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NYS HCV Drug Criteria, NYS Hearing Sept 18
  Jules Levin, NATAP
Yesterday I trekked up to Albany, NY, the state capitol at 6am to attend the 9am start of the:
"New York State Medicaid Drug Utilization Review Board" https://www.health.ny.gov/health_care/medicaid/program/dur/ meeting which was an all day affair, in the imposing state capital building.
I was able to provide testimony for only 2 minutes in the open commentary period in the morning. The meeting included discussion of numerous different drugs & category of drugs of which HCV was only one so there was testimony on numerous other drugs. Of course I testified that the medicaid restrictions being imposed in other states are too harsh & that denying therapy is harmful & inappropriate. I said that delaying therapy until a patient has F3/F4 increases the risk for liver cancer (HCC), as well a patient can still get liver cancer with F2. I said this is NYS, the most progressive state in the world & has always provided good healthcare access. I also said denying access to therapy for substance abusers is inappropriate, don't do it, that 50% of the 3.2 mill estimated to have HCV in the USA were infected through injection drug use: http://natap.org/2014/AASLDEASL/AASLDEASL_03.htm
I also said we have been waiting for years for this treatment, it is the most important medical science breakthrough, the only time in history as far as I know that we can cure a virus & with only 12 weeks of tolerable with relatively few side-effects therapy. We should be celebrating this breakthrough rather than harshly denying & restricting access to curative treatment, its inhumane.
After a lunch break state officials who presumably developed the plan presented their recommendations for HCV drug criteria, which included this:
- to be treated a patient had to have F3/F4. There was a doctor on the panel who expressed exception to this. Of note, the state officials who presented their criteria recommendations relied on the new AASLD/IDSA HCV Guidelines recommendations that say to prioritize F3/F4 for treatment. Observers at this meeting appeared to agree, as I spoke with several, that they may not have imposed this harsh restriction if it not were for the AASLD/IDSA HCV Guidelines.
- patients with extra-hepatic manifestations could be exempt, and they listed a bunch which included diabetes and several of the usual extraheptic manifestations
- HIV coinfection is an extra-hepatic manifestation so it can be treated. A key point is their language said only HIV+ individuals with undetectable HIV viral load could be treated.
- they did not confine approved clinicians to only hepatitis experts like hematologists, gastroenterologists, as other states have imposed, an overly harsh restriction. They said trained, knowledgable & experienced clinicians can treat and their list included NPs, infectious disease specialists which means that HIV clinicians will be able to treat connected patients, while other states have excluded ID & HIV docs. The language they used included: clinicians who managed 20 HCV infected patients and treated 10 in the past 12 months. There was also continuing education and licensure in that definition too.
- regarding substance abusers, they explicitly said high risk alcohol & substance abusers should not be treated but then they said this should be left up to the treater's discretion which is a big relief, so this means if a patient is an IDU or uses alcohol, the doctor or clinicians can use their discretion to treat the patient. This is good, as other states like California require a urinalysis, and several states including Illinois require 6-12 months abstinence & for a patient to seek treatment for substance abuse before they can be treated.
Then, the full committee voted unanimously to accept all that was proposed.
They announced there will be a commentary period where they will invite public commentary on these restrictions, and I will distribute the links for that & all the relevant information I can gather to address this concern, this restriction to healthcare.
October 10th is expected approval date for the FDA to approve Sofosbuvir+Ledipasvir, it mitt be a few days earlier. Expected approvals for the other new therapies are expected during October through December: Abbvie 3D, JNJ's simeprevir+sofosbuvir, and BMS's daclatasvir.
They said they would meet again several months later after these expiated approvals to review the situation & consider guidelines.
Now, having reviewed the key guidelines it is crucial for stakeholder communities to come together to fight these restriction, to prevent similarly harsh restrictions from being imposed after the new approvals.
As I mentioned before I plan to communicate soon with the key links to submit public commentary, for relevant information.
In the meantime we need to gather the forces in NYC & NYS to address this barrier to care.

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