FDA-approved, for example:

• Hepatitis B (chronic) – adefovir, entecavir, lamivudine, Pegasys, tenofovir disoproxil fumarate, Vemlidy
• Hepatitis C – ledipasvir/sofosbuvir, Mavyret, ribavirin, sofosbuvir/velpatasvir, Vosevi, Zepatier

Note: The above list may not include all FDA-approved indications.

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

• All PA requests must include clinical diagnosis, drug name, dose, and frequency.
• A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
• For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
• Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

Preferred Hepatitis C Product Reference Table:

CTP=Child Turcotte Pugh, DAA=direct-acting antiviral, eGFR=estimated glomerular filtration rate, GT=genotype, HCV=hepatitis C virus, PEG=peginterferon alfa, PI=protease inhibitor, RBV=ribavirin, SOF=sofosbuvir

¹This Reference Table is intended for use as a reference only and does not guarantee prior authorization approval. PA requests for preferred regimens must meet PA criteria (see below for complete prior authorization criteria).

²Regimen is not FDA-approved in all clinical scenarios. Regimen is supported by the AASLD-IDSA treatment guidelines. Recommendations for testing, managing, and treating hepatitis C.  http://www.hcvguidelines.org. Accessed December 16, 2019.

adefovir (> one unit/day), Baraclude solution (> 20 mL/day), entecavir tablets (> one unit/day), lamivudine solution (> 20 mL/day), and lamivudine 100 mg tablets (> one unit/day)

• Documentation of the following is required:
  • diagnosis of chronic hepatitis B; and
  • clinical rationale for exceeding the quantity limits. 

ledipasvir/sofosbuvir

• Documentation of the following is required for treatment-naïve members without cirrhosis:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1, 4, 5, or 6; and
  • one of the following:
    • for genotype 1, member is ≥  three years of age; or
    • for genotype 4, 5, 6, member is ≥18 years of age and clinical rationale for use instead of sofosbuvir/velpatasvir or member is ≥ three and <18 years of age; and
  • appropriate dosing; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3); and
  • one of the following:
    • for genotype 1, member is ≥ three and < 18 years old and requested duration is 12 weeks; or 
    • for genotype 1, member is ≥ 18 years old and baseline viral load (within the last six months) < 6 million IU/mL and requested duration is eight weeks; or 
    • both of the following:
      • for genotype 1, baseline viral load (within the last six months) ≥ 6 million IU/mL and requested duration is 12 weeks; and
      • clinical rationale for use instead of sofosbuvir/velpatasvir; or
    • for genotypes 4, 5, and 6, requested duration is 12 weeks.

• Documentation of the following is required for treatment-naïve members with compensated cirrhosis or treatment-experienced members (failed treatment with an interferon with or without ribavirin and/or protease inhibitor) without cirrhosis:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1, 4, 5, or 6; and
  • one of the following:
    • member is ≥ 18 years of age and clinical rationale for use instead of sofosbuvir/velpatasvir; or
    • member is ≥  three and < 18 years of age; and
  • appropriate dosing; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3 to F4, documentation of cirrhosis); and
  • requested duration is 12 weeks.

• Documentation of the following is required for treatment-experienced members (failed treatment with an interferon with or without ribavirin and/or protease inhibitor) with compensated cirrhosis:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1, 4, 5, or 6; and
  • one of the following:
    • member is ≥ 18 years of age and clinical rationale for use instead of sofosbuvir/velpatasvir; or
    • member is ≥  three and < 18 years of age; and
  • appropriate dosing; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • one of the following:
    • for genotype 1, member is ≥  three and < 18 years old and requested duration is 24 weeks; or 
    • for genotype 1, member is ≥ 18 years old and requested duration is 12 weeks and requested regimen includes ribavirin; or
    • for genotype 1, member is ≥ 18 years old and requested duration is 24 weeks and prescriber provides clinical rationale for use of 24-week treatment with ledipasvir/sofosbuvir instead of 12-week treatment with ledipasvir/sofosbuvir and ribavirin; or
    • for genotype 4, 5, and 6, requested duration is 12 weeks.

