Genotype 1 Treatment Naïve No Cirrhosis Options
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1 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 1a, test for NS5A RAS first, if present, choose another regimen 2 If < 6 million HCV RNA, non-black, no HIV coinfection = 8 weeks
2 Genotype 1 Treatment Naïve Compensated Cirrhosis Options Elbasvir/Grazoprevir (Zepatier ) x 12 weeks 1 Ledipasvir/Sofosbuvir (Harvoni ) x 12 weeks 1 If genotype 1a, test for NS5A RAS first, if present, choose another regimen
3 Genotype 2 Treatment Naïve No Cirrhosis Options Glecaprevir/Pibrentasvir (Mavyret ) x 8 weeks
4 Genotype 2 Treatment Naïve Compensated Cirrhosis Options
5 Genotype 3 Treatment Naïve No Cirrhosis Options Glecaprevir/Pibrentasvir (Mavyret ) x 8 weeks
6 Genotype 3 Treatment Naïve Compensated Cirrhosis Options
7 Genotype 4 Treatment Naïve No Cirrhosis Options Elbasvir/Grazoprevir (Zepatier ) x 12 weeks 1 Glecaprevir/Pibrentasvir (Mavyret ) x 8 weeks Ledipasvir/Sofosbuvir (Harvoni ) x 12 weeks
8 Genotype 4 Treatment Naïve Compensated Cirrhosis Options Elbasvir/Grazoprevir (Zepatier ) x 12 weeks Ledipasvir/Sofosbuvir (Harvoni ) x 12 weeks
9 Genotype 5 or 6 Treatment Naïve No Cirrhosis Options Glecaprevir/Pibrentasvir (Mavyret ) x 8 weeks Ledipasvir/Sofosbuvir (Harvoni ) x 12 weeks
10 Genotype 5 or 6 Treatment Naïve Compensated Cirrhosis Options Ledipasvir/Sofosbuvir (Harvoni ) x 12 weeks
11 Peginterferon/Ribavirin-Experienced, Genotype 1 Without Cirrhosis Options Elbasvir/Grazoprevir (Zepatier ) x 12 weeks 1 Glecaprevir/Pibrentasvir (Mavyret ) x 8 weeks Ledipasvir/Sofosbuvir (Harvoni ) x 12 weeks 1 If genotype 1a, test for NS5A RAS first, if present, choose another regimen
12 Peginterferon/Ribavirin-Experienced, Genotype 1 With Compensated Cirrhosis Options Elbasvir/Grazoprevir (Zepatier ) x 12 weeks 1 1 If genotype 1a, test for NS5A RAS first, if present, choose another regimen
13 NS3 Protease Inhibitor (Telaprevir, Boceprevir or Simeprevir) + Peginterferon/Ribavirin-Experienced, Genotype 1 Without Cirrhosis Options Ledipasvir/Sofosbuvir (Harvoni ) x 12 weeks
14 NS3 Protease Inhibitor (Telaprevir, Boceprevir or Simeprevir) + Peginterferon/Ribavirin-Experienced, Genotype 1 With Compensated Cirrhosis Options
15 Non-NS5A Inhibitor, Sofosbuvir-Containing Regimen- Experienced, Genotype 1 without Cirrhosis Options regardless of subtype Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi ) x 12 weeks for genotype 1a patients for genotype 1b patients
16 Non-NS5A Inhibitor, Sofosbuvir-Containing Regimen- Experienced, Genotype 1 with Cirrhosis Options regardless of subtype Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi ) x 12 weeks for genotype 1a patients for genotype 1b patients
17 NS5A Inhibitor DAA-Experienced Genotype 1-6 Patients Without Cirrhosis or With Compensated Cirrhosis Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi ) x 12 weeks 1 1 If genotype 3 with cirrhosis, the addition of weight-based ribavirin is recommended
18 Peginterferon/Ribavirin-Experienced, Genotype 2 Without Cirrhosis Options Glecaprevir/Pibrentasvir (Mavyret ) x 8 weeks
19 Peginterferon/Ribavirin-Experienced, Genotype 2 With Compensated Cirrhosis Options
20 Sofosbuvir + Ribavirin-Experienced, Genotype 2 Without Cirrhosis or With Compensated Cirrhosis Options
21 Peginterferon/Ribavirin-Experienced, Genotype 3 Without Cirrhosis Options 1 1 Baseline RAS testing for Y93H is recommended. If detected, choose a different regimen or add weightbased ribavirin.
22 Peginterferon/Ribavirin-Experienced, Genotype 3 Without Cirrhosis Options When Y93H Substitution Is Identified Glecaprevir/Pibrentasvir (Mavyret ) x 16 weeks Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi ) x 12 weeks
23 Peginterferon/Ribavirin-Experienced, Genotype 3 With Compensated Cirrhosis Options Elbasvir/Grazoprevir (Zepatier ) plus Sofosbuvir 400mg x 12 weeks Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi ) x 12 weeks
24 Peginterferon/Ribavirin-Experienced, Genotype 4 Without Cirrhosis Options Elbasvir/Grazoprevir (Zepatier ) x 12 weeks 1 Glecaprevir/Pibrentasvir (Mavyret ) x 8 weeks Ledipasvir/Sofosbuvir (Harvoni ) x 12 weeks 1 Only for patients who experienced virologic relapse, not treatment failure on Peg/Rib
25 Peginterferon/Ribavirin-Experienced, Genotype 4 With Compensated Cirrhosis Options Elbasvir/Grazoprevir (Zepatier ) x 12 weeks 1 1 Only for patients who experienced virologic relapse, not treatment failure on Peg/Rib
26 Peginterferon/Ribavirin-Experienced, Genotype 5 or 6 Without Cirrhosis Options Glecaprevir/Pibrentasvir (Mavyret ) x 8 weeks Ledipasvir/Sofosbuvir (Harvoni ) x 12 weeks 1 If genotype 1a, test for NS5A RAS first, if present, choose another regimen
27 Peginterferon/Ribavirin-Experienced, Genotype 5 or 6 With Compensated Cirrhosis Options Ledipasvir/Sofosbuvir (Harvoni ) x 12 weeks
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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
Daklinza Sovaldi. Daklinza (daclatasvir) and Sovaldi (sofosbuvir) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Daklinza Sovaldi Page: 1 of 7 Last Review Date: June 24, 2016 Daklinza Sovaldi Description Daklinza
Harvoni. Harvoni (ledipasvir & sofosbuvir) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.32 Subject: Harvoni Page: 1 of 9 Last Review Date: March 18, 2016 Harvoni Description Harvoni (ledipasvir
See 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
Harvoni (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
Direct-acting Antiviral (DAA) Regimens in Late-stage Development: Which Patients Should Wait? Fred Poordad, MD
Direct-acting Antiviral (DAA) Regimens in Late-stage Development: Which Patients Should Wait? Fred Poordad, MD The HCV Lifecycle: Multiple Targets Polymerase Inhibitors Protease Inhibitors NS5A Inhibitors
Clinical 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
SUMMACARE 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