HARVARD PILGRIM HEALTH CARE Generic Brand HICL GCN Exception/Other DACLATASVIR DAKLINZA 41377 ELBASVIR/GRAZOPREVIR ZEPATIER 43030 GLECAPREVIR/PIBRENTASVIR MAVYRET 44453 OMBITASVIR/PARITAPREVIR/ RITONAVIR TECHNIVIE 41734 OMBITASVIR/PARITAPREVIR/ VIEKIRA RITONAVIR/ DASABUVIR PAK 41644 OMBITASVIR/PARITAPREVIR/ RITONAVIR/ DASABUVIR VIEKIRA XR 41644 SIMEPREVIR OLYSIO 40771 SOFOSBUVIR SOVALDI 40795 SOFOSBUVIR/LEDIPASVIR HARVONI 41457 SOFOSBUVIR/VELPATASVIR EPCLUSA 43561 SOFOSBUVIR/VELPATASVIR/ VOXILAPREVIR VOSEVI 44428 Do not review this guideline with physicians; if the caller wishes to initiate a request then a MRF must be completed. This drug requires a written request for prior authorization. All requests for high-impact medications require review by a pharmacist prior to final approval. GUIDELINES FOR USE Section I: 1. Is the request for a patient with chronic hepatitis C (confirmed diagnosis for a minimum of 6 months)? If yes, continue to #2. Please use status code #238 and the denial text below: DENIAL TEXT: Per your health plan s Hepatitis C Medication guideline, this medication is only covered for members with a diagnosis of chronic hepatitis C (confirmed diagnosis for a minimum of 6 months). Your physician did not submit documentation to indicate that you have been diagnosed with Hepatitis C for at least 6 months and therefore your request was not approved. 2. Is the request for additional weeks of treatment beyond what was originally approved within the past 365 days? If yes, continue to #10. If no, continue to #3. 3. Is the patient at least 18 years old? If yes, continue to #4. Please use status code #238 and the denial text below: DENIAL TEXT: Per your health plan s Hepatitis C Medication guideline, this medication is only covered for members 18 years of age and older. Your physician indicated that you are under the age of 18 and therefore your request was not approved. Page 1 of 14
GUIDELINES FOR USE (CONTINUED) HARVARD PILGRIM HEALTH CARE 4. Is the requested medication being prescribed by a gastroenterologist, infectious disease specialist, or a hepatologist? If yes, continue to #5. Please use status code #238 and the denial text below: DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is only covered when prescribed by a gastroenterologist, infectious disease specialist, or a physician specializing in the treatment of hepatitis (i.e. hepatologist). Your physician did not indicate that he or she specializes in one of these areas and therefore your request was not approved. 5. Has the patient s liver disease been staged using either an invasive or non-invasive testing method (e.g. liver biopsy confirming METAVIR score, transient elastography (Fibroscan) score, FibroTest/FibroSURE score, APRI score, or radiological imaging) within the past 3 years? If yes, continue to #6. Please use status code #238 and the denial text below: DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is only covered when the degree of liver disease has been staged within the past 3 years and documentation has been submitted. Your physician did not submit documentation that your liver disease has been staged within the past 3 years and therefore your requested was not approved. 6. Has the provider attested that the patient is not currently participating in illicit substance abuse or alcohol abuse, or that the patient is receiving substance or alcohol abuse counseling services as an adjunct to HCV treatment? If yes, continue to #7. Please use status code #238 and the denial text below: DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is only covered for patients who are not actively participating in illicit substance use or alcohol use, or who are receiving substance or alcohol abuse counseling services. Your physician indicated that you are not receiving substance or alcohol abuse counseling services and therefore your request was not approved. 7. Has the reviewer reviewed the patient s prescription profile for potential drug interactions and confirmed there are no medications in the profile that are contraindicated or may reduce the efficacy of the requested medication? If yes, continue to #8. Please use status code #238 and the denial text below: DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, coverage of the requested medication requires that you are not taking another drug that interacts or may reduce the efficacy of the requested medication. You may be taking a medication that interacts with the requested medication and therefore your request was not approved. Page 2 of 14
