. Patient under 24 months.
  2. Patient experienced treatment failure or adverse drug reaction with an OTC second-generation antihistamine.
  3. There is a documented medical condition that prohibits use of an OTC second-generation antihistamine.
Prescription products to be subject to prior authorization:
  1. Clarinex
  2. Allegra/Allegra D
  3. Zyrtec/Zyrtec D
  4. Semprex D
Request to exempt Mysoline from the Mandatory Generic Program should be denied, because no supporting clinical information was provided to the Committee, and there was no justification for an exemption. UnanimousApproved

F. Commissioner's Action:

The Commissioner of Health has determined that second-generation prescription antihistamines should be subject to prior authorization under the Medicaid program effective April 30, 2003, consistent with the criteria and guidelines recommended by the Committee.