Mavyret  

• Documentation of the following is required for treatment-naïve members with or without compensated cirrhosis:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1, 2, 3, 4, 5, or 6; and
  • member is ≥ 12 years of age; and
  • requested dose is three 100 mg/40 mg tablets once daily; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3 to F4, documentation of cirrhosis); and
  • requested duration is eight weeks.

• Documentation of the following is required for treatment-experienced members (failed treatment with interferon, peginterferon, ribavirin only; sofosbuvir plus peginterferon and ribavirin only; or sofosbuvir plus ribavirin only) with or without compensated cirrhosis:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1, 2, 3, 4, 5, or 6; and
  • member is ≥ 12 years of age; and
  • requested dose is three 100 mg/40 mg tablets once daily; and
  • for genotype 3, requested duration is 16 weeks; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3 to F4, documentation of cirrhosis); and
  • for genotype 1, 2, 4, 5, or 6, one of the following:
    • absence of cirrhosis and requested duration is eight weeks; or 
    • compensated cirrhosis and requested duration is 12 weeks.

• Documentation of the following is required for treatment-experienced members (failed treatment with sofosbuvir plus simeprevir or a HCV protease inhibitor plus peginterferon alfa and ribavirin only) with or without compensated cirrhosis:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1; and
  • member is ≥ 12 years of age; and
  • requested dose is three 100 mg/40 mg tablets once daily; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3 to F4, documentation of cirrhosis); and
  • requested duration is 12 weeks.

• Documentation of the following is required for treatment-experienced members (failed treatment with an HCV NS5A inhibitor without an HCV protease inhibitor) with or without compensated cirrhosis:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1; and
  • member is ≥ 12 years of age; and
  • requested dose is three 100 mg/40 mg tablets once daily; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3 to F4, documentation of cirrhosis); and
  • requested duration is 16 weeks.

Pegasys for Hepatitis B

• Documentation of the following is required:
  • diagnosis of hepatitis B.

ribavirin 200 mg capsule

• Documentation of the following is required:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype; and
  • clinical rationale for requested capsule formulation instead of the 200 mg tablets.

ribavirin 600 mg tablets and ribavirin dose pack

• Documentation of the following is required:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype; and
  • clinical rationale for requested formulation instead of the 200 mg tablets.

sofosbuvir/velpatasvir

• Documentation of the following is required for treatment-naïve or treatment-experienced members (failed treatment with peginterferon alfa and ribavirin, with or without protease inhibitor) with or without compensated cirrhosis:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1, 2, 3, 4, 5, or 6; and
  • member is ≥ 18 years of age; and
  • requested dose is 400 mg/100 mg once daily; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3 to F4, documentation of cirrhosis); and
  • requested duration is 12 weeks; and
  • for genotype 3, one of the following:
    • member is treatment-naïve without cirrhosis; or
    • member is treatment-naïve with compensated cirrhosis or treatment-experienced without cirrhosis and testing results document absence of NS5A resistance-associated substitution Y93H; or
    • requested regimen includes ribavirin and one of the following:
      • member is treatment-naïve with compensated cirrhosis or treatment-experienced without cirrhosis and testing results document presence of NS5A resistance-associated substitution Y93H; or
      • member is treatment-experienced with compensated cirrhosis.

Vemlidy 

• Documentation of the following is required:
  • diagnosis of chronic hepatitis B; and
  • member is ≥ 18 years of age; and
  • one of the following:
    • for members not previously treated with a nucleoside analog, clinical rationale for use instead of entecavir; or
    • history of prior treatment with a nucleoside analog (i.e., member is treatment-experienced); and
  • request is within quantity limit of one unit/day.

