Hepatitis C

Drugs - Daklinza, Epclusa, Harvoni, Mavyret, Olysio, Sovaldi, Technivie, Viekira Pak, Viekira XR, Vosevi, Zepatier

November 2017

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
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’ ability 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-Naive Patients

Preferred	Nonpreferred
Mavyret	Zepatier Viekira Pak/Viekira XR Harvoni Epclusa Sovaldi Olysio Daklinza

Genotype 1 Treatment-Experienced Patients

Preferred	Nonpreferred
Mavyret Vosevi	None

Genotype 2 Treatment-Naïve Patients

Preferred	Nonpreferred
Mavyret	Epclusa Sovaldi

Genotype 2 Treatment-Experienced Patients

Preferred	Nonpreferred
Mavyret Vosevi	None

Genotype 3 Treatment-Naïve Patients

Preferred	Nonpreferred
Mavyret	Epclusa Sovaldi Daklinza

Genotype 3 Treatment-Experienced Patients

Preferred	Nonpreferred
Mavyret Vosevi	None

Genotype 4 Treatment-Naïve Patients

Preferred	Nonpreferred
Mavyret	Technivie Zepatier Harvoni Epclusa Sovaldi

Genotype 4 Treatment-Experienced Patients

Preferred	Nonpreferred
Mavyret Vosevi	None

Genotype 5 or 6 Treatment-Naïve Patients

Preferred	Nonpreferred
Mavyret	Harvoni Epclusa

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: Daklinza, Harvoni, Mavyret, Olysio, Sovaldi, Viekira Pak, Viekira XR, Vosevi, Zepatier

Treatment-Naïve Patients

Preferred	Nonpreferred
Mavyret	Zepatier Viekira Pak/Viekira XR Harvoni Epclusa Sovaldi Olysio Daklinza

Treatment-Experienced Patients

Preferred	Nonpreferred
Mavyret Vosevi	None

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

Prescriber Requirements

Criteria 1: Regimen is prescribed by (or had a documented consult with) a gastroenterologist, hepatologist, infectious disease specialist, or a practitioner specializing in the treatment of hepatitis. Notes of consultation with specialist must be attached to authorization request AND

Criteria 2: Both the treating clinician and the patient are confident that the patient can effectively start and successfully adhere to treatment. The treating clinician must attest that the patient has been evaluated for “readiness” for treatment, including identification of potential impediments to effective treatment (e.g., difficulties with compliance, missing appointments, adequate social support, and adequate control of mental health conditions, alcohol use disorder, and IV drug use). Potential impediments to successful treatment must be addressed in treatment notes prior to initiating treatment and submitted with authorization request. Specifically:

If the patient has a history of alcohol use disorder, the patient must be abstinent from alcohol for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from alcohol for at least 3 months AND
- Are receiving treatment at an approved facility and agree to abstain from alcohol during treatment AND
- Are under the care of an addition medicine/chemical dependency treatment provider and provider attests the patient agrees to abstain from alcohol use during treatment.
If the patient has a history of IV drug use, the patient must be abstinent from IV drugs for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from IV drug use for at least 3 months AND
- Are receiving chemical dependency treatment AND
- The treating chemical dependency provider (addiction medicine specialist or buprenorphine waived provider) attests that the patient has abstained from use for 3 months AND
- The chemical dependency provider has reviewed a urine tox screen completed within 30 days prior to the initiation of hepatitis C treatment

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, are provided at time of request AND

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

Criteria 7: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 1.

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

For patients under the age of 18 requesting Harvoni:

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 12 through 17 OR
Weighs at least 35 kg

For patients over the age of 18:

Patient has met Criteria 1 through 7 of the Preferred Drug Criteria AND

Patient meets the drug specific criteria in Table 2, Tier Approach to Nonpreferred Drugs for Treatment-Naïve, 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 (CPT class B/C) 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 ≥ 7.1
- 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 2. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Over the Age of 18, Genotype 1

Tier	Nonpreferred Drug	PA Criteria Genotype 1, age > 18
1	Zepatier	Must meet all PA criteria for nonpreferred drug above and patient has renal impairment. If applicable, prescriber provides rationale that potential drug interaction(s) between the patient’s current medication regimen and the preferred or other nonpreferred agents cannot be mitigated.
2	Viekira Pak/Viekira XR	Must meet all PA criteria for nonpreferred drug above, have a contraindication to Zepatier. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.
3	Harvoni	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Zepatier and Viekira Pak/Viekira XR. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.
4	Epclusa	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Zepatier and Viekira Pak/Viekira XR and supply clinical rationale as to why Harvoni cannot be used. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.
5	Sovaldi	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Zepatier and Viekira Pak/Viekira XR and supply clinical rationale as to why Harvoni and Epclusa cannot be used. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.
6	Olysio	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Zepatier and Viekira Pak/Viekira XR and supply clinical rationale as to why Harvoni and Epclusa cannot be used. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis. Olysio must be used in combination with Sovaldi or Peg-IFN-alfa and ribavirin.
7	Daklinza	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Zepatier and Viekira Pak/Viekira XR and supply clinical rationale as to why Harvoni and Epclusa and Olysio cannot be used. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis. Daklinza must be used in combination with Sovaldi.

