Hepatitis C Treatment Criteria Commercial & Minnesota Health Care Programs

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1 Last update: February 23, 2015 Hepatitis C Treatment Criteria Commercial & Minnesota Health Care Programs Please see healthpartners.com for Medicare coverage criteria. Table of Contents 1. Harvoni 2. Sovaldi 3. VieKira Pak 4. Olysio Harvoni Requests meeting all of criteria below will be approved. 1. Treatment is prescribed by a physician or advanced practice provider within a gastroenterology, hepatology, infectious disease or transplant specialty practice. 2. Patients 18 years of age meeting ALL the following disease criteria as evidenced by written documentation from the medical record: A. Laboratory confirmed diagnosis of chronic hepatitis C genotype 1 virus; and, B. Pretreatment viral load within one year of regimen start date; and, C. Liver disease as evidenced by one of the following: 1) Solid organ transplant recipient (e.g., liver, heart, kidney); or, 2) Diagnosed with hepatocellular carcinoma and listed for liver transplantation; or, 3) Listed for a liver transplant; or, 4) Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 5-10 (Class B/C) and MELD score is 20; or, 5) Advanced fibrosis or compensated cirrhosis as measured by: a. Metavir fibrosis score F2 upon biopsy; or b. Radiologic imaging consistent with cirrhosis (e.g., nodules, enlarged liver, tortuous hepatitis arteries, ascites, or portal hypertension); or c. Evidence from a non-invasive test as below: i. APRI 0.7; or, ii. FibroTest/FibroSure 0.48; or, iii. Fibrospect 42; or, iv. Transient ultrasound elastography (Fibroscan/ShearWave) 7.1 kpa; or, v. Magnetic resonance elastography 4.8 kpa; or, 6) Severe complications of hepatitis C infection as defined below: a. Type 2 or 3 essential mixed cryoglobulinemia with end-organ manifestations (e.g., vasculitis); or,

2 b. Hepatitis C induced renal disease including nephrotic syndrome or membranoproliferative glomerulonephritis; or, 7) HIV-1 coinfection. 3. The patient is motivated, has been counseled and is likely to complete treatment as prescribed. Potential impediments to successful treatment must be addressed in the treatment notes prior to initiating treatment and submitted with the authorization request. An attestation has been completed by both the provider AND patient. The care team should also ensure that the patient has evidence of health insurance coverage and evidence of a stable living arrangement for the duration of treatment. 4. Patients with a history of alcohol use must be abstinent from alcohol use for six months or longer prior to requesting treatment approval. Exceptions will be considered for patients who have abstained from alcohol for at least three months if they are: B. The patient attests that they agree to abstain from alcohol use during treatment. 5. Patients with a history of intravenous drug use must be abstinent from intravenous drugs for six months or longer. Exceptions will be considered for patients who have abstained from intravenous drugs for at least three months if they are: B. The provider attests that the patient has abstained from use for three months and has a negative urine tox screen within thirty days of starting therapy (medical record documentation required). 6. The drug regimen meets ALL the following criteria as evidenced by written documentation from the medical record: A. An FDA-approved regimen is prescribed; and, B. Use is not in combination with any other direct acting antiviral (e.g., Victrelis, Olysio, Sovaldi, and, C. A plan for managing any drug interactions is indicated. 7. The proposed start date will be provided at the time of the prior authorization request. Drug supplies will not be dispensed until one week before the start date. 8. Virologic response will be submitted at 4 weeks of therapy and at 12 weeks after completion of treatment. Patients with the following conditions are not eligible for hepatitis C treatment: 1. Creatinine clearance < 30mL/min or on hemodialysis; or, 2. Currently pregnant or planning on becoming pregnant in the next six months; or, 3. Severe end organ disease and is not eligible for solid organ transplant; or, 4. Clinically-significant illness or any other major medical disorder that may interfere with a patient s ability to complete a course of treatment; or,

