Pharmacy and Therapeutics Committee

New York State Office Of Medicaid Management
Pharmacy and Therapeutics Meeting Summary from Previous Meeting - June 9, 2006

Agenda and Introduction

The Medicaid Pharmacy & Therapeutics Committee met on Friday, June 9, 2006 from 8:45 a.m. to 3:00 p.m. in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

Ms. Desmond introduced two new Committee members: Marla Suzan Eglowstein, MD (consumer advocate), and Susan P. Bruce, PharmD, BCPS (pharmacologist).

She then reminded the public that the purpose of the public comment is to allow representatives to provide comments regarding topics before the committee. It was suggested that written comments be provided prior to the meeting, and that the public comment period be used as an opportunity to summarize those comments. Ms Desmond reviewed the process to be used whereby the committee reviews available clinical literature regarding comparable efficacy, and evidence of clinical superiority in a therapeutic class, and then reviews confidential financial information relating to the determination of preferred drugs. The committee then makes recommendations to the Commissioner of Health.

Dr. Martin (Chairperson) reminded the public not to contact individual committee members directly but to submit evidence based peer-reviewed literature to the Department in writing prior to the meeting. He also emphasized that the NYS Medicaid program does not have a formulary. All drugs currently covered by Medicaid remain available under the preferred drug program. He noted that the determination of preferred and non-preferred drugs does not prohibit a prescriber from obtaining any of the medications covered under Medicaid.

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 addressed the committee:

  1. Schroeder, Scott, MD, Director Pediatric Pulmonary, Albany Medical Center, Albany, NY
  2. Calder, Robert, MD, Executive Medical Director, Merck & Co., Inc., North Wales, PA
  3. Mydler, Thomas T., MD, Medical Science Specialist in Global Medical Affairs, Schering-Plough Corporation, Parkville, MO
  4. Alam, Imtiaz, MD, Medical Director, Austin Hepatitis Center, Austin, TX
  5. Goldman, Donna E., MD, Medical Liaison, Virology, Roche, Nutley, NJ
  6. Brown, Jr., Robert S., MD, MPH, Division Chief, Liver Disease and Transplantation, Columbia University College of Physicians & Surgeons, New York, NY
  7. Whitbread, John, PhD, Regional Scientific Manager, Takeda Pharmaceuticals, West Sayville, NY
  8. Busch, Robert S., MD, Endocrinologist, The Endocrine Group, LLP, Albany, NY
  9. Saint-Jacques, Henock, MD, FACC, Cardiologist, North General Hospital, New York, NY
  10. Reiss, Robert A., PharmD, Sr. Regional Medical Scientist, GlaxoSmithKline, Spencerport, NY
  11. Leibowitz, Jonas, MD, Physician, Endocrinology, Diabetes and Osteoporosis Consultants, LLP, Yonkers, NY
  12. Nath, C. Ranjan, MD, Medical Director, Diabetes and Metabolism Center, Phelps Memorial Hospital Center, Sleepy Hollow, NY
  13. Kane, Michael P., PharmD, Associate Professor, Albany College of Pharmacy, Albany, NY
  14. Tolbert, Jerome V., MD, PhD, Endocrinologist, Private Practice, New York, NY
  15. Jain, Rajinder, MD, Medical Director, Amsterdam Hospital Diabetes Center, Troy Endocrinology, Troy, NY
  16. Rogler, Barbara, RPh, MS, Clinical Education Consultant, Pfizer, Inc., Delmar, NY
  17. Riolo, Jon V., PhD, Senior Regional Scientific Manager, Gastroenterology, AstraZeneca, Getzville, NY
  18. Dillon, Michael J., MS, RPh, Scientific Affairs Liaison, Santarus Inc., Clifton Park, NY

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

Public comments:

On the topic of identification of preferred drugs in the therapeutic class of Leukotriene Modifiers:

  • Information regarding clinical trial results (safety, efficacy, indications, mode of action, dosing, adverse events, and effects on growth rate) for drugs in this category was presented.
  • The Committee was asked to consider the prevalence of pediatric asthma, adherence with different dosing formulations, and the Asthma guidelines in the review of this category.

