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    Hepatitis C

    Drugs - Epclusa, Harvoni, lepidasvir-sofosbuvir, Mavyret, Sovaldi, sofusbuvir-valpatasvir, Viekira Pak, Vosevi, Zepatier

    January 2021
    Effective date for Fee-for-Service and all Managed Care Medical Assistance Plans: January 1, 2021

    Therapeutic area - Hepatitis C Direct-Acting Antivirals

    Criteria

    • All drugs used to treat Hepatitis C infections require prior authorization.
    • Hepatitis C drug authorization criteria will vary by patient’s genotype.
    • Preferred drugs require patients to meet preferred drug authorization criteria before payment.
    • Nonpreferred drugs require patients to meet nonpreferred drug authorization criteria before payment.
    • A tiered approach is used for genotypes where there are multiple nonpreferred treatment options.
    • Certain requested regimen with no FDA-approved treatment duration will be evaluated on a case-by-case basis. All other requested regimens must meet treatment duration described in the FDA-approved label.
    • Prior authorization requests for patients with mixed genotypes will be evaluated on a case-by-case basis.
    • Providers should fax the completed Hepatitis C Drug Prior Authorization Form (DHS-7085) to the MHCP Prescription Drug Prior Authorization Agent.

    Exclusion Criteria (applies to all drugs and genotypes)

    • Clinically significant drug interactions with patient’s existing medications that cannot be mitigated
    • Pregnancy
    • Severe end organ disease and not eligible for transplant (e.g. liver, heart, lung, kidney)
    • Clinically-significant illness or any other major medical disorder that may interfere with patients’ abilities to complete a course of treatment
    • Patients who, in the professional judgment of the primary treating clinician, would not achieve a long term clinical benefit from HCV treatment (e.g. patients with multisystem organ failure; receiving palliative care or in hospice; significant pulmonary or cardiac disease; and malignancy outside of the liver not meeting oncologic criteria for cure)
    • Decompensated liver disease with CPT > 12 or MELD > 20
    • MELD ≤ 20 and one of the following:
      • Cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery
      • Malignancy outside the liver not meeting oncologic criteria for cure
      • Hepatocellular carcinoma
      • Intrahepatic cholangiocarcinoma
      • Hemangiosarcoma
    • Contraindication to requested drug or drug combination
    • Requested duration of therapy is longer or shorter than therapy duration listed in FDA-approved label of requested drug
    • Indeterminate HCV genotype

    Continuity of Care (applies to all drugs and genotypes)

    At the time of treatment initiation, patient must have evidence of Minnesota Health Care Programs (MHCP) insurance coverage for the duration of treatment.

    Table 1: MHCP Preferred Drug List - Hepatitis C Direct-Acting Antivirals; all require prior authorization

    Genotype 1 Treatment-Naïve Patients

    Preferred Nonpreferred
    Mavyret Zepatier 
    Sofosbuvir-velpatasvir
    Epclusa
    Lepidasvir-sofosbuvir
    Harvoni tablet
    Harvoni pellet
    Sovaldi tablet
    Sovaldi pellet
    Viekira Pak

    Genotype 1 Treatment-Experienced Patients

    Preferred Nonpreferred
    Mavyret
    Vosevi    		 None

    Genotype 2 Treatment-Naïve Patients

    Preferred Nonpreferred
    Mavyret Sofosbuvir-velpatasvir
    Epclusa
    Sovaldi tablet
    Sovaldi pellet

    Genotype 2 Treatment-Experienced Patients

    Preferred Nonpreferred
    Mavyret 
    Vosevi    		  None

    Genotype 3 Treatment-Naïve Patients

    Preferred Nonpreferred
    Mavyret Sofosbuvir-velpatasvir
    Epclusa
    Sovaldi tablet
    Sovaldi pellet

    Genotype 3 Treatment-Experienced Patients

    Preferred Nonpreferred
    Mavyret
    Vosevi    		 None

    Genotype 4 Treatment-Naïve Patients

    Preferred  Nonpreferred
    Mavyret Zepatier
    Sofosbuvir-velpatasvir
    Epclusa 
    Lepidasvir-sofosbuvir
    Harvoni tablet
    Harvoni pellet
    Sovaldi tablet
    Sovaldi pellet

    Genotype 4 Treatment-Experienced Patients

    Preferred Nonpreferred
    Mavyret
    Vosevi    		 None

     Genotype 5 or 6 Treatment-Naïve Patients

    Preferred Nonpreferred
    Mavyret Sofosbuvir-velpatasvir
    Epclusa 
    Lepidasvir-sofosbuvir
    Harvoni tablet
    Harvoni pellet

    Genotype 5 or 6 Treatment-Experienced Patients

    Preferred Nonpreferred
    Mavyret
    Vosevi    		 None

    Criteria for Genotype 1 – all drugs require prior authorization

    Hepatitis C Genotype 1: Sofosbuvir-velpatasvir, Epclusa, Harvoni, lepidasvir-sofosbuvir, Mavyret, Sovaldi, Vosevi, Zepatier

    Treatment-Naïve Patients

    Preferred Nonpreferred
    Mavyret Zepatier
    Sofosbuvir-velpatasvir
    Epclusa
    Lepidasvir-sofosbuvir
    Harvoni tablet
    Harvoni pellet
    Sovaldi tablet
    Sovaldi pellet
    Viekira Pak

    Treatment-Experienced Patients

    Preferred Nonpreferred
    Mavyret
    Vosevi    		 None

    Preferred Drug Prior Authorization Criteria for Treatment-Naïve Patients, Genotype 1

    Prescriber Requirements

    Criteria 1: The regimen may be prescribed by a primary care provider, a gastroenterologist, hepatologist, or infectious disease specialist

    OR

    If the patient has any ONE of the following, the regimen must be prescribed by a gastroenterologist, hepatologist, infectious disease specialist, or a nurse practitioner or physician assistant working with a gastroenterologist, hepatologist, or infectious disease specialist:

    • Patient is treatment-experienced OR
    • Patient has Hepatitis B and/or HIV co-infection OR
    • Patient has undergone liver transplantation OR
    • Patient has liver cancer OR
    • Patient has severe liver disease defined as:
      • APRI > 1.5 OR
      • FibroSURE > 0.49 OR
      • Fibroscan > 9.5 kPa OR
      • FIB-4 > 3.25 OR
      • MR Elastography > 6 kPa OR
      • Fibrospect > 42 OR
      • Liver Biopsy > F3 AND

    Criteria 2: If the patient has a substance use disorder or IV drug use, the patient must:

    • Be enrolled in a substance use disorder treatment program and provider’s attestation of enrollment is provided at time of request OR
    • Be counseled about measures to reduce the risk of HCV transmission to others; and evidence of counseling is provided at time of request AND
    • Be offered at least TWO of the following harm reduction services, as described in AASLD/IDSA HCV guidelines:
      • Condom distribution (e.g. written prescription for condoms, clinic receipt of condom purchase for distribution within the past 12 months, etc.)
      • Access to sterile syringes (e.g. written prescription for needles and syringes, copy of educational materials on syringe access and disposal provided to the patient, etc.)
      • Naloxone training and distribution (e.g. written prescription for naloxone, copy of current naloxone training protocol etc.)
      • Medication-assisted treatment options (e.g. provider’s attestation of methadone program enrollment, prescription for buprenorphine substantiated by pharmacy claims data.) OR
    • Not be candidate for ANY of the harm reduction services above; and provider provides the reason the patient is not a candidate for each of the harm reduction services above

    Criteria 3: The treating clinician must provide documentation to attest the patient is screened for evidence of current or prior hepatitis B virus (HBV) infection before starting treatment with direct-acting antivirals. The treating clinician must also have a monitoring plan in place for HBV flare-ups or reactivation during treatment and post-treatment follow up AND

    • Where indicated, the treating clinician must provide documentation that the patient has been counseled on the HBV reactivation adverse events management plan AND the risk of HBV reactivation including serious liver injury and death AND

    Criteria 4: Clinical documentation of patient’s liver cirrhosis status (e.g. no cirrhosis, compensated cirrhosis, etc.) that corresponds to the requested therapy duration AND

    Criteria 5: Pretreatment detectable HCV RNA viral load value, measured within 1 year of treatment start date, is provided at time of request AND

    Criteria 6: Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request AND

    Criteria 7: Patient is 12 years of age or older OR weighs at least 45 kg with a diagnosis of hepatitis C, genotype 1

    Nonpreferred Drug Prior Authorization Criteria for Treatment-Naïve Patients, Genotype 1

    For patients between the age of 3 and 11 requesting Harvoni tablet/pellet or lepidasvir-sofosbuvir:

    • Patient is NOT a candidate for Mavyret AND
    • Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND
    • Patient has a diagnosis of hepatitis C, genotype 1 AND
    • Patient is between the age of 3 and 11 AND
    • Patient meets the drug specific criteria in Table 2, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 1 OR

    For patients between the age of 6 and 11 requesting Epclusa tablet or velpatasvir-sofosbuvir:

    • Patient is NOT a candidate for Mavyret AND
    • Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND
    • Patient has a diagnosis of hepatitis C, genotype 1 AND
    • Patient meets either of the following:
      • Age 6 through 11 OR
      • Weighs at least 17 kg
    • Patient meets the drug specific criteria in Table 2, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 1

    Table 2. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 1

    Tier Nonpreferred Drug PA Criteria Genotype 1, age < 12
    1 Sofosbuvir-velpatasvir Must meet all PA criteria for nonpreferred drugs above.
    2 Epclusa Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 cannot be used. 
    3 Lepidasvir-sofosbuvir Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 or 2 cannot be used.
    4 Harvoni tablet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, or 3 cannot be used.
    5 Harvoni pellet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, or 3 cannot be used.

     For patients over the age of 12:

    Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND

    Patient meets the drug specific criteria in Table 3, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Over the Age of 12, Genotype 1 AND

    Patient has HCV infection with at least ONE of the four conditions listed below:

    • Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 7-12 and MELD is ≤20.
    • Abdominal imaging where radiologist determines findings are suggestive of cirrhosis (e.g. nodules; enlarged liver, especially in the left lobe; tortuous hepatic arteries; ascites; portal hypertension)
    • Evidence of one or more noninvasive tests indicating a fibrosis score of ≥ F3, such as:
      • APRI (AST to platelet ratio index) ≥ 1.5
      • FibroSURE ≥ 0.49
      • FibroScan ≥ 9.5
      • Fibrosis-4 index (FIB-4) > 3.25
      • MR Elastography ≥ 6 kPa
      • Fibrospect ≥ 42
    • HCV infections with one of the following:
      • Post solid organ transplant (e.g. heart; kidney; liver)
      • Awaiting liver transplant
      • Stage I-III hepatocellular carcinoma meeting Milan criteria
      • HCV infection post liver transplant
      • Severe complications of HCV as defined below:
        • Type 2 or Type 3 essential mixed cryoglobulinemia with end organ manifestations
        • HCV-induced renal disease (e.g. nephrotic syndrome or mebranoproliferative glomerulonephritis (MPGN)

    Table 3. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Over the Age of 12, Genotype 1

    Tier Nonpreferred Drug PA Criteria Genotype 1, age > 12
    1 Zepatier Must meet all PA criteria for nonpreferred drugs above.
    2 Sofosbuvir-velpatasvir Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 cannot be used.
    3 Epclusa Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 or 2 cannot be used.
    4 Lepidasvir-sofosbuvir Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2 or 3 cannot be used.
    5 Harvoni tablet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, 3 or 4 cannot be used.
    6 Harvoni pellet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, 3, 4, or 5 cannot be used.
    7 Sovaldi tablet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, 3, 4, 5 or 6 cannot be used.
    8 Viekira Pak Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, 3, 4, 5, 6 or 7 cannot be used.

    Preferred Drug Prior Authorization Criteria for Treatment-Experienced Patients, Genotype 1

    Prescriber Requirements

    Criteria 1: If the patient has any ONE of the following, the regimen must be prescribed by a gastroenterologist, hepatologist, infectious disease specialist, or a nurse practitioner or physician assistant working with a gastroenterologist, hepatologist, or infectious disease specialist:

    • Patient is treatment-experienced OR
    • Patient has Hepatitis B and/or HIV co-infection OR
    • Patient has undergone liver transplantation OR
    • Patient has liver cancer OR
    • Patient has severe liver disease defined as:
      • APRI > 1.5 OR
      • FibroSURE > 0.49 OR
      • Fibroscan > 9.5 kPa OR
      • FIB-4 > 3.25 OR
      • MR Elastography > 6 kPa OR
      • Fibrospect > 42 OR
      • Liver Biopsy > F3 AND

    Criteria 2: If the patient has a substance use disorder or IV drug use, the patient must:

    • Be enrolled in a substance use disorder treatment program and provider’s attestation of enrollment is provided at time of request OR
    • Be counseled about measures to reduce the risk of HCV transmission to others; and evidence of counseling is provided at time of request AND
    • Be offered at least TWO of the following harm reduction services, as described in AASLD/IDSA HCV guidelines:
      • Condom distribution (e.g. written prescription for condoms, clinic receipt of condom purchase for distribution within the past 12 months, etc.)
      • Access to sterile syringes (e.g. written prescription for needles and syringes, copy of educational materials on syringe access and disposal provided to the patient, etc.)
      • Naloxone training and distribution (e.g. written prescription for naloxone, copy of current naloxone training protocol etc.)
      • Medication-assisted treatment options (e.g. provider’s attestation of methadone program enrollment, prescription for buprenorphine substantiated by pharmacy claims data.) OR
    • Not be candidate for ANY of the harm reduction services above; and provider provides the reason the patient is not a candidate for each of the harm reduction services above

