Mavyret (glecaprevir/pibrentasvir)
|
|
- Kory Nash
- 6 years ago
- Views:
Transcription
1 (glecaprevir/pibrentasvir) Override(s) Prior Authorization Quantity Limit Medication (glecaprevir/pibrentasvir) Approval Duration Based on Genotype, Treatment Status, or Cirrhosis Status. Quantity Limit 3 tablets per day APPROVAL DURATION Genotype and Status (HCV mono-infected) Genotypes 1, 2, 3, 4, 5, or 6 (treatment-naïve*, without cirrhosis) Genotypes 1, 2, 3, 4, 5, or 6 (treatment-naïve*, with compensated cirrhosis) Genotype 1 (treatment-experienced ± with an NS5A inhibitor 2 and without prior treatment with an NS3/4A protease inhibitor 3, with compensated cirrhosis or without cirrhosis) Genotype 1 (treatment-experienced ± with an NS3 /4A protease inhibitor 3 and without prior treatment with an NS5A inhibitor 2, with compensated cirrhosis or without cirrhosis) Genotype 3 (dual* treatment-experienced or triple treatment-experienced, with compensated cirrhosis or without cirrhosis) Genotypes 1, 2, 4, 5, or 6 (dual* treatmentexperienced, or triple treatment-experienced, without cirrhosis) Genotypes 1, 2, 4, 5, and 6 (dual* treatmentexperienced, or triple treatment-experienced, with compensated cirrhosis) Associated Treatment Regimens Total Approval Duration for (glecaprevir/pibrentasvir) 8 weeks 12 weeks 16 weeks 12 weeks 16 weeks 8 weeks 12 weeks 2 = NS5A inhibitor regimens included ledipasvir and sofosbuvir or daclatasvir with peginterferon and ribavirin. 3 = NS3/4A protease inhibitor regimens included simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with peginterferon and ribavirin. *The ENDURANCE-1, -2,-4 (AASLD October 2016 abstracts); EXPEDITION-IV (Gane AASLD abstract 2016); SURVEYOR-I (Kwo 2017; EASL April 2016); and SURVEYOR-II parts 2-4 (Kwo 2017; EASL April 2016) clinical trials define dual treatment-experienced as a prior trial of interferon/peginterferon and ribavirin and/or sofosbuvir. PAGE 1 of 7 09/01/2017 WEB-PEC
2 ± The MAGELLAN-1 part 1 (Poordad et al. 2016, 2017) clinical trial defines DAA treatment-experienced as a prior trial of NS3/4A protease inhibitors; (simeprevir, asunaprevir, boceprevir, telaprevir, paritaprevir) OR NS5A inhibitors (ledipasvir, daclatasvir, ombitasvir). The ENDURANCE-1, -2,-4; EXPEDITION-IV; and SURVEYOR-I, -II clinical trials define triple treatmentexperienced as a prior trial of peginterferon, ribavirin, and sofosbuvir. APPROVAL CRITERIA Requests for (glecaprevir/pibrentasvir) may be approved if the following criteria are met: I. Individual is 18 years of age or older; AND II. A copy of the baseline quantitative hepatitis C virus (HCV) RNA test result is provided to document baseline level of viremia; AND III. One of the following: A. Documentation is provided for an FDA approved, compendia supported, or Medicaid covered diagnosis of chronic hepatitis C (CHC) infection, which includes a positive HCV RNA test result at least 6 months following either a baseline positive HCV RNA result or reactive HCV antibody test (AASLD/IDSA 2017, CDC 2013); OR B. Individual is unable to delay treatment for 6 months owing to concurrent factors [such as but not limited to, advanced liver disease (Metavir fibrosis stage of F3 or F4 2 ), post liver transplant recipients, co infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV), coexistent liver diseases (such as nonalcoholic steatohepatitis), chronic HCV infection associated extrahepatic manifestations (such as membranoproliferative glomerulonephritis, glomerular disease, cryoglobulinemia syndrome)] (AASLD/IDSA 2017); AND C. Documentation is provided for an FDA approved, compendia supported, or Medicaid covered diagnosis of CHC infection, which includes a reactive HCV antibody (CDC 2013), and a subsequent positive HCV RNA result (CDC 2013); AND IV. Individual does not have a short life expectancy (less than 12 months owing to non-liver related comorbid conditions) that cannot be remediated by treating HCV, by transplantation or other directed therapy (AASLD/IDSA 2017); AND V. Individual has compensated liver disease 1 (with or without cirrhosis); AND VI. Individual is using in the following antiviral treatment regimen: A. As monotherapy for one of the following: 1. Individual is treatment-naïve, with compensated 1 cirrhosis or without cirrhosis, and Genotypes 1, 2, 3, 4, 5, or 6; OR 2. Individual is treatment-experienced with a prior HCV NS5A inhibitor regimen (ledipasvir and sofosbuvir or daclatasvir with peginterferon with ribavirin) without prior HCV treatment with an NS3/4A protease inhibitor (simeprevir and sofosbuvir or simeprevir, boceprevir, telaprevir with PAGE 2 of 7 09/01/2017