3 5. Patients who in the professional judgment of the primary treating clinician would not achieve a long term clinical benefit from HCV treatment (e.g., patients with multisystem organ failure, receiving palliative care or are enrolled in hospice, the presence of significant pulmonary or cardiac disease, and malignancy outside of the liver not meeting oncologic criteria for cure); or, 6. Decompensated liver disease with Child-Pugh-Turcotte > 10 or MELD > 20; or, 7. MELD 20 and one of the following: A. Cardiopulmonary disease that cannot be correct and is a prohibitive risk for surgery; or, B. Malignancy outside of the liver not meeting oncologic criteria for cure; or, C. Hepatocellular carcinoma with metastatic spread or not listed for liver transplant; or, D. Intrahepatic cholangiocarcinoma; or, E. Hemangiosarcoma. Harvoni will be approved in genotype 1 patients meeting the above criteria as follows: 1. Non-cirrhotic, treatment naïve, and pretreatment HCV RNA <6 million IU/mL patients will be approved for 8 weeks total duration. 2. Cirrhotic patients (Metavir F4 or equivalent) who failed previous chronic hepatitis C treatment will be approved for 24 weeks total duration Providers will be asked, but not required, to use in combination with Ribavirin for 12 weeks total duration. 3. All others will be approved for 12 weeks total duration. When the total duration of the regimen is longer than 8 weeks duration, approvals will initially be for 8 weeks. The remaining weeks will be approved when the 4 week HCV RNA is <25 IU/mL. Consultation with the prescriber will occur when the 4 week viral load is not <25 IU/mL. Requests for use in prior direct acting antiviral failures, for combinations of any marketed direct acting antiviral medications, and all other requests not meeting the above criteria will be reviewed on a case by case basis.

4 Sovaldi Requests meeting all of criteria below will be approved. 1. Treatment is prescribed by a physician or advanced practice provider within a gastroenterology, hepatology, infectious disease or transplant specialty practice. 2. Patients 18 years of age meeting ALL the following disease criteria as evidenced by written documentation from the medical record: A. Laboratory confirmed diagnosis of chronic hepatitis C virus; and, B. Pretreatment viral load within one year of regimen start date; and, C. Liver disease as evidenced by one of the following: 3. Solid organ transplant recipient (e.g., liver, heart, kidney); or, 4. Diagnosed with hepatocellular carcinoma and listed for liver transplantation; or, 5. Listed for a liver transplant; or, 6. Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 5-10 (Class B/C) and MELD score is 20; or, 7. Advanced fibrosis or compensated cirrhosis as measured by: A. Metavir fibrosis score F2 upon biopsy; or B. Radiologic imaging consistent with cirrhosis (e.g., nodules, enlarged liver, tortuous hepatitis arteries, ascites, or portal hypertension); or C. Evidence from a non-invasive test as below: 1) APRI 0.7; or, 2) FibroTest/FibroSure 0.48; or, 3) Fibrospect 42; or, 4) Transient ultrasound elastography (Fibroscan/ShearWave) 7.1 kpa; or, 5) Magnetic resonance elastography 4.8 kpa; or, 8. Severe complications of hepatitis C infection as defined below: A. Type 2 or 3 essential mixed cryoglobulinemia with end-organ manifestations (e.g., vasculitis); or, B. Hepatitis C induced renal disease including nephrotic syndrome or membranoproliferative glomerulonephritis; or, 9. HIV-1 coinfection. 10. The patient is motivated, has been counseled and is likely to complete treatment as prescribed. Potential impediments to successful treatment must be addressed in the treatment notes prior to initiating treatment and submitted with the authorization request. An attestation has been completed by both the provider AND patient. The care team should also ensure that the patient has evidence of health insurance coverage and evidence of a stable living arrangement for the duration of treatment. 11. Patients with a history of alcohol use must be abstinent from alcohol use for six months or longer prior to requesting treatment approval. Exceptions will be considered for patients who have abstained from alcohol for at least three months if they are:

5 B. The patient attests that they agree to abstain from alcohol use during treatment. 12. Patients with a history of intravenous drug use must be abstinent from intravenous drugs for six months or longer. Exceptions will be considered for patients who have abstained from intravenous drugs for at least three months if they are: B. The provider attests that the patient has abstained from use for three months and has a negative urine tox screen within thirty days of starting therapy (medical record documentation required). 13. The drug regimen meets ALL the following criteria as evidenced by written documentation from the medical record: A. An FDA-approved regimen is prescribed; and, B. Use is not in combination with any other direct acting antiviral (e.g., Victrelis, Olysio, or Harvoni ; and, C. A plan for managing any drug interactions is indicated. 14. The proposed start date will be provided at the time of the prior authorization request. Drug supplies will not be dispensed until one week before the start date. 15. Virologic response will be submitted at 4 weeks of therapy and at 12 weeks after completion of treatment. Patients with the following conditions are not eligible for hepatitis C treatment: 1. Creatinine clearance < 30mL/min or on hemodialysis; or, 2. Currently pregnant or planning on becoming pregnant in the next six months; or, 3. Severe end organ disease and is not eligible for solid organ transplant; or, 4. Clinically-significant illness or any other major medical disorder that may interfere with a patient s ability to complete a course of treatment; or, 5. Patients who in the professional judgment of the primary treating clinician would not achieve a long term clinical benefit from HCV treatment (e.g., patients with multisystem organ failure, receiving palliative care or are enrolled in hospice, the presence of significant pulmonary or cardiac disease, and malignancy outside of the liver not meeting oncologic criteria for cure); or, 6. Decompensated liver disease with Child-Pugh-Turcotte > 10 or MELD > 20; or, 7. MELD 20 and one of the following: A. Cardiopulmonary disease that cannot be correct and is a prohibitive risk for surgery; or, B. Malignancy outside of the liver not meeting oncologic criteria for cure; or, C. Hepatocellular carcinoma with metastatic spread or not listed for liver transplant; or, D. Intrahepatic cholangiocarcinoma; or, E. Hemangiosarcoma.

