HARVARD PILGRIM HEALTH CARE Generic Brand HICL GCN Exception/Other SOFOSBUVIR/VELPATASVIR EPCLUSA TBD CUSTOMER SERVICE REPRESENTATIVE (CSR) If the member lives in Rhode Island or if the prescribing physician s office is located in Rhode Island, then the CSR will enter an open-ended authorization for the medication, by HICL, regardless of the state in which the prescription is filled. The member s address should be verified through MedAccess. The physician s address may be verified through MedAccess or by asking the caller in which state the physician is located. (Due to state legislation, a RI physician is not required to submit medical or clinical information regarding a PA request). All other requests require a Medication Request Form (MRF) be submitted for review. PA COORDINATOR (PAC) If the member lives in Rhode Island or if the prescribing physician s office is located in Rhode Island, then an open-ended authorization should be entered for the medication, by HICL, regardless of the state in which the prescription is filled. The member s address should be verified through MedAccess. The physician s address may be verified through MedAccess or by verifying in which state the physician is located. (Due to state legislation, a RI physician is not required to submit medical or clinical information regarding a PA request). GUIDELINES FOR USE 1. Is the request for a patient with chronic hepatitis C with one of the following conditions? Gentoype 2 Genotype 3 Genotype 1, treatment-experienced w/ compensated cirrhosis and ribavirin ineligible Gentoype 4, treatment-experienced (Please note: Harvoni is also indicated; however, the level of evidence is higher w/ Epclusa) If yes, continue to #3. If no, continue to #2. 2. Has the prescriber indicated that treatment with Harvoni would be clinically inappropriate, or that the patient was or will be unable to tolerate treatment with Harvoni? If yes, continue to #3. If no, do not approve. Please use status code #238 and the provided denial text. medication is only covered for patients in whom treatment with Harvoni (ledipasvir/sofosbuvir) would be clinically inappropriate or who were, or will be, unable to tolerate treatment with Harvoni. Your physician did not indicate that treatment with Harvoni would be clinically inappropriate or that you were, or will be, unable to tolerate treatment with Harvoni and therefore your Coverage of Harvoni requires prior authorization. You should discuss with your physician if prior authorization for treatment with Harvoni should be requested. Revised: 7/06/2016 Page 1 of 6
GUIDELINES FOR USE (CONTINUED) 3. Is the patient at least 18 years old? HARVARD PILGRIM HEALTH CARE If yes, continue to #4. 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 4. Is the requested medication being prescribed by a gastroenterologist, infectious disease specialist, physician specializing in the treatment of hepatitis (e.g. hepatologist)? If yes, continue to #5. medication is only covered when prescribed by a gastroenterologist, infectious disease specialist, or a physician specializing in the treatment of hepatitis (e.g. hepatologist). Your physician did not indicate that he or she specializes in one of these areas and therefore your 5. Does the patient have end stage renal disease, or require dialysis? medication is not covered for patients who have end stage renal disease (ESRD) or require dialysis. Your physician indicated that you have ESRD or require dialysis and therefore your If no, continue to #6. 6. 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 Epclusa? If yes, continue to #7. medication is covered for patients who have been counseled regarding the potential for acidreducing medications (e.g. antacids, H2 blockers and proton pump inhibitors) to decrease the effectiveness of Epclusa. Your physician has not indicated that you have been counseled on the drug interactions between Epclusa and acid-reducing medications and therefore your Revised: 7/06/2016 Page 2 of 6
GUIDELINES FOR USE (CONTINUED) HARVARD PILGRIM HEALTH CARE 7. Is the patient currently taking any of the following medications: amiodarone, atorvastatin, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifampin, rifabutin, rifapentine, rosuvastatin, or St. John s Wort? DENIAL TEXT: Per your health plan s Sofosbuvir/Velpatasvir (Epclusa) guideline, FDAapproved product information recommends the following medications not be taken with Epclusa: amiodarone, atorvastatin, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifampin, rifabutin, rifapentine, rosuvastatin, or St. John s Wort. Your physician indicated that you are currently taking one of these medications and therefore your If no, continue to #8. 8. Does the patient have a history of a liver transplant? medication is not covered for patients who have had a liver transplant because there are other medications that should be used, such as Harvoni. Your physician indicated that you had a liver transplant and therefore your Plesae discuss alternative options with your provider. If no, continue to #9. 9. 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 #10. medication is only covered when the degree of liver disease has been staged using an invasive or non-invasive test within the past 3 years and documentation has been submitted. Your physician did not indicate that your liver disease has been staged within the past 3 years and/or did not provide documentation and therefore your requested was not approved. Revised: 7/06/2016 Page 3 of 6
