Drug Utilization Review (DUR) Board Meeting Summary - December 9, 2010

Agenda and Introduction

The Drug Utilization Review Board met on Thursday December 9, 2010 from 9:00 A.M. to 4:30 P.M., in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

A. Background Materials Provided:

The DUR Board members were provided copies of materials submitted by interested parties in advance of the meeting.

B. Public Comment Period:

The following speakers provided comments to the DUR Board:

  1. Dube, Christine, PharmD, Director, Medical Sciences, MedImmune LLC, Gaithersburg, MD
  2. Baran, Daniel, MD, Senior Regional Medical Director, Merck and Co. Inc., North Wales, PA
  3. Pan, Phillip, MD, Associate Director, Neonatology, Bellevue Woman's Center, Niskayuna, NY

C. Key Issues Presented by Interested Parties and Discussed by the DUR Board during the Public Comment Period:

Palivizumab
The Board was asked to consider information regarding study results including dosing and indications. The Board was also asked to consider the potential variability of the respiratory syncytial virus (RSV) season, and the importance of avoiding delays in or disruption of dosing schedules. Testimony addressed concerns with the differences in the risk factors, age of use, and number of doses recommended in the new guidelines.

Pegylated Interferons
The DUR Board was asked to consider information regarding pegylated interferons including Hepatitis C treatment guidelines, indications, adverse events, and information regarding dosing and administration.

D. Presentations and Discussions:

The following speakers presented to the DUR Board:

  1. Figge, James, MD, MBA Medical Director, Office of Health Insurance Programs, New York State Department of Health
  2. Shields, Barbara, RN, Director of Utilization Management, Division of Provider Relations and Utilization Management, Office of Health Insurance Programs, New York State Department of Health
  3. Catanzaro, Linda, PharmD, Clinical Assistant Professor Director, Pharmacotherapy Information Center Program Chair, HIV Continuing Education Programs, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo
  4. Fillippeli, Susan, PhD, Communication Specialist/Project Manager HID Solutions, Inc. Health Information Designs, Inc
  5. Doloresco, Fred, PharmD, Clinical Assistant Professor, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo
  6. Wrobel, Mark, PharmD, Clinical Assistant Professor, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo
  7. Coe, Holly, PharmD, Clinical Assistant Professor, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo
  8. Ho, Mei-Jen, PharmD, MSPH, Clinical Assistant Professor, School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo
  9. Probst, Luke, PharmD., BCPS, Associate Director of Pharmacy - Pediatric Services, Upstate Golisano Children's Hospital
  10. Finnerty, Molly, MD, Director, Bureau of Evidence Based Services and Implementation Science, NYS Psychiatric Institute, NYS Office of Mental Health

Propoxyphene
Dr. Wrobel and Dr. Doloresco presented the propoxyphene utilization review. The Board was informed of the recent FDA warnings and recommendations and the black box warning associated with the risk of serious life-threatening adverse events including death. Discussion included the potential public health concerns associated with use of this drug. The Board was also provided with NYS Medicaid claims utilization information regarding propoxyphene containing products.

Proton Pump Inhibitors
Dr. Coe and Dr. Doloresco presented information to the Board regarding proton pump inhibitors (PPIs) including indications, safety issues, adverse events, dosing and administration, and appropriate duration of therapy based on diagnosis. The Board was provided information from studies demonstrating the high incidence of inappropriate utilization of PPIs nationwide. The Board was also provided with NYS Medicaid claims utilization information specifically related to potential overutilization of PPIs. Prior authorization requirements from comparator State Medicaid programs were also reviewed.

New York State Medicaid Utilization Threshold Program
Ms. Shields presented the New York State Medicaid Utilization Threshold Program overview. The DUR Board was provided information on the modernization of the thresholds, the impact of the modernization, and next steps. The Board was also provided a monthly breakdown on overrides and communications.

Prescriber Education Program (PEP)
Dr. Figge and Dr. Catanzaro presented an update of the Prescriber Education Program (PEP). The DUR Board was provided with a detailed description of the PEP and the development of the Drug Information Response Center. Points of discussion included identification of prescriber education topics, module development, current modules that have been implemented and modules still in development.

Palivizumab Guidelines Update
Dr. Probst presented a comparison of the 2006 and 2009 American Academy of Pediatrics (AAP) palivizumab guidelines.

Psychiatric Services and Clinical Knowledge Enhancement System (PSYCKES) Update
Dr. Finnerty presented the PSYCKES overview and discussed the program's impact on improving the safety and quality of psychotropic medication management. She discussed the PSYCKES Continuous Quality Improvement Quarterly Report for the third quarter of this year. Dr. Finnerty also discussed implementation status, project selections, feedback and prescribing trends noted within clinics in the project. Also presented were the support mechanisms utilized by the Office of Mental Health for the project, Phase II indicator sets for future projects, and how PSYCKES may be integrated with other State agency programs.

Retrospective Drug Utilization Review (RDUR) Overview
Dr. Fillippeli and Dr. Ho presented the RDUR overview. The Board was provided detailed information regarding the process, timeline, and the flow of information within the RDUR program. Dr. Fillippeli discussed Health Information Design's role in the process and the reports they provide. Dr. Ho provided an overview of the University at Buffalo's individual profile review process.

