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Drug Category: Anti-infectives

Medication Class/Individual Agents: Hepatitis antivirals

I. Prior-Authorization Requirements

 Hepatitis Antiviral Agents – Combination Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

dasabuvir / ombitasvir / paritaprevir / ritonavir extended-release Viekira XR PA  
elbasvir / grazoprevir Zepatier PA  
glecaprevir / pibrentasvir Mavyret PD PA  
ledipasvir / sofosbuvir Harvoni BP PD PA  
ombitasvir / paritaprevir / ritonavir Technivie PA  
ombitasvir / paritaprevir / ritonavir / dasabuvir Viekira Pak PA  
sofosbuvir / velpatasvir Epclusa BP PD PA  
sofosbuvir / velpatasvir / voxilaprevir Vosevi PD PA  

PLEASE SEE SECTION III BELOW FOR PREFERRED HEPATITIS C PRODUCT REFERENCE TABLE

 

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.

 

Please note: For evaluation criteria where medical records and results of diagnostic tests assessing hepatic fibrosis and liver disease stage are required, staging information must clearly demonstrate early stage (e.g., Metavir Score F0-F2) or advanced stage (e.g., Metavir Score F3-F4) disease.  If results are inconclusive, further diagnostic testing may be required.

 

Hepatitis B Virus (HBV) Nucleoside Analog Reverse Transcriptase Inhibitor:

  • Tenofovir alafenamide is a prodrug of tenofovir FDA-approved for the treatment of chronic HBV infection in adults with compensated liver disease. No dosage adjustment is required in patients with mild, moderate, or severe renal impairment.

Hepatitis C Virus (HCV) Combination Products:

  • Ledipasvir/sofosbuvir is a once-daily combination of ledipasvir, an HCV NS5A inhibitor, and sofosbuvir, an HCV NS5B polymerase inhibitor, that is FDA-approved for the treatment of chronic HCV genotype 1, 4, 5, or 6 infection. The FDA-approved treatment duration is eight, 12 or 24 weeks depending on prior treatment history, cirrhosis status, and baseline viral load. Eight weeks of treatment can be considered for treatment-naïve adults with HCV genotype 1 without cirrhosis and baseline HCV viral load <6 million IU/mL.
  • Ombitasvir/paritaprevir/ritonavir/dasabuvir includes fixed-dose ombitasvir, an HCV NS5A inhibitor, paritaprevir, an HCV NS3/4A protease inhibitor and ritonavir, a CYP3A inhibitor co-packaged with dasabuvir, an HCV non-nucleoside NS5B palm polymerase inhibitor. Ombitasvir/paritaprevir/ritonavir/dasabuvir with or without ribavirin is indicated for the treatment of patients with chronic HCV genotype 1 infection including those with compensated cirrhosis. The FDA-approved treatment duration is 12 or 24 weeks depending on prior treatment history and cirrhosis status.
  • Ombitasvir/paritaprevir/ritonavir includes fixed-dose ombitasvir, an HCV NS5A inhibitor, paritaprevir, an HCV NS3/4A protease inhibitor and ritonavir, a CYP3A inhibitor. Ombitasvir/paritaprevir/ritonavir with ribavirin is indicated for the treatment of patients with chronic HCV genotype 4 infection without cirrhosis. Administration without ribavirin may be considered in treatment-naïve patients with contraindication or intolerance to ribavirin. The FDA-approved treatment duration is 12 weeks.
  • Elbasvir/grazoprevir is a once-daily combination of elbasvir, an HCV NS5A inhibitor, and grazoprevir, an HCV NS3/4A protease inhibitor.  Elbasvir/grazoprevir with or without ribavirin is indicated for the treatment of patients with chronic HCV genotypes 1 or 4 infection including those with compensated cirrhosis. The FDA-approved treatment duration is 12 or 16 weeks depending on HCV genotype, prior treatment history, and for patients HCV with genotype 1a infection, the presence of certain NS5A polymorphisms at baseline.
  • Sofosbuvir/velpatasvir is a once-daily combination of sofosbuvir, an HCV NS5B polymerase inhibitor, and velpatasvir, an HCV NS5A inhibitor, that is FDA approved for the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection. The FDA-approved treatment duration is 12 weeks regardless of the presence or absence of cirrhosis. The addition of ribavirin is recommended in patients with decompensated cirrhosis.
  • Glecaprevir/pibrentasvir is a once-daily combination of glecaprevir, an HCV NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor. It is indicated for the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection in adults, including patients with moderate-to-severe renal impairment. It is also approved for adults with HCV genotype 1 who have been previously treated with an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. The recommended treatment duration is eight, 12, or 16 weeks depending on genotype, prior treatment history, and cirrhosis status.
  • Sofosbuvir/velpatasvir/voxilaprevir is a once-daily combination of sofosbuvir, an HCV NS5B polymerase inhibitor, velpatasvir, an HCV NS5A inhibitor, and voxilaprevir, an HCV NS3/4A protease inhibitor. It is indicated for the treatment of chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection in adults who have been previously treated with an HCV regimen containing an NS5A inhibitor. It is also indicated for the treatment of chronic HCV genotype 1a or 3 infection in adults who have been previously treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. The FDA-approved treatment duration is 12 weeks.