3 VIII. peginterferon and ribavirin) with compensated 1 cirrhosis or without cirrhosis, and Genotype 1; OR 3. Individual is treatment-experienced with a prior HCV NS3/4A protease inhibitor regimen (simeprevir and sofosbuvir or simeprevir, boceprevir, telaprevir with peginterferon and ribavirin) without prior HCV treatment with an NS5A inhibitor (ledipasvir and sofosbuvir or daclatasvir with peginterferon with ribavirin), with compensated cirrhosis 1 or without cirrhosis, and Genotype 1; OR 4. Individual is dual or triple treatment-experienced (peginterferon/interferon and ribavirin, or peginterferon and ribavirin and sofosbuvir) but without prior treatment-experience with an HCV NS3/4A protease inhibitor regimen (simeprevir and sofosbuvir or simeprevir, boceprevir, telaprevir with peginterferon and ribavirin) or NS5A inhibitor (ledipasvir and sofosbuvir or daclatasvir with peginterferon with ribavirin), with compensated cirrhosis 1 or without cirrhosis, and Genotypes 1, 2, 3, 4, 5, or 6. AND Prescriber meets the following experience and training ( A. Prescriber is a hepatologist, gastroenterologist, infectious disease specialist, transplant physician or health care practitioner experienced and trained in the treatment of Hepatitis C viral (HCV) or a healthcare practitioner under the direct supervision of a listed specialist; AND B. Prescriber has clinical experience defined as: 1. Management and treatment of at least 10 patients with HCV infection in the last 12 months and at least 10 HCV- related CME credits in the last 12 months; OR 2. Management and treatment of HCV infection in partnership (defined as consultation, preceptorship, or via telemedicine) with an experienced HCV provider who meets the above criteria (glecaprevir/pibrentasvir) may not be approved for the following: I. Individual has moderate to severe hepatic impairment (Child-Pugh Class B-C); OR II. Individual is requesting in concurrent therapy with contraindicated or not recommended agents, such as but not limited to atazanavir and rifampin; OR III. Individual is using in combination with a regimen containing a non-nucleoside NS5B polymerase inhibitor (such as dasabuvir) or nucleotide NS5B polymerase inhibitor [such as sofosbuvir, ledipasvir/sofosbuvir, sofosbuvir/velpatasvir, or sofosbuvir/velpatasvir/voxilaprevir]; OR IV. Individual is using in combination with a regimen containing another NS5A inhibitor [such as daclatasvir, ledipasvir/sofosbuvir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, ombitasvir, or sofosbuvir/velpatasvir/voxilaprevir]; OR PAGE 3 of 7 09/01/2017
4 V. Individual is using in combination with a regimen containing another NS3/4A protease inhibitor [such as simeprevir, elbasvir/grazoprevir, paritaprevir, or sofosbuvir/velpatasvir/voxilaprevir]; OR VI. Individual is requesting the regimen for re-treatment and either failed to achieve a SVR (defined as a lower limit HCV RNA of 25 IU/mL) or relapsed after achieving a SVR during a prior successfully completed treatment regimen consisting of sofosbuvir/velpatasvir, elbasvir/grazoprevir, ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir, sofosbuvir/velpatasvir/voxilaprevir. Notes: 1. Compensated Liver Disease: According to the American Association for the Study of Liver Diseases (AASLD, 2009, 2016), the specific criteria for compensated liver disease include all of the following: a total bilirubin; serum albumin; prothrombin time/inr; presence of ascites; and presence of hepatic encephalopathy. However, these criteria do not establish a comprehensive definition of compensated liver disease. The AASLD guidance refers to compensated liver disease as Class A based on the Child Pugh-Turcotte (CPT) classification scoring system Child Pugh Classification (AASLD/IDSA 2016) Parameters Points Assigned 1 point 2 points 3 points Total Bilirubin (µmol/l) < >50 Serum Albumin (g/l) > <28 Prothrombin time/inr < >2.30 Ascites None Mild Moderate to Severe Hepatic Encephalopathy None Grade I-II (or suppressed with medication Grade III-IV (or refractory) Child Pugh Score Interpretation (AASLD/IDSA 2009, 2016) Class A 5-6 points Well compensated liver disease Class B 7-9 points Significant functional compromise (moderate hepatic impairment) Class C points Uncompensated liver disease (severe hepatic impairment) 2. Metavir Scoring System for Fibrosis Staging (AASLD 2009): Stage (F) 0 No Fibrosis 1 Periportal fibrotic expansion 2 Periportal septae 1 (septum) 3 Porto central septae 4 Cirrhosis PAGE 4 of 7 09/01/2017
5 3. Hepatitis C virus (HCV) direct acting antiviral (DAA) agents have a black box warning for risk of hepatitis B virus (HBV) reactivation in individuals with HCV-HBV co-infection. Individuals should be tested for evidence of current or prior HBV infection prior to initiation of DAA therapy. HBV reactivation has been reported in HCV/HBV co-infected individuals currently taking or previously completed DAA therapy and not concomitantly receiving HBV antiviral therapy. Some cases of HBV reactivation have led to fulminant hepatitis, hepatic failure, and death. Individuals should be monitored for hepatitis flare or HBV reactivation during and following HCV DAA therapy. Individuals should be appropriately managed for HBV infection as indicated. Key References: American Association for the Study of Liver Diseases. Diagnosis, Management, and Treatment of Hepatitis C: An Update. AASLD Practice Guidelines. Hepatology. 2009; 49(4): Available from: Accessed on: February 9, American Association for the Study of Liver Diseases and the Infectious Disease Society of America, in collaboration with the International Antiviral Society-USA. Recommendations for testing, managing and treating hepatitis C. Available at Published on: January 29, Updated on: September 27, Accessed on: May 12, Bourliere M, Gordon SC, Flamm SL et al. Sofosbuvir, velpatasvir, and voxilaprevir for previously treated HCV infection. New Engl J Med. 2017; 22: Bruix J and Sherman M. Management of Hepatocellular Carcinoma: An Update. An American Association for the Study of Liver Disease Practice Guideline. Hepatology. 