Drug Utilization Review (DUR) Board Meeting Summary - July 2, 2009

Agenda and Introduction

The Drug Utilization Review Board met on Thursday, July 2, 2009 from 9:00 A.M. to 5:00 P.M., in Meeting Room 2, Concourse, Empire State Plaza, Albany, New York.

A. Background Materials Provided:

The Board 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 Board:

  1. Neil Inhaber, MD, Fellow of the Royal College of Physicians and Surgeons of Canada, Clinical Development, Jazz Pharmaceuticals
  2. Richard G. Fiscella, RPh, MPH, Clinical Professor, University of Illinois at Chicago, Consultant to Allegan.
  3. Donna King, PhD, Associate Director Regional Medical and Research Specialist, Endocrine Care, Pfizer Inc.

C. Key issues raised by interested parties and the Drug Utilization Review Board during the public comment period:

Sodium oxybate (Xyrem):

The Board was asked to consider information regarding utilization, safety, effectiveness and appropriate use.

Human Growth Hormone:

The Board was asked to consider information regarding monitoring utilization trends and general utilization, especially with regard to indications for use including pediatric growth hormone deficiency, Turner Syndrome, small for gestational age, idiopathic short stature, Prader-Willi syndrome, and adult growth hormone deficiency in the Medicaid population.

Cyclosporine Ophthalmic Suspension (Restasis):

The Board was asked to consider information regarding utilization data and surveys, with regard to the indication of keratoconjunctivitis sicca (KCS), and addressing the underlying pathophysiology of dry eye.

D. Presentations and Discussion:

The following DUR Board Members contributed to discussions:

  1. Lehmann, David F., MD, PharmD. Professor of Medicine and Pharmacology, SUNY Upstate Medical University
  2. McIntyre, John, MD, Private Practice of Psychiatry, Professor of Psychiatry, University of Rochester
  3. Speert, Marc, RPh, District Pharmacy Coordinator, Sears Holding Company, K-Mart Pharmacy
  4. Briscoe-Dwyer, Leigh, PharmD, BCPS, CGP, Corporate Director, Contracting, North Shore - LIJ Health System
  5. Ho, Benedict, RPh, Pharmacy District Manager, Duane Reade Inc.
  6. O'Mara, Seana, PharmD, Clinical Pharmacist, Department of Veterans Affairs, Rochester Outpatient Clinic
  7. Shah, Samir, RPh, Pharmacy District Manager, Rite Aid Corporation
  8. Paladino, Joseph, PharmD, Clinical Professor, State University of New York at Buffalo, School of Pharmacy and Pharmaceutical Sciences
  9. Najib, Jadwiga, PharmD, Professor of Clinical Pharmacy, Long Island University, Arnold and Marie Schwartz College of Pharmacy
  10. Naioti, John F., Jr., RPh, Drug Utilization Review Manager, New York State Department of Health, Office of Health Insurance Programs

The following speakers presented to the Board:

  1. Lehmann, David, MD, PharmD, Professor of Medicine and Pharmacology, State University of New York Upstate Medical University
  2. Figge, James, MD, Medical Director, Office of Health Insurance Programs, New York State Department of Health (NYSDOH)
  3. Finnerty, Molly, MD, Director, Bureau of Evidence Based Services & Implementation Science, NYS Psychiatric Institute, Office of Mental Health
  4. Wrobel, Mark, PharmD, Clinical Assistant Professor. School of Pharmacy & Pharmaceutical Sciences, State University of New York at Buffalo
  5. Coe, Holly, PharmD, Clinical Assistant Professor, School of Pharmacy & Pharmaceutical Sciences, State University of New York at Buffalo
  6. Brown, Jack, PharmD, MS, BCPS , Clinical Assistant Professor of Pharmacy and Public Health, School of Pharmacy & Pharmaceutical Sciences, State University of New York at Buffalo
  7. Fahr, Rita, RPh, Medicaid Pharmacy Program, Office of Health Insurance Programs, New York State Department of Health (NYSDOH)