 

The following regimens are not recommended by treatment guidelines for routine use in the treatment of chronic hepatitis C.1 Requests for these regimens will be reviewed on a case-by-case basis taking into consideration medical necessity for use over a standard of care regimen (e.g., regimen containing a combination product recommended for routine use).

  • Monotherapy with peginterferon alfa, ribavirin, or a direct-acting antiviral
  • Sovaldi (sofosbuvir) plus peginterferon alfa and ribavirin
  • Sovaldi (sofosbuvir) plus Daklinza (daclatasvir) for HCV genotype 1
  • Sovaldi (sofosbuvir) plus ribavirin for 24 weeks
  • Technivie (ombitasvir/paritaprevir/ritonavir)
  • Viekira (ombitasvir/paritaprevir/ritonavir/dasabuvir)
  • Viekira XR (dasabuvir/ombitasvir/paritaprevir/ritonavir extended-release)

1. AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C.  http://www.hcvguidelines.org. Accessed October 3, 2017.

 

 Hepatitis Antiviral Agents – Miscellaneous Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

adefovir Hepsera # PA   - > 30 units/month
entecavir solution Baraclude PA   - > 600 mL/month 
entecavir tablet Baraclude # PA   - > 30 units/month
interferon alfa-2b Intron A test  
lamivudine 100 mg tablet Epivir HBV # PA   - > 30 units/month 
lamivudine 5 mg/mL solution Epivir HBV PA   - > 600 mL/month
peginterferon alfa-2a Pegasys PA  
peginterferon alfa-2b Pegintron PA  
ribavirin 200 mg capsule Rebetol PA  
ribavirin 400 mg and 600 mg PA  
ribavirin dose pack PA  
ribavirin solution Rebetol PA   - ≥ 19 years
ribavirin tablet Copegus # test  
tenofovir alafenamide Vemlidy PA  
tenofovir disoproxil fumarate powder Viread PA   - ≥ 13 years
tenofovir disoproxil fumarate tablet Viread # PA   - > 30 units/month

 Hepatitis Antiviral Agents – Single Agents

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

daclatasvir Daklinza PA  
sofosbuvir Sovaldi PD PA  
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
PD Preferred Drug. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class.
 

II. Therapeutic Uses

FDA-approved, for example:

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

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

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III.  Evaluation Criteria for Approval

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.
  • Additional criteria may apply, depending upon the member’s condition and requested medication (see below).

  

Preferred Hepatitis C Product Reference Table:

 HCV GT 

Treatment History 

Cirrhosis Status 

 Preferred Regimen(s) 
(listed in alphabetical order)1
 

GT1 

Naïve

Non-cirrhotic

• Epclusa x 12 weeks
• Harvoni x 8 weeks
(if viral load <6 million IU/mL)
• Mavyret x 8 weeks

       GT1 (cont.) 

Naïve

Cirrhotic (CTP A)

• Epclusa x 12 weeks

       GT1 (cont.) 

