Prior Authorization Policy
http://www.paramounthealthcare.com/providers
Web document
Description of Medication
Ribavirin is a synthetic nucleoside analog (purine analog) with antiviral activity. The mechanism by which the combination of ribavirin and an interferon product exerts its’ effects against the hepatitis C virus has not been fully established.
FDA-APPROVED INDICATIONS1-3, 12
Rebetol
Rebetol is indicated in combination with interferon alfa-2b (pegylated and nonpegylated) for the treatment of Chronic Hepatitis C (CHC) in patients 3 years of age and older with compensated liver disease.
Copegus
Copegus is indicated in combination with Pegasys for the treatment of adults with CHC virus infection who have compensated liver disease and have not been previously treated with alpha interferon. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A) and patients with HIV disease that is clinically stable (e.g., antiretroviral therapy not required or receiving stable antiretroviral therapy).
Moderiba
Moderiba is indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in adults with compensated liver disease not previously treated with interferon alpha, and in CHC patients coinfected with HIV.
Ribasphere
Ribasphere is indicated in combination with peginterferon alfa-2a for the treatment of adults with CHC virus infection who have compensated liver disease and have not been previously treated with alpha interferon. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A).
Ribavirin
Rebetol (ribavirin capsule or oral solution) Copegus (ribavirin tablet), Moderiba (ribavirin tablet),
Ribasphere (ribavirin tablet), Ribapak (ribavirin tablet), ribavirin (generic capsule and tablet)
Pharmacy Benefit Commercial HMO / PPO / CDHP
Setting
Self-administered: Oral
Medical Benefit
Approval period Initial approval: 8 weeks
Continued approval: up to 48 weeks
CPT/HCPCS code J8499, J7699
Available through Paramount’s specialty pharmacy network.
Recommended authorization criteria
For all patients with hepatitis C infection, ribavirin must be prescribed by, or in consultation with, a gastroenterologist, specializing in hepatology, an infectious disease physician, or a transplant physician.
CRITERIA FOR APPROVAL
1. Does the patient have any of the following contraindications to ribavirin therapy?
Hemoglobin <8.5 g/dL
Hemoglobinopathy
Poorly controlled or deteriorating cardiac disease
Patient or the partner of the patient is pregnant
Unwilling to use adequate contraception (self or partner)
The patient is currently receiving or will be receiving Videx (didanosine) [If yes, no further questions.]
Yes No
2. Does the patient meet one of the following:
Has a creatinine clearance (CrCl) ≥50 mL/min OR
Has CrCl <50 mL/min and will use reduced dose of ribavirin and interferon with careful monitoring by a specialist
[If no, no further questions.]
Yes No
3. Prior to initiating therapy, did the patient have a diagnosis of chronic hepatitis C virus (HCV) infection as confirmed by detectable viral load in the serum? [If no, no further questions.]
Yes No
4. Does the patient have genotype 2 or 3 infection? [If no, skip to question 6.]
Yes No 5. Has the patient received ≥ 24 weeks of therapy as part of this treatment course?
[No further questions.]
Yes No 6. Is the patient being prescribed ribavirin as part of a three-drug treatment regimen
that includes peginterferon alfa (e.g. Pegasys, PegIntron) and Victrelis? [If yes, skip to question 17.]
Yes No
7. Is the patient being prescribed ribavirin as part of a three-drug regimen that includes peginterferon alfa (e.g. Pegasys, PegIntron) and Incivek?
[If yes, skip to question 26.]
Yes No
8. Is the patient being prescribed ribavirin as part of a two-drug treatment regimen that includes non-pegylated interferon alfa (e.g. Intron)?
[If no, skip to question 10.]
Yes No
9. Has the patient had a documented adverse reaction (ADR) or is the patient at higher risk for an ADR with pegylated interferon alfa (e.g. Pegasys, PegIntron)? [If yes, skip to question 16.]
[If no, no further questions.]
Yes No
10. Is the patient being prescribed ribavirin as part of a two-drug treatment regimen that includes pegylated interferon alfa (e.g. Pegasys, PegIntron)?
[If no, skip to question 16.]
Yes No
11. Is the patient Genotype 1 or Genotype 4? [If no, no further questions.]
Yes No 12. Has the patient received ≥ 12 weeks of therapy as part of this treatment course?
[If no, no further questions.]
Yes No 13. Did the patient have undetectable HCV RNA at week 12 of treatment?
[If yes, skip to question 16.]
Yes No 14. Has the patient received ≥ 24 weeks of therapy as part of this treatment course?
[If no, no further questions.]
Yes No 15. Did the patient have undetectable HCV RNA after 24 weeks of treatment?
[If no, no further questions.]
Yes No 16. Has the patient received ≥ 48 weeks of therapy as part of this treatment course?
[No further questions.]
Yes No 17. Does the patient meet all of the following criteria for approval? Yes No
Has genotype 1 infection
HCV RNA will be assessed at weeks 4, 8, 12, and 24 of treatment
Has/will receive 4 weeks of PEG-IFN and ribavirin prior to starting Victrelis
[If no, no further questions.]
18. Has the patient received ≥12 weeks of PEG-IFN and ribavirin and ≥8 weeks Victrelis?
[If no, no further questions.]
Yes No
19. Did the patient have HCV RNA ≥100 IU/mL at week 12 of treatment? [If yes, no further questions.]
Yes No 20. Has the patient received ≥24 weeks of PEG-IFN and ribavirin and ≥20 weeks
Victrelis?
[If no, no further questions.]
Yes No
21. Did the patient have undetectable HCV RNA at week 24 of treatment? [If no, no further questions.]
Yes No 22. Does the patient meet one of the following?
Patient has cirrhosis OR
Patient was poorly IFN responsive (<1.0-log10 HCV-RNA decline in viral
load) at week 4 of treatment [If yes, no further questions.]
