PRIOR AUTHORIZATION PROTOCOL FOR HEPATITIS C TREATMENT

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1 PRIOR AUTHORIZATION PROTOCOL FOR HEPATITIS C TREATMENT HARVONI (90mg ledipasvir/400mg sofosbuvir): tablet (PREFERRED AGENT) SOVALDI (sofosbuvir ): 400mg tablets (PREFERRED AGENT ) OLYSIO (simeprivir) PEG-INTRON (peginterferon alfa 2b) RIBAVIRIN tablets or capsules PEGASYS (peginterferon alfa 2a) VICTRELIS (boceprevir) VIEKIRA PAK (Ombitasvir 12.5mg, paritaprevir 75mg, ritonavir 50mg tablets and dasabuvir 250mg) TECHNIVIE (Ombitasvir 12.5mg, paritaprevir 75mg, ritonavir 50mg tablets) DAKLINZA (Daclatasvir) ANY OTHER NEWLY MARKETED AGENT for treatment of Hepatitis C NOTE: WHERE APPLICABLE AND APPROPRIATE FOR GENOTYPE, if the request is for a treatment regimen that includes any other direct acting antiviral (DAA) other than HARVONI or SOVALDI, the patient has a documented medical reason (intolerance, hypersensitivity, contraindication, etc.) for not using HARVONI or SOVALDI. (Please see TREATMENT SUMMARY BELOW) The presence of ANY of the following excludes approval: 1. Severe or uncontrolled co-morbidities 2. Severe renal impairment or End Stage Renal Disease (ESRD), (with the exception of Viekira Pak without Ribavirin) 3. Contraindication to any component of the treatment regimen All Initial requests MUST meet the following requirements: 1. Patient Age 18 or older, AND 2. Patient does not have a limited life expectancy of less than 12 months due to non-liver related comorbid conditions, (complete medical history, co-morbidities and complications of liver disease have been provided), AND 3. Patient has one of the following: History of liver transplant,or Is HIV co-infected or HBV co-infected, OR Serious extrahepatic manifestations of Hepatitis C such as leukocytoclastic vasculitis, membranoproliferative glomerulonephritis, or symptomatic cryoglobulinemia, OR A Metavir fibrosis score of F2-F4 documented by a liver biopsy, OR A Metavir fibrosis score of F2-F4 documented by Fibroscan, OR A Metavir fibrosis score of F2-F4 documented by a blood test, OR Physical findings consistent with substantial or advanced fibrosis or cirrhosis Hospitalization within the past 12 months for a condition attributed to hepatic cirrhosis, OR History of hepatic encephalopathy requiring medication management and/or hospitalization Within the past 12 months, OR History of portal hypertension as demonstrated by variceal bleeding or radiographic evidence or Transjugular Intrahepatic Portsystemic Shunt (TIPS) procedure, AND 4. Lab testing within three (3) months of starting treatment (copy of results required): ALT/AST Genotype Detectable HCV RNA viral load CBC (for treatment regimens with ribavirin, and hemoglobin is at least 10g/dL) GFR HIV CD4 Count (if HIV co-infected)

2 TSH (for interferon regimens) INR 5. Lab testing within one (1) month of starting treatment (copy of results required): Pregnancy test in women of childbearing age (for treatment regimens with ribavirin), with patient agreeing to use two or more forms of contraception, and will have monthly pregnancy tests during therapy, AND 6. If the patient is actively abusing alcohol or IV drugs, or has a history of abuse documentation has been provided of prescriber counseling regarding the risks of alcohol or IV drug abuse, and offer of referral for substance abuse disorder treatment, AND 7. If the patient has a history of failed treatment due to non-adherence, documentation has been provided that the causes of non-adherence have been corrected or addressed, AND 8. The dose that has been prescribed for the patient is consistent with the dosing recommendations listed below, and is prescribed by a specialist in hepatology / gastroenterology / infectious disease/ or transplant, AND 9. Presence of previous treatment, treatment regimen and response, AND 10. If the patient is cirrhotic, there is documentation of compensated or decompensated disease, AND 11. Provider has addressed all potential drug interactions with Hepatitis C regimen (including discontinuation of the interacting drug, dose reduction, or counseling of the patient of the risks associated with the use of both medications), AND 12. The beneficiary will be referred to participate in Hepatitis C educational and counseling program provided by the health plan. AND 13. Physician has provided a standing lab order with the request to authorize and obtain SVR12 as required. Treatment for patients with Hepatitis C Genotypes 1, 2, 3, or 4 infections with Hepatocellular Carcinoma: All initial requests must meet the following additional requirement Documentation of testing confirming the diagnosis of Hepatocellular Carcinoma through either Imaging Testing (such as Ultrasound, Computed Tomography, Magnetic Resonance Imaging), Laparoscopy, or Biopsy. Treatment of recurrent HCV infection post liver transplant: (Does not require patient to have advanced to severe fibrosis) Documentation of liver transplant including date of transplant, treatment history and current HCV Viral Load Contraindications to treatment with interferon: 1. A baseline neutrophil count below 1500/uL, a baseline Platelet count below 90,000/uL or baseline hemoglobin below 10g/dL 2. Autoimmune Hepatitis and other autoimmune disorders 3. Hypersensitivity to PEG (Pegylated interferon) or any of its components 4. Decompensated Hepatic disease 5. History of depression or clinical features consistent with depression 6. History of preexisting cardiac disease 7. Transplant of kidney, heart, or other solid organ (excluding liver transplant) Contraindications to treatment with ribavirin: 2. GFR < Pregnancy 4. Hemoglobinopathy