On the topic of identification of preferred drugs in the therapeutic class of Hepatitis C Agents:

  • Information regarding trial results (indications, dosing [weight based vs. fixed], length of treatment per genotype, efficacy with ribavirin, relapse rates, safety, adverse events, tolerability, adherence, sustained virologic response [SVR], treatment of high viral load) for drugs in this class was presented.
  • The Committee was asked to consider dosing in obese patients, ease of administration, support services, the differences in the 2 available pegylated interferons, the importance of physician choice, use with Hepatitis B and/or HIV coinfection, and use in cirrhotic patients in the review of this category.

On the topic of identification of preferred drugs in the therapeutic class of Thiazolidinediones:

  • Information regarding trial results (safety, efficacy, tolerability, adverse reactions, effects on hemoglobin A1C, micro and macrovascular risks and diabetic dyslipidemia, drug interactions) for drugs in this category was presented.
  • The Committee was asked to consider the effects of TZDs on beta cells and duration of therapy, the difficulties in treating diabetic patients, the need to treat cardiovascular co-morbidities and the importance of physician choice in the review of this category.

On the topic of Establishment of procedures for newly approved prescription drugs subject to the Preferred Drug Program (PDP):

  • The Committee was asked to consider that new drugs in categories subject to the PDP be available without prior authorization until P&T Committee review after six months of general availability.

On the topic of the Transition of the Prescription Proton Pump Inhibitor (PPI) and Second Generation Antihistamine (SGA) Programs to the Preferred Drug Program (PDP):

  • Limited new clinical information since the previous reviews (SGAs - January 2003; PPIs - June 2005) for drugs in these categories was presented.
  • The Committee was asked to consider new efficacy studies, adverse events studies, and the potential impact of prior authorization programs on other therapeutic classes not subject to these programs.

Pharmacy and Therapeutics Committee Response:

  • A committee member asked if there is evidence that Pegasys will be effective at any patient weight. The presenter indicated that a similar response can be expected in patients up to 85 kilograms (kg). Decreased response rates have been noted in patients over 85kg, if fat in the liver is greater than 50%, SVR may be reduced, and with metabolic syndrome, increased insulin levels may affect interferon.
  • A committee member commented that for the SGA review, transition to the PDP is legislatively mandated, and the committee will focus on new clinical data since 2003. A question was also raised regarding whether there was Leukotriene Modifier (LTM) data on allergy diagnosis alone. It was indicated that the LTM data included both allergy and asthma diagnoses. In response to a speaker's economic analyses of SGA utilization, DOH staff clarified that contrary to the speakers' statement, the Department's fiscal impact analysis of SGA did include consideration of 3 therapeutic classes: Second Generation Antihistamines, Leukotriene Modifiers, and Intranasal Steroids. A gradual increase in utilization of LTMs was noted, but the fiscal analysis still indicates substantial savings. Further, the use of LTM for non-allergy indications must be considered. A Committee member noted that the LTM and Intranasal Steroid therapeutic classes are now included in the PDP, lessening any potential impact of LTM growth.

D. Clinical Presentation and Discussion: Proposal to identify preferred drugs in the therapeutic class of Leukotriene Modifiers

Leukotriene Modifiers
Drugs Affected:Accolate (zafirlukast), Singulair (montelukast)

Jeanne Kennicutt, RPh, MBA, First Health Services Corporation (FHSC); Robert Correia, PharmD, NYS Department of Health, Office of Medicaid Management (DOH/OMM)

Ms. Kennicutt described the medications in this category, discussed indications, pharmacology, comparative efficacy and tolerability, safety, drug interactions, and adverse effects. She discussed the LTM's place in therapy based on recommendation by the National Heart, Lung, and Blood Institute and the National Institute of Health guidelines as well as the American Academy of Allergy, Asthma and Immunology guidelines for the pharmacotherapy of asthma. Based on a review of clinical studies, it was recommended that there is no conclusive evidence of difference in efficacy between the two drugs.

