Medicaid Pharmacy and Therapeutics Committee Agenda for September 18, 2008

The Pharmacy & Therapeutics Committee will meet September 18, 2008, from 8:30 a.m. to 4:00 p.m., Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

Agenda Items:

A. Review of the Multiple Sclerosis Agents therapeutic class for inclusion to the Preferred Drug Program.

Description: The Committee will review the drugs in this therapeutic class to recommend preferred and non-preferred status.

Drugs Affected: Avonex (interferon beta-1a), Betaseron (interferon beta-1b), Copaxone (glatiramer acetate), Rebif (interferon beta-1a)

B. Review of the Dipeptidyl Peptidase-4 (DPP- 4) Inhibitor therapeutic class for inclusion to the Preferred Drug Program.

Description: The Committee will review the drugs in this therapeutic class to recommend preferred and non-preferred status.

Drug Affected: Januvia (sitagliptin), Janumet (sitagliptin/metformin HCL)

C. Re-review of Preferred Drug Program therapeutic classes.

Description: The Committee will re-review the drugs in the following therapeutic classes to recommend preferred and non-preferred status.

The Committee will review new clinical and financial information pertaining to the following therapeutic classes to recommend preferred and non-preferred drugs in each class. The Committee will only consider clinical information which is new since the previous review of the therapeutic class. New clinical information may include a new drug or drug product information, new indications, new safety information or new comparative clinical trials. Those wishing to submit new clinical information must do so at least two (2) weeks prior to the date of the meeting or the Committee may not have ample time to review the information.

1. Beta2 Adrenergic Agents - Inhaled Short Acting (Previous review date November 2, 2007)

Drugs Affected: Accuneb (albuterol), albuterol, Alupent (metaproterenol), Maxair Autohaler (pirbuterol), metaproterenol, ProAir HFA (albuterol), Proventil (albuterol), Proventil HFA (albuterol), Ventolin HFA (albuterol), Xopenex (levalbuterol), Xopenex HFA (levalbuterol)

2. Beta2 Adrenergic Agents - Inhaled Long Acting (Previous review date November 2, 2007)

Drugs Affected: Brovana (arformoterol), Foradil (formoterol), Perforomist (formoterol), Serevent Diskus (salmeterol)

3. Anticholinergics - Inhaled (Previous review date November 2, 2007)

Drug Affected: Atrovent HFA (ipratropium), Combivent (ipratropium/albuterol), Duoneb (ipratropium/albuterol), ipratropium, ipratropium/albuterol, Spiriva (tiotropium)

4. Corticosteroids - Inhaled (Previous review date November 2, 2007)

Drugs Affected: Advair Diskus (fluticasone/salmeterol), Advair HFA (fluticasone/salmeterol), Aerobid/Aerobid-M (flunisolide), Asmanex (mometasone), Azmacort (triamcinolone), Flovent Diskus (fluticasone), Flovent HFA (fluticasone), Pulmicort Flexhaler (budesonide), Qvar (beclomethasone), Symbicort (budesonide/formoterol)

5. Leukotriene Modifiers (Previous review date November 2, 2007)

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

6. Anti-Virals (Previous review date November 2, 2007)

Drugs Affected: acyclovir, famciclovir, Famvir (famciclovir), Valtrex (valacyclovir), Zovirax (acyclovir)

7. Anti-Fungals (Previous review date November 2, 2007)

Drugs Affected: ciclopirox, Grifulvin V (griseofulvin), Gris-PEG (griseofulvin), griseofulvin, itraconazole, Lamisil (terbinafine), Penlac (ciclopirox), Sporanox (itraconazole), terbinafine

8. Phosphate Binders/Regulators (Previous review date November 2, 2007)

Drugs Affected:Fosrenol (lanthanum), Phoslo (calcium acetate), Renagel (sevelamer HCL), Renvela (sevelamer carbonate)

9. Pegylated Interferons (Previous review date November 2, 2007)

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

10. Immunomodulators - Topical (Previous review date Novmber 2, 2007)

Drugs Affected: Elidel (pimecrolimus), Protopic (tacrolimus)

11. Immunomodulators - Injectable (Previous review date November 2, 2007)

Drugs Affected: Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), Kineret (anakinra)

Agenda Timeline (subject to change based on meeting proceedings)

Time Agenda Topic
8:30 - 8:45 Welcome and Introductions
8:45 - 10:15 Public Comments Period*
10:15-12:00 Clinical review of Multiple Sclerosis, DPP- 4 Inhibitors; Clinical re-review of Beta2 Adrenergic Agents, Anticholinergics, Corticosteroids
12:00 - 1:30 Lunch Break/Executive Session (evaluation of trade secret supplemental rebate information)
1:30 - 2:00 Final Recommendations for therapeutic classes reviewed in the morning session
2:00 - 3:00 Clinical re-review of Leukotriene Modifiers, Anti-Virals, Anti-Fungals, Phosphate Binders/Regulators, Pegylated Interferons, Immunomodulators
3:00 - 3:30 Afternoon Break/Executive Session (evaluation of trade secret supplemental rebate information)
3:30 - 3:45 Final Recommendations for preferred drugs reviewed in the afternoon session
3:45 - 4:00 DOH Update, Final Comments and Adjournment

*Interested parties must notify DOH at least one (1) week prior to the meeting of their request to address the committee during the public comment period. Requests may be made by calling 518-486-3209 or e-mailing ppno@health.state.ny.us (please reference P&T Committee). Public comments are limited to the specific topics on the agenda, must be brief (2 minutes), and the total comment period will not exceed 90 minutes. All written statements must be received at least one (1) week in advance of the meeting. Written statements should summarize key points and may not exceed two (2) pages in length. NOTE: New clinical information must be submitted two (2) weeks prior to the date of the meeting.

NOTE: Those wishing to submit clinical information must do so at least two (2) weeks prior to the date of the meeting or the Committee may not have ample time to review the information. For the therapeutic classes being re-reviewed, the Committee will only review new information since previous review.

Posted August 15, 2008