2005; 42(5): Accessed on: February 9, Centers for Disease Control and Prevention. Testing for HCV Infection: An Update of Guidance for Clinicians and Laboratorians. MMWR. 2013; 62(18): Available from: Accessed on: February 9, Charlton M, Gane E, Manns MP, et. al. Sofosbuvir and Ribavirin for Treatment of Compensated Recurrent Hepatitis C Virus Infection After Liver Transplantation. Available from: Gastroenterology. 2015; 148(1): Accessed on: February 9, Curry MP, O Leary JG, Bzowej N, ASTRAL-4 Investigators, et al. Sofosbuvir and Velpatasvir for HCV in Patients with Decompensated Cirrhosis. N Engl J Med. 2015; 373: Available from: Accessed on: February 9, DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health website. Accessed on: March 1, Del Bello D, Cha A, Sorbera M, et al. Real-World Sustained Virologic Response Rates of Sofosbuvir-Containing Regimens in Patients Coinfected With Hepatitis C and HIV. Clin Infect Dis. 2016; 62(12): doi: /cid/ciw119. European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C J Hepatol. 2017; 66(1): Available from: Accessed on: February 9, Feld JJ, Jacobson IM, Hezode C, ASTRAL-1 Investigators, et al. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015; 373: Available from: Accessed on: February 9, PAGE 5 of 7 09/01/2017
6 Fontana RJ, Brown Jr RS, Moreno-Zamora A, et al. Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection. Liver Transpl. 2016; 22(4): doi: /lt Forns X, Charlton M, Denning J, et al. Sofosbuvir Compassionate Use Program for Patients With Severe Recurrent Hepatitis C After Liver Transplantation. Hepatology. 2015; 61 (5): Available from: Accessed on: February 9, Foster GR, Afdhal N, Roberts SK, ASTRAL-2 and ASTRAL-3 Investigators, et al. Sofosbuvir and Velpatasvir for HCV Genotype 2 and 3 Infection. N Engl J Med. 2015; 373: Available from: Accessed on: February 9, Foster GR, Irving WL, Cheung MC, et al. Impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis J Hepatol. 2016; 64(6): doi: /j.jhep Herzer K, Papadopoulos-Kohn A, Walker A, et al. Daclatasvir, Simeprevir and Ribavirin as a Promising Interferon-Free Triple Regimen for HCV Recurrence after Liver Transplant. Digestion. 2015; 91(4): doi: / Incivek [Package insert]. Cambridge, MA. Vertex Pharmaceuticals Incorporated, Available from: Accessed on: February 9, Kwo P, Poordad F, Astryan A, et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatology. 2017; 67: [Package insert]. North Chicago, IL. AbbVie Inc Available from: Accessed on August 3, Nelson DR, Cooper JN, Lalezari JP, et al. All-Oral 12-Week Treatment With Daclatasvir Plus Sofosbuvir in Patients With Hepatitis C Virus Genotype 3 Infection: ALLY-3 Phase III Study. Hepatology. 2015; 61(4): Available from: Accessed on: February 9, PL Detail-Document, Cytochrome P450 Drug Interactions. Pharmacist s Letter/Prescriber s Letter. May PL Detail-Document, OATP Drug Interactions. Pharmacist s Letter/Prescriber s Letter. March PL Detail-Document, P-glycoprotein Drug Interactions. Pharmacist s Letter/Prescriber s Letter. April Poordad F, Schiff ER, Vierling JM, et al. Daclatasvir With Sofosbuvir and Ribavirin for Hepatitis C Virus Infection With Advanced Cirrhosis or Post-Liver Transplantation Recurrence. Hepatology. 2016; 63(5): Available from: Accessed on: February 9, Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus Sofosbuvir for Previously Treated or Untreated Chronic HCV Infection. N Engl J Med. 2014; 370(3): Available from: Accessed on: February 9, U.S. Food & Drug Administration. Drugs@FDA: FDA Approved Drug Products (Package inserts). Available from: Accessed on: February 17, Vosevi [Package insert]. Foster City, CA. Gilead Science, Incorporated, Available from: Accessed on: July 20, Wyles DL, Ruane PJ, Sulkowski MS, et al. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV- 1. N Engl J Med. 2015; 373(8): Available from: Accessed on: February 9, PAGE 6 of 7 09/01/2017
7 Welzel TM, Petersen J, Ferenci P, et al. Safety and efficacy of daclatasvir plus sofosbuvir with or without ribavirin for the treatment of chronic HCV genotype 3 infection: Interim results of a multicenter European compassionate use program. 66th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) [Abstract 37]. Hepatology. 2015; 62 (1): 225A. Available from: Accessed on: February 9, PAGE 7 of 7 09/01/2017
Mavyret (glecaprevir/pibrentasvir)
Mavyret (glecaprevir/pibrentasvir) Override(s) Approval Duration Prior Authorization Based on Genotype, Treatment Status, or Quantity Limit Cirrhosis Status. **South Carolina, Indiana and Washington Medicaid
More informationSovaldi (sofosbuvir)
Market DC Sovaldi (sofosbuvir) Override(s) Prior Authorization Quantity Limit Approval Duration Based on Genotype, Treatment status, Cirrhosis status, or Ribavirin Eligibility status **IN, SC, WA Medicaid
More informationHarvoni (sofosbuvir/ledipasvir
Market DC Override(s) Prior Authorization Quantity Limit (sofosbuvir/ledipasvir) Approval Duration Based on Genotype, Treatment status, Baseline HCV RNA status, Cirrhosis status, Transplant status, or
More informationSovaldi (sofosbuvir) GA Medicaid