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

Prescriber Requirements

If the patient has a history of alcohol use disorder, the patient must be abstinent from alcohol for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from alcohol for at least 3 months AND
- Are receiving treatment at an approved facility and agree to abstain from alcohol during treatment AND
- Are under the care of an addition medicine/chemical dependency treatment provider and provider attests the patient agrees to abstain from alcohol use during treatment.
If the patient has a history of IV drug use, the patient must be abstinent from IV drugs for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from IV drug use for at least 3 months AND
- Are receiving chemical dependency treatment AND
- The treating chemical dependency provider (addiction medicine specialist or buprenorphine waived provider) attests that the patient has abstained from use for 3 months AND
- The chemical dependency provider has reviewed a urine tox screen completed within 30 days prior to the initiation of hepatitis C treatment.

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

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, are provided at time of request AND

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

Criteria 8: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 1.

Criteria for Genotype 2 – all drugs require prior authorization

Hepatitis C Genotype 2: Epclusa, Mavyret, Sovaldi, Vosevi

Treatment-Naïve Patients

Preferred	Nonpreferred
Mavyret	Epclusa Sovaldi

Treatment-Experienced Patients

Preferred	Nonpreferred
Mavyret Vosevi	None

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

Prescriber Requirements

If the patient has a history of alcohol use disorder, the patient must be abstinent from alcohol for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from alcohol for at least 3 months AND
- Are receiving treatment at an approved facility and agree to abstain from alcohol during treatment AND
- Are under the care of an addition medicine/chemical dependency treatment provider and provider attests the patient agrees to abstain from alcohol use during treatment.
If the patient has a history of IV drug use, the patient must be abstinent from IV drugs for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from IV drug use for at least 3 months AND
- Are receiving chemical dependency treatment AND
- The treating chemical dependency provider (addiction medicine specialist or buprenorphine waived provider) attests that the patient has abstained from use for 3 months AND
- The chemical dependency provider has reviewed a urine tox screen completed within 30 days prior to the initiation of hepatitis C treatment.

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, are provided at time of request AND

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

Criteria 7: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 2.

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

For patients under the age of 18 requesting Sovaldi:

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

Patient has a diagnosis of hepatitis C, genotype 2 AND

Patient will use Sovaldi in combination with ribavirin AND

Patient meets either of the following:

Age 12 through 17 OR
Weighs at least 35 kg

For patients over the age of 18:

Patient has met Criteria 1 through 7 of the Preferred Drug Criteria AND

Patient meets the drug specific criteria in Table 3, Tier Approach to Nonpreferred Drugs for Treatment-Naïve, 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 (CPT class B/C) 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 ≥ 7.1
- 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 Drug for Treatment-Naïve Patients over the Age of 18, Genotype 2

Tier	Nonpreferred Drug	PA Criteria
1	Epclusa	Must meet all PA criteria for nonpreferred drug above. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.
2	Sovaldi	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Epclusa. Sovaldi must be used in combination with ribavirin. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.

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

Prescriber Requirements

If the patient has a history of alcohol use disorder, the patient must be abstinent from alcohol for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from alcohol for at least 3 months AND
- Are receiving treatment at an approved facility and agree to abstain from alcohol during treatment AND
- Are under the care of an addition medicine/chemical dependency treatment provider and provider attests the patient agrees to abstain from alcohol use during treatment.
If the patient has a history of IV drug use, the patient must be abstinent from IV drugs for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from IV drug use for at least 3 months AND
- Are receiving chemical dependency treatment AND
- The treating chemical dependency provider (addiction medicine specialist or buprenorphine waived provider) attests that the patient has abstained from use for 3 months AND
- The chemical dependency provider has reviewed a urine tox screen completed within 30 days prior to the initiation of hepatitis C treatment.

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

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, are provided at time of request AND

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

Criteria 8: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 2.

