Vemlidy

Drug - Vemlidy® (tenofovir alafenamide fumarate [TAF]) [Gilead Sciences, Inc.]

January 2018

Therapeutic area - Hepatitis B

Approval criteria

• Be 18 years old or older AND
• Be prescribed by, or in consultation with, a gastroenterologist, hepatologist, or infectious disease specialist AND
• Have diagnosis of chronic hepatitis B with compensated liver disease AND
• Have tried and failed Viread OR Baraclude at up to maximally indicated doses unless contraindicated or clinically significant adverse effects are experienced

Drug	Maximum Daily Dose
Viread	300mg
Baraclude	1mg

Renewal criteria

• Documentation/claims history demonstrating that the patient has been adherent with therapy AND
• Documentation showing that the patient’s condition continues to benefit from treatment in at least one of the following:
  • Sustained clearance of HBeAg and HBV DNA
  • Normalization of serum ALT level
  • Decrease in inflammation on liver biopsy

Denial criteria

• Patient is currently using any of the following P-gp inducers:  oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort OR
• Patient has decompensated liver disease (Child-Pugh B or C) OR
• Patient is taking concurrent Viread (tenofovir disoproxil fumarate) OR
• Patient is HIV-1 positive and using TAF as monotherapy (must have additional antiviral therapy if HIV-1 positive for coverage of both disease states)

Quantity limits

• 34 tablets per 34 days if patient is not currently using carbamazepine OR
• 68 tablets per 34 days if patient is currently using carbamazepine

Questions?

MHCP Provider Call Center 651-431-2700 or 800-366-5411