Hepatitis C Prior Authorization Policy
|
|
- Shanna Beatrix Miles
- 6 years ago
- Views:
Transcription
1 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, consideration of medical necessity, generally accepted medical practice standards, and approved by the IEHP Pharmacy and Therapeutics Subcommittee. Drugs Requiring Prior Authorization Review: Daklinza (daclatasvir), Epclusa (velpatasvir, sofosbuvir), Harvoni (ledipasvir, sofosbuvir), Mavyret (glecaprevir, pibrentasvir), Olysio (simeprevir), Pegasys (peginterferon alfa-2a), Ribavirin, Sovaldi (sofosbuvir), Viekira XR (dasabuvir, ombitasivir, paritaprevir, ritonavir), Vosevi (sofosbuvir, velpatasvir, voxilaprevir), Zepatier (elbasvir, grazoprevir) Formulary Alternatives: None Policy/Criteria: A. Drug: Mavyret (glecaprevir/pibrentasvir) Diagnosis: a. Chronic hepatitis C Specialist: a. IEHP Hepatitis Center of Excellence specialist Criteria: a. Age 18 years of age or older; b. Confirmed diagnosis of chronic hepatitis C and genotype; c. Documented baseline quantitative HCV RNA test; d. Must meet treatment criteria in Section I: Identifying treatment candidates; i. If debilitating fatigue is the only treatment criteria, IEHP clinical pharmacist review required.
2 e. Requested drug must be used in an antiviral treatment regimen and duration recommended by the AASLD (please see Section II: HCV Treatment Regimen). Re-authorization Criteria: a. Re-treatment request with history of failing to achieve a SVR, or relapse after achieving a SVR with a prior completed treatment regimen consisting of Sovaldi or Harvoni, will be reviewed by IEHP pharmacist in accordance to the AASLD recommendations. Formulary Status: Non-formulary preferred, PA applies B. Drug: Harvoni (ledipasvir/sofosbuvir) Diagnosis: a. Chronic hepatitis C Specialist: a. IEHP Hepatitis Center of Excellence specialist Criteria: a. Age 18 years of age or older; b. Confirmed diagnosis of chronic hepatitis C and genotype; c. Documented baseline quantitative HCV RNA test; d. Must meet treatment criteria in Section I: Identifying treatment candidates; i. If debilitating fatigue is the only treatment criteria, IEHP clinical pharmacist review required. e. Requested drug must be used in an antiviral treatment regimen and duration recommended by the AASLD (please see Section II: HCV Treatment Regimen). i. For genotype 1 treatment for naïve patients without cirrhosis, 8 week duration is recommended for members who meet all of the following criteria: 1. Non-black 2. HIV-uninfected 3. HCV RNA level is <6 million IU/mL f. Failure, contraindication, clinically significant adverse effects to preferred agents: Mavyret. Requests will be reviewed by IEHP pharmacist. Re-authorization Criteria: a. Re-treatment request with history of failing to achieve a SVR, or relapse after achieving a SVR with a prior completed treatment regimen consisting of Sovaldi or Harvoni, will be reviewed by IEHP pharmacist in accordance to the AASLD recommendations.
3 Formulary Status: Non-formulary, PA applies C. Drugs: Daklinza (daclatasvir), Epclusa (velpatasvir/sofosbuvir), Olysio (simeprevir), Pegasys (peginterferon alfa-2a), Sovaldi (sofosbuvir), Viekira XR (dasabuvir/ombitasivir/paritaprevir/ ritonavir), Vosevi (sofosbuvir/velpatasvir/voxilaprevir), Zepatier (elbasvir/grazoprevir) Diagnosis: a. Chronic hepatitis C Specialist: a. IEHP Hepatitis Center of Excellence specialist Criteria: a. Age 18 years of age or older; b. Confirmed diagnosis of chronic hepatitis C and genotype; c. Documented baseline quantitative HCV RNA test; d. Must meet treatment criteria in Section I: Identifying treatment candidates; i. If debilitating fatigue is the only treatment criteria, IEHP clinical pharmacist review required. e. Requested drug must be used in an antiviral treatment regimen and duration recommended by the AASLD (please see Section II: HCV Treatment Regimen); f. Failure, contraindication, clinically significant adverse effects to preferred agents: Mavyret. Requests will be reviewed by IEHP pharmacist. Re-authorization Criteria: a. Re-treatment request with history of failing to achieve a SVR, or relapse after achieving a SVR with a prior completed treatment regimen consisting of Sovaldi or Harvoni, will be reviewed by IEHP pharmacist in accordance to the AASLD recommendations. Formulary Status: Non-formulary, PA applies Section I: Identifying Treatment Candidates A. Any of the following clinical states identify candidates for treatment: 1. Evidence of Stage 2 or greater hepatic fibrosis/cirrhosis including one of the following: Liver biopsy confirming a METAVIR score F2 or greater; OR Transient elastography (Fibroscan ) score greater than or equal to 7.1 kpa; OR FibroSure score of greater than or equal to 0.48; OR APRI score greater than 0.7 OR FIB-4 greater than 3.25.