Dr. Correia provided the Department's clinical review for this category. He discussed the differences in the indications for both drugs in the class including the age differences, and the additional indication of allergic rhinitis for montelukast. He also addressed dosing, drug interactions and adverse drug reactions. He discussed clinical trials including head-to-head data. He indicated that at this time there is no adequate evidence of overall clinical superiority to justify preferential availability of either product.

E. Clinical Presentation and Discussion: Proposal to identify preferred drugs in the therapeutic class of Hepatitis C Agents

Hepatitis C Agents

Drugs Affected: PEG-Intron, PEG-Intron Redipen (peginterferon alfa-2b), Pegasys, Pegasys Convenience Pack (peginterferon alfa-2a)

Rob Coppola, PharmD, (FHSC); Robert Correia, PharmD, (DOH/OMM)

Dr. Coppola described the medications in this category, including the effect of pegylation, indications, pharmacology, pharmacokinetics, dosing, adverse effects, and use in pregnancy and renal disease. He indicated that the two pegylated interferons have not been compared in a randomized controlled head to head trial using similar ribavirin doses. In two trials (Fried and Manns), there appeared to be no significant difference between peginterferon alfa-2b and peginterferon alfa-2a when used in combination with ribavirin.

A committee member asked if the Consensus Guidelines for the treatment of Hepatitis C included treatment of Hepatitis B. Dr. Coppola indicated that an Update of Recommendations for the treatment of Hepatitis B was released in 2004. Dr. Correia indicated that while PEG-Intron (peginterferon alfa-2b) does not have an indication for the treatment of chronic Hepatitis B, Intron A (interferon alfa-2b) does. He also indicated that there are several oral treatments for Hepatitis B, with fewer side effects than the interferons, and a promising new drug is currently in phase 3 trials.

Dr. Correia provided the Department's recommendations regarding the clinical review for this category of drugs. He reiterated that there are no published head to head trials between these drugs. He indicated that unpublished studies that were presented during public testimony had not been submitted for Committee review and could not be evaluated for quality. He discussed the use of the peg-interferons in the treatment of chronic Hepatitis B, in patients with HCV/HIV coinfection, and in patients in methadone treatment programs. The differences in standard versus weight based dosing were also discussed. He indicated that at this time there is no adequate evidence of overall clinical superiority to justify preferential availability of any one product, although each may demonstrate preferential characteristics within specificsub-populations.

A committee member asked if there was data to show that peginterferon alfa-2b was preferred for the methadone treatment population because of the availability of a non-reusable injection device. Dr. Correia indicated that there is currently no data, but researchers from an ongoing National Institutes of Health (NIH) study had presented this opinion.

F. Clinical Presentation and Discussion: Proposal to identify preferred drugs in the therapeutic class of Thiazolidinediones

Thiazolidinediones (TZDs)

Drugs Affected: Actos (pioglitazone), Actoplus met (pioglitazone/metformin), Avandia (rosiglitazone), Avandamet (rosiglitazone/metformin), Avandaryl (rosiglitazone/glimepiride)

Susan L. Norris, MD, MPH, Oregon Health & Science University, Evidence-based Practice Center (OHSU EPC); Rob Coppola, PharmD, (FHSC); Robert Correia, PharmD, (DOH/OMM)

Dr. Norris presented the summary of the OHSU review of TZDs and discussed the outcomes of key areas of inquiries based on findings from clinical trials, including head-to-head trials. She provided the outcomes of studies comparing efficacy, the prevention of macro and microvascular complications, weight control, effect on delaying onset of clinical diabetes, progression of cardiac risk factors, safety, adverse events, hypoglycemic effects, and efficacy within certain subgroups.

