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New York State Medicaid Preferred Drug Program Epclusa® Prior Authorization Worksheet Fax Number: (800) 268-2990 Enrollee Information ENROLLEE NAME: ENROLLEE MEDICAID ID NUMBER (2 LETTERS, 5 NUMBERS, 1 LETTER): ENROLLEE DATE OF BIRTH: GENDER: Female Male Prescriber Information PRESCRIBER NAME: CONTACT PERSON: 10-DIGIT NPI NUMBER: OFFICE PHONE NUMBER: ( ) - OFFICE FAX NUMBER: ( ) - Are you a gastroenterologist, hepatologist, transplant physician, or infectious disease specialist? YES NO If no, are you working in collaboration with a specialist listed above? YES NO If no, do you have clinical experience with the management and treatment of hepatitis c virus (HCV) infection? YES NO Clinical experience is defined as the management AND treatment of at least 10 patients with HCV infection within the past 12 months and at least 10 HCV-related CME credits in the last 12 months. Clinical Criteria MEDICAL STATUS Diagnosis (Please check all that apply): Chronic Hepatitis C Infection HCV Genotype: Has documentation confirming genotype been submitted? Has the patient had a baseline quantitative HCV RNA level completed? Baseline quantitative HCV RNA ________ IU/mL Date completed: Yes 5 Yes Yes No 6 No No Hepatic laboratory testing completed at baseline? Yes No Please check the box that best describes the patient’s cirrhosis status? No cirrhosis Compensated cirrhosis (Child-Pugh A) Decompensated cirrhosis (Child-Pugh B or C) Yes Yes Yes No No No Was screening for evidence of current or prior Hepatitis B virus (HBV) infection completed? Yes No 1 2 3 4 ___________ Health care professionals should screen all patients for evidence of current or prior HBV infection before starting treatment with DAAs, and monitor patients using blood tests for HBV flare-ups or reactivation during treatment and post-treatment follow-up. PREGNANCY For female patients of child bearing potential: Has a negative pregnancy test been collected within 30 days prior to initiation of therapy OR medical record submitted documenting pregnancy status? Yes No Yes ____ No Yes Yes No No Yes No TREATMENT HISTORY Was the current Epclusa® regimen initiated at another healthcare facility or previously covered by another health plan? If yes, how many weeks of previous therapy have been completed prior to the date of this request? Please check the box that best describes the patient’s HCV Treatment status: Treatment-naïve Treatment-experienced If treatment-experienced is the patient non-responder to: Pegylated interferon + ribavirin For billing questions, call 1-800-343-9000. For clinical concerns or Preferred Drug Program questions, visit www.nyhealth.gov and http://newyork.fhsc.com or call 1-877-309-9493. © 2016, Magellan Health Services, Inc. All Rights Reserved. Magellan Medicaid Administration Zepatier Prior Authorization Worksheet Pegylated interferon + ribavirin + HCV protease inhibitor (telaprevir, boceprevir or simeprevir) Other: Yes No TREATMENT READINESS Please indicate which of the following scales/assessment tools was used to evaluate the readiness of the patient (only one is required): SAMHSA-HRSA Center for Integrated Health Solutions – Drug & Alcohol Screening Tools – Available at: http://www.integration.samhsa.gov/clinical-practice/screening-tools If checked, please provide the name of SAMSHA-HRSA drug and alcohol screening tool used (required): Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) – Available at: www.prepc.org Has the patient demonstrated treatment readiness, including the ability to adhere to the prescribed treatment regimen? Yes No CONTINUATION OF THERAPY REQUESTS **THIS PORTION IS NOT REQUIRED FOR INITIAL THERAPY REQUESTS WEEK 4 ( ±2 WEEKS) HCV RNA LEVEL: DATE TAKEN: WEEK 12 ( ±2 WEEKS) HCV RNA LEVEL: DATE TAKEN: Has documentation confirming HCV RNA levels at the appropriate week