HARVARD PILGRIM HEALTH CARE GUIDELINES FOR USE (CONTINUED) 8. Is the request for Epclusa, Harvoni, Viekira Pak or Vosevi? If yes, continue to #9. If no, continue to Section II. 9. Has the patient been counseled regarding the potential for antacids, H2 blockers and proton pump inhibitors, including over-the-counter (OTC) medications, to decrease the efficacy of the medication? If yes, continue to Section II. Please use status code #238 and the denial text below: DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is covered for patients who have been counseled regarding the potential for acid-reducing medications (e.g. antacids, H2 blockers and proton pump inhibitors) to decrease the effectiveness of the medication. Your physician has not indicated that you have been counseled about this drug interactions and therefore your request was not approved. 10. Did the patient receive a complete course of therapy as initially approved? If yes, do not approve. Please use status code #238 and the denial text below: DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is not covered if you already received a complete course of therapy as initially approved. Your physician indicated that you received a complete course of therapy and therefore your request was not approved. If no, continue to #11. 11. Is the request for a new course of therapy because the patient was non-adherent with the initially approved course of therapy? If yes, do not approve. DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is not covered for a new course of therapy if you were previously treated within the past 365 days. Your physician indicated that you already received a partial course of therapy within the past year and therefore your request was not approved. If no, continue to #12. 12. Was the anticipated start date delayed, resulting in the need to extend the end date to provide a complete course of therapy? If yes, approve by HICL to allow a complete treatment course and enter the fill count. APPROVAL TEXT: Your request for [requested medication] has been approved with a quantity limit of [# tablet(s) per day] for an additional [x-week] period. DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is not covered for a new course of therapy if you were previously treated within the past 365 days. Your physician indicated that you already received a partial course of therapy within the past year and therefore your request was not approved. Page 3 of 14
GUIDELINES FOR USE (CONTINUED) Section II Harvoni (sofosbuvir/ledipasvir) HARVARD PILGRIM HEALTH CARE 1. Is the request for a patient with the following condition and according to the submitted request they are not black (African American) or HIV positive? Genotype 1; treatment-naïve; without cirrhosis; HCV RNA viral load, taken within the past 12 months, less than 6 million IU/mL If yes, approve by HICL for 8 weeks with a fill count of 2. (A quantity limit of one tablet per Please use status code #056 and the following approval text. APPROVAL TEXT (8-week request): Your request for Harvoni has been approved with a quantity limit of one tablet per day for an 8-week period. PARTIAL DENIAL TEXT (12-week request): Your request for Harvoni has been partially approved with a quantity limit of one tablet per day for an 8-week period. Per your health plan s Hepatitis C Medications guideline, patients who were not previously treated for chronic hepatitis C infection, do not have cirrhosis and have a HCV viral load level less than 6 million IU/mL within the 12 months prior to starting treatment with Harvoni and are not African American or HIV-positive are approved for an 8-week treatment course. If HCV RNA level was not drawn within past 12 months, DENIAL TEXT (HCV RNA level not drawn within past 12 months): Per your health plan s Hepatitis C Medications guideline, coverage of this medication requires submission of a viral load (HCV RNA) level taken within the last 12 months. Your physician did not submit [documentation of a viral load level or a viral load level that was taken within the past 12 months] and therefore your request was not approved. If no, continue to #2. 