HEPATITIS C TREATMENT GUIDELINES

Transcription

1 HEPATITIS C TREATMENT GUIDELINES Updated May 21, 2014 INSTRUCTIONS: 1. Review the posted Hepatitis C Treatment Guidelines document to validate that your patient meets the criteria for treatment. 2. Complete the online Hepatitis C Prior Authorization Form in its entirety. 3. Print, Sign and fax the completed Prior Authorization Form along with copies of laboratory results, required documentation from medical record, and all other supporting information to: PerformRx at

2 DRUGS PREFERRED PEGINTRON (peginterferon alfa 2b): 50mcg/0.5mL, 80mcg/0.5mL, 120mcg/0.5mL powder for injection in Redipens or glass vials COPEGUS (ribavirin): 200mg tablet REBETOL (ribavirin): 200mg capsule SOVALDI (sofosbuvir): 400mg tablets OLYSIO (simeprivir): 375mg capsules DRUGS NOT PREFERRED PEGASYS (peginterferon alfa 2a): 180mcg/ml single use glass vials or prefilled syringe INCIVEK (telaprivir): 375mg tablets VICTRELIS (boceprevir): 200mg capsules All Initial requests MUST meet the following requirements: 1. Patient Age 18 or older, AND 2. Medical history: Past medical history and co morbidities Complications of chronic liver disease Symptoms, AND 3. Psychiatric history: Psychiatric disorders, past and present Substance abuse (if there is a history of substance abuse, an attestation that the patient is drug and alcohol free) Conditions affecting compliance, AND 4. Lab testing within three (3) months of starting treatment (copy of results required): ALT/AST, albumin, bilirubin, total and direct, prothrombin time Genotype HCV RNA viral load CBC, ferritin, iron saturation TSH, ANA Serum creatinine, glucose, uric acid ECG, echocardiogram, stress test in the presence of heart disease 5. Lab testing within one (1) month of starting treatment (copy of results required): Urine drug screen Blood alcohol level Pregnancy test in women of childbearing age, with patient agreeing to use two or more forms of contraception, and will have monthly pregnancy tests during therapy, AND 2

3 6. Serum HBsAg, anti HBc, anti HBs, anti HAV, AND 7. HIV serology (CD4+ T cell count and HIV RNA are required for patients co infected with HIV, AND In patients with lower CD4 counts (e.g., <200 cells/mm3), it may be preferable to delay HCV therapy until CD4 counts increase) 8. The patient has had a Liver biopsy showing advanced to severe fibrosis. Either Ishak Stage >3 or Metavir Score >2, AND Ishak stage > 3 Ishak Staging Scale Fibrous Category measurement Histologic descripton 0 1.9% No fibrosis 1 3.0% Fibrous expansion of some portal areas (+/ ) short fibrous septa 2 3.6% Fibrous expansion of most portal areas (+/ ) short fibrous septa 3 6.5% Fibrous expansion of some portal areas with occasional portal to portal (P P)bridging % Fibrous expansion of portal areas with marked P P and portal to central (P C) bridging % Marked P P and/or P C bridging with occasional nodules % Cirrhosis, probable or definite Stage 1 Stage 2 Stage 3 Stage 4 Metavir score > 2 Metavir Fibrosis Classification Portal / periportal fibrosis Septal fibrosis Bridging fibrosis with architectural distortion Cirrhosis, probable cirrhosis 9. Patient is sofosbuvir treatment naïve (no claims history or reference in medical records to previous trial and failure of sofosbuvir), AND 10. The dose that has been prescribed for the patient is consistent with the dosing recommendations listed below, and the prescriber is a hepatologist / gastroenterologist / infectious disease specialist/transplant specialist, AND 11. For a pegylated interferon alpha product, PegIntron is the preferred agent 12. Presence of previous treatment, treatment regimen and response Treatment Naïve / Previous Relapsed Previous Partial Responders / Null Responders 3