6 Sovaldi will be approved in patients meeting the above criteria as follows: 1. Genotype 1 A. Use with pegylated interferon and ribavirin for a duration of 12 weeks B. Approvals will initially be for 8 weeks. The remaining 4 weeks will be approved when the 4 week HCV RNA is <25 IU/mL. Consultation with the prescriber will occur when the 4 week viral load is not <25 IU/mL. 2. Genotype 2 A. Use with ribavirin for a duration of 12 weeks in patients who are treatment naïve. In patients who are treatment experienced and/or have cirrhosis, up to 16 weeks of therapy with ribavirin may be approved. B. Approvals will initially be for 8 weeks. The remaining 4 or 8 weeks will be approved when the 4 week HCV RNA is <25 IU/mL. Consultation with the prescriber will occur when the 4 week viral load is not <25 IU/mL.. 3. Genotype 3 A. Use with ribavirin for a duration of 24 weeks. B. Approvals will initially be for 8 weeks. The remaining 16 weeks will be approved when the 4 week HCV RNA is <25 IU/mL. Consultation with the prescriber will occur when the 4 week viral load is not <25 IU/mL. 4. Genotype 4 A. Use with ribavirin for a duration of 24 weeks or use with ribavirin and pegylated interferon for a duration of 12 weeks. B. Approvals will initially be for 8 weeks. The remaining 16 weeks will be approved when the 4 week HCV RNA is <25 IU/mL. Consultation with the prescriber will occur when the 4 week viral load is not <25 IU/mL. Requests for use in prior direct acting antiviral failures, for combinations of any marketed direct acting antiviral medications, and all other requests not meeting the above criteria will be reviewed on a case by case basis.

7 VieKira Pak Harvoni is the preferred genotype 1 virus treatment. Therefore, documented clinical inappropriateness or inability to tolerate Harvoni will be required prior to VieKira Pak OR Olysio approval. Requests meeting all of criteria below will be approved. 1. Treatment is prescribed by a physician or advanced practice provider within a gastroenterology, hepatology, infectious disease or transplant specialty practice. 2. Patients 18 years of age meeting ALL the following disease criteria as evidenced by written documentation from the medical record: A. Laboratory confirmed diagnosis of chronic hepatitis C genotype 1 virus; and, B. Pretreatment viral load within one year of regimen start date; and, C. Liver disease as evidenced by one of the following: 3. Solid organ transplant recipient (e.g., liver, heart, kidney); or, 4. Diagnosed with hepatocellular carcinoma and listed for liver transplantation; or, 5. Listed for a liver transplant; or, 6. Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 5-10 (Class B/C) and MELD score is 20; or, 7. Advanced fibrosis or compensated cirrhosis as measured by: A. Metavir fibrosis score F2 upon biopsy; or B. Radiologic imaging consistent with cirrhosis (e.g., nodules, enlarged liver, tortuous hepatitis arteries, ascites, or portal hypertension); or C. Evidence from a non-invasive test as below: 1) APRI 0.7; or, 2) FibroTest/FibroSure 0.48; or, 3) Fibrospect 42; or, 4) Transient ultrasound elastography (Fibroscan/ShearWave) 7.1 kpa; or, 5) Magnetic resonance elastography 4.8 kpa; or, 8. Severe complications of hepatitis C infection as defined below: A. Type 2 or 3 essential mixed cryoglobulinemia with end-organ manifestations (e.g., vasculitis); or, B. Hepatitis C induced renal disease including nephrotic syndrome or membranoproliferative glomerulonephritis; or, 9. HIV-1 coinfection. 10. The patient is motivated, has been counseled and is likely to complete treatment as prescribed. Potential impediments to successful treatment must be addressed in the treatment notes prior to initiating treatment and submitted with the authorization request. An attestation has been completed by both the provider AND patient. The care team should also ensure that the patient has

