Daklinza denials in California external review
In the California DMHC record, independent physician reviewers decided 59 published external-review cases involving Daklinzaand overturned the plan’s denial in 81.4%. 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 | 29 | 79.3% |
| Hepatitis C | 16 | 87.5% |
What the reviewers wrote
Where the denial was overturned
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.
Nature of Statutory Criteria/Case Summary: An enrollee has requested Sovaldi, Daklinza and Ribasphere for treatment of his 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 limited life expectancy due to non-liver-related conditions. The guidelines state that patients with cirrhosis are high priority for treatment. The guidelines recommend that cirrhotic patients with genotype 3 hepatitis C who have failed treatment with Sovaldi and ribavirin should be treated with Sovaldi, Daklinza, and ribavirin for 24 weeks if ineligible for peg-interferon.
Where the denial was upheld
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.
Nature of Statutory Criteria/Case Summary: An enrollee has requested Daklinza and Sovaldi 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 limited life expectancy due to non-liver-related conditions. Per the guidelines, patients with cirrhosis are high priority for treatment. In cirrhotic treatment-naïve genotype 3 patients, therapy is recommended with Sovaldi and Daklinza for 24 weeks.
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 Daklinza, 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