Download Hepatitis C PA Criteria

MHCP Enrolled Providers – Pharmacies
Fee-for-Service PA Criteria Sheet – Hepatitis C Direct Acting Antivirals
(April 2017)
Drugs
Therapeutic Area
Daklinza, Epclusa, Harvoni, Olysio, Sovaldi, Technivie, Viekira Pak, Viekira XR, Zepatier
Hepatitis C Direct Acting Antivirals
All drugs in the Hepatitis C PDL category (Table 1) require prior authorization. Providers should fax the completed Hepatitis C
Drug Prior Authorization Form (DHS-7085) to the MHCP Prescription Drug Prior Authorization Agent.





Hepatitis C drug authorization criteria vary by patient’s genotype
Preferred drugs require Patients to meet only preferred drug authorization criteria before payment.
Non preferred drugs require Patients to meet preferred drug authorization criteria AND non-preferred drug authorization
criteria
Tiered approach is used for genotypes where there are more than one non-preferred treatment options
Prior authorization requests for patients with these conditions will be evaluated on a case-by-case basis:
 Mixed genotypes
 Previously treated with HCV direct acting antivirals
<br>
Background information:
As of June 2016, the wholesale acquisition cost (WAC) for FDA-approved oral direct acting antivirals for hepatitis C were:
Drug Name
Daklinza
Epclusa
Harvoni
Olysio
Sovaldi
Technivie
Viekira Pak/
Viekira XR
Zepatier
Genotypes
1,3
1,2,3,4,5,6
1,4,5,6
1,4
1,2,3,4
4
1
Treatment Duration
12-24 weeks
12 weeks
12-24 weeks
12-24 weeks
12-24 weeks
12 weeks
12-24 weeks
1,4
12-16 weeks
Table 1: MHCP Preferred Drug List – Hepatitis C – protease/polymerase inhibitors and direct acting antivirals
Preferred Drugs –Genotype 1
Non-Preferred Drugs – Genotype 1
Zepatier
Viekira Pak/Viekira XR
Harvoni
Epclusa
Sovaldi
Olysio (in combination with Sovaldi)
Daklinza (in combination with Sovaldi)
Preferred Drugs – Genotype 2
Non-Preferred Drugs – Genotype 2
Epclusa
Sovaldi
Preferred Drugs – Genotype 3
Non-Preferred Drugs – Genotype 3
Epclusa
Sovaldi
Daklinza (in combination with Sovaldi)
Preferred Drugs – Genotype 4
Non-Preferred Drugs – Genotype 4
Zepatier
Technivie
Harvoni
Epclusa
Sovaldi
Preferred Drugs – Genotype 5
Non-Preferred Drugs – Genotype 5
Harvoni
Epclusa
Preferred Drugs – Genotype 6
Non-Preferred Drugs – Genotype 6
Harvoni
Epclusa
Hepatitis C Genotype 1: Daklinza, Harvoni, Olysio, Sovaldi, Viekira Pak, Viekira XR, Zepatier
Preferred Drug: Zepatier
Non Preferred Drug: Daklinza, Harvoni, Olysio, Sovaldi, Viekira Pak, Viekira XR
Prior Authorization Criteria for Preferred Drug

Prescriber Requirements
 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

Prescriber Requirements
 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, adequate control of mental health conditions, alcohol use disorder, 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, 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 use during treatment OR
 are under the care of an addiction medicine/chemical dependency treatment provider and provider attests
that patient agrees to abstain from alcohol use during treatment.
 If the patient has a history of IV drug use, 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 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
initiation of hepatitis C treatment. AND
 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

Patient is 18 years of age or older with a diagnosis of Hepatitis C, genotype 1
AND

Clinical documentation of genotype and subtype are provided at time of request
AND

Patient with HCV genotype 1a infection must complete an NS5A resistance test for associated polymorphism
AND


