Pharmacy Medical Necessity Guidelines: Hepatitis C Virus
|
|
- Lora Greer
- 5 years ago
- Views:
Transcription
1 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) or Medical (MED) Benefit RX Department to Review RXUM This Pharmacy Medical Necessity Guideline applies to the following: INTotal Health Medicaid Plan INTotal Health Medicaid Plan INTotal Health FAMIS Plan INTotal Health FAMIS Plan Fax Numbers: RXUM: OVERVIEW Per the Centers for Disease Control and Prevention, Hepatitis C is a liver infection caused by the Hepatitis C virus (HCV). Hepatitis C is a blood-borne virus. Today, most people become infected the Hepatitis C virus by sharing needles or other equipment to inject drugs. For some people, Hepatitis C is a short-term illness but for 70% 85% of people who become infected Hepatitis C, it becomes a long-term, chronic infection. Chronic Hepatitis C is a serious disease than can result in long-term health problems, even death. The majority of infected persons might not be aware of their infection because they are not clinically ill. There is no vaccine for Hepatitis C. The best way to prevent Hepatitis C is by avoiding behaviors that can spread the disease, especially injecting drugs. FDA-APPROVED MEDICATIONS F HEPATITIS C VIRUS Mavyret (Glecaprevir + Pibrentasvir) Epclusa (Sofobuvir + Velpatasvir) Zepatier (Elbasvir + Grazoprevir) Harvoni (Ledipasvir + Sofosbuvir) Sovaldi (Sofosbuvir) Daklinza (Daclatasvir) Olysio (Simeprevir) Technivie (Ombitasvir + Paritaprevir + Ritonavir) Viekira (Ombitasvir + Paritaprevir + Ritonavir + Dasabuvir) Vosevi (Sofosbuvir + Velpatasvir + Voxilaprevir) 1
2 FDA approved indications for treatment naïve INTotal Health Formulary Preference GT1 GT2 GT3 GT4 GT5 GT6 First-tier Mavyret 8 wk Mavyret 8 wk Mavyret 8 wk Mavyret 8 wk Mavyret 8 wk Mavyret 8 wk Second-tier Zepatier 12wk* Epclusa 12 wk Epclusa 12 wk Zepatier 12wk Epclusa 12 wk Epclusa 12 wk Third-tier Epclusa 12 wk Sovaldi + Daklinza 12wk* Sovaldi + Daklinza 12wk* Epclusa 12 wk Harvoni 12wk Harvoni 12wk * 1a w ith polymorphisms Epclusa 12w k *w ith 24w k AASLD/IDSA Update: Sep. 21, 2017 COVERAGE GUIDELINES INTotal Health may provide medication therapy coverage for qualifying members meeting all guidelines as outlined by DMAS criteria: 1. All requests will be reviewed for FDA approved label indications and guidelines; 2. Member must be 18 years of age or older; 3. Prescriber must be a gastroenterologist, hepatologist, infectious disease specialist or transplant specialist; 4. A baseline HCV-RNA (in 4 weeks of request) must be obtained before treatment initiation At TW4, if the HCV RNA is 25 IU/mL, or at any time point thereafter, all treatment should be reevaluated; 5. Prescriber must review the Hepatitis C Therapy Patient Agreement the patient, and the prescriber and member must sign the agreement to acknowledge he/she has been informed about the requirements of the treatment program and understand the expectations set forth in the agreement. [see attached agreement form]; 6. Members must be evaluated for de (which is defined as a Child-Pugh score greater than 6 [class B or C]); 7. Members must be evaluated for severe renal impairment (egfr <30 ml/min/1.73m 2 ) or end 2
3 stage renal disease (ESRD) requiring hemodialysis; 8. If member s life expectancy is less than a year they do not qualify for hepatitis C treatment Individual Drug Coverage Criteria: MAVYRET (glecaprevir and pibrentasvir) The plan may authorize coverage for Mavyret when all of the above criteria for therapy inclusion are met 1. The member does not have de (Child Turcotte Pugh [CTP] class B or C) or moderate to severe hepatic impairment 2. Mavyret will not be given in combination any other Hepatitis C indicated medications/ treatment regimens 3. The member has not previously failed a treatment regimen that includes both an NS5A inhibitor an NS3/4A protease inhibitor (eg, Technivie, Viekira Pak, Viekira XR, Vosevi, Zepatier) ZEPATIER (elbasvir and grazoprevir) The plan may authorize coverage for Zepatier when all of the above criteria for therapy inclusion are met 1. Member has had an inadequate response, intolerance or contraindication to the preferred product Mavyret. 2. Zepatier will not be given in combination any of the following drugs that are organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors, strong inducers of CYP3A or efevirenz: Phenytoin, carbamazepine, rifampin, St. John s Wort, efavirenz, atazanavir, darunavir, lopinavir, saquinavir, tipranavir, or cyclosporine. 3. Zepatier will not be given in combination Hepatitis C protease inhibitor (e.g., teleprevir [Lincivek], simpeprevir [Olysio], sofosbuvir [Sovaldi], Harvoni, Viekira 4. Member has been shown to have HCV Genotype 1a, 1b, or 4: For Genotype 1a: 5. Member has tested negatively for the presence of resistance-associated polymorphisms 6. Member has had an inadequate response, intolerance or contraindication to Epclusa For Genotype 1b: 7. Member is treatment-naïve, treatment experienced 3
