Hepatitis Prior Authorization Request CVS Caremark administers the specialty pharmacy benefit plan for the patient identified. This patient s benefit plan requires prior authorization for certain medications in order for the drug to be covered. To make an appropriate determination, providing the most accurate diagnosis for the use of the prescribed medication is necessary. Please respond below and fax this form to Assurant Health at 414-299-7555. If you have questions regarding the prior authorization, please contact Assurant Health Rx Srvcs @ 1800-800-1212 ext 6777. Patient s Name: Date: Patient s ID: Patient s Date of Birth: Physician s Name: Specialty: NPI#: Physician Office Telephone: Physician Office Fax: Generic ribavirin is the preferred product when prescribing Moderiba or Ribasphere RibaPak; and Harvoni and Sovaldi are the preferred regimens when prescribing a Viekira Pak or Technivie regimen for your patient s health plan. Please attach all necessary lab(s) or clinical for supporting documentation. 1. What is the prescribed drug regimen for patient's course of treament? Harvoni monotherapy Sovaldi + Olysio + ribavirin Harvoni + ribavirin Sovaldi + ribavirin Viekira Pak Victrelis + PEG-IFN + ribavirin Viekira Pak + ribavirin Pegasys monotherapy Sovaldi + PEG-IFN + ribavirin Peg Intron monotherapy Olysio + PEG-IFN + ribavirin PEG-IFN + ribavirin Sovaldi + Olysio Daklinza + Sovaldi Technivie Technivie + ribavirin Other Specify product if ribavirin is being prescribed: generic ribavirirn Moderiba Ribasphere RibaPak Other Complete the following section if brand ribavirin (Moderiba or Ribasphere RibaPak) is being prescribed. If not, continue to question #7. 2. Is the prescriber willing to switch to generic ribavirin? Yes No If Yes, skip to #7 (if applicable) and fax a new prescription to 800-323-2445. 3. Does the patient have a paid claim for the requested branded medication (i.e., Moderiba or Ribasphere RibaPak) in the previous 30 days? Yes No If Yes, document therapy start date and approval # and skip to #7 (if applicable): 4. Has the patient failed treatment with generic ribavirin due to an intolerable adverse event (example: rash, nausea, vomiting)? Yes No 5. Was the intolerable adverse event attributed to an inactive ingredient of the generic medication? Yes No 6. Was this documented in the patients chart? Yes No Action Required: Documentation is required for approval. Provide SPECIFIC and DETAILED chart documentation or MedWatch form of this trial and failure included in adverse reaction. 7. What is the patient's BASELINE viral load? Date of lab work: Action Required: Attach supporting documentation. Page 1 of 5
8. Indicate the SPECIFIC date patient will or has start(ed) this course of therapy? DO NOT USE "ASAP" (MM/DD/YYYY) 9. Indicate planned duration of therapy: weeks If Harvoni is being prescribed, will 8 weeks of treatment with Harvoni be adequate for this patient? Yes No Indicate current week of treatment (if applicable): Action Required: Attach documentation of treatment plan including regimen and duration. 10. What is the ICD code? 11. What is the diagnosis? Chronic hepatitis C Hepatitis B, including HDV Co-infection (for Pegasys and PegIntron only) - skip to Section F Acute hepatitis C (Pegasys, PegIntron and ribavirin only) - no further questions Chronic myeloid leukemia, CML (Pegasys and Peg Intron only) - no further questions Giant cell tumor of the bone (Pegasys only) - no further questions Other 12. What is the patient's genotype? If genotype 1, specify the subtype: 1a 1b Mixed Unknown 13. What is the prescriber's specialty? 14. What is the METAVIR fibrosis score? Unavailable 15. Provide previous treatment regimen(s), outcome and the length of therapy. If new to therapy, mark: Not applicable (treatment naïve), skip to #17 Outcome: Relapser Nonresponder Outcome: Relapser Nonresponder Outcome: Relapser Nonresponder 16. Has the patient failed treatment with a HCV protease inhibitor (eg, Incivek, Olysio, Victrelis, paritaprevir) despite adequate dosing and duration of therapy? Yes No 17. Does the patient have any of the following? Indicate below or mark "None of the above." Cirrhosis HIV co-infection Recurrent HCV infection post liver transplantation Decompensated liver disease/moderate to severe hepatic impairment (Child Turcotte Pugh [CTP] class B or C) None