Medicaid Pharmacy and Therapeutics Committee

New York State Office Of Medicaid Management
Pharmacy and Therapeutics Meeting Summary from Previous Meeting - June 3, 2005
With Final Determinations - Updated 8/15/05

Agenda

The Medicaid Pharmacy and Therapeutics Committee met on Friday June 3, 2005, from 10:30 a.m. to 3:00 p.m. in Meeting Room 4, Concourse, Empire State Plaza, Albany, New York.

A. Background Materials Provided:

The Committee was provided copies of e-mails from interested parties and written materials submitted by interested parties in advance of the meeting. In addition, a clinical evaluation of current research of outcomes by DOH regarding the use of erectile dysfunction drugs (ED) and proton pump inhibitors (PPIs) in the Medicaid program was provided to the Committee.

B. Public Comment Period:

The following speakers addressed the committee:

  1. Michael Dillon, R.Ph., Scientific Affair Liaison, Northeast Region, Santarus, Inc.
  2. David J. Russell, M.D., Senior Director, Regional Medical & Research Specialist, Pfizer.
  3. James Harnett, Ph.D., US Outcomes Research, Pfizer.
  4. Douglas Levine, M.D., FACG, Executive Director, Strategic Developer, Nexium, Brand Leader, Astra-Zeneca.
  5. Thomas Achtyl, M.D., Amsterdam, NY.
  6. Steven L. Cohn, M.D., FACP, Chief - Division of General Internal Medicine, Director-Medical Consultation Service, Clinical Professor of Medicine, SUNY - Downstate.
  7. Scott T. Williams, Market Manager, Men's Health Network.
  8. William Oberheim, M.D., Capital District.
  9. Monique D. Morehead, Pharm D., Health Science Executive, TAP Pharmaceuticals.
  10. Michael Burgess, Executive Director, Senior Action Council.
  11. Robert Normanda, Jr., M.D., Medical Science Liaison for ICOS.
  12. Jose A. Goris, M.D., Downstate New York.

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

Issues RaisedP&T Committee Response
On the topic of prior authorization of ED drugs:
  • Treatment of ED may create an opportunity for early detection and treatment of serious, concomitant conditions in men.
  • Treatment of ED, often a side effect of other drugs or underlying medical conditions, may lead to better patient compliance with taking their medication for other conditions.
  • Requiring prior authorization can result in an additional administrative burden for prescribers, and takes time away from patient care.

On the topic of prior authorization of PPI drugs:

  • Not all PPIs have the same indications or mechanism of delivery, and such differences should be considered.
  • Some, but not all PPIs are approved for younger children. It was requested that prior authorization not be applied to children age 12 months to 11 years.
  • Patients should not be required to use OTC PPIs prior to using prescription PPIs.
  • No one prescription PPIs should be preferred over other prescription PPIs.
  • Requiring prior authorization can result in an additional administrative burden for prescribers, and takes time away from patient care.
On the topic of prior authorization of ED drugs:
  • The current Medicaid prior authorization process does not deny any request to prescribe the drug.
  • To ease the potential administrative burden, the questions being asked during the prior authorization process can be shortened and compressed.
  • A study should be done to find out just how long it takes providers to complete the prior authorization process using the voice interactive phone system (VIPS).

On the topic of prior authorization of proton pump inhibitor (PPIs) drugs:

  • The current Medicaid prior authorization process does not deny a request to prescribe any drug.
  • Patients are not being required to use an over-the-counter (OTC) before the prescription version PPIs. The prescriber can request and received approval without use of the OTC PPI.
  • To ease the potential administrative burden, the questions being asked during the prior authorization process can be shortened and compressed.

