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 of HCV genotype 1, 4, 5, 6? 3. Does the member have a diagnosis of chronic hepatitis C infection confirmed by quantitative HCV RNA analysis within the last 6 months? 4. Is the member at least 18 years of age? Rational: Safety and efficacy has not been established in pediatric patients. 5. Is the member currently supervised by a gastroenterologist, infectious disease specialist, or hepatologist? Rational: All persons with current active HCV infection should be linked to a practitioner who is prepared to provide comprehensive management. Lack of appropriate practitioner assessment can result in negative health outcomes. 6. Has the member had all the appropriate pre-treatment testing? HIV status in the past 6 months; AND Pregnancy test if a woman of child-bearing age in the past 30 days 7. Has the member failed treatment with any of the following: Elbasvir/grazoprevir (Zepatier) Daclatasvir plus sofosbuvir (Daklinza + Sovaldi) Ledipasvir/sofosbuvir (Harvoni) Paritaprevir/ritonavir/ombitasvir (Technivie) Paritaprevir/ritonavir/ombitasvir plus dasabuvir (Viekira Pak) No: Move to next No: Category 1 denial. evaluation Yes: Category 3 denial. Note: members with GT1 infection who have failed treatment with sofosbuvir +/- ribavirin or pegylated interferon may be eligible for retreatment. Reinfection will be reviewed by MD to evaluate for medical appropriateness of retreatment. 1 P age
Sofosbuvir (Sovaldi) and Genotype 2, 3, 4, 5 or 6 infection Sofosbuvir/velpatasvir (Epclusa) Sofosbuvir + Simeprevir (Sovaldi + Olysio) 8. Does the member have expected survival from non-hcv associated morbidities of greater than 5 years AND A biopsy or transient elastography (Fibroscan) to indicate advanced fibrosis (METAVIR F3) or cirrhosis (METAVIR F4); OR Radiologic, laboratory (APRI score >1.5 or FIB-4 score >3.25), or clinical evidence (ascites, portal hypertension) of cirrhosis 9. Does the member have one of the following extrahepatic manifestations of Hepatitis C (with documentation from a relevant specialist that their condition is related to HCV) and have an expected survival from non-hcv-associated morbidities greater than 5 years? Type 2 or 3 cryoglobulinemia with end-organ manifestations (i.e. leukocytoclastic vasculitis); OR Proteinuria, nephrotic syndrome, or membranoproliferative glomerulonephritis; OR Porphyria cutanea tarda 10. Does the patient have Hepatitis C in the transplant setting, expected survival from non-hcv-associated morbidities of greater than 5 years, and include the following scenarios: Patient is listed for a transplant and it is essential to prevent recurrent hepatitis C infection posttransplant; OR Post solid organ transplant 11. Does the patient have HIV coinfection and METAVIR stage F2 or greater (APRI 1.0) AND Member is under the care of a specialist with experience in HIV evaluation No: Move to next Yes: Move the #12 No: Move to next Yes: Move the #12 Yes: Move the next 2 P age
CD4 count >200 (per CDC: CD4 count 200 has been shown to result in lower HCV treatment response rates and higher rates of toxicity) 12. Has the patient been evaluated for current alcohol and substance use with a validated screening instrument? Valid screening tools include but are not limited to AUDIT for alcohol abuse DAST for drug use 13. Is the member actively using illicit drugs or abusing alcohol. Active use will be evaluated by a UDS negative for alcohol and illicit drugs within 30 days of the start of treatment. 14. Is the patient enrolled and adherent to a treatment program under the care of an addiction specialist? 15. Review fill history for the member. Has the member shown compliance to previous medical therapy evidenced by 80% or greater adherence to maintenance medication for other chronic conditions (HTN, diabetes, etc.)? 16. Does the member have decompensated cirrhosis and ALL of the following HCV genotype 1 or 4 infection Ribavirin eligible Total Bilirubin 10mg/dL CrCl 40mL/min Hemoglobin 10g/dL Platelet count >30,000/mm 3 17. Does the member have significant renal impairment (CrCl 30mL/min), end stage renal disease, or require renal dialysis? No: Move to next No: Move to #15. If no UDS submitted, forward to MD for medical appropriateness. appropriateness (category 5) Rational: Efficacy of therapy is contingent on adherence to medication.. Rational: Values listed are reflective of data and population studied in clinical trials. Yes: Category 3 denial. Rational: Safety and efficacy have not been established in patients with severe renal impairment. 3 P age
