Medicaid Pharmacy and Therapeutics Committee Agenda for June 10, 2009
The Pharmacy & Therapeutics (P&T) Committee will meet June 10, 2009, 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 the Topical Immunomodulator therapeutic class, which includes pimecrolimus (Elidel) and tacrolimus (Protopic), 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. The Topical Immunomodulator therapeutic class will also be re-reviewed in the context of the Preferred Drug Program as indicated in Section B. (1.) below.
B. Preferred Drug Program
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comparative clinical trials (placebo-only controlled studies, information in abstract form alone, posters, and unpublished data is poor quality evidence for the purpose of re-review and submission is discouraged).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 May 27, 2009 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 - 10). Any new clinical information must be submitted to the Department by May 27, 2009. The Committee is only interested in clinical information that is new since the previous review.
1. Topical Immunomodulators (previous review date September 18, 2008)
Drugs Affected: Elidel (pimecrolimus), Protopic (tacrolimus)
2. Sedative Hypnotics/Sleep Agents (previous review date April 30, 2008)
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, zaleplon, zolpidem
3. Otic Fluoroquinolones (previous review date June 12, 2008)
Drugs Affected: Cipro HC (ciprofloxacin/hydrocortisone), Ciprodex (ciprofloxacin/dexamethasone), Floxin (ofloxacin), ofloxacin
4. Ophthalmic Fluoroquinolones (previous review date April 30, 2008)
Drugs Affected: Ciloxan (ciprofloxacin), ciprofloxacin, IQUIX (levofloxacin), Ocuflox (ofloxacin), ofloxacin, Quixin (levofloxacin), Vigamox (moxifloxacin), Zymar (gatifloxacin)
5. Oral Antihistamines (previous review date April 30, 2008)
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)
6. Ophthalmic Antihistamines (previous review date April 30, 2008)
Drugs Affected: Elestat (epinastine), Emadine (emedastine), ketotifen Rx, Optivar (azelastine), Patanol (olopatadine), Pataday (olopatadine)
7. Leukotriene Modifiers (previous review date September 18, 2008)
Drugs Affected: Accolate (zafirlukast), Singulair (montelukast)
8. Ophthalmic NSAIDs (previous review date December 13, 2007)
Drugs Affected: Acular (ketorolac), Acular LS (ketorolac), Acular PF (ketorolac), diclofenac, flurbiprofen, Nevanac (nepafenac), Ocufen (flurbiprofen), Voltaren (diclofenac), Xibrom (bromfenac)
9. Ophthalmic Alpha-2 Adrenergic Agonists (previous review date December 13, 2007)
Drugs Affected: Alphagan P (brimonidine), brimonidine, Iopidine (apraclonidine)
10. Third Generation Cephalosporins (previous review date June 12, 2008)
Drugs Affected: Cedax (ceftibuten), cefdinir, cefpodoxime proxetil, Omnicef (cefdinir), Suprax (cefixime), Spectracef (cefditoren), Vantin (cefpodoxime proxetil)
New information is known to exist for the therapeutics classes listed below (items 11 - 16). The Committee will evaluate the following therapeutic classes to determine the significance of the new information on preferred and non-preferred status.
11. Oral Fluoroquinolones (previous review date June 12, 2008)
Drugs Affected: Avelox (moxifloxacin), ciprofloxacin, ciprofloxacin ER, Cipro (ciprofloxacin), Cipro XR (ciprofloxacin ER), Factive (gemifloxacin), Levaquin (levofloxacin), Noroxin (norfloxacin), ofloxacin, Proquin XR (ciprofloxacin)
12. Serotonin Receptor Agonists - Triptans (previous review date June 12, 2008)
Drugs Affected: Amerge (naratriptan), Axert (almotriptan), Frova (frovatriptan), Imitrex (sumatriptan), Maxalt (rizatriptan), Relpax (eletriptan), sumatriptan, Treximet (sumatriptan/naproxen), Zomig (zolmitriptan)
13. Injectable Immunomodulators (previous review date September 18, 2008)
Drugs Affected: Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), Kineret (anakinra)
14. Nasal Corticosteroids (previous review date April 30, 2008)
Drugs Affected: Beconase AQ (beclomethasone dipropionate), Flonase (fluticasone propionate), flunisolide, fluticasone propionate, Nasacort AQ (triamcinolone acetonide), Nasarel (flunisolide), Nasonex (mometasone furoate), Omnaris (ciclesonide), Rhinocort Aqua (budesonide), Veramyst (fluticasone furoate)
15. Phosphate Binder/Regulators (previous review date September 18, 2008)
Drugs Affected: calcium acetate, Eliphos (calcium acetate), Fosrenol (lanthanum), Phoslo (calcium acetate), Renagel (sevelamer HCL), Renvela (sevelamer carbonate)
16. Ophthalmic Prostaglandin Agonists (previous review date April 30, 2008)
Drugs Affected: Lumigan (bimatoprost), Travatan (travoprost), Travatan Z (travoprost), Xalatan (latanoprost)
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 - 11:00||PDP re-review of Oral Fluoroquinolones, Otic Fluoroquinolones, Ophthalmic Fluoroquinolones, Third Generation Cephalosporins, Oral Antihistamines, Ophthalmic Antihistamines, Ophthalmic NSAIDs, Ophthalmic Alpha-2 Adrenergic Agents, Ophthalmic Prostaglandin Agonists|
|11:00 - 12:15||PDP re-review and CDRP review of Topical Immunomodulators|
|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||PDP re-review of Leukotriene Modifiers, Nasal Corticosteroids, Sedative Hypnotics/Sleep Agents, Serotonin Receptor Agonists (Triptans), Injectable Immunomodulators, Phosphate Binders/Regulators|
|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 June 3, 2009 of their request to address the Committee during the public comment period. Requests may be made by calling 518-486-3209 or e-mailing firstname.lastname@example.org (please reference P&T Committee).
- Public comments are limited to therapeutic classes on the agenda with 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 June 3, 2009. 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 May 27, 2009 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.
Posted May, 11, 2009