Sovaldi (sofosbuvir) GA Medicaid Override(s) Prior Authorization Quantity Limit Medication Sovaldi (sofosbuvir) Approval Duration Based on Genotype, Treatment status, Cirrhosis status, Hepatocellular Carcinoma
More informationPegylated Interferon Agents for Hepatitis C
Applicable X X X X X X X Pegylated Interferon Agents for Hepatitis C Override(s) Prior Authorization Quantity Limit Initial for Monotherapy or Combination with Ribavirin based on Genotype, Status, or Co-Infection
More informationHARVARD PILGRIM HEALTH CARE RECOMMENDED MEDICATION REQUEST GUIDELINES
HARVARD PILGRIM HEALTH CARE Generic Brand HICL GCN Exception/Other DACLATASVIR DAKLINZA 41377 ELBASVIR/GRAZOPREVIR ZEPATIER 43030 GLECAPREVIR/PIBRENTASVIR MAVYRET 44453 OMBITASVIR/PARITAPREVIR/ RITONAVIR
More informationHepatitis C Prior Authorization Policy
Hepatitis C Prior Authorization Policy Line of Business: Medi-Cal P&T Approval Date: November 15, 2017 Effective Date: January 1, 2018 This policy has been developed through review of medical literature,
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C First Generation Agents Page 1 of 16 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C First Generation Agents - Through Preferred
More informationPHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline
PHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline Preferred Regimen Based on Diagnosis: Mavyret (glecaprevir/pibrentasvir ) Non-Preferred: Daklinza (daclatasvir) Epclusa (sofosbuvir/velpatasvir)
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C First Generation Agents Page 1 of 18 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C First Generation Agents - Through Preferred
More informationDrug Class Prior Authorization Criteria Hepatitis C
Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: Interim (pending P&T approval) Effective Date: July 1, 2018 This policy has been developed through review
More informationDrug Class Prior Authorization Criteria Hepatitis C
Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: Interim Criteria Pending P&T Approval Effective Date: August 16, 2018 This drug class prior authorization
More informationVosevi (sofosbuvir/velpatasvir/voxilaprevir)
Vosevi (sofosbuvir/velpatasvir/voxilaprevir) Policy Number: 5.01.646 Last Review: 10/2017 Origination: 10/2017 Next Review: 11/2018 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide
More informationDrug Class Monograph
Drug Class Monograph Class: Chronic Hepatitis C Drugs(s): Daclatasvir (Daklinza), Dasabuvir/ombitasivir/paritaprevir/ritonavir (Viekira Pak), Elbasvir/grazoprevir (Zepatier), Peginterferon alfa-2a (Pegasys),
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C Second Generation Antivirals Page 1 of 30 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C Second Generation Antivirals Through
More informationDrug Class Monograph
Drug Class Monograph Class: Chronic Hepatitis C Drugs(s): Daclatasvir (Daklinza), Dasabuvir/ombitasivir/paritaprevir/ritonavir (Viekira XR), Elbasvir/grazoprevir (Zepatier), Peginterferon alfa-2a (Pegasys),
More informationMedical Policy An independent licensee of the Blue Cross Blue Shield Association
Hepatitis C Second Generation Antivirals Page 1 of 32 Medical Policy An independent licensee of the Blue Cross Blue Shield Association Title: See also: Hepatitis C Second Generation Antivirals Through
More informationChronic Hepatitis C Drug Class Monograph
Chronic Hepatitis C Drug Class Monograph Line of Business: Medi-Cal Effective Date: July 10, 2017 (Interim Guidelines; Final Review and Approval by the P&T Subcommittee Pending) This policy has been developed
More informationClinical Criteria for Hepatitis C (HCV) Therapy
Diagnosis Clinical Criteria for Hepatitis C (HCV) Therapy Must have chronic hepatitis C (HCV infection > 6 months), genotype and sub-genotype specified to determine the length of therapy; Liver biopsy
More informationChronic Hepatitis C Drug Class Prior Authorization Protocol
Line of Business: Medi-Cal Effective Date: August 16, 2017 Revision Date: August 16, 2017 Chronic Hepatitis C Drug Class Prior Authorization Protocol This policy has been developed through review of medical
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Harvoni) Reference Number: CP.CPA.175 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
More informationHepatitis C Resistance Associated Variants (RAVs)
Hepatitis C Resistance Associated Variants (RAVs) Atif Zaman, MD MPH Oregon Health & Science University Professor of Medicine Division of Gastroenterology and Hepatology Nothing to disclose Disclosure
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Epclusa) Reference Number: CP.CPA.286 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
More information2017 UnitedHealthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 1146-7 Program Prior Authorization/Notification Medication Harvoni (ledipasvir/sofosbuvir) P&T Approval Date 10/2014, 2/2015,
More informationClinical Policy: Glecaprevir/Pibrentasvir (Mavyret) Reference Number: HIM.PA.SP36 Effective Date: Last Review Date: 06.18
Clinical Policy: (Mavyret) Reference Number: HIM.PA.SP36 Effective Date: 08.01.17 Last Review Date: 06.18 Line of Business: HIM Revision Log See Important Reminder at the end of this policy for important
More informationPHARMACY PRIOR AUTHORIZATION Hepatitis C Clinical Guideline