D. Clinical Presentation and Discussion on Erectile Dysfunction Drugs:

Robert Correia, Pharm D. presented background clinical information, NYS Medicaid utilization and prior authorization recommendations for the ED class of drugs. Current NYS Medicaid policy was discussed. The findings indicated extensive overuse of the medications compared to other State Medicaid programs, and concerns about the clinical as well as financial implications of such overuse. ED use in the NYS Medicaid program was reported as accounting for 50% of the total national Medicaid expenditures for ED products, while representing about 10% of the national Medicaid recipient confirming considerable overuse. In addition there is clear evidence of misuse of the medication among the public, including young persons.

Committee members discussed various options for controlled utilization of ED drugs, including restrictions on a particular agent, additional age restrictions, post payment of medical records for evidence of audits erectile dysfunction work-up, and reducing the number of prior authorization questions. The DOH explained the current limits on utilization. The Committee was concerned with easing the administrative burden of prior authorization for practitioners. There was further discussion about the number and content of the specific questions to be used when a prior authorization is requested. After further discussions and considering the concerns raised by the public, the Committee voted to recommend that prior authorization be instituted for all ED drugs, using two criteria (questions) for the VIPS. It was further recommended that after six months of operation, the Committee receive feedback on the operation of the prior authorization for these drugs, and outcomes of the prior authorization process.

E. Clinical Presentation and Discussion on Proton Pump Inhibitor Drugs:

Dr. Correia presented background clinical information, NYS Medicaid utilization and prior authorization recommendations for the prescription PPI class of drugs. The DOH indicated that extensive direct-to- consumer (DTC) advertising had created demand for these prescription drugs even when non-prescription therapies, including non-prescription PPIs, are available. PPIs were reported to account for almost 6% of total Medicaid expenditure for all drugs with the strong potential for overuse and misuse. Total utilization in SFY 2004-2005 was 2.1M claims, at a cost of $285M.

Outcomes from the Oregon Drug Effectiveness Review program were presented. In that nationally recognized study, extensive, objective clinical research indicated that there are no substantial differences in the efficacy among PPIs, including the OTC version.

Prilosec OTC is covered under the Medicaid program. The OTC PPI costs $22 per claim, while the prescription version of PPIs costs on average $130 per claim. The DOH recommended prior authorization for all prescription versions of oral PPIs to assure that utilization is appropriate, and that the comparable OTC version is considered by the prescriber.

The Committee discussed the use of the OTC PPI and issues related to the FDA-approved indications included for that product. The issue of coverage for youngsters was also discussed, and it was determined that other PPIs also have approved indications for those between two years and 18 years of age. The issue of the Medicaid price paid for generic PPIs was raised as a concern, indicating the prices paid appeared to be well above those for commercial firms. The Committee then discussed the proposed criteria for approval of a prior authorization request; considered concerns raised by the public, and developed alternative language which limits the questions to two basic concerns related to appropriate use of these types of medications.

F. Election of Officers:

The Committee voted via paper ballot and elected a Committee Chair and Vice-Chair. The following members were elected:

  • Chairman: Glenn Martin, M.D.
  • Vice Chairman: William Scheer, R.Ph.

G. Scheduling of Next Meeting:

The Committee discussed several options for upcoming meetings including the rotation of meetings on Thursdays and Fridays. The next P&T Committee meeting will be scheduled sometime during the last two weeks of August 2005. The meeting was adjourned at 2:50 p.m.

H. 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 RecommendationsCommissioner's Final Decision

Prior Authorization of ED Drugs:

A. All erectile dysfunction drugs should be subject to prior authorization utilizing the current NYS Medicaid VIPS (which would not result in a denial).

B. Prior authorization for these drugs be re-evaluated following six months of operation. The DOH should provide the following information to the Committee:

  • Outcomes on the process-including complaints
  • The financial impact of this program
  • Utilization data-stratified by age groups 20-30, 31-40, etc.
  • Data on the length of VIPS calls if available

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

  1. Does the patient's medical record have a diagnosis of erectile dysfunction based on an office examination? (Y/N)
  2. Have you completed risk-reduction counseling of this patient in regard to the spread of STDs and HIV? (Y/N)


Approved as recommended.