Experienced (PEG/RBV)

Non-cirrhotic

• Epclusa x 12 weeks
• Mavyret x 8 weeks

       GT1 (cont.) 

Experienced (PEG/RBV)

Cirrhotic (CTP A)

• Epclusa x 12 weeks

       GT1 (cont.) 

Experienced (PI+PEG/RBV)

Non-cirrhotic or cirrhotic (CTP A)

• Epclusa x 12 weeks

       GT1 (cont.) 

Experienced (SOF+PEG/RBV or SOF+RBV)

Non-cirrhotic

• Epclusa x 12 weeks (GT 1b)2
• Mavyret x 8 weeks
• Vosevi x 12 weeks (GT 1a)

       GT1 (cont.) 

Experienced (SOF+PEG/RBV or SOF+RBV)

Cirrhotic (CTP A)

• Epclusa x 12 weeks (GT 1b)2
• Mavyret x 12 weeks (GT 1a)
• Vosevi x 12 weeks (GT 1a)

       GT1 (cont.) 

Experienced (SOF+SMV)

Non-cirrhotic or cirrhotic (CTP A)

• Epclusa x 12 weeks (GT 1b)2
• Mavyret x 12 weeks (GT 1a)
• Vosevi x 12 weeks (GT 1a)

       GT1 (cont.) 

Experienced (NS5A inhibitor)

Non-cirrhotic or cirrhotic (CTP A)

• Mavyret x 16 weeks (no prior PI)
• Vosevi x 12 weeks

GT2 

Naïve or experienced (PEG/RBV)

Non-cirrhotic

• Epclusa x 12 weeks
• Mavyret x 8 weeks

       GT2 (cont.) 

Naïve or experienced (PEG/RBV)

Cirrhotic (CTP A)

• Epclusa x 12 weeks

       GT2 (cont.) 

Experienced (SOF+RBV)

Non-cirrhotic

• Epclusa x 12 weeks2
• Mavyret x 8 weeks

       GT2 (cont.) 

Experienced (SOF+RBV)

Cirrhotic (CTP A)

• Epclusa x 12 weeks2

       GT2 (cont.) 

Experienced (NS5A inhibitor)

Non-cirrhotic or cirrhotic (CTP A)

• Vosevi x 12 weeks

GT3 

Naïve

Non-cirrhotic

• Epclusa x 12 weeks
• Mavyret x 8 weeks

       GT3 (cont.) 

Naïve

Cirrhotic (CTP A)

• Epclusa x 12 weeks (plus RBV2 if Y93H substitution is present)

       GT3 (cont.) 

Experienced (PEG/RBV)

Non-cirrhotic

• Epclusa x 12 weeks (plus RBV2 if Y93H substitution is present)

       GT3 (cont.) 

Experienced (PEG/RBV)

Cirrhotic (CTP A)

• Epclusa +RBV x 12 weeks2

       GT3 (cont.) 

Experienced (SOF+PEG/RBV or SOF+RBV)

Non-cirrhotic or cirrhotic (CTP A)

• Mavyret x 16 weeks 
• Vosevi x 12 weeks

       GT3 (cont.) 

Experienced (NS5A inhibitor)

Non-cirrhotic or cirrhotic (CTP A)

• Vosevi x 12 weeks (plus RBV2if cirrhosis is present)

GT4, 5, or 6 

Naïve or experienced (PEG/RBV)

Non-cirrhotic

• Epclusa x 12 weeks
• Mavyret x 8 weeks

       GT4, 5, or 6 (cont.) 

Naïve or experienced (PEG/RBV)

Cirrhotic (CTP A)

• Epclusa x 12 weeks

       GT4, 5, or 6 (cont.) 

Experienced (SOF+PEG/RBV or SOF+RBV)

Non-cirrhotic

• Mavyret x 8 weeks 
• Vosevi x 12 weeks2

       GT4, 5, or 6 (cont.) 

Experienced (SOF+PEG/RBV or SOF+RBV)

Cirrhotic (CTP A)

• Mavyret x 12 weeks
• Vosevi x 12 weeks2

       GT4, 5, or 6 (cont.) 