4 2. Evidence of extra-hepatic manifestation of hepatitis C virus, such as type 2 or 3 essential mixed cryoglobulinemia with end-organ manifestations (e.g. vasculitis), or kidney disease (e.g. proteinuria, nephrotic syndrome or membranoproliferative glomerulonephritis). 3. Persons with hepatocellular carcinoma with a life expectancy of greater than 12 months. 4. Pre- and post-liver transplant, or other solid organ transplant. 5. HIV-1 co-infection. 6. Hepatitis B co-infection. 7. Other coexistent liver disease (e.g. nonalcoholic steatohepatitis). 8. Type 2 diabetes mellitus (insulin resistant). 9. Porphyria cutanea tarda. 10. Debilitating fatigue impacting quality of life (e.g., secondary to extra-hepatic manifestations and/or liver disease). 11. Men who have sex with men with high-risk sexual practices. 12. Active injection drug users. 13. Persons on long-term hemodialysis. 14. Women of childbearing age who wish to get pregnant. 15. HCV-infected health care workers who perform exposure-prone procedures. B. Patient Readiness and Adherence: 1. Patients shall be evaluated for readiness to initiate treatment. 2. Patients selected for treatment shall be able and willing to strictly adhere to treatment protocols prescribed by their provider. 3. Caution shall be exercised with patients who have a history of treatment failure with prior hepatitis C treatment due to non-adherence with treatment regimen and appointments. Patients shall be educated regarding potential risks and benefits of hepatitis C virus therapy, as well as the potential for resistance and failed therapy if medication is not taken as prescribed. C. Age requirements: Treatment candidate must be 18 years of age or older. D. Populations Unlikely to Benefit from Hepatitis C Virus Treatment: According to AASLD/IDSA hepatitis C virus Guidelines, patients with limited life expectancy for whom hepatitis C virus therapy would not improve symptoms or prognosis do not require treatment. Chronic hepatitis C is associated with a wide range of comorbid conditions. Little evidence exists to support initiation of hepatitis C virus treatment in patients with limited life expectancy (less than 12 months) due to non liver-related comorbid conditions. For these patients, the benefits of hepatitis C virus treatment are unlikely to be realized, and palliative care strategies should take precedence. In patients with a life expectancy less than 12 months, treatment is not recommended.