Preferred Regimen Based on Diagnosis: Mavyret (glecaprevir/pibrentasvir) PHARMACY PRI AUTHIZATION Hepatitis C Clinical Guideline Non-Preferred: Daklinza (daclatasvir) Epclusa (sofosbuvir/velpatasvir) Harvoni
More informationMonitoring Patients Who Are Starting HCV Treatment, Are On Treatment, Or Have Completed Therapy
Monitoring Patients Who Are Starting HCV Treatment, Are On Treatment, Or Have Completed Therapy WV ECHO August 10, 2017 Selection of patients for HCV treatment Despite current guidance to treat everyone,
More informationHepatitis C Agents
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.41 Subject: Hepatitis C Agents Page: 1 of 19 Last Review Date: December 8, 2017 Hepatitis C Agents
More informationHepatitis C Agents
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.41 Subject: Hepatitis C Agents Page: 1 of 20 Last Review Date: March 16, 2018 Hepatitis C Agents Description
More informationClinical Policy: Simeprevir (Olysio) Reference Number: CP.CPA.289 Effective Date: Last Review Date: Line of Business: Commercial
Clinical Policy: (Olysio) Reference Number: CP.CPA.289 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
More informationCurrent trends in CHC 1st genotype treatment
Current trends in CHC 1st genotype treatment Tarik Asselah MD, PhD Professor of Medicine Hepatology, Chief INSERM UMR 1149, Hôpital Beaujon, Clichy, France Disclosures Employee of Paris Public University
More informationClinical Policy: Daclatasvir (Daklinza) Reference Number: HIM.PA.SP27 Effective Date: Last Review Date: 06.18
Clinical Policy: (Daklinza) Reference Number: HIM.PA.SP27 Effective Date: 01.01.17 Last Review Date: 06.18 Line of Business: HIM Revision Log See Important Reminder at the end of this policy for important
More informationHepatitis C Virus Clinical Criteria Update September 18, For: New York State Medicaid
Hepatitis C Virus Clinical Criteria Update September 18, 2014 For: New York State Medicaid 1 Purpose Characterize the place in therapy for the agents utilized for management of chronic hepatitis C (CHC)
More informationHepatitis C Update: What s New in 2017
Hepatitis C Update: What s New in 2017 Cody A. Chastain, MD Assistant Professor of Medicine Viral Hepatitis Program Division of Infectious Diseases Vanderbilt University Medical Center Cody.a.Chastain@Vanderbilt.edu
More informationClinical Policy: Daclatasvir (Daklinza) Reference Number: CP.CPA.283 Effective Date: Last Review Date: Line of Business: Commercial
Clinical Policy: (Daklinza) Reference Number: CP.CPA.283 Effective Date: 11.01.16 Last Review Date: 08.18 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for
More informationHepatitis C Genotypes
9/2/21 OBJECTIVES Project ECHO HCV Collaborative HCV in 21: New Therapies and New Opportunities Paulina Deming, PharmD Assistant Director Hepatitis C Programs, ECHO Institute Associate Professor College
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Vosevi) Reference Number: CP.HNMC.41 Effective Date: 07.26.17 Last Review Date: 11.17 Line of Business: Medicaid Medi-Cal Revision Log See Important Reminder at the end of this policy
More informationClinical Policy: Daclatasvir (Daklinza) Reference Number: ERX.SPA.131 Effective Date:
Clinical Policy: (Daklinza) Reference Number: ERX.SPA.131 Effective Date: 10.01.16 Last Review Date: 08.18 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
More informationTreating HCV Prior to Liver Transplantation. What Are the Treatment Options? Xavier Forns Liver Unit Hospital Clinic, CIBEREHD, IDIBAPS Barcelona
Treating HCV Prior to Liver Transplantation What Are the Treatment Options? Xavier Forns Liver Unit Hospital Clinic, CIBEREHD, IDIBAPS Barcelona Disclosures Unrestricted Grant Support: Janssen and Abbvie
More informationCriteria for Indiana Medicaid Hepatitis C Agents
Prepared for State of Indiana by OptumRx EXECUTIVE SUMMARY Purpose: Promote prudent prescribing of Setting & Population: All members Type of Criteria: Increased Risk of ADE Non-Preferred Agent Appropriate
More informationHCV in 2017: New Therapies and New Opportunities. Presentation prepared by: Date prepared: OBJECTIVES
Project ECHO HCV Collaborative HCV in 217: New Therapies and New Opportunities Paulina Deming, PharmD Assistant Director Hepatitis C Programs, ECHO Institute Associate Professor College of Pharmacy University
More informationPharmacy Medical Necessity Guidelines: Medications for the Treatment of Hepatitis C
Pharmacy Medical Necessity Guidelines: Medications for the Treatment of Hepatitis C Effective: July 1, 2018 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical
More information2017 UnitedHealthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2052-10 Program Prior Authorization/Medical Necessity Medication Harvoni (ledipasvir/sofosbuvir) P&T Approval Date 4/2015, 8/2015,
More informationJOHNS HOPKINS HEALTHCARE
JOHNS HOPKINS HEALTHCARE Subject: Clinical Criteria for Hepatitis C (HCV) Therapy Department: Pharmacy Lines of Business: PPMCO Policy Number: MEDS92 Effective Date: 04/15/2015 Revision Date: 08/15/2015
More informationRATIONALE FOR INCLUSION IN PA PROGRAM
RATIONALE FOR INCLUSION IN PA PROGRAM Background Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with
More informationDrug Class Prior Authorization Criteria Hepatitis C