Pretreatment detectable HCV RNA viral load measured within 1 year of treatment start date are provided at time of
request
AND
Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request
Exclusion Criteria:
1. Clinically significant drug interactions with patient’s existing medications
2. Pregnancy
3. Severe end organ disease and not eligible for transplant (e.g. liver, heart, lung, kidney)
4. Clinically-significant illness or any other major medical disorder that may interfere with patients’ ability to complete a course of
treatment
5. 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)
6. Decompensated liver disease with CPT > 12 or MELD > 20
7. MELD ≤ 20 and one of the following:
a. Cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery
b. Malignancy outside the liver not meeting oncologic criteria for cure
c. Hepatocellular carcinoma
d. Intrahepatic cholangiocarcinoma
e. Hemangiosarcoma
8. Indeterminate HCV genotype
CONTINUITY OF CARE
 At the time of treatment initiation patient, has evidence of Minnesota Health Care Programs (MHCP) insurance coverage
for the duration of treatment
Prior Authorization Criteria for Non Preferred Drug



Patient has met the Preferred Drug Authorization Criteria; AND
Patient’s Creatinine Clearance (CrCL) > 30 mL/min OR currently not on hemodialysis AND
Patient has a contraindication to Zepatier OR ribavirin with at least one of the conditions listed in 1 through 6
1. Patient is currently taking organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors, strong inducers of
cytochrome P450 3A, or efavirenz
2. Known hypersensitivity reactions to ribavirin such as Stevens-Johnson syndrome, toxic, epidermal necrolysis, and
erythema multiforme
3. Autoimmune hepatitis
4. Hemoglobinopathies
5. Creatinine Clearance (CrCL) < 50 mL/min
6. Coadministration with didanosine
AND

Patient has HCV infection with at least one of the conditions listed in 1 through 4:
1. Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 5 – 10 (CPT Class B/C) and
MELD is ≤ 20; OR
2. Abdominal imaging where radiologist determines findings are suggestive of cirrhosis (e.g. nodules; enlarged liver,
especially the left lobe; tortuous hepatic arteries; ascites; or portal hypertension); OR
3. Evidence of one or more non-invasive tests indicating a fibrosis score of ≥ F3, such as:
i. APRI (AST to platelet ratio index) ≥ 1.5
ii. FibroSURE ≥ 0.49
iii. FibroScan ≥ 7.1
iv. Fibrosis-4 index (FIB-4) > 3.25
v. MR Elastography ≥ 6 kPa
vi. Fibrospect ≥ 42
4. HCV infection with one of the following:
i. Post solid organ transplant (e.g. Heart, Kidney, Liver)
ii. Awaiting Liver transplant
iii. Stage I-III Hepatocellular Carcinoma meeting Milan Criteria
iv. HCV Infection post liver transplant
v. Severe complications of HCV as defined below
A. Type 2 or Type 3 essential mixed cryoglobulinemia with end organ manifestations
B. HCV induced renal disease (e.g. Nephrotic syndrome or membranoproliferative glomerulonephritis
(MPGN)