2. Is the request for a patient with one of the following conditions? Genotype 1; treatment-naïve; without cirrhosis and with an HCV RNA viral load, taken within the past 12 months, greater than or equal to 6 million IU/mL Genotype 1; treatment-naïve; without cirrhosis; HCV RNA viral load, taken within the past 12 months, less than 6 million IU/mL AND either HIV positive or African American/Black Genotype 1; treatment-naïve; compensated cirrhosis Genotype 1; treatment-experienced with an NS3 protease inhibitor plus PEG-IFN/ribavirin; without cirrhosis Genotype 1, 4, 5 or 6; treatment-experienced with PEG-IFN/ribavirin; without cirrhosis Genotype 4, 5 or 6; treatment-naïve; without cirrhosis or with compensated cirrhosis Genotype 5 or 6; treatment-experienced with PEG-IFN/ribavirin; compensated cirrhosis If yes, approve by HICL for 12 weeks with a fill count of 3. (A quantity limit of one tablet per APPROVAL TEXT: Your request for Harvoni has been approved with a quantity limit of one tablet per day for a 12-week period. If no, continue to #3. Page 4 of 14
GUIDELINES FOR USE (CONTINUED) HARVARD PILGRIM HEALTH CARE If HCV RNA level was not drawn within past 12 months, DENIAL TEXT (if HCV RNA level was not drawn within past 12 months): Per your health plan s Hepatitis C Medications guideline, coverage of this medication requires submission of a viral load (HCV RNA) level taken within the last 12 months. Your physician did not submit [documentation of a viral load level or a viral load level that was taken within the past 12 months] and therefore your request was not approved. 3. Is the request for a patient with one of the following conditions? Genotype 1, 4, 5 or 6; treatment-naïve or treatment-experienced; recurrent HCV Infection post-liver transplantation; without cirrhosis or with compensated cirrhosis Genotype 1, 4, 5 or 6; decompensated cirrhosis If yes, continue to #4. If no, continue to #6. 4. Will ribavirin be administered concurrently with Harvoni? If yes, approve by HICL for 12 weeks with a fill count of 3. (A quantity limit of one tablet per APPROVAL TEXT: Your request for Harvoni has been approved with a quantity limit of one tablet per day for a 12-week period. Please note, it is very important that ribavirin be taken together with Harvoni during your 12 weeks of treatment to improve the likelihood that your condition will be cured. Do not start therapy until you have both ribavirin and Harvoni. If you have any questions, speak with your provider. If no, continue to #5. 5. Did the provider provide clinical rationale for not using ribavirin for a patient with Genotype 1, 4, 5 or 6 with decompensated cirrhosis? If yes, approve by HICL for 24 weeks with a fill count of 6. (A quantity limit of one tablet per APPROVAL TEXT: Your request for Harvoni has been approved with a quantity limit of one tablet per day for a 24-week period. If request is for a patient with genotype 1, 4, 5 or 6 with decompensated cirrhosis, DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is covered for patients with your condition when used in combination with ribavirin. Your physician did not indicate that you will be taking Harvoni in combination with ribavirin, or provide clinical rationale for not using ribavirin, and therefore your request was not approved. If request is for a patient with genotype 1, 4, 5 or 6; recurrent HCV infection post-liver transplantation, ribavirin is required; DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is covered for patients with your condition when used in combination with ribavirin. Your physician did not indicate that you will be taking Harvoni in combination with ribavirin and therefore your request was not approved. Page 5 of 14
GUIDELINES FOR USE (CONTINUED) HARVARD PILGRIM HEALTH CARE 6. Is the request for a patient with one of the following conditions? Genotype 1, 4, 5 or 6; treatment-experienced with a sofosbuvir-based regimen; decompensated cirrhosis If yes, continue to #7. If no, continue to Section III. 7. Will ribavirin be administered concurrently with Harvoni? If yes, approve by HICL for 24 weeks with a fill count of 6. (A quantity limit of one tablet per APPROVAL TEXT: Your request for Harvoni has been approved with a quantity limit of one tablet per day for a 24-week period. Please note, it is very important that ribavirin be taken together with Harvoni during your 24 weeks of treatment to improve the likelihood that your condition will be cured. Do not start therapy until you have both ribavirin and Harvoni. If you have any questions, speak with your provider. DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is covered for patients with your condition when used in combination with ribavirin. Your physician did not indicate that you will be taking Harvoni in combination with ribavirin and therefore your request was not