Sofosbuvir denials: what the review data shows

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi and Ribasphere Ribapak for treatment of his hepatitis C virus (HCV). Findings: The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. This applies regardless of fibrosis stage or viral load. AASLD/IDSA provides the following justification for the above treatment recommendation: Sofosbuvir 400 mg daily was combined with weight-based ribavirin (RBV), 1000 mg to 1200 mg, to treat HCV genotype 2 treatment-naive patients across 3 clinical trials: FISSION, POSITRON, and VALENCE.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Daklinza, Sovaldi, and weight-based ribavirin for treatment of his hepatitis C virus. Findings: The physician reviewer found that according to the joint guidelines issued by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) for patients with HCV genotype 3 infections with cirrhosis, in whom prior treatment with sofosbuvir and ribavirin has failed the recommended regimens include two treatment options. Daily daclatasvir (Daklinza) and sofosbuvir (Sovaldi) for 24 with weight-based ribavirin for interferon ineligible patients and daily sofosbuvir (Sovaldi) and weight-based ribavirin plus weekly peginterferon for 12 weeks for interferon ineligible patients.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested Daklinza to be used in conjunction with Sovaldi for 12 weeks for treatment of his hepatitis C virus (HCV). Findings: The physician reviewer found that according to the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) “Successful hepatitis C treatment results in sustained virologic response (SVR), which is tantamount to virologic cure, and as such, is expected to benefit nearly all chronically infected persons.” Guidelines further state that “The goal of treatment of HCV-infected persons is to reduce all-cause mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma, by the achievement of virologic cure as evidenced by a sustained virologic response.” In this case, the patient has F2 fibrosis,…

Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi and Daklinza for treatment of his hepatitis C virus (HCV). Findings: The physician reviewer found that the American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA) guidelines, relative to this patient’s case, state: `Daily daclatasvir (60 mg*) plus sofosbuvir (400 mg) for 12 weeks is a recommended regimen for treatment-naïve patients with HCV genotype 3 infection who do not have cirrhosis. Rating: Class I, Level A`. The medical necessity of HCV eradication as per American Association for the Study of Liver Diseases/Infectious Diseases Society of America (AASLD/IDSA) recommendations exists irrespective of fibrosis score. However, the submitted records reflect illicit drug use.

These are outcomes from California’s external review program — an independent physician panel that binds the insurer. Every state has an equivalent process, and internal appeals succeed even more often. Cite the outcome record for Sofosbuvirwhen you appeal: reviewers routinely find that denials like yours didn’t hold up.