Pharmacy and Therapeutics Committee

New York State Office Of Medicaid Management
Pharmacy and Therapeutics Meeting Summary from Previous Meeting - May 5, 2006

Agenda

The Medicaid Pharmacy & Therapeutics Committee met on Friday, May 5, 2006 from 8:45 a.m. to 3:00 p.m. in Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

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. Tuluca, Luciano, MD, DO, Clinical Director, Rehab. Medicine, Jacobi Medical Center, Bronx, NY
  2. Dube, Christine, PharmD, Sr. Scientific Affairs Liaison, Ortho McNeil Janssen, Torrington, CT
  3. VanZile, Peter, PharmD, Sr. Regional Medical Scientist, GlaxoSmithKline, Succasunna, NJ
  4. Elkind, Arthur, MD, Director, Elkind Headache Center, Mount Vernon, NY
  5. Kaiser, Fran E., MD, Executive Medical Director, Merck & Co., Dallas, TX
  6. Govaker, David, MD, Medical Director, Pfizer Inc., New York, NY
  7. Jacob, Patricia, PharmD, Sr. Regional Medical Scientist, GlaxoSmithKline, North Plainfield, NJ
  8. Green, Mark, MD, Director, Columbia University Headache Center, New York, NY
  9. Saljanin, Kristina, Patient, Migraine Sufferer, Sunnyside, NY
  10. Bruni, Oreste Joseph, MD, Chairman Emergency Dept., New Island Hospital, Bethpage, NY
  11. Khordoc, Cindy, PharmD, Regional Scientific Manager, Respiratory, AstraZeneca, Smithtown, NY
  12. Thacker, Kimberley, MD, VP, CNS Medical Affairs, Sanofi-Aventis, Bridgewater, NJ
  13. Walsh, John, MD, South Shore Family Practice Associates, PC, East Islip, NY
  14. Cozza, Teresa, PsyD, Regional Scientific Manager, Takeda Pharmaceuticals, Clayton, DE
  15. Icenhour, Danny, PharmD, Director-Professional Information Services, King Pharmaceuticals, Bristol, TN
  16. Walsleben, Joyce, RN, PhD, Assoc. Prof. NYU School of Medicine; Head Behavioral Sleep Medicine, NYU Sleep Disorder Center, New York, NY
  17. Docherty, John, MD, Adjunct Professor of Psychiatry, Weill Cornell Medical College, White Plains, NY
  18. Rhodes, Virginia, MD, Senior Medical Liaison, Roche, Nutley, NJ
  19. Horodysky, Motria, PharmD, Sr. Oncology Medical Scientist, GlaxoSmithKline, Verona, NJ

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 Long Acting Narcotics:

  • Information regarding trial results (safety, efficacy, indications, dosing and dosing formulations, adverse events, patient preference, quality of life) for drugs in this category was presented.
  • The Committee was asked to consider the potential for misuse and abuse, tolerability profiles, alternatives to oral dosing, and brand versus generic formulations in the review of this category.

On the topic of identification of preferred drugs in the therapeutic class of Serotonin Receptor Agonists (Triptans):

  • Information regarding trial results (indications, efficacy at multiple endpoints, safety, drug interactions, bioavailability, adverse events, trial design, consistency, tolerability) for drugs in this class was presented.
  • The Committee was asked to consider the onset and duration of action and dosing formulations of the triptans, the impact of migraine headaches as a disease, the importance of patient information and options, and the use of triptans in menstrual migraine and cluster headaches.

On the topic of identification of preferred drugs in the therapeutic class of Sedative Hypnotics:

  • Information regarding trial results (safety, efficacy, tolerance, pharmacokinetics, duration of therapy, mechanism of action, next-day effects, withdrawal, rebound insomnia, and drug interactions) for drugs in this category was presented.
  • The Committee was asked to consider the prevalence and impact of insomnia, the effects of insomnia and the importance of understanding sleep, treatment of the different symptoms of insomnia, treatment of primary insomnia as well as insomnia secondary to comorbidities, and abuse liability in the review of this category.

On the topic of identification of preferred drugs in the therapeutic class of Anti-Emetics:

  • Information regarding trial results (indications, dosing, safety, efficacy, pharmacokinetics, adverse effects, and drug interactions) for drugs in this category was presented.
  • The Committee was asked to consider dosing formulations, and post marketing experience in the review of this category.

