Victrelis (Boceprevir)
Prior Authorization Approval Criteria Victrelis (boceprevir)
Generic name: boceprevir
Brand name: Victrelis
Medication class: antiviral agent; protease inhibitor
FDA-approved uses: Treatment of chronic Hepatitis C virus genotype 1 infection, in combination with peginterferon alfa and ribavirin in patients 18 years of age or older with compensated liver disease in previously untreated patients and in those who have failed previous therapy with interferon and ribavirin.
Available dosage forms: 200mg capsules
Usual dose: 800mg three times daily (every 7-9 hours)
Approximate monthly cost: $188.88/day or $5,288.64/ 4 weeks or $31,731.84 / 24 weeks (based on AWP 2011) or $58,175.04 for 44 weeks
Duration of therapy: duration of treatment is adjusted using response guided therapy guidelines. (see table below under criteria for continuation) The recommended duration of boceprevir therapy ranges from 24 to 44 weeks depending on previous treatment status, HCV RNA at weeks 8 and 24, and presence of cirrhosis. Dosage reductions of boceprevir are not recommended for any reason.
Criteria for use (bullet points below are all inclusive unless otherwise noted): The indicated diagnosis (including any applicable labs and /or tests) and medication usage must be supported by documentation from the patient’s medical records. Must have tried and failed Viekira or meet at least one of the following conditions: Member is a pregnant woman and the indicated treatment regimen with Viekira will include ribavirin Member is a male whose female partner is pregnant and the indicated treatment regimen with Viekira will include ribavirin Member has hemoglobinopathy and the indicated treatment regimen with Viekira will include ribavirin Member has severe hepatic impairment Member has known hypersensitivity to ritonavir For all patients, therapy should be initiated with peginterferon alfa and ribavirin for 4 weeks prior to starting boceprevir therapy (treatment weeks 1 through 4). Must only be used in combination with peginterferon alfa and ribavirin. Must never have been previously treated with a regimen that includes boceprevir or other HCV NS3/4A protease inhibitors. Must be clinically diagnosed with chronic hepatitis C genotype 1 with compensated liver disease including compensated cirrhosis (decompensated cirrhosis is a contraindication to therapy). The criteria listed above applies to Fallon Health Plan and its subsidiaries. Fallon Health Department of Pharmacy Services Page 1 of 5
Must have detectable baseline HCV RNA Must be 18 years of age or older. Must not have con-infection with Hepatitis B, HIV or a history of organ transplant. Patient can be treatment-naive or had previous therapy with interferon and ribavirin and failed. . If the patient has received treatment with interferon and ribavirin before, documentation must be provided indicating what their response to therapy was (including HCV RNA levels at weeks 4, 12, 24, and completion) and if they were a partial responder, non-responder, or relapse. Patients must have a negative pregnancy test prior to therapy, willing to use 2 or more forms of contraception during therapy and for 6 months after cessation of therapy (due to the long half-life of ribavirin). Length of approval will be based according to the response-guided regimen. HCV RNA levels should be assessed at weeks 8, 12, and 24 of total therapy. Members will be allowed to continue treatment for up to 4 weeks after each HCV RNA assessment. Updated clinical notes and lab values must be forwarded to FCHP within these 4 weeks to continue treatment.
Criteria for continuation of therapy: Treatment should be discontinued in patients with HCV RNA levels of 100 units/mL or greater at treatment week 12 or confirmed detectable HCV RNA at treatment week 24.
Recommended Duration of Therapy for Boceprevir (after 4 week lead in therapy with peginterferon and ribavirin) Patient HCV RNA HCV RNA HCV RNA Recommendation Type at Wk 8 at Wk 12 at Wk 24 Previously Complete 3-drug regimen Undetectable Undetectable untreated through wk 28 patient Continue 3-drug regimen without through wk 36, cirrhosis Detectable Undetectable then continue peginterferon alfa and ribavirin through wk 48 Previous Complete 3-drug regimen Undetectable Undetectable partial through wk 36 responder Continue 3-drug regimen or through wk 36, relapsers Detectable Undetectable then continue peginterferon without alfa cirrhosis and ribavirin through wk 48 Patients Complete 3-drug regimen with through wk 48 cirrhosis Treatment 100 Futility Discontinue three-medicine units/mL Detectable Rules: All regimen. or greater Patients
Caution: associated with mild additional reduction in hemoglobin concentrations compared with therapy with peginterferon alfa and ribavirin alone. may result in worsening of neutropenia associated with the use of peginterferon alfa and ribavirin alone.