8 evidence of health insurance coverage and evidence of a stable living arrangement for the duration of treatment. 11. Patients with a history of alcohol use must be abstinent from alcohol use for six months or longer prior to requesting treatment approval. Exceptions will be considered for patients who have abstained from alcohol for at least three months if they are: B. The patient attests that they agree to abstain from alcohol use during treatment. 12. Patients with a history of intravenous drug use must be abstinent from intravenous drugs for six months or longer. Exceptions will be considered for patients who have abstained from intravenous drugs for at least three months if they are: B. The provider attests that the patient has abstained from use for three months and has a negative urine tox screen within thirty days of starting therapy (medical record documentation required). 13. The drug regimen meets ALL the following criteria as evidenced by written documentation from the medical record: A. An FDA-approved regimen is prescribed; and, B. Use is not in combination with any other direct acting antiviral (e.g., Victrelis, Olysio, Sovaldi, or Harvoni ; and, C. A plan for managing any drug interactions is indicated. 14. The proposed start date will be provided at the time of the prior authorization request. Drug supplies will not be dispensed until one week before the start date. 15. Virologic response will be submitted at 4 weeks of therapy and at 12 weeks after completion of treatment. Patients with the following conditions are not eligible for hepatitis C treatment: 1. Creatinine clearance < 30mL/min or on hemodialysis; or, 2. Currently pregnant or planning on becoming pregnant in the next six months; or, 3. Severe end organ disease and is not eligible for solid organ transplant; or, 4. Clinically-significant illness or any other major medical disorder that may interfere with a patient s ability to complete a course of treatment; or, 5. Patients who in the professional judgment of the primary treating clinician would not achieve a long term clinical benefit from HCV treatment (e.g., patients with multisystem organ failure, receiving palliative care or are enrolled in hospice, the presence of significant pulmonary or cardiac disease, and malignancy outside of the liver not meeting oncologic criteria for cure); or, 6. Decompensated liver disease with Child-Pugh-Turcotte > 10 or MELD > 20; or, 7. MELD 20 and one of the following:

9 A. Cardiopulmonary disease that cannot be correct and is a prohibitive risk for surgery; or, B. Malignancy outside of the liver not meeting oncologic criteria for cure; or, C. Hepatocellular carcinoma with metastatic spread or not listed for liver transplant; or, D. Intrahepatic cholangiocarcinoma; or, E. Hemangiosarcoma. VieKira Pak will be approved as follows in genotype 1 patients meeting the above criteria AND with documented clinical inappropriateness or inability to tolerate Harvoni : 1. Non-cirrhotic, genotype 1b patients will be approved for 12 weeks total duration. 2. Cirrhotic, genotype 1a patients who failed previous chronic hepatitis C treatment will be approved for 24 weeks total duration when used in combination with ribavirin. 3. All others will be approved for 12 weeks total duration when used in combination with ribavirin. Approvals will initially be for 8 weeks. The remaining weeks will be approved when the 4 week HCV RNA is <25 IU/mL. Consultation with the prescriber will occur when the 4 week viral load is not <25 IU/mL. Requests for use in prior direct acting antiviral failures, for combinations of any marketed direct acting antiviral medications, and all other requests not meeting the above criteria will be reviewed on a case by case basis.