Drug Class Prior Authorization Criteria Hepatitis C Line of Business: Medicaid P & T Approval Date: November 14, 2018 Effective Date: January 1, 2019 This drug class prior authorization criteria have been
More informationClinical Policy: Ledipasvir/Sofosbuvir (Harvoni) Reference Number: HIM.PA.SP3 Effective Date: Last Review Date: Line of Business: HIM
Clinical Policy: (Harvoni) Reference Number: HIM.PA.SP3 Effective Date: 08.01.16 Last Review Date: 06.18 Line of Business: HIM Revision Log See Important Reminder at the end of this policy for important
More informationSASKATCHEWAN FORMULARY BULLETIN Update to the 62nd Edition of the Saskatchewan Formulary
April 1, 2017 Bulletin #165 ISSN 1923-0761 SASKATCHEWAN FORMULARY BULLETIN Update to the 62nd Edition of the Saskatchewan Formulary Related Information for Prescribers: Only prescribers who have completed
More informationHepatitis C Virus Management
Hepatitis C Virus Management FDA-Approved Medications Hepatitis C is caused by a virus and results in liver inflammation, which can lead to advanced liver disease and/or liver cancer. An estimated 3 to
More informationClinical Criteria for Hepatitis C (HCV) Therapy
Clinical Criteria for Hepatitis C (HCV) Therapy Pre-Treatment Evaluation o Must have chronic hepatitis C and HCV genotype and sub-genotype documented; o Patients who have prior exposure to DAA therapy
More informationLength of Authorization: 8-16 weeks. Requires PA: All direct-acting antivirals for treatment of Hepatitis C. Approval Criteria
Hepatitis C Direct-Acting Antivirals Goals: Approve use of cost-effective treatments supported by the evidence. Provide consistent patient evaluations across all hepatitis C treatments. Ensure appropriate
More informationHepatitis C (Direct Acting Antiviral Medications for Treatment of Hepatitis C) No Fibrosis Score Requirement HMO and PPO (except Control)
Hepatitis C (Direct Acting Antiviral Medications for Treatment of Hepatitis C) No Fibrosis Score Requirement HMO and PPO (except Control) Policy Number: Original Effective Date: MM.04.036 06/01/2015 Lines
More informationPharmacy Coverage Guidelines are subject to change as new information becomes available.
DIRECT ACTING ANTIVIRAL AGENTS FOR HEPATITIS C VIRUS (HCV): DAKLINZA (daclatasvir) oral tablet EPCLUSA (velpatasvir, sofosbuvir) oral tablet HARVONI (ledipasvir, sofosbuvir) oral tablet MAVYRET (glecaprevir,
More informationMolina Healthcare of Texas Hepatitis C Drugs (Medicaid)
Texas Standard Prior Authorization Form Addendum Molina Healthcare of Texas Hepatitis C Drugs (Medicaid) This fax machine is located in a secure location as required by HIPAA Regulations. Complete / Review
More informationPharmacy Medical Necessity Guidelines: Medications for the Treatment of Hepatitis C
Pharmacy Medical Necessity Guidelines: Medications for the Treatment of Hepatitis C Effective: March 13, 2018 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical
More informationPrimary Care Approach to Diagnosis and Management of Chronic Hepatitis C Brian Viviano, D.O.
Primary Care Approach to Diagnosis and Management of Chronic Hepatitis C Brian Viviano, D.O. Objectives Epidemiology of chronic hepatitis C CDC guidelines on screening or hepatitis C Diagnosing hepatitis
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2132-1 Program Prior Authorization/Medical Necessity Medication Mavyret (glecaprevir/pibrentasvir) P&T Approval Date 9/2017 Effective
More informationPrior Authorization Guideline
Prior Authorization Guideline Guideline Name Olysio (simeprevir) Formulary UnitedHealthcare Community & State Formulary Note Approval Date 2/19/2014 Revision Date 7/9/2014 1. Indications Drug Name: Olysio
More informationClinical Criteria for Hepatitis C (HCV) Therapy
Clinical Criteria for Hepatitis C (HCV) Therapy Pre-Treatment Evaluation o Must have chronic hepatitis C and HCV genotype and sub-genotype documented; o Patients who have prior exposure to DAA therapy
More informationLength of Authorization: 8-16 weeks. Requires PA: All direct-acting antivirals for treatment of Hepatitis C. Approval Criteria
Hepatitis C Direct-Acting Antivirals Goals: Approve use of cost-effective treatments supported by the medical evidence. Provide consistent patient evaluations across all hepatitis C treatments. Ensure
More informationGenotype 1 Treatment Naïve No Cirrhosis Options
Genotype 1 Treatment Naïve No Cirrhosis Options Elbasvir/Grazoprevir (Zepatier ) x 12 weeks 1 Glecaprevir/Pibrentasvir (Mavyret ) x 8 weeks Ledipasvir/Sofosbuvir (Harvoni ) x 8-12 weeks 2 1 If genotype
More informationPharmacy Medical Necessity Guidelines: Hepatitis C Virus
Pharmacy Medical Necessity Guidelines: Hepatitis C Virus Effective: January 1, 2018 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review Pharmacy (RX)
More informationLength of Authorization: 8-16 weeks. Requires PA: All direct-acting antivirals for treatment of Hepatitis C. Approval Criteria
Hepatitis C Direct-Acting Antivirals Goals: Approve use of cost-effective treatments supported by the evidence. Provide consistent patient evaluations across all hepatitis C treatments. Ensure appropriate
More informationHEPATITIS C: UPDATE AND MANAGEMENT
HEPATITIS C: UPDATE AND MANAGEMENT José Franco, MD Professor of Medicine Associate Dean for Educational Improvement Associate Director, Kern Institute STAR Center Director José Franco, MD Disclosures I