    Criteria 3: The treating clinician must provide documentation to attest that the patient is screened for evidence of current or prior hepatitis B virus (HBV) infection before starting treatment with direct-acting antivirals AND the provider has a monitoring plan for HBV flare-ups or reactivation during treatment and post-treatment follow-up AND

    • Where indicated, the treating clinician must provide documentation that the patient has been counseled on the HBV reactivation adverse events management plan AND the risk of HBV reactivation including serious liver injury and death AND

    Criteria 4: Clinical documentation of patient’s liver cirrhosis status (e.g. no cirrhosis, compensated cirrhosis, etc.) that corresponds to the requested therapy duration AND

    Criteria 5: Clinical documentation of patient’s prior treatment including drug name and date(s) of therapy AND

    Criteria 6: Pretreatment detectable HCV RNA viral load value, measured within 1 year of treatment start date, is provided at time of request AND

    Criteria 7: Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request AND

    Criteria 8: Patient is 12 years of age or older OR weighs at least 45 kg with a diagnosis of hepatitis C, genotype 1 if requesting Mavyret OR

    Criteria 9: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 1 if requesting Vosevi

    Criteria for Genotype 2 – all drugs require prior authorization

    Hepatitis C Genotype 2: Sofosbuvir-velpatasvir, Epclusa, Mavyret, Sovaldi, Vosevi

    Treatment-Naïve Patients

    Preferred  Nonpreferred
    Mavyret Sofosbuvir-velpatasvir
    Epclusa
    Sovaldi tablet
    Sovaldi pellet

    Treatment-Experienced Patients

    Preferred Nonpreferred
    Mavyret 
    Vosevi    		 None

    Preferred Drug Prior Authorization Criteria for Treatment-Naïve Patients, Genotype 2

    Prescriber Requirements

    Criteria 1: The regimen may be prescribed by a primary care provider, a gastroenterologist, hepatologist, or infectious disease specialist

    OR

    If the patient has any ONE of the following, the regimen must be prescribed by a gastroenterologist, hepatologist, infectious disease specialist, or a nurse practitioner or physician assistant working with a gastroenterologist, hepatologist, or infectious disease specialist:

    • Patient is treatment-experienced OR
    • Patient has Hepatitis B and/or HIV co-infection OR
    • Patient has undergone liver transplantation OR
    • Patient has liver cancer OR
    • Patient has severe liver disease defined as:
      • APRI > 1.5 OR
      • FibroSURE > 0.49 OR
      • Fibroscan > 9.5 kPa OR
      • FIB-4 > 3.25 OR
      • MR Elastography > 6 kPa OR
      • Fibrospect > 42 OR
      • Liver Biopsy > F3 AND

    Criteria 2: If the patient has a substance use disorder or IV drug use, the patient must:

    • Be enrolled in a substance use disorder treatment program and provider’s attestation of enrollment is provided at time of request OR
    • Be counseled about measures to reduce the risk of HCV transmission to others; and evidence of counseling is provided at time of request AND
    • Be offered at least TWO of the following harm reduction services, as described in AASLD/IDSA HCV guidelines:
      • Condom distribution (e.g. written prescription for condoms, clinic receipt of condom purchase for distribution within the past 12 months, etc.)
      • Access to sterile syringes (e.g. written prescription for needles and syringes, copy of educational materials on syringe access and disposal provided to the patient, etc.)
      • Naloxone training and distribution (e.g. written prescription for naloxone, copy of current naloxone training protocol etc.)
      • Medication-assisted treatment options (e.g. provider’s attestation of methadone program enrollment, prescription for buprenorphine substantiated by pharmacy claims data.) OR
    • Not be candidate for ANY of the harm reduction services above; and provider provides the reason the patient is not a candidate for each of the harm reduction services above

    Criteria 3: The treating clinician must provide documentation to attest the patient is screened for evidence of current or prior hepatitis B virus (HBV) infection before starting treatment with direct-acting antivirals. The treating clinician must also have a monitoring plan in place for HBV flare-ups or reactivation during treatment and post-treatment follow up AND

    • Where indicated, the treating clinician must provide documentation that the patient has been counseled on the HBV reactivation adverse events management plan AND the risk of HBV reactivation including serious liver injury and death AND

    Criteria 4: Clinical documentation of patient’s liver cirrhosis status (e.g. no cirrhosis, compensated cirrhosis, etc.) that corresponds to the requested therapy duration AND

    Criteria 5: Pretreatment detectable HCV RNA viral load value, measured within 1 year of treatment start date, is provided at time of request AND

    Criteria 6: Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request AND

    Criteria 7: Patient is 12 years of age or older OR weighs at least 45 kg with a diagnosis of hepatitis C, genotype 2

    Nonpreferred Drug Prior Authorization Criteria for Treatment-Naïve Patients, Genotype 2

    For patients between the age of 3 and 11 requesting Sovaldi tablet/pellet:

    • Patient is NOT a candidate for Mavyret AND
    • Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND
    • Patient has a diagnosis of hepatitis C, genotype 2 AND
    • Patient is between the age of 3 and 11 AND
    • Patient meets the drug specific criteria in Table 4, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 2 OR

    For patients between the age of 6 and 11 requesting Epclusa tablet/pellet or velpatasvir-sofosbuvir:

    • Patient is NOT a candidate for Mavyret AND
    • Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND
    • Patient has a diagnosis of hepatitis C, genotype 2 AND
    • Patient meets either of the following:
      • o Age 6 through 11 OR
      • o Weighs at least 17 kg
    • Patient meets the drug specific criteria in Table 4, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 2

    Table 4. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 2

    Tier Nonpreferred Drug PA Criteria Genotype 2, age < 12
    1 Sofosbuvir-velpatasvir Must meet all PA criteria for nonpreferred drugs above.
    2 Epclusa Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 cannot be used.
    3 Sovaldi tablet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 or 2 cannot be used.
    4 Sovaldi pellet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 or 2 cannot be used.

    For patients over the age of 12:

    Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND

    Patient meets the drug specific criteria in Table 5, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Over the Age of 12, Genotype 2 AND

    Patient has HCV infection with at least ONE of the four conditions listed below:

    • Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 7-12 and MELD is ≤20
    • Abdominal imaging where radiologist determines findings are suggestive of cirrhosis (e.g. nodules; enlarged liver, especially in the left lobe; tortuous hepatic arteries; ascites; portal hypertension)
    • Evidence of one or more noninvasive tests indicating a fibrosis score of ≥ F3, such as:
      • APRI (AST to platelet ratio index) ≥ 1.5
      • FibroSURE ≥ 0.49
      • FibroScan ≥ 9.5
      • Fibrosis-4 index (FIB-4) > 3.25
      • MR Elastography ≥ 6 kPa
      • Fibrospect ≥ 42
      HCV infections with one of the following:
      • Post solid organ transplant (e.g. heart; kidney; liver)
      • Awaiting liver transplant
      • Stage I-III hepatocellular carcinoma meeting Milan criteria
      • HCV infection post liver transplant
      • Severe complications of HCV as defined below:
        • Type 2 or Type 3 essential mixed cryoglobulinemia with end organ manifestations
        • HCV-induced renal disease (e.g. nephrotic syndrome or mebranoproliferative glomerulonephritis (MPGN)

    Table 5. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Over the Age of 12, Genotype 2

    Tier Nonpreferred Drug PA Criteria Genotype 2, age > 12
    1 Sofosbuvir-velpatasvir Must meet all PA criteria for nonpreferred drugs above.
    2 Epclusa Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 cannot be used.
    3 Sovaldi tablet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 or 2 cannot be used.
    4 Sovaldi pellet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, or 3 cannot be used.