Tier Approach to Non Preferred Drug for Genotype 1
Tier
1
2
Non Preferred Drug
Vikiera Pak/Viekira XR
Harvoni
3
Epclusa
4
Sovaldi
5
Olysio
6
Daklinza
PA Criteria
Must meet all PA criteria for non preferred drug above
Must meet all PA criteria for non preferred drug above and have a contraindication to
Viekira Pak/Viekira XR
Must meet all PA criteria for non preferred drug above and have a contraindication to
Viekira Pak/Viekira XR and supply clinical rationale as to why Harvoni cannot be used
Must meet all PA criteria for non preferred drug above and have a contraindication to
Viekira Pak/Viekira XR and supply clinical rationale as to why Harvoni and Epclusa
cannot be used and
Must be used in combination with Peg-IFN-alfa and ribavirin
Must meet all PA criteria for non preferred drug above and have a contraindication to
Viekira Pak/Viekira XR and supply clinical rationale as to why Harvoni and Epclusa
cannot be used and
Must be used in combination with Sovaldi or Peg-IFN-alfa and ribavirin
Must meet all PA criteria for non preferred drug above and have a contraindication to
Viekira Pak/Viekira XR and supply clinical rationale as to why Harvoni and Epclusa and
Olysio cannot be used and
Must be used in combination with Sovaldi
Denial Criteria
• Combination therapy with Epclusa, Daklinza, Harvoni, Olysio, Sovaldi, Viekira Pak and/or Viekira XR
• Use of Zepatier for genotypes other than 1 and 4
Duration of Treatment
Treatment
Maximum Duration of
approval*
ZEPATIER
12 weeks
ZEPATIER + ribavirin
16 weeks
Genotype 1b: treatment-naive or PegIFN/RBV-experienced
ZEPATIER
12 weeks
Genotype 1a or 1b: PegIFN/RBV/PI-experienced
ZEPATIER + ribavirin
12 weeks
Genotype 1, without cirrhosis
DAKLINZA + SOVALDI
12 weeks
Genotype 1, compensated (Child-Pugh A) cirrohosis
DAKLINZA + SOVALDI
12 weeks
Genotype 1, decompensated (Child-Pugh B or C) cirrhosis
DAKLINZA + SOVALDI
+ ribavirin
12 weeks
DAKLINZA + SOVALDI
+ ribavirin
12 weeks
EPCLUSA
12 weeks
EPCLUSA + ribavirin
12 weeks
HARVONI
12 weeks
HARVONI
12 weeks
HARVONI
12 weeks
HARVONI + ribavirin
12 weeks
Patient population
Genotype 1a: treatment-naive or PegIFN/RBV-experienced without
baseline NS5A polymorphism
Genotype 1a: treatment-naive or PegIFN/RBV-experienced with
baseline NS5A polymorphism
Genotype 1, post-transplant
Genotype 1, without cirrhosis or with compensated cirrhosis (ChildPugh A)
Genotype 1, decompensated cirrhosis (Child-Pugh B or C)
Genotype 1, treatment-naive without cirrhosis or with compensated
cirrhosis (Child-Pugh A)
Genotype 1, treatment-experienced without cirrhosis
Genotype 1, treatment-experienced with compensated cirrhosis
(Child-Pugh A)
Genotype 1, treatment-naïve and treatment-experienced with
compensated cirrhosis (Child-Pugh B or C)
Genotype 1 without cirrhosis/with compensated cirrhosis (Child-Pugh
A)
Genotype 1 without cirrhosis/with compensated cirrhosis (Child-Pugh
A), with/without HIV-1 coinfection
Genotype 1
Genotype 1a, without cirrhosis
Genotype 1a, with compensated cirrhosis
Genotype 1b, with or without compensated cirrhosis
OLYSIO + SOVALDI
12 weeks/24 weeks
OLYSIO + Peg-IFN-alfa
+ ribavirin
12 weeks **
SOVALDI + Peg-IFNalfa + ribavirin
12 weeks
VIEKIRA PAK/VIEKIRA
XR + ribavirin
VIEKIRA PAK/VIEKIRA
XR + ribavirin
VIEKIRA PAK/VIEKIRA
XR
12 weeks
24 weeks ***
12 weeks
*Duration of treatment based on manufacturer approved FDA label
** Followed by 12 or 36 additional weeks of Peg-INF-alfa + RBV depending on prior response status and presence of HIV-1 coinfection
**VIEKIRA PAK administered with ribavirin for 12 weeks may be considered for some patients based on prior treatment history
Hepatitis C Genotype 2: Epclusa, Sovaldi
Preferred Drug: Epclusa
Non Preferred Drug: Sovaldi
Prior Authorization Criteria for Preferred Drug

Prescriber Requirements
 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

Prescriber Requirements
 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, adequate control of mental health conditions, alcohol use disorder, 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, 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 use during treatment OR
 are under the care of an addiction medicine/chemical dependency treatment provider and provider attests
that patient agrees to abstain from alcohol use during treatment.
 If the patient has a history of IV drug use, 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 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
initiation of hepatitis C treatment