of the above HIV Co-Infection 18. Is the patient currently receiving antiretroviral therapy (ART)? If Yes, skip to #20 Yes No 19. What is the patient's CD4 count? cells/mm 3 20. Will the patient be receiving treatment with any of the following: Indicate below or mark "None of the above." efavirenz (Sustiva, Atripla) etravirine (Intelence) Maraviroc darunavir (Prezista, Prezcobix) nevirapine (Viramune) tipranavir (Aptivus) List continues on following page. rilpivirine (Edurant, Complera) lopinavir/ritonavir (Kaletra) Ritonavir-boosted saquinavir Ritonavir-boosted lopinavir Fosamprenavir Ritonavir-boosted tipranavir Elvitegravir/cobicistat/tenofovir/emtricitabine (Stribild) Other HIV protease inhibitors (eg, atazanavir [Reyataz, Evotaz], fosamprenavir [Lexiva], saquinavir [Invirase] None of the above Page 2 of 5
Complete the following section(s) based on the prescribed regimen and complete section I, if applicable. Section A: Harvoni (with or without ribavirin) 21. Will Harvoni be used with other drugs containing sofosbuvir, including Sovaldi? Yes No 22. Does the patient have decompensated cirrhosis? Yes No 23. Is the patient ineligible to receive ribavirin? Yes No If Yes, document reason for ineligibility: 24. Does the patient have documented anemia? Yes No If No, no further questions. 25. What is the patient s baseline hemoglobin level? g/dl Section B: Viekira (with or without ribavirin) 25. Does the patient have a paid claim for Viekira Pak in the previous 30 days? Yes No If Yes, document therapy start date and approval # and skip to #29: 26. Is the prescriber willing to switch to one of the preferred regimens? If Yes, indicate regimen, fax a new prescription to 800-323-2445 and continue to appropriate section below. Yes, Harvoni regimen Specify drug regimen: Yes, Sovaldi regimen Specify drug regimen: No, continue to request Viekira Pak regimen Other 27. Has the patient had an inadequate treatment response to a previous trial of Harvoni or Sovaldi? Yes No Action Required: If Yes, attach supporting documentation and skip to #29. 28. Does the patient have a documented contraindication, intolerance or confirmed adverse event to Harvoni or Sovaldi? Yes No Action Required: If Yes, attach supporting documentation. 29. Will Viekira Pak be given in combination with any of the following drugs that are highly dependent on CYP3A for clearance, strong inducers of CYP3A or CYP2C8, or strong inhibitors of CYP2C8? Indicate below or mark "None of the above." alfuzosin HCl (Uroxatral) lovastatin (Advicor, Altoprev, Mevacor) carbamazepine (Carbatrol, Epitol, Equetro, Tegretol) simvastatin (Simcor, Vytorin, Zocor) phenytoin (Dilantin, Phenytek) pimozide (Orap) phenobarbital (Luminal) efavirenz (Atripla, Sustiva) gemfibrozil (Lopid) triazolam (Halcion) rifampin (Rifadin, Rifamate, Rifater, Rimactane) orally administered midazolam St. John s wort ergot derivatives (ergotamine [Cafergot, Ergomar, Medihaler, Migergot, Wigraine, Wigrettes], dihydroergotamine [D.H.E. 45, Migranal], ergonovine [Ergotrate], methylergonovine [Methergine]) ethinyl estradiol-containing medications (eg, Lo Loestrin Fe, Ortho Tri-Cyclen Lo, Ortho Evra, NuvaRing) sildenafil or Revatio when used for the treatment of pulmonary arterial hypertension (PAH) None of the above Section C: Olysio + PEG-IFN + Ribavirin In addition, if patient is currently on therapy, section I must be completed. 30. If patient's genotype is 1a, is the NS3 Q80K polymorphism present? Yes No Unknown Action Required: Attach Q80K polymorphism testing results. Section D: Sovaldi + Ribavirin 31. Is the request for a patient with hepatocellular carcinoma awaiting liver transplantation? Yes No If No, skip to #33 32. Does the patient meet the MILAN criteria? Indicate below or mark "None of the above." Tumor size 5cm or less in diameter with single hepatocellular carcinomas OR 3 tumor nodules or less, each 3cm or less in diameter with multiple tumors No extrahepatic manifestations of the cancer or evidence of vascular invasion of tumor None of the above Page 3 of 5
