Pharmacy and Therapeutics Committee

New York State Office Of Medicaid Management
Pharmacy and Therapeutics Meeting Summary from Previous Meeting - October 14, 2005

Agenda

The Medicaid Pharmacy and Therapeutics Committee met on Friday, October 14, 2005 from 10:30 a.m. to 3:00 p.m. in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

A. Background Materials Provided:

The Committee was provided copies of written materials submitted by interested parties in advance of the meeting. In addition, summaries of the Xyrem and levothyroxine agenda items were distributed to parties attending the meeting.

B. Public Comment Period:

The following speakers addressed the committee:

  1. Philip Katz, Hogan & Hartson, LLP, Washington DC.
  2. Michael Kane, Pharm D., FCCP, BCPS, The Endocrine Group, Albany, NY.
  3. Carolyn Becker, MD, Endocrine Society, Chevy Chase, MD.

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

On the topic of the exemption of levothyroxine from the NYS Mandatory Generic Drug Program:

  • All interested parties that presented to the P & T Committee were in favor of exemption of levothyroxine products from the NYS Medicaid Mandatory Generic Drug Program.
  • Concerns were raised that unless an exemption was approved, a switch in levothryroxine products would result in additional medical visits, and potential negative changes in medical conditions.

D. Responses:

On the topic of the exemption of levothyroxine from the NYS Mandatory Generic Drug Program:

  • Dr. Martin (Chairman) summarized the interested parties' concerns for Committee consideration.

E. Discussion: Proposal for prior authorization of Risperdal Consta, by selected, qualified mental health programs:
Barry Brauth, Office of Mental Health (OMH)
Lou Ropler, MD, Office of Mental Health (OMH)

Mr. Brauth discussed the availability of the injectable, long-acting Risperdal formulation that has been found cost prohibitive by OMH clinics. The product is currently billable through physician's offices. OMH has requested that the Committee address the specific prior authorization criteria for this product when it is being billed by selected, qualified mental health programs. Under this proposal NYS Medicaid will cover Risperdal Consta provided by facilities under the jurisdiction of the OMH to include clinics, Continuing Day Treatment Programs, Partial Hospitalization Programs, and Assertive Community Treatment teams licensed by OMH and Article 28 providers which are co-licensed by OMH and DOH, but not the mental health clinics licensed solely under Article 28.

A brief review of the dosing and approved indications, as well as a discussion of who should be receiving this drug was provided. Mr. Brauth noted that OMH and DOH had notified over 350 mental health service providers advising them of the proposed policy regarding Risperdal Consta. He indicated that there was widespread support for this proposed approach, although there was some concern regarding the 30month length of approved treatment.

Committee members raised several questions, and discussed various aspects in the treatment of schizophrenia and use of Risperdal Consta, including issues related to non-compliance, poly-pharmacy, age range for use, prior authorization requirements and questions, and the long term use and safety of the product. The Committee reviewed each proposed question for approval of prior authorization under the Voice Interactive System (VIPS). Having a diagnosis of schizophrenia or schizoaffective disorder was considered appropriate. Determining if there was only one prescriber of antipsychotic medication was deemed important as poly pharmacy prescribing is common in the treatment of mental health disorders; however there was concerns that the prescriber may or may not be aware if there were other prescribers. There was further discussion about the number and content of the specific questions to be used when a prior authorization is obtained.

After further discussions and considering the information and concerns raised by the speakers and the membership, the Committee voted to recommend that Medicaid reimburse for Risperdal Consta with prior authorization and this proposal should only apply to qualified mental health outpatient programs as noted in the proposal. The proposed criteria were amended to reflect the Committee's recommendations. The Committee also requested that the DOH confirm whether there is the technical capacity to increase the approval period from three months to six months.

F. Clinical Presentation and Discussion: Proposal to require prior authorization of Xyrem:
Robert L. Correia, Pharm D., Office of Medicaid Management

Dr. Correia presented background clinical, project utilization and prior authorization recommendations for gamma hydroxybutyrate (GHB) / sodium oxybate. Xyrem, (brand name) has very limited FDA-approved indications for the treatment of cataplexy in patients with narcolepsy. GHB had an extensive history of abuse and was effectively banned by the Date Rape Prohibition Act of 2000 (Public Law 106-172) which reclassified it as a Schedule I Controlled Substance. This law was subsequently modified to allow treatment of cataplexy in patients with narcolepsy, and on July 17, 2002, the FDA approved sodium oxybate (Xyrem®, Orphan Medical Inc.) for this use. Currently it is uniquely categorized in a bifurcated controlled substance schedule, being classified federally as both Schedule III for medical use, and Schedule I for illicit use, subject to penalties under Schedule I (the most restrictive schedule of the Controlled Substances Act). The current FDA-approved labeling for Xyrem states in the "Black Box" warning section "Sodium oxybate is GHB, a known drug of abuse."

Committee members raised concerns about the proposal for NYS Medicaid to cover this drug. The Committee reviewed the proposed use of the VIPS prior authorization system, how to verify the prescriber and patient were included in the registry, whether there were medical claims data available to confirm the required diagnosis, the number of Xyrem approved providers in New York State and concerns with the specificity of the diagnosis of narcolepsy with cataplexy.