    Preferred Drug Prior Authorization Criteria for Treatment-Experienced Patients, Genotype 2

    Prescriber Requirements

    Criteria 1: If the patient has any ONE of the following, the regimen must be prescribed by a gastroenterologist, hepatologist, infectious disease specialist, or a nurse practitioner or physician assistant working with a gastroenterologist, hepatologist, or infectious disease specialist:

    • Patient is treatment-experienced OR
    • Patient has Hepatitis B and/or HIV co-infection OR
    • Patient has undergone liver transplantation OR
    • Patient has liver cancer OR
    • Patient has severe liver disease defined as:
      • APRI > 1.5 OR
      • FibroSURE > 0.49 OR
      • Fibroscan > 9.5 kPa OR
      • FIB-4 > 3.25 OR
      • MR Elastography > 6 kPa OR
      • Fibrospect > 42 OR
      • Liver Biopsy > F3 AND

    Criteria 2: If the patient has a substance use disorder or IV drug use, the patient must:

    • Be enrolled in a substance use disorder treatment program and provider’s attestation of enrollment is provided at time of request OR
    • Be counseled about measures to reduce the risk of HCV transmission to others; and evidence of counseling is provided at time of request AND
    • Be offered at least TWO of the following harm reduction services, as described in AASLD/IDSA HCV guidelines:
      • Condom distribution (e.g. written prescription for condoms, clinic receipt of condom purchase for distribution within the past 12 months, etc.)
      • Access to sterile syringes (e.g. written prescription for needles and syringes, copy of educational materials on syringe access and disposal provided to the patient, etc.)
      • Naloxone training and distribution (e.g. written prescription for naloxone, copy of current naloxone training protocol etc.)
      • Medication-assisted treatment options (e.g. provider’s attestation of methadone program enrollment, prescription for buprenorphine substantiated by pharmacy claims data.) OR
    • Not be candidate for ANY of the harm reduction services above; and provider provides the reason the patient is not a candidate for each of the harm reduction services above

    Criteria 3: The treating clinician must provide documentation to attest that the patient is screened for evidence of current or prior hepatitis B virus (HBV) infection before starting treatment with direct-acting antivirals AND the provider has a monitoring plan for HBV flare-ups or reactivation during treatment and post-treatment follow-up AND

    • Where indicated, the treating clinician must provide documentation that the patient has been counseled on the HBV reactivation adverse events management plan AND the risk of HBV reactivation including serious liver injury and death AND

    Criteria 4: Clinical documentation of patient’s liver cirrhosis status (e.g. no cirrhosis, compensated cirrhosis, etc.) that corresponds to the requested therapy duration AND

    Criteria 5: Clinical documentation of patient’s prior treatment including drug name and date(s) of therapy AND

    Criteria 6: Pretreatment detectable HCV RNA viral load value, measured within 1 year of treatment start date, is provided at time of request AND

    Criteria 7: Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request AND

    Criteria 8: Patient is 12 years of age or older OR weighs at least 45 kg with a diagnosis of hepatitis C, genotype 2 if requesting Mavyret OR

    Criteria 9: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 2 if requesting Vosevi

    Criteria for Genotype 3 – all drugs require prior authorization

    Hepatitis C Genotype 3: Epclusa, Mavyret, Sovaldi, Vosevi, sofosbuvir-velpatasvir

    Treatment-Naïve Patients

    Preferred Nonpreferred
    Mavyret Sofosbuvir-velpatasvir
    Epclusa
    Sovaldi tablet
    Sovaldi pellet

    Treatment-Experienced Patients

    Preferred Nonpreferred
    Mavyret
    Vosevi    		 None

    Preferred Drug Prior Authorization Criteria for Treatment-Naïve Patients, Genotype 3

    Prescriber Requirements

    Criteria 1: The regimen may be prescribed by a primary care provider, a gastroenterologist, hepatologist, or infectious disease specialist

    OR

    If the patient has any ONE of the following, the regimen must be prescribed by a gastroenterologist, hepatologist, infectious disease specialist, or a nurse practitioner or physician assistant working with a gastroenterologist, hepatologist, or infectious disease specialist:

    • Patient is treatment-experienced OR
    • Patient has Hepatitis B and/or HIV co-infection OR
    • Patient has undergone liver transplantation OR
    • Patient has liver cancer OR
    • Patient has severe liver disease defined as:
      • APRI > 1.5 OR
      • FibroSURE > 0.49 OR
      • Fibroscan > 9.5 kPa OR
      • FIB-4 > 3.25 OR
      • MR Elastography > 6 kPa OR
      • Fibrospect > 42 OR
      • Liver Biopsy > F3 AND

    Criteria 2: If the patient has a substance use disorder or IV drug use, the patient must:

    • Be enrolled in a substance use disorder treatment program and provider’s attestation of enrollment is provided at time of request OR
    • Be counseled about measures to reduce the risk of HCV transmission to others; and evidence of counseling is provided at time of request AND
    • Be offered at least TWO of the following harm reduction services, as described in AASLD/IDSA HCV guidelines:
      • Condom distribution (e.g. written prescription for condoms, clinic receipt of condom purchase for distribution within the past 12 months, etc.)
      • Access to sterile syringes (e.g. written prescription for needles and syringes, copy of educational materials on syringe access and disposal provided to the patient, etc.)
      • Naloxone training and distribution (e.g. written prescription for naloxone, copy of current naloxone training protocol etc.)
      • Medication-assisted treatment options (e.g. provider’s attestation of methadone program enrollment, prescription for buprenorphine substantiated by pharmacy claims data.) OR
    • Not be candidate for ANY of the harm reduction services above; and provider provides the reason the patient is not a candidate for each of the harm reduction services above

    Criteria 3: The treating clinician must provide documentation to attest the patient is screened for evidence of current or prior hepatitis B virus (HBV) infection before starting treatment with direct-acting antivirals. The treating clinician must also have a monitoring plan in place for HBV flare-ups or reactivation during treatment and post-treatment follow up AND

    • Where indicated, the treating clinician must provide documentation that the patient has been counseled on the HBV reactivation adverse events management plan, including the risks of HBV reactivation, including serious liver injury and death AND

    Criteria 4: Clinical documentation of patient’s liver cirrhosis status (e.g. no cirrhosis, compensated cirrhosis, etc.) that corresponds to the requested therapy duration AND

    Criteria 5: Pretreatment detectable HCV RNA viral load value, measured within 1 year of treatment start date, is provided at time of request AND

    Criteria 6: Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request AND

    Criteria 7: Patient is 12 years of age or older OR weighs at least 45 kg with a diagnosis of hepatitis C, genotype 3.

