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NYS DURB Hearing on Harvoni Criteria Nov 20 2014 in Albany, NY
  Jules Levin, NATAP
Yesterday members of our NYS Hepatitis C Coalition and myself attended and testified at the NYS DURB hearing. Despite great testimony from 8 advocates NYS officials recommended to the committee that the F3/F4 restriction remain & the committee voted unanimously to approve, saying they would meet again after the Abbvie approval & as you can see in slide #4 NYS said they will "....Evaluate Hepatitis C medication criteria at 6 months from implementation. Determine clinical and fiscal impact of new drugs in the pipeline. Review and evaluate any new drugs at a future DUR Board", clearly the decision comes from the very top NYS officials, the Governor's office I presume, and the state officials & the committee had decided in advance what the outcome would be, it was baked in the cake no matter what we said. However, apparently they did drop from the previously recommended criteria what we as a coalition requested them to drop - that HIV+ had to have undetectable HIV viral load - and - language "risk-based behavior" suggesting that treatment access could be used against drug users, whom by the way make up at least 50% of those HCV-infected in the USA.
Another important point from the meeting yesterday in exciting Albany & the glamorous Empire State Plaza was the NYS officials again relying on the AASLD/IDSA/IAS-USA HCV Guidance on treatment access restrictions. Although most recently the panel rescinded their old language suggesting prioritizing F3 was "ok", they said they never intended to suggest this, STILL the NYS official who presented the recommendations to the committee - she initially said most recently the Guidance was changed so I expected she would report the rescission & the new improved language, BUT she did NOT, she reported the old language that the Guidance suggests prioritizing & treating F3 before others!
nEW Guidance - that - ".....all patients who receive advice from their doctor to take newest medications should not be denied. The decision across the board should be in the hands of the clinician and the patient to make the decision. Unfortunately payers across America are denying treatment when a doctor has prescribed it for their patient. We adamantly disagree with this decision. Our Guidance is not intended to be used by payers to deny access to treatment"
AASLD/IDSA Guidelines Improves Restrictions Language
This report from California group holding hearing on Dec 18 reverses its opinion from earlier this year to this:
"results suggest that the introduction of LDV/SOF for both treatment-naïve and treatment-experienced individuals would confer substantial clinical benefits in comparison to historical treatment standards and even in relation to other sofosbuvir-based regimens. While the use of this new regimen would increase treatment costs, such use appears to be cost-effective by conventional standards."
CTAF Report: Newest Treatments for Hepatitis C, Genotype 1: next public meeting of the California Technology Assessment Forum (CTAF) on Thursday, December 18, 2014 in Oakland, California. - (11/18/14)
Dear Providers,
The draft clinical criteria for the use of Harvoni (SOF/LVD) was presented to the NYSDOH Drug Utilization Review Board (DURB) on Thursday, November 20, 2014. The DURB voted to adopt the following recommendations:
·Activate Harvoni coverage
·Continue using clinical criteria approved for Sovaldi during the September 18, 2014 DURB meeting and implemented on October 16, 2014. This includes:
·FDA labeling and compendia supported use
·Prescribed by an experienced and trained provider (this allows experienced and trained PCPs to continue to prescribe)
·Patient readiness and adherence
·Disease prognosis and severity (this criteria restricts the prescribing of Harvoni to those with advanced liver disease (i.e., F3/F4, extra hepatic manifestations or coinfection such as HIV and/or HBV)
The criteria will be piloted for six (6) months from implementation. In addition, NYSDOH will determine clinical and fiscal impact of new drugs in the pipeline and review and evaluate any new drugs at future DUR meetings.
The meeting summary is not yet posted. However, the audio cast from the meeting is available at.http://www.health.ny.gov/events/webcasts/archive/index.htm
The meeting summary, including the criteria will be posted within 30 days of the meeting at:http://www.health.ny.gov/health_care/medicaid/program/dur/meetings/2014/index.htm. The summary is updated after final determinations are made by the NYS Commissioner of Health.
**At this time, the DURB is accepting comments on the criteria. Comments can be sent to dur@health.ny.gov.
Please let me know if you have any questions.
Thank you.
Colleen Flanigan
Director, Viral Hepatitis Section
New York State Department of Health
AIDS Institute
Empire State Plaza, Corning Tower – 429
Albany, NY 12237
(o) 518-486-6806
(f) 518-474-2749
NEW EMAIL: colleen.flanigan@health.ny.gov




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