Olysio denials: what the review data shows
Independent reviewers have decided 30 published cases where an insurer denied Olysio — and they overturned the insurer 46.7% of the time. A denial for Olysio is a starting position, not a final answer.
Conditions behind olysio denials
| Category | Decisions | Overturned |
|---|---|---|
| Hepatitis C | 11 | 72.7% |
| Hepatitis C Virus | 6 | 16.7% |
| Hepatitis C Genotype 1 | 4 | 25% |
| Cirrhosis | 4 | 100% |
| Hepatitis C Genotype 1a | 3 | 0% |
What the insurer actually argued
| Reason given | Decisions | Overturned |
|---|---|---|
Medical Necessity The plan said the care wasn’t medically necessary. The most common fight, and the most winnable. | 25 | 48% |
Experimental/Investigational The plan called the treatment unproven. These turn on published evidence, so the appeal is a literature argument. | 5 | 40% |
Where the denial was overturned
Nature of Statutory Criteria/Case Summary: An enrollee has requested a 12 week course of Sovaldi and Olysio for treatment of his hepatitis C virus genotype 1a. Three physician reviewers found that per the American Association for the Study of Liver Diseases (AASLD) and Infectious Disease Society of America (IDSA) guidelines, all patients with chronic active hepatitis C are eligible for treatment and should be treated with U.S. Food and Drug Administration (FDA) approved antiviral therapy regardless of fibrosis score. 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. Overall, the data supports treatment in all hepatitis C virus infected persons, except those with limited life expectancy due to non-liver-related comorbid conditions.
Nature of Statutory Criteria/Case Summary: An enrollee has requested Olysio and Sovaldi for treatment of his hepatitis C. Two physician reviewers found that the current medical evidence supports the requested medications in this clinical setting. Per the American Association for the Study of Liver Diseases and Infectious Diseases Society of America guidelines, all patients with chronic active hepatitis C should be treated regardless of fibrosis score. The medical evidence supports treatment in all patients with hepatitis C, except those with limited life expectancy less than 12 months due to non-liver-related comorbid conditions. The goal of treatment is to reduce all-cause mortality and liver-related health adverse consequences, including end-stage liver disease and hepatocellular carcinoma.
Where the denial was upheld
Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Olysio 150 mg and Sovaldi 400 mg with ribavirin 600 mg for duration of 24 weeks. 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), “Deferral of treatment is recommended, pending availability of data for patients with HCV genotype 1, regardless of subtype, in whom previous treatment with any HCV nonstructural protein 5A (NS5A) inhibitors has failed, who do not have cirrhosis, and do not have reasons for urgent retreatment”. This patient’s records do not document the presence of cirrhosis, and no other reason for urgent re-treatment compatible with the guidelines is provided.
A 63-year-old female enrollee has requested Sovaldi and Olysio for treatment of her hepatitis C virus (HCV). Findings: Three physician reviewers found that HCV treatment is medically necessary for treatment of the patient’s medical condition. While HCV treatment is necessary, the requested treatment of Sovaldi and Olysio is class B, and not class A per the latest American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) guidelines. Newer treatment options exist for this patient with similar efficacy recommended for patients with HCV genotype 1a infection who do not have cirrhosis, in whom prior peg-interferon and ribavirin treatment has failed. The first treatment option is the fixed-dose combination of ledipasvir/sofosbuvir for 12 weeks.
Figures and quotations on this page come from 42,749 published decisions in the California DMHC Independent Medical Review dataset. These are California outcomes — every state runs an equivalent external review, but the rates here are California’s. Excerpts are quoted verbatim from the public record and describe this treatment generally, not any individual case.
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 Olysiowhen you appeal: reviewers routinely find that denials like yours didn’t hold up.
SOURCE: CALIFORNIA DMHC INDEPENDENT MEDICAL REVIEW OUTCOMES (CHHS OPEN DATA) · DERIVED AGGREGATE STATISTICS ONLY · METHODOLOGY