3 Contraindications to treatment with Sovaldi: 2. HCV monotherapy 3. Significant drug drug interactions 4. GFR<30 Contraindications to treatment with : 1. GFR<30 *not listed in package insert, per sofosbuvir labeling the medication has not been studied in this group of patients Contraindications to treatment with Viekira Pak: 2. Severe hepatic impairment 3. Concurrent use of drugs highly dependent on CYP3A4 for clearance and for which elevated plasma levels are associated with serious and/or life-threatening events 4. Concurrent use of strong inducers of CYP3A and CYP2C8 or strong inhibitors of CYP2C8 Contraindications to treatment with Technivie: 2. Severe hepatic impairment 3. Concurrent use of drugs highly dependent on CYP3A for clearance; moderate and strong inducers of CYP3A Contraindications to treatment with Daklinza: 2. Strong inducers of CYP3A, including phenytoin, carbamazepine, rifampin, and St. John s wort. APPROVAL CONSIDERATIONS MUST BE REVIEWED BY MEDICAL DIRECTOR FOR MEDICAL NECESSITY Dose and Duration of Therapy: (SEE TREATMENT SUMMARY THAT FOLLOWS) Approvals of requests will be consistent with package labeling or current guidelines, at FDA approved dosing. These regimens are subject to change as newly marketed agents become available. ALL regimens are for 28 day supply per fill (See REFILL CONSIDERATIONS BELOW).

4 Hepatitis C Treatment Treatment Summary (Preferred regimens are in BOLD) TREATMENT NAÏVE- Genotype 1a with Viral load < 6 million Genotype 1b with Viral load < 6 million Genotype 1a with Viral load > 6 million Genotype 1b with Viral load > 6 million Genotype 2 Sovaldi with Ribavirin [<75 kg] to 1200 mg [>75 kg]) 8 weeks (or if patient coinfected with HIV) Genotype 3 Daklinza with Sovaldi (Class 1, Level A) Sovaldi with Ribavirin and PEG-IFN (Class 1, Level A) Genotype 4 Genotype 5 Genotype 6 TREATMENT NAÏVE-WITH CIRRHOSIS Genotype 1a Genotype 1b Genotype 2 Genotype 3 Sovaldi with Ribavirin [<75 kg] to 1200 mg [>75 kg]) Sovaldi with Ribavirin and PEG-IFN [<75 kg] to 1200 mg [>75 kg]) (Class 1, Level A) Daklinza with Sovaldi (interferon ineligible) (Class IIa, Level C) -16 weeks *treatment to 16 weeks must be on a case by case basis Genotype 4 Genotype 5 Genotype 6

