Prior Auth Protocol

FDA Approved Indications:

Treatment of genotype 1 chronic hepatitis C (CHC), in combination therapy with peginterferon alfa and ribavirin, in adult patients with compensated liver disease, including cirrhosis, who are treatment-naive or who have been previously treated with interferon-based treatment, including prior null responders, partial responders, and relapsers.

Health Net Approved Indications and Usage Guidelines:

AASLD and IDSA 2014 guidelines do not recommend the use of Incivek for treatment of genotype 1 chronic hepatitis C
Failure or clinically significant adverse effects to Sovaldi based therapy.

Definitions:
Sustained virological response (SVR)	HCV RNA negative 24 weeks after cessation of treatment with peginterferon alfa and ribavirin.
Previous Null Responder	Patient who had <2-log₁₀ reduction in HCV RNA at week 12 of previous treatment with peginterferon alfa and ribavirin.
Previous Partial Responder	Patient who failed to achieve SVR after at least 12 weeks (i.e., patient had detectable HCV RNA levels at week12) of previous treatment with peginterferon alfa and ribavirin, but demonstrated a ≥2-log₁₀ reduction in HCV RNA by 12 weeks.
Previous Relapser	Patient who had an undetectable HCV RNA level by at least 12 weeks of previous treatment with peginterferon alfa and ribavirin, but failed to demonstrate maintenance of SVR (i.e. developed detectable HCV RNA levels) following previous treatment.

Coverage is Not Authorized For:

Monotherapy with Incivek (i.e., not in combination with peginterferon alfa and ribavirin)
Acute hepatitis C or uncontrolled autoimmune hepatitis
Patients with signs of liver decompensation [e.g. ascites, persistent jaundice, wasting, variceal hemorrhage, hepatic encephalopathy] before or during treatment. These patients should be considered for liver transplantation.
Patients with previous failure with treatment regimen that includes Incivek or other HCV NS3/4A protease inhibitors (e.g Olysio or Victrelis)
Quadruple therapy (Sovaldi+(Olysio, Incivek,or VIctrelis)+peginterferon+ribavirin) combination
Non-FDA approved indications, which are not listed in the Health Net Approved Indications and usage guidelines section unless there is sufficient documentation of efficacy and safety in the published literature

General Information:

AASLD and IDSA 2014 guideline recommends Sovaldi as the first line treatment for patients eligible to receive peginterferon alfa. Olysio can be recommended as an alternative to Sovaldi for peginterferon eligible patients.
Incivek must only be used in combination with peginterferon alfa and ribavirin.
A high proportion of null responders (particularly those with cirrhosis) did not achieve SVR and had telaprevir resistance-associated substitutions emerge on treatment with Incivek.
Serious skin reactions, including Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) and Stevens-Johnson Syndrome (SJS) were reported in less than 1% of subjects who received Incivek combination treatment compared to none who received peginterferon alfa and ribavirin alone.
Efficacy has not been established for patients who have previously failed therapy with treatment regiment that includes Incivek or other HCV NS3/4A protease inhibitors (e.g. boceprevir).
Safety and efficacy has not been established in patients with: solid organ transplant; HCV and human immunodeficiency virus co-infection; HCV patients with hepatitis B virus co-infection; and hepatic impairment defined by a Child-Pugh score >/= 7 (class B and C) or decompensated liver disease.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Sovaldi*	400 mg PO QD	Up to 24 weeks
Olysio*	150 mg PO QD with food	Up to 12 weeks

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Incivek with peginterferon alfa and ribavirin* *Require prior authorization	Treatment-Naive, Prior Relapse Patients, Prior Partial and Null Responder Patients 1125 mg PO BID (10-14 hours apart) with food (not low fat)	Treatment-Naive and Prior Relapse Patients: Initial authorization is 8 weeks. 1. If HCV RNA levels are less than or equal to 1000 IU/mL (including undetectable) at week 4, authorize Incivek for an additional 4 weeks AND authorize peginterferon alfa and ribavirin dual therapy for an additional 8 weeks. Incivek triple therapy complete at week 12. Recheck viral load at week 12 to evaluate peginterferon alfa and ribavirin continuation. 2. If HCV RNA levels are greater than 1000 IU/mL at week 4, no additional authorization of Incivek triple therapy. 3. If HCV RNA levels are undetectable at week 12 after being undetectable at week 4, authorize peginterferon alfa and ribavirin for an additional 8 weeks. Peginterferon alfa and ribavirin dual therapy complete at week 24. 4. If HCV RNA levels are undetectable at week 12 after being detectable but 1000 IU/mL or less at week 4, authorize peginterferon alfa and ribavirin for an additional 12 weeks. Recheck viral load at week 24. 5. If HCV RNA levels are detectable but less than 1000 IU/mL at week 12, authorize peginterferon alfa and ribavirin for an additional 12 weeks. Recheck viral load at week 24. 6. If HCV RNA levels are detectable and greater than 1000 IU/mL at week 12, no additional authorization of peginterferon alfa and ribavirin. 7. If HCV RNA levels are undetectable at week 24, authorize peginterferon alfa and ribavirin for an additional 24 weeks. Peginterferon alfa and ribavirin dual therapy complete at week 48. 8. If HCV RNA levels are detectable at week 24, no additional authorization of peginterferon alfa and ribavirin. Prior Partial and Null Responder Patients: Initial authorization is 8 weeks. 1. If HCV RNA levels are less than or equal to 1000 IU/mL at week 4, authorize Incivek for an additional 4 weeks AND authorize peginterferon alfa and ribavirin dual therapy for an additional 8 weeks. Incivek triple therapy complete at week 12. Recheck viral load at week 12 to evaluate peginterferon alfa and ribavirin continuation. 2. If HCV RNA levels are greater than 1000 IU/mL at week 4, no additional authorization of Incivek triple therapy. 3. If HCV RNA levels are less than or equal to 1000 IU/mL at week 12, authorize peginterferon alfa and ribavirin dual therapy for an additional 12 weeks. Recheck viral load at week 24 to evaluate peginterferon alfa and ribavirin continuation. 4. If HCV RNA levels are greater than 1000 IU/mL at week 12, no additional authorization of peginterferon alfa and ribavirin. 5. If HCV RNA levels are undetectable at week 24, authorize peginterferon alfa and ribavirin for an additional 20 weeks. Peginterferon alfa and ribavirin dual therapy complete at week 48. 6. If HCV RNA levels are detectable at week 24, no additional authorization of peginterferon alfa and ribavirin.

Product Availability:

375 mg tablets

References:

Incivek, [Prescribing Information] Cambridge, MA: Vertex; April 2013.
Ghany MG, Strader DB, Thomas DL, Leonard SB. Diagnosis, Management, and Treatment of Hepatitis C: An Update. American Association for the Study of Liver Diseases. Hepatology. 2009. Volume 49, Number 9: 1335-1374.
AASLD and IDSA. Recommendations for Testing, Managing, and Treating Hepatitis C. January 2014. Available at http://www.hcvguidelines.org/. Accessed February 06, 2014.