18. Will the patient and provider comply with case management and adherence monitoring including measuring and reporting of a post-treatment viral load? 19. Is the member currently on any medication(s) that aren t recommended for concomitant use? Acid Reducing Agents: Antacids, H2-receptor antagonists, PPI Antiarrhythmics: amiodarone Anticonvulsants: carbamazepine, phenytoin, phenobarbital, oxcarbazepine Antimycobacterials: rifabutin, rifampin, rifapentine Herbal supplements: St. John s wort HIV Protease Inhibitors: tipranavir/ritonavir combination 20. Is the member being prescribed the appropriate concomitant therapy based on genotype? 21. Has the member met the approval criteria for applicable concomitant therapy (Ribavirin, Interferon, etc.)? 22. Is the duration of treatment appropriate based on genotype and concomitant therapy per treatment table? **WVCH reserves the right to approve medication on a monthby-month basis to monitor for patient adherence to therapy, ongoing drug/alcohol free status, and pregnancy status (as it pertains to ribavirin concomitant therapy) if applicable. Yes: approve Currently no dose recommendations can be made for patients with severe renal impairment (egfr <30mL/min/1.73m2) or with ESRD. Yes: Forward to Medical Director These medications decrease serum concentrations of HCV treatment and decrease efficacy. or forward to pharmacist of Medical Director for approve as amended authorization per indication Sovaldi-Formulary PA required 1. Is the patient being treated for a funded condition by the Oregon Health Plan? No: Category 1 denial 4 P age
2. Does the member have a diagnosis of HCV genotype 1, 2, 3, or 4? 3. Does the member have a diagnosis of chronic hepatitis C infection confirmed by quantitative HCV RNA analysis within the last 6 months? 4. Is the member at least 18 years of age? Rational: Safety and efficacy has not been established in pediatric patients. 5. Is the member currently supervised by a gastroenterologist, infectious disease specialist, or hepatologist? Rational: All persons with current active HCV infection should be linked to a practitioner who is prepared to provide comprehensive management. Lack of appropriate practitioner assessment can result in negative health outcomes. 6. Has the member had all the appropriate pre-treatment testing? HIV status in the past 6 months; AND Pregnancy test if a woman of child-bearing age in the past 30 days 7. Does the member have an expected survival from non-hcv associated morbidities of greater than 5 years AND: A biopsy or transient elastography (Fibroscan) to indicate advanced fibrosis (METAVIR F3) or cirrhosis (METAVIR F4); OR Radiologic, laboratory (APRI score >1.5 or FIB-4 score >3.25), or clinical evidence (ascites, portal hypertension) or cirrhosis 8. Does the member have one of the following extrahepatic manifestations of Hepatitis C (with documentation from a relevant specialist that their condition is related to HCV) and have an expected survival from non-hcv-associated morbidities greater than 5 years?. evaluation evaluation No: Move to next Yes: Move the #11 5 P age
Type 2 or 3 cryoglobulinemia with end-organ manifestations (i.e. leukocytoclastic vasculitis); OR Proteinuria, nephrotic syndrome, or membranoproliferative glomerulonephritis; OR Porphyria cutanea tarda 9. Does the patient have Hepatitis C in the transplant setting, expected survival from non-hcv-associated morbidities of greater than 5 years, AND Patient is listed for a transplant and it is essential to prevent recurrent hepatitis C infection posttransplant; OR Post solid organ transplant 10. Does the patient have HIV coinfection and METAVIR stage F2 or greater (APRI 1.0) AND Member is under the care of a specialist with experience in HIV CD4 count >200 (per CDC: CD4 count 200 has been shown to result in lower HCV treatment response rates and higher rates of toxicity) 11. Has the patient been evaluated for current alcohol and substance use with a validated screening instrument? Valid screening tools include but are not limited to AUDIT for alcohol abuse DAST for drug use 12. Is the member actively using illicit drugs or abusing alcohol. Active use will be evaluated by a UDS negative for alcohol and illicit drugs within 30 days of the start of treatment. 13. Is the patient enrolled and adherent to a treatment program under the care of an addiction specialist? No: Move to next Yes: Move the next Yes: Category 3 denial Rational: Safety and efficacy of Sovaldi have not been established in post-liver transplant patients. Exceptions may be made for those with HC awaiting liver transplant per package insert FDA approval. No: Move to #14. If no UDS submitted, forward to MD for medical appropriateness 6 P age
