Pharmacy and Therapeutics Committee Meeting Summary - November 4, 2010

Agenda and Introduction

The Medicaid Pharmacy & Therapeutics Committee met on Thursday, November 4, 2010 from 8:30 a.m. to 4:30 p.m. in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

The review of buprenorphine used in the treatment of opioid dependence was tabled.

A. Background Materials Provided:

The Committee was provided copies of written materials submitted by interested parties in advance of the meeting.

B. Public Comment Period:

The following speakers provided comment to the committee:

  1. Ganguli, Sohini, PharmD, Senior Area Medical Manager, Sanofi-Aventis, Boonton, NJ
  2. Kivior, Julie, BSN, Outcomes Liaison, Eli Lilly & Company, Indianapolis, IN
  3. Gerety, Gregg, MD, The Endocrine Group, Albany, NY

C. Key issues raised by interested parties and the Pharmacy and Therapeutics Committee pertaining to the clinical review of the following therapeutic classes/drugs:

Public comments:

Insulin (Long-Acting, Rapid-Acting, Mixes):

  • The Committee was asked to consider a head to head trial of long acting insulins, the importance of optimizing hemoglobin A1C and meeting glycemic goals, dosing and dosing devices, adherence, onset of glucose-lowering activity, duration of action, contraindications, adverse events, and predictability of insulin activity. The Committee was also asked to consider the incidence of diabetes and the impact of treating diabetes on the healthcare system when making their recommendation.

D. Clinical Presentation and Discussion

Barbara Rogler, PharmD, MS, Magellan Medicaid Administration; Robert Correia, PharmD, NYS Department of Health, Office of Health Insurance Programs (DOH/OHIP), Fred Doloresco, PharmD, and Linda Catanzaro, PharmD, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo; John Naioti, RPh, DUR Program Manager, DOH/OHIP, Judith Barrett, RPh, DOH/OHIP, Monica Toohey, RPh, DOH/OHIP.

Preferred Drug Program

Proposal to identify preferred drugs in the therapeutic class of Insulin (Long-Acting, Rapid-Acting, Mixes)

Dr. Rogler discussed characteristics of the long and rapid acting insulins being reviewed including onset, peak and duration of action, mechanism of action, indications, dosing, dosage forms, method of administration, pharmacokinetics, and product stability. She also discussed the insulin mixes included in the review noting they may be valuable in reducing the number of insulin injections needed per day. She reviewed the different pen devices available and the FDA alert from 2009 cautioning against sharing insulin pens and devices. Dr. Correia noted slight differences between products in these classes could impact product selection for patients, and concluded that it would be preferable to include as broad a selection of these products as possible as preferred products.

The Committee discussed once a day versus twice a day dosing of the long acting insulins reviewed. They discussed the management of diabetic patients in primary care, and the focus on preventing both microvascular and macrovascular complications by managing the entire patient, including hemoglobin A1C, and adverse events such as hypoglycemia and weight gain.

Clinical Drug Review Program (CDRP)

After reviewing becaplermin gel (Regranex) at the March 11, 2010 meeting, the Committee reviewed additional information in order to evaluate for CDRP inclusion.

Dr. Catanzaro summarized the clinical information that was presented at the March 11, 2010 meeting. Dr. Doloresco provided utilization data regarding identification of prescriber and pharmacy outliers and commercial insurer comparative information, as requested by the Committee at the March 11, 2010 meeting.

Mr. Naioti reiterated the action taken by the Medicaid Drug Utilization Review (DUR) Board at their November 12, 2009 meeting regarding becaplermin gel. He focused on the black box warning in the product's labeling and the DUR Board's determination that becaplermin gel met the criteria for inclusion into the CDRP.

After considering the information provided and the concerns raised by the membership, including the black box warning for increased mortality secondary to malignancy, the need for proper wound care, and the data confirming potential overutilization throughout the State (as opposed to outliers in certain geographical areas), the Committee unanimously recommended to include becaplermin gel in the Clinical Drug Review Program. Approval criteria are listed in Section F- Recommendations of the Pharmacy & Therapeutics Committee.

