Epclusa denials in California external review
In the California DMHC record, independent physician reviewers decided 123 published external-review cases involving Epclusaand overturned the plan’s denial in 88.6%. 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 | 46 | 91.3% |
| Hepatitis C Virus | 31 | 87.1% |
What the reviewers wrote
Where the denial was overturned
Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage of Epclusa tablets 400/100 sofosbuvir/velpatasvir tablets 400/100 mg for 12 week duration or Harvoni 90/400 mg for 12 week duration for treatment of the enrollee’s hepatitis C virus.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. This applies regardless of fibrosis stage. The patient should be considered treatment-naive as she failed interferon/ribavirin rather than PEG-interferon/ribavirin.
Nature of Statutory Criteria/Case Summary: The enrollee has requested authorization and coverage for Epclusa 400 mg-100 mg and ribavirin 1200 mg for 12 weeks. The Health Plan has denied this request indicating that the requested medications are not medically necessary for treatment of the enrollee’s medical condition.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 the medical condition should be treated except those with life expectancy less than 12 months due to non-liver-related conditions. This applies in all cases, regardless of fibrosis stage. Per the guidelines, Epclusa for 12 weeks is recommended as a first-line regimen for non-cirrhotic treatment-naive genotype 3 patients, and those who failed peg-interferon and ribavirin.
Where the denial was upheld
Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Epclusa for treatment of the enrollee’s hepatitis C. 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 recommendation applies to all patients, regardless of fibrosis stage. The guidelines recommend that treatment-naive, genotype 1a patients should be treated with regimens including Zepatier (with ribavirin when NS5A resistance is found) and Epclusa. However, although the U.S.
Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Epclusa 400-100 mg tablets for 12 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), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. The guidelines do not comment on the treatment of genotype 6 hepatitis C after failure of a direct-acting antiviral agent but reference re-treatment after peg-interferon and ribavirin failures only.
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 Epclusa, 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