4 8. Member is treatment experienced and NS3/4 protease inhibitor For Genotype 4: 9. Member is treatment-naïve 10. Member failed prior treatment (virologic relapse after treatment) 11. Member failed prior treatment (on-treatment virologic failure) 12. Member has had an inadequate response, intolerance or contraindication to Epclusa EPCLUSA (sofosbuvir and velpatasvir) The plan may authorize coverage for Epclusa when all of the above criteria for therapy inclusion are met 1. Member has had an inadequate response, intolerance or contraindication to the preferred product Mavyret. 2. Epclusa will not be used in combination other drugs containing sofosbuvir, including Sovaldi 3. IF the member has HIV coinfection, Epclusa will not be used in combination cobicistat and tenofovir disoproxil fumarate 4. Member will not be receiving treatment tipranavir 5. Member has been shown to have HCV Genotype 1a, 1b, 2, 3, 4, 5, or 6 For Genotype 1a: 6. Member was tested for resistance-associated polymorphisms 7. One or more resistance-associated polymorphisms are present 8. No NS5A polymorphisms are present 9. Member has had an inadequate response, intolerance or contraindication to Zepatier. For Genotype 1b: 10. Member has had an inadequate response, intolerance or contraindication to Zepatier. For Genotype 2: 11. Member is treatment naïve 12. Member failed prior treatment 13. Member failed prior treatment sofosbuvir For Genotype 3: 4
5 14. Member is treatment naïve 15. Member failed prior treatment, no 16. Member failed prior treatment, 17. Member failed prior treatment sofosbuvir For Genotype 4: 18. Member is treatment naïve 19. Member failed prior treatment (virologic relapse after treatment) 20. Member has had an inadequate response, intolerance or contraindication to Zepatier 21. Member failed prior treatment (on-treatment virologic failure) For Genotype 5 or 6: 22. Member is treatment naïve 23. Member failed prior treatment SOVALDI (sofosbuvir) DAKLINZA (daclatasvir) The plan may authorize coverage for Sovaldi Daklinza when all of the above criteria for therapy inclusion are met 1. Member has had an inadequate response, intolerance or contraindication to the preferred product Mavyret. 2. IF Member has HIV coinfection, Member will not be receiving treatment tipranavir 3. Member has been shown to have HCV Genotype 2 or 3 4. Member has had an inadequate response, intolerance or contraindication to the preferred product [Epclusa] 5. Daklinza will be used in combination Sovaldi HARVONI (ledipasvir and sofosbuvir) The plan may authorize coverage for Harvoni when all of the above criteria for therapy inclusion are met 1. Member has had an inadequate response, intolerance or contraindication to the preferred product Mavyret. 2. Harvoni will not be used in combination other drugs containing sofosbuvir, including Sovaldi 5
6 3. IF the member has HIV coinfection, Harvoni will not be used in combination cobicistat and tenofovir disoproxil fumarate 4. Member will not be receiving treatment tipranavir 5. Member has been shown to have HCV Genotype 1a, 1b, 4, 5, or 6 For Genotype 1a: 6. Member was tested for resistance-associated polymorphisms 7. One or more resistance-associated polymorphisms are present 8. Member has had an inadequate response, intolerance or contraindication to [Epclusa]. 9. No NS5A polymorphisms are present 10. Member has had an inadequate response, intolerance or contraindication to [Zepatier] 11. Member has had an inadequate response, intolerance or contraindication to [Epclusa] 12. Harvoni will not be prescribed in combination ANY of the following: Amiodarone Hepatitis C protease inhibitors (e.g., telaprevir [Incivek], simeprevir [Olysio], sofosbuvir [Sovaldi], elbasvir/grazoprevir [Zepatier], Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir [Viekira Pak]) 13. Member is treatment-naïve 14. Member is treatment experienced, 15. Member is treatment experienced, (Child Turcotte Pugh [CTP] class A) Genotype 1b: 16. Member has had an inadequate response, intolerance or contraindication to [Zepatier] 17. Member has had an inadequate response, intolerance or contraindication to [Epclusa] 18. Harvoni will not be prescribed in combination ANY of the following: Amiodarone Hepatitis C protease inhibitors (e.g., telaprevir [Incivek], simeprevir [Olysio], sofosbuvir [Sovaldi], elbasvir/grazoprevir [Zepatier], Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir [Viekira Pak]) 19. Member is treatment-naïve 20. Member is treatment experienced, 6