    Nonpreferred Drug Prior Authorization Criteria for Treatment-Naïve Patients, Genotype 3

    For patients between the age of 3 and 11 requesting Sovaldi tablet/pellet:

    • Patient is NOT a candidate for Mavyret AND
    • Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND
    • Patient has a diagnosis of hepatitis C, genotype 3 AND
    • Patient is between the age of 3 and 11 AND
    • Patient meets the drug specific criteria in Table 6, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 3 OR

    For patients between the age of 6 and 11 requesting Epclusa tablet or velpatasvir-sofosbuvir:

    • Patient is NOT a candidate for Mavyret AND
    • Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND
    • Patient has a diagnosis of hepatitis C, genotype 3 AND
    • Patient meets either of the following:
      • Age 6 through 11 OR
      • Weighs at least 17 kg
    • Patient meets the drug specific criteria in Table 6, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 3

    Table 6. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 3

    Tier Nonpreferred Drug PA Criteria Genotype 3, age < 12
    1 Sofosbuvir-velpatasvir Must meet all PA criteria for nonpreferred drugs above.
    2 Epclusa Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 cannot be used.
    3 Sovaldi tablet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 or 2 cannot be used.
    4 Sovaldi pellet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 or 2 cannot be used.


    For patients over the age of 12:

    Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND

    Patient meets the drug specific criteria in Table 7, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients over the Age of 12, Genotype 3 AND

    Patient has HCV infection with at least ONE of the four conditions listed below:

    • Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 7-12 and MELD is ≤20
    • Abdominal imaging where radiologist determines findings are suggestive of cirrhosis (e.g. nodules; enlarged liver, especially in the left lobe; tortuous hepatic arteries; ascites; portal hypertension)
    • Evidence of one or more noninvasive tests indicating a fibrosis score of ≥ F3, such as:
      • APRI (AST to platelet ratio index) ≥ 1.5
      • FibroSURE ≥ 0.49
      • FibroScan ≥ 9.5
      • Fibrosis-4 index (FIB-4) > 3.25
      • MR Elastography ≥ 6 kPa
      • Fibrospect ≥ 42
    • HCV infections with one of the following:
      • Post solid organ transplant (e.g. heart; kidney; liver)
      • Awaiting liver transplant
      • Stage I-III hepatocellular carcinoma meeting Milan criteria
      • HCV infection post liver transplant
      • Severe complications of HCV as defined below:
        • Type 2 or Type 3 essential mixed cryoglobulinemia with end organ manifestations
        • HCV-induced renal disease (e.g. nephrotic syndrome or mebranoproliferative glomerulonephritis (MPGN)

    Table 7. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Over the Age of 12, Genotype 3

    Tier Nonpreferred Drug PA Criteria Genotype 3, age > 12
    1 Sofosbuvir-velpatasvir Must meet all PA criteria for nonpreferred drugs above.
    2 Epclusa Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 cannot be used.
    3 Sovaldi tablet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 or 2 cannot be used.
    4 Sovaldi pellet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, or 3 cannot be used.

    Preferred Drug Prior Authorization Criteria for Treatment-Experienced Patients, Genotype 3

    Prescriber Requirements

    Criteria 1: If the patient has any ONE of the following, the regimen must be prescribed by a gastroenterologist, hepatologist, infectious disease specialist, or a nurse practitioner or physician assistant working with a gastroenterologist, hepatologist, or infectious disease specialist:

    • Patient is treatment-experienced OR
    • Patient has Hepatitis B and/or HIV co-infection OR
    • Patient has undergone liver transplantation OR
    • Patient has liver cancer OR
    • Patient has severe liver disease defined as:
      • APRI > 1.5 OR
      • FibroSURE > 0.49 OR
      • Fibroscan > 9.5 kPa OR
      • FIB-4 > 3.25 OR
      • MR Elastography > 6 kPa OR
      • Fibrospect > 42 OR
      • Liver Biopsy > F3 AND

    Criteria 2: If the patient has a substance use disorder or IV drug use, the patient must:

    • Be enrolled in a substance use disorder treatment program and provider’s attestation of enrollment is provided at time of request OR
    • Be counseled about measures to reduce the risk of HCV transmission to others; and evidence of counseling is provided at time of request AND
    • Be offered at least TWO of the following harm reduction services, as described in AASLD/IDSA HCV guidelines:
      • Condom distribution (e.g. written prescription for condoms, clinic receipt of condom purchase for distribution within the past 12 months, etc.)
      • Access to sterile syringes (e.g. written prescription for needles and syringes, copy of educational materials on syringe access and disposal provided to the patient, etc.)
      • Naloxone training and distribution (e.g. written prescription for naloxone, copy of current naloxone training protocol etc.)
      • Medication-assisted treatment options (e.g. provider’s attestation of methadone program enrollment, prescription for buprenorphine substantiated by pharmacy claims data.) OR
    • Not be candidate for ANY of the harm reduction services above; and provider provides the reason the patient is not a candidate for each of the harm reduction services above

    Criteria 3: The treating clinician must provide documentation to attest that the patient is screened for evidence of current or prior hepatitis B virus (HBV) infection before starting treatment with direct-acting antivirals AND the provider has a monitoring plan for HBV flare-ups or reactivation during treatment and post-treatment follow-up AND

    • Where indicated, the treating clinician must provide documentation that the patient has been counseled on the HBV reactivation adverse events management plan AND the risk of HBV reactivation including serious liver injury and death AND

    Criteria 4: Clinical documentation of patient’s liver cirrhosis status (e.g. no cirrhosis, compensated cirrhosis, etc.) that corresponds to the requested therapy duration AND

    Criteria 5: Clinical documentation of patient’s prior treatment including drug name and date(s) of therapy AND

    Criteria 6: Pretreatment detectable HCV RNA viral load value, measured within 1 year of treatment start date, is provided at time of request AND

    Criteria 7: Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request AND

    Criteria 8: Patient is 12 years of age or older OR weighs at least 45 kg with a diagnosis of hepatitis C, genotype 3 if requesting Mavyret OR

    Criteria 9: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 3 if requesting Vosevi

    Criteria for Genotype 4 – all drugs require prior authorization

    Hepatitis C Genotype 4: Sofosbuvir-velpatasvir, Epclusa, Harvoni, lepidasvir-sofosbuvir, Mavyret, Sovaldi, Vosevi, Zepatier

    Treatment-Naïve Patients

    Preferred Nonpreferred
    Mavyret Zepatier
    Sofosbuvir-velpatasvir
    Epclusa
    Lepidasvir-sofosbuvir
    Harvoni tablet
    Harvoni pellet
    Sovaldi tablet
    Sovaldi pellet