The following Department of Health staff contributed to the discussions:

  1. Jones, Linda, RN, Director, Medicaid Pharmacy Program, Office of Health Insurance Programs, New York State Department of Health (NYSDOH)
  2. McNamara, Daniel, RPh, Pharmacy Consultant, Office of Health Insurance Programs, NYSDOH
  3. Correia, Robert, PharmD, Pharmacy Consultant, Office of Health Insurance Programs, NYSDOH

Medication Therapy Management Program

Ms Fahr responded to a question, raised at a previous meeting regarding asthma services directed at children, that NYS supports asthma coalitions throughout the State, including the South Bronx Asthma Partnership that is dedicated to working with the pediatric population.

The Prescriber Education Program

The Prescriber Education Program (PEP) update was presented by Dr. Lehmann and Dr. Figge. Dr. Lehmann discussed the upcoming PEP module for hypertension in the African American Medicaid population. The module will bring evidence based best practice information to prescribers and should help to improve patient adherence to prescribed pharmacotherapy by providing tools to prescribers. Dr. Figge discussed the OMH website and PEP website where videos addressing polypharmacy and cardio metabolic side effects can be accessed. Also on the PEP website is a link to the new federally based asthma guidelines and a link to the diabetes tools.

Psychiatric Services and Clinical Knowledge Enhancement System (PSYCKES)

The PSYCKES update was presented by Dr. Finnerty who discussed PSYCKES being used in the participating agencies and the resulting impact on improving the safety and quality of psychotropic medication management. The Board was presented the PSYCKES Continuous Quality Improvement Quarterly Report for the first quarter of this year. The Board was presented with implementation status, project selections, initial feedback and prescribing trends of the clinics in the project. Also presented were the support mechanisms utilized by OMH for the project, new indicator sets for future projects, and how PSYCKES may be integrated with other State agency programs.

Miconazole nitrate/zinc oxide/white petrolatum ointment (Vusion)

The Board was presented with a review of miconazole nitrate/zinc oxide/white petrolatum ointment (Vusion) in regard to public health concern of the agent's potential for development of drug resistance and the agent's use for non-FDA approved indications. The Board was also provided with information on prior authorization requirements from comparator state Medicaid programs.

Ophthalmic cyclosporine (Restatis)

The Board was presented with a review of ophthalmic cyclosporine (Restasis) regarding data indicating the utilization of the agent inconsistent with FDA-approved indications and compendia accepted uses. The Board was also provided with information on prior authorization requirements from comparator state Medicaid programs.

Sodium oxybate (Xyrem)

The Board was advised by State staff that the New York Medicaid Pharmacy & Therapeutics Committee (P&TC) reviewed sodium oxybate (Xyrem) on November 14, 2005 at which time the P&TC voted to recommend that Medicaid not reimburse for gamma-hydroxy butyric acid (GHB) under any name until a live interactive telephone prior authorization system is in place, which would provide more appropriate types of controls. The Commissioner of Health approved the recommendation.

The Board was presented with a review of sodium oxybate (Xyrem) in regard to public health concern of the agent's potential abuse associated with adverse events and death, the agent's use for non-FDA approved indications, and the agent's potential for illicit use, abuse and diversion.

The Board was also provided with information on prior authorization requirements from comparator state Medicaid programs.

Human Growth Hormone

The Board was presented with a review of human growth hormone (HGH) in regard to public health concerns with cancer and increased risks of diabetes, abuse and illicit use, and use for non-FDA approved indications.

The Board was also provided with information on prior authorization requirements from comparator state Medicaid programs.

E. Executive Session:

The Board recessed the public session at 11:50 A.M. to go into executive session for review of confidential Medicaid beneficiary cases. No official action was taken in the executive session. The executive session was recessed at 1:15 P.M.