Experienced (NS5A inhibitor)

Non-cirrhotic or cirrhotic (CTP A)

• Vosevi x 12 weeks

Unique Populations 

GT 1, 4, 5, or 6, age ≥ 12 and <18 years old 

Naïve or experienced (PEG/RBV)

Non-cirrhotic or cirrhotic (CTP A)

• Harvoni x 12 weeks (24 weeks if GT1, treatment-experienced [PEG/RBV] with cirrhosis [CTP A])

GT 2 or 3, age ≥12 and <18 years old 

Naïve or experienced (PEG/RBV)

Non-cirrhotic or cirrhotic (CTP A)

• Sovaldi+RBV x 12 weeks (GT 2)
• Sovaldi+RBV x 24 weeks (GT 3)

GT1-6, eGFR<30 mL 

DAA-naïve or DAA-experienced

Non-cirrhotic or cirrhotic (CTP A)

• Mavyret x 8, 12, or 16 weeks (based on genotype, presence of cirrhosis, and prior treatment experience)

GT 1-6, 
CTP B or C 

Naïve or experienced (PEG/RBV±PI)

Cirrhotic (CTP B or C)

• Epclusa +RBV x 12 weeks

GT 1-6, 
CTP B or C 

Experienced (SOF or NS5A-based regimen)

Cirrhotic (CTP B or C)

• Epclusa +RBV x 24 weeks2

GT 1, 4, 5, or 6,
liver transplant 

Naïve or experienced (PEG/RBV±PI)

Non-cirrhotic or cirrhotic (CTP A, B, or C)

• Harvoni +RBV x 12 weeks2

GT 2 or 3,
liver transplant 

Naïve or experienced (no prior NS5A inhibitor)

Non-cirrhotic

• Mavyret x 12 weeks2

GT 2 or 3,
liver transplant 

Naïve or experienced (PEG/RBV)

Cirrhotic (CTP A)

• Daklinza+Sovaldi+RBV x 12 weeks2

GT 2 or 3,
liver transplant 

Naïve or experienced (PEG/RBV±PI)

Cirrhotic (CTP B or C)

• Epclusa +RBV x 12 weeks2

GT 1 or 4,
kidney transplant 

Naïve or experienced (PEG/RBV±PI)

Non-cirrhotic or cirrhotic (CTP A)

• Harvoni x 12 weeks2

GT 2, 3, 5, or 6,
kidney transplant 

Naïve or experienced (no prior NS5A inhibitor)

Non-cirrhotic or cirrhotic (CTP A)

• Mavyret x 12 weeks2

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. Prior authorization requests for preferred regimens must meet prior authorization 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 January 5, 2018.

 

adefovir (> 30 units/month), Baraclude solution (> 600 mL/month), entecavir tablets (> 30 units/month), lamivudine solution (> 600 mL/month), and lamivudine 100 mg tablets (> 30 units/month)

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

 

Daklinza

  • Documentation of the following is required for HCV genotype 3 for treatment-naïve members without cirrhosis:
    • diagnosis of chronic hepatitis C; and
    • hepatitis C virus genotype 3; and
    • contraindication to all combination products FDA-approved for the treatment of hepatitis C virus genotype 3 infection; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • requested dose is 60 mg once daily; or
      • medical necessity for requested dose of either 30 mg or 90 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); and
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • requested regimen includes sofosbuvir 400 mg once daily and requested duration is 12 weeks.

 

  • Documentation of the following is required for HCV genotype 3 for treatment-naïve members with compensated cirrhosis:
    • diagnosis of chronic hepatitis C; and
    • hepatitis C virus genotype 3; and
    • contraindication to all combination products FDA-approved for the treatment of hepatitis C virus genotype 3 infection; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • requested dose is 60 mg once daily; or
      • medical necessity for requested dose of either 30 mg or 90 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
    • requested regimen includes sofosbuvir 400 mg once daily and requested duration is 24 weeks; and
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • documentation of initiation of treatment; or
      • for continuation of treatment beyond 12 weeks, documentation of HCV RNA lab values at weeks four and six (if HCV RNA is detectable at week four) supporting continued use; and
    • one of the following:
      • testing results document absence of NS5A Y93H resistance-associated substitution; or
      • testing results document presence of NS5A Y93H resistance-associated substitution and requested regimen includes ribavirin.