     Treatment-Experienced Patients

    Preferred Nonpreferred
    Mavyret
    Vosevi    		 None

    Preferred Drug Prior Authorization Criteria for Treatment-Naïve Patients, Genotype 4

    Prescriber Requirements

    Criteria 1: The regimen may be prescribed by a primary care provider, a gastroenterologist, hepatologist, or infectious disease specialist

    OR

    If the patient has any ONE of the following, the regimen must be prescribed by a gastroenterologist, hepatologist, infectious disease specialist, or a nurse practitioner or physician assistant working with a gastroenterologist, hepatologist, or infectious disease specialist:

    • Patient is treatment-experienced OR
    • Patient has Hepatitis B and/or HIV co-infection OR
    • Patient has undergone liver transplantation OR
    • Patient has liver cancer OR
    • Patient has severe liver disease defined as:
      • APRI > 1.5 OR
      • FibroSURE > 0.49 OR
      • Fibroscan > 9.5 kPa OR
      • FIB-4 > 3.25 OR
      • MR Elastography > 6 kPa OR
      • Fibrospect > 42 OR
      • Liver Biopsy > F3 AND

    Criteria 2: If the patient has a substance use disorder or IV drug use, the patient must:

    • Be enrolled in a substance use disorder treatment program and provider’s attestation of enrollment is provided at time of request OR
    • Be counseled about measures to reduce the risk of HCV transmission to others; and evidence of counseling is provided at time of request AND
    • Be offered at least TWO of the following harm reduction services, as described in AASLD/IDSA HCV guidelines:
      • Condom distribution (e.g. written prescription for condoms, clinic receipt of condom purchase for distribution within the past 12 months, etc.)
      • Access to sterile syringes (e.g. written prescription for needles and syringes, copy of educational materials on syringe access and disposal provided to the patient, etc.)
      • Naloxone training and distribution (e.g. written prescription for naloxone, copy of current naloxone training protocol etc.)
      • Medication-assisted treatment options (e.g. provider’s attestation of methadone program enrollment, prescription for buprenorphine substantiated by pharmacy claims data.) OR
    • Not be candidate for ANY of the harm reduction services above; and provider provides the reason the patient is not a candidate for each of the harm reduction services above

    Criteria 3: The treating clinician must provide documentation to attest the patient is screened for evidence of current or prior hepatitis B virus (HBV) infection before starting treatment with direct-acting antivirals. The treating clinician must also have a monitoring plan in place for HBV flare-ups or reactivation during treatment and post-treatment follow up AND

    • Where indicated, the treating clinician must provide documentation that the patient has been counseled on the HBV reactivation adverse events management plan, including the risks of HBV reactivation, including serious liver injury and death AND

    Criteria 4: Clinical documentation of patient’s liver cirrhosis status (e.g. no cirrhosis, compensated cirrhosis, etc.) that corresponds to the requested therapy duration AND

    Criteria 5: Pretreatment detectable HCV RNA viral load value, measured within 1 year of treatment start date, is provided at time of request AND

    Criteria 6: Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request AND

    Criteria 7: Patient is 12 years of age or older OR weighs at least 45 kg with a diagnosis of hepatitis C, genotype 4

    Nonpreferred Drug Prior Authorization Criteria for Treatment-Naïve Patients, Genotype 4

    For patients between the age of 3 and 11 requesting Harvoni tablet/pellet or lepidasvir-sofosbuvir:

    • Patient is NOT a candidate for Mavyret AND
    • Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND
    • Patient has a diagnosis of hepatitis C, genotype 4 AND
    • Patient is between the age of 3 and 11 AND
    • Patient meets the drug specific criteria in Table 8, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 4 OR

    For patients between the age of 6 and 11 requesting Epclusa tablet or velpatasvir-sofosbuvir:

    • Patient is NOT a candidate for Mavyret AND
    • Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND
    • Patient has a diagnosis of hepatitis C, genotype 4 AND
    • Patient meets either of the following:
      • Age 6 through 11 OR
      • Weighs at least 17 kg
    • Patient meets the drug specific criteria in Table 8, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 4

    Table 8. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 4

    Tier Nonpreferred Drug PA Criteria Genotype 4, age < 12
    1 Sofosbuvir-velpatasvir Must meet all PA criteria for nonpreferred drugs above.
    2 Epclusa Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 cannot be used.
    3 Lepidasvir-sofosbuvir Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 or 2 cannot be used.
    4 Harvoni tablet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, or 3 cannot be used.
    5 Harvoni pellet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, 3, or 4 cannot be used.

    For patients over the age of 12:

    Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND

    Patient meets the drug specific criteria in Table 9, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Over the Age of 12, Genotype 4 AND

    Patient has HCV infection with at least ONE of the four conditions listed below:

    • Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 7-12 and MELD is ≤20
    • Abdominal imaging where radiologist determines findings are suggestive of cirrhosis (e.g. nodules; enlarged liver, especially in the left lobe; tortuous hepatic arteries; ascites; portal hypertension)
    • Evidence of one or more noninvasive tests indicating a fibrosis score of ≥ F3, such as:
      • APRI (AST to platelet ratio index) ≥ 1.5
      • FibroSURE ≥ 0.49
      • FibroScan ≥ 9.5
      • Fibrosis-4 index (FIB-4) > 3.25
      • MR Elastography ≥ 6 kPa
      • Fibrospect ≥ 42
    • HCV infections with one of the following:
      • Post solid organ transplant (e.g. heart; kidney; liver)
      • Awaiting liver transplant
      • Stage I-III hepatocellular carcinoma meeting Milan criteria
      • HCV infection post liver transplant
      • Severe complications of HCV as defined below:
        • Type 2 or Type 3 essential mixed cryoglobulinemia with end organ manifestations
        • HCV-induced renal disease (e.g. nephrotic syndrome or mebranoproliferative glomerulonephritis (MPGN)

    Table 9. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Over the Age of 12, Genotype 4

    Tier Nonpreferred Drug PA Criteria Genotype 4, age >12
    1 Sofosbuvir-velpatasvir  Must meet all PA criteria for nonpreferred drugs above. 
    2 Zepatier Must meet all PA criteria for nonpreferred drugs. The provider must supply clinical rationale as to why sofosbuvir-velpatasvir cannot be used.
    3 Epclusa Must meet all PA criteria for nonpreferred drugs above and have a documented contraindication to Zepatier. The prescriber must provide compelling clinical evidence of why sofosbuvir-velpatasvir cannot be used.
    4 Lepidasvir-sofosbuvir Must meet all PA criteria for nonpreferred drugs above and have a documented contraindication to Zepatier and supply clinical rationale as to why Epclusa and sofosbuvir-velpatasvir cannot be used.
    5 Harvoni Must meet all PA criteria for nonpreferred drugs above and have a documented contraindication to Zepatier and supply clinical rationale as to why Epclusa and sofosbuvir-velpatasvir cannot be used. The prescriber must also provide compelling clinical evidence of why the lepidasvir-sofosbuvir cannot be used.
    6 Sovaldi Must meet all PA criteria for nonpreferred drugs above and have a documented contraindication to Zepatier and supply clinical rationale as to why Epclusa, Harvoni, sofosbuvir-velpatasvir, and lepidasvir-sofosbuvir cannot be used. Sovaldi must be used in combination with ribavirin and Peg-IFN.