7 21. Member is treatment experienced, (Child Turcotte Pugh [CTP] class A) Genotype 4: 22. Member has had an inadequate response, intolerance or contraindication to [Zepatier] 23. Member has had an inadequate response, intolerance or contraindication to [Epclusa] 24. Harvoni will not be prescribed in combination ANY of the following: Amiodarone Hepatitis C protease inhibitors (e.g., telaprevir [Incivek], simeprevir [Olysio], sofosbuvir [Sovaldi], elbasvir/grazoprevir [Zepatier], Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir [Viekira Pak]) 25. Member is treatment-naïve 26. Member is treatment experienced, 27. Member is treatment experienced, (Child Turcotte Pugh [CTP] class A) Genotype 5 or 6: 28. Member has had an inadequate response, intolerance or contraindication to [Epclusa] 29. Harvoni will not be prescribed in combination ANY of the following: Amiodarone Hepatitis C protease inhibitors (e.g., telaprevir [Incivek], simeprevir [Olysio], sofosbuvir [Sovaldi], elbasvir/grazoprevir [Zepatier], Ombitasvir/Paritaprevir/Ritonavir/Dasabuvir [Viekira Pak]) 30. Member is treatment-naïve 31. Member is treatment experienced, 32. Member is treatment experienced, (Child Turcotte Pugh [CTP] class A) 7
8 LIMITATIONS 1. Approval duration as per table. 2. Quantity limits standard daily dosing. GENOTYPE 1A: Naïve Naïve &, & MAVYRET ZEPATIER EPCLUSA 16 8 weeks SOVALDI+ DAKLINZA HARVONI RIBAVIRIN weeks * * * * 8
9 and NS3/4 protease inhibitor, and NS3/4 protease inhibitor, GENOTYPE 1B: Naive and NS3/4 protease inhibitor experienced experienced GENOTYPE 2: Naïve Failed prior treatment sofosbuvir and ribavirin or * * 8 weeks * * 8 weeks 9
10 Without experienced GENOTYPE 3: Naive GENOTYPE 4: Naive Failed prior treatment PEG-IFN and ribavirin (virologic relapse after treatment) Failed prior treatment PEG-IFN and ribavirin (ontreatment virologic failure) PEG-IFN/Riba experienced PEG-IFN/Riba experienced, GENOTYPE 5: Naive 24 weeks 16 weeks 16 weeks 12 8 weeks 8 weeks 16 * 16 12weeks * * 10
11 GENOTYPE 6: Naive ^ w/ *indicates concomitant therapy CODES None. REFERENCES 1. AASLD-IDSA. Recommendations for testing, managing, and treating hepatitis C. Accessed February 19, DRUGDEX System (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. Available at: (cited: October/3/2016). APPROVAL HISTY Date Revision No. Reason for Change Sections Affected 5/25/ INTotal Policy Created All 2.0 Reviewed no updates All 6/29/ Preferred formulary status All change per P&T Committee. Criteria change per DMAS. 10/19/ Preferred formulary status All change per P&T. Format Change. 2/22/ Preferred formulary status change per P&T All ADDITIONAL INFMATION 11
PHARMACY 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 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 informationINFECTIOUS DISEASE AGENTS: HEPATITIS C - DIRECT - ACTING ANTIVIRAL
Ohio Department of Medicaid Prior Authorization Form Unified PDL HEPATITIS C TREATMENT Member ID# Patient Name: DOB: Patient Address: Provider DEA: Provider NPI: Provider Name: Phone: Provider Address:
More informationState of Maine Department of Health & Human Services MaineCare/MEDEL Prior Authorization Form HEPATITIS C TREATMENT
State of Maine Department of Health & Human Services MaineCare/MEDEL Prior Authorization Form HEPATITIS C TREATMENT HCV Phone: 1-888-445-0497 www.mainecarepdl.org Fax: 1-888-879-6938 Member ID #: Patient
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 informationState of Maine Department of Health & Human Services MaineCare/MEDEL Prior Authorization Form HEPATITIS C TREATMENT
State of Maine Department of Health & Human Services MaineCare/MEDEL Prior Authorization Form HEPATITIS C TREATMENT HCV Phone: 1-888-445-0497 www.mainecarepdl.org Fax: 1-888-879-6938 Member ID #: Patient
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 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 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 informationDaklinza 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
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 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: 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) QUEST Integration Formulary