 

  • Documentation of the following is required for HCV genotype 3 for treatment-experienced members (failed treatment with peginterferon alfa and ribavirin) without cirrhosis:
    • diagnosis of chronic hepatitis C; and
    • hepatitis C virus genotype 3; and
    • contraindication to all combination products FDA-approved for the treatment of hepatitis C virus genotype 3 infection; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • requested dose is 60 mg once daily; or
      • medical necessity for requested dose of either 30 mg or 90 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); and
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • testing results document absence of NS5A Y93H resistance-associated substitution; or
      • testing results document presence of NS5A Y93H resistance-associated substitution and requested regimen includes ribavirin; and
    • requested regimen includes sofosbuvir 400 mg once daily and requested duration is 12 weeks.

 

  • Documentation of the following is required for HCV genotype 3 for treatment-experienced members (failed treatment with peginterferon alfa and ribavirin) with compensated cirrhosis:
    • diagnosis of chronic hepatitis C; and
    • hepatitis C virus genotype 3; and
    • contraindication to all combination products FDA-approved for the treatment of hepatitis C virus genotype 3 infection; and
    • member is ≥ 18 years of age; and
    • one of the following:
      • requested dose is 60 mg once daily; or
      • medical necessity for requested dose of either 30 mg or 90 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
    • requested regimen includes sofosbuvir 400 mg once daily and ribavirin; and
    • requested duration is 24 weeks; and
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • documentation of initiation of treatment; or
      • for continuation of treatment beyond 12 weeks, documentation of HCV RNA lab values at weeks four and six (if HCV RNA is detectable at week four) supporting continued use.

 

ledipasvir/sofosbuvir

  • Documentation of the following is required for treatment-naïve members without cirrhosis:
    • diagnosis of chronic hepatitis C; and
    • hepatitis C virus genotype 1, 4, 5, or 6; and
    • member is ≥ 12 years of age; and
    • requested dose is 90 mg/400 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); and
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • for genotype 1, member is ≥ 12 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, member is ≥ 18 years old and 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
      • both of the following:
        • for genotypes 4, 5, and 6, requested duration is 12 weeks; and
        • clinical rationale for use instead of sofosbuvir/velpatasvir.

 

  • Documentation of the following is required for treatment-naïve members with compensated cirrhosis or treatment-experienced members (age ≥ 12 and < 18 years and failed treatment with an interferon based regimen with or without ribavirin, or age ≥ 18 years and failed treatment with peginterferon alfa and ribavirin with or without a protease inhibitor) without cirrhosis:
    • diagnosis of chronic 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 ≥ 12 and < 18 years of age; and
    • requested dose is 90 mg/400 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter).

 

  • Documentation of the following is required for treatment-experienced members (age ≥ 12 and < 18 years and failed treatment with an interferon based regimen with or without ribavirin, or age ≥ 18 years and failed treatment with peginterferon alfa and ribavirin with or without a protease inhibitor) with compensated cirrhosis:
    • diagnosis of chronic 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 ≥ 12 and < 18 years of age; and
    • requested dose is 90 mg/400 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • for genotype 1, member is ≥ 12 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; and
    • for genotype 1 only, one of the following:
      • documentation of initiation of treatment; or
      • for continuation of treatment beyond 12 weeks, documentation of HCV RNA lab values at weeks four and six (if HCV RNA is detectable at week four) supporting continued use.

  

Mavyret  

  • Documentation of the following is required for treatment-naïve members with or without compensated cirrhosis:
    • diagnosis of chronic 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 glecaprevir/pibrentasvir 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • absence of cirrhosis and requested duration is eight weeks; or
      • all of the following:
        • compensated cirrhosis and requested duration is 12 weeks; and
        • for members ≥ 18 years of age, clinical rationale for use instead of sofosbuvir/velpatasvir; and
        • for genotype 1, 4, 5, or 6, clinical rationale for use instead of ledipasvir/sofosbuvir.

