Medicaid Pharmacy and Therapeutics Committee Agenda for April 30, 2008

The Pharmacy & Therapeutics Committee will meet April 30, 2008, from 8:30 a.m. to 4:00 p.m., Meeting Room 2, Concourse, Empire State Plaza, Albany, New York.

The Committee will consider a request to exempt tacrolimus from the requirements of the Mandatory Generic Drug Program.

Drugs Affected: Prograf

The Committee will re-review the Preferred Drug Program (PDP) therapeutic classes detailed below and recommend preferred and non-preferred drugs.

The Committee will review new clinical and financial information pertaining to the following therapeutic classes and 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: 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. Therapeutic Class: ACE Inhibitors (Previous review date May 9, 2007)

Drugs Affected: Accupril (quinapril), Aceon (perindopril erbumine), Altace capsule (ramipril), Altace tablet (ramipril), benazepril, Capoten (captopril), captopril, enalapril maleate, fosinopril, lisinopril, Lotensin (benazepril), Mavik (trandolapril), moexipril, Monopril (fosinopril), Prinivil (lisinopril), quinapril, ramipril capsule, trandolapril, Univasc (moexipril), Vasotec (enalapril maleate), Zestril (lisinopril)

2. Therapeutic Class: ACE Inhibitor/Diuretic Combinations (Previous review date May 9, 2007)

Drugs Affected: Accuretic (quinapril/hctz), benazepril/hctz, Capozide (captopril/hctz), captopril/hctz, enalapril maleate/hctz, fosinopril/hctz, lisinopril/hctz, Lotensin HCT (benazepril/hctz), moexipril/hctz, Monopril HCT (fosinopril/hctz), Prinzide (lisinopril/hctz), Quinaretic (quinapril/hctz), quinapril/hctz, Uniretic (moexipril/hctz), Vaseretic (enalapril maleate/hctz), Zestoretic (lisinopril/hctz)

3. Therapeutic Class: Dihydropyridine Calcium Channel Blockers (Previous review date May 9, 2007)

Drugs Affected: Adalat CC (nifedipine CC), Afeditab CR (nifedipine CR), amlodipine, Cardene (nicardipine), Cardene SR (nicardipine SR), DynaCirc (isradipine), DynaCirc CR (isradipine CR), felodipine ER, isradipine, nicardipine HCl, Nifediac CC (nifedipine CC), Nifedical XL (nifedipine XL), nifedipine, nifedipine ER, nifedipine SA, Norvasc (amlodipine), Plendil (felodipine ER), Procardia (nifedipine), Procardia XL (nifedipine XL), Sular (nisoldipine)

4. Therapeutic Class: ACE Inhibitor/Calcium Channel Blocker Combinations (Previous review date May 9, 2007)

Drugs Affected: amlodipine/benazepril, Lexxel (enalapril maleate/felodipine ER), Lotrel (amlodipine/benazepril), Tarka (trandolapril/verapamil ER)

5. Therapeutic Class: Angiotensin Receptor Blockers (ARB) (Previous review date May 9, 2007)

Drugs Affected: Atacand (candesartan cilexetil), Avapro (irbesartan), Azor (olmesartan/amlodipine), Benicar (olmesartan medoxomil), Cozaar (losartan), Diovan (valsartan), Exforge (valsartan/amlodipine), Micardis (telmisartan), Teveten (eprosartan mesylate)

6. Therapeutic Class: ARB/Diuretic Combinations (Previous review date May 9, 2007)

Drugs Affected: Atacand HCT (candesartan cilexetil/hctz), Avalide (irbesartan/hctz), Benicar HCT (olmesartan medoxomil/hctz), Diovan HCT (valsartan/hctz), Hyzaar (losartan/hctz), Micardis HCT (telmisartan/hctz), Teveten HCT (eprosartan/hctz)

7. Therapeutic Class: Beta Blockers (Previous review date May 9, 2007)

Drugs Affected: acebutolol, atenolol, betaxolol, bisoprolol fumarate, Bystolic (nebivolol), carvedilol, Coreg (carvedilol), Coreg CR (carvedilol CR), Corgard (nadolol), Inderal (propranolol), Inderal LA (propranolol LA), Innopran XL (propranolol XL), Kerlone (betaxolol), labetalol, Levatol (penbutolol), Lopressor (metoprolol tartrate), metoprolol succinate XL, metoprolol tartrate, nadolol, pindolol, propranolol, propranolol SA, Sectral (acebutolol), Tenormin (atenolol), timolol maleate, Toprol XL (metoprolol succinate XL), Trandate (labetalol), Zebeta (bisoprolol fumarate)

8. Therapeutic Class: Beta Blocker/Diuretic Combinations (Previous review date May 9, 2007)

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

9. Therapeutic Class: HMG-CoA Reductase Inhibitors (Statins) (Previous review date May 9, 2007)

Drugs Affected: Advicor (lovastatin/niacin extended-release), Altoprev (lovastatin extended-release), Caduet (atorvastatin/amlodipine), Crestor (rosuvastatin), Lescol (fluvastatin), Lescol XL (fluvastatin XL), Lipitor (atorvastatin), lovastatin, Mevacor (lovastatin), Pravachol (pravastatin), pravastatin, Pravigard PAC (pravastatin/buffered aspirin), Simcor (simvastatin/niacin extended-release), simvastatin, Vytorin (simvastatin/ezetimibe), Zocor (simvastatin)