After further discussions the Committee voted to recommend that Medicaid not reimburse for GHB under any name until a live interactive telephone prior authorization system is in place, which would provide more appropriate types of controls. A question was also raised as to why the Medicaid program would cover this drug at all.

G. Clinical Presentation and Discussion: Proposal to exempt brand named levothyroxine from the Mandatory Generic Program requirements.

The NYS Medicaid program proposed to exempt all brand name levothyroxine sodium oral prescription medications from prior authorization under the Mandatory Generic Drug Program. Dr. Correia noted that the use of this exemption does not preclude the prescribing or substitution of the FDA-rated equivalent products and should not be considered an opinion on the bioequivalence of the generic versions. This exemption pertains only to the New York Medicaid Mandatory Generic Program, and has no impact on State or federal generic substitution laws or requirements. NYS Medicaid actively encourages the use of generic equivalents when appropriate.

Dr. Correia presented background information, noting that annual reimbursement for all levothyroxine sodium oral products, including both brands and equivalent products, is about $9 million gross (less than 0.2% of the Medicaid annual pharmacy expenditure). The difference between the highest brand reimbursement and the generic for the most common dosages (50 to 100 mcg) is less than $5 per month.

Committee member comments noted that regimen adherence may be more of an issue on maintaining proper blood levels of the drugs than the variances in the different FDA rating of the various products. After further discussion and considering the information and concerns raised by the speakers and the membership, the Committee voted to recommend that Medicaid exempt brand named levothyroxine from the Mandatory Generic Program requirements.

H. Executive Session:

The Committee adjourned the public session at 11:50 A.M. to go into executive session for orientation for Committee members on requirements related to the NYS ethics laws and requirements. The executive session was adjourned at 2:50 P.M.

I. Recommendations of the Pharmacy and Therapeutics Committee:

The following recommendations developed by the P&T Committee are to be submitted to the Commissioner of Health for final determination.

Description of RecommendationsCommissioner's Final Decision
Proposal to reimburse Risperdal Consta, with prior authorization (PA) for selected, qualified mental health programs:
  • A. Risperdal Consta should be subject to prior authorization utilizing the current NYS Medicaid VIPS.

  • B. If the current billing system allows this, prior authorization for Risperdal Consta for a three month period should be allowed for the initial approval, then have an approval option to allow a six month PA.

  • C. The following clinical questions be used in the VIPS prior authorization process:

    • 1. Does the patient have a diagnosis of schizophrenia or schizoaffective disorder?
    • 2. Can the patient tolerate a minimum of 2 mg per day of oral risperidone?
    • 3. To the best of your knowledge, are you the only prescriber of antipsychotic medications for this patient?
    • 4. Is the patient 18 years of age and older?
    • 5. Has the patient been tried on regimens of oral anti-psychotics and found to be poorly adherent?


      For patients currently on Risperdal Consta:


    • 6. Has the patient been on other antipsychotic drugs for longer than 60 days since the treatment with Risperdal Consta began?
    • 7. For patients on Risperdal Consta, is the patient compliant with current therapy?
    • 8. For re-authorization, has the patient shown measurable improvement in target symptoms since Risperdal Consta therapy was initiated?





Approved as Recommended


Approved as Recommended




Approved as Recommended
















Approved as Recommended
Proposal to required prior authorization of Xyrem:

A. The Committee voted to recommend that Medicaid not reimburse for Xyrem (GHB) under any name until a live interactive telephone prior authorization system is in place.

Approved as Recommended
Proposal to exempt brand named levothyroxine from the Mandatory Generic Program requirements.

A. The Committee voted to recommend that Medicaid exempt brand named levothyroxine from the Mandatory Generic Program requirements.

Approved as Recommended

Final Determinations by the Commissioner of Health and Analysis of Impacts:

1. Commissioner's Determination: Reimburse Risperdal Consta, with prior authorization (PA) for selected, qualified mental health programs.

  • The impacts of this final determination are as follows:

  • A. State Public Health Population:
    • Potentially improves public health outcomes by providing access to Risperdal Consta for appropriate Medicaid recipients.
    • Use of prior authorization serves to prevent potential over-utilization by Medicaid recipients, and encourages use of more cost effective alternatives when appropriate.
  • B. Program Providers:
    • Limited additional time and effort will be required by mental health clinic practitioners to complete a prior authorization process for Risperdal Consta.
  • C. Fiscal Impact to State Health Program:
    • Through additional reimbursement to selected, qualified mental health programs, additional Medicaid expenditures are estimated at $ 60 M (gross) when fully annualized.

2. Commissioner's Determination: Medicaid not reimburse for Xyrem (GHB) under any name until a live interactive telephone prior authorization system is in place.

  • The impacts of this final determination are as follows:

  • A. State Public Health Population:
    • None at this time

  • B. Program Providers:
    • None at this time

  • C. Fiscal Impact to State Health Program:
    • None at this time

3. Commissioner's Determination: Medicaid shall exempt brand named levothyroxine from the Mandatory Generic Program requirements.

  • The impacts of this final determination are as follows:

  • A. State Public Health Population:
    • Avoids potential complications from requiring the use of generic levothyroxine, when these drugs present unique and unusual equivalency issues.

  • B. Program Providers:
    • No changes to current practices.

  • C. Fiscal Impact to State Health Program:
    • Potential additional expenditure of $9M annually due to use of brand, rather than generic levothyroxine.

Revised Summary Posted 05-01-06