    Preferred Drug Prior Authorization Criteria for Treatment-Experienced Patients, Genotype 4

    Prescriber Requirements

    Criteria 1: If the patient has any ONE of the following, the regimen must be prescribed by a gastroenterologist, hepatologist, infectious disease specialist, or a nurse practitioner or physician assistant working with a gastroenterologist, hepatologist, or infectious disease specialist:

    • Patient is treatment-experienced OR
    • Patient has Hepatitis B and/or HIV co-infection OR
    • Patient has undergone liver transplantation OR
    • Patient has liver cancer OR
    • Patient has severe liver disease defined as:
      • APRI > 1.5 OR
      • FibroSURE > 0.49 OR
      • Fibroscan > 9.5 kPa OR
      • FIB-4 > 3.25 OR
      • MR Elastography > 6 kPa OR
      • Fibrospect > 42 OR
      • Liver Biopsy > F3 AND

    Criteria 2: If the patient has a substance use disorder or IV drug use, the patient must:

    • Be enrolled in a substance use disorder treatment program and provider’s attestation of enrollment is provided at time of request OR
    • Be counseled about measures to reduce the risk of HCV transmission to others; and evidence of counseling is provided at time of request AND
    • Be offered at least TWO of the following harm reduction services, as described in AASLD/IDSA HCV guidelines:
      • Condom distribution (e.g. written prescription for condoms, clinic receipt of condom purchase for distribution within the past 12 months, etc.)
      • Access to sterile syringes (e.g. written prescription for needles and syringes, copy of educational materials on syringe access and disposal provided to the patient, etc.)
      • Naloxone training and distribution (e.g. written prescription for naloxone, copy of current naloxone training protocol etc.)
      • Medication-assisted treatment options (e.g. provider’s attestation of methadone program enrollment, prescription for buprenorphine substantiated by pharmacy claims data.) OR
    • Not be candidate for ANY of the harm reduction services above; and provider provides the reason the patient is not a candidate for each of the harm reduction services above

    Criteria 3: The treating clinician must provide documentation to attest that the patient is screened for evidence of current or prior hepatitis B virus (HBV) infection before starting treatment with direct-acting antivirals AND the provider has a monitoring plan for HBV flare-ups or reactivation during treatment and post-treatment follow-up AND

    • Where indicated, the treating clinician must provide documentation that the patient has been counseled on the HBV reactivation adverse events management plan AND the risk of HBV reactivation including serious liver injury and death AND

    Criteria 4: Clinical documentation of patient’s liver cirrhosis status (e.g. no cirrhosis, compensated cirrhosis, etc.) that corresponds to the requested therapy duration AND

    Criteria 5: Clinical documentation of patient’s prior treatment including drug name and date(s) of therapy AND

    Criteria 6: Pretreatment detectable HCV RNA viral load value, measured within 1 year of treatment start date, is provided at time of request AND

    Criteria 7: Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request AND

    Criteria 8: Patient is 12 years of age or older OR weighs at least 45 kg with a diagnosis of hepatitis C, genotype 4 if requesting Mavyret OR

    Criteria 9: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 4 if requesting Vosevi

    Criteria for Genotype 5 or 6 – all drugs require prior authorization

    Hepatitis C Genotype 5 or 6: Sofosbuvir-velpatasvir, Epclusa, Mavyret, Harvoni, lepidasvir-sofosbuvir, Vosevi

    Treatment-Naïve Patients

    Preferred Nonpreferred
    Mavyret Sofosbuvir-velpatasvir
    Epclusa
    Lepidasvir-sofosbuvir
    Harvoni tablet
    Harvoni pellet

    Treatment-Experienced Patients

    Preferred Nonpreferred
    Mavyret
    Vosevi    		 None

    Preferred Drug Prior Authorization Criteria for Treatment-Naïve Patients, Genotype 5 or 6

    Prescriber Requirements

    Criteria 1: The regimen may be prescribed by a primary care provider, a gastroenterologist, hepatologist, or infectious disease specialist

    OR

    If the patient has any ONE of the following, the regimen must be prescribed by a gastroenterologist, hepatologist, infectious disease specialist, or a nurse practitioner or physician assistant working with a gastroenterologist, hepatologist, or infectious disease specialist:

    • Patient is treatment-experienced OR
    • Patient has Hepatitis B and/or HIV co-infection OR
    • Patient has undergone liver transplantation OR
    • Patient has liver cancer OR
    • Patient has severe liver disease defined as:
      • APRI > 1.5 OR
      • FibroSURE > 0.49 OR
      • Fibroscan > 9.5 kPa OR
      • FIB-4 > 3.25 OR
      • MR Elastography > 6 kPa OR
      • Fibrospect > 42 OR
      • Liver Biopsy > F3 AND

    Criteria 2: If the patient has a substance use disorder or IV drug use, the patient must:

    • Be enrolled in a substance use disorder treatment program and provider’s attestation of enrollment is provided at time of request OR
    • Be counseled about measures to reduce the risk of HCV transmission to others; and evidence of counseling is provided at time of request AND
    • Be offered at least TWO of the following harm reduction services, as described in AASLD/IDSA HCV guidelines:
      • Condom distribution (e.g. written prescription for condoms, clinic receipt of condom purchase for distribution within the past 12 months, etc.)
      • Access to sterile syringes (e.g. written prescription for needles and syringes, copy of educational materials on syringe access and disposal provided to the patient, etc.)
      • Naloxone training and distribution (e.g. written prescription for naloxone, copy of current naloxone training protocol etc.)
      • Medication-assisted treatment options (e.g. provider’s attestation of methadone program enrollment, prescription for buprenorphine substantiated by pharmacy claims data.) OR
    • Not be candidate for ANY of the harm reduction services above; and provider provides the reason the patient is not a candidate for each of the harm reduction services above

    Criteria 3: The treating clinician must provide documentation to attest the patient is screened for evidence of current or prior hepatitis B virus (HBV) infection before starting treatment with direct-acting antivirals. The treating clinician must also have a monitoring plan in place for HBV flare-ups or reactivation during treatment and post-treatment follow up AND

    • Where indicated, the treating clinician must provide documentation that the patient has been counseled on the HBV reactivation adverse events management plan, including the risks of HBV reactivation, including serious liver injury and death AND

    Criteria 4: Clinical documentation of patient’s liver cirrhosis status (e.g. no cirrhosis, compensated cirrhosis, etc.) that corresponds to the requested therapy duration AND