Dr. Coppola described the medications in this category, including pharmacology, indications, pharmacokinetic properties, efficacy, adverse events, contraindications, drug interactions, effect on lipid profile, dosing, and monitoring. Based on a review of available clinical studies and trials, it was noted that there does not appear to be conclusive evidence of difference in efficacy among the drugs.

Dr. Correia provided the Department's recommendations regarding the clinical review for this category of drugs. He discussed product indications, potential for drug interactions, as well as the fact that there is good evidence these drugs are equivalent in efficacy for lowering hemoglobin A1C. He indicated that there is evidence for both TZDs having positive impacts on lipid parameters, blood pressure, and cardiovascular outcomes, however these impacts are modest. He emphasized the current standard of care is to treat diabetic patients aggressively for dyslipidemias and hypertension, and it is unknown what, if any, different impact the TZDs have in that context. He also discussed effects of the drugs on weight, edema, and in heart failure. He concluded that the significance of any marginal differences in intermediate or surrogate markers for these drugs in terms of clinical outcomes remains undetermined at this time, and there is a lack of evidence of overall clinical superiority to justify preferential availability of any product in this class.

A committee member asked Dr. Norris (OHSU) if she had any comments on new information on the TZDs since July 2005, which was the end date for the inclusion criteria in the Oregon Drug Class Review on TZDs. She indicated that there is conflicting evidence with regard to lipids, and there is less data for pioglitazone than rosiglitazone with regard to blood pressure effects. As for newer studies, she indicated that there was no additional information.

G. Discussion: Establishment of procedures for newly approved prescription drugs subject to the Preferred Drug Program

DOH introduced proposed procedures by which the Committee could incorporate drugs which have been newly approved by the FDA, and are in categories already included in the PDP. The objective of the process is to assure timely review of new drug entities with a significant impact on care, while maintaining a relatively stable preferred drug list. It was noted that the NYS Medicaid program covers all new drug entities by manufacturers who participate in the federal rebate program. New drugs are generally covered within one month of their inclusion in the national pricing system used by NYS Medicaid. The following process was proposed:

  • The Committee will be notified of the availability of new drugs which are within a therapeutic class already subject to the PDP.
  • Newly approved drugs in categories subject to the PDP will generally require prior authorization as a non-preferred drug until the P&TC completes the annual review of the therapeutic class, and considers the clinical and fiscal impact of all drugs within the class.
  • The P&TC may recommend an ad hoc evaluation be undertaken promptly, prior to the annual review, when a newly approved drug provides substantial new benefits within the existing therapeutic class, or when new clinical information on an existing drug indicates a potential health and/or safety issue.

The Committee discussed the proposal, clarifying that the ad hoc review process would also be used when there was a substantial change in the clinical safety of drugs within the PDP.

Following a vote, the proposal was adopted unanimously.

H. Clinical Presentation and Discussion: Proposal to transition the Prescription Proton Pump Inhibitor (PPI) and Second Generation Antihistamine (SGA) Programs to the Preferred Drug Program

This is an administrative transition required by State law. Clinical reviews by the P&TC have been previously completed for these categories. The P&TC reviewed only new clinical information since the previous reviews (SGAs - January 2003; PPIs - June 2005).

Drugs Affected:

Proton Pump Inhibitors: Aciphex (rabeprazole), Nexium (esomeprazole), omeprazole, Prevacid (lansoprazole), Prevacid NapraPAC (lansoprazole/naproxen), Prilosec (omeprazole), Prilosec OTC (omeprazole), Protonix (pantoprazole), Zegerid (omeprazole/sodium bicarbonate)

Second Generation Antihistamines: Allegra/Allegra-D (fexofenadine), Clarinex/Clarinex-D (desloratadine), Claritin/Claritin-D (loratadine), loratadine/loratadine-D, fexofenadine, Semprex-D (acrivastine), Zyrtec/Zyrtec-D (cetirizine).

