Medicaid Pharmacy and Therapeutics Committee Agenda for March 11, 2010
The Pharmacy & Therapeutics (P&T) Committee will meet March 11, 2010, from 8:15 a.m. to 4:30 p.m., Meeting Room 6, Concourse, Empire State Plaza, Albany, New York
A. Clinical Drug Review Program
Description: The Committee will consider requiring prior authorization for becaplermin (Regranex) in order to evaluate and address appropriate utilization consistent with approved indications including factors associated with long-term efficacy, public health and potential for overuse or misuse.
Description: The Committee will re-review the glucagon-like peptide-1 (GLP-1) receptor agonist therapeutic class.
Drugs affected: exenatide (Byetta), liraglutide (Victoza)
B. Preferred Drug Program Re-review
Description: The Committee will re-review each therapeutic class subject to the Preferred Drug Program periodically as described and listed below. Therapeutic classes not included on this agenda will be re-reviewed at a later date.
- The Committee will review new clinical and financial information as required, to recommend preferred and non-preferred drugs.*
- The Committee will only consider clinical information which is new since the previous review of the therapeutic class and then consider financial information.
- New clinical information may include a new drug or drug product information, new indications, new safety information or new published comparative clinical trials (placebo-only controlled studies, information in abstract form alone, posters, and unpublished data is poor quality evidence for the purpose of re-review and submission is discouraged).
- Those wishing to submit new clinical information must do so in an electronic format by February 25, 2010 or the Committee may not have ample time to review the information.
*The current preferred and non-preferred status of drugs subject to the Preferred Drug List (PDL) may be viewed at https://newyork.fhsc.com/downloads/providers/NYRx_PDP_PDL.pdf
No relevant new clinical information was found for the therapeutic classes listed below (items 1 - 8). Any new clinical information must be submitted to the Department by February 25, 2010. The Committee is only interested in clinical information that is new since the previous review.
1. ACE Inhibitors (previous review date April 24, 2009)
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), perindopril erbumine, Prinivil (lisinopril), quinapril, ramipril capsule, trandolapril, Univasc (moexipril), Vasotec (enalapril maleate), Zestril (lisinopril)
2. ACE Inhibitor/Diuretic Combinations (previous review date April 24, 2009)
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. Dihydropyridine Calcium Channel Blockers (previous review date April 24, 2009)
Drugs Affected: Adalat CC (nifedipine CC), Afeditab CR (nifedipine CR), amlodipine, Cardene SR (nicardipine SR), DynaCirc CR (isradipine CR), felodipine ER, isradipine, nicardipine HCl, Nifediac CC (nifedipine CC), Nifedical XL (nifedipine XL), nifedipine, nifedipine ER, nifedipine SA, nisoldipine, Norvasc (amlodipine), Plendil (felodipine ER), Procardia (nifedipine), Procardia XL (nifedipine XL), Sular (nisoldipine)
4. ACE Inhibitor/Calcium Channel Blockers (previous review date April 24, 2009)
Drugs Affected: benazepril/amlodipine, Lexxel (enalapril maleate/felodipine ER), Lotrel (benazepril/amlodipine), Tarka (trandolapril/verapamil ER)
5. Beta Blockers (previous review date April 24, 2009)
Drugs Affected: acebutolol, atenolol, betaxolol, bisoprolol fumarate, Bystolic (nebivolol), carvedilol, Coreg (carvedilol), Coreg CR (carvedilol CR), Corgard (nadolol), 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)
6. Beta Blocker/Diuretic Combinations (previous review date April 24, 2009)
Drugs Affected: atenolol/chlorthalidone, bisoprolol fumarate/HCTZ, Corzide (nadolol/bendroflumethiazide), Lopressor HCT (metoprolol tartrate/HCTZ), metoprolol tartrate/HCTZ, nadolol/bendroflumethiazide, propranolol/HCTZ, Tenoretic (atenolol/chlorthalidone), Ziac (bisoprolol fumarate/HCTZ)
7. Bisphosphonates - Oral (previous review date April 24, 2009)
Drugs Affected: Actonel (risedronate), Actonel with Calcium (risedronate with calcium carbonate), alendronate, Boniva (ibandronate), Fosamax (alendronate), Fosamax Plus D (alendronate plus cholecalciferol)
8. Calcitonins - Nasal (previous review date April 24, 2009)
Drugs Affected: calcitonin-salmon, Fortical (calcitonin-salmon), Miacalcin (calcitonin-salmon)
New information is known to exist for the therapeutics classes listed below (items 9 - 14). The Committee will evaluate the following therapeutic classes to determine the significance of the new information on preferred and non-preferred status.