10 Olysio Harvoni is the preferred genotype 1 virus treatment. Therefore, documented clinical inappropriateness or inability to tolerate Harvoni will be required prior to VieKira Pak OR Olysio approval. Requests meeting all of criteria below will be approved. 1. Treatment is prescribed by a physician or advanced practice provider within a gastroenterology, hepatology, infectious disease or transplant specialty practice. 2. Patients 18 years of age meeting ALL the following disease criteria as evidenced by written documentation from the medical record: A. Laboratory confirmed diagnosis of chronic hepatitis C genotype 1 virus; and, B. Pretreatment viral load within one year of regimen start date; and, C. Liver disease as evidenced by one of the following: 3. Solid organ transplant recipient (e.g., liver, heart, kidney); or, 4. Diagnosed with hepatocellular carcinoma and listed for liver transplantation; or, 5. Listed for a liver transplant; or, 6. Decompensated liver disease as defined by Child-Pugh-Turcotte classification score 5-10 (Class B/C) and MELD score is 20; or, 7. Advanced fibrosis or compensated cirrhosis as measured by: A. Metavir fibrosis score F2 upon biopsy; or B. Radiologic imaging consistent with cirrhosis (e.g., nodules, enlarged liver, tortuous hepatitis arteries, ascites, or portal hypertension); or C. Evidence from a non-invasive test as below: 1) APRI 0.7; or, 2) FibroTest/FibroSure 0.48; or, 3) Fibrospect 42; or, 4) Transient ultrasound elastography (Fibroscan/ShearWave) 7.1 kpa; or, 5) Magnetic resonance elastography 4.8 kpa; or, 8. Severe complications of hepatitis C infection as defined below: A. Type 2 or 3 essential mixed cryoglobulinemia with end-organ manifestations (e.g., vasculitis); or, B. Hepatitis C induced renal disease including nephrotic syndrome or membranoproliferative glomerulonephritis; or, 9. HIV-1 coinfection. 10. The patient is motivated, has been counseled and is likely to complete treatment as prescribed. Potential impediments to successful treatment must be addressed in the treatment notes prior to initiating treatment and submitted with the authorization request. An attestation has been completed by both the provider AND patient. The care team should also ensure that the patient has evidence of health insurance coverage and evidence of a stable living arrangement for the duration of treatment.

11 11. Patients with a history of alcohol use must be abstinent from alcohol use for six months or longer prior to requesting treatment approval. Exceptions will be considered for patients who have abstained from alcohol for at least three months if they are: B. The patient attests that they agree to abstain from alcohol use during treatment. 12. Patients with a history of intravenous drug use must be abstinent from intravenous drugs for six months or longer. Exceptions will be considered for patients who have abstained from intravenous drugs for at least three months if they are: B. The provider attests that the patient has abstained from use for three months and has a negative urine tox screen within thirty days of starting therapy (medical record documentation required). 13. The drug regimen meets ALL the following criteria as evidenced by written documentation from the medical record: A. An FDA-approved regimen is prescribed; and, B. Use is not in combination with any other direct acting antiviral (e.g., Victrelis, Olysio, Sovaldi, or Harvoni ; and, C. A plan for managing any drug interactions is indicated. 14. The proposed start date will be provided at the time of the prior authorization request. Drug supplies will not be dispensed until one week before the start date. 15. Virologic response will be submitted at 4 weeks of therapy and at 12 weeks after completion of treatment. Patients with the following conditions are not eligible for hepatitis C treatment: 1. Creatinine clearance < 30mL/min or on hemodialysis; or, 2. Currently pregnant or planning on becoming pregnant in the next six months; or, 3. Severe end organ disease and is not eligible for solid organ transplant; or, 4. Clinically-significant illness or any other major medical disorder that may interfere with a patient s ability to complete a course of treatment; or, 5. Patients who in the professional judgment of the primary treating clinician would not achieve a long term clinical benefit from HCV treatment (e.g., patients with multisystem organ failure, receiving palliative care or are enrolled in hospice, the presence of significant pulmonary or cardiac disease, and malignancy outside of the liver not meeting oncologic criteria for cure); or, 6. Decompensated liver disease with Child-Pugh-Turcotte > 10 or MELD > 20; or, 7. MELD 20 and one of the following: A. Cardiopulmonary disease that cannot be correct and is a prohibitive risk for surgery; or, B. Malignancy outside of the liver not meeting oncologic criteria for cure; or,

12 C. Hepatocellular carcinoma with metastatic spread or not listed for liver transplant; or, D. Intrahepatic cholangiocarcinoma; or, E. Hemangiosarcoma. Olysio will be approved as follows in genotype 1 patients meeting the above criteria AND with documented clinical inappropriateness or inability to tolerate Harvoni : 1. When used with pegylated interferon and ribavirin, Olysio will be approved for a duration of 12 weeks. Pegylated interferon and ribavirin will continue for an additional duration of 12 or 36 weeks. Approvals for Olysio and Pegylated interferon will initially be for 8 weeks. The remaining 4 weeks for Olysio and 4 or 28 weeks for pegylated interferon will be approved when the 4 week HCV RNA is <25 IU/mL. Consultation with the prescriber will occur when the 4 week viral load is not <25 IU/mL. Requests for use in prior direct acting antiviral failures, for combinations of any marketed direct acting antiviral medications, and all other requests not meeting the above criteria will be reviewed on a case by case basis.

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