Kim Peterson, MS, (OHSU EPC); Rob Coppola, PharmD, (FHSC); Jeanne Kennicutt, RPh, MBA, (FHSC); Robert Correia, PharmD, (DOH/OMM)

Ms. Peterson presented an abbreviated OHSU review of SGAs focusing on new evidence. She discussed clinical trials, including head to head trials, comparing efficacy for both adults and children in the treatment of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR) and chronic idiopathic urticaria (CIU). She also discussed trials comparing safety, adverse events, and uses within certain certain subgroups (i.e. age, racial groups, gender).

A committee member questioned the results of a trial that concluded cetirizine was more efficacious than fexofenadine for CIU. Ms. Peterson indicated that it was a 28 day trial with 116 participants. A committee member indicated that the 4% symptom-free endpoint for fexofenadine in that trial seemed low and questioned whether fexofenadine was effective for the treatment for CIU, and if it is generally prescribed for that indication.

Ms. Kennicutt provided a brief description of the medications in the SGA category. She indicated that since the February 2003 review, there is no significant evidence of clinical relevance that would prompt a recommendation for a change in the current prior authorization program for drugs in this class.

Dr. Correia provided the Department's recommendations regarding the clinical review for SGAs. He discussed the updated OHSU report which reveals that there has been little additional clinical research in this drug class since the last review. He indicated that the new evidence for effectiveness and adverse effects is limited, of only fair quality, or conflicting, and that overall, there is no significant new evidence of clinical superiority to justify preferential availability of any one product.

Dr. Coppola provided a brief description of the medications in the PPI category. He discussed several new clinical trials comparing PPIs from the last year including a trial with a primary endpoint of erosive esophagitis healing, a trial that measured time to first and sustained symptom relief in gastroesophageal reflux disease (GERD), and a trial assessing pharmacokinetics of a PPI in adolescents with symptoms of GERD.

Dr. Correia provided the Department's recommendations regarding the clinical review for PPIs. He discussed the OHSU EPC report which is currently being updated, and the EPC staff was able to share with the Department new clinical information since the last time this drug class was reviewed. He discussed dosing in clinical trials, safety and efficacy, and the combination PPI and antacid immediate release formulation. He notes that the US Department of Health and Human Services Agency for Healthcare Research and Quality (AHRQ) presented an opinion on PPIs in December 2005 which states: "Studies show that overall, each PPI works about as well as another for relieving symptoms". He concluded that overall, there is no significant new clinical information about the drugs in this class to justify preferential availability of any one product.

A committee member mentioned that in the clinical information submitted to the Committee, there was mention of anecdotal evidence of problems with using Prilosec OTC in pediatric patients and asked if there was anything in the literature to substantiate this. Neither Dr. Coppola nor Dr. Correia was aware of any published reports in this area.

I. Executive Session:

The Committee recessed the public session at 11:40 A.M. to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Leukotriene Modifiers, Hepatitis C Agents, Thiazolidinediones. No official action was taken in the executive session. The executive session was recessed at 12:45 P.M.

The Committee recessed the public session at 1:30 P.M. to go into executive session for review of the transition process and financial information relating to the transition of the Prescription Proton Pump Inhibitors and Second Generation Antihistamines to the Preferred Drug Program, including the determination of preferred drugs in those classes. No official action was taken in the executive session. The executive session was recessed at 2:00 P.M.

J. 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 Recommendations Commissioner's Final Decision
Proposal: Identification of preferred drugs in the category of Leukotriene Modifiers

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
Accolate, Singulair

Non-preferred Drug
None

B. The Committee unanimously recommended the following clinical questions be used as the basis for approving use of a non-preferred drug, should the Commissioner's final decision include a non-preferred drug:

  • Q: Has your patient experienced treatment failure with a preferred leukotriene modifier?

  • Q: Has your patient experienced an adverse drug reaction with a preferred leukotriene modifier?

  • Q: Is there a documented history of successful therapeutic control with a non-preferred leukotriene modifier and transition to a preferred leukotriene modifier is medically contraindicated?