 

  • Documentation of the following is required for treatment-experienced members (failed treatment with interferon, peginterferon, ribavirin only) with or without compensated cirrhosis:
    • diagnosis of chronic 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 glecaprevir/pibrentasvir 100 mg/40 mg tablets once daily; and
    • for genotype 3, both of the following:
      • requested duration is 16 weeks; and
      • for members ≥ 18 years of age, clinical rationale for use instead of sofosbuvir/velpatasvir; 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • documentation of initiation of treatment; or
      • for continuation of treatment beyond 12 weeks, documentation of HCV RNA lab values at weeks four and six (if HCV RNA is detectable at week four) supporting continued use; and
    • for genotype 1, 2, 4, 5, or 6, one of the following:
      • absence of cirrhosis and requested duration is eight weeks; or
      • all of the following:
        • compensated cirrhosis and requested duration is 12 weeks; and
        • for members ≥ 18 years of age, clinical rationale for use instead of sofosbuvir/velpatasvir; and
        • for genotype 1, 4, 5, or 6, clinical rationale for use instead of ledipasvir/sofosbuvir.

 

  • Documentation of the following is required for treatment-experienced members (failed treatment with sofosbuvir plus simeprevir or a protease inhibitor plus peginterferon alfa and ribavirin only) with or without compensated cirrhosis:
    • diagnosis of chronic hepatitis C; and
    • hepatitis C virus genotype 1; and
    • member is ≥ 12 years of age; and
    • requested dose is three glecaprevir/pibrentasvir 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • requested duration is 12 weeks; and
    • for members ≥ 18 years of age with genotype 1b and failed treatment with sofosbuvir and simeprevir, clinical rationale for use instead of sofosbuvir/velpatasvir; and
    • for members ≥ 18 years of age who previously failed treatment with an HCV protease inhibitor plus peginterferon alfa and ribavirin, clinical rationale for use instead of ledipasvir/sofosbuvir and sofosbuvir/velpatasvir.

 

  • Documentation of the following is required for treatment-experienced members (failed treatment with sofosbuvir plus peginterferon and ribavirin or sofosbuvir plus ribavirin only) with or without compensated cirrhosis:
    • diagnosis of chronic 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 glecaprevir/pibrentasvir 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • documentation of initiation of treatment; or
      • for continuation of treatment beyond 12 weeks, documentation of HCV RNA lab values at weeks four and six (if HCV RNA is detectable at week four) supporting continued use
    • for genotype 1, 2, 4, 5, or 6, one of the following:
      • absence of cirrhosis and requested duration is eight weeks; or
      • both of the following:
        • compensated cirrhosis and requested duration is 12 weeks; and
        • for members ≥ 18 years of age with genotype 1b or 2, clinical rationale for use instead of sofosbuvir/velpatasvir.

 

  • 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 chronic hepatitis C; and
    • hepatitis C virus genotype 1; and
    • member is ≥ 12 years of age; and
    • requested dose is three glecaprevir/pibrentasvir 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • documentation of initiation of treatment; or
      • for continuation of treatment beyond 12 weeks, documentation of HCV RNA lab values at weeks four and six (if HCV RNA is detectable at week four) supporting continued use; and
    • requested duration is 16 weeks.

  

Pegasys for Hepatitis B

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

 

Rebetol solution for members ≥ 19 years of age

  • Documentation of the following is required:
    • diagnosis of chronic hepatitis C; and
    • hepatitis C virus genotype; and
    • medical necessity for the solution formulation.

SmartPA: Claims for Rebetol solution will usually process at the pharmacy without a PA request for members ≥ 19 years of age if the member has a history of paid MassHealth pharmacy claims for at least 90 days in the past 120 days of the respective medication.

 

ribavirin 200 mg capsule

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

  

ribavirin 400 mg, 600 mg tablets and ribavirin dose pack

  • Documentation of the following is required:
    • diagnosis of chronic 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 chronic 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); 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 Y93H resistance-associated substitution; 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 Y93H resistance-associated substitution; or
        • member is treatment-experienced with compensated cirrhosis.