F. DUR Board Discussion:

  • The Board raised questions regarding off label usage, the coding of diagnosis, and the process for confirming diagnosis for the use of miconazole nitrate/zinc oxide/white petrolatum ointment (Vusion).
  • Discussion also focused on the prescribing of ophthalmic cyclosporine (Restasis) by ophthalmologists and optometrists versus prescribing by non-ocular specialists.
  • Discussion from the Board focused on the use of sodium oxybate (Xyrem) for fibromyalgia and in patients with a history of substance abuse. The Board also discussed patient assessment for narcolepsy with cataplexy and the desire to restrict the prescribing of this medication to sleep specialists, if possible.
  • The Board also discussed human growth hormone and focused on the difference in FDA approved indications between pediatrics and adults. The Board discussed the idea of an automated screening process at the point of service to help alleviate prescriber burden of certain subsets.

G. DUR Board Action:

Human Growth Hormone

The DUR Board took the following actions regarding Growth Hormone:

  • Agreed that human growth hormone (HGH) met the criteria for inclusion into the CDRP
  • Recommended that the Medicaid P&TC consider HGH for inclusion into the CDRP for patients over 21 years of age.
  • Recommended that the P&TC consider the following questions be asked of the prescriber when prior authorization is requested for HGH:
    1. Does the patient have childhood onset or adult onset growth hormone deficiency or is the patient an adult with short bowel syndrome?
    2. Does the patient have any of the following contraindications: acute critical illness, obesity with upper airway obstruction, sleep apnea or severe respiratory impairment (if diagnosed with Prader-Willi syndrome), active malignancy, diabetic retinopathy (unless prescribing Zorbtive), closed epiphyses?
    3. For patients being prescribed Zorbtive for short bowel syndrome, is the patient on specialized nutritional support?

Sodium oxybate (Xyrem)

The DUR Board took the following actions regarding sodium oxybate (Xyrem):

  • Discussion, from the Board, included that sodium oxybate (Xyrem) meets all three criteria for CDRP but there were concerns on the lack of appropriate controls under the current system and the potential effect this would have on public health safety if this agent was covered.
  • The Board recommended that Medicaid not reimburse for GHB under any name until more appropriate types of controls are in place to determine medical necessity. The prescriber prevails provision does not allow proper control.
  • The Board also recommended the State should be allowed to deny a prior authorization request unless a drug is determined to be medically necessary; however that discussion was tabled until the next meeting.

Ophthalmic cyclosporine (Restasis)

The DUR Board took the following actions regarding ophthalmic cyclosporine (Restasis):

  • Noted that based on the information provided, ophthalmic cyclosporine (Restasis) does not meet the criteria for inclusion into the CDRP.
  • The Board voted to table further discussions on ophthalmic cyclosporine (Restasis) until the pharmacy claim system had capability to identify a prescribers specialty.
  • The Board recommended that the state pursue expeditiously the automation capability to identify a prescriber by specialty for purposes of assuring appropriate prescribing.

Miconazole nitrate/zinc oxide/white petrolatum ointment (Vusion)

The DUR Board took the following actions regarding Miconazole nitrate/zinc oxide/white petrolatum ointment (Vusion):

  • Noted that based on the information provided, miconazole nitrate/zinc oxide/white petrolatum ointment (Vusion) does not meet the criteria for inclusion into the CDRP.
  • Recommended that miconazole nitrate/zinc oxide/white petrolatum ointment (Vusion) utilization be controlled via age and quantity limits.
  • Recommended a maximum age of 5 years old.
  • Recommended quantity be limited to 100 grams in a 90 day period.
  • Recommended that the following questions be asked when limits are exceeded necessitating a prior authorization:
    1. Is this agent being used to treat diaper dermatitis?
    2. Is the patient immunocompromised?

The meeting adjourned at 4:15 P.M.

Meeting Summary Posted 8/10/09