Mandatory Generic Drug Program (MGDP)

At the April 29, 2010 meeting, the Committee recommended a review of the criteria for justification of exemption of brand-name products from the MGDP.

Ms. Barrett provided background information for the MGDP. Dr. Correia reiterated the Department policy that exemptions from the MGDP do not preclude the prescribing of generic equivalents and should not be considered an opinion on the bioequivalency of generic drugs. He provided a review of considerations used by the FDA when determining bioequivalence of generic versus brand name drugs in an attempt to address misconceptions about the current FDA process. He noted the FDA processes have continually evolved and have become more comprehensive over time.

He provided excerpts from federal Circuit Court decisions pertaining to challenges to the FDA's determination of bioequivalence that repeatedly upheld the FDA's regulatory implementation of bioequivalence requirements. He then reviewed the current MGDP criteria for justification for exemption noting the exemption form is available on the DOH website. He concluded that the current exemption process is not meant to challenge the FDA's determination of bioequivalence of drugs, but to provide a mechanism for interested parties to submit clinical evidence to the Commissioner of Health as well as the FDA. He also noted drugs subject to prior authorization under the MGDP remain available for use within the Medicaid program for specific patient needs.

The Committee discussed the list of current exemptions and the pending exemption request, the "prescriber prevails" provision, and industry efforts to persuade prescribers to continue prescribing brand name drugs when generics become available.

After considering the information provided and the concerns raised by the membership, the Committee was unable to advise the Commissioner of Health regarding evidence to justify current exemptions. The Committee agreed to assist the Commissioner with the review and evaluation of current and pending exemptions as needed.

E. Executive Session:

The Committee recessed the public session at 9:45 AM to go into executive session for review of financial information relating to the Committee's recommendations of preferred drugs. No official action was taken in the executive session. The executive session was recessed at 10:25 AM.

F. Recommendations of the Pharmacy and Therapeutics Committee submitted to the Commissioner of Health for final determination.

Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously (unless otherwise noted) recommended the following:

Recommendations of Pharmacy and Therapeutics Committee Commissioner's Final Determination
The standard clinical questions be used in the prior authorization review process for non-preferred drugs:

  • Q: Has your patient experienced treatment failure with preferred drugs in the class?
  • Q: Has your patient experienced an adverse drug reaction with preferred drugs in the class?
  • Q: Is there a documented history of successful therapeutic control with a non-preferred drug and transition to a preferred drug is medically contraindicated?
Approved as Recommended
Insulin, Long-Acting:

Preferred Drugs
Lantus (insulin glargine), Levemir (insulin detemir)

Non-preferred Drugs
None
Approved as Recommended
Insulin, Rapid-Acting:

Preferred Drugs
Apidra (insulin glulisine), Humalog (insulin lispro), Novolog (insulin aspart)

Non-preferred Drugs
None
Approved as Recommended
Insulin - Mixes

Preferred Drugs
Humalog Mix 50-50 and 75-25 (insulin lispro protamine/insulin lispro), Novolog Mix 70-30 (insulin aspart protamine/insulin aspart)

Non-preferred Drugs
None
Approved as Recommended
Review of additional information regarding the inclusion of becaplermin gel (Regranex) in the Clinical Drug Review Program.

The Committee recommended that Medicaid include becaplermin gel (Regranex) in the Clinical Drug Review Program.

The Committee recommended the following criteria be utilized in the prior authorization process of becaplermin gel (Regranex):

  1. Has the patient been diagnosed with a lower extremity diabetic neuropathic ulcer?
  2. Is becaplermin gel being used as an adjunct to good ulcer/wound care including debridement, pressure relief and infection prevention?
  3. If the patient has an existing infection at the ulcer/wound site, is the infection being treated?
  4. Does the patient have a neoplasm at the site of the ulcer, or any known malignancy?
  5. To the best of your knowledge, how many 15 gram tubes of becaplermin gel (Regranex) has this patient used in his/her lifetime?
    (If 3 or more): What is the clinical rationale for prescribing more than two (2) tubes as there is a five-fold risk of death secondary to malignancy in patients using three or more tubes in their lifetime?