     

Sovaldi  

  • Documentation of the following is required for HCV genotype 3 in treatment-naïve members without cirrhosis:
    • diagnosis of chronic hepatitis C; and
    • hepatitis C virus genotype 3; and
    • member is ≥ 18 years of age; and
    • requested dose is 400 mg once daily; and
    • clinical rationale for use instead of sofosbuvir/velpatasvir; 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
    • requested duration is 12 weeks and requested regimen includes daclatasvir; and
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter).

 

  • Documentation of the following is required for HCV genotype 3 in treatment-naïve members with compensated cirrhosis:
    • diagnosis of chronic hepatitis C; and
    • hepatitis C virus genotype 3; and
    • member is ≥ 18 years of age; and
    • requested dose is 400 mg once daily; and
    • clinical rationale for use instead of sofosbuvir/velpatasvir; 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • documentation of initiation of treatment; or
      • for continuation of treatment beyond 12 weeks, documentation of HCV RNA lab values at weeks four and six (if HCV RNA is detectable at week four) supporting continued use; and
    • one of the following:
      • requested duration is 24 weeks, requested regimen includes daclatasvir, and testing results document absence of NS5A Y93H resistance-associated substitution; or
      • requested duration is 24 weeks, requested regimen includes daclatasvir and ribavirin, and testing results document presence of NS5A Y93H resistance-associated substitution.

 

  • Documentation of the following is required for HCV genotype 3 in treatment-experienced members (failed treatment with peginterferon alfa and ribavirin) without cirrhosis:
    • diagnosis of chronic hepatitis C; and
    • hepatitis C virus genotype 3; and
    • member is ≥ 18 years of age; and
    • requested dose is 400 mg once daily; and
    • clinical rationale for use instead of sofosbuvir/velpatasvir; 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • requested duration is 12 weeks, requested regimen includes daclatasvir, and testing results document absence of NS5A Y93H resistance-associated substitution; or
      • requested duration is 12 weeks, requested regimen includes daclatasvir and ribavirin, and testing results document presence of NS5A Y93H resistance-associated substitution.

 

  • Documentation of the following is required for HCV genotype 3 in treatment-experienced members (failed treatment with peginterferon alfa and ribavirin) with compensated cirrhosis:
    • diagnosis of chronic hepatitis C; and
    • hepatitis C virus genotype 3; and
    • member is ≥ 18 years of age; and
    • requested dose is 400 mg once daily; and
    • clinical rationale for use instead of sofosbuvir/velpatasvir; 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 duration is 24 weeks and requested regimen includes daclatasvir and ribavirin; and
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • documentation of initiation of treatment; or
      • for continuation of treatment beyond 12 weeks, documentation of HCV RNA lab values at weeks four and six (if HCV RNA is detectable at week four) supporting continued use.

 

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 30 units/30 days.

SmartPA: Claims for Vemlidy within the quantity limit of 30 units/30 days 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 chronic 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); 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 chronic 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); 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 chronic 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • documentation of initiation of treatment; or
      • for continuation of treatment beyond 12 weeks, documentation of HCV RNA lab values at weeks four and six (if HCV RNA is detectable at week four) supporting continued use; 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 protease inhibitor plus peginterferon alfa and ribavirin only):
    • diagnosis of chronic 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • documentation of initiation of treatment; or
      • for continuation of treatment beyond 12 weeks, documentation of HCV RNA lab values at weeks four and six (if HCV RNA is detectable at week four) supporting continued use; 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 chronic 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
    • treatment will be discontinued if viral load is detectable at week four of treatment and has increased by greater than 10-fold (> 1 log10 IU/mL) on repeat testing at week six (or thereafter); and
    • one of the following:
      • documentation of initiation of treatment; or
      • for continuation of treatment beyond 12 weeks, documentation of HCV RNA lab values at weeks four and six (if HCV RNA is detectable at week four) supporting continued use; 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, and 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.

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Original Effective Date: 04/2004

Last Revised Date: 07/2019


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Last updated 07/15/19