Yes No
23. Is the request for retreatment of chronic HCV infection? [If no, skip to question 25.]
Yes No 24. With prior therapy, did the patient have <2-log10 drop in HCV-RNA after 12 weeks
of treatment (i.e., null response)? [If yes, no further questions.]
Yes No
25. Did the patient have undetectable HCV RNA at week 8 of treatment? [No further questions.]
Yes No 26. Does the patient meet both of the following?
Has genotype 1 infection
HCV RNA will be assessed at weeks 4, 12, and 24 of treatment [If no, no further questions.]
Yes No
27. Has the patient received ≥4 weeks of ribavirin in combination with Incivek and PEG-IFN?
[If no, no further questions.]
Yes No
28. Did the patient have HCV RNA >1,000 IU/mL at week 4 of treatment? [If yes, no further questions.]
Yes No 29. Has the patient received ≥12 weeks of ribavirin in combination with Incivek and
PEG-IFN?
[If no, no further questions.]
Yes No
30. Did the patient have HCV RNA >1,000 IU/mL at week 12 of treatment? [If yes, no further questions.]
Yes No 31. Is the patient treatment-naïve or prior relapser to HCV therapy?
[If no, skip to question 34.]
Yes No 32. Does the patient have cirrhosis?
[If yes, skip to question 34.]
Yes No 33. Did the patient have undetectable HCV RNA at weeks 4 and 12 of treatment?
[If yes, no further questions.]
Yes No 34. Has the patient received ≥24 weeks of ribavirin in combination with Incivek and
peginterferon alfa?
[If no, no further questions.]
Yes No
35. Did the patient have undetectable HCV RNA at week 24 of treatment? Yes No
Special Populations - Retreatment Due to Nonresponse or Relapse
Retreatment is considered for patients who did not achieve SVR with their prior course of therapy.8 For nonresponders and relapsers to IFN monotherapy, higher SVR can be achieved with retreatment with IFN and ribavirin combination therapy.8,10 The addition of protease inhibitor to PEG-IFN and ribavirin increases the rates of SVR and shortens the duration of treatment for genotype 1 nonresponders and relapsers.12
Exclusions (Limitations)
Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria or under the following circumstances. Criteria will be updated as new published data are available.
Oral formulations13: Hypersensitivity to ribavirin or any component of the formulation; women who are pregnant or may become pregnant; males whose female partners are pregnant; patients with hemoglobinopathies (eg, thalassemia major, sickle cell anemia); patients with autoimmune hepatitis; concomitant use with didanosine.
Ribasphere capsules and Rebetol capsules/solution13: Additional contraindications: Patients with a CrCl <50 mL/minute.
Oral combination therapy with alfa interferons13: Autoimmune hepatitis, hepatic decompensation (Child-Pugh score >6; class B and C) in cirrhotic chronic hepatitis C monoinfected patients prior to treatment, hepatic decompensation (Child-Pugh score ≥6) in cirrhotic chronic hepatitis C patients coinfected with HIV prior to treatment. Also refer to individual monographs for Interferon Alfa-2b (Intron A), Peginterferon Alfa-2b, and Peginterferon Alfa-2a (Pegasys) for additional contraindication information.
Indications lacking evidence to support medical necessity as defined below14:
1) The drug is not FDA approved for the indication prescribed; PLUS
a. Standard medical reference compendia state that the drug is ineffective or unsafe for the off-label
indication requested; OR
b. The medical compendia is silent on the topic for the indication requested; AND
i. One or more medical articles exist that conclude the drug is unsafe and/or ineffective; OR
ii. One or more medical articles concludes that safety and efficacy cannot be determined; OR
iii. Less than two articles in medical literature show safety and effectiveness for the indication
prescribed
*Major medical articles must meet uniform requirements for manuscripts to biomedical journals, be published in major peer-reviewed professional medical journals, be sound in methodology, sound statistically, and free from overt bias.
Endorsed: 07/30/14
Approved: 08/12/14
Revised:
Reviewed:
Criteria adapted from CVS/Caremark Prior Authorization Policy MDC 558-A. Effective 04/2014
REFERENCES
1. Rebetol[package insert]. Kenilworth, NJ: Schering Corporation; October 2012.
2. Copegus [package insert]. Nutley, NJ: Roche Laboratories Inc.; August 2011.
3. Ribasphere [package insert]. Cranberry Township, PA: Three Rivers Pharmaceuticals, LLC.; February 2012. 4. PegIntron [package insert]. Kenilworth, NJ: Schering-Plough Corporation; August 2009.
5. Victrelis [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; February 2013. 6. Incivek [package insert]. Cambridge, MA: Vertex Pharmaceuticals Inc.; April 2013.
7. Dienstag JL, McHutchinson JG. American Gastroenterological Association Medical Position on the Management of Hepatitis C.
Gastroenterology. 2006;130(1):225-230.
8. Thompson A, Patel K, Tillman H, et al. Directly acting antivirals for the treatment of patients with hepatitis C infection: a clinical development update addressing key future challenges. J Hepatol. 2009;50(1):184-194.
9. Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009;49(4):1335-1374.
10. Ghany MG, Nelson DR, Strader DB, et al. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology. 2011;54(4):1433-1444.
11. Singal AG, Waljee AK, Shiffman M, et al. Meta-analysis: re-treatment of genotype 1 hepatitis C nonresponders and relapsers after failing interferon and ribavirin combination therapy. Aliment Pharmacol Ther. 2010;32:969-983.
12. Moderiba [package insert]. North Chicago, IL: AbbVie, Inc.; November 2013.
14. Ohio Revised Code Title [17] XVII Corporations – Partnerships; Chapter 1751 Health Insuring Corporation law; 1751.66
