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MHCP Enrolled Providers – Pharmacies
Fee-for-Service PA Criteria Sheet – Hepatitis C
(November 2015)
Drugs
Therapeutic Area
Viekira Pak, Daklinza, Technivie, Harvoni, Sovaldi, Olysio
Hepatitis C
To facilitate the PA process, providers are encouraged to fill out the Hepatitis C Drug Prior Authorization Form (DHS-7085) (PDF)
to request authorization of preferred and non-preferred drugs used to treat Hepatitis C.
Hepatitis C drug authorization criteria vary by drug status. Preferred drugs require recipients to meet only preferred drug
authorization criteria before payment. To be eligible for authorization and payment of a non-preferred drug, recipients need to
meet preferred drug authorization criteria and non-preferred drug authorization criteria.
MHCP Preferred Drug List – Hepatitis C – protease/polymerase inhibitors and direct acting antivirals
Preferred Drugs –Genotype 1
Non-Preferred Drugs – Genotype 1
Viekira Pak
Harvoni
Olysio
Sovaldi
Preferred Drugs – Genotype 3
Non-Preferred Drugs – Genotype 3
Daklinza (in combination with Sovaldi)
Sovaldi
Preferred Drugs – Genotype 4 (without cirrhosis)
Technivie
Non-Preferred Drugs – Genotype 4
Sovaldi
Preferred Drug Authorization Criteria (Viekira Pak)

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
 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
 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
 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
<br>
Exclusion Criteria
1. Creatinine Clearance (CrCL) < 30 mL/min or on hemodialysis
2. Pregnant
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 with metastatic spread
d. Intrahepatic cholangiocarcinoma
e. Hemangiosarcoma
<br>
CONTINUITY OF CARE
At the time of treatment initiation patient has evidence of fee-for-service health insurance coverage for the duration of treatment
Preferred Drug Authorization Criteria (Daklinza)
 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
 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
 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
 Daklinza will be administered in conjunction with Sovaldi (sofosbuvir) 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
<br>
Exclusion Criteria
1. Creatinine Clearance (CrCL) < 30 mL/min or on hemodialysis
2. Pregnant
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 with metastatic spread
d. Intrahepatic cholangiocarcinoma
e. Hemangiosarcoma
<br>
CONTINUITY OF CARE
At the time of treatment initiation patient has evidence of fee-for-service health insurance coverage for the duration of treatment
Preferred Drug Authorization Criteria (Technivie)

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
 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
 Patient is 18 years of age or older with a diagnosis of Hepatitis C, genotype 4 AND
 Patient does not have cirrhosis 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
<br>
Exclusion Criteria
1. Creatinine Clearance (CrCL) < 30 mL/min or on hemodialysis
2. Pregnant
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 with metastatic spread
d. Intrahepatic cholangiocarcinoma
e. Hemangiosarcoma
8. Evidence of cirrhosis
<br>
CONTINUITY OF CARE
At the time of treatment initiation patient has evidence of fee-for-service health insurance coverage for the duration of treatment
Non-Preferred Drug Authorization Criteria (Harvoni, Olysio, Sovaldi)



OR




Recipient has met the Preferred Drug Authorization Criteria; AND
Recipient has genotype 2; AND
Recipient has HCV infection with at least one of the conditions listed in 1 through 5:
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. 4. Biopsy > F3;
5. 5. 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)
Recipient has met the Preferred Drug Authorization Criteria; AND
Recipient has genotype 1, 3 or 4; AND
Recipient has a contraindication to a preferred regimen; AND
Recipient has HCV infection with at least one of the conditions listed in 1 through 5:
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. 4. Biopsy > F3;
5. 5. 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)
OR
 Request is for Sovaldi and patient meets criteria for (and will be using) Daklinza for genotype 3.
<br>
Denial Criteria
 Genotype 5 or 6
 Combination therapy with Sovaldi and Olysio
 Use of Harvoni for genotypes other than 1
<br>
Duration of Treatment
HCV Mono-infected and HCV/HIV
co-infected
Treatment
Maximum Duration of
approval*
Genotype 1a without cirrhosis
VIEKIRA PAK + ribavirin
12 weeks
Genotype 1a with cirrhosis
VIEKIRA PAK + ribavirin
12 weeks/24 weeks**
Genotype 1b without cirrhosis
VIEKIRA PAK
12 weeks
Genotype 1b with cirrhosis
VIEKIRA PAK + ribavirin
12 weeks
Genotype 1, treatment-naïve
Genotype 1, treatment-experienced
without cirrhosis
Genotype 1, treatment-experienced with
cirrhosis
Genotype 1, treatment-naïve with prior
relapse
HARVONI
8 weeks/12 weeks
HARVONI
12 weeks
HARVONI
24 weeks
OLYSIO + Peg-IFN-alfa and RBV
12 weeks
Genotype 1, prior non-responders
(including partial and null responders)
Genotype 1 or 4
OLYSIO + Peg-IFN-alfa and RBV
12 weeks
SOVALDI + Peg-IFN-alfa and RBV
12 weeks
Genotype 2
SOVALDI + ribavirin
12 weeks
Genotype 3
DAKLINZA + SOVALDI
12 weeks
Genotype 3
SOVALDI + ribavirin
24 weeks
Genotype 4 without cirrhosis
TECHNIVIE + ribavirin
12 weeks
Hepatocellular carcinoma
SOVALDI + ribavirin
48 weeks or until liver transplantation,
whichever occurs first
**VIEKIRA PAK administered with ribavirin for 12 weeks may be considered for some patients based on prior treatment history
*Duration of treatment based on manufacturer approved FDA label
MHCP Provider Call Center 651-431-2700 or 800-366-5411