NICE recommends Ocaliva for NHS use

The National Institute for Health and Care Excellence (NICE) has approved Ocaliva (obeticholic acid) for routine use by the National Health Service (NHS) in England, Wales and Northern Ireland, US drugmaker Intercept Pharmaceuticals (Nasdaq: ICPT) announced today..

Ocaliva has been conditionally approved in the European Union for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. The NHS is expected to make Ocaliva available to patients with PBC within 90 days of the NICE’s final appraisal publication and Intercept will work with local reimbursement authorities to help ensure eligible patients obtain access.

According to the NICE, the medicines cost-effectiveness watchdog, it is estimated that there are up to 20,000 people affected by PBC in the UK. It occurs when bile gradually builds up in the liver, damaging it and leading to cirrhosis. Ocaliva is a new type of drug which reduces the production of bile and stops the disease from progressing.