Protocol for daclatasvir (Daklinza ) Approved October 2015 (updated February 2018)

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1 PREFERRED AGENTS: (See drug specific NOTES for exceptions.) Protocol for daclatasvir (Daklinza ) Approved October 2015 (updated February 2018) For genotype 1, Mavyret and Zepatier are preferred. For genotypes 2 and 3, Mavyret is preferred. For genotype 4, Epclusa, Mavyret and Zepatier are preferred. NOTE: Request for Daklinza may be approved for individuals with genotype 1, 2, 3 or 4 who meet one of the following criteria AND criteria for approval listed below: I. Individual has had trials and inadequate response to preferred agent(s) of each genotype. OR II. Individual is currently completing a course of therapy with requested agent. OR III. Individual has documented intolerance to any ingredient in the preferred regimen, which is not part of requested nonpreferred regimen. OR IV. Individual is concurrently using an agent that cannot be substituted or temporarily discontinued during the course of hepatitis C treatment (for reasons including but not limited to drug interactions or contraindication to preferred agent). OR V. Individual has a diagnosis of hepatitis C genotype 2 or 3 who is post-liver allograft transplant recipient and requested regimen consists of Daklinza (daclatasvir) + Sovaldi (sofosbuvir) ± ribavirin. CRITERIA FOR APPROVAL: 1. Patient is at least 18 years of age. AND 2. Must be used in combination with sofosbuvir (Sovaldi ). AND 3. Diagnosis of chronic hepatitis C genotype 1*, 2*, 3 or 4*, labs showing genotype and detectable HCV RNA levels from within the past 90 days must be received. AND 4. Patient must have ONE of the following to be considered at highest risk for hepatitis C-related complications (must receive documentation): 4.1 Patient has stage 2 fibrosis (Metavir F2) or higher confirmed by one of the following OR Liver biopsy Transient elastography (FibroScan) score greater than 7.1 kpa FibroTest (FibroSURE) score of greater than or equal to 0.48 APRI score greater than 0.7 FIB-4 (Fibrosis-4 index) greater than 3.25 Radiological imaging consistent with cirrhosis (e.g., evidence of portal hypertension) NJCRX February 2018

2 4.2 Patient is an organ transplant recipient (AASLD/IDSA 2014). OR 4.3 Patient has type 2 or 3 essential mixed cryoglobulinemia with end-organ manifestations (e.g. vasculitis) (AASLD/IDSA 2014). OR 4.4 Patient has nephrotic syndrome or membranoproliferative glomerulonephritis (AASLD/IDSA 2014). OR 4.5 Patient has proteinuria (AASLD/IDSA 2014) as defined by one of the following: One lab result of albumin-to-creatinine ratio (ACR) of greater than 300 mg/g taken within the past 30 days (must receive documentation) One lab result of ACR of greater than or equal to 30 mg/g taken within the past 30 days AND a second lab result of ACR greater than or equal to 30 mg/g taken within 60 days prior to the most recent test (must receive documentation): 4.6 Patient has HIV-1 co-infection (AASLD/IDSA 2014) confirmed by antiretroviral use, on-file diagnosis or lab results. AND 5. Prescribed by one of the following: hepatologist, gastroenterologist, infectious disease specialist, or liver transplant specialist. AND 6. For treatment experienced patients, must receive medication names, length of therapy, and whether patient is a relapser, null responder, partial responder, or treatment naïve to previous Hepatitis C therapy. (Provide medication names, dates of fill or length of therapy from the previous therapy.) 7. Patient has evidence of compliance (adherent to therapy) as demonstrated by refill records. AND 8. Initial quantity dispensed will be limited to 14 days dosage units ( format). AND 9. Patient is not receiving any other hepatitis C therapy except Sovaldi. AND 10. Patient must not have any of the following: 10.1 Severe renal impairment (CrCl < 30 ml/min) 10.2 Contraindications to requested hepatitis C therapy (See PI for complete list.) 10.3 Patient must not be on any therapies identified by the prescribing information or AASLD/IDSA Guidelines as therapies not recommended for coadministration (See PI and guidelines for complete list.) 10.4 Patient has a contraindication or drug interaction to sofosbuvir (Sovaldi ) Limited life expectancy (< 12 months due to non-liver related comorbidities): Per AASLD guidelines 2015, HCV therapy would not improve symptoms or prognosis in this patient population and do not require treatment. 11. For ribavirin intolerant/ineligible requests, the patient must meet at least one of the following (documentation must be received including a copy of lab work from within the past 30 days if applicable for the reason provided): 11.1 Patient has a contraindication to ribavirin. (See PI for complete list.) 11.2 Patient is on therapy identified by the prescribing information or AASLD/IDSA Guidelines as therapies not recommended for coadministration. (See PI and guidelines for complete list.) 11.3 Patient has hemoglobin levels that preclude use of ribavirin. (See PI.) 11.4 Patient previously had a side effect or allergic reaction to ribavirin therapy. 12. For patients with decompensated cirrhosis, the requested drug(s) must be prescribed by Page 2 of 5