5 Section II: HCV Treatment Regimen (AASLD Recommendation) Treatment History and HCV Genotype Cirrhosis status Regimen Regimen Duration (GT) Bolded = Non-Formulary Preferred Hepatitis C Drug Regimen Naïve GT 1a 8 weeks, non-black, HIVuninfected, HCV RNA level <6 million IU/mL (No baseline high fold-change NS5A RAVs for elbasvir are detected) + RBV (Baseline high fold-change NS5A RAVs for elbasvir are detected) (No baseline high fold-change NS5A RAVs for elbasvir are detected) + RBV (Baseline high fold-change NS5A RAVs for elbasvir are detected) 8 weeks 16 weeks 16 weeks Naïve GT 1b 8 weeks, non-black, HIVuninfected, HCV RNA level 8 weeks
6 <6 million IU/mL Sofosbuvir/velpatasvir 400/100 mg Sofosbuvir/velpatasvir 400/100 mg Experienced GT 1a (failed PEG-IFN and RBV treatment) 8 weeks Sofosbuvir/velpatasvir 400/100 mg (No baseline high fold-change NS5A RAVs for elbasvir are detected) + RBV (Baseline high fold-change NS5A RAVs for elbasvir are detected) Sofosbuvir/velpatasvir 400/100 mg (No baseline high fold-change NS5A RAVs for elbasvir are detected) + RBV (Baseline high fold-change NS5A RAVs for elbasvir are detected) 16 weeks 16 weeks Experienced GT 1b (failed PEG-IFN and RBV treatment) 8 weeks
7 Experienced GT 1a/1b (failed NS3 Protease Inhibitor {telaprevir, boceprevir or simeprevir} + PEG- IFN + RBV) Sofosbuvir/velpatasvir 400/100 mg Experienced GT 1a/1b (failed non-ns5a inhibitor, sofosbuvir containing regimen) and Sofosbuvir/velpatasvir/voxilaprevir 400/100/100mg (for genotype 1a) (for genotype 1b) Experienced GT 1a/1b (failed NS5A inhibitor DAA) and Sofosbuvir/velpatasvir/voxilaprevir 400/100/100mg Naïve GT2 8 weeks Cirrhosis Experienced GT2 (failed PEG-IFN and RBV) 8 weeks
8 Experienced GT2 (failed sofosbuvir + RBV) and Naïve GT3 8 weeks Experienced GT3 (failed PEG-IFN and RBV) + sofosbuvir 400mg Experienced GT3 (failed DAA experienced, including NS5A inhibitors) and Sofosbuvir/velpatasvir/voxilaprevir 400/100/100mg Sofosbuvir/velpatasvir/voxilaprevir 400/100/100mg + RBV (for prior NS5S inhibitor failure and cirrhosis) Naïve GT4 8 weeks Experienced GT4 (failed PEG-IFN and RBV) 8 weeks
9 Experienced GT4 (failed DAA experienced, including NS5A inhibitors) and Sofosbuvir/velpatasvir/voxilaprevir 400/100/100mg Naïve GT 5 or 6 8 weeks Experienced GT5 or GT 6 (failed PEG-IFN and RBV) 8 weeks Experienced GT4 (DAA experienced, including NS5A inhibitors) and Sofosbuvir/velpatasvir/voxilaprevir 400/100/100mg Clinical Justification: Please refer to the American Association for the Study of Liver Diseases (AASLD) HCV Clinical Practice Guideline.
10 References: 1. American Association for the Study of Liver Diseases. Available from: 2. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. J Hepatol. 2011; 55(2): Epub 2011 Mar Poordad F. Big Changes Are Coming in Hepatitis C Curr Gastroenterol Rep 2011; 13(1): Hofmann WP, Zeuzem S. A new standard of care for the treatment of chronic HCV infection. Nat Rev Gastroenterol Hepatol 2011; 8(5): Pawlotsky JM. The Results of Phase III Clinical Trials With Telaprevir and Boceprevir Presented at the Liver Meeting 2010: A New Standard of Care for Hepatitis C Virus Genotype 1 Infection, But With Issues Still Pending. Gastroenterology. 2011; 140(3): Victrelis [package insert]. Whitehouse Statin, NJ: Merck & Co., Inc; 2011, Prescribing Information. 7. Poordad F, McCone J, Bacon B et al. Boceprevir for untreated chronic HCV genotype 1 infection. NEJM 2011; 364: Bacon B, Gordon S, Lawitz E et al. Boceprevir for previously treated chronic HCV genotype 1 infection. NEJM 2011; 364: Jensen DM. A new era of hepatitis C therapy begins. N Engl J Med. 2011; 364(13): INCIVEK (telaprevir) Prescribing Information. 