Criteria for Genotype 3 – all drugs require prior authorization

Hepatitis C Genotype 3: Epclusa, Daklinza, Mavyret, Sovaldi, Vosevi

Treatment-Naïve Patients

Preferred	Nonpreferred
Mavyret	Epclusa Sovaldi Daklinza

Treatment-Experienced Patients

Preferred	Nonpreferred
Mavyret Vosevi	None

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

Prescriber Requirements

If the patient has a history of alcohol use disorder, the patient must be abstinent from alcohol for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from alcohol for at least 3 months AND
- Are receiving treatment at an approved facility and agree to abstain from alcohol during treatment AND
- Are under the care of an addition medicine/chemical dependency treatment provider and provider attests the patient agrees to abstain from alcohol use during treatment.
If the patient has a history of IV drug use, the patient must be abstinent from IV drugs for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from IV drug use for at least 3 months AND
- Are receiving chemical dependency treatment AND
- The treating chemical dependency provider (addiction medicine specialist or buprenorphine waived provider) attests that the patient has abstained from use for 3 months AND
- The chemical dependency provider has reviewed a urine tox screen completed within 30 days prior to the initiation of hepatitis C treatment.

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, are provided at time of request AND

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

Criteria 7: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 3.

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

For patients under the age of 18 requesting Sovaldi:

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

Patient has a diagnosis of hepatitis C, genotype 3 AND

Patient will use Sovaldi in combination with ribavirin AND

Patient meets either of the following:

Age 12 through 17 OR
Weighs at least 35 kg

For patients over the age of 18:

Patient has met Criteria 1 through 7 of the Preferred Drug Criteria AND

Patient meets the drug specific criteria in Table 4, Tier Approach to Nonpreferred Drugs for Treatment-Naïve, 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 (CPT class B/C) 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 ≥ 7.1
- 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 4. Tier Approach to Nonpreferred Drug for Treatment-Naïve Patients over the age of 18, Genotype 3

Tier	Nonpreferred Drug	PA Criteria
1	Epclusa	Must meet all PA criteria for nonpreferred drug above. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.
2	Sovaldi	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Epclusa and Sovaldi must be used in combination with ribavirin. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.
3	Daklinza	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Epclusa and Daklinza must be used in combination with Sovaldi. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.

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

Prescriber Requirements

If the patient has a history of alcohol use disorder, the patient must be abstinent from alcohol for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from alcohol for at least 3 months AND
- Are receiving treatment at an approved facility and agree to abstain from alcohol during treatment AND
- Are under the care of an addition medicine/chemical dependency treatment provider and provider attests the patient agrees to abstain from alcohol use during treatment.
If the patient has a history of IV drug use, the patient must be abstinent from IV drugs for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from IV drug use for at least 3 months AND
- Are receiving chemical dependency treatment AND
- The treating chemical dependency provider (addiction medicine specialist or buprenorphine waived provider) attests that the patient has abstained from use for 3 months AND
- The chemical dependency provider has reviewed a urine tox screen completed within 30 days prior to the initiation of hepatitis C treatment.

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

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, are provided at time of request AND

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

Criteria 8: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 3.

Criteria for Genotype 4 – all drugs require prior authorization

Hepatitis C Genotype 4: Epclusa, Harvoni, Mavyret, Sovaldi, Technivie, Vosevi, Zepatier

Treatment-Naïve Patients

Preferred	Nonpreferred
Mavyret	Technivie Zepatier Harvoni Epclusa Sovaldi

Treatment-Experienced Patients

Preferred	Nonpreferred
Mavyret Vosevi	None

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

Prescriber Requirements

If the patient has a history of alcohol use disorder, the patient must be abstinent from alcohol for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from alcohol for at least 3 months AND
- Are receiving treatment at an approved facility and agree to abstain from alcohol during treatment AND
- Are under the care of an addition medicine/chemical dependency treatment provider and provider attests the patient agrees to abstain from alcohol use during treatment.
If the patient has a history of IV drug use, the patient must be abstinent from IV drugs for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from IV drug use for at least 3 months AND
- Are receiving chemical dependency treatment AND
- The treating chemical dependency provider (addiction medicine specialist or buprenorphine waived provider) attests that the patient has abstained from use for 3 months AND
- The chemical dependency provider has reviewed a urine tox screen completed within 30 days prior to the initiation of hepatitis C treatment.

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, are provided at time of request AND

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

Criteria 7: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 4.