Approved as Recommended
Proposal: : Identification of preferred drugs in the category of Hepatitis C Agents

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
PEG-Intron, PEG-Intron Redipen, Pegasys, Pegasys Convenience Pack

Non-preferred Drug
None

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process, should the Commissioner's final decision include a non-preferred drug.

Approved as Recommended
Proposal: Identification of preferred drugs in the category of Thiazolidinediones

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
Actos, Actoplus met, Avandia, Avandamet, Avandaryl

Non-preferred Drug
None

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process, should the Commissioner's final decision include a non-preferred drug.

Approved as Recommended
Proposal: Establishment of procedures for newly approved prescription drugs subject to the Preferred Drug Program

To establish procedures to address drugs newly approved by the FDA, which are in a therapeutic class already in the Preferred Drug Program (PDP), the Committee unanimously recommended the following:

  • The Committee will be notified of the availability of new drugs within PDP classes.
  • Newly approved drugs in categories subject to the PDP will generally require prior authorization as a non-preferred drug until the P&TC completes the annual review of the therapeutic class, and considers the clinical and fiscal impact of all drugs within the class.
  • The P&TC may recommend an ad hoc evaluation be undertaken prior to the annual review, when a newly approved drug provides substantial new benefits within the existing therapeutic class, or when new clinical information on an existing drug indicates a potential health and/or safety issue.


Approved as Recommended
Proposal: Transition of the Prescription Proton Pump Inhibitor (PPI) Program to the Preferred Drug Program

A. Based on the submitted or presented new clinical information, available since the previous review, and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
Nexium, Prevacid Capsule, Prilosec OTC

Non-preferred Drugs
Aciphex, omeprazole, Prevacid Solutab, Prevacid Suspension, Prevacid NapraPAC, Prilosec, Protonix, Zegerid Packet, Zegerid Capsule

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process.

Approved as Recommended
Proposal: Transition of the Second Generation Antihistamine (SGA) Program to the Preferred Drug Program

A. Based on the submitted or presented new clinical information, available since the previous review, and on the financial information provided during the executive session, the Committee unanimously recommended the following:

Preferred Drugs
OTC loratadine products (i.e. Claritin), OTC loratadine D products (i.e. Claritin D)

Non-preferred Drugs
Allegra, Allegra-D, Clarinex, Clarinex-D, fexofenadine, Semprex-D, Zyrtec, Zyrtec-D

B. The Committee unanimously recommended the standard clinical questions be used in the prior authorization review process and that the following additional clinical question be added for this drug class:

  • Q: Is the patient under twenty-four (24) months of age?
Approved as Recommended

Additional question to be the first question.

K. Election of Officers:

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

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

The meeting adjourned at 2:10 PM.

Meeting Summary Posted June 21, 2006

L. Final Determinations:

The Commissioner has determined that Medicaid will require prior authorization under the Preferred Drug Program (PDP) for non-preferred drugs, as listed above, in the following classes: Leukotriene Modifiers, Hepatitis C Agents, Thiazolidinediones, Proton Pump Inhibitors and Second Generation Antihistamines. Preferred drugs will not require prior authorization.

The impacts of this final determination are as follows:

  1. State Public Health Population:
    • Minimal effects as a large majority of Medicaid patients currently utilize those drugs which have been determined to be preferred.
    • Use of prior authorization for non-preferred products encourages use of more cost effective drugs within the same therapeutic class when appropriate.
  2. Program Providers:
    • Limited additional time and effort will be required by prescribers to complete the prior authorization process for non-preferred drugs.
  3. Fiscal Impact to State Health Program:
    • Through the changes in utilization to more cost effective drugs, and the receipt of supplemental rebates from pharmaceutical manufacturers, annual savings for these categories of drugs under the Preferred Drug Program are estimated at $72.8M, adjusting for the implementation of Medicare Part D.

Posted September 6, 2006.