4 APPROVAL CONSIDERATIONS: Compliance: 1. A nurse case manager will reach out to all members approved for treatment, with the intent to educate and ensure successful completion of the regimen. 2. The nurse case manager will guide and reinforce compliance through ongoing interaction with the member. 3. Demonstrated non compliance with the treatment regimen, defined as two consecutive missed doses or more than four missed doses in a four week period, renders the treatment ineffective and may result in denial of additional authorizations. In the presence of previous substance abuse (including alcohol and prescription drugs), ALL: 1. No alcohol or illicit drug use within 6 months of treatment onset, AND 2. Negative drug and / or blood alcohol level 30 days prior to treatment onset, AND 3. Physician attestation of patient abstinence from drugs and alcohol, and is compliant with treatment program participation as documented by a copy of the note in the patient s medical record. The presence of ANY of the following excludes approval: 1. Severe or uncontrolled co morbidities 2. Sever renal impairment or End Stage Renal Disease (ESRD) 3. Transplant (except liver) 4. Disorders of mood, thought, or cognition expected to negatively impact treatment compliance 5. Substance abuse (positive urine drug screen or blood alcohol level) 6. Less than severe fibrosis on biopsy 7. Contraindication to any component of the treatment regimen Contraindications to treatment with interferon: 1. A baseline neutrophil count below 1500/uL, a baseline Platelet count below 90,000/uL or baseline hemoglobin below 10g/dL 2. Intolerance to IFN 3. Autoimmune Hepatitis and other autoimmune disorders 4. Hypersensitivity to PEG or any of its components 5. Decompensated Hepatic disease 6. History of depression or clinical features consistent with depression 7. History of preexisting cardiac disease 8. Transplant of kidney, heart, or other solid organ (excluding liver transplant). 4

5 Contraindications to treatment with ribavirin: 1. Hypersensitivity to drug, class, or components 2. Autoimmune hepatitis 3. GFR < Pregnancy 5. Hemoglobinopathy Contraindications to treatment with Sovaldi: 1. Hypersensitivity to drug, class, or components 2. HCV monotherapy 3. Significant drug drug interactions Contraindications to treatment with Olysio: 1. Hypersensitivity to drug, class, or components 2. HCV monotherapy 3. Significant drug drug interactions WHEN CRITERIA FOR APPROVAL FOR THE TREATMENT OF HEPATITIS C INFECTION IS MET**: The patient will be placed into one of the following categories: Hepatitis C Genotype 1 infection: Go to section I Hepatitis C Genotype 2 infection: Go to section II Hepatitis C Genotype 3 infection: Go to section III Hepatitis C Genotype 4 infection: Go to section IV Hepatitis C Genotypes 5 and 6 infections: Go to section V Hepatitis C Genotypes 1, 2, 3, or 4 infections with Hepatocellular Carcinoma with Ribavirin and Sovaldi: Go to section VI **These treatment regimens are for patients that are treatment naïve, relapser with Pegylated interferon and Ribavirin, or coinfected with HIV. For partial responders or null responders, please refer to the most current dosing guidelines. 5

6 Section I: Treatment for patients with Hepatitis C Genotype 1 infection: Interferon eligible patients: Approve Sovaldi 400mg tablet #28 for 28 days with Ribavirin and Pegylated Interferon for a total of 12 weeks. Interferon ineligible patients: Approve Sovaldi 400mg tablet #28 tablets for 28 day supply with Olysio #28 for 28 day supply for a total of 12 weeks. Section II: Treatment for patients with Hepatitis C Genotype 2 infection: Approve Sovaldi 400mg tablet #28 tablets for a 28 day supply with Ribavirin for 12 weeks. Section III: Treatment for patients with Hepatitis C Genotypes 3 infection: Interferon eligible patients: Approve Sovaldi 400mg tablet #28 for a 28 day supply with Ribavirin and Pegylated Interferon for a total of 12 weeks. Interferon ineligible patients: Approve Sovaldi 400mg tablet #28 tablets for 28 day supply with Ribavirin for a total of 24 weeks. Section IV: Treatment for patients with Hepatitis C Genotype 4 infection: Interferon eligible patients: Approve Sovaldi 400mg tablet #28 for 28 days with Ribavirin and Pegylated Interferon for a total of 12 weeks. Interferon ineligible patients: Approve Sovaldi 400mg tablet #28 for 28 days with Ribavirin for a total of 24 weeks. Section V: Treatment for patients with Hepatitis C Genotypes 5 or 6 infections with Ribavirin and Sovaldi: Approve Sovaldi 400mg tablet #28 for 28 days with Ribavirin and Pegylated Interferon for a total of 12 weeks. Per AASLD guidelines: No data are available to support the use of a non PEG containing regimen for patients with HCV genotype 5 or 6 infection. Section VI: Treatment for patients with Hepatitis C Genotypes 1, 2, 3, or 4 infections with Hepatocellular Carcinoma with Ribavirin and Sovaldi: All initial requests must meet the following additional requirement: Documentation of testing confirming the diagnosis of Hepatocellular Carcinoma through either Imaging Testing (such as Ultrasound, Computed Tomography, Magnetic Resonance Imaging), Laparoscopy, or Biopsy. Approve Ribavirin and Sovaldi for 24 weeks (Sovaldi 400mg tablet #28 tablets for a 28 day supply with five refills). o The patient may be approved for an additional 24 weeks after receiving confirmation the patient has not yet received a transplant. o If the patient has received a transplant, treatment is stopped. Deny with the appropriate rationale. 6