3 a liver transplant specialist. Summary of recommendations/duration of treatment Patient population Treatment Total approval duration No prior liver transplant Treatment naïve patients Genotype 1a or 1b (without cirrhosis)* DAK + SOV 12 weeks Genotype 1a or 1b (with compensated cirrhosis)* Genotype 2* (RBV intolerant patients) DAK + SOV 12 weeks Genotype 3 (without cirrhosis) Daklinza + SOV 12 weeks Treatment experienced patients with PEG/RBV Genotype 1* or 3 (without cirrhosis) DAK + SOV 12 weeks Genotype 1* (with compensated cirrhosis) Treatment experienced patients with Incivek/Victrelis + PEG/RBV Genotype 1* (without cirrhosis) DAK + SOV 12 weeks Genotype 1* (with compensated cirrhosis) Patients with decompensated cirrhosis (CTP class B or C) Genotype 1*, 2*, 3 and 4* Post-liver transplant Genotype 1*, 2*, 3 or 4* (treatment naïve, without decompensated cirrhosis) KEY: RBV = Ribavirin; DAK = Daklinza; SOV = Sovaldi DAK + SOV + low initial dose Ribavirin (600 mg, increased as tolerated) DAK + SOV + low initial dose Ribavirin (600 mg, increased as tolerated) 12 weeks 12 weeks * Although indicated for genotype 3 in package insert, August 7, 2015 AASLD Guidelines also recommend use for genotypes 1, 2 and 4. Refer to tables for alternative scoring equivalents and summary of treatment duration. Page 3 of 5

4 Child-Turcotte-Pugh (CTP) classification for severity of cirrhosis Clinical and lab criteria Points* Encephalopathy None Grade 1 or 2 (or precipitant-induced) Grade 3 or 4 (or chronic) Ascites None Mild/Moderate (diuretic-responsive) Severe (diuretic-refractory) Bilirubin (mg/dl) < > 3 Albumin (g/dl) > < 2.8 Prothrombin time (PT) [sec prolonged] or INR < 4 < > 6 > 2.3 * CTP class is obtained by adding score for each parameter (total points) Class A = 5-6 points (least severe liver disease) Class B = 7-9 points (moderately severe liver disease) Class C = points (most severe liver disease) From: Core Concepts. Evaluation and Prognosis of Patients with Cirrhosis (Karla Thornton, MD, MPH) Comparison of scoring systems for histological stage (fibrosis) METAVIR Batts-Ludwig Knodell Ishak Page 4 of 5

5 REFERENCES: American Association for the Study of Liver Diseases (AASLD)/Infectious Disease Society of America (IDSA). Recommendations for Testing, Managing, and Treating Hepatitis C. March, (Summary of Recommendations for When and in Whom to Initiate HCV Therapy. August, 2015). Accessed August 10, 2015 Daklinza [Prescribing Information]. Bristol-Myers Squibb Company; Princeton, NJ; July Page 5 of 5