Approved as recommended.









Question 1 is amended as follows:

1. Does the patient's medical record have a diagnosis of erectile dysfunction based on a health professional's office examination? (Y/N)

Question 2 is approved as recommended

Prior Authorization of Prescription PPIs:

A. All prescription PPI drugs should be subject to prior authorization utilizing the current NYS Medicaid VIPS (which would not result in a denial).

B. The DOH should provide the following information to the Committee on the outcomes of prior authorization for these products following six months of operation, including:

  • Outcomes on the process-including complaints
  • The financial impact of this program
  • Data on the length of VIPS calls if available

C. The following questions be used for the VIPS prior authorization approval process:

  1. Does the patient have a documented diagnosis that requires the use of PPIs?
  2. Does the patient have a documented medical reason to not use an over-the-counter PPI?


Approved as recommended.



Approved as recommended.







Questions are amended as follows:


1. Have you considered an alternate over-the-counter drug therapy for the symptoms described, prior to prescribing only a proton pump inhibitor?

2. Does the patient have a documented diagnosis that requires only the use of PPI's

3. Does the patient have a documented medical reason to not use an over-the-counter PPI?
Election of P&T Committee Chair and Vice-Chair: Unanimous

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

1. Commissioner's Determination: All erectile dysfunction drug products should be subject to prior authorization under the Medicaid program.

The impacts of this final determination are as follows:

1. State Public Health Population:

  • Reduces the over-utilization and potential fraud and abuse by Medicaid recipients related to erectile dysfunction medications.
  • Potentially improves public health outcomes for Medicaid recipients as a result of educational efforts to encourage risk-reduction counseling with patients regarding STDs and HIV.
  • Some recipients may experience some minor delays in obtaining new prescriptions for erectile dysfunction drugs when the prescriber has failed to obtain a required prior authorization. However, all requests for erectile dysfunction drugs will be authorized, except in cases where there is substantial evidence of fraud or abuse.

2. Program Providers:

  • Encourages appropriate evaluation and prescribing for erectile dysfunction, and related disease states, and encourages counseling for associated health risks.
  • Limited additional time and effort will be required by prescribers, or their agents, to complete a prior authorization process for new prescriptions for erectile dysfunction drugs. Denials would occur only in the circumstance of substantial evidence of fraud and abuse.

3. Fiscal Impact to State Health Program :

  • Through the reduction of overuse, misuse and potential fraud, annualized Medicaid savings, are estimated at $ 4-6 M (gross) for SFY 2005-06. Full annualized savings for erectile dysfunction drugs in SFY 2006-07, after reflecting changes resulting from Medicare Part D, are estimated at $8-9M.

2. Commissioner's Determination: All oral prescription proton pump inhibitor drugs should be subject to prior authorization under the Medicaid program.

The impacts of this final determination are as follows:

1. State Public Health Population:

  • More appropriate utilization of prescription proton pump inhibitors by Medicaid recipients, and increased use of cost-effective over the counter alternative drug therapies as well as over the counter versions of proton pump inhibitors where medically appropriate.
  • Some recipients may experience some minor delays in obtaining new prescriptions for proton pump inhibitors when the prescriber has failed to obtain a required prior authorization. However, all requests for prescription proton pump inhibitors will be authorized.

2. Program Providers:

  • Encourages use of more cost-effective, readily available alternative drug therapies, as well as over the counter prescription proton pump inhibitors, when medically appropriate.
  • Limited time and effort will be required by prescribers to complete a prior authorization process for new prescriptions for proton pump inhibitors.

3. Fiscal Impact to State Health Program:

  • Through reduced overuse of oral prescription drug proton pump inhibitors, Medicaid savings for SFY 2005-6 are estimated at $39M (gross). Annualized savings for SFY 05-06, after reflecting changes resulting from Medicare Part D, are estimated at $75M.