SUMMACARE COMMERCIAL MEDICATION REQUEST GUIDELINES

Transcription

1 Generic Brand HICL GCN Exception/Other TELAPREVIR INCIVEK This drug requires a written request for prior authorization. All requests for hepatitis C medications require review by a pharmacist prior to final approval. GUIDELINES FOR USE 1. Is the requested medication being used with ribavirin AND peginterferon alfa; (NOTE: The patient must have an active prior authorization for ribavirin and peginterferon alfa before proceeding.)? If yes, continue to # Is the patient currently taking the requested medication as indicated on the MRF, claims history, or prior authorization history? If yes, continue to #11. If no, continue to #3. 3. Does the patient have a diagnosis of chronic hepatitis C, genotype 1? If yes, continue to #4. DENIAL TEXT: See the denial text at the end of the guideline 4. Is the patient at least 18 years old? If yes, continue to #5. 5. Is the patient currently supervised by a gastroenterologist, infectious disease specialist, physician specializing in the treatment of hepatitis (for example, hepatologist), or a specially trained group such as ECHO (Extension for Community Healthcare Outcomes) model? If yes, continue to #6. Revised 12/3/2015 Page 1 of 7

2 GUIDELINES FOR USE (CONTINUED) 6. Has the patient completed a prior course of therapy with a protease inhibitor (for example, telaprevir [Incivek], simeprevir [Olysio], or boceprevir [Victrelis]) and has not achieved a sustained virologic response (SVR)? If yes, do not approve. If no, continue to #7. 7. Is the patient currently taking rifampin? If yes, do not approve. If no, continue to #8. 8. Does the patient have a coinfection with hepatitis B? If yes, do not approve. 9. Does the patient have a history of a previous organ transplant? If yes, continue to #10. If no, approve #6 tablets per day for 8 weeks. PAC: The days supply is based on the benefit structure. Enter the Maximum Daily Dose (MDD) = 6 tablets and a duration of 56 days. APPROVAL TEXT: Our guideline for renewal requires HCV RNA level at baseline and at 4 weeks of telaprevir therapy (level 1,000 IU/mL or less). Please also document if the patient is one of these treatment groups: prior relapse patient, prior partial responder, prior null responder patients, or a treatment-naïve patients with cirrhosis. Drugs that are contraindicated with Incivek include alfuzosin, rifampin, ergot derivatives, cisapride, St. John's wort, atorvastatin, lovastatin, simvastatin, pimozide, sildenafil or tadalafil (when used for pulmonary arterial hypertension [PAH]), orally administered midazolam and triazolam. Incivek may increase serum levels of immunosuppressants such as cyclosporine, sirolimus, and tacrolimus; anticipate significant dose reduction and prolongation of dosing interval of immunosuppressants for transplant patients that are taking Incivek. Revised 12/3/2015 Page 2 of 7

3 GUIDELINES FOR USE (CONTINUED) TELAPREVIR 10. Is this a patient with a history of liver transplant and hepatitis C medications (triple therapy) being prescribed by a transplant center and transplant physician? If yes, approve #6 tablets per day for 8 weeks. PAC: The days supply is based on the benefit structure. Enter the Maximum Daily Dose (MDD) = 6 tablets and a duration of 56 days. APPROVAL TEXT: Our guideline for renewal requires HCV RNA level at baseline and at 4 weeks of telaprevir therapy (level 1,000 IU/mL or less). Please also document if the patient is one of these treatment groups: prior relapse patient, prior partial responder, prior null responder patients, or a treatment-naïve patients with cirrhosis. Drugs that are contraindicated with Incivek include alfuzosin, rifampin, ergot derivatives, cisapride, St. John's wort, atorvastatin, lovastatin, simvastatin, pimozide, sildenafil or tadalafil (when used for pulmonary arterial hypertension [PAH]), orally administered midazolam and triazolam. Incivek may increase serum levels of immunosuppressants such as cyclosporine, sirolimus, and tacrolimus; anticipate significant dose reduction and prolongation of dosing interval of immunosuppressants for transplant patients that are taking Incivek. DENIAL TEXT: See the initial denial text. INITIAL DENIAL TEXT: Our guideline for requires that patient has no history of solid organ transplant, except in the case of liver transplant patients managed by a transplant center. Other approval criteria include: concurrent use of ribavirin and peginterferon alfa and a diagnosis of chronic hepatitis C, genotype 1 without a coinfection with hepatitis B for a patient with a minimum age of 18 years who is currently supervised by a gastroenterologist, infectious disease specialist, physician specializing in the treatment of hepatitis (for example, hepatologist), or a specially trained group such as ECHO (Extension for Community Healthcare Outcomes) model and the patient has not failed therapy with telaprevir (Incivek), simeprevir (Olysio), or boceprevir (Victrelis) and is not currently taking rifampin. Revised 12/3/2015 Page 3 of 7