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

Patient is 18 years of age or older with a diagnosis of Hepatitis C, genotype 2

AND
Clinical documentation of genotype and subtype are provided at time of request

AND
Pretreatment detectable HCV RNA viral load measured within 1 year of treatment start date are provided at time of
request

AND
Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request
Exclusion Criteria:
1. Creatinine Clearance (CrCL) < 30 mL/min or on hemodialysis
2. Clinically significant drug interactions with patient’s existing medications
3. Pregnancy
4. Severe end organ disease and not eligible for transplant (e.g. liver, heart, lung, kidney)
5. Clinically-significant illness or any other major medical disorder that may interfere with patients’ ability to complete a course of
treatment
6. 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)
7. Decompensated liver disease with CPT > 12 or MELD > 20
8. MELD ≤ 20 and one of the following:
a. Cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery
b. Malignancy outside the liver not meeting oncologic criteria for cure
c. Hepatocellular carcinoma
d. Intrahepatic cholangiocarcinoma
e. Hemangiosarcoma
9. Indeterminate HCV genotype
CONTINUITY OF CARE
 At the time of treatment initiation, patient has evidence of Minnesota Health Care Programs (MHCP) insurance coverage
for the duration of treatment
Prior Authorization Criteria for Non Preferred Drug


Patient has met the Preferred Drug Authorization Criteria; AND
Patient has a contraindication to Epclusa OR ribavirin
AND

Patient has HCV infection with at least one of the conditions listed in 1 through 4:
1. Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 5 – 10 (CPT Class B/C)
and MELD is ≤ 20; OR
2. Abdominal imaging where radiologist determines findings are suggestive of cirrhosis (e.g. nodules; enlarged
liver, especially the left lobe; tortuous hepatic arteries; ascites; or portal hypertension); OR
3. Evidence of one or more non-invasive tests indicating a fibrosis score of ≥ F3, such as:
i. APRI (AST to platelet ratio index) ≥ 1.5
ii. FibroSURE ≥ 0.49
iii. FibroScan ≥ 7.1
iv. Fibrosis-4 index (FIB-4) > 3.25
v. MR Elastography ≥ 6 kPa
vi. Fibrospect ≥ 42
4. HCV infection with one of the following:
i. Post solid organ transplant (e.g. Heart, Kidney, Liver)
ii. Awaiting Liver transplant
iii. Stage I-III Hepatocellular Carcinoma meeting Milan Criteria
iv. HCV Infection post liver transplant
v. Severe complications of HCV as defined below
A. Type 2 or Type 3 essential mixed cryoglobulinemia with end organ manifestations
B. HCV induced renal disease (e.g. Nephrotic syndrome or membranoproliferative
glomerulonephritis (MPGN)
Denial Criteria
• Combination therapy with Sovaldi
• Use of Epclusa for genotypes other than 2 and 3
Duration of Treatment
• 12 weeks
• 12 weeks of Epclusa in combination with ribavirin if patient has decompensated cirrhosis (Child-Pugh B and C)
Hepatitis C Genotype 3: Epclusa, Daklinza, Sovaldi
Preferred Drug: Epclusa
Non Preferred Drug: Daklinza, Sovaldi
Prior Authorization Criteria for Preferred Drug

Prescriber Requirements
 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

Prescriber Requirements
 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, adequate control of mental health conditions, alcohol use disorder, 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, 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 use during treatment OR
 are under the care of an addiction medicine/chemical dependency treatment provider and provider attests
that patient agrees to abstain from alcohol use during treatment.
 If the patient has a history of IV drug use, 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 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
initiation of hepatitis C treatment
 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

Patient is 18 years of age or older with a diagnosis of Hepatitis C, genotype 3

AND
Clinical documentation of genotype and subtype are provided at time of request

AND
Pretreatment detectable HCV RNA viral load measured within 1 year of treatment start date are provided at time of
request

