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NYS Medicaid Sovaldi Criteria. Are they discriminatory & illegal, a lawsuit in the making? Comment Period Open Now
  Download the PDF here
Jules Levin, NATAP
NYS officials slides of criteria attached for download
Very soon, Oct 10 for Sovaldi+Ledipasvir, and during October thru December other new interferon free therapies are expected to be approved by the FDA and available in pharmacies: Abbvie's 3D, Janssen's Simeprevir+Sofosbuvir, BMS' daclatasvir. However, numerous state medicaid programs, the biggest in the USA, including now NYS are ready to implement harsh restrictions to access. Some states want to deny access to treatment to IDUs despite that 50% of HCV-infected in the USA were infected by injection drug use. A lawsuit could be brought immediately to question the legality of these restrictions which many have said appear to be discriminatory & illegal. It is clear these new therapies are cost-effective. They are 12 weeks of relatively tolerable & easy to take medu=ications which have showed in large scale phase 3 studies of thousands of patients that they provide a cure rate, an SVR, of up to 100%. After years of suffering interferon therapy which prevented many patients from being treated now we could eradicate HCV from the USA, we could save lives & eradicate HCV within 10 years IF the state & federal governments would provide a solution to unfettered access to treatment. These restrictions take aim at & do the most harm to the most vulnerable & disenfranchised patients. Read ahead
Medicaid HCV Treatment Restrictions Denying Care & Treatment, which HCV Guidelines Committee Supported - (09/11/14)
The September 18 DURB meeting summary is now public and can be viewed at the following link:
I have also attached a copy of the presentation from the meeting.
If you'd like to view the webcast, it is accessible on the DOH website at the following link: (2:18 NYS presented the proposed criteria that the DURB Committee unanimously approved)
As mentioned, the public comment period is open for five days. Comments can be sent to dur@health.ny.gov.
The draft clinical criteria for the use of Sofosbuvir (Sovaldi) was presented to the NYSDOH Drug Utilization Review Board (DURB) on Thursday, September 18, 2014. The DURB voted to adopt the criteria based on:
· FDA labeling
· Prescribed by an experienced and trained provider (this allows experienced and trained PCPs to continue to prescribe)
· Patient readiness and adherence (this criteria was used instead of criteria requiring periods of abstinence)
· Disease progression and severity (this criteria restricts the prescribing of Sovaldi 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 and will be re-evaluated at that time.
FROM Jules:
I want to bring to your attention several key points NYS officials raised in the criteria they proposed in their slide presentation which the DURB committee unanimously approved, and the slide set is attached here below-
(1) as you can see in slide 10 they use & rely on the AASLD/EASL Guidelines for cover for their recommendation that only F3/F4 be treated. This is wholly inappropriate & dangerous to patients, liver disease (HCC) can develop without having F3 stage disease; these staging teats are well known for making mistakes so a patient could be F3 but the test says he is F2; once a patient develops cirrhosis the risk & consequences are irreparable, meaning that even if a patient is cured after achieving an SVR after they have cirrhosis for the rest of their life they have to do surveillance to check if they have HCC, they have to do an MRI every 6 months for the rest of their life, thesis recommended & accepted as standard of care, this alone costs $3000 a year in perpetuity, forever, after 20-30 years this costs the same os the HCV treatment. Liver cancer takes years to develop so it may be in development stages years before an F3 diagnosis, and as mentioned these tests are notorious for making mistakes as a patient could have F# but the test says F2, a misdiagnosis that can occur as everyone knows well.
(2) in slide 14 they say 57,897 patients could be treated under medicaid & I assume they use this to estimate what the costs would be. State medicaid's & NYS too appear to over-inflate the number of patients that would be treated in the 1st year or each year thereafter. The healthcare system is not capable of treating all the patients eligible in one year, I estimate 10,000-15,000 per year could be treated in the 1st year.
(3) Unlike severe restrictions in other states, fortunately the NYS criteria proposed allow for Infectious Disease specialists to treat HCV, presumably this will permit HIV specialists to treat HCV, while other states have only permitted hematologists or gastroenterologists to treat & not ID docs. HIV specialists who have experience treating HCV are often very well trained & experienced in treating HCV & to prevent them from treating as some stats have done creates an extremely difficult situation for HIV/HCV coinfected patients & their clinicians, an absurd restriction, some HIV specialists are some of the best HCV treaters.
(4) on slide 19 it says:
Patient has demonstrated treatment readiness and ability to adhere to drug regimen; AND
To be evaluated by using scales or assessment tools that are readily available to healthcare practitioners at http://www.integration.samhsa.gov/clinical-practice/screening-toolsor https://prepc.org/ to determine a patient's readiness (e.g. substance abuse potential) to begin hepatitis C treatment
The author of this assessment tool Jeff Weiss says the tool should be used to identify what issues or barriers a patient has in order to help the clinician ready & prepare for successful treatment, the tool is not to be used to filter out patients from treatment, so the language in the criteria need to be changed.
(5) This is the biggest problem, onside 20 you can see that patient must have F3/F4.This is I suggest illegal & discriminatory.
Any patient who wants to be treated should be able to be treated, such a restriction does not occur in any disease in the USA. This restriction is likely illegal and the director of a national medicaid association, Matt Salo, has said that if sued they would likely lose. This policy is discrimination against women who have HCV & want to get pregnant, if she has earlier stage disease, she should not be prevented from getting treatment. As well, as mentioned above these tests are notorious for sometimes being incorrect, they may say you have stage 2 but you might have stage 3, and liver cancer can develop without having F3, liver cancer takes years to develop and may be ongoing for years before a patient progresses to F3.
(6) Unbelievable, in slide 23 it says an HIV+ patient must have undetectable HIV viral load to be treated, this is totally unacceptable without any medical support. A patient with detachable HIV viral can be treated & should be if the circumstances for treatment are present, this decision should be up to the patient & their clinician. I don't know why they recommended this but I think it might be related to adherence concerns because there is no data to suggest such a patient can't respond equally well to HCV therapy. And what about an HIV+ patient who has tried but can't achieve undetectable HIV viral load, should that person be penalized & refused HCV treatment & perhaps die!
(7) on slide 25 it says, what do they mean "no signs go high-risk behavior", does this suggest IDUs cannot be treated? In HIV IDUs are treated!, NYS officials are suggesting IDUs should not be treated? This statement gives leeway to a treater to deny treatment based on what might be his/her whimsical random notion of what is "high-risk"; is smoking pot high risk?, denied!. Can lifestyles or behaviors at the whim of a clinicians be used as an exuse by the clinician to deny treatment. There are boundless ways this language can be used & mis-interpreted.
"No sign(s) of high risk behavior (recurring alcoholism, IV drug use, etc.) or failure to complete HCV disease evaluation appointments and procedures should be evident in follow-up reviews."

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