11. Jacobson I, McHutchison J, Dusheiko G, et al. Telaprevir for Previously Untreated Chronic Hepatitis C Virus Infection. N Engl J Med. 2011; 364: Zeuzem S, Andreone P, Pol S, et al. Telaprevir for Retreatment of HCV Infection. N Engl J Med. 2011; 364: Jacobson, Ira. SVR results of a once-daily regimen of simeprevir (SMV, TMC435) plus sofosbuvir (SOF, GS-7977) with or without ribavirin in and non- HCV genotype 1 treatment-naïve and prior null responder patients: The COSMOS study. AASLD 2013 Nov. 14. OLYSIO [package insert]. Titusville, NJ: Janssen Therapeutics, Division of Janssen Products, LP; Sovaldi [package insert]. Foster City, CA: Gilead Sciences Inc.; Department of Veterans Affairs National Hepatitis C Resource Center Program and the Office of Public Health. Chronic Hepatitis C Virus (HCV) Infection: Treatment Considerations. March 27, Available from: Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014a; 370(20): Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or for chronic HCV without cirrhosis. N Engl J Med. 2014; 370(20): Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014; 370(17): Ferenci P, Bernstein D, Lalezari J, et al. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014; 370(21): Poordad F, Hezode C, Trinh R, et al. ABT-450/r-Ombitasvir and Dasabuvir with Ribavirin for Hepatitis C with Cirrhosis. N Engl J Med. 2014;[Epub ahead of print]
11 22. Lawitz E, Poordad FF, Pang PS, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014a; 383(9916): Lawitz E, Sulkowski MS, Ghalib R, et al. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet. 2014b; 384(9956): Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014; 370(17): Andreone P, Colombo MG, Enejosa JV, et al. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatmentexperienced patients with HCV genotype 1b infection. Gastroenterology. 2014; 147(2): Janssen Therapeutics. Simeprevir [package insert] Titusville, NJ, Janssen Therapeutics. 27. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med May 16; 368(20): Jacobson IM, Gordon SC, Kowdley KV, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med May 16; 368(20): Zeuzem S, Dusheiko GM, Salupere R. Sofosbuvir + ribavirin for 12 or 24 weeks for patients with HCV genotype 2 or 3: the VALENCE trial. In: Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; November 1-5, 2013; Washington, DC. Abstract Lawitz E, Poordad F, Brainard DM, et al. Sofosbuvir in combination with pegifn and ribavirin for provides high SVR rates in HCV-infected genotype 2 or 3 treatment experienced patients with and without compensated cirrhosis: results from the LONESTAR-2 study. In: Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; November 1-5, 2013; Washington, DC. Abstract LB Sulkowski MS, Rodriguez-Torres M, Lalezari JP, et al. All-oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotype 1, 2, and 3 infection in patients co-infected with HIV (PHOTON-1). In: Program and abstracts of the 64th Annual Meeting of the American Association for the Study of Liver Diseases; November 1-5, 2013; Washington, DC. Abstract American Association for the Study of Liver Diseases. Recommendation for Testing, Managing and Treating Hepatitis C. Available at: Assessed July, 12, California Department of Health Care Services Utilization and Treatment Policy for Simeprevir and Sofosbuvir in the Management of Hepatitis C. 34. California Department of Health Care Services Treatment Policy for the Management of Chronic Hepatitis C. 35. Gilead Sciences. Epclusa [package insert] Foster City, CA, Gilead Sciences, Inc. 36. Gilead Sciences: Vosevi [package insert] Foster City, CA, Gilead Sciences, Inc. 37. AbbVie: Mavyret [package insert] North Chicago, IL, AbbVie Inc.
12 Change Control Date Change 08/16/2017 Added Harvoni as NF Preferred to the Medi-Cal Formulary (at parity with Epclusa) 11/15/2017 Document format updated AASLD updated with new drugs added: Mavyret and Vosevi Removed all alternative regimens as first line recommended treatments are available for all genotypes Mavyret is now the preferred agent due to shorter duration of therapy and pan-genotypic coverage Vosevi added as one of the recommended regimens for treatment experienced patients Added additional guidance; if debilitating fatigue is the only indication for treatment, IEHP clinical pharmacist review is required.