33. If patient's genotype is 1, does the patient have documented IFN ineligibility? Yes No If Yes, document reason for IFN ineligibility: Section E: Victrelis + PEG-IFN + Ribavirin (Only required for continuation of therapy) In addition, if patient is currently on therapy, section I must be completed. 34. Was the patient poorly interferon responsive (ie, less than 1.0-log 10 decline in viral load (HCV-RNA]) at week 4 of treatment? If Yes, no further questions in section. Yes No Not applicable 35. With prior therapy with PEG-IFN and ribavirin, did the patient have less than 2-log 10 drop in viral load (HCV- RNA) after 12 weeks of treatment (ie, null responder)? Yes No Not applicable Section F: Pegasys/PegIntron - Hepatitis B Virus Infection 36. How long has the patient received Pegasys/PegIntron for the treatment of hepatitis B? weeks If request is for continuation of therapy, no further questions. 37. Has the patient been HBsAg positive for at least 6 months? Yes No 38. What is the patient's serum HBV-DNA? copies/ml or IU/mL 39. What is the patient s HBeAg type? Negative Positive 40 Does the patient have liver biopsy showing chronic hepatitis with moderate to severe necroinflammation? If Yes, no further questions Yes No 41. Does the patient have persistent or intermittently elevated ALT greater than 2x the upper limit of normal? Yes No Section G: Technivie (with or without ribavirin) 42. Does the patient have a paid claim for Technivie in the previous 30 days? Yes No If Yes, document therapy start date and approval # and skip to #46: 43. Is the prescriber willing to switch to one of the preferred regimens? If Yes, indicate regimen, fax a new prescription to 800-323-2445 and continue to appropriate section below. Yes, Harvoni regimen Specify drug regimen: Yes, Sovaldi regimen Specify drug regimen: No, continue to request a Technivie regimen Other 44. Has the patient had an inadequate treatment response to a previous trial of Harvoni or Sovaldi? Yes No Action Required: If Yes, attach supporting documentation and skip to #46. 45. Does the patient have a documented contraindication, intolerance or confirmed adverse event to Harvoni or Sovaldi? Yes No Action Required: If Yes, attach supporting documentation. 46. Will Technivie be given in combination with any of the following drugs that are highly dependent on CYP3A for clearance or that are moderate or strong inducers of CYP3A? alfuzosin HCl (Uroxatral) lovastatin (Advicor, Altoprev, Mevacor) List continues on following page. carbamazepine (Carbatrol, Epitol, Equetro, Tegretol) simvastatin (Simcor, Vytorin, Zocor) phenytoin (Dilantin, Phenytek) pimozide (Orap) phenobarbital (Luminal) efavirenz (Atripla, Sustiva) triazolam (Halcion) orally administered midazolam rifampin (Rifadin, Rifamate, Rifater, Rimactane) St. John s wort ergot derivatives (ergotamine [Cafergot, Ergomar, Medihaler, Migergot, Wigraine, Wigrettes], dihydroergotamine [D.H.E. 45, Migranal], ergonovine [Ergotrate], methylergonovine [Methergine]) ethinyl estradiol-containing medications (eg, Lo Loestrin Fe, Ortho Tri-Cyclen Lo, Ortho Evra, NuvaRing) sildenafil or Revatio when used for the treatment of pulmonary arterial hypertension (PAH) None of the above Page 4 of 5
Technivie without ribavirin 47. Does the patient have a history of intolerance to ribavirin? Yes No 48. Does the patient have documented anemia? Yes No 49. What is the patient s baseline hemoglobin level? g/dl 50. Is the patient ineligible to receive ribavirin? Yes No If Yes, document reason for ribavirin ineligibility: Section H: Daklinza + Sovaldi 51. Will the patient be receiving treatment with a strong inducer of CYP3A (e.g., phenytoin, carbamazepine, St. John s wort)? Yes No 52. Does the prescribed daily dose of Daklinza exceed 60 mg? Yes No 53. Does the patient need to take Daklinza concurrently with a moderate CYP3A inducer (e.g., bosentan, dexamethasone, efavirenz, etravirine, modafinil, nafcillin, rifapentine)? Yes No Section I: Continuation of Therapy (Required for continuation of Victrelis or Olysio + PEG-IFN + ribavirin) 54. Document the following where applicable: A) Treatment week B) HCV-RNA Level (IU/mL Only) C) Date (to be) Completed Week 4 IU/mL Undetectable / / Week 8 IU/mL Undetectable / / Week 12 IU/mL Undetectable / / Week 24 IU/mL Undetectable / / Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines. I attest that this information is accurate and true, and that documentation supporting this information is available for review if requested by CVS Caremark or the benefit plan sponsor. X Prescriber or Authorized Signature Date (mm/dd/yy) OFFICE CONTACT: PHONE: EXT: Page 5 of 5