Hepatitis C (Direct Acting Antiviral Medications for Treatment of Hepatitis C) QUEST Integration Formulary Policy Number: Original Effective Date: MM.04.036 06/01/2015 Lines of Business: Current Effective
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 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 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 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 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 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 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 informationDaklinza 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 5.01.36 Subject: Daklinza Page: 1 of 8 Last Review Date: March 18, 2016 Daklinza Description Daklinza (daclatasvir)
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 informationDaklinza 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 4 Last Review Date: September 18, 2015 Daklinza Sovaldi Description
More informationClinical Policy: Elbasvir/Grazoprevir (Zepatier) Reference Number: OH.PHAR.PPA.08 Effective Date: Last Review Date: 12.18
Clinical Policy: (Zepatier) Reference Number: OH.PHAR.PPA.08 Effective Date: 01.19 Last Review Date: 12.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationAddress: City: State: ZIP code: Inferferon Product Requested (Include Strength):
Please complete this entire form and fax it to: 866-940-7328. If you have questions, please call 800-310-6826. This form contains multiple pages. Please complete all pages to avoid a delay in our decision.
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 informationHepatitis C Medications Hawaii PRIOR AUTHORIZATION REQUEST FORM
Please complete this entire form and fax it to: 866-940-7328. If you have questions, please call 800-310-6826. This form contains multiple pages. Please complete all pages to avoid a delay in our decision.
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 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 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 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 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 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 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: (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 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 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 informationAmeriHealth Caritas Iowa Request for Prior Authorization Hepatitis C Treatments
Form applies to IA Health Link and hawk-i plans. Please print accuracy is important. Fax completed form to 1-855-825-2714. Provider Help Desk: 1-855-328-1612. AmeriHealth Caritas Iowa member ID #: Patient
More informationADAP Coverage of HCV Treatment Medications. Amanda Bowes November 29, 2017
ADAP Coverage of HCV Treatment Medications Amanda Bowes November 29, 2017 AGENDA Background National ADAP Formulary Database: HCV Coverage NASTAD Consultation: Strategies to Increase Hepatitis C Treatment
More informationHCV Treatment in 2016: Genotypes 1, 2, and 3. Cody A. Chastain, MD October 12, 2016
HCV Treatment in 2016: Genotypes 1, 2, and 3 Cody A. Chastain, MD October 12, 2016 Disclosures I have no financial disclosures. Caveats I will only discuss treatment of GT 1-3. Majority of US population
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 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 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 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 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 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 informationHIV/HCV Coinfection: Why It Matters and What To Do About It. Cody A. Chastain, MD 10/26/16
HIV/HCV Coinfection: Why It Matters and What To Do About It Cody A. Chastain, MD 10/26/16 Disclosures I have no relevant financial disclosures. Objectives At the end of this lecture, the learner will be
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 informationPharmacologic Considerations of HCV Treatment. Autumn Zuckerman, PharmD, BCPS, AAHIVP
Pharmacologic Considerations of HCV Treatment Autumn Zuckerman, PharmD, BCPS, AAHIVP Objectives Review pharmacokinetic properties of currently utilized Hepatitis C medications Review drug interactions
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 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 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 informationZepatier is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C) due to potential toxicity (1).
