NYS DOH Review Viekira Pak & Preferred Status for HCV Drugs

NYS DOH Review Viekira Pak & Preferred Status for HCV Drugs

Update 3/9/2015: On Feb 26, DURB decided to move Viekira Pak to preferred status and change clinical criteria for NYS Medicaid Fee-for-service members.

On February 26th, the New York State Drug Utilization Review Board will meet to review and recommend NYS Medicaid clinical criteria for Viekira Pak – the most recently approved Hepatitis C therapy – marketed by AbbVie.

The meeting agenda also includes a Preferred Drug Program review of all currently non-preferred HCV medications. A preferred drug list specifies which drugs are available to patients without receiving prior approval.

This review may result in a recommendation for preferred or non-preferred status for each currently non-preferred HCV medication, including:

• Copegus (ribavirin)
• Harvoni (ledipasvir/sofosbuvir)
• Moderiba (ribavirin)
• Olysio (simeprevir)
• Rebetol (ribavirin), Ribapak (ribavirin), Ribasphere (ribavirin), ribavirin
• Sovaldi (sofosbuvir)
• Victrelis (boceprevir)
• Viekira (ombitasvir/paritaprevir/ritonavir with dasabuvir)

Currently, the only HCV medications on the NYS Medicaid Preferred Drug List are: Incivek, Victrelis and ribavirin.

The Drug Utilization Review (DUR) Board will meet on February 26, 2015 from 9:00 a.m. to 4:00 p.m. Meeting Room 6, Concourse, Empire State Plaza, Albany, New York.

Public comment is invited either in person or written statement.

Submit your request to address the NYS Health Department DURB by Feb 19th: Requests may be made by phone (518-486-3209) or e-mail (dur@health.ny.gov). 

Below is full text of the meeting agenda found at www.health.ny.gov/health_care/medicaid/program/dur/meetings/2015/02/agenda_durb.pdf.

Medicaid Drug Utilization Review Board

Meeting Agenda for February 26, 2015

The Drug Utilization Review (DUR) Board will meet on February 26, 2015 from 9:00 a.m. to 4:00 p.m.
Meeting Room 6, Concourse, Empire State Plaza, Albany, New York    

Agenda Items
A. The DUR Board will review the following pharmacotherapies and recommend
clinical criteria and/or interventions to ensure appropriate utilization:

1. Inhaled Antibiotics for Cystic Fibrosis
(tobramycin inhalation – Bethkis, Kitabis, Tobi solution, Tobi Podhaler; aztreonam – Cayston)

2. Agents for Pulmonary Fibrosis
(nintedanib – Ofev, pirfenidone – Esbriet)

3. Topical Antifungals for Onycomycosis
(ciclopirox – Penlac, efinaconazole – Jublia, tavaborole – Kerydin)

4. Cystine Depleting Agents
(Cysteamine Bitartrate – Cystagon, Procysbi)

5. Hepatitis C Virus – Recently Approved Therapies
(ombitasvir/paritaprevir/ritonavir with dasabuvir – Viekira)

The Hepatitis C Virus agenda item will also include a Preferred Drug Program (PDP) review of new clinical and financial information for the Hepatitis C – Direct Acting Antiviral therapeutic class (PDP class listed below). The Board will review new clinical and financial information and recommend preferred or non-preferred status for products within the therapeutic class.

Hepatitis C – Direct Acting Antivirals
Copegus (ribavirin), Harvoni (ledipasvir/sofosbuvir), Moderiba (ribavirin), Olysio (simeprevir), Rebetol (ribavirin), Ribapak (ribavirin), Ribasphere (ribavirin), ribavirin, Sovaldi (sofosbuvir), Victrelis (boceprevir), Viekira (ombitasvir/paritaprevir/ritonavir with dasabuvir)

The current preferred or non-preferred status of products in the Hepatitis C – Direct Acting Antiviral therapeutic class may be viewed at: https://newyork.fhsc.com/downloads/providers/NYRx_PDP_PDL.pdf

B. DUR Program Updates:

1. Retrospective Evaluation of Clinical Editing
2. Prescriber Education Program

Agenda Timeline (subject to change based on meeting proceedings)

9:00 – 9:15 Welcome and Introductions
9:15 – 10:15 Public Comment Period*
10:15 – 12:30 Agenda Items (from list above)
12:30 – 2:00 Lunch/Executive Session
2:00 – 3:45 Agenda Items (from list above)
3:45 – 4:00 Final Comments and Adjournment

* Interested parties must notify the Department of Health (the Department) at least one (1) week prior to the meeting of their request to address the DUR Board during the public comment period. Requests may be made by phone (518-486-3209) or e-mail (dur@health.ny.gov). Public comments are limited to the specific topics on the agenda, must be brief (2 minutes), and the total comment period will not exceed sixty (60) minutes.

All written statements must be received in an electronic format (dur@health.ny.gov) up to one (1) week in advance of the meeting. Written statements should summarize key points and may not exceed two (2) pages in length. If the submission of clinical information greater than two (2) pages in length is needed, the information must be received at least two (2) weeks prior to the meeting date or the Board may not have ample time to review the
information. Please contact Department staff by e-mail (dur@health.ny.gov) prior to sending any information greater than two (2) pages.

Note: All information must be submitted to the Department. Information should not be submitted directly to DUR Board members. The Department will ensure that all information received (according to the guidelines above) is available for DUR Board member review prior to the meeting.