7 REFILL CONSIDERATIONS: Demonstrated non compliance with the treatment regimen, defined as two (2) consecutive missed doses or more than four (4) missed doses in a four week period, renders the treatment ineffective and may result in denial of additional authorizations Evidence of substance abuse may result in denial of additional authorizations Failure to submit follow up pregnancy result for patient of child bearing age every 30 days, or a result demonstrating pregnancy may result in denial of additional authorizations REFERENCES: 1. Yee HS. Currie SL. Darling JM. Et al. Management and treatment of hepatitis C viral infection: Recommendations from the Department of Veterans Affairs Hepatitis C Resource Center Program and the National Hepatitis C Program Office. Practice Guidelines. American Journal of Gastroenterology. 2006;101: National Institutes of Health. Chronic Hepatitis C: Current Disease Management. National Institute of Diabetes and Digestive and Kidney Diseases. U.S. Department of Health and Human Services. Available at: Last updated November Accessed May 9, Ghany MG, Strader DB, Thomas DL, Seef LB. Diagnosis, management and treatment of Hepatitis C: An Update. American Association for the Study of Liver Diseases Practice Guideline. Hepatology. 2008; 49(4): Lok ASF. McMahon BJ. Chronic Hepatitis B. American Association for the Study of Liver Diseases Practice Guidelines. Hepatology. 2007;45(2): NIH Consensus Development Program: National Institutes Health Consensus Conference Statement June 10 12, Management of Hepatitis C. guidelines. Available from URL: 6. Department of Veterans Affairs. A Supplement to Federal Practitioner. VA recommendations version 5.0. Patients with chronic Hepatitis C. 2003;20(5): Alberti A. Clumeck N. Collins S. et al. Short statement of the first European Consensus Conference on the treatment of chronic Hepatitis C and B in HIV Co infected patients. March 1 2, Paris, France. Published in the Journal of Hepatology in May Available at Accessed May 14, Soriano V. Highlights of the 2nd International Workshop on HIV and Hepatitis Co infection. January 12 14, Amsterdam, The Netherlands. Medscape HIV/AIDS. 2006;12(1). Available at Accessed May 14, Soriano V. Puoti M. Sulkowski M. et al. Care of patients with Hepatitis C and HIV co infection. AIDS. 2004;18: Swan T. Raymond D. Sherman KE. Et al. Hepatitis C Virus and HIV/HCV Co infection. A critical review of research and treatment. Treatment Action Group (TAG). July Available at: Accessed May 14, Department of Veterans Affairs. Hepatitis C Resource Centers. Management and treatment of Hepatitis C virus infection in HIV infected adults: Recommendation from the Veterans Affairs Hepatitis C Resource Center Program and National Hepatitis C Program Office. American Journal of Gastroenterology. 2005;100(10): Also available online at: pr/prtop 06/2005_coinf_recs.pdf. Accessed May 14, Pegasys and Copegus package information. Roche Pharmaceuticals. June PegIntron and Rebetrol package information. Schering Corporation. January Victrelis prescribing information. Schering Corporation. May Incivek prescribing information. Vertex Pharmaceuticals Inc. May Yee HS. Chang MF. Christine P. Et al. Update on the Management and Treatment of Hepatitis C Virus Infection: Recommendations from the Department of Veteran Affairs Hepatitis C Resource Center Program and the National Hepatitis C Program Office. Practice Guidelines. American Journal of Gastroenterology. 2012: 107:

8 17. Sovaldi (package insert). Foster City, California: Gilead Corporation 12/2013. Accessed through: disease/sovaldi/sovaldi_pi.pdf 18. Olysio (package insert). Titusville, New Jersey: Janssen Therapeutics 12/ American Association for The Study of Liver Diseases Treatment Guidelines: Accessed through: report/initial treatment hcv infection patients starting treatment Revision/Review Date: 6/22/2014 8