4 GUIDELINES FOR USE (CONTINUED) TELAPREVIR 11. Renewal criteria for treatment week 9, the patient has an approved PA for telaprevir: Did the patient have a HCV RNA level/viral load of 1,000 IU/mL or less at 4 weeks of telaprevir therapy? If yes, approve #6 tablets per day for 4 weeks. Maximum telaprevir therapy is not to exceed 12 weeks. PAC: The days supply is based on the benefit structure. Enter the Maximum Daily Dose (MDD) = 6 tablets and a duration of 28 days; total telaprevir therapy duration not to exceed 84 days (12 weeks). APPROVAL TEXT: Drugs that are contraindicated with Incivek include alfuzosin, rifampin, ergot derivatives, cisapride, St. John's wort, atorvastatin, lovastatin, simvastatin, pimozide, sildenafil or tadalafil (when used for pulmonary arterial hypertension [PAH]), orally administered midazolam and triazolam. Incivek may increase serum levels of immunosuppressants such as cyclosporine, sirolimus, and tacrolimus; anticipate significant dose reduction and prolongation of dosing interval of immunosuppressants for transplant patients that are taking Incivek. RENEWAL DENIAL TEXT: Our renewal guideline for requires HCV RNA level/viral load of less than 1,000 IU/mL at 4 weeks of telaprevir therapy. CLINICAL SPECIALISTS: If HCV RNA level greater than 1,000 IU/mL at week 4, triple therapy will be discontinued at this time. Review the prior authorization history and close peginterferon PA ( PA, if applicable). CLINICAL SPECIALISTS: Please review peginterferon/ribavirin dosing regimens: For treatment-naïve and prior relapse patients with undetectable HCV-RNA at weeks 4 and 12, dual therapy is for a total treatment duration of 24 weeks. For treatment-naïve and prior relapse patients with detectable (1,000 IU/mL or less) HCV-RNA at weeks 4 and/or 12, dual therapy is for a total duration of 48 weeks. For prior partial and null responder patients dual therapy is for a total duration of 48 weeks. For treatment-naïve patients with cirrhosis who have undetectable HCV-RNA levels at week 4 and 12, dual therapy for a total duration of 48 weeks would be beneficial. Revised 12/3/2015 Page 4 of 7

5 From the Incivek package insert (Vertex): TELAPREVIR Table 1: Recommend Treatment Duration (See also Table 2 for Treatment Futility Rules) Treatment-Naïve and Prior Relapse Patients HCV RNA* Triple Therapy INCIVEK, Dual Therapy Peginterferon alfa Total Treatment Duration peginterferon alfa Undetectable (Target First 12 weeks Additional 12 weeks 24 weeks Not Detected) at Weeks 4 and 12 Detectable (1000 IU/mL or less) at Weeks 4 and/or 12 First 12 weeks Additional 36 weeks 48 weeks Prior Partial and Null Responder Patients Triple Therapy INCIVEK, peginterferon alfa Dual Therapy Peginterferon alfa Total Treatment Duration All Patients First 12 weeks Additional 36 weeks 478 weeks *In clinical trials, HCV RNA in plasma was measured using a COBAS TaqMan assay with a lower limit of quantification of 25 IU/mL and a limit of detection of 10 IU/mL. See Laboratory Tests (5.6) for a description of HCV-RNA assay recommendations. Table 2: Treatment Futility Rules: All Patients HCV RNA Action Week 4 or Week 12: Greater than 1000 Discontinue INCIVEK and peginterferon alfa IU/mL (INCIVEK treatment complete at 12 weeks) Week 24: Detectable Discontinue peginterferon alfa If peginterferon alfa or ribavirin is discontinued for any reason, INCIVEK must also be discontinued. Revised 12/3/2015 Page 5 of 7

6 RATIONALE Ensure appropriate utilization of telaprevir based on FDA approved indication. FDA APPROVED INDICATIONS Incivek, in combination with peginterferon alfa, is indicated for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis, who are treatment-naïve (patients who have not received interferon-based drug therapy for their infection) or who have previously been treated with interferon-based treatment and not responded adequately, including prior null responders, partial responders, and relapsers. FDA APPROVED DOSAGE Incivek 1125mg (three 375mg tablets) orally twice daily is added to peginterferon alfa and ribavirin for the first twelve weeks of therapy. OTHER INFORMATION Currently AASLD treatment guidelines recommend that any use of telaprevir in HIV co-infected or transplant populations infected with HCV should be done with caution and under close clinical monitoring. A clinical trial evaluating use of telaprevir triple therapy in HCV/HIV coinfected patients showed significantly higher rates of SVR than in patients treated with peginterferon/ribavirin alone. Note on HCV RNA levels defined by lab as undetectable versus detectable but not quantifiable: Commercially available quantitative HCV RNA assays may have differing limits for quantification and detection. The lower limit of detection is 10 or 50 IU/mL HCV RNA (depends on assay used by lab). The FDA suggests that labs testing HCV RNA levels for patients taking protease inhibitors must use an assay with a lower limit of quantification of 25 IU/mL or less, and a lower limit of detection of IU/mL. Generally, patients with detectable but not quantifiable levels of HCV RNA will have lower SVR rates with triple therapy; a detectable but not quantifiable HCV RNA level should not be considered equivalent to an undetectable level. When the product package insert (or MedImpact PA guideline) specifies 'undetectable HCV RNA level', generally an undetectable HCV RNA result is required. Revised 12/3/2015 Page 6 of 7

7 REFERENCES Arora S, Thornton K, Murata G, et al. Outcomes of Treatment for Hepatitis C Virus Infection by Primary Care Providers. NEJM 364; 23: Dietrich D, et al. 19 th Conference on Retroviruses and Opportunistic Infections (CROI): Abstract 47: Presented March 6, Ghany M, Nelson D, Strader D, Thomas D, and Seeff L. An Update on Treatment of Genotype I Chronic Hepatitis C Virus Infection: 2011 Practice Guidelines by the American Association for the Study of Liver Diseases. Hepatology 2011; 54 (4): Accessed online March 9, 2012 at: pdf Harrington P, Zeng W, and Naeger L. Clinical relevance of detectable but not quantifiable hepatitis C virus RNA during boceprevir or telaprevir treatment. Hepatology 2012; Apr 55 (4): Vertex Pharmaceuticals. Incivek package insert. Cambridge, MA. May RATIONALE Commercial X HIEx X Created: 11/3/11 Effective 01/01/2016 Client Approval: P&T Approval: Revised 12/3/2015 Page 7 of 7