14. Review fill history for the member. Has the member shown compliance to previous medical therapy evidenced by 80% or greater adherence to maintenance medication for other chronic conditions (HTN, diabetes, etc.)? 15. Does the member have a diagnosis of decompensated cirrhosis? 16. Does the member have significant renal impairment (CrCl 30mL/min), end stage renal disease, or require renal dialysis? 17. Will the patient and provider comply with case management and adherence monitoring including measuring and reporting of a post-treatment viral load? 18. Is the member currently on any medication(s) that aren t recommended for concomitant use? Antiarrhythmics: amiodarone Anticonvulsants: carbamazepine, phenytoin, phenobarbital, oxcarbazepine Antimycobacterials: rifabutin, rifampin, rifapentine Herbal supplements: St. John s wort HIV Protease Inhibitors: tipranavir/ritonavir combination 19. Is the member being prescribed the appropriate concomitant therapy based on genotype? No: Move to next No: Move to next No: Move to next appropriateness (category 5) Rational: Efficacy of therapy is contingent on adherence to medication. Yes: Category 3 denial. Rational: Safety and efficacy of Sovaldi have not been established in patients with decompensated cirrhosis. Yes: Category 3 denial. Rational: Safety and efficacy have not been established in patients with severe renal impairment. Currently no dose recommendations can be made for patients with severe renal impairment (egfr <30mL/min/1.73m2) or with ESRD. Yes: Forward to Medical Director These medications decrease serum concentrations of HCV treatment and decrease efficacy. 7 P age
20. Has the member met the approval criteria for applicable concomitant therapy (Ribavirin, Interferon, etc.)? 21. Is the duration of treatment appropriate based on genotype and concomitant therapy per treatment table? **WVCH reserves the right to approve medication on a monthby-month basis to monitor for patient adherence to therapy, ongoing drug/alcohol free status, and pregnancy status (as it pertains to ribavirin concomitant therapy) if applicable. Yes: approve or forward to pharmacist of Medical Director for approve as amended authorization per indication Non-formulary Medication (Daklinza, Viekira Pak, Technivie, Zepatier) 1. Is the patient being treated for a funded condition by the Oregon Health Plan? 2. Is the requested Direct Acting Antiviral have FDA approval for the HCV genotype that is being treated? 3. Does the member have a diagnosis of chronic hepatitis C infection confirmed by quantitative HCV RNA analysis within the 6 months? 4. Is the member at least 18 years of age? 5. Is the medication being prescribed by, or in consultation with a gastroenterologist, infectious disease specialist, or hepatologist? Rational: All persons with current active HCV infection should be linked to a practitioner who is prepared to provide comprehensive management. Lack of appropriate practitioner assessment can result in negative health outcomes. 6. Has the member had all the appropriate pre-treatment testing? HIV status in the past 6 months; AND Pregnancy test if a woman of child-bearing age in the past 30 days 7. Does the member have expected survival from non-hcv associated morbidities of greater than 5 years AND: Yes: Move #10 No: Category 1 denial Safety and effectiveness in children less than 18 have not been established appropriateness appropriateness No: Move to next 8 P age
A biopsy, transient elastography (Fibroscan) to indicate advanced fibrosis (METAVIR F3) or cirrhosis (METAVIR F4); OR Radiologic, laboratory (APRI score >1.5 or FIB-4 score >3.25), or clinical evidence (ascites, portal hypertension) or cirrhosis 8. Does the member have one of the following extrahepatic manifestations of Hepatitis C (with documentation from a relevant specialist that their condition is related to HCV) and have an expected survival from non-hcv-associated morbidities greater than 5 years? Type 2 or 3 cryoglobulinemia with end-organ manifestations (i.e. leukocytoclastic vasculitis); OR Proteinuria, nephrotic syndrome, or membranoproliferative glomerulonephritis; OR Porphyria cutanea tarda 9. Does the patient have HIV coinfection and METAVIR stage F2 or greater (APRI 1.0) AND the patient is under treatment by a specialist with experience in HIV? 10. Has the patient been evaluated for current alcohol and substance use with a validated screening instrument? Valid screening tools include but are not limited to AUDIT for alcohol abuse DAST for drug use 11. Is the member actively using illicit drugs or abusing alcohol? Active use will be evaluated by a UDS negative for alcohol and illicit drugs within 30 days of the start of treatment. 12. Is the patient enrolled and adherent to a treatment program under the care of an addiction specialist? 13. Review fill history for the member. Has the member shown compliance to previous medical therapy evidenced by 80% or Yes: Move to #10 Yes: Move to #10 No: Move to next appropriateness appropriateness No: Move to #12. If no UDS submitted, forward to MD appropriateness No: forward to MD for medical appropriateness. 9 P age