Drug 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Ribavirin () Reference Number: CP.HNMC.252 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Medicaid - HNMC Revision Log See Important Reminder at the end of this policy
More information9/21/2014. Sarah Naidoo, PharmD, BCPS September 26, 2014
Sarah Naidoo, PharmD, BCPS September 26, 2014 Be able to discuss changes in hepatitis C treatment Be able to provide recommendations to providers regarding hepatitis C treatment Be able to provide patient
More information4/30/2015. Interactive Case-Based Presentations and Audience Discussion. Debika Bhattacharya, MD, MSc. Learning Objectives
4/3/215 Interactive Case-Based Presentations and Audience Discussion Debika Bhattacharya, MD, MSc Assistant Clinical Professor University of California Los Angeles Los Angeles, California Formatted:4-27-215
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 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 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 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 informationHepatits C Criteria Direct Acting Antiviral Medications
Hepatits C Criteria Direct Acting Antiviral Medications Harvoni-Formulary PA required 1. Is the patient being treated for a funded condition by the Oregon Health Plan? 2. Does the member have a diagnosis
More informationTreatment of Hepatitis C with simeprevir (Olysio ) PLUS sofosbuvir (Sovaldi ) Archived Medical Policy
Treatment of Hepatitis C with simeprevir (Olysio ) PLUS sofosbuvir (Sovaldi ) Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO Louisiana,
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 informationMavyret (glecaprevir/pibrentasvir)
(glecaprevir/pibrentasvir) Override(s) Prior Authorization Quantity Limit Medication (glecaprevir/pibrentasvir) Approval Duration Based on Genotype, Treatment Status, or Cirrhosis Status. Quantity Limit
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 informationHepatitis C Direct-Acting Antivirals
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 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 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 informationMavyret (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 informationLength of Authorization: 8-12 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 informationUpdates in the Management of HCV: What Clinicians Who Care for Patients With HCV Need to Know Today
Updates in the Management of HCV: What Clinicians Who Care for Patients With HCV Need to Know Today The treatment paradigm for hepatitis C virus (HCV) is changing very rapidly. In the short time since
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 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 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 informationHepatitis C Medications Prior Authorization Criteria
Hepatitis C Medications Authorization Criteria Epclusa (/velpatasvir), Harvoni (ledipasvir/), Sovaldi (), Daklinza (daclatasvir), Zepatier (elbasvir/grazoprevir), Olysio (simeprevir), Viekira Pak (ombitasvir/paritaprevir/ritonavir;
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 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 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 informationSelecting HCV Treatment
Selecting HCV Treatment Caveats Focus on treatment selection for genotypes 1, 2, and 3. Majority of US population infected with GT 1, 2, or 3 GT 4 treatment closely reflects GT 1 treatment GT 5 and 6 are
More informationPARTNERSHIP HEALTHPLAN OF CALIFORNIA
Authorization for the Treatment of Hepatitis C 4665 Business Center Drive Fairfield, California 94534 October 1, 2017 Re: Authorization for the use of Mavyret/Zepatier/Epclusa/Harvoni/Viekira/Sovaldi/Daklinza/
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 information6/2/2015. Interactive Case-Based Presentations and Audience Discussion
6/2/215 Interactive Case-Based Presentations and Audience Discussion Andrew Aronsohn, MD Assistant Professor of Medicine University of Chicago Medical Center Chicago, Illinois Formatted:5-6-215 Washington,
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 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 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 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 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 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 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 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 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 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 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 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 informationIFN-free therapy in naïve HCV GT1 patients
IFN-free therapy in naïve HCV GT1 patients Paris Hepatitis Conference Paris, 12th January, 2015 Pr Tarik Asselah MD, PhD; Service d Hépatologie & INSERM U773 University Paris Diderot, Hôpital Beaujon,