approved. Epclusa (sofosbuvir/velpatasvir) 1. Is the request for a patient with one of the following conditions? Genotype 1, 2, 3, 4, 5 or 6; treatment-naïve; without cirrhosis Genotype 1, 2, 3, 4, 5 or 6; treatment naïve, compensated cirrhosis Genotype 1, 2, 4, 5 or 6; treatment-experienced with PEG-IFN/ribavirin, without cirrhosis or with compensated cirrhosis Genotype 1; treatment-experienced with an NS3 Protease Inhibitor plus PEG-IFN/ribavirin; without cirrhosis or with compensated cirrhosis Genotype 1b; treatment-experienced with non-ns5a Inhibitor, sofosbuvir-based regimen; without cirrhosis or with compensated cirrhosis Genotype 2; treatment-experienced with sofosbuvir/ribavirin; without cirrhosis or with compensated cirrhosis Genotype 3; treatment-experienced with PEG-IFN/ribavirin, without cirrhosis If yes, approve by HICL for 12 weeks with a fill count of 3. (A quantity limit of one tablet per APPROVAL TEXT: Your request for Epclusa has been approved with a quantity limit of one tablet per day for a 12-week period. If no, continue to #2. Page 6 of 14
HARVARD PILGRIM HEALTH CARE GUIDELINES FOR USE (CONTINUED) 2. Is the request for a patient with one of the following conditions? Genotype 1, 4, 5, or 6; treatment-experienced with a sofosbuvir- or an NS5A-based regimen; decompensated cirrhosis If yes, continue to #3. If no, continue to #4. 3. Will ribavirin be administered concurrently with Epclusa? If yes, approve by HICL for 24 weeks with a fill count of 6. (A quantity limit of one tablet per APPROVAL TEXT: Your request for Epclusa has been approved with a quantity limit of one tablet per day for a 24-week period. Please note, it is very important that ribavirin be taken together with Epclusa during your 24 weeks of treatment to improve the likelihood that your condition will be cured. Do not start therapy until you have both ribavirin and Epclusa. If you have any questions, speak with your provider. DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is covered for patients with your condition when used in combination with ribavirin. Your physician did not indicate that you will be taking Epclusa in combination with ribavirin and therefore your request was not approved. 4. Is the request for a patient with one of the following conditions? Genotype 1, 2, 3, 4, 5 or 6; decompensated cirrhosis If yes, continue to #5. If no, continue to Section III. 5. Will ribavirin be administered concurrently with Epclusa? If yes, approve by HICL for 12 weeks with a fill count of 3. (A quantity limit of one tablet per APPROVAL TEXT: Your request for Epclusa has been approved with a quantity limit of one tablet per day for a 12-week period. Please note, it is very important that ribavirin be taken together with Epclusa during your 12 weeks of treatment to improve the likelihood that your condition will be cured. Do not start therapy until you have both ribavirin and Epclusa. If you have any questions, speak with your provider. If no, continue to #6. 8. Did the provider provide clinical rationale for not using ribavirin? If yes, approve by HICL for 24 weeks with a fill count of 6. (A quantity limit of one tablet per APPROVAL TEXT: Your request for Epclusa has been approved with a quantity limit of one tablet per day for a 24-week period. Page 7 of 14
HARVARD PILGRIM HEALTH CARE GUIDELINES FOR USE (CONTINUED) DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is covered for patients with your condition when used in combination with ribavirin. Your physician did not indicate that you will be taking Epclusa in combination with ribavirin, or provide clinical rationale for not using ribavirin, and therefore your request was not approved. Mavyret (glecaprevir, pibrentasvir) 1. Is the request for a patient with one of the following conditions? Genotype 1, 2, 3, 4, 5 or 6; treatment-naïve; without cirrhosis Genotype 1, 2, 4, 5 or 6; treatment-experienced with PEG-IFN/ribavirin, without cirrhosis Severe renal impairment (egfr < 30 ml/min or ESRD) and one of the above conditions If yes, approve by HICL for 8 weeks with a fill count of 2. (A quantity limit of three tablets per APPROVAL TEXT: Your request for Mavyret has been approved with a quantity limit of three tablets per day for an 8-week period. If no, continue to #2. 