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

For patients under the age of 18 requesting Harvoni:

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 12 through 17 OR
Weighs at least 35 kg

For patients over the age of 18:

Patient has met Criteria 1 through 7 of the Preferred Drug Criteria AND

Patient meets the drug specific criteria in Table 5, Tier Approach to Nonpreferred Drugs for Treatment-Naïve, 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 (CPT class B/C) 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 ≥ 7.1
- 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 Drug for Treatment-Naïve Patients Over the age of 18, Genotype 4

Tier	Nonpreferred Drug	PA Criteria
1	Technivie	Must meet all PA criteria for nonpreferred drug above. Patient also must not be on dialysis.
2	Zepatier	Must meet all PA criteria for nonpreferred drug above and has renal impairment. Patient must also have a contraindication to Technivie.
3	Harvoni	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Technivie and Zepatier. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.
4	Epclusa	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Technivie and Zepatier and supply clinical rationale as to why Harvoni cannot be used. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.
5	Sovaldi	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Technivie and Zepatier and supply clinical rationale as to why Harvoni and Epclusa cannot be used. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis and Must be used in combination with Peg-IFN-alfa and ribavirin.

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

Prescriber Requirements

If the patient has a history of alcohol use disorder, the patient must be abstinent from alcohol for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from alcohol for at least 3 months AND
- Are receiving treatment at an approved facility and agree to abstain from alcohol during treatment AND
- Are under the care of an addition medicine/chemical dependency treatment provider and provider attests the patient agrees to abstain from alcohol use during treatment.
If the patient has a history of IV drug use, the patient must be abstinent from IV drugs for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from IV drug use for at least 3 months AND
- Are receiving chemical dependency treatment AND
- The treating chemical dependency provider (addiction medicine specialist or buprenorphine waived provider) attests that the patient has abstained from use for 3 months AND
- The chemical dependency provider has reviewed a urine tox screen completed within 30 days prior to the initiation of hepatitis C treatment.

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

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, are provided at time of request AND

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

Criteria 8: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 4.

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

Hepatitis C Genotype 5 or 6: Epclusa, Mavyret, Harvoni, Vosevi

Treatment-Naïve Patients

Preferred	Nonpreferred
Mavyret	Harvoni Epclusa

Treatment-Experienced Patients

Preferred	Nonpreferred
Mavyret Vosevi	None

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

Prescriber Requirements

If the patient has a history of alcohol use disorder, the patient must be abstinent from alcohol for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from alcohol for at least 3 months AND
- Are receiving treatment at an approved facility and agree to abstain from alcohol during treatment AND
- Are under the care of an addition medicine/chemical dependency treatment provider and provider attests the patient agrees to abstain from alcohol use during treatment.
If the patient has a history of IV drug use, the patient must be abstinent from IV drugs for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from IV drug use for at least 3 months AND
- Are receiving chemical dependency treatment AND
- The treating chemical dependency provider (addiction medicine specialist or buprenorphine waived provider) attests that the patient has abstained from use for 3 months AND
- The chemical dependency provider has reviewed a urine tox screen completed within 30 days prior to the initiation of hepatitis C treatment.

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, are provided at time of request AND

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

Criteria 7: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 5 or 6.

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

For patients under the age of 18 requesting Harvoni:

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 12 through 17 OR
Weighs at least 35 kg

For patients over the age of 18:

Patient has met Criteria 1 through 7 of the Preferred Drug Criteria AND

Patient meets the drug specific criteria in Table 6, Tier Approach to Nonpreferred Drugs for Treatment-Naïve, 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 (CPT class B/C) 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 ≥ 7.1
- 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 6. Tier Approach to Nonpreferred Drugs for Treatment-Naïve Patients Over the Age of 18, Genotype 5 or 6

Tier	Nonpreferred Drug	PA Criteria
1	Harvoni	Must meet all PA criteria for nonpreferred drug above. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis.
2	Epclusa	Must meet all PA criteria for nonpreferred drug above and have a contraindication to Harvoni. Patient also must have creatinine clearance (CrCL) > 30 mL/min OR not currently on hemodialysis

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

Prescriber Requirements

If the patient has a history of alcohol use disorder, the patient must be abstinent from alcohol for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from alcohol for at least 3 months AND
- Are receiving treatment at an approved facility and agree to abstain from alcohol during treatment AND
- Are under the care of an addition medicine/chemical dependency treatment provider and provider attests the patient agrees to abstain from alcohol use during treatment.
If the patient has a history of IV drug use, the patient must be abstinent from IV drugs for at least 6 months prior to the initiation of treatment. Exceptions will be considered for patients who:
- Have abstained from IV drug use for at least 3 months AND
- Are receiving chemical dependency treatment AND
- The treating chemical dependency provider (addiction medicine specialist or buprenorphine waived provider) attests that the patient has abstained from use for 3 months AND
- The chemical dependency provider has reviewed a urine tox screen completed within 30 days prior to the initiation of hepatitis C treatment.

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

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, are provided at time of request AND

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

Criteria 8: Patient is 18 years of age or older with a diagnosis of hepatitis C, genotype 5 or 6.

Questions?

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