After New York’s attorney general requested information from 16 health insurance companies over allegations they were restricting coverage of drugs that can cure hepatitis C, Aetna said it will expand coverage for some of the medications and will continue to do so as new research findings become available.
Claimants argue that some insurance companies have inappropriately rationed care by denying patients expensive, but effective, medications. Insurance companies argue that they are simply making sure the most appropriate medications are used for such designated diseases or conditions.
“Empire Blue Cross Blue Shield is committed to the ongoing evaluation of the safety and efficacy of drug therapies, and to continuing to evolve our coverage policies based on new clinical evidence and real life experience,” Sally Kweskin, Aetna company spokeswoman, recently told Patient Daily.
Aetna operates Empire Blue Cross Blue Shield.
After several months of ongoing clinical review of the medical evidence and safety concerns surrounding hepatitis C treatments, coverage for Empire Blue Cross Blue Shield employer and individual health insurance plans was expanded for six of the newer oral treatments effective Dec. 7, 2015.
“Coverage for these treatments (Harvoni, Sovaldi, Olysio, Daklinza, Viekira Pak and Technivie) include those in all stages of fibrosis, with a few clinical conditions,” Kweskin said. “This decision was based on evolving medical evidence and unrelated to any regulatory inquiries.”
Kweskin explained that the newer oral hepatitis C drugs were approved through the FDA breakthrough therapy process and tested in far fewer people than typical clinical trials, which meant there was limited knowledge of these drugs.
“Given the concerns around safety and relative benefits and harms, our former policy applied to members in the most advanced stages of liver disease and those at highest risk for liver complications,” she said.
Despite these restrictions, Kweskin explained that new studies have allowed for the possibility of expanding insurance coverage.
“However, the American Association for the Study of Liver Disease and the Infectious Disease Society of America removed more population restrictions from its recommendations, and the Food and Drug Administration broadened Harvoni’s indication to include more populations,” Kweskin said. “We believe sufficient clinical and real-world experience data has been made available on these drugs in the past two years to expand coverage.”
The expanded coverage applies to those who still have hepatitis C after six months of diagnosis, confirmed with an HCV RNA test, Kweskin said.
“This is consistent with an American Association for the Study of Liver Disease and the Infectious Disease Society of America treatment recommendation,” she said. “Clinical studies have shown that 20 to 50 percent of all people who become infected with Hepatitis C no longer have the disease after six months with no treatment.”
Kweskin further explained that it is important that the appropriate resources are used for those who need therapy to eradicate the disease. This means making sure the medications are used for the right illnesses.
“The coverage for Harvoni specifically applies to those who have genotypes 1, 4, 5 and 6 and compensated liver disease with or without cirrhosis, or genotypes 1 and 4 and decompensated liver disease with cirrhosis following allograft liver transplant,” she said.
Aetna says Hep C coverage likely to expand with new research