    Criteria 5: Pretreatment detectable HCV RNA viral load value, measured within 1 year of treatment start date, is provided at time of request AND

    Criteria 6: Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request AND

    Criteria 7: Patient is 12 years of age or older OR weighs at least 45 kg with a diagnosis of hepatitis C, genotype 5 or 6

    Nonpreferred Drug Prior Authorization Criteria for Treatment-Naïve Patients, Genotype 5 or 6

    For patients between the age of 3 and 11 requesting Harvoni tablet/pellet or lepidasvir-sofosbuvir:

    • Patient is NOT a candidate for Mavyret AND
    • Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND
    • Patient has a diagnosis of hepatitis C, genotype 5 or 6 AND
    • Patient is between the age of 3 and 11 AND
    • Patient meets the drug specific criteria in Table 10, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 5 or 6 OR

    For patients between the age of 6 and 11 requesting Epclusa tablet or velpatasvir-sofosbuvir:

    • Patient is NOT a candidate for Mavyret AND
    • Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND
    • Patient has a diagnosis of hepatitis C, genotype 5 or 6 AND
    • Patient meets either of the following:
      • Age 6 through 11 OR
      • Weighs at least 17 kg
    • Patient meets the drug specific criteria in Table 10, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 5 or 6

    Table 10. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Under the Age of 12, Genotype 5 or 6

    Tier Nonpreferred Drug PA Criteria Genotype 5 or 6, age < 12
    1 Sofosbuvir-velpatasvir Must meet all PA criteria for nonpreferred drugs above.
    2 Epclusa Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 cannot be used.
    3 Lepidasvir-sofosbuvir Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 or 2 cannot be used.
    4 Harvoni tablet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, or 3 cannot be used.
    5 Harvoni pellet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, 3, or 4 cannot be used.

    For patients over the age of 12:

    Patient has met Criteria 1 through 6 of the Preferred Drug Criteria AND

    Patient meets the drug specific criteria in Table 11, Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Over the Age of 12, Genotype 5 or 6 AND

    Patient has HCV infection with at least ONE of the four conditions listed below:

    • Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 7-12 and MELD is ≤20
    • Abdominal imaging where radiologist determines findings are suggestive of cirrhosis (e.g. nodules; enlarged liver, especially in the left lobe; tortuous hepatic arteries; ascites; portal hypertension)
    • Evidence of one or more noninvasive tests indicating a fibrosis score of ≥ F3, such as:
      • APRI (AST to platelet ratio index) ≥ 1.5
      • FibroSURE ≥ 0.49
      • FibroScan ≥ 9.5
      • Fibrosis-4 index (FIB-4) > 3.25
      • MR Elastography ≥ 6 kPa
      • Fibrospect ≥ 42
    • HCV infections with one of the following:
      • Post solid organ transplant (e.g. heart; kidney; liver)
      • Awaiting liver transplant
      • Stage I-III hepatocellular carcinoma meeting Milan criteria
      • HCV infection post liver transplant
      • Severe complications of HCV as defined below:
        • Type 2 or Type 3 essential mixed cryoglobulinemia with end organ manifestations
        • HCV-induced renal disease (e.g. nephrotic syndrome or mebranoproliferative glomerulonephritis (MPGN)

    Table 11. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Over the Age of 12, Genotype 5 or 6

    Tier Nonpreferred Drug PA Criteria Genotype 5 or 6, age > 12
    1 Sofosbuvir-velpatasvir Must meet all PA criteria for nonpreferred drugs above.
    2 Epclusa Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 cannot be used.
    3 Lepidasvir-sofosbuvir Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1 or 2 cannot be used.
    4 Harvoni tablet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, or 3 cannot be used.
    5 Harvoni pellet Must meet all PA criteria for nonpreferred drugs above. The prescriber must provide compelling clinical evidence of why drug in tier 1, 2, 3, or 4 cannot be used.

    Preferred Drug Prior Authorization Criteria for Treatment-Experienced Patients, Genotype 5 or 6

    Prescriber Requirements

    Criteria 1: If the patient has any ONE of the following, the regimen must be prescribed by a gastroenterologist, hepatologist, infectious disease specialist, or a nurse practitioner or physician assistant working with a gastroenterologist, hepatologist, or infectious disease specialist:

    • Patient is treatment-experienced OR
    • Patient has Hepatitis B and/or HIV co-infection OR
    • Patient has undergone liver transplantation OR
    • Patient has liver cancer OR
    • Patient has severe liver disease defined as:
      • APRI > 1.5 OR
      • FibroSURE > 0.49 OR
      • Fibroscan > 9.5 kPa OR
      • FIB-4 > 3.25 OR
      • MR Elastography > 6 kPa OR
      • Fibrospect > 42 OR
      • Liver Biopsy > F3 AND

    Criteria 2: If the patient has a substance use disorder or IV drug use, the patient must:

    • Be enrolled in a substance use disorder treatment program and provider’s attestation of enrollment is provided at time of request OR
    • Be counseled about measures to reduce the risk of HCV transmission to others; and evidence of counseling is provided at time of request AND
    • Be offered at least TWO of the following harm reduction services, as described in AASLD/IDSA HCV guidelines:
      • Condom distribution (e.g. written prescription for condoms, clinic receipt of condom purchase for distribution within the past 12 months, etc.)
      • Access to sterile syringes (e.g. written prescription for needles and syringes, copy of educational materials on syringe access and disposal provided to the patient, etc.)
      • Naloxone training and distribution (e.g. written prescription for naloxone, copy of current naloxone training protocol etc.)
      • Medication-assisted treatment options (e.g. provider’s attestation of methadone program enrollment, prescription for buprenorphine substantiated by pharmacy claims data.) OR
    • Not be candidate for ANY of the harm reduction services above; and provider provides the reason the patient is not a candidate for each of the harm reduction services above

    Criteria 3: The treating clinician must provide documentation to attest that the patient is screened for evidence of current or prior hepatitis B virus (HBV) infection before starting treatment with direct-acting antivirals AND the provider has a monitoring plan for HBV flare-ups or reactivation during treatment and post-treatment follow-up AND

    • Where indicated, the treating clinician must provide documentation that the patient has been counseled on the HBV reactivation adverse events management plan AND the risk of HBV reactivation including serious liver injury and death AND

    Criteria 4: Clinical documentation of patient’s liver cirrhosis status (e.g. no cirrhosis, compensated cirrhosis, etc.) that corresponds to the requested therapy duration AND

    Criteria 5: Clinical documentation of patient’s prior treatment including drug name and date(s) of therapy AND

    Criteria 6: Pretreatment detectable HCV RNA viral load value, measured within 1 year of treatment start date, is provided at time of request AND

    Criteria 7: Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request AND

    Criteria 8: Patient is 12 years of age or older OR weighs at least 45 kg with a diagnosis of hepatitis C, genotype 5 or 6 if requesting Mavyret OR

    Criteria 9: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 5 or 6 if requesting Vosevi

    Questions?

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

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