greater adherence to maintenance medication for other chronic conditions (HTN, diabetes, etc.). 14. Does the medication requested have FDA indication for the treatment of HCV in decompensated cirrhosis? 15. Does the member have significant renal impairment (CrCL 30mL/min), end stage renal disease, or require renal dialysis and does the medication have FDA approval for use in patients with renal impairment? If no renal impairment Move to next. 16. Is the member currently on any medication(s) that is not recommended for concomitant use per current package insert? 17. Does the member have contraindication to formulary options? 18. Has the member met the approval criteria for applicable concomitant therapy (Ribavirin, Interferon, etc.)? 19. Is the duration of treatment appropriate based on genotype and concomitant therapy per treatment table and FDA approved labeling? **WVCH reserves the right to approve medication on a month-by-month basis to monitor for patient adherence to therapy, ongoing drug/alcohol free status, and pregnancy status (as it pertains to ribavirin concomitant therapy) if applicable. No: Move to next No: Move to next Yes: Approve Rational: Efficacy of therapy is contingent on adherence to medication No: If Yes, Category 3 denial. Rational: Safety and efficacy of therapy has not been established on decompensation cirrhosis No FDA indication for treatment of renal impairment: Category 3 denial Rational: Safety and efficacy in selected medication has not been established in patients with severe renal impairment. Currently no dose recommendations can be made for patients with severe renal impairment (egfr <30mL/min/1.73m2) or with ESRD. Yes: Forward to Medical Director for medical evaluation No: Category 15 denial. Exceptions may be considered for new HCV drugs to market that are less costly than current formulary options but have not yet gone through P&T process. y for medical evaluation or forward to pharmacist or Medical Director for amended approval. 10 P age
Population Recommended Regimen Alternative Regimen Genotype 1 Treatment Naïve Non-cirrhotic Genotype 1a Genotype 1b Cirrhotic Genotype 1a Genotype 1b Treatment Experienced (INF + RBV) Non-cirrhotic Genotype 1a Genotype 1b Cirrhotic Genotype 1a Harvoni x 12 weeks Zepatier x 12 weeks (with no baseline NS5A RAV for elbasvir detected) Havoni x 12 weeks Zepatier x 12 weeks Harvoni x 12 weeks Zepatier x 12 weeks (with no baseline NS5A RAV for elbasvir detected) Harvoni x 12 weeks Zepatier x 12 weeks Harvoni x 12 weeks Zepatier x 12 weeks (with no baseline NS5A RAV for elbasvir detected) Harvoni x 12 weeks Zepatier x 12 weeks Harvoni + RBV x 12 weeks Viekira Pak + RBV x 12 weeks Zepatier + RBV x 16 weeks with polymorphism Viekira Pak x 12 weeks Viekira Pak + RBV x 24 weeks (listed AASLD as alternate therapy) Viekira Pak + RBV x 12 weeks Viekira Pak + RBV x 12 weeks Viekira Pak x 12 weeks 11 P age
Genotype 1b Treatment Experienced (Other Regimens) INF + RBV + Protease Inhibitor Non-Cirrhotic Zepatier x 12 weeks (with no baseline NS5A RAV for elbasvir detected) Harvoni + RBV x 12 weeks Zepatier x 12 weeks Viekira Pak + RBV x 12 weeks Harvoni x 12 weeks based on limited data Cirrhotic Harvoni x 24 weeks Harvoni + RBV x 12 weeks (limited data) Sovaldi* Non-Cirrhotic Harvoni + RBV x 12 weeks Defer Treatment Cirrhotic Harvoni + RBV x 24 weeks Defer Treatment Genotype 2 Treatment Naïve Sovaldi + RBV x 12 weeks Treatment Experienced no cirrhosis Treatment Experienced compensated cirrhosis Sovaldi + RBV x 12 weeks Sovaldi + RBV x 12 weeks Sovaldi + RBV x 16-24 weeks (IIaB) Genotype 3 Treatment Naïve Sovaldi + RBV + IFN x 12 weeks Treatment Experienced Sovaldi + RBV + IFN x 12 weeks Sovaldi + RBV x 24 weeks Daklinza + Sovaldi x 12 weeks Treatment Experienced with compensated Sovaldi + RBV + IFN x 12 weeks Daklinza + Sovaldi + RBV x 24 (IIaB) cirrhosis Genotype 4 Treatment Naïve Harvoni x 12 weeks Technivie + RBV x 12 weeks (no cirrhosis) Zepatier x 12 weeks Treatment Experienced Technivie x 12 weeks Zepatier x 12 weeks (16 weeks if virologic failure while on IFN/RBV) (IIaB) Harvoni x 12 weeks (RBV ineligible; no cirrhosis) (IIaB) 12 P age
Harvoni x 24 weeks (cirrhosis) 13 P age