Medicaid Pharmacy and Therapeutics Committee Agenda for September 11, 2009
The Pharmacy & Therapeutics (P&T) Committee will meet September 11, 2009, from 8:00 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 drug/drug class listed below 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.
1. Growth Hormones
The Growth Hormone therapeutic class will also be re-reviewed in the context of the Preferred Drug Program as indicated in Section C. (5.) below. See Section C. (5.) for the list of drugs.
2. Adcirca (tadalafil)
3. Xyrem (sodium oxybate)
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.
1. Alzheimer's Agents
Drugs Affected: Aricept/Aricept ODT (donepezil), Cognex (tacrine), Exelon (rivastigmine), galantamine, galantamine ER, Namenda (memantine), Razadyne (galantamine), Razadyne ER (galantamine ER)
2. Sulfasalazine Derivatives
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
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.
- 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comparative clinical trials (placebo-only controlled studies, information in abstract form alone, posters, and unpublished data is poor quality evidence for the purpose of re-review and submission is discouraged).
*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 - 4). Any new clinical information must be submitted to the Department by August 30, 2009. The Committee is only interested in clinical information that is new since the previous review.
1. Inhaled Beta-2 Adrenergic Agents - Long Acting (previous review date Sept 18, 2008)
Drugs Affected: Brovana (arformoterol), Foradil (formoterol), Perforomist (formoterol), Serevent Diskus (salmeterol)
2. Anti-Virals (previous review date September 18, 2008)
Drugs Affected: acyclovir, famciclovir, Famvir (famciclovir), Valtrex (valacyclovir), Zovirax (acyclovir)
3. Anti-Fungals (previous review date September 18, 2008)
Drugs Affected: ciclopirox, Grifulvin V (griseofulvin), Gris-PEG (griseofulvin), griseofulvin, itraconazole, Lamisil (terbinafine), Penlac (ciclopirox), Sporanox (itraconazole), terbinafine
4. Long Acting Narcotics (previous review date April 30, 2008)
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)
New information is known to exist for the therapeutics classes listed below (items 5 - 10). The Committee will evaluate the following therapeutic classes to determine the significance of the new information on preferred and non-preferred status.
5. Growth Hormones (previous review date December 13, 2007)
Drugs Affected: Genotropin (somatropin), Humatrope (somatropin), Norditropin (somatropin), Nutropin (somatropin), Omnitrope (somatropin), Saizen (somatropin), Tev-Tropin (somatropin), Zorbtive (somatropin)
6. Multiple Sclerosis Agents (previous review date September 18, 2008)
Drugs Affected: Avonex (interferon beta-1a), Betaseron (interferon beta-1b), Copaxone (glatiramer acetate), Rebif (interferon beta-1a)
7. Pegylated Interferons (previous review date September 18, 2008)
Drugs Affected: PEG-Intron (peginterferon alfa-2b), Pegasys (peginterferon alfa-2a)
8. Inhaled Beta-2 Adrenergic Agents - Short Acting (previous review date Sept 18, 2008)
Drugs Affected: Accuneb (albuterol), albuterol solution, Alupent (metaproterenol), Maxair Autohaler (pirbuterol), metaproterenol, ProAir HFA (albuterol), Proventil HFA (albuterol), Ventolin HFA (albuterol), Xopenex (levalbuterol), Xopenex HFA (levalbuterol)
9. Inhaled Anticholinergics (previous review date September 18, 2008)
Drugs Affected: Atrovent HFA (ipratropium), Combivent (ipratropium/albuterol), Duoneb (ipratropium/albuterol), ipratropium, ipratropium/albuterol, Spiriva (tiotropium)
10. Thiazolidinediones (previous review date June 12, 2008)
Drugs Affected: Actos (pioglitazone), Actoplus Met (pioglitazone/metformin), Avandia (rosiglitazone), Avandamet (rosiglitazone/metformin), Avandaryl (rosiglitazone/glimepiride), Duetact (pioglitazone/glimepiride)
|8:00 - 8:15||Welcome and Introductions|
|8:15 - 9:45||Public Comment Period|
|9:45 - 10:00||Break|
|10:00 - 11:00||PDP review of Alzheimer's Agents and Sulfasalazine Derivatives
PDP re-review of Short and Long Acting Inhaled Beta-2 Adrenergic Agents, Inhaled Anticholinergics, Growth Hormones
|11:00 - 12:30||CDRP review of Growth Hormones, Adcirca and Xyrem|
|12:30 - 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 Multiple Sclerosis Agents, Long Acting Narcotics, Pegylated Interferons, Thiazolidinediones, Anti-Virals, Anti-Fungals|
|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, 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 email@example.com (please reference P&T Committee).
- 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, 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 August 30, 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.