FDA-approved, for example:

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

Note: The above list may not include all FDA-approved and Non-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.
• Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
• 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

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

Please note, pediatric dosing formulations of Brand name Epclusa and Harvoni are preferred. For all other strengths, generics are preferred.

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
  • medical necsesity 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 of age and requested duration is 12 weeks; or 
    • for genotype 1, member is ≥ 18 years of age 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; and
    • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• 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; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• 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 of age and requested duration is 24 weeks; or 
    • for genotype 1, member is ≥ 18 years of age and requested duration is 12 weeks and requested regimen includes ribavirin; or
    • for genotype 1, member is ≥ 18 years of age 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; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• Documentation of the following is required for treatment-naïve or treatment-experienced members with decompensated cirrhosis (CTP class B or C) :
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1, 4, 5, or 6; and
  • member is ≥  three years of age; and
  • appropriate dosing; and
  • clinical rationale for use instead of sofosbuvir/velpatasvir; and
  • decompensated cirrhosis; and 
  • member is not s/p liver or kidney transplant; 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
  • requested regimen does not have drug-drug interactions with member’s concomitant medications; and
  • one of the following:
    • member is treatment-naïve or treatment-experienced (prior failure of peginterferon and ribavirin with or without an HCV protease inhibitor only) and one of the following:
      • requested regimen includes ribavirin and requested duration is 12 weeks; or
      • requested duration is 24 weeks and contraindication or prior intolerance to ribavirin; or
    • member is treatment-experienced (prior failure of sofosbuvir- or NS5A inhibitor-containing regimen) and both of the following:
      • requested regimen includes ribavirin; and
      • requested duration is 24 weeks.

Mavyret  

• Documentation of the following is required for treatment-naïve members with or without compensated cirrhosis or the following off-label indications: Treatment-naïve members post-liver transplant, post-kidney transplant, or HCV-Negative Organ Recipients from HCV-Positive Donors with or without compensated cirrhosis (CTP class A):
  • member is ≥ three years of age; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications; and
  • for tablets, requested quantity is ≤ three units/day; and
  • for packets of pellets, requested quantity is ≤ five units/day.

• 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 ≥ three 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; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• 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 ≥ three 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; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• 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 ≥ three 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; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• Documentation of the following is required for requests noting prior failure with Mavyret or Vosevi:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1, 2, 3, 4, 5, or 6; and
  • member is ≥ three years of age; and
  • member has previously failed Mavyret or Vosevi; and
  • requested regimen includes glecaprevir/pibrentasvir three 100 mg/40 mg tablets once daily, sofosbuvir 400 mg once daily, and ribavirin; and
  • 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
  • member does not have decompensated cirrhosis; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• Documentation of the following is required for treatment-experienced members (no prior NS5A failure) post-liver transplant with or without compensated cirrhosis (CTP class A):
  • diagnosis of hepatitis C and s/p liver transplant; and
  • hepatitis C virus genotype 1, 2, 3, 4, 5, or 6; and
  • member is ≥ three years of age; and
  • appropriate dosing; and
  • for members with compensated cirrhosis, requested regimen includes ribavirin; and
  • one of the following:
    • for genotype 1, 2, 4, 5, or 6 and requested duration is 12 weeks; or
    • for genotype 3 (prior failure of peginterferon/ribavirin with or without sofosbuvir) and 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
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• Documentation of the following is required for treatment-experienced members (no prior NS5A failure) post-kidney transplant with or without compensated cirrhosis (CTP class A):
  • diagnosis of hepatitis C and s/p kidney transplant; and
  • hepatitis C virus genotype 1, 2, 3, 4, 5, or 6; and
  • member is ≥ three years of age; and
  • appropriate dosing; and
  • requested duration is 12 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
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

SmartPA: Claims for Mavyret tablet at a quantity of ≤ three units/day or Mavyret pellet packet at a quantity of ≤ five units/day will usually pay at the pharmacy without a PA request for members age ≥ three years of age if there are no paid MassHealth pharmacy claims for hepatitis C drug in all claims history, there are no paid MassHealth pharmacy claims for drugs suggestive of decompensated cirrhosis in all claims history, and there is no history of paid MassHealth pharmacy claims within the last 90 days for a drug that may lower DAA efficacy.

Pegasys for chronic hepatitis B

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

ribavirin 200 mg capsule

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

sofosbuvir/velpatasvir

• Documentation of the following is required for treatment-naïve members with or without compensated cirrhosis or the following off-label indications: Treatment-naïve members post-liver transplant, post-kidney transplant, or HCV-Negative Organ Recipients from HCV-Positive Donors with or without compensated cirrhosis (CTP class A):
  • member is ≥ three years of age; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications; and
  • requested quantity is ≤ one unit/day.

• Documentation of the following is required for 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 ≥ three 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; and
  • for members ≥ 18 years of age with genotype 3, one of the following:
    • absence of cirrhosis and one of the following:
      • testing results document absence of NS5A resistance-associated substitution Y93H; or
      • testing results document presence of NS5A resistance-associated substitution Y93H and requested regimen includes ribavirin; or
    • compensated cirrhosis and requested regimen includes ribavirin; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications. 

