Medicaid Pharmacy and Therapeutics Committee Agenda for September 16, 2010
The Pharmacy & Therapeutics (P&T) Committee will meet September 16, 2010, from 8:30 a.m. to 4:30 p.m., Meeting Room 6, Concourse, Empire State Plaza, Albany, New York
A. 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.
1. Atypical Antipsychotics*
Drugs Affected: Abilify (aripiprazole), clozapine, Clozaril (clozapine), FazaClo (clozapine), Fanapt (iloperidone), Geodon (ziprasidone), Invega (paliperidone), risperidone, Risperdal (risperidone), Saphris (asenapine), Seroquel (quetiapine), Seroquel XR (quetiapine), Zyprexa (olanzapine)
* No prior authorization under the Preferred Drug Program will be required for any atypical antipsychotic determined to be non-preferred.
2. Benzodiazepines - Rectal
Drug Affected: Diastat (diazepam)
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 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comparative clinical trials (placebo-only controlled studies, information in abstract form alone, posters, and unpublished data is poor quality evidence for the purpose of re-review and submission is discouraged).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 September 3, 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 - 3). Any new clinical information must be submitted to the Department by September 3, 2010. The Committee is only interested in clinical information that is new since the previous review.
1. Inhaled Beta-2 Adrenergic Agents - Short Acting (previous review date September 11, 2009)
Drugs Affected: Accuneb (albuterol), albuterol solution, levalbuterol, Maxair Autohaler (pirbuterol), ProAir HFA (albuterol), Proventil HFA (albuterol), Ventolin HFA (albuterol), Xopenex (levalbuterol), Xopenex HFA (levalbuterol)
2. Skeletal Muscle Relaxants (previous review date February 26, 2009)
Drugs Affected: Amrix (cyclobenzaprine ER), baclofen, carisoprodol, carisoprodol compound, carisoprodol compound-codeine, chlorzoxazone, cyclobenzaprine, Dantrium (dantrolene), dantrolene, Fexmid (cyclobenzaprine), metaxalone, methocarbamol, orphenadrine, orphenadrine compound, orphenadrine compound forte, Parafon Forte DSC (chlorzoxazone), Robaxin (methocarbamol), Skelaxin (metaxalone), Soma (carisoprodol), tizanidine, Zanaflex (tizanidine)
3. Anti-Fungals (previous review date September 11, 2009)
Drugs Affected: ciclopirox laquer, Grifulvin V (griseofulvin), Gris-PEG (griseofulvin), griseofulvin, itraconazole, Lamisil (terbinafine), Penlac (ciclopirox), Sporanox (itraconazole), terbinafine
New information is known to exist for the therapeutics classes listed below (items 4 - 11). The Committee will evaluate the following therapeutic classes to determine the significance of the new information on preferred and non-preferred status.
4. Inhaled Beta-2 Adrenergic Agents - Long Acting (previous review date September 11, 2009)
Drugs Affected: Brovana (arformoterol), Foradil (formoterol), Perforomist (formoterol), Serevent Diskus (salmeterol)
5. Inhaled Anticholinergics (previous review date September 11, 2009)
Drugs Affected: Atrovent HFA (ipratropium), Combivent (ipratropium/albuterol), Duoneb (ipratropium/albuterol), ipratropium, ipratropium/albuterol, Spiriva (tiotropium)
6. Corticosteroids - Inhaled (previous review date April 24, 2009)
Drugs Affected: Advair Diskus (fluticasone/salmeterol), Advair HFA (fluticasone/salmeterol), Aerobid/Aerobid-M (flunisolide), Alvesco (ciclesonide), Asmanex (mometasone), Azmacort (triamcinolone), Dulera (mometasone furoate/formoterol fumarate dihydrate), Flovent Diskus (fluticasone), Flovent HFA (fluticasone), Pulmicort Flexhaler (budesonide), Qvar (beclomethasone), Symbicort (budesonide/formoterol)
7. Thiazolidinediones (previous review date September 11, 2009)
Drugs Affected: Actos (pioglitazone), Actoplus Met (pioglitazone/metformin), Actoplus Met XR (pioglitazone/metformin), Avandia (rosiglitazone), Avandamet (rosiglitazone/metformin), Avandaryl (rosiglitazone/glimepiride), Duetact (pioglitazone/glimepiride)
8. Long Acting Narcotics (previous review date September 11, 2009)
Drugs Affected: Avinza (morphine sulfate ER), Duragesic (fentanyl), Embeda (morphine sulfate and naltrexone hydrochloride ER), Exalgo (hydromorphone HCL ER), 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)
9. Prescription Non-Steroidal Anti-Inflammatory Agents (previous review date February 26, 2009)
Drugs Affected: Anaprox (naproxen sodium), Anaprox DS (naproxen sodium DS) Arthrotec (diclofenac sodium/misoprostol), Cataflam (diclofenac potassium), Clinoril (sulindac), Daypro (oxaprozin), diclofenac potassium, diclofenac sodium, diclofenac sodium XR, diflunisal, etodolac, etodolac SA, Feldene (piroxicam), fenoprofen, Flector (diclofenac epolamine), flurbiprofen, ibuprofen, Indocin (indomethacin), indomethacin, indomethacin SR, ketoprofen, ketoprofen SA, ketorolac, Mobic (meloxicam), meclofenamate, mefenamic acid, meloxicam, nabumetone, Nalfon (fenoprofen), Naprelan (naproxen sodium CR), Naprosyn (naproxen), Naprosyn EC (naproxen EC), naproxen, naproxen sodium, naproxen EC, oxaprozin, Pennsaid (diclofenac sodium topical solution), piroxicam, Ponstel (mefenamic acid), sulindac, tolmetin, Vimovo (naproxen and esomeprazole magnesium), Voltaren (diclofenac sodium), Voltaren XR (diclofenac sodium DR), Voltaren Gel (diclofenac sodium), Zipsor (diclofenac potassium)
10. Alzheimer's Agents (previous review date September 11, 2009)
Drugs Affected: Aricept/Aricept ODT (donepezil), Cognex (tacrine), Exelon (rivastigmine), galantamine, galantamine ER, Namenda (memantine), Razadyne (galantamine), Razadyne ER (galantamine ER), rivastigmine
11. Anti-Virals (previous review date September 11, 2009)
Drugs Affected: acyclovir, famciclovir, Famvir (famciclovir), valacyclovir, Valtrex (valacyclovir), Zovirax (acyclovir)
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 - 12:00||PDP review of Atypical Antipsychotics & Benzodiazepines - Rectal|
|12:00 - 1:30||Lunch Break/Executive Session (evaluation of trade secret supplemental rebate information)|
|1:30 - 1:45||Summary of final recommendations|
|1:45 - 3:00||PDP re-review of Inhaled Beta-2 Adrenergic Agents, Inhaled Anticholinergics, Inhaled Corticosteroids, Thiazolidinediones, Skeletal Muscle Relaxants, Long Acting Narcotics, Prescription NSAIDs, Anti-Virals, Anti- Fungals, Alzheimer's Agents|
|3:00 - 3:30||Afternoon Break/Executive Session (evaluation of trade secret supplemental rebate information)|
|3:30 - 3:45||Summary of final recommendations|
|3:45 - 4:30||Final Comments and Adjournment|
- Interested parties must notify DOH by September 3, 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 September P&TC Meeting). Please note this is a new mailbox.
- Public comments are limited to therapeutic classes on the agenda and new clinical information for the PDP classes being re-reviewed. Comments 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 September 3, 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 September 3, 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.