9. Angiotensin Receptor Blockers (ARBs) (previous review date April 24, 2009)
Drugs Affected: Atacand (candesartan cilexetil), Avapro (irbesartan), Azor (olmesartan/amlodipine), Benicar (olmesartan medoxomil), Cozaar (losartan), Diovan (valsartan), Exforge (valsartan/amlodipine), Exforge HCT (valsartan/amlodipine/HCTZ), Micardis (telmisartan), Teveten (eprosartan mesylate), Twynsta (telmisartan/amlodipine), Valturna (valsartan/aliskiren)
10. ARB/Diuretic Combinations (previous review date April 24, 2009)
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)
11. HMG-CoA Reductase Inhibitors/Statins (previous review April 24, 2009)
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, Simcor (simvastatin/niacin extended-release), simvastatin, Vytorin (simvastatin/ezetimibe), Zocor (simvastatin)
12. Triglyceride Lowering Agents (previous review date April 24, 2009)
Drugs Affected: Antara (fenofibrate), fenofibrate, Fenoglide (fenofibrate), Fibricor (fenofibric acid), gemfibrozil, Lipofen (fenofibrate), Lofibra (fenofibrate), Lopid (gemfibrozil), Lovaza (Omega-3 acid ethyl esters), Tricor (fenofibrate), Triglide (fenofibrate), Trilipix (fenofibric acid delayed release)
13. Proton Pump Inhibitors (PPIs) (previous review date April 24, 2009)
Drugs Affected: Aciphex (rabeprazole), Kapidex (dexlansoprazole), lansoprazole, Nexium (esomeprazole), omeprazole, omeprazole OTC, pantoprazole, Prevacid (lansoprazole), Prevacid OTC (lansoprazole OTC), Prilosec (omeprazole), Prilosec OTC (omeprazole), Protonix (pantoprazole)
14. Dipeptidyl Peptidase-4 (DPP- 4) Inhibitors (previous review date September 18, 2008)
Drugs Affected: Januvia (sitagliptin), Janumet (sitagliptin/metformin HCL), Onglyza (saxagliptin)
Agenda Timeline (subject to change based on meeting proceedings)
|8:15 - 8:30||Welcome and Introductions|
|8:30 - 10:00||Public Comment Period|
|10:00 - 10:15||Break|
|10:15 - 11:30||CDRP review of Regranex and re-review of GLP-1 receptor agonists|
|11:30 - 12:15||Clinical re-review of ACE Inhibitors, ACE Inhibitor/Diuretic, Calcium Channel Blockers (CCBs), ACE Inhibitor/CCB, Beta Blockers, Beta Blocker/Diuretic|
|12:15 - 1:15||Lunch Break/Executive Session (evaluation of trade secret supplemental rebate information)|
|1:15 - 1:45||Summary of final recommendations|
|1:45 - 3:15||Clinical re-review of Bisphosphonates, Calcitonins, ARBs, ARB/Diuretic, Statins, Triglyceride Lowering Agents, PPIs, DPP-4 Inhibitors|
|3:15 - 3:45||Afternoon Break/Executive Session (evaluation of trade secret supplemental rebate information)|
|3:45 - 4:15||Summary of final recommendations|
|4:15 - 4:30||Final Comments and Adjournment|
- Interested parties must notify DOH by March 4, 2010 of their request to address the Committee during the public comment period. Requests may be made by calling 518-486-3209 or e-mailing email@example.com (please reference P&T Committee).
- Public comments are limited to therapeutic classes on the agenda and new clinical information, must be brief (2 minutes), and the total comment period will not exceed 90 minutes.
- All written statements must be received in an electronic format by March 4, 2010. Written statements should summarize key points and may not exceed two (2) pages in length.
- Any studies cited should be referenced, with the primary source of funding included.
- New clinical information must be submitted in an electronic format by February 25, 2010 or the Committee may not have ample time to review the information.