AND
Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request
Exclusion Criteria:
1. Creatinine Clearance (CrCL) < 30 mL/min or on hemodialysis
2. Clinically significant drug interactions with patient’s existing medications
3. Pregnancy
4. Severe end organ disease and not eligible for transplant (e.g. liver, heart, lung, kidney)
5. Clinically-significant illness or any other major medical disorder that may interfere with patients’ ability to complete a course of
treatment
6. 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)
7. Decompensated liver disease with CPT > 12 or MELD > 20
8. MELD ≤ 20 and one of the following:
a. Cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery
b. Malignancy outside the liver not meeting oncologic criteria for cure
c. Hepatocellular carcinoma
d. Intrahepatic cholangiocarcinoma
e. Hemangiosarcoma
9. Indeterminate HCV genotype
CONTINUITY OF CARE
 At the time of treatment initiation, patient has evidence of Minnesota Health Care Programs (MHCP) insurance coverage
for the duration of treatment
Prior Authorization Criteria for Non Preferred Drug



Patient has met the Preferred Drug Authorization Criteria; AND
Provide a clinical rationale as to why Epclusa cannot be used AND
Daklinza must be used in combination with Sovaldi
AND

Patient has HCV infection with at least one of the conditions listed in 1 through 4:
1. Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 5 – 10 (CPT Class B/C)
and MELD is ≤ 20; OR
2. Abdominal imaging where radiologist determines findings are suggestive of cirrhosis (e.g. nodules; enlarged
liver, especially the left lobe; tortuous hepatic arteries; ascites; or portal hypertension); OR
3. Evidence of one or more non-invasive tests indicating a fibrosis score of ≥ F3, such as:
i. APRI (AST to platelet ratio index) ≥ 1.5
ii. FibroSURE ≥ 0.49
iii. FibroScan ≥ 7.1
iv. Fibrosis-4 index (FIB-4) > 3.25
v. MR Elastography ≥ 6 kPa
vi. Fibrospect ≥ 42
4. HCV infection with one of the following:
i. Post solid organ transplant (e.g. Heart, Kidney, Liver)
ii. Awaiting Liver transplant
iii. Stage I-III Hepatocellular Carcinoma meeting Milan Criteria
iv. HCV Infection post liver transplant
v. Severe complications of HCV as defined below
A. Type 2 or Type 3 essential mixed cryoglobulinemia with end organ manifestations
B. HCV induced renal disease (e.g. Nephrotic syndrome or membranoproliferative
glomerulonephritis (MPGN)

Tiered Approach to Non Preferred Drug for Genotype 3
Tier
1
Non Preferred Drug
Sovaldi
2
Daklinza (in combination with
Sovaldi)
PA Criteria
Must meet all PA criteria for non preferred drug above and supply clinical
rationale as to why Epclusa cannot be used; and
Must be used in combination with ribavirin
Must meet all PA criteria for non preferred drug above and supply clinical
rationale as to why Epclusa cannot be used; and
Supply clinical rationale as to why Daklinza will not be used in combination with
Sovaldi
Denial Criteria
• Combination therapy with Daklinza and Sovaldi
• Use of Epclusa for genotypes other than 2 and 3
Duration of Treatment
• 12 weeks
• 12 weeks of Epclusa in combination with ribavirin if patient has decompensated cirrhosis (Child-Pugh B and C)
• 24 weeks of Sovaldi when used in combination with ribavirin
Hepatitis C Genotype 4: Epclusa, Harvoni, Sovaldi, Technivie, Zepatier
Preferred Drug: Zepatier
Non Preferred Drug: Epclusa, Harvoni, Sovaldi, Technivie
Prior Authorization Criteria for Preferred Drug

Prescriber Requirements
 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

Prescriber Requirements
 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, adequate control of mental health conditions, alcohol use disorder, 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, 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 use during treatment OR
 are under the care of an addiction medicine/chemical dependency treatment provider and provider attests
that patient agrees to abstain from alcohol use during treatment.
 If the patient has a history of IV drug use, 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 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
initiation of hepatitis C treatment.
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