HARVARD PILGRIM HEALTH CARE GUIDELINES FOR USE (CONTINUED) 10. Does the patient have evidence of stage 2 or greater hepatic fibrosis indicated by one of the following: Liver biopsy confirming a METAVIR score of F2, F3 or F4 Ishak score > 3 Transient elastography (Fibroscan) score > 7.5 kpa FibroTest (FibroSURE) score > 0.48 Radiological imaging demonstrating cirrhosis (e.g. evidence of portal hypertension or ascites) If yes, continue to #11. If no, do not approve. Please use status code #238 and the denial text below. medication is only covered for patients with moderate to advanced scarring of the liver (fibrosis) or compensated cirrhosis as indicated by one of the following test results: a liver biopsy METAVIR score of F2 or greater, an Ishak score of 3 or greater, a Fibroscan score of 7.5 kpa or greater, a FibroSURE score of 0.48 or greater, or radiological imaging demonstrating cirrhosis. Your physician did not indicate that you have moderate to advanced scarring of the liver or compensated cirrhosis and therefore your 11. 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 #12. medication is only covered for patients who are not actively participating in illicit substance abuse or alcohol abuse, or who are receiving substance or alcohol abuse counseling services. Your physician indicated that you are either currently abusing illicit substances or alcohol, or are not receiving substance or alcohol abuse counseling services and therefore your request was not approved. 12. Is the patient co-infected with HIV? If yes, continue to #13. If no, continue to #17. 13. Is the patient s antiretroviral regimen being managed by a physician specializing in the treatment of HIV? If yes, continue to #14. medication is covered for patients with HIV co-infection whose medications used to treat his or her HIV (called antiretroviral medications) are being managed by a physician specializing in the treatment of HIV. Your physician did not indicate that your antiretroviral medication regimen is being managed by a physician specializing in the treatment of HIV and therefore your request was not approved. Revised: 7/06/2016 Page 4 of 6
GUIDELINES FOR USE (CONTINUED) HARVARD PILGRIM HEALTH CARE 14. During treatment with Epclusa, will the patient be taking an antiretroviral regimen containing one of the fllowing: efavirenz (Sustiva; Atripla), etravirine (Intelence), or tipranavir (Aptivus) concomitantly with ritonavir (Norvir; Kaletra)? medication is not covered for patients with HIV co-infection who will be taking certain medications used to treat his or her HIV (called antiretroviral medications) during treatment with Epclusa. These antiretroviral medications include efavirenz (Sustiva; Atripla),etravirine (Intelence), and tipranavir (Aptivus) when taken with ritonavir (Norvir, Kaletra), and any other products containing one of these active ingredients. Your physician indicated that during treatment with Epclusa you will be taking at least one of these antiretroviral medications and therefore your If no, continue to #15. 15. During treatment with Epclusa, will the patient be taking an antiretroviral regimen containing tenofovir disoproxyl fumarate (Viread; Complera; Stribild)? If yes, continue to #16. If no, continue to #17. 16. Is the patient s creatinine clearance (CrCl) < 60mL/min? medication is not covered for patients with HIV co-infection and reduced kidney function who will also be taking a tenofovir disoproxyl fumarate-containing medication during treatment with Epclusa. Your physician indicated that you have reduced kidney function and during treatment with Epclusa you will be taking a medication containing tenofovir disoproxyl fumarate and therefore your A different formulation of tenfovor is available that may be a treatment option when taken during treatment with Epclusa. Please discuss this with your provider. If no, continue to #17. 17. Does the patient have one of the following conditions? Decompensated cirrhosis Gentoype 2 or 3 and treatment-experienced with sofosbuvir Gentoype 3 with compensated cirrhosis and treatment-experienced with peg-ifn/ribavirin If yes, continue to #18. If no, continue to #19. Revised: 7/06/2016 Page 5 of 6
HARVARD PILGRIM HEALTH CARE 18. Did the provider indicate that Epclusa will be administered in combination with ribavirin? If yes, continue to #19 medication is only covered for certain conditions (e.g., decompensated cirrhosis, genotype 2 or 3 and previously treated with sofosbuvir, or genotype 3 with cirrhosis and previously treated with pegylated-interferon and ribavirin) when used in combination with ribavirin. Your physician did not indicate that you will be taking Epclusa in combination with ribavirin and therefore your 19. Approve by HICL for 12 weeks with a fill count of 3. (A quantity limit of one tablet per day is hard-coded). Please use status code #056 and the following approval language: APPROVAL TEXT (Eplcusa without ribavirin): Your request for Epclusa has been approved with a quantity limit of one tablet per day for a 12-week period. APPROVAL TEXT (Epclusa with ribavirin): 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. RATIONALE Ensure appropriate utilization of Epclusa (sofosbuvir/velpatasvir) based on FDA approved indication. FDA APPROVED INDICATIONS For the treatment of adult patients with chronic hepatitis C genotype 1, 2, 3, 4, 5, or 6 infection. FDA APPROVED DOSAGE One 400mg/100mg tablet taken once daily with or without food. Treatment regimen and duration in patients with genotypes 1, 2, 3, 4, 5 or 6: Patient Population Patients without cirrhosis and patients with compensated cirrhosis (Child-Pugh A) Patients with decompensated cirrhosis (Child-Pugh B and C) Recommended Treatment Regimen Epclusa for 12 weeks Epclusa + ribavirin for 12 weeks REFERENCES 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 February 24, 2016. Accessed July 6, 2016. Epclusa [Prescribing Information]. Foster City, CA: Gilead Sciences; June 2016. Created: 7/7/16 Effective: 7/8/16 P&T Approval: 9/12/16 Revised: 7/06/2016 Page 6 of 6