The Committee also recommended continued prescriber education with regard to becaplermin gel and requested a status report in one year.
Approved as Recommended
Review of the criteria for justification of exemption of brand-name products from the Mandatory Generic Drug Program (MGDP).

The Committee recommended that the Commissioner evaluate the current list of exemptions and the one pending exemption request. The Committee agreed to assist the Commissioner with evaluating any specific areas related to the information submitted on the MGDP Exemption Request Form, as needed.
In reference to the one pending exemption request, Prograf (tacrolimus) to be subject to prior authorization under the requirements of the MGDP.
No other changes to the program.

Ms. Toohey presented an updated process for re-review of therapeutic drug classes subject to the preferred drug program.

G. Additional Discussion:

Dr. Martin (Chairperson) expressed appreciation to the Committee, and on behalf of the Committee to the Commissioner of Health, State staff, Magellan Medicaid Administration, Oregon Health & Sciences University, and all others involved for their service to and participation in the Pharmacy and Therapeutics Committee process.

Tony Merola, DOH/OHIP expressed appreciation to the Committee on behalf of State staff for their service and dedication.

The meeting adjourned at 12:20 PM

Meeting Summary Posted 12/07/2010

H. Final Determinations

1. Preferred Drug Program(PDP)

The Commissioner has determined that the Medicaid program will require prior authorization under the PDP for non-preferred drugs in each of the drug classes as listed in Section F.

Preferred Drugs will not require prior authorization

The impact of this final determination is as follows:

a. State Public Health Population:

No impact on Medicaid enrollees,

b. Program Providers:

No impact on prescribers or pharmacies, as all products in each of the therapeutic classes reviewed were determined to be preferred

c. State Health Program:

Annual gross savings associated with these therapeutic classes under the PDP are estimated at $5.5M. The savings are achieved through the receipt of supplemental rebates from pharmaceutical manufacturers.

2. Clinical Drug Review Program (CDRP)

The Commissioner has determined that the Medicaid program will require prior authorization under the CDRP for becaplermin gel (Regranex) as detailed in Section F.

The impact of this final determination is as follows:

a. State Public Health Population:

Products requiring prior authorization under the CDRP will continue to be covered by the Medicaid program. The prior authorization requirement will have a minimal effect on Medicaid enrollees and will ensure the product is being used in a medically appropriate manner.

Program Providers:

A minimal impact on prescribers and pharmacies as they are familiar with the prior authorization process. The prior authorization process is simple to use and available twenty-four hours a day, seven days a week.

Prescribers will need to initiate the prior authorization process and will be asked for clinical information to support appropriate use of the product. Pharmacies will need to complete the prior authorization process prior to submitting the claim.

State Health Program:

Prior authorization through the CDRP will reinforce appropriate use and will also provide an additional means to detect and deter overuse.

The fiscal impact will depend on changes in utilization associated with assuring the appropriate use of the product. Utilization is expected to decrease subsequent to the implementation of the prior authorization requirement.

3. Mandatory Generic Drug Program (MGDP)

The Commissioner has determined that the Medicaid program will subject Prograf (tacrolimus) to prior authorization under the requirements of the MGDP. No other changes to the program or exception process as indicated in Section F.

a. State Public Health Population:

Products requiring prior authorization under the MGDP will continue to be covered by the Medicaid program. The prior authorization requirement will have a minimal effect on Medicaid enrollees and will ensure multi-source brand name product remains available for use when medically necessary.

b. Program Providers:

There will be a minimal impact on prescribers and pharmacies as they are familiar with the prior authorization process. The prior authorization process is simple to use and available twenty-four hours a day, seven days a week.

Prescribers will need to initiate the prior authorization process and will be asked for clinical information to support appropriate use of the multi-source brand name product. Pharmacies will need to complete the prior authorization process prior to submitting the claim.

c. State Health Program:

The fiscal impact will depend on changes in utilization to more cost effective generic products. Utilization of the multi-source brand name products is expected to decrease subsequent to the implementation of the prior authorization requirement.

Final Determinations Posted 05/02/2011