Patient is 18 years of age or older with a diagnosis of Hepatitis C, genotype 4

AND
Clinical documentation of genotype and subtype are provided at time of request

AND
Pretreatment detectable HCV RNA viral load measured within 1 year of treatment start date are provided at time of
request

AND
Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request
Exclusion Criteria:
1. Clinically significant drug interactions with patient’s existing medications
2. Pregnancy
3. Severe end organ disease and not eligible for transplant (e.g. liver, heart, lung, kidney)
4. Clinically-significant illness or any other major medical disorder that may interfere with patients’ ability to complete a course of
treatment
5. 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)
6. Decompensated liver disease with CPT > 12 or MELD > 20
7. MELD ≤ 20 and one of the following:
a. Cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery
b. Malignancy outside the liver not meeting oncologic criteria for cure
c. Hepatocellular carcinoma
d. Intrahepatic cholangiocarcinoma
e. Hemangiosarcoma
8. Indeterminate HCV genotype
CONTINUITY OF CARE
 At the time of treatment initiation, patient has evidence of Minnesota Health Care Programs (MHCP) insurance coverage
for the duration of treatment
Prior Authorization Criteria for Non Preferred Drug



Patient has met the Preferred Drug Authorization Criteria; AND
Patient’s Creatinine Clearance (CrCL) > 30 mL/min OR currently not on hemodialysis AND
Patient has a contraindication to Zepatier OR ribavirin with at least one of the conditions listed in 1 through 6
7. Patient is currently taking organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors, strong inducers of
cytochrome P450 3A, or efavirenz
8. Known hypersensitivity reactions to ribavirin such as Stevens-Johnson syndrome, toxic, epidermal necrolysis, and
erythema multiforme
9. Autoimmune hepatitis
10. Hemoglobinopathies
11. Creatinine Clearance (CrCL) < 50 mL/min
12. Coadministration with didanosine
AND


Patient has HCV infection with at least one of the conditions listed in 1 through 4:
1. Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 5 – 10 (CPT Class B/C)
and MELD is ≤ 20; OR
2. Abdominal imaging where radiologist determines findings are suggestive of cirrhosis (e.g. nodules; enlarged
liver, especially the left lobe; tortuous hepatic arteries; ascites; or portal hypertension); OR
3. Evidence of one or more non-invasive tests indicating a fibrosis score of ≥ F3, such as:
i. APRI (AST to platelet ratio index) ≥ 1.5
ii. FibroSURE ≥ 0.49
iii. FibroScan ≥ 7.1
iv. Fibrosis-4 index (FIB-4) > 3.25
v. MR Elastography ≥ 6 kPa
vi. Fibrospect ≥ 42
4. HCV infection with one of the following:
i. Post solid organ transplant (e.g. Heart, Kidney, Liver)
ii. Awaiting Liver transplant
iii. Stage I-III Hepatocellular Carcinoma meeting Milan Criteria
iv. HCV Infection post liver transplant
v. Severe complications of HCV as defined below
A. Type 2 or Type 3 essential mixed cryoglobulinemia with end organ manifestations
B. HCV induced renal disease (e.g. Nephrotic syndrome or membranoproliferative
glomerulonephritis (MPGN)
Tiered Approach to Non Preferred Drug for Genotype 4
Tier
1
Non Preferred Drug
Technivie
2
Harvoni
3
Epclusa
4
Sovaldi
PA Criteria
Must meet all PA criteria for non preferred drug above and have a contraindication to
Zepatier
Must meet all PA criteria for non preferred drug above and have a contraindication to
Zepatier and Technivie
Must meet all PA criteria for non preferred drug above and have a contraindication to
Zepatier and Technivie and supply clinical rationale as to why Harvoni cannot be used
Must meet all PA criteria for non preferred drug above and have a contraindication to
Zepatier and Technivie and supply clinical rationale as to why Harvoni and Epclusa
cannot be used; and
Must be used in combination with peg-INF-alfa and ribavirin
Denial Criteria
• Combination therapy with Epclusa, Harvoni, Sovaldi, Technivie
• Use of Zepatier for genotypes other than 1 and 4
Duration of Treatment
• 12 weeks
• 16 weeks of Zepatier in combination with ribavirin if patient is peginerferon alfa + ribavirin-experienced
Hepatitis C Genotype 5 & 6: Epclusa, Harvoni
Preferred Drug: Harvoni
Non Preferred Drug: Epclusa
Prior Authorization Criteria for Preferred Drug

