Express Scripts is a HUGE PBM and they would be so stupid to approve a prescription for a patient on VP or Technivie where it was not indicated. You have to submit Lab values and scans to prove which fibrosis level you are as well as physical signs of decomponsation - Ascites - Varices - DIRECT elevated bilirubin - jaundice etc. VP and Technivie are NOT indicated for such patients and the PI for Technivie says indicated only for non cirrhotics. i can assure you Express scripts would NEVER allow this to happen. Now having said that, 10 of the 26 reported cases were from Europe and were in patients in a program that received both medicines before they were FDA approved - so guidance on appropriate patient types who should be prescribed both medicines were not followed and patients received these drugs when they shouldn't have received them.[/QUOTE
Not entirely correct:
1. Insurance company and PBM only requires proof of F4 (fibrosure or fibroscan). If a drug is not recommended, it is the clinician's discretion to use the drug. Under the old label, Viekira was NOT RECOMMENDED in moderate liver disease (CPB). Viekira was only contraindicated in severe liver disease (CPC).
2. 30% of the decomps were in the European Compassionate Care Program (MAP). That is 8 patients.
3. Of the remaining 18 patients, not all of them were decompensated at baseline. The new PI states, "Hepatic decompensation and hepatic failure, including liver transplantation or fatal outcomes, have been reported MOSTLY in patients with advanced cirrhosis. Monitor for clinical signs and symptoms of hepatic decompensation."