5 PREVIOUSLY TREATED PATIENTS No Cirrhosis or Compensated Cirrhosis GENOTYPE FAILED TREATMENT REGIMEN TREATMENT OPTIONS DURATION PEG-IFN /Ribavirin OR Sovaldi/ PEG-IFN and Ribavirin Incivek OR Victrelis OR Olysio/ PEG-IFN and Ribavirin Olysio and Sovaldi No recommendations at this time-defer treatment No recommendations at this time-defer treatment PEG-IFN /Ribavirin (Ribavirin ineligible) OR Sovaldi/ PEG-IFN and Ribavirin Incivek OR Victrelis OR Olysio/ PEG-IFN and Ribavirin (Ribavirin ineligible) Olysio and Sovaldi Previous treatment with any protein 5A (NS5A) inhibitors (daclatasvir/sofosbuvir, ledipasvir/sofosbuvir, or paritaprevir/ritonavir/ombitasvir plus dasabuvir) Refer to current guidelines after testing for resistanceassociated variants that confer decrease susceptibility to NS3 protease inhibitors and to NS5A inhibitors. Genotype 2 PEG-IFN /Ribavirin Sovaldi with Ribavirin and [>75 kg]) Sovaldi with Ribavirin (interferon ineligible) (weightbased RBV (1000 mg [<75 kg] to 1200 mg [>75 kg]) 16-*treatment to 24 weeks must be on a case by case basis

6 Genotype 2 Sovaldi/Ribavirin Sovaldi with Ribavirin and [>75 kg]) Genotype 3 PEG-IFN /Ribavirin Daklinza with Sovaldi (Class I, Level A) Sovaldi with Ribavirin and [>75 kg]) (Class I, Level A) Genotype 3 PEG-IFN /Ribavirin Sovaldi with Ribavirin and [>75 kg]) (Class I, Level A) Daklinza with Sovaldi and Ribavirin (interferon ineligible) (Class IIa, Level C) Genotype 3 Sovaldi with Ribavirin and PEG-IFN (Class IIa Level C) Daklinza with Sovaldi and Ribavirin (weight-based RBV [>75 kg]) (Class IIa Level C) Genotype 4 PEG-IFN /Ribavirin Genotype 5 PEG-IFN /Ribavirin Genotype 6 PEG-IFN /Ribavirin Genotype 1 and 4 DE OR HEPATOCELLULAR CARCINOMA (initial dose of 600 mg, increased as tolerated) (Class IIb, Level C) Daklinza with (low initial dose of 600mg, increased as tolerated) (Class II, Level A) Daklinza with Sovaldi (Ribavirin ineligible) (Class IIb, Level C) (Previously treated with Sovaldi) Genotype 2 and 3 Daklinza with (low initial dose of 600mg, increased as tolerated) (Class II, Level A) [<75 kg] to 1200 mg [>75 kg]) (Class IIb, Level B) **may be approved for up to 48 weeks once confirmation patient has not yet received transplant

7 Genotype 5 and 6 No recommendations at this timedefer treatment No recommendations at this time-defer treatment POST TRANSPLANT Genotype 1 or 4, Compensated Cirrhosis [<75 kg] to 1200 mg [>75 kg] (Class I. Level B) Genotype 2, Compensated Cirrhosis Daklinza with (low initial dose of 600mg, increased as tolerated) (Class I, Level B) (Ribavirin ineligible) (Class I, Level B) Daklinza with (low initial dose of 600mg, increased as tolerated) (Class II, Level A) [<75 kg] to 1200 mg [>75 kg]) (Class IIb, Level C) Daklinza with Sovaldi (ribavirin ineligible) (Class IIb, Level C) Genotype 3, Compensated Cirrhosis [<75 kg] to 1200 mg [>75 kg]) (Class I, Level B) Daklinza with (low initial dose of 600mg, increased as tolerated) (Class II, Level A) Daklinza with Sovaldi (ribavirin ineligible) (Class IIb, Level C) Genotype 3, Decompensated Cirrhosis (initial dose of 600 mg, increased as tolerated) (Class I, Level B) Continuation of therapy to be completed by Health Plan or Case Management REFILL CONSIDERATIONS: 1. The health plan will reach out to all members approved for treatment, with the intent to educate and ensure successful completion of the regimen. 2. The health plan will guide and reinforce compliance through ongoing interaction with the member. 3. Repeat viral load at treatment week 4, week 8, week 12 and following completion of therapy to establish SVR. If quantitative HCV viral load is detectable at week 4 of treatment, repeat quantitative HCV RNA viral load testing is recommended after 2 additional weeks of treatment (treatment week 6). If quantitative HCV viral load has increased by greater than 10-fold (>1 log10 IU/mL) on repeat testing at week 6 (or thereafter), then discontinuation of HCV treatment is recommended. Revision/Review Date: 9 /2015

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