More informationSubject: Hepatitis C Drug Therapy
09-J0000-53 Original Effective Date: 01/01/06 Reviewed: 07/11/18 Revised: 11/15/18 Subject: Hepatitis C Drug Therapy THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION
More informationHepatitis C Elimination: Screening, Linkage and Treatment. Eric Lawitz, MD The Texas Liver Institute San Antonio, Texas
Hepatitis C Elimination: Screening, Linkage and Treatment Eric Lawitz, MD The Texas Liver Institute San Antonio, Texas Hepatitis C: Worldwide Presence Worldwide prevalence: 130-150 million Viral hepatitis
More informationOutpatient Pharmacy Effective Date: August 15, 2014
Therapeutic Class Code: W5Y, W5V, W0B, W0D, W0A, W0E Therapeutic Class Description: Hepatitis C Virus nucleotide analog NS5B RNA Dependent Polymerase Inhibitor, Hepatitis C Virus NS3/4A Serine Protease
More information10/21/2016. Susanna Naggie, MD, MHS Associate Professor of Medicine Duke University Durham, North Carolina. Learning Objectives
A Crash Course on the AASLD/IDSA Hepatitis C Virus Infection Treatment Guidelines: What s New Susanna Naggie, MD, MHS Associate Professor of Medicine Duke University Durham, North Carolina FORMATTED: 1/3/16
More informationDescription of Antivirals for Hepatitis C. LCDR Dwayne David, PharmD, BCPS, NCPS Cherokee Nation Infectious Diseases
Description of Antivirals for Hepatitis C LCDR Dwayne David, PharmD, BCPS, NCPS Cherokee Nation Infectious Diseases Dwayne-David@cherokee.org Objectives Compare the different classes of direct-acting antiviral
More informationTreatment of HCV infection in daily clinical practice. Which are the optimal options for Genotypes 2 and 3? Jiannis Vlachogiannakos
Treatment of HCV infection in daily clinical practice. Which are the optimal options for Genotypes 2 and 3? Jiannis Vlachogiannakos Associate Professor of Gastroenterology Academic Department of Gastroenterology
More informationClinical Policy: Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) Reference Number: GA.PMN.25 Product: Medicaid Effective Date: 9/17
Clinical Policy: Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi) Reference Number: GA.PMN.25 Product: Medicaid Effective Date: 9/17 Last Review Date: 9/17 Revision Log See Important Reminder at the end of
More information5/12/2016. Learning Objectives. Management of Hepatitis C Virus Genotype 2 or 3 Infected Treatment-Naive or Experienced Patients
5/12/216 Management of Hepatitis C Virus Genotype 2 or 3 Infected Treatment-Naive or Experienced Patients Alexander Monto, MD Professor of Clinical Medicine University of California San Francisco San Francisco,
More informationTopic: Sovaldi, sofosbuvir Date of Origin: March 14, Committee Approval Date: August 15, 2014 Next Review Date: March 2015
Medication Policy Manual Policy No: dru332 Topic: Sovaldi, sofosbuvir Date of Origin: March 14, 2014 Committee Approval Date: August 15, 2014 Next Review Date: March 2015 Effective Date: October 1, 2014
More informationSOFOSBUVIR/VELPATASVIR Generic Brand HICL GCN Exception/Other SOFOSBUVIR/ VELPATASVIR
Generic Brand HICL GCN Exception/Other SOFOSBUVIR/ VELPATASVIR EPCLUSA 43561 GUIDELINES FOR USE 1. Is the patient at least 18 years old? If yes, continue to #2. 2. Does the patient have a diagnosis of
More informationTreatment of Hepatitis C with sofosbuvir/ledipasvir (Harvoni )
Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana, Inc.(collectively referred to as the Company ), unless otherwise provided
More informationManagement of HCV in Decompensated Liver Disease
Management of HCV in Decompensated Liver Disease Michael P. Manns Hannover Medical School (MHH) Department of Gastroenterology, Hepatology and Endocrinology Helmholtz Center for Infection Research (HZI),
More informationHepatitis C Policy Discussion
Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program Oregon State University, 500 Summer Street NE, E35 Salem, Oregon 97301-1079 Phone 503-947-5220 Fax 503-947-1119
More informationUnitedHealthcare Pharmacy Clinical Pharmacy Programs
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 1231-1 Program Prior Authorization/Notification Medication Mavyret (glecaprevir/pibrentasvir) P&T Approval Date 9/2017 Effective
More informationUpdate on Hepatitis C. Francesco Negro Hôpitaux Universitaires de Genève Berne, November 15, 2017
Update on Hepatitis C Francesco Negro Hôpitaux Universitaires de Genève Berne, November 15, 2017 The global prevalence of HCV was 1 0% (95% uncertainty interval 0 8 1 1) in 2015: 71 1 million (62 5 79
More informationNew Antivirals for Hep C in Context of HIV: Vosevi and Mavyret
New Antivirals for Hep C in Context of HIV: Vosevi and Mavyret John Scott, MD, MSc, FIDSA November 16, 2017 This presentation is intended for educational use only and does not in any way constitute medical
More informationThe Changing World of Hepatitis C
The Changing World of Hepatitis C Alnoor Ramji Gastroenterology & Hepatology Clinical Associate Professor Division of Gastroenterology University Of British Columbia St. Paul s Hospital Site Disclosures
More informationSASKATCHEWAN FORMULARY BULLETIN Update to the 62nd Edition of the Saskatchewan Formulary