Pharmacy and Therapeutics Committee Response:

  • A committee member asked if there is a weight limit for the use of Duragesic Patches in low weight patients. The presenter indicated that the lowest dose patch should be used in patients weighing less than 50kg.
  • A committee member asked the size of the clinical trial involving the use of frovatriptan in menstrual related migraine, and the age of the trial participants. The presenter indicated that several hundred women of the age of menstruation were participating.
  • A committee member asked the difference in speed of onset between the intranasal and injectable dosage form of a triptan. The presenter indicated that the onset of the intranasal formulation is more equivalent to the onset of the oral dosage form rather than the injectable form, however this has not been tested head to head.
  • A committee member expressed concerns about recent news articles on the potential misuse or overuse of sedatives/hypnotics, and the impact on the public.
  • A member asked if the 2mg Lunesta dose was appropriate in the elderly population, and if there was a use for the 1mg dose. The presenter indicated that with the 1mg, 2mg and 3mg dosing flexibility of Lunesta, the 2mg was appropriate for the elderly, and the 1mg dose could be used in patients at risk for falls.
  • A committee member asked why when Rozerem was new to the market, pharmaceutical representatives indicated that it should only be used in treatment naïve patients. The presenter indicated that because Rozerem has no muscle relaxant effects, patients who had previously taken a sedative hypnotic such as Ambien may not "feel" the Rozerem working, and therefore may not think it was effective.
  • A committee member inquired about Rozerem's effect on Prolactin. The presenter commented that during a six month study, Prolactin levels did increase, but remained within normal range, and monitoring of Prolcatin levels is not required.
  • A committee member asked if generic Zofran was coming soon. The presenter indicated that Zofran will be off patent at the end of 2006, and generics are anticipated.

D. Clinical Presentation and Discussion: Proposal to identify preferred drugs in the therapeutic class of Long Acting Narcotics

Long Acting Narcotics

Drugs Affected: Avinza (morphine sulfate ER), Duragesic (fentanyl), fentanyl, Kadian (morphine sulfate SR), morphine sulfate SR, MS Contin (morphine sulfate CR), Oramorph SR (morphine sulfate SR), oxycodone HCl CR, Oxycontin (oxycodone HCl CR).

Roger Chou, MD, Oregon Health & Science University, Evidence-based Practice Center (OHSU EPC); Rob Coppola, PharmD, First Health Services Corporation (FHSC); Robert Correia, PharmD, NYS Department of Health, Office of Medicaid Management (DOH/OMM)

Dr. Chou presented the OHSU review of long acting narcotics and discussed clinical trials, including head to head trials, comparing efficacy, safety, adverse events and use of these medications in certain subpopulations (age, gender, race, subgroups of pain). Several committee members inquired about DOH's capability to identify and track narcotic diversion and if any medication was of particular concern. Dr. Correia and Ms. Desmond (DOH) responded that New York has prescription requirements to prevent inappropriate use and diversion of controlled substances.

Dr. Coppola described the medications in this category, discussed indications, pharmacology, comparative efficacy and tolerability, adverse effects, pregnancy category, metabolism and black box warnings.

Dr. Correia provided the Department's recommendations regarding the clinical review for this category of drugs. He discussed appropriate utilization of long acting narcotics, summarized available data, and noted that with the exception of dosage form specific concerns, these agents demonstrate overall equivalent efficacy and comparable safety. He indicated that at this time there is no adequate evidence of overall clinical superiority to justify preferential availability of any one product.

E. Clinical Presentation and Discussion: Proposal to identify preferred drugs in the therapeutic class of Serotonin Receptor Agonists (Triptans)

Serotonin Receptor Agonists (Triptans)

Drugs Affected: Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Imitrex (sumatriptan) tablet/nasal/injection, Maxalt (rizatriptan) tablet/MLT, Relpax (eletriptan), Zomig (zolmitriptan) tablet/nasal/ZMT.

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

Ms. Peterson presented the OHSU review of serotonin receptor agonists (triptans) and discussed clinical trials, including head to head trials, comparing efficacy, safety, and use of these medications in certain subpopulations (age, gender, race). She discussed controversy and limitations with certain trial designs. A committee member stated that encapsulation should be considered when evaluating study data, and Ms. Peterson agreed. Another question was raised by the committee regarding the mixing of different triptans in clinical practice. Dr. Correia stated that he couldn't speak to what happens in clinical practice, but the contraindication to mixing different triptans was supported in the literature.

Dr. Coppola described the medications in this category, including the different dosage forms, indications, pharmacology, comparative efficacy and different measures of clinical outcomes, adverse effects, pregnancy category, drug interactions, and the significance of onset and duration of action.

Dr. Correia provided the Department's recommendations regarding the clinical review for this category of drugs. He discussed the difficulty in comparing the triptans due to prior triptan use by study participants, doses compared in clinical trials, study participants who may have been required to wait for headache pain to become moderate to severe before treatment, alteration per study protocol of drug delivery system, and subjective outcomes. He stated that few head to head trials of triptans have been published in peer-reviewed journals, and are of better quality than even fair quality using standard criteria, and at this time there is no adequate evidence of overall clinical superiority to justify preferential availability of any one product.