Prescriber Requirements
 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

Prescriber Requirements
 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, adequate control of mental health conditions, alcohol use disorder, 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, 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 use during treatment OR
 are under the care of an addiction medicine/chemical dependency treatment provider and provider attests
that patient agrees to abstain from alcohol use during treatment.
 If the patient has a history of IV drug use, 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 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
initiation of hepatitis C treatment
 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

Patient is 18 years of age or older with a diagnosis of Hepatitis C, genotype 5 or 6
AND

Clinical documentation of genotype and subtype are provided at time of request

AND
Pretreatment detectable HCV RNA viral load measured within 1 year of treatment start date are provided at time of
request

AND
Provider attests to submit SVR12 results to the Department via fax at 651-431-7424 or upon request
Exclusion Criteria:
1. Creatinine Clearance (CrCL) < 30 mL/min or on hemodialysis
2. Clinically significant drug interactions with patient’s existing medications
3. Pregnancy
4. Severe end organ disease and not eligible for transplant (e.g. liver, heart, lung, kidney)
5. Clinically-significant illness or any other major medical disorder that may interfere with patients’ ability to complete a course of
treatment
6. 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)
7. Decompensated liver disease with CPT > 12 or MELD > 20
8. MELD ≤ 20 and one of the following:
a. Cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery
b. Malignancy outside the liver not meeting oncologic criteria for cure
c. Hepatocellular carcinoma
d. Intrahepatic cholangiocarcinoma
e. Hemangiosarcoma
9. Indeterminate HCV genotype
CONTINUITY OF CARE
 At the time of treatment initiation, patient has evidence of Minnesota Health Care Programs (MHCP) insurance coverage
for the duration of treatment
Prior Authorization Criteria for Non Preferred Drug


Patient has met the Preferred Drug Authorization Criteria; AND
Provide a clinical rationale as to why Harvoni cannot be used
AND

Patient has HCV infection with at least one of the conditions listed in 1 through 4:
1. Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 5 – 10 (CPT Class B/C)
and MELD is ≤ 20; OR
2. Abdominal imaging where radiologist determines findings are suggestive of cirrhosis (e.g. nodules; enlarged
liver, especially the left lobe; tortuous hepatic arteries; ascites; or portal hypertension); OR
3. Evidence of one or more non-invasive tests indicating a fibrosis score of ≥ F3, such as:
i. APRI (AST to platelet ratio index) ≥ 1.5
ii. FibroSURE ≥ 0.49
iii. FibroScan ≥ 7.1
iv. Fibrosis-4 index (FIB-4) > 3.25
v. MR Elastography ≥ 6 kPa
vi. Fibrospect ≥ 42
4. HCV infection with one of the following:
i. Post solid organ transplant (e.g. Heart, Kidney, Liver)
ii. Awaiting Liver transplant
iii. Stage I-III Hepatocellular Carcinoma meeting Milan Criteria
iv. HCV Infection post liver transplant
v. Severe complications of HCV as defined below
A. Type 2 or Type 3 essential mixed cryoglobulinemia with end organ manifestations
B. HCV induced renal disease (e.g. Nephrotic syndrome or membranoproliferative
glomerulonephritis (MPGN)
Denial Criteria
• Combination therapy with Harvoni
• Use of Harvoni for genotypes other than 5 and 6
Duration of Treatment
• 12 weeks
MHCP Provider Call Center 651-431-2700 or 800-366-5411