2. Is the request for a patient with one of the following conditions? Genotype 1, 2, 3, 4, 5 or 6; treatment-naïve; compensated cirrhosis Genotype 1, 2, 4, 5 or 6; treatment-experienced with PEG-IFN/ribavirin, compensated cirrhosis Genotype 1; treatment-experienced with an NS3 Protease Inhibitor plus PEG-IFN/ribavirin; without cirrhosis or with compensated cirrhosis Genotype 1; treatment-experienced with a non-ns5a inhibitor, sofosbuvir-based regimen; without cirrhosis or with compensated cirrhosis Genotype 1, 2, 3, 4, 5 or 6; treatment-naïve or treatment-experienced; recurrent HCV Infection post-liver transplantation; without cirrhosis Genotype 2 or 3; treatment-naïve or treatment-experienced; recurrent HCV Infection post-liver transplantation; compensated cirrhosis Genotype 2; treatment-experienced with sofosbuvir/ribavirin; without cirrhosis or with compensated cirrhosis Severe renal impairment (egfr < 30 ml/min or ESRD) and one of the above conditions If yes, approve by HICL for 12 weeks with a fill count of 3. (A quantity limit of three tablets per APPROVAL TEXT: Your request for Mavyret has been approved with a quantity limit of three tablets per day for a 12-week period. If no, continue to Section III. Page 8 of 14
GUIDELINES FOR USE (CONTINUED) HARVARD PILGRIM HEALTH CARE Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 1. Is the request for a patient with one of the following conditions? Genotype 1a; treatment-experienced with a non-ns5a inhibitor, sofosbuvir-based regimen; without cirrhosis or with compensated cirrhosis Genotype 1; treatment-experienced with an NS5A inhibitor; without cirrhosis or with compensated cirrhosis Genotype 3; treatment-experienced with PEG-IFN/ribavirin; compensated cirrhosis Genotype 3, 4, 5 or 6; treatment-experienced with a direct acting antiviral regimen (including an NS5A inhibitor); without cirrhosis or with compensated cirrhosis If yes, approve by HICL for 12 weeks with a fill count of 3. (A quantity limit of one tablet per APPROVAL TEXT: Your request for Vosevi has been approved with a quantity limit of one tablet per day for a 12-week period. If no, continue to #2. 2. Is the request for a patient with genotype 3, treatment-experienced with a direct acting antiviral regimen and prior NS5A inhibitor failure, and with compensated cirrhosis? If yes, continue to #3. If no, continue to Section III. 3. Will ribavirin be administered concurrently with Vosevi? If yes, approve by HICL for 12 weeks with a fill count of 3. (A quantity limit of one tablet per APPROVAL TEXT: Your request for Vosevi has been approved with a quantity limit of one tablet per day for a 12-week period. Please note, it is very important that ribavirin be taken together with Vosevi during your 12 weeks of treatment to improve the likelihood that your condition will be cured. Do not start therapy until you have both ribavirin and Vosevi. If you have any questions, speak with your provider. DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is covered for patients with your condition when used in combination with ribavirin. Your physician did not indicate that you will be taking Vosevi in combination with ribavirin and therefore your request was not approved. Page 9 of 14
GUIDELINES FOR USE (CONTINUED) HARVARD PILGRIM HEALTH CARE Daklinza (daclatasvir), Sovaldi (sofosbuvir), Olysio (simeprevir), Technivie (ombitasvir/paritaprevir/ritonavir), Viekira Pak/ Viekira XR (ombitasvir/paritaprevir/ritonavir/dasabuvir), Zepatier (elbasvir/grazoprevir) 1. Is the request for one of the following non-preferred Hepatitis C medications? Daklinza (daclatasvir) Sovaldi (sofosbuvir) Olysio (simeprevir) Technivie (ombitasvir/paritaprevir/ritonavir) Viekira Pak/ Viekira XR (ombitasvir/paritaprevir/ritonavir/dasabuvir) Zepatier (elbasvir/grazoprevir) If yes, continue to Section III. If no, please refer to above criteria. Section III 1. Is the requested medication a recommended treatment regimen for this patient s condition according to the current AASLD/IDSA HCV Treatment Guidelines? If yes, continue to #2. DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication may only be covered for patients with your condition if it is a recommended treatment regimen according to the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) HCV Treatment Guidelines. Your physician did not indicate that you have one of these conditions and therefore your request was not approved. 2. Is one of Harvard Pilgrim s preferred therapies, e.g., Epclusa, Harvoni, Mavyret or Vosevi, not recommended by the AASLD/IDSA HCV Treatment Guidelines for this patient s condition or did the provider provide clinical rationale (e.g. shorter duration of therapy, higher level of evidence or strength of recommendation, ribavirin ineligible) for not using one of the preferred therapies? If yes, continue to #3. DENIAL TEXT: Per your health plan s Hepatitis C Medications guideline, this medication is only covered for your condition if there is a clinical reason why you cannot use one of Harvard Pilgrim s preferred therapies, such as [select appropriate therapies], for your condition. Your physician did not indicate you could not use one of the preferred therapies and therefore your request was not approved. Page 10 of 14