F. Clinical Presentation and Discussion: Proposal to identify preferred Beta Blocker Combination products in the therapeutic class of Beta Blockers

Beta Blocker Combination products

Drugs Affected: atenolol/chlorthalidone, bisoprolol fumarate/HCTZ, Corzide (nadolol/bendroflumethiazide), Inderide (propranolol/HCTZ), Inderide LA (propranolol LA/HCTZ), Lopressor HCT (metoprolol tartrate/HCTZ), metoprolol tartrate/HCTZ, propranolol/HCTZ, Tenoretic (atenolol/chlorthalidone), Timolide (timolol maleate/HCTZ), Ziac (bisoprolol fumarate/HCTZ).

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

Dr. Coppola indicated that the therapeutic class of beta blockers was discussed at length at the March 9th, 2006 P&TC meeting, but the final recommendations were not made for the combination products. He provided a brief overview of the products in the class, indicating that the beta blockers can be considered equally effective in the treatment of hypertension, and the combination products are considered a convenience dosage form.

Dr. Correia provided the Department's recommendations regarding the clinical review for this category of drugs. He discussed product indications, efficacy in the treatment of hypertension, pregnancy category and pediatrics information. He indicated that at this time there is no adequate evidence of overall clinical superiority to justify preferential availability of any one product.

G. Clinical Presentation and Discussion: Proposal to identify preferred drugs in the therapeutic class of Sedative Hypnotics

Sedative Hypnotics

Drugs Affected: Ambien (zolpidem), Ambien CR (zolpidem CR), chloral hydrate, Dalmane (flurazepam), Doral (quazepam), estazolam, flurazepam, Halcion (triazolam), Lunesta (eszopiclone), Prosom (estazolam), Restoril (temazepam), Rozerem (ramelteon), Somnote (chloral hydrate), Sonata (zaleplon), temazepam, triazolam.

Marian McDonagh, PharmD, (OHSU EPC); Rob Coppola, PharmD (FHSC); Robert Correia, PharmD, (DOH/OMM)

Dr. McDonagh presented the OHSU review of sedative hypnotics and discussed clinical trials, including head-to-head trials, comparing efficacy (short and long term), safety (including long-term safety), patient preference, adverse events, and use of these medications in certain subpopulations (age, gender, race, pregnancy, patients with comorbidities).

Dr. Coppola described the medications in this category, including indications, pharmacology, adverse effects, pregnancy category, use in the elderly and in pediatrics, drug interactions, and the challenge in treating chronic insomnia with medical or behavioral comorbidities.

Dr. Correia provided the Department's recommendations regarding the clinical review for this category of drugs. He discussed the evidence for short term and long term efficacy for the drugs in the category, and noted that for the newer sedative hypnotics, evidence is still emerging with more widespread use. He discussed use of these agents in the elderly noting risk versus benefit. He also reviewed the use of and risks of chloral hydrate. He concluded that at this time there is no adequate evidence of overall clinical superiority to justify preferential availability of any one product.

Several committee members raised concerns regarding recent news reports about one of the newer sedative hypnotics. Ms. Desmond, Dr. Correia and Dr. Coppola in turn indicated that that is why the Department relies on comparative, clinical evidence in the literature. Anecdotal evidence is often not backed up by long term evidence, and with newer treatments emerging, there is a lack of long term evidence. As the medications are more heavily prescribed, more events may emerge. A committee member also commented that in many cases, the events that have been reported in the press are not new; they are just being more openly reported.

H. Clinical Presentation and Discussion: Proposal to identify preferred drugs in the therapeutic class of Anti-Emetics

Drugs Affected: Anzemet (dolasetron), Kytril (granisetron) tablet/solution, Zofran (ondansetron) tablet/solution/ODT.

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

Ms. Peterson presented the OHSU review of anti-emetics and discussed clinical trials comparing efficacy, safety, and adverse events with use of the drugs in chemotherapy, radiation therapy, pregnancy, and post operatively. Trials were performed for use in adults, pediatrics and pregnancy. None was found consistently superior in efficacy or more tolerable than any other.

Dr. Coppola described the medications in this category, including indications, pharmacology, adverse effects including cardiac adverse events, and pregnancy category. He noted the American Society of Clinical Oncology and the American Society of Health System Pharmacists guidelines, which both indicate equivalent safety and efficacy of these drugs. He also noted that the response rates of the oral preparations have generally equaled those obtained from the use of parenteral formulations.

Dr. Correia provided the Department's recommendations regarding the clinical review for this category of drugs. He noted that none of these medications are FDA approved for use in pregnancy, but all are pregnancy category B, and all have labeling relevant to pediatric use. He also noted that in comparisons of the oral forms of these drugs, there was no difference in complete response at 24 hours, acute and delayed complete response rates. There were no differences in overall tolerability and safety for oral dosage forms. He concluded that at this time there is no adequate evidence of overall clinical superiority to justify preferential availability of any one product.