been submitted? Yes No Has the patient completed all HCV evaluation appointments and procedures and demonstrated compliance to their treatment regimen? Yes No CURRENT TREATMENT REGIMEN Please indicate the treatment regimen that is being prescribed: HCV Genotype Specific Patient Population with or without Cirrhosis (if applicable) Treatment Regimen Treatment Duration Epclusa Epclusa 12 weeks 12 weeks Epclusa + RBV 12 weeks Epclusa Epclusa Epclusa + RBV 12 weeks 12 weeks 12 weeks Preferred Regimens (Genotypes 2 and 3 only) 2,3 Patients without cirrhosis 2,3 Patients with compensated cirrhosis (Child-Pugh A) 2,3 Patients with decompensated cirrhosis (Child-Pugh B and C) Non-Preferred Regimens (Genotype 1, 4, 5, 6)* 1, 4, 5, 6 1, 4, 5, 6 1, 4, 5, 6 Patients without cirrhosis Patients with compensated cirrhosis (Child-Pugh A) Patients with decompensated cirrhosis (Child-Pugh B and C) A dosage recommendation cannot be made for patients with severe renal impairment or end stage renal disease *Please consider using another Hepatitis C Direct Acting Antivirals for Genotypes 1, 4, 5 and 6: Harvoni (genotypes 1, 4, 5, and 6) Technivie (genotype 4) Viekira Pak/Viekira XR (genotype 1) Zepatier (genotypes 1 and 4) Please provide dosing information for the treatment regimen selected above: Epclusa DIRECTIONS: 1 tablet daily with or without food Ribavirin Other Ribavirin Product Other Revision Date: November 2016 STRENGTH: DIRECTIONS: STRENGTH: DIRECTIONS: QUANTITY: REFILLS: QUANTITY: REFILLS: QUANTITY: For billing questions, call 1-800-343-9000. For clinical concerns or Preferred Drug Program questions, visit www.nyhealth.gov and http://newyork.fhsc.com or call 1-877-309-9493. REFILLS: Page 2 Magellan Medicaid Administration Zepatier Prior Authorization Worksheet Please answer the following questions if requesting a non-preferred ribavirin product as part of treatment: Patient has experienced a treatment failure with a preferred drug. Yes No Patient has experienced an adverse drug reaction with a preferred drug. Yes No There is a documented history of successful therapeutic control with a non-preferred drug and transition to a preferred drug is medically contraindicated. Yes No Other (Please specify the clinical reason the patient is unable to use a preferred agent in the same drug class. If necessary, fax additional pages): Please provide any additional information that should be considered in the space below: I attest that this is medically necessary for this patient and that all of the information on this form is accurate to the best of my knowledge. I attest that documentation of the above diagnosis and medical necessity is available for review if requested by New York Medicaid. PRESCRIBER’S SIGNATURE Revision Date: November 2016 DATE For billing questions, call 1-800-343-9000. For clinical concerns or Preferred Drug Program questions, visit www.nyhealth.gov and http://newyork.fhsc.com or call 1-877-309-9493. Page 3 Sofosbuvir/Velpatasvir (Epclusa®) Sofosbuvir/velpatasvir (Epclusa®) is the first fixed-dose combination drug approved for the treatment of chronic hepatitis C virus (HCV) infection in genotypes 1, 2, 3, 4, 5, and 6.1 It is indicated for patients without cirrhosis or with compensated cirrhosis (ChildPugh A), and in patients with decompensated cirrhosis (Child-Pugh B or C) in combination with ribavirin (RBV). Sofosbuvir/velpatasvir, a fixed-dose combination of 2 direct-acting antiviral (DAA) agents, received Food and Drug Administration (FDA) approval in June 2016. Sofosbuvir is an HCV nucleotide analog NS5B polymerase inhibitor. Velpatasvir is a pangenotypic HCV NS5A inhibitor. Both compounds interfere with viral replication. Advantages of sofosbuvir/velpatasvir Sofosbuvir/velpatasvir is taken orally once daily, with or without food, in an adult patient.1 It is available in a fixed-dose combination tablet containing 