GUIDELINES FOR USE (CONTINUED) HARVARD PILGRIM HEALTH CARE 3. Does the AASLD/IDSA HCV treatment guidance recommend any of the following for this patient s condition? Use of the requested medication in combination with ribavirin Use of the requested medication in combination with another HCV antiviral therapy Resistance testing If yes, continue to #4 If no, approve by HICL for the recommended treatment duration per the AASLD/IDSA guidelines and enter a fill count. APPROVAL TEXT: Your request for [requested medication] has been approved with a quantity limit of one tablet per day for a [# of weeks]-week period. 4. In accordance with the AASLD/IDSA HCV treatment guidance, did the provider indicate the medication would be taken in combination with ribavirin, with another HCV antiviral therapy, and/or was resistance testing performed and submitted supporting the use of the requested treatment regimen? If yes, approve by HICL for the recommended treatment duration per the AASLD/IDSA guidance and enter a fill count. If concomitant therapy with another HCV medication requiring PA, please enter an approval for both medications. APPROVAL TEXT: Your request for [requested medication] has been approved with a quantity limit of [# of tablets] tablet per day for a [# of weeks]-week period. Please note, it is very important that [requested medication] be taken together with [ribavirin or concomitant HCV medication] during your entire course of treatment to improve the likelihood that your condition will be cured. Do not start therapy until you have both [requested medication] and [ribavirin or concomitant HCV medication]. If you have any questions, speak with your provider. DENIAL TEXT (combination treatment regimens): Per your health plan s Hepatitis C Medications guideline, this medication is only covered for patients with your condition when used in combination with [ribavirin or concomitant HCV medication]. Your physician did not indicate that you will be taking [requested medication] in combination with [ribavirin or concomitant HCV medication] and therefore your request was not approved. DENIAL TEXT (resistance testing): Per your health plan s Hepatitis C Medications guideline, this medication is only covered for patients with your condition when resistance testing has been performed and submitted which supports thus use of the requested medication. Your physician did not provide resistance testing supporting the use of the requested medication and therefore your request was not approved. RATIONALE Ensure appropriate utilization of Hepatitis C medications based on FDA approved indications and AASLD and IDSA Guidance. Chronic Hepatitis C is defined as inflammation of the liver lasting longer than 6 months. Page 11 of 14
HARVARD PILGRIM HEALTH CARE FDA APPROVED INDICATIONS Daklinza is a hepatitis C virus NS5A inhibitor indicated for use with sofosbuvir (Sovaldi) for the treatment of chronic HCV Genotype 3 infection. Epclusa is indicated for the treatment of adult patients with chronic HCV genotype 1, 2, 3, 4, 5, or 6 infection. Harvoni is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. Mavyret is indicated for the treatment of patients with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A). Mavyret is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. Olysio is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. Its efficacy has been established in combination with peginterferon alfa and ribavirin in HCV genotype 1 infected subjects with compensated liver disease (including cirrhosis). OLYSIO must not be used as monotherapy. Sovaldi is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral treatment regimen. Technivie is indicated in combination with ribavirin for the treatment of patients with genotype 4 chronic hepatitis C virus (HCV) infection without cirrhosis. Viekira Pak and Viekira XR are indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) with genotype 1b infection without cirrhosis or with compensated cirrhosis and with genotype 1a infection