E. DUR Board Discussion

Palivizumab Guidelines

The DUR Board discussed the major differences between the 2006 and 2009 palivizumab guidelines. Points of discussion focused on the age during the RSV season and number of doses recommended for those with a gestational age between 32 weeks and 34 weeks 6 days.

Propoxyphene

The DUR Board discussed propoxyphene containing products regarding quantity/frequency/duration limits and inclusion in the Clinical Drug Review Program (CDRP). The discussion focused on the black box warning and the FDA's recent request for a voluntary recall and that propoxyphene should no longer be prescribed or dispensed due to the potential for life threatening events associated with a single dose.

Pegylated Interferons

The DUR Board discussed pegylated interferons and the recommendation for quantity, frequency, and duration limits. The discussion focused on obtaining genotypes and requiring the recommended testing at the appropriate intervals to ensure proper length of therapy.

Proton Pump Inhibitors

The DUR Board discussed proton pump inhibitors with regard to appropriate quantity and treatment duration for specific diagnoses. The discussion focused on overutilization.

F. DUR Board Action:

Palivizumab Guidelines

The DUR Board took the following action(s) regarding palivizumab guidelines:

  • Follow the American Academy of Pediatrics 2009 palivizumab guidelines with the exception of the 32 - 34 week 6 day gestational age infants, for which up to 5 doses may be considered.

Propoxyphene

The DUR Board took the following action(s) regarding propoxyphene:

  • FDA recommendations should be followed and propoxyphene should not be prescribed or dispensed.

In the event the State is required to continue propoxyphene reimbursement, propoxyphene meets the criteria for inclusion into the CDRP

  • Recommended that the Medicaid Pharmacy and Therapeutics Committee consider propoxyphene for inclusion into the CDRP, including the following question to be asked of the prescriber when prior authorization is requested for propoxyphene:
    1. Has the patient failed treatment with all other analgesics reimbursable by NYS Medicaid?
      • Provide a list of failed medications.
  • Propoxyphene be limited to a maximum of 30 dosage units over a maximum of a 5 day period with no refills, with a frequency limit of 180 days. The following prior authorization question will be asked when the limits are exceeded:
    1. Q: What is the clinical rationale that would justify use beyond the set limits?

Pegylated Interferons

The DUR Board took the following action(s) regarding pegylated interferons:

  • Duration limits will be instituted for pegylated interferons to ensure appropriate utilization. Prior authorization will be required for the initial 14 weeks of therapy to determine the appropriate duration of therapy based on genotype.
    • The following prior authorization questions would be asked at initiation of therapy:
      1. Is the patient diagnosed with Hepatitis C Virus?
      2. What is the patient's Hepatitis C genotype?
      3. What is the patient's quantitative HCV RNA baseline?
      4. Is this product being co administered with ribavirin?
      5. Does the patient have a comorbidity requiring adjustment to the expected duration of therapy for patients with genotype 2 and 3?
    • Further documentation required for the continuation of therapy at weeks 14 and 26:
      1. After 12 weeks of therapy obtain a quantitative HCV RNA. Continuation is supported if the patient has an undetectable HCV RNA or at least a 2 log decrease compared to baseline.
      2. After 24 weeks of therapy obtain a HCV RNA. Continuation for genotype 1 and 4 is supported if the patient has an undetectable HCV RNA.

Proton Pump Inhibitors

The DUR Board took the following action(s) regarding proton pump inhibitors:

  • Quantity, frequency, and duration limits will be instituted for proton pump inhibitors to ensure appropriate utilization.
  • The duration and quantity limits will be based on FDA approved dosing and administration labeling as follows:
    • Duration limits:
      • Mild/moderate GERD, acute healing of duodenal/gastric ulcers (including NSAID-induced): 60 days
      • Maintenance treatment of duodenal ulcers: 365 days
      • H. pylori: 14 days
    • Quantity limits:
      • GERD, erosive esophagitis, healing and maintenance of duodenal/gastric ulcers (including NSAID-induced), prevention of NSAID-induced ulcers: once daily dosing (30 units every 30 days).
      • Hypersecretory conditions, Barrett's esophagitis, H. pylori, refractory GERD: twice daily dosing (60 units every 30 days).
  • The following prior authorization questions will be asked when the duration limits are exceeded:
    1. Has the patient been diagnosed with a hypersecretory condition (Zollinger-Ellison Syndrome), erosive esophagitis (including Barrett's), severe GERD, or is the patient currently taking PPIs for prevention of NSAID-induced ulcers?
    2. If no, what is the clinical justification for the duration of treatment?
  • The following prior authorization questions will be asked when the quantity limits are exceeded:
    1. Has the patient been diagnosed with a hypersecretory condition (Zollinger-Ellison Syndrome)?
    2. If no, what is the clinical justification for exceeding the daily quantity limit?

The meeting adjourned at 3:45 pm

Meeting Summary Posted 01/10/2011