400 mg of sofosbuvir and 100 mg of velpatasvir. Treatment duration is 12 weeks for all patients with genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) or decompensated cirrhosis (Child-Pugh B or C). The concurrent use of RBV is recommended in patients with decompensated cirrhosis (Child-Pugh B or C). Published phase 3 trials have demonstrated the efficacy of sofosbuvir/velpatasvir in patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection. The primary endpoint was defined as HCV RNA less than the lower level of quantification (<25 IU/mL) at 12 weeks post-treatment (SVR12). Published phase III trials: Trial Population Treatment Duration SVR12 Rates GT 1, 2, 4, 5, and 6 TN and TE, without cirrhosis or with compensated cirrhosis Epclusa® 12 weeks 99% (618/624) ASTRAL-12 Placebo 12 weeks 0% (0/116) GT 2 TN and TE, without cirrhosis or with compensated cirrhosis Epclusa® 12 weeks 99% (133/134) SOF + RBV 12 weeks 94% (124/132) Epclusa® 12 weeks 95% (264/277) SOF + RBV 24 weeks 80% (221/275) Epclusa® 12 weeks 83% (75/90) Epclusa® + RBV 12 weeks 94% (82/87) Epclusa® 24 weeks 86% (77/90) ASTRAL-23 ASTRAL-33 ASTRAL-44 GT 3 TN and TE, without cirrhosis or with compensated cirrhosis GT 1, 2, 3, 4, and 6 TN and TE, with decompensated cirrhosis (Child-Pugh B) GT = genotype; RBV = ribavirin; SOF = sofosbuvir; SVR = sustained virologic response; TE = treatment-experienced subjects (including those who have failed a peginterferon alfa + ribavirin based regimen with or without an HCV protease inhibitor); TN = treatment-naive subjects. Updated 2/22/2017 Cautions1 Prior to initiating therapy with any HCV direct acting antiviral (DAA) agent, all patients should be tested for evidence of current or prior hepatitis B virus (HBV) infection by measuring hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (antiHBs) and hepatitis B core antibody (anti-HBc). In patients with serologic evidence of HBV infection, monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during treatment with a DAA agent and during post-treatment follow-up. Coadministration of sofosbuvir/velpatasvir with amiodarone is not recommended due to risk of serious symptomatic bradycardia. Sofosbuvir/velpatasvir should not be used with other products that contain sofosbuvir. Sofosbuvir/velpatasvir should not be used with P-glycoprotein (P-gp) inducers and/or moderate CYP inducers, including rifampin, St. John’s wort, and carbamazepine. Coadministration would decrease concentrations of velpatasvir and/or sofosbuvir and may potentially reduce therapeutic effect. Velpatasvir is an inhibitor of drug transporters P-gp, breast cancer resistance protein (BCRP), organic anion-transporting polypeptide (OATP) 1B1, OATP1B3, and OATP2B1. Coadministration of sofosbuvir/velpatasvir with drugs that are substrates of these transporters may increase the exposure of such drugs. Drugs, such as antacids, histamine-2 (H-2) receptor antagonists and proton pump inhibitors (PPI) that increase gastric pH may decrease the concentration of velpatasvir. For patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m 2) or end stage renal disease, no dosing recommendations are available. No dosage adjustment of sofosbuvir/velpatasvir is recommended for geriatric patients or patients with hepatic impairment. For patients with decompensated cirrhosis, clinical and hepatic laboratory monitoring (including direct bilirubin) is recommended. Sofosbuvir/velpatasvir itself has no contraindications. The sofosbuvir/velpatasvir + ribavirin combination is contraindicated in all patients in which ribavirin is contraindicated. No adequate human data are available to evaluate what risk sofosbuvir/velpatasvir poses to pregnancy outcomes, if any. Ribavirin is Pregnancy Category X. Sofosbuvir/velpatasvir + ribavirin is contraindicated in pregnant women and male partners of pregnant women.5 Safety and