Sovaldi denials in California external review
In the California DMHC record, independent physician reviewers decided 206 published external-review cases involving Sovaldiand overturned the plan’s denial in 72.8%. That is a historical result among cases that reached this program, not a forecast for an individual appeal.
By condition
| Condition | Decisions | Overturned |
|---|---|---|
| Hepatitis C Virus | 68 | 67.6% |
| Hepatitis C | 68 | 77.9% |
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. | 200 | 73.5% |
Experimental/Investigational The plan called the treatment unproven. These turn on published evidence, so the appeal is a literature argument. | 6 | 50% |
What the reviewers wrote
Where the denial was overturned
Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi and ribavirin for treatment of his hepatitis C virus. Findings: The physician reviewer found that the proposed treatment is medically necessary and is considered the standard of care for the treatment of the patients with hepatitis C virus (HCV) genotype 2. Per the American Association for the Study of Liver Diseases/Infectious Disease Society of America (AASLD/IDSA) guidelines, all patients with chronic active HCV 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.
Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi and Daklinza for 12 weeks 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) “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.
Where the denial was upheld
Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi and ribavirin for treatment of the enrollee’s chronic hepatitis C virus genotype 1a and 2b. 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 treatment guideline applies regardless of fibrosis stage or viral load. Per guidelines, when multiple genotypes are present, therapy should be chosen to maximize efficacy against each genotype. In this case, the patient was already treated with Sovaldi and Ribapak, as Sovaldi is a component of the Harvoni that was provided.
Nature of Statutory Criteria/Case Summary: an enrollee has requested authorization and coverage for a 12 week extension of Sovaldi, Daklinza and ribavirin. Findings: The physician reviewer found that according to 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 life expectancy less than 12 months due to non-liver-related conditions. However, this patient has started a 12-week course of Sovaldi, Daklinza, and ribavirin.
Figures and quotations on this page come from 42,749 published decisions in the California DMHC Independent Medical Review dataset. These are California external-review outcomes. Other state and federal programs have different eligibility rules, processes, and current availability; the rates here do not transfer to those programs or predict an individual result. Excerpts are quoted verbatim from the public record and describe this treatment generally, not any individual case.
These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Sovaldi, then check the rights and deadlines that apply to your plan.
SOURCE: CALIFORNIA DMHC INDEPENDENT MEDICAL REVIEW OUTCOMES (CHHS OPEN DATA) · AGGREGATES + DEIDENTIFIED DECISION EXCERPTS/REFERENCE IDS · METHODOLOGY