10. Therapeutic Class: Cholesterol Absorption Inhibitors (Previous review date November 2, 2007)

Drugs Affected: Zetia (ezetimibe)

11. Therapeutic Class: Triglyceride Lowering Agents (Previous review date May 9, 2007)

Drugs Affected: Antara (fenofibrate), fenofibrate, Fenoglide (fenofibrate), gemfibrozil, Lipofen (fenofibrate), Lofibra (fenofibrate), Lopid (gemfibrozil), Lovaza [formerly Omacor] (Omega-3 acid ethyl esters), Tricor (fenofibrate), Triglide (fenofibrate)

12. Therapeutic Class: Long Acting Narcotics (Previous review date May 9, 2007)

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

13. Therapeutic Class: Sedative Hypnotics/Sleep Agents (Previous review date May 9, 2007)

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, zolpidem

14. Therapeutic Class: Central Nervous System (CNS) Stimulants (Previous review date June 14, 2007)

Drugs Affected: Adderall (amphetamine salt combo), Adderall XR (amphetamine salt combo XR), amphetamine salt combo, Concerta (methylphenidate), Daytrana (methylphenidate), Desoxyn (methamphetamine), Dexedrine (dextroamphetamine sulfate), Dexedrine Spansule (dextroamphetamine), dexmethylphenidate, dextroamphetamine sulfate, dextroamphetamine sulfate SA, Dextrostat (dextroamphetamine sulfate), Focalin (dexmethylphenidate), Focalin XR (dexmethylphenidate XR), Metadate CD (methylphenidate CD), Metadate ER (methylphenidate ER), Methylin ER (methylphenidate ER), Methylin (methylphenidate), methylphenidate, methylphenidate ER, Provigil (modafinil), Ritalin (methylphenidate), Ritalin SR (methylphenidate SR), Ritalin LA (methylphenidate LA), Vyvanse (lisdexamfetamine dimesylate)

15. Therapeutic Class: Antihistamines - Second Generation (Previous review date November 2, 2007)

Drugs Affected: Allegra/Allegra-D (fexofenadine), cetirizine/cetirizine-D OTC, Clarinex/Clarinex-D (desloratadine), Claritin/Claritin-D OTC (loratadine), loratadine/loratadine D OTC, fexofenadine, Semprex-D (acrivastine), Xyzal (levocetirizine), Zyrtec/Zyrtec-D (cetirizine), Zyrtec/Zyrtec-D OTC (cetirizine)

16. Therapeutic Class: Intranasal Steroids (Previous review date May 9, 2007)

Drugs Affected: Beconase AQ (beclomethasone dipropionate), Flonase (fluticasone propionate), flunisolide, fluticasone propionate, Nasacort AQ (triamcinolone acetonide), Nasarel (flunisolide), Nasonex (mometasone furoate), Rhinocort Aqua (budesonide), Veramyst (fluticasone furoate)

17. Therapeutic Class: Proton Pump Inhibitors (PPI) (Previous review date May 9, 2007)

Drugs Affected: Aciphex (rabeprazole), Nexium (esomeprazole), omeprazole, omeprazole OTC, pantoprazole, Prevacid (lansoprazole), Prevacid NapraPAC (lansoprazole/naproxen), Prilosec (omeprazole), Prilosec OTC (omeprazole), Protonix (pantoprazole), Zegerid (omeprazole)

18. Therapeutic Class: Ophthalmic Quinolones (Previous review date May 9, 2007)

Drugs Affected: Ciloxan solution/ointment (ciprofloxacin), ciprofloxacin, IQUIX (levofloxacin), Ocuflox (ofloxacin), ofloxacin, Quixin (levofloxacin), Vigamox (moxifloxacin), Zymar (gatifloxacin)

19. Therapeutic Class: Ophthalmic Antihistamines (Previous review date May 9, 2007)

Drugs Affected: Elestat (epinastine), Emadine (emedastine), ketotifen Rx, Optivar (azelastine), Patanol (olopatadine), Pataday (olopatadine)

20. Therapeutic Class: Ophthalmic Prostaglandin Agonists (Previous review date June 14, 2007)

Drugs Affected: Lumigan (bimatoprost), Travatan (travoprost), Travatan Z (travoprost), Xalatan (latanoprost)

Agenda Timeline (subject to change based on meeting proceedings)

Time Agenda Topic
8:30 - 8:45 Welcome and Introductions
8:45 - 10:00 Public Comments Period*
10:00 - 10:15 Break
10:15 - 10:45 Review of tacrolimus for Mandatory Generic Drug Program Exemption
10:45 - 12:15 Clinical Re-review of ACE Inhibitors, ACE Inhibitors/Diuretics, CCB, ACE Inhibitors/CCB, ARBs, ARBs/Diuretics, Beta Blockers, Beta Blockers/Diuretics, Statins, Cholesterol Absorption Inhibitors, Triglyceride Lowering Agents
12:15 - 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 Long Acting Narcotics, Sedative Hypnotic/Sleep Agents, Central Nervous System (CNS) Stimulants, 2nd Generation Antihistamines, Nasal Steroids, PPIs, Ophthalmic Quinolones, Ophthalmic Antihistamines, Ophthalmic Prostaglandin Agonists
3:00 - 3:30 Afternoon Break/Executive Session (evaluation of trade secret supplemental rebate information)
3:30 - 3:45 Final Recommendations for preferred drugs in classes 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.

Posted March 28, 2008