Approval Criteria:
- Member must be 12 years of age or older or weigh at least 45kg; AND
- An FDA approved diagnosis of Chronic Hepatitis C (CHC) genotype-1, genotype-2, genotype-3, genotype-4, genotype-5, or genotype-6; AND
- Mavyret™ must be prescribed by a gastroenterologist, infectious disease specialist, or transplant specialist or the member must have been evaluated for hepatitis C treatment by a gastroenterologist, infectious disease specialist, or transplant specialist within the last three months; AND
- Hepatitis C Virus (HCV) genotype testing must be confirmed and indicated on prior authorization request; AND
- Member has chronic HCV infection defined by:
- If the member has a liver fibrosis score ≥F1 (METAVIR equivalent) then only one detectable and quantifiable HCV RNA (>15 IU/mL) test within the last 12 months is required; OR
- If the member has a liver fibrosis score <F1 (METAVIR equivalent) then the following must be met:
- Positive (i.e., reactive) HCV antibody test and has a recent (within the last 3 months) detectable and quantifiable HCV RNA (>15 IU/mL); OR
- Two detectable and quantifiable HCV RNA (>15 IU/mL) tests at least six months apart.
- The following regimens and requirements based on cirrhosis status, genotype, and treatment history will apply:
- Treatment-naïve without cirrhosis and genotype-1, -2, -3, -4, -5, or -6:
- Treatment-naïve with compensated cirrhosis (Child-Pugh A) and genotype-1, -2, -3, -4, -5, or -6:
- Treatment-experienced with an NS5A inhibitor without prior treatment with an NS3/4A protease inhibitor (PI) without cirrhosis or with compensated cirrhosis (Child-Pugh A) and genotype-1, -2, -3, -4, -5, or -6:
- Mavyret™ for 16 weeks
- Examples of NS5A inhibitors include: daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir
- Examples of NS3/4A PI include: boceprevir, glecaprevir, grazoprevir, paritaprevir, simeprevir, telaprevir, voxilaprevir
- Treatment-experienced with an NS3/4A PI without prior treatment with an NS5A inhibitor without cirrhosis or with compensated cirrhosis (Child-Pugh A) and genotype-1, -2, -3, -4, -5, or -6:
- Mavyret™ for 12 weeks
- Examples of NS5A inhibitors include: daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir
- Examples of NS3/4A PI include: boceprevir, glecaprevir, grazoprevir, paritaprevir, simeprevir, telaprevir, voxilaprevir
- Treatment-experienced with pegylated interferon, ribavirin, and/or sofosbuvir without prior treatment with an NS3/4A PI or NS5A inhibitor without cirrhosis and genotype-1, -2, -4, -5, or -6:
- Mavyret™ for 8 weeks
- Examples of NS5A inhibitors include: daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir
- Examples of NS3/4A PI include: boceprevir, glecaprevir, grazoprevir, paritaprevir, simeprevir, telaprevir, voxilaprevir
- Treatment-experienced with pegylated interferon, ribavirin, and/or sofosbuvir without prior treatment with an NS3/4A PI or NS5A inhibitor with compensated cirrhosis (Child-Pugh A) and genotype-1, -2, -4, -5, or -6:
- Mavyret™ for 12 weeks
- Examples of NS5A inhibitors include: daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir
- Examples of NS3/4A PI include: boceprevir, glecaprevir, grazoprevir, paritaprevir, simeprevir, telaprevir, voxilaprevir
- Treatment-experienced with pegylated interferon, ribavirin, and/or sofosbuvir without prior treatment with an NS3/4A PI or NS5A inhibitor without cirrhosis or with compensated cirrhosis (Child-Pugh A) and genotype-3:
- Mavyret™ for 16 weeks
- Examples of NS5A inhibitors include: daclatasvir, elbasvir, ledipasvir, ombitasvir, pibrentasvir, velpatasvir
- Examples of NS3/4A PI include: boceprevir, glecaprevir, grazoprevir, paritaprevir, simeprevir, telaprevir, voxilaprevir
- New regimens will apply as approved by the FDA
- Member must sign and submit the Hepatitis C Intent to Treat contract; AND
- Member’s pharmacy must submit the Hepatitis C Therapy Pharmacy Agreement for each member on therapy; AND
- The prescriber must verify that they will provide SoonerCare with all necessary labs to evaluate hepatitis C therapy efficacy including Sustained Virologic Response (SVR-12); AND
- Prescriber must agree to counsel members on potential harms of illicit IV drug use or alcohol use and member must agree to no illicit IV drug use or alcohol use while on treatment and post-therapy; AND
- Must have documentation of initiation of immunization with the hepatitis A and B vaccines; AND
- Member must not have decompensated cirrhosis or moderate or severe hepatic impairment (Child-Pugh B or -C); AND
- Female members must not be pregnant and must have a pregnancy test immediately prior to therapy initiation. Male and female members must be willing to use two forms of non-hormonal birth control while on therapy; AND
- Member must not be taking the following medications: carbamazepine, rifampin, ethinyl estradiol containing medications, St. John’s wort, atazanavir, darunavir, lopinavir, ritonavir, efavirenz, atorvastatin, lovastatin, simvastatin, rosuvastatin doses greater than 10mg, cyclosporine doses greater than 100mg per day; AND
- All other clinically significant issues must be addressed prior to starting therapy including but not limited to the following: neutropenia, anemia, thrombocytopenia, surgery, depression, psychosis, epilepsy, obesity, weight-management, severe concurrent medical diseases, such as but not limited to, retinal disease, or autoimmune thyroid disease.
- Prescribing physician must verify that they will work with the member to ensure the member remains adherent to hepatitis C therapies; AND
- Members must be adherent for continued approval. Treatment gaps of therapy longer than 3 days/month will result in denial of subsequent requests for continued therapy.
- Approvals for treatment regimen initiation for 12 weeks of therapy will not be granted prior to the 10th of a month in order to prevent prescription limit issues from affecting the member’s compliance.
Mavyret Initiation Form
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