SmartPA: Claims for Vemlidy within the quantity limit of one unit/day will usually process at the pharmacy without a PA request for members ≥ 18 years of age if the member has a history of MassHealth medical claims for chronic hepatitis B, and a history of paid MassHealth pharmacy claims for a nucleoside analog.^†

Vosevi

• Documentation of the following is required for treatment-experienced members (failed treatment with an HCV NS5A inhibitor) with or without compensated cirrhosis:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1, 2, 3, 4, 5, or 6; and
  • member is ≥ 18 years of age; and
  • requested dose is 400 mg/100 mg/100 mg once daily; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3 to F4, documentation of cirrhosis); and
  • requested duration is 12 weeks; and
  • for genotype 3 and compensated cirrhosis, requested regimen includes ribavirin.

• Documentation of the following is required for treatment-experienced members (failed treatment with sofosbuvir without an HCV NS5A inhibitor) with or without compensated cirrhosis:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1a or 3; and
  • clinical rationale for use instead of Mavyret; and
  • member is ≥ 18 years of age; and
  • requested dose is 400 mg/100 mg/100 mg once daily; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3 to F4, documentation of cirrhosis); and
  • requested duration is 12 weeks. 

Zepatier

• Documentation of the following is required for HCV genotype 1 in treatment-naïve members or treatment-experienced members (failed treatment with peginterferon alfa and ribavirin only):
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1; and
  • contraindication to all combination products FDA-approved for the treatment of hepatitis C virus genotype 1 infection; and
  • member is ≥ 18 years of age; and
  • requested dose is 50 mg/100 mg once daily; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3 to F4, documentation of cirrhosis); and
  • member does not have decompensated cirrhosis; and
  • one of the following:
    • for genotype 1a, testing results document absence of NS5A resistance-associated substitutions at amino acid positions 28, 30, 31, and 93, and requested duration is 12 weeks; or 
    • for genotype 1a, testing results document presence of NS5A resistance-associated substitutions at amino acid positions 28, 30, 31, or 93, and requested regimen includes ribavirin and requested duration is 16 weeks; or 
    • for genotype 1b, requested duration is 12 weeks.

• Documentation of the following is required for HCV genotype 1 in treatment-experienced members (failed treatment with a HCV protease inhibitor plus peginterferon alfa and ribavirin only):
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1; and
  • contraindication to all combination products FDA-approved for the treatment of hepatitis C virus genotype 1 infection; and
  • member is ≥ 18 years of age; and
  • requested dose is 50 mg/100 mg once daily; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3 to F4, documentation of cirrhosis); and
  • member does not have decompensated cirrhosis; and
  • requested regimen includes ribavirin; and
  • one of the following:
    • for genotype 1a, testing results document absence of NS5A resistance-associated substitutions at amino acid positions 28, 30, 31, and 93, and requested duration is 12 weeks; or 
    • for genotype 1a, testing results document presence of NS5A resistance-associated substitutions at amino acid positions 28, 30, 31, or 93, and requested duration is 16 weeks; or 
    • for genotype 1b, requested duration is 12 weeks.

• Documentation of the following is required for HCV genotype 4 in treatment-naïve or treatment-experienced members (failed treatment with peginterferon alfa and ribavirin only):
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 4; and
  • contraindication to all combination products FDA-approved for the treatment of hepatitis C virus genotype 4 infection; and
  • member is ≥ 18 years of age; and
  • requested dose is 50 mg/100 mg once daily; and
  • medical records and results of diagnostic tests assessing hepatic fibrosis including tests supporting liver disease staging (e.g., APRI, Fibroscan, Fibrosure, FIB-4); and
  • stage of liver disease is early stage (e.g., Metavir Score F0 to F2), or advanced stage (e.g., Metavir Score F3 to F4, documentation of cirrhosis); and
  • member does not have decompensated cirrhosis; and
  • one of the following:
    • member is treatment-naïve, and requested duration is 12 weeks; or 
    • member has a history of relapse to prior peginterferon alfa and ribavirin treatment, and requested duration is 12 weeks; or 
    • member has a history of on-treatment virologic failure (failure to suppress or breakthrough) while on peginterferon alfa and ribavirin treatment, requested regimen includes ribavirin, and requested duration is 16 weeks.

^†Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.