April 1, 2018 Bulletin #170 ISSN 1923-0761 SASKATCHEWAN FMULARY BULLETIN Update to the 62nd Edition of the Saskatchewan Formulary Related Information for Prescribers: The April 1, 2018 updates to existing
More informationClinical Criteria for Hepatitis C (HCV) Therapy
Clinical Criteria for Hepatitis C (HCV) Therapy Pre-Treatment Evaluation o Must have chronic hepatitis C and HCV genotype and sub-genotype documented; o Patients who have prior exposure to DAA therapy
More information2017 Bruce Lucas Hepatology and Liver Transplant Symposium October 13th 2017 Management of Hepatitis C in Pre- and Post-Transplant Patients
2017 Bruce Lucas Hepatology and Liver Transplant Symposium October 13th 2017 Management of Hepatitis C in Pre- and Post-Transplant Patients Jens Rosenau, MD Associate Professor of Medicine Acting Director
More informationNew York State HCV Provider Webinar Series. Side Effects of Therapy
New York State HCV Provider Webinar Series Side Effects of Therapy Objectives Understand the basics of HCV therapy Review the currently available regimens for treatment of HCV Appreciate side effects related
More informationSUMMACARE COMMERCIAL MEDICATION REQUEST GUIDELINES
Generic Brand HICL GCN Exception/Other TELAPREVIR INCIVEK 37629 This drug requires a written request for prior authorization. All requests for hepatitis C medications require review by a pharmacist prior
More informationIt is the policy of health plans affiliated with Centene Corporation that Mavyret is medically necessary when the following criteria are met:
Clinical Policy: (Mavyret) Reference Number: CP.CPA.285 Effective Date: 08.15.17 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important
More informationHepatitis C (Direct Acting Antiviral Medications for Treatment of Hepatitis C) Fibrosis Score Requirement QUEST Integration
Hepatitis C (Direct Acting Antiviral Medications for Treatment of Hepatitis C) Fibrosis Score Requirement QUEST Integration Policy Number: Original Effective Date: MM.04.036 06/01/2015 Lines of Business:
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Mavyret) Reference Number: CP.HNMC.39 Effective Date: 08.15.17 Last Review Date: 11.17 Line of Business: Medicaid Medi-Cal Revision Log See Important Reminder at the end of this policy
More informationMassimo Puoti SC Malattie Infettive AO Ospedale Niguarda Cà Granda, Milano. Eradicazione da HCV e nuove prospettive: Prospetive Terapeutiche future
Massimo Puoti SC Malattie Infettive AO Ospedale Niguarda Cà Granda, Milano Eradicazione da HCV e nuove prospettive: Prospetive Terapeutiche future DAA classes and subclasses Drug Class Subclass Potency
More informationPrior Authorization Guideline
Prior Authorization Guideline Guideline Name Sovaldi (sofosbuvir) Formulary UnitedHealthcare Community & State Formulary Note Approval Date 2/19/2014 Revision Date 7/8/2014 1. Indications Drug Name: Sovaldi
More information2017 United Healthcare Services, Inc.
UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P 2055-10 Program Prior Authorization/Medical Necessity Medication Olysio (simeprevir) P&T Approval Date 4/2015, 11/2015, 8/2016,
More informationHCV Management in Decompensated Cirrhosis: Current Therapies
Treatment of Patients with Decompensated Cirrhosis and Liver Transplant Recipients Paul Y. Kwo, MD, FACG Professor of Medicine Gastroenterology/Hepatology Division Stanford University email pkwo@stanford.edu
More informationSVR Updates from the 2013 EASL
Updates from the 2013 EASL By Tracy Swan, Treatment Action Group Streamlining HCV Treatment Treatment for hepatitis C virus (HCV) is becoming simpler, shorter, and more effective. All-oral combinations
More informationAssociate Professor of Medicine University of Chicago
Nancy Reau, MD Associate Professor of Medicine University of Chicago Management of Hepatitis C: New Drugs and New Paradigms HCV is More Lethal than HIV Infection HCV superseded HIV as a cause of death
More informationHepatitis C: Difficult-to-treat Patients 11th Paris Hepatology Conference 16th January 2018 Stefan Zeuzem, MD University Hospital, Frankfurt, Germany
Hepatitis C: Difficult-to-treat Patients 11th Paris Hepatology Conference 16th January 2018 Stefan Zeuzem, MD University Hospital, Frankfurt, Germany PHC 2018 - www.aphc.info Disclosures Advisory boards:
More informationClinical Policy: Daclatasvir (Daklinza) Reference Number: ERX.SPMN.180
Clinical Policy: (Daklinza) Reference Number: ERX.SPMN.180 Effective Date: 10/16 Last Review Date: 09/16 Coding Implications Revision Log See Important Reminder at the end of this policy for important
More informationUniversal HCV treatment: Strategies for simplification
Universal HCV treatment: Strategies for simplification PARIS HEPATOLOGY CONFERENCE 3 January 217 Tarik Asselah (MD, PhD) Hepatology & Chief INSERM UMR 1149, Hôpital Beaujon, Clichy, France. Disclosures
More informationPrior Approval Criteria Hepatitis C Virus Medications DRAFT
Therapeutic Class Code: W5Y, W5V, W0B, W0D, W0A, W0E Therapeutic Class Description: Hepatitis C Virus nucleotide analog NS5B RNA Dependent Polymerase Inhibitor, Hepatitis C Virus NS3/4A Serine Protease
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Viekira XR, Viekira Pak) Reference Number: ERX.SPA.129 Effective Date: 10.01.16 Last Review Date: 08.17 Line of Business: Commercial [Prescription Drug Plan] Revision Log See Important
More information