Viekira Pak denials in California external review
In the California DMHC record, independent physician reviewers decided 45 published external-review cases involving Viekira Pakand overturned the plan’s denial in 80%. 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 | 17 | 94.1% |
| Hepatitis C Virus | 14 | 57.1% |
What the reviewers wrote
Where the denial was overturned
Nature of Statutory Criteria/Case Summary: An enrollee has requested Viekira Pak for treatment of his chronic hepatitis C virus (HCV). Findings: The physician reviewer found thatthe American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) guidelines state the following: `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.” Evidence clearly supports treatment in all HCV-infected persons, except those with limited life expectancy (less than 12 months) due to non-liver-related comorbid conditions.
Nature of Statutory Criteria/Case Summary: An enrollee has requested Viekira Pak or Harvoni for treatment of his hepatitis C virus (HCV). Findings: Two physician reviewers found that according to the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) recommendations for testing, managing, and treating hepatitis C, patients with chronic active hepatitis C are eligible for treatment and should be treated with FDA approved antiviral therapy regardless of fibrosis score. Moreover, “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 Viekira Pak 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), all patients with chronic hepatitis C should be treated except those with limited life expectancy due to non-liver-related conditions. The guidelines report that patients with cirrhosis are highest priority for therapy. Per guidelines, genotype 1b patients with cirrhosis who have failed Sovaldi-based therapy should be treated with a different regimen, such as Harvoni. Ribavirin for 24 weeks and Viekira Pak is not recommended.
Nature of Statutory Criteria/Case Summary: An enrollee has requested Viekira Pak for treatment of his hepatitis C virus. Findings: The physician reviewer found that according to the most recent joint guidelines issued by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America, all patients with chronic hepatitis C, regardless of fibrosis, should be treated except those with limited life expectancy due to non-liver-related comorbid conditions. Per the guidelines, treatment-naive genotype 1b patients should be treated with Viekira Pak for 12 weeks, or with Harvoni for 12 weeks. This recommendation is based on multiple high-quality clinical trials showing cure rates of over 90% and safety with either medication.
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 Viekira Pak, 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