BioCentury
ARTICLE | Clinical News

Sovaldi sofosbuvir regulatory update

August 11, 2014 7:00 AM UTC

Oregon’s Pharmacy and Therapeutics Committee proposed guidelines that would restrict access to Gilead’s HCV drug Sovaldi sofosbuvir in the state’s Medicaid program. The guidelines would allow Sovaldi only for patients with late stage liver damage, including HCV/HIV co-infected patients with cirrhosis, cirrhotic patients without ongoing progressive decompensation and patients with HCV infection in the transplant setting. In all cases, the proposed guidelines specify that expected survival from non-HCV associated morbidity must be >5 years.

According to a spokesperson for the Oregon Health Authority, treating 30% of the 5,600 known HCV cases among Oregon Medicaid patients would cost about $168 million - or about 45% of the state’s annual Medicaid pharmacy budget. A subcommittee of Oregon’s Health Evidence Review Commission was scheduled to meet last week to discuss the guidelines. If adopted by the subcommittee and subsequently approved by the full commission on Aug. 14, the guidelines would come into effect on Oct. 1. ...