Medicaid Pharmacy and Therapeutics Committee Agenda for June 12, 2008

The Pharmacy & Therapeutics Committee will meet June 12, 2008, from 8:45 a.m. to 4:30 p.m., Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

Agenda Items:

A. Review of the Anticoagulants - Injectable therapeutic class for inclusion to the Preferred Drug Program.

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

Drugs Affected: Arixtra (fondaparinux sodium), Fragmin (dalteparin sodium), Innohep (tinzaparin sodium), Lovenox (enoxaparin sodium)

B. Review of the Niacin Derivative therapeutic class for inclusion to the Preferred Drug Program.

Description: The Committee will review the therapeutic class to recommend whether the class should be included in the Preferred Drug Program.

Drug Affected: Niaspan (niacin extended release)

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. Bisphosphonates - Oral (Previous review date May 9, 2007)

Drugs Affected: Actonel (risedronate), Actonel with Calcium (risedronate with calcium carbonate), alendronate, Boniva (ibandronate), Fosamax (alendronate), Fosamax Plus D (alendronate plus cholecalciferol)

2. Calcitonins - Nasal (Previous review date May 9, 2007)

Drugs Affected: Fortical (calcitonin-salmon), Miacalcin (calcitonin-salmon)

3. Cyclooxygenase II (COX II) Inhibitors (Previous review date June 14, 2007)

Drug Affected: Celebrex (celecoxib)

4. Serotonin Receptor Agonists (Triptans) (Previous review date May 9, 2007)

Drugs Affected: Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Imitrex (sumatriptan), Maxalt (rizatriptan), Relpax (eletriptan), Treximet (sumatriptan/naproxen sodium), Zomig (zolmitriptan)

5. Anti-Emetics (Previous review date November 2, 2007)

Drugs Affected: Anzemet (dolasetron), granisetron, Kytril (granisetron), ondansetron, Zofran (ondansetron)

6. Fluoroquinolones - Oral (Previous review date May 9, 2007)

Drugs Affected: Avelox (moxifloxacin), Cipro (ciprofloxacin), Cipro XR (ciprofloxacin ER), ciprofloxacin, ciprofloxacin ER, Factive (gemifloxacin), Floxin (ofloxacin), Levaquin (levofloxacin), Noroxin (norfloxacin), ofloxacin, Proquin XR (ciprofloxacin), Tequin (gatifloxacin)

7. Cephalosporins - Third Generation (Previous review date Nov 2, 2007)

Drugs Affected: Cedax (ceftibuten), cefdinir, cefixime, cefpodoxime proxetil, Omnicef (cefdinir), Suprax (cefixime), Spectracef (cefditoren), Vantin (cefpodoxime proxetil)

8. Fluoroquinolones - Otic (Previous review date Nov 2, 2007)

Drugs Affected: Cipro HC (ciprofloxacin/hydrocortisone), Ciprodex (ciprofloxacin/dexamethasone), Floxin (ofloxacin), ofloxacin

9. Thiazolidinediones (Previous review date May 9, 2007)

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

10. Selective Alpha Adrenergic Blockers (Previous review date June 14, 2007)

Drugs Affected: Flomax (tamsulosin), Uroxatral (alfuzosin)

11. Urinary Tract Antispasmodics (Previous review date June 14, 2007)

Drugs Affected: Detrol (tolterodine), Detrol LA (tolterodine LA), Ditropan (oxybutynin), Ditropan XL (oxybutynin XL), Enablex (darifenacin), oxybutynin, oxybutynin ER, Oxytrol (oxybutynin), Sanctura (trospium), Sanctura XR (trospium), Vesicare (solifenacin)

Agenda Timeline (subject to change based on meeting proceedings)

Time Agenda Topic
8:45 - 9:00 Welcome and Introductions
9:00 - 10:45 Public Comments Period*
10:45-12:00 Clinical review of Anticoagulants - Injectable, Niacin Derivatives and re-review of Bisphosphonates, Nasal Calcitonins, COX II Inhibitors
12:00 - 1:30 Lunch Break/Executive Session (evaluation of trade secret supplemental rebate information)
1:30 - 1:45 Final Recommendations for preferred drugs in classes reviewed in the morning session
1:45 - 3:00 Clinical Re-review of Triptans, Anti-Emetics, Oral Fluoroquinolones, Cephalosporins-Third Generation, Otic Fluoroquinolones, TZDs, Selective Alpha Adrenergic Blockers, Urinary Tract Antispasmodics
3:00 - 3:45 Afternoon Break/Executive Session (evaluation of trade secret supplemental rebate information)
3:45 - 4:00 Final Recommendations for preferred drugs reviewed in the afternoon session
4:00 - 4:15 DUR Update on Ophthalmic NSAID usage.
4:15 - 4:30 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 May 13, 2008