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 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 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 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 informationClinical Policy: Elbasvir/grazoprevir (Zepatier) Reference Number: ERX.SPMN.181
Clinical Policy: (Zepatier) Reference Number: ERX.SPMN.181 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 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 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: () Reference Number: CP.HNMC.178 Effective Date: 11.16 Last Review Date: 11.17 Line of Business: Medicaid Medi-Cal 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 informationDirect Acting Antivirals for the Treatment of Hepatitis C Infection
Hepatitis C Core Curriculum, Module 2 Direct Acting Antivirals for the Treatment of Hepatitis C Infection Jason J. Schafer, PharmD, MPH, BCPS, AAHIVP Objectives Discuss the evolution of hepatitis C treatment
More informationTreatment of Hepatitis C with ombitasvir, paritaprevir, and ritonavir (Technivie )
Treatment of Hepatitis C with ombitasvir, paritaprevir, and ritonavir (Technivie ) Applies to all products administered or underwritten by Blue Cross and Blue Shield of Louisiana and its subsidiary, HMO
More informationHarvoni. 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: December 2, 2016 Harvoni Description Harvoni (ledipasvir
More informationHarvoni. 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
More informationClinical Policy: Glecaprevir/Pibrentasvir (Mavyret) Reference Number: CP.PHAR.348 Effective Date: 09/17
Clinical Policy: (Mavyret) Reference Number: CP.PHAR.348 Effective Date: 09/17 Last Review Date: 09/17 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationHepatitis C in Correctional Facilities: Big Problem, Bigger Opportunity. Cody A. Chastain, MD
Hepatitis C in Correctional Facilities: Big Problem, Bigger Opportunity Cody A. Chastain, MD Disclosures Research supported by Gilead Sciences Inc.: Site investigator for HIV/HCV SWITCH Registry Study
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: (Daklinza) Reference Number: HIM.PA.SP27 Effective Date: Last Review Date: 01/17 Line of Business: Health Insurance Marketplace Coding Implications Revision Log See Important Reminder
More informationClinical Policy: Glecaprevir/Pibrentasvir (Mavyret) Reference Number: GA.PMN.24 Product: Medicaid Effective Date: 9/17
Clinical Policy: Glecaprevir/Pibrentasvir (Mavyret) Reference Number: GA.PMN.24 Product: Medicaid Effective Date: 9/17 Last Review Date: 9/17 Revision Log See Important Reminder at the end of this policy
More informationSee Important Reminder at the end of this policy for important regulatory and legal information.
Clinical Policy: Dasabuvir, Ombitasvir, Paritaprevir, Ritonavir (Viekira XR, Viekira Pak) Reference Number: OH.PHAR.PPA.09 Effective Date: 07/17 Last Review Date: 09/17 Line of Business: Medicaid See Important
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 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 informationDATE: 6/03 LAST REVIEW DATE:
SUBJECT: Chronic Hepatitis C (Pegasys, Peg-Intron, ribavirin, Olysio, Sovaldi, Harvoni, ledipasvir/sofosbuvir, Viekira, Viekira XR, Daklinza, Technivie, Zepatier, Epclusa, sofosbuvir/velpatasvir, Vosevi,
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 informationOptimizing HCV Treatment Continuity and Outcomes
Optimizing HCV Treatment Continuity and Outcomes Empowering Pharmacists to Take Action Faculty Michelle T. Martin, PharmD, BCPS, BCACP Clinical Pharmacist University of Illinois Hospital and Health Sciences
More informationREQUEST FOR PRIOR AUTHORIZATION Hepatitis C Treatments
Fax completed form to: 866-940-7328 Prior Authorization Phone Number: 800-310-6826 IA Medicaid Member ID # Patient name Date of Birth Patient address Patient phone Provider NPI Prescriber name Phone Prescriber
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 informationHarvoni. Harvoni (ledipasvir & sofosbuvir) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Harvoni Page: 1 of 7 Last Review Date: June 19, 2015 Harvoni Description Harvoni (ledipasvir &
More informationUPDATES IN HEPATITIS C
UPDATES IN HEPATITIS C S A R A H N A I D O O, P H A R M, B C P S AP RI L 13, 2014 OBJECTIVES Be able to discuss changes in hepatitis c treatment Be able to provide recommendations to providers regarding
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: 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 information1/16/2019. Goals of HCV Therapy. Objectives. Treating Hepatitis C and HIV Co Infection. Cure Defined as sustained virologic response (SVR)
HCV ECHO WESTERN STATES HCV ECHO WESTERN STATES Treating Hepatitis C and HIV Co Infection Paulina Deming, Pharm D Associate Professor, College of Pharmacy Assistant Director, Viral Hepatitis Programs,
More informationHarvoni. Harvoni (ledipasvir & sofosbuvir) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.03.32 Subject: Harvoni Page: 1 of 7 Last Review Date: December 3, 2015 Harvoni Description Harvoni (ledipasvir
More information