I. Executive Session:

The Committee recessed the public session at 11:25 A.M. to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Long Acting Narcotics, Serotonin Receptor Agonists (Triptans), Beta Blocker Combinations. No official action was taken in the executive session. The executive session was recessed at 12:40 P.M.

The Committee recessed the public session at 2:00 P.M. to go into executive session for review of financial information relating to the determination of preferred drugs in the following classes: Sedative Hypnotics, Anti-Emetics. No official action was taken in the executive session. The executive session was recessed at 2:45 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 RecommendationsCommissioner's Final Decision
Proposal: Identification of preferred drugs in the category of Long Acting Narcotics

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the following drugs are recommended to be preferred. The Committee unanimously recommended the following:

Preferred Drugs
Duragesic, fentanyl patch, Kadian, morphine sulfate SR, Oramorph SR

Non-preferred Drugs:
Avinza, MS Contin, oxycodone HCl CR, Oxycontin

B. The Committee unanimously recommended the following clinical questions be used as the basis for approving use of the non-preferred drug:

  • Q: Has your patient experienced treatment failure with a preferred long acting narcotic?

  • Q: Has your patient experienced an adverse drug reaction with a preferred long acting narcotic?

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

Approved as Recommended
Proposal: Identification of preferred drugs in the category of Serotonin Receptor Agonists (Triptans)

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the following drugs are recommended to be preferred. The Committee unanimously recommended the following:

Preferred Drugs
Imitrex tablet/nasal/injection, Maxalt tablet/MLT

Non-preferred Drugs
Amerge, Axert, Frova, Relpax, Zomig tablet/nasal/ZMT

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

Approved as Recommended
Proposal: Identification of preferred Beta Blocker Combination products in the category of Beta Blockers

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the following drugs are recommended to be preferred. The Committee unanimously recommended the following:

Preferred Drugs
atenolol/chlorthalidone, bisoprolol fumarate/HCTZ, metoprolol tartrate/HCTZ, propranolol/HCTZ

Non-preferred Drugs
Corzide, Inderide, Inderide LA, Lopressor HCT, Tenoretic, Timolide, Ziac

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

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

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the following drugs are recommended to be preferred. The Committee recommended the following (with a vote of 4 to 2):

Preferred Drugs
Ambien CR, chloral hydrate, estazolam, flurazepam, temazepam, triazolam

Non-preferred Drugs
Ambien, Dalmane, Doral, Halcion, Lunesta, Prosom, Restoril, Rozerem, Somnote, Sonata

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

Approved as Recommended
Proposal: Identification of preferred drugs in the category of Anti-Emetics

A. Based on the submitted or presented clinical information and on the financial information provided during the executive session, the following drugs are recommended to be preferred. The Committee unanimously recommended the following:

Preferred Drugs
Kytril tablet/solution, Zofran tablet/solution/ODT

Non-preferred Drug
Anzemet

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

Approved as Recommended

K. Additional Discussion:

Ms. Desmond 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, and that the public comment period be used as an opportunity to summarize those comments. The committee reviews available clinical literature for clinical superiority in a therapeutic class, and then reviews financial information relating to the determination of preferred drugs. The committee then makes recommendations to the Commissioner of Health. Ms. Desmond 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. She noted that the determination of preferred and non-preferred drugs does not prohibit a prescriber from obtaining any of the medications covered under Medicaid.

Dr. Martin (Chairman) reminded the public that correspondence relating to the preferred drug program should be directed to the Department, not to individual committee members.

Ms. Desmond noted that the next meeting will take place on June 9th, 2006, and the agenda will be posted 30 days prior.

L. Old Business:

Mr. Anthony Merola, RPh, MBA (DOH/OMM) presented a report on the outcomes of the Second Generation Antihistamine (SGA) Prior Authorization Program. Mr. Merola provided the Committee with background on the administration of the program. There were the following findings:

  • The average yearly cost to the Medicaid program for all SGAs (Rx and OTC) decreased from $65M to $30M, a change of approximately 54%
  • The average number of claims for all SGAs (Rx and OTC) decreased from 1.1M to 980,000, a change of only 8%
  • The average cost per claim to the Medicaid program has decreased from approximately $61 to $30
  • Overall, utilization data demonstrates significant reductions in prescribing practices and payments for SGAs

The meeting adjourned at 2:50 PM.

Meeting summary posted May 22, 2006.

M. 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: Long Acting Narcotics, Serotonin Receptor Agonists (Triptans), Beta Blocker Combination Products, Sedative Hypnotics and Anti-Emetics. 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 $21.3M, adjusting for the implementation of Medicare Part D.

Posted September 6, 2006.