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Zepatier Page: 1 of 6 Last Review Date: June 24, 2016 Zepatier Description Zepatier (elbasvir,
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 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 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 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 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 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 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 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 informationClinical Policy: Sofosbuvir/Velpatasvir (Epclusa) Reference Number: OH.PHAR.PPA.05 Effective Date: Last Review Date: 12.18
Clinical Policy: (Epclusa) Reference Number: OH.PHAR.PPA.05 Effective Date: 01.19 Last Review Date: 12.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationZepatier. (elbasvir, grazoprevir) New Product Slideshow
Zepatier (elbasvir, grazoprevir) New Product Slideshow Introduction Brand name: Zepatier Generic name: Elbasvir, grazoprevir Pharmacological class: HCV NS5A inhibitor + HCV NS3/4A protease inhibitor Strength
More informationClinical Policy: Ombitasvir/Paritaprevir/Ritonavir (Technivie) Reference Number: CP.PHAR.276 Effective Date: Last Review Date: 08.
Clinical Policy: (Technivie) Reference Number: CP.PHAR.276 Effective Date: 09.16 Last Review Date: 08.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
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 informationClinical Policy: Dasabuvir/ombitasvir/paritaprevir/ritonavir (Viekira XR, Viekira Pak) Reference Number: ERX.SPMN.178
Clinical Policy: (Viekira XR, Viekira Pak) Reference Number: ERX.SPMN.178 Effective Date: 10/16 Last Review Date: 09/16 Coding Implications Revision Log See Important Reminder at the end of this policy
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 informationMEDICAL POLICY EFFECTIVE DATE: 9/1/2016 REVISED DATE: 1/1/2017
Page 1 of 19 DESCRIPTION: Hepatitis C Drug Coverage Criteria For all Regimens (see individual drugs for drug specific requirements). Based upon our assessment of the peer-reviewed literature, the drugs
More informationZepatier. Zepatier (elbasvir, grazoprevir) and Ribavirin. Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Zepatier Page: 1 of 6 Last Review Date: March 18, 2016 Zepatier Description Zepatier (elbasvir,
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 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 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 informationProfessional Practice Meeting February Hepatitis C
Professional Practice Meeting February 2018 Hepatitis C Hepatitis C Overview Hepatitis C Virus Enveloped, single-stranded RNA virus 6 main genotypes: Rapidly mutating virus makes vaccination design difficult
More informationClinical Policy: Ledipasvir/Sofosbuvir (Harvoni) Reference Number: OH.PHAR.PPA.10 Effective Date: Last Review Date: 12.18
Clinical Policy: (Harvoni) Reference Number: OH.PHAR.PPA.10 Effective Date: 01.19 Last Review Date: 12.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
More informationClinical Policy: Daclatasvir (Daklinza) Reference Number: LA.PHAR.274 Effective Date: 09/16 Last Review Date: 07/18 Line of Business: Medicaid
Clinical Policy: (Daklinza) Reference Number: LA.PHAR.274 Effective Date: 09/16 Last Review Date: 07/18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
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 informationManagement of Chronic HCV 2017 and Beyond
Management of Chronic HCV 2017 and Beyond Blaire E Burman, MD Virginia Mason Gastroenterology & Hepatology Relevant Disclosures No financial disclosures to report Leaning Objectives Burden of HCV Prevalence
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 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 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 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 information