The criteria listed above applies to Fallon Health Plan and its subsidiaries. Fallon Health Department of Pharmacy Services Page 2 of 5
Boceprevir has not been studied in patients with decompensated cirrhosis or in patients who have had an organ transplant The safety and efficacy of boceprevir have not been established in patients with confection with HIV or hepatitis B
Monitoring: Complete blood cell counts (with white blood cell differential counts) should be obtained before treatment, at treatment weeks 4, 8, and 12, and as clinically necessary. HCV RNA should be monitored at treatment weeks 4, 8, 12, and 24; at the end of treatment; and during follow-up, or more frequently if clinically appropriate.
Contraindication: All contraindications to peginterferon alfa and ribavirin also apply since Victrelis must be administered with peginterferon alfa and ribavirin. Boceprevir is contraindicated for use in conjunction with potent CYP3A4/5 inducers; such agents may reduce boceprevir plasma concentrations, resulting in reduced efficacy. These include (but are not limited to) carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort. (For further reference, online drug interaction checker is useful www.hep-druginteractions.org) Boceprevir use is also contraindicated in conjunction with CYP3A4/5 substrates for which elevated plasma concentrations are associated with serious and/or life- threatening events. These include alfuzosin, dihydroergotamine, ergonovine, ergotamine, methylergonovine, cisapride, lovastatin, simvastatin, drospirenone, pimozide, triazolam, oral midazolam, and sildenafil and tadalafil when used in the treatment of pulmonary arterial hypertension All contraindications to peginterferon alfa and ribavirin also apply since boceprevir must be administered with peginterferon alfa and ribavirin which includes: . use in pregnant women or men whose female partners are pregnant. . patients with hemoglobinopathies . autoimmune hepatitis . hepatic decompensation . creatinine clearance less than 50 mL/min . hypersensitivity to any of the product components.
Not approved if: Patient has been treated with Boceprevir before. Has co-infection with Hepatitis B Has co-infection with HIV. Has had an organ transplant. Patient has any contraindications to the use of Victrelis, peginterferon alfa or ribavirin. Special considerations: No dosage adjustments are necessary in patients with renal or hepatic impairment. At this time, no head-to-head studies have been conducted, and the individual studies with boceprevir and telaprevir have used the agents in conjunction with different pegylated interferons, with different ribavirin doses, and for differing durations of therapy, making direct comparisons difficult. A 4-week lead-in phase with peginterferon alfa and ribavirin prior to initiation of boceprevir has been associated with higher rates of SVR and fewer occurrences of resistance-associated variants Comparison of the FDA-Approved Indications for Boceprevir and Telaprevir Boceprevir Telaprevir Proprietary Victrelis Incivek name
The criteria listed above applies to Fallon Health Plan and its subsidiaries. Fallon Health Department of Pharmacy Services Page 3 of 5
Manufacturer Merck Vertex Pharmaceuticals Approval date May 13, 2011 May 23, 2011 Chronic hepatitis C genotype 1 infection in adult patients with compensated liver Chronic hepatitis C genotype 1 infection disease, in adult patients with compensated liver including cirrhosis, who are treatment-naive disease, including cirrhosis, who are Indication or who have failed previous therapy with treatment-naive or who have failed interferon-based treatment, including prior previous null therapy with interferon and ribavirin responders, partial responders, and relapsers aFDA = Food and Drug Administration.
Comparison of the Contraindications for Boceprevir and Telaprevir Boceprevir Telaprevir Contraindications to peginterferon alfaa X X Contraindications to ribavirina X X CYP3A substrates X CYP3A4/5 substrates X Potent CYP3A4/5 inducers X Potent CYP3A inducers X Pregnancyb X X aMust be used in combination with these drugs. bContraindicated because of the required peginterferon and ribavirin therapy.
Comparison of the Warnings and Precautions for Boceprevir and Telaprevir Boceprevir Telaprevir Reduced hemoglobin concentrations √ √ Neutropenia √ All cautions associated with peginterferon alfa √ √ All cautions associated with ribavirin √ √ Pregnancy Category B B Hepatic Impairment- use not recommended √ ESRD or hemodialysis-has not been studied √ Renal Impairment- CrCl < 50mL/min-use not recommended √ Pregnancy Category resulting from required concurrent X X peginterferon and ribavirin therapy Serious skin reactions √ Skin rashes √
The criteria listed above applies to Fallon Health Plan and its subsidiaries. Fallon Health Department of Pharmacy Services Page 4 of 5
FCHP Pharmacy and Therapeutics Committee approval: ______
Date: ______
Adopted: 09/07/2011 Revised: 03/14/2012, 06/10/2015 Effective: 6/10/15
The criteria listed above applies to Fallon Health Plan and its subsidiaries. Fallon Health Department of Pharmacy Services Page 5 of 5