• Documentation of the following is required for treatment-naïve or treatment-experienced members with decompensated cirrhosis (CTP class B or C) :
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1, 2, 3, 4, 5, or 6; and
  • decompensated cirrhosis (Child Pugh Class B or C); and
  • member is not s/p liver or kidney transplant; and 
  • member is ≥ three 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
  • requested regimen does not have drug-drug interactions with member’s concomitant medications; and
  • one of the following:
    • member is treatment-naïve or treatment-experienced (prior failure of peginterferon and ribavirin with or without an HCV protease inhibitor only) and one of the following:
      • requested regimen includes ribavirin and requested duration is 12 weeks; or
      • requested duration is 24 weeks and contraindication or prior intolerance to ribavirin; or
    • member is treatment-experienced (prior failure of sofosbuvir- or NS5A inhibitor-containing regimen) and both of the following:
      • requested regimen includes ribavirin; and
      • requested duration is 24 weeks.

• Documentation of the following is required for treatment-experienced members post-liver transplant with or without cirrhosis (CTP class A, B or C) :
  • diagnosis of hepatitis C and s/p liver transplant; and
  • hepatitis C virus genotype 1, 2, 3, 4, 5, or 6; and
  • member is ≥ three 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
  • requested regimen does not have drug-drug interactions with member’s concomitant medications; and
  • one of the following:
    • absence of cirrhosis or compensated cirrhosis and requested duration is 12 weeks; or
    • decompensated cirrhosis and both of the following:
      • requested regimen includes ribavirin; and
      • requested duration is 12 weeks (treatment-naïve) or 24 weeks (treatment-experienced).

• Documentation of the following is required for treatment-naïve members or treatment-experienced^† members post-kidney transplant with or without compensated cirrhosis (CTP class A):
  • diagnosis of hepatitis C and s/p liver transplant; and
  • hepatitis C virus genotype 1, 2, 3, 4, 5, or 6; and
  • member is ≥ three years of age; and
  • appropriate dosing; and
  • requested duration is 12 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
  • requested regimen does not have drug-drug interactions with member’s concomitant medications. 

SmartPA: Claims for generic sofosbuvir/velpatasvir, Epclusa 200 mg/50 mg tablet, Epclusa pellet packet, at a quantity of ≤ one unit/day will usually pay at the pharmacy without PA for members age ≥ three years of age if there are no paid MassHealth pharmacy claims for hepatitis C drug in all claims history, there are no paid MassHealth pharmacy claims for drugs suggestive of decompensated cirrhosis in all claims history, and there is no history of paid MassHealth pharmacy claims within the last 90 days for a drug that may lower DAA efficacy.

Sovaldi

• Documentation of the following is required for treatment-naïve members or treatment-experienced members with or without compensated cirrhosis (CTP A):
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 2 or 3; and
  • member is ≥ three years of age; and
  • clinical rationale for use instead of sofosbuvir/velpatasvir and Mavyret; and 
  • appropriate dosing; and
  • requested duration is 12 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
  • one of the following:
    • for genotype 2, requested duration is 12 weeks; or
    • for genotype 3, requested duration is 24 weeks; and
  • requested regimen includes ribavirin; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications. 

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; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• 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
  • 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
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• Documentation of the following is required for requests noting prior failure with Mavyret or Vosevi:
  • diagnosis of hepatitis C; and
  • hepatitis C virus genotype 1, 2, 3, 4, 5, or 6; and
  • member is ≥ 18 years of age; 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 does not have drug-drug interactions with member’s concomitant medications; and 
  • one of the following:
    • both of the following:
      • member has previously failed Mavyret and requested regimen is 400 mg/100 mg/100 mg once daily for 12 week; and
      • for members with compensated cirrhosis, requested regimen includes ribavirin; or
    • both of the following:
      • member has previously failed Vosevi or Mavyret plus Sovaldi and requested regimen is 400 mg/100 mg/100 mg once daily plus ribavirin for 24 weeks; and
      • clinical rationale for use instead of Mavyret plus Sovaldi plus ribavirin.

• Documentation of the following is required for treatment-experienced (failed treatment with sofosbuvir or an HCV NS5A inhibitor) members post-liver transplant with or without compensated cirrhosis:
  • diagnosis of hepatitis C; and
  • one of the following:
    • genotype 1, 2, 3, 4, 5, or 6 and prior treatment failure with an HCV NS5A inhibitor; or
    • both of the following:
      • genotype 1 or 3 and prior treatment failure with sofosbuvir without an HCV NS5A inhibitor; and
      • clinical rationale for use instead of Mavyret; or
    • genotype 4, 5, or 6 and prior treatment failure with sofosbuvir without an HCV NS5A inhibitor; and 
  • member is ≥ 18 years of age; and
  • requested dose is 400 mg/100 mg/100 mg once daily; and
  • for members with compensated cirrhosis, requested regimen includes ribavirin; and
  • requested duration is 12 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
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• Documentation of the following is required for treatment-experienced (failed treatment with sofosbuvir or an HCV NS5A inhibitor) members post-kidney transplant with or without compensated cirrhosis:
  • diagnosis of hepatitis C s/p kidney transplant; and
  • 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
  • for members with compensated cirrhosis, requested regimen includes ribavirin; and
  • requested duration is 12 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
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

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; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• 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; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

• 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; and
  • requested regimen does not have drug-drug interactions with member’s concomitant medications.

^†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.