Download Project Inform Letter to California Department of Health Office of AIDS

June 20, 2014
Karen Mark, MD, MPH
Chief of the Office of AIDS
California Department of Public Health
SENT VIA EMAIL: [email protected]
RE: Draft ADAP Prior Authorization Policy for Sofosbuvir & Simeprevir
Dear Dr. Mark,
Project Inform, which represent constituents at risk for and living with the hepatitis C virus (HCV), are
pleased that the State Office of AIDS is promulgating guidelines outlining the ADAP treatment policy for the
lifesaving medications sofosbuvir and simeprevir. We appreciate that ADAP is adding this important drug to
the formulary, especially given Gilead’s refusal to provide appropriate supplemental rebates to ensure
affordability.
We are concerned that the draft policy is too restrictive given the health crisis caused by HCV in California
and the tremendous opportunity that sofosbuvir provides to improve health, save lives, considerably reduce
health care costs, and eliminate HCV in the vulnerable HIV/HCV co-infected population by curing the
disease. Early treatment prevents liver damage and liver cancer, improves quality of life, and stems the tide
of onward transmission. An estimated 25% of people living with HIV are co-infected with HCV. What’s
more, HCV is the primary cause of hepatocellular carcinoma, the fastest growing cancer in the U.S. Given
this, and the extraordinary cure rate of the new medication, now is the time to act aggressively against
HCV.
The proposed policy that patients have to have advanced liver disease (i.e., METAVIR F3-4 or equivalent),
or have recognized extrahepatic manifestations of HCV (leukocytoclastic vasculitis, symptomatic
cryoglobulinemia, or membranoproliferative glomerulonephritis), despite mild liver disease, to receive
treatment authorization is a policy that requires patients to be seriously sick from a chronic, infectious, lifethreatening disease before they can be offered the cure. It is a great disservice to patients, particularly
those who are co-infected with HIV, and to the public health. Treatment should be available to all patients
who are highly motivated to get cured of the virus (i.e., patients likely to adhere to the treatment regimen)
and who are identified by their physicians as appropriate treatment candidates.
In addition, the proposed policy that patients have to have advanced liver disease (i.e., METAVIR F3-4 or
equivalent) to receive treatment authorization is arbitrary, as results are +/- 1 fibrosis stage – even liver
biopsy cannot conclusively differentiate between stage 2 and stage 3 disease. Requiring a liver biopsy
exposes patients to a procedure that has a higher morbidity and mortality rate than the treatment itself.
Non-invasive tests, such as Fibrotest and Fibroscan, can distinguish people with a low versus high
likelihood of advanced fibrosis, which may include those who are on the F2-F4 range, and along with
provider and patient discretion, should be the standard on which to base treatment decisions.1
If CDPH maintains the current draft policy, treatment authorization should be expanded to include the
following patients:
• All individuals at METAVIR F2 or equivalent due to rapid progression of HCV in co-infected
individuals.2
• All HIV/HCV co-infected males and transgender females who have condomless sex with males,
regardless of METAVIR score, to prevent sexual transmission via anal sex, which is a welldocumented route of transmission in the scientific literature for these populations.
• All women of childbearing age (15 to 44 years of age), regardless of METAVIR score, to prevent
vertical transmission to potential future children.
We understand that Gilead has offered the "solution" of individuals using the patient assistance or co-pay
assistance program when they are unable to access sofosbuvir through insurance coverage or ADAP. We
have many concerns about this avenue of access. This “solution” requires healthcare providers and
patients to navigate additional administrative processes and creates significant barriers to treatment
access. It is unclear what coverage will be available to those who are unable to access treatment due to
overly restrictive treatment guidelines in payer programs. We urge the State Office of AIDS to clarify these
issues with Gilead. We also urge you to consider an exceptions process for access if the current guidelines
are maintained.
Thank you for allowing Project Inform the opportunity to express our concerns about the proposed policy.
Please contact us if you have questions or require additional information. We look forward to your response
to our concerns.
Sincerely,
Emalie Huriaux, MPH
Director of Federal & State Affairs
[email protected]
cc: Ron Chapman, MD, MPH, Director, California Department of Public Health;
Celia Banda-Brown, ADAP Chief, California Department of Public Health;
Anne Donnelly, Director of Health Care Policy, Project Inform;
David Evans, Director of Research Advocacy, Project Inform
1
See attached article (Gonzalez) about the lack of discrimination between Stage 2 and 3 using noninvasive testing,
as well as the attached editorial (Lai) which summarizes where we are with the field. The non-invasive tests can tell
you with reasonable accuracy no/limited fibrosis (F0-F1) and more advanced disease. As you can see in the
Gonzalez article, F2 is often lumped together with F3/F4 because there is a very limited ability to distinguish. There
are some studies that look at diagnosis cirrhosis (F4 vs. no F4) with non-invasive markers, but again these do not
discriminate well. Putting several tests together (such as Fibrotest and Fibroscan) increases the ability to accurately
assess > F2 disease but most people feel the strength of these tests is to identify lack of fibrosis versus extensive
fibrosis and that performance in the middle is limited.
2
See attached articles that highlight the more severe nature of liver disease in HIV in a cross-sectional perspective
(Kirk), as well as a signal of more rapid progression over time (Konerman, Sulkowski).