Pegasys denials in California external review

What the reviewers wrote

Where the denial was overturned

A 57-year-old male enrollee has requested medical therapy with Pegasys or Peginterferon alpha-2a and Ribavirin for treatment of his hepatitis C. Findings: The physician reviewer found that Hepatitis C virus (HCV)-related end-stage liver disease is the leading clinical indication of liver transplantation (LT) in the United States as reported by the Bureau of Health Resources Development. HCV recurrence after LT is almost universal and occurs early, with histological recurrence observed in up to 70% of patients during the first year after LT (Gane, 2003). Cirrhosis develops in up to 30% of transplant recipients after 5 years with persistent HCV viremia, and may be associated with graft failure and the need for re-transplantation (Gane, 1996). This leads to lower patient survival rates compared to non-HCV transplant recipients (Forman, et al).

A 48-year-old male enrollee has requested for Pegasys for treatment of his hepatitis C virus. Findings: The physician reviewer found that widespread interest in maintenance therapy has been fueled by the published randomized trial of maintenance therapy with interferon in which patients after six months of virologic nonresponse to interferon received either 24 additional months of interferon or no treatment. The patients who received treatment had significantly lower Hepatic Activity Indices (HAI). At present, there are three large randomized controlled trials of maintenance therapy in patients with HCV infection who failed to achieve sustained virologic response following previous therapy with conventional treatment.

Where the denial was upheld

A 48-year-old male enrollee has requested for an additional 12 weeks of Pegasys and ribavirin for treatment of his hepatitis C virus. Findings: The physician reviewer found that the current approved treatment for hepatitis C is pegylated interferon (Pegasys) plus ribavirin for a total of 48 weeks in genotype-1 patients. Some studies have suggested that a longer treatment period may be warranted in those patients who have a late documented viral clearance while on therapy. Currently, a 12-week time point is used to determine the presence of an early viral response (EVR); however, many studies indicate that a 4-week point may also be useful in predicting a response to 48 weeks of therapy.

Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Pegasys. This patient presents with localized right-sided pleural mesothelioma and underwent right thoracotomy, radial right parietal pleurectomy, complete pulmonary decortication, partial resection of the diaphragm with complex reconstruction, hilar and mediastinal lymph node dissection. She also received adjuvant radiation therapy to the right hemithorax. There is no documentation indicating that she received adjuvant cisplatin plus pemetrexed, which is considered standard therapy per current national guidelines. As such, the patient would benefit from adjuvant cisplatin and pemetrexed. Currently, there is insufficient data to support the use of Pegasys in the setting of mesothelioma.

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 Pegasys, then check the rights and deadlines that apply to your plan.