Medicaid Pharmacy and Therapeutics Committee Agenda for April 29, 2010
The Pharmacy & Therapeutics (P&T) Committee will meet April 29, 2010, from 8:30 a.m. to 4:30 p.m., Meeting Room 6, Concourse, Empire State Plaza, Albany, New York
A. The Committee will consider a request to exempt tacrolimus from the requirements of the Mandatory Generic Drug Program.
Drugs Affected: Prograf (tacrolimus)
B. Preferred Drug Program: Initial Review
Description: The Committee will review the following therapeutic classes for Preferred Drug Program inclusion and recommend preferred and non-preferred status.
Drugs Affected: Fortamet (metformin HCl ER), Glucophage (metformin HCl), Glucophage XR (metformin HCl ER), Glumetza (metformin HCl ER), metformin HCl, metformin HCl ER, Riomet solution (metformin HCl)
2. Xanthine Oxidase Inhibitors
Drugs Affected: allopurinol, Zyloprim (allopurinol), Uloric (febuxostat)
C. 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 to be re-reviewed in 2010 and not included on this agenda have been previously addressed or 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comparative clinical trials (placebo-only controlled studies, information in abstract form alone, posters, and unpublished data is poor quality evidence for the purpose of re-review and submission is discouraged).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 April 14, 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 April 14, 2010. The Committee is only interested in clinical information that is new since the previous review.
1. Third Generation Cephalosporins (previous review date June 10, 2009)
Drugs Affected: Cedax (ceftibuten), cefdinir, cefditoren pivoxil, cefpodoxime proxetil, Omnicef (cefdinir), Suprax (cefixime), Spectracef (cefditoren), Vantin (cefpodoxime proxetil)
2. Oral Fluoroquinolones (previous review date June 10, 2009)
Drugs Affected: Avelox (moxifloxacin), ciprofloxacin, ciprofloxacin ER, Cipro (ciprofloxacin), Cipro XR (ciprofloxacin ER), Factive (gemifloxacin), Levaquin (levofloxacin), Noroxin (norfloxacin), ofloxacin, Proquin XR (ciprofloxacin)
3. Phosphate Binder/Regulators (previous review date June 10, 2009)
Drugs Affected: calcium acetate, Eliphos (calcium acetate), Fosrenol (lanthanum), Phoslo (calcium acetate), Renagel (sevelamer HCL), Renvela (sevelamer carbonate)
4. Progestins (for Cachexia) (previous review date April 24, 2009)
Drugs Affected: megestrol acetate, Megace (megestrol acetate), Megace ES (megestrol acetate)
5. Selective Alpha Adrenergic Blockers (previous review date April 24, 2009)
Drugs Affected: Flomax (tamsulosin), Rapaflo (silodosin), tamsulosin, Uroxatral (alfuzosin)
6. Sulfasalazine Derivatives (previous review date September 11, 2009)
Drugs Affected: Asacol/Asacol HD (mesalamine), Apriso (mesalamine), Azulfidine (sulfasalazine), Azulfidine Entab (sulfasalazine DR/EC), balsalazide, Colazal (balsalazide), Dipentum (olsalazine), Lialda (mesalamine), Pentasa (mesalamine), sulfasalazine, sulfasalazine DR/EC
7. Serotonin Receptor Agonists -Triptans (previous review date June 10, 2009)
Drugs Affected: Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Imitrex (sumatriptan), Maxalt (rizatriptan), Relpax (eletriptan), sumatriptan, Treximet (sumatriptan/naproxen), Zomig (zolmitriptan)
8. Anti-Emetics (previous review date April 24, 2009)
Drugs Affected: Anzemet (dolasetron), granisetron, Granisol (granisetron), Kytril (granisetron), ondansetron, Sancuso (granisetron patch), Zofran (ondansetron)
New information is known to exist for the therapeutics classes listed below (items 9 - 15). The Committee will evaluate the following therapeutic classes to determine the significance of the new information on preferred and non-preferred status.