without cirrhosis or with compensated cirrhosis for use in combination with ribavirin. Vosevi is indicated for the treatment of adult patients with chronic HCV infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who have: genotype 1, 2, 3, 4, 5, or 6 infection and have previously been treated with an HCV regimen containing an NS5A inhibitor. genotype 1a or 3 infection and have previously been treated with an HCV regimen containing sofosbuvir without an NS5A inhibitor. Zepatier is indicated for the treatment of chronic hepatitis C, genotypes 1 or 4 infection in adults (with or without ribavirin). Generic Name / Target of Inhibition Brand NS5A NS5B NS3/4A Mavyret pibrentasvir glecaprevir Vosevi (retreatment) velpatasvir sofosbuvir voxilaprevir Epclusa velpatasvir sofosbuvir Harvoni ledipasvir sofosbuvir Sovaldi sofosbuvir Zepatier elbasvir grazoprevir Daklinza daclatasvir Viekira ombitasvir dasabuvir paritaprevir Technivie ombitasvir paritaprevir Olysio simeprevir Page 12 of 14
HARVARD PILGRIM HEALTH CARE REFERENCES Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. NEJM 2014; 370 (20): 1889-1898. 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; 147:359-365. Afdhal N, Reddy R, Nelson D, Lawitz E, Gordon S, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. NEJM 2014; 370 (16): 1483-1493. Bourlière et al. An integrated safety and efficacy analysis of >500 patients with compensated cirrhosis treated with ledipasvir/sofosbuvir with or without ribavirin. In: The Liver Meeting 2014; November 7 11, 2014; Boston. Abstract 82. Bourlière M, Bronowicki JP, de Ledinghen V, et al. Ledipasvir/sofosbuvir fixed-dose combination Is safe and efficacious in cirrhotic patients who have previously failed protease-inhibitor based triple therapy. In: The Liver Meeting 2014; November 7 11, 2014; Boston. Abstract LB-6. Chronic Hepatitis Guide: Causes, Symptoms and Treatment Options. Drugs.com. Harvard Health Publications, n.d. Web. 18 Aug. 2016. Daklinza [Prescribing Information]. Princeton, NJ: Bristol-Myers Squibb Company; April 2016. Guidance from the American Association for the Study of Liver Diseases (AASLD) and the Infectious Disease Society of America (IDSA) Recommendations for Testing, Managing, and Treating Hepatitis C. Available online at http://www.hcvguidelines.org/full-report-view Updated September 21, 2017. Accessed September 25, 2017. Epclusa [Prescribing Information]. Foster City, CA: Gilead Sciences; August 2017. Epclusa [Product Formulary Monograph]. Foster City, CA: Gilead Sciences; August 2016. Eron JJ, Wyles D, Sulkowski MS, et al. TURQUOISE-I: Safety and efficacy of ABT- 450/R/ombitasvir, dasabuvir, and ribavirin in patients co-infected with hepatitis C and HIV-1. Presented at: 54 th Interscience Conference on Antimicrobial Agents and Chemotherapy; Washington, DC: September 7, 2014. 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: 1594-1603. Ferenci P, Bernstein D, Lalezari J, et al. ABT-450/r-ombitasvir and dasabavir with or without ribavirin for HCV. N Engl J Med. 2014; 370:1983-1992. Harvoni [Prescribing Information]. Foster City, CA: Gilead Sciences; April 2017. Harvoni [Product Formulary Monograph]. Foster City, CA: Gilead Sciences; October 2014. Kowdley K, Gordon S, Reddy R, Rossaro L, Bernstein D, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. NEJM 2014; 370 (20): 1879-1888. Kwo PY, Mantry PS, Coakley E, et al An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med. 2014; 371: 2375-2382. Olysio [Prescribing Information]. Titusville, NJ: Janssen Pharmaceuticals; May 2016. 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; 370: 1973-1982. Rutherford, Anna E. Overview of Chronic Hepatitis. Merck Manuals Professional Edition. N.P., July 2016. Web. 18 Aug. 2016. Sovaldi [Prescribing Information]. Foster City, CA. Gilead Sciences; May 2015. Technivie [Prescribing Information]. North Chicago, IL: Abbvie Inc.; June 2016. Viekira Pak [Prescribing Information]. North Chicago, IL: AbbVie, Inc.; June 2016. Viekira XR [Prescribing Information]. North Chicago, IL: AbbVie, Inc.; July 2016. Page 13 of 14
HARVARD PILGRIM HEALTH CARE Zepatier [Prescribing Information]. Whitehouse Station, NJ: Merck & Co., Inc: January 2016. 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; 370:1604-1614. Vosevi [Prescribing Information]. Foster City, CA: Gilead Sciences; July 2017. Mavyret [Prescribing Information]. North Chicago, IL: AbbVie Inc. August 2017. Created: 08/01/16 Effective: 10/01/17 P&T Approval: 09/11/17 Page 14 of 14