effectiveness of sofosbuvir/velpatasvir has not been established in pediatric patients, human immunodeficiency virus (HIV) co-infected patients or liver transplantation recipients. Where does sofosbuvir/velpatasvir fit into therapy and how should it be used? In January 2014, The American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) in collaboration with the International Antiviral Society – USA, launched www.hcvguidelines.org for the purpose of disseminating expert opinion on management of chronic HCV as newer HCV DAA become available and treatment evidence emerges. It is likely that guidelines for optimal regimens will continue to evolve and will need to integrate patient-specific as well as economic factors. Many patient-specific factors must be taken into consideration when deciding to initiate therapy and baseline host and viral factors will affect relapse rates and treatment duration. The goal of treatment is undetectable HCV RNA at least 12 weeks post-treatment (SVR12). Sofosbuvir/velpatasvir is included in the guidelines and is recommended for patients with HCV genotype 1, 2, 3, 4, 5, or 6 infection that are either treatment-naïve or experienced. Additionally, the fixed-dose combination is an option for patients with compensated or decompensated cirrhosis. Sofosbuvir/velpatasvir treatment regimen and duration recommendations (per FDA-approved indications)1 HCV Genotype 1, 2, 3, 4, 5, 6 RBV = ribavirin Updated 2/22/2017 Patient Population Recommended Treatment Duration Treatment-naïve or experienced without cirrhosis 12 weeks Treatment-naïve or experienced with compensated cirrhosis (Child-Pugh A) 12 weeks Treatment-naïve or experienced with decompensated cirrhosis (Child-Pugh B or C) 12 weeks + RBV References: 1. Sofosbuvir and velpatasvir (Epclusa®) [package insert]. Gilead Sciences, Inc. Foster City, CA; June 2016. http://hcvadvocate.org/hepatitis/factsheets_pdf/epclusa_pi.pdf. Accessed July 1, 2016. 2. Feld JJ, Jacobson IM, Hézode C, et al. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. NEJM. 2015;373(27):2599-2607. 3. Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. NEJM. 2015;373(27):2608-2617. 4. Curry MP, O’Leary JG, Bzowej N, et al. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. NEJM. 2015;373(27):26182628. 5. Ribavirin (COPEGUS®) [package insert]. Roche Laboratories, Inc. Nutley, NJ; December 2002. http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21511_Copegus_lbl.pdf. Accessed July 2, 2016. Updated 2/22/2017 Sofosbuvir/Velpatasvir Initiation and Monitoring Once patient readiness for chronic hepatitis C virus (HCV) treatment has been determined, the algorithm below outlines key decision points for initiating and monitoring combination therapy including sofosbuvir. Note: Ribavirin is contraindicated in pregnancy; therefore all female patients of childbearing age (or female partners of male patients) should ensure they are not pregnant prior to beginning treatment with ribavirin and should use 2 methods of non-hormonal birth control throughout treatment. Also note that HCV RNA testing should be conducted using a sensitive assay. Prior to initiating HCV DAA therapy, test all patients for evidence of HBV infection by measuring HBsAg, anti-HBs, and anti-HBc Has the patient been diagnosed with HCV genotype 1, 2, 3, 4, 5, or 6 and received quantitative HCV RNA testing NO STOP Yes Without cirrhosis or with compensated (Child Pugh A) cirrhosis: sofosbuvir/velpatasvir 1 tablet daily for 12 weeks Decompensated (Child Pugh B or C) cirrhosis: sofosbuvir/velpatasvir 1 tablet daily with ribavirin for 12 weeks Obtain HCV RNA level 12 weeks after the end of treatment to determine sustained virologic response (SVR 12) anti-HBc = hepatitis B core antibody; anti-HBs = hepatitis B surface antibody; DAA = direct acting antiviral; HBsAg = hepatitis B surface antigen Updated 2/22/2017