9. Injectable Immunomodulators (previous review date June 10, 2009)
Drugs Affected: Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), Kineret (anakinra), Simponi (golimumab)
10. Otic Fluoroquinolones (previous review date June 10, 2009)
Drugs Affected: Cetraxal (ciprofloxacin), Cipro HC (ciprofloxacin/hydrocortisone), Ciprodex (ciprofloxacin/dexamethasone), Floxin (ofloxacin), ofloxacin
11. Sedative Hypnotics/Sleep Agents (previous review date June 10, 2009)
Drugs Affected: Ambien (zolpidem), Ambien CR (zolpidem CR), chloral hydrate, Dalmane (flurazepam), Doral (quazepam), Edluar (zolpidem sublingual tablet), estazolam, flurazepam, Halcion (triazolam), Lunesta (eszopiclone), Prosom (estazolam), Restoril (temazepam), Rozerem (ramelteon), Somnote (chloral hydrate), Sonata (zaleplon), temazepam, triazolam, zaleplon, zolpidem
12. Central Nervous System Stimulants (previous review date April 24, 2009)
Drugs Affected: Adderall (amphetamine salt combo), Adderall XR (amphetamine salt combo XR), amphetamine salt combo, amphetamine salt combo ER, 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, Nuvigil (armodafinil), Procentra (dextroamphetamine sulfate), Provigil (modafinil), Ritalin (methylphenidate), Ritalin SR (methylphenidate SR), Ritalin LA (methylphenidate LA), Vyvanse (lisdexamfetamine dimesylate)
13. Anticoagulants - Injectable (previous review date April 24, 2009)
Drugs Affected: Arixtra (fondaparinux sodium), Fragmin (dalteparin sodium), Innohep (tinzaparin sodium), Lovenox (enoxaparin sodium)
14. Urinary Tract Antispasmodics (previous review date April 24, 2009)
Drugs Affected: Detrol (tolterodine), Detrol LA (tolterodine LA), Ditropan (oxybutynin), Ditropan XL (oxybutynin XL), Enablex (darifenacin), Gelnique (oxybutynin gel), oxybutynin, oxybutynin ER, Oxytrol (oxybutynin), Sanctura (trospium), Sanctura XR (trospium), Toviaz (fesoterodine fumarate), Vesicare (solifenacin)
15. Erythropoiesis Stimulating Agents (ESAs) (previous review date April 24, 2009)
Drugs Affected: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), Procrit (epoetin alfa)
Agenda Timeline (subject to change based on meeting proceedings)
|8:30 - 8:45||Welcome and Introductions|
|8:45 - 10:15||Public Comment Period|
|10:15 - 10:30||Break|
|10:30 - 11:00||Request to exempt Prograf (tacrolimus) from the requirements of the Mandatory Generic Drug Program|
|11:00 - 12:15||Review new PDP drug classes Biguanides , Xanthine Oxidase Inhibitors PDP re-review of 3rd Generation Cephalosporins, Oral Fluoroquinolones, Phosphate Binders/Regulators, Progestins|
|12:15 - 1:45||Lunch Break/Executive Session (evaluation of supplemental rebate information)|
|1:45 - 2:00||Summary of final recommendations|
|2:00 - 3:15||PDP re-review of Selective Alpha Adrenergic Blockers, Sulfasalazine Derivatives, Anticoagulants, Anti-Emetics, Inj. Immunomodulators, Otic Fluoroquinolones, Sedative Hypnotics/Sleep Agents, Central Nervous System Stimulants, Triptans, Urinary Tract Antispasmodics, ESAs|
|3:15 - 3:45||Afternoon Break/Executive Session (evaluation of 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 April 21, 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 items on the agenda and new clinical information for the PDP classes being re-reviewed. Comments must be brief (2 minutes) and the public comment period will not exceed 90 minutes.
- All written statements must be received in an electronic format by April 21, 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.
- Clinical information must be submitted in an electronic format by April 14, 2010 or the Committee may not have ample time to review the information. For the therapeutic classes subject to the PDP re-review, submitted clinical information must be new since the previous review of the therapeutic class.