2017 United Healthcare Services, Inc.

Transcription

1 UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2017 P Program Prior Authorization/Medical Necessity Medication Olysio (simeprevir) P&T Approval Date 4/2015, 11/2015, 8/2016, 12/2016, 9/2017 Effective Date 11/1/2017; Oxford only: 11/1/ Background: Olysio (simeprevir) is a hepatitis C virus (HCV) NS3/4A protease inhibitor indicated for the treatment of adults with chronic hepatitis C virus (HCV) infection 1 : In combination with Sovaldi (sofosbuvir) in patients with HCV genotype 1 without cirrhosis or with compensated cirrhosis In combination with peginterferon alfa (Peg-IFN-alfa) and ribavirin (RBV) in patients with HCV genotype 1 or 4 without cirrhosis or with compensated cirrhosis. Limitations of use: 1 Efficacy of Olysio in combination with Peg-IFN-alfa and RBV is substantially reduced in patients infected with HCV genotype 1a with an NS3 Q80K polymorphism.olysio is not recommended in patients who have previously failed with a treatment regimen that included Olysio or other HCV protease inhibitors. 2. Coverage Criteria a : A. For the treatment of chronic hepatitis C genotype 1 or 4 infection in peginterferon eligible patients who are without cirrhosis or have compensated cirrhosis, Olysio in combination with peginterferon alfa and ribavirin will be approved based on all of the following criteria: 1. One of the following: (1) Both of the following: (a) Diagnosis of chronic hepatitis C genotype 1a infection (b) Patient does not have the NS3 Q80K polymorphism (2) Diagnosis of chronic hepatitis C genotype 1b infection

2 (3) Diagnosis of chronic hepatitis C genotype 4 infection 2. For quality purposes only, please provide stage of liver disease (e.g., APRI score, FibroSure score, Fibroscan score, or other methods) this information will not be considered as part of the coverage decision 3. Patient has not experienced failure with a previous treatment regimen that includes Olysio or other HCV NS3/4A protease inhibitor [e.g., Incivek (telaprevir), Victrelis (boceprevir)] 4. One of the following: a. Patient is without cirrhosis b. Patient has compensated cirrhosis (Child-Pugh A) 5. Used in combination with peginterferon alfa and ribavirin 6. One of the following: a. Prescribed by one of the following: (1) Hepatologist (2) Gastroenterologist (3) Infectious Disease Specialist (4) HIV Specialist Certified through the American Academy of HIV Medicine (5) Transplant physician b. For UnitedHealthcare New York or Oxford New York Fully Insured only: Prescribed by a provider with clinical experience* in the management and treatment

3 of hepatitis C virus (HCV) infection and listed on the New York Hepatitis C Medicaid Practitioner List found at 7. Physician/provider asserts patient demonstrates treatment readiness, including the ability to adhere to the treatment regimen 8. One of the following: a. All of the following: (1) History of intolerance or contraindication to Epclusa (sofosbuvir/velpatasvir) (2) History of intolerance or contraindication to Harvoni (sofosbuvir/ledipasvir) (3) History of intolerance or contraindication to Mavyret (glecaprevir/pibrentasvir) b. Patient is currently on Olysio Authorization will be issued for 12 weeks. B. For the treatment of chronic hepatitis C genotype 1 infection without cirrhosis, Olysio in combination with Sovaldi (sofosbuvir) will be approved based on all of the following criteria: 1. Diagnosis of chronic hepatitis C genotype 1 infection 2. For quality purposes only, please provide stage of liver disease (e.g., APRI score, FibroSure score, Fibroscan score, or other methods) this information will not be considered as part of the coverage decision

4 3. Patient is without cirrhosis 4. Used in combination with Sovaldi (sofosbuvir) 5. One of the following: a. Prescribed by one of the following: (1) Hepatologist (2) Gastroenterologist (3) Infectious Disease Specialist (4) HIV Specialist Certified through the American Academy of HIV Medicine (5) Transplant physician b. For UnitedHealthcare New York or Oxford New York Fully Insured only: Prescribed by a provider with clinical experience* in the management and treatment of hepatitis C virus (HCV) infection and listed on the New York Hepatitis C Medicaid Practitioner List found at 6. Physician/provider asserts patient demonstrates treatment readiness, including the ability to adhere to the treatment regimen 7. Patient has not experienced failure with a previous treatment regimen that includes Olysio or other HCV NS3/4A protease inhibitor [e.g., Incivek (telaprevir), Victrelis (boceprevir)] 8. One of the following:

5 a. All of the following: (1) History of intolerance or contraindication to Epclusa (sofosbuvir/velpatasvir) (2) History of intolerance or contraindication to Harvoni (sofosbuvir/ledipasvir) (3) History of intolerance or contraindication to Mavyret (glecaprevir/pibrentasvir) b. Patient is currently on Olysio Authorization will be issued for 12 weeks C. For the treatment of chronic hepatitis C genotype 1 infection with compensated cirrhosis, Olysio in combination with Sovaldi (sofosbuvir) will be approved based on all of the following criteria: 1. Diagnosis of chronic hepatitis C genotype 1 infection 2. For quality purposes only, please provide stage of liver disease (e.g., APRI score, FibroSure score, Fibroscan score, or other methods) this information will not be considered as part of the coverage decision 3. Patient has compensated cirrhosis (Child-Pugh A) 3. Used in combination with Sovaldi (sofosbuvir) 4. One of the following: a. Prescribed by one of the following:

6 (1) Hepatologist (2) Gastroenterologist (3) Infectious Disease Specialist (4) HIV Specialist Certified through the American Academy of HIV Medicine (5) Transplant physician b. For UnitedHealthcare New York or Oxford New York Fully Insured only: Prescribed by a provider with clinical experience* in the management and treatment of hepatitis C virus (HCV) infection and listed on the New York Hepatitis C Medicaid Practitioner List found at 5. Physician/provider asserts patient demonstrates treatment readiness, including the ability to adhere to the treatment regimen 6. Patient has not experienced failure with a previous treatment regimen that includes Olysio or other HCV NS3/4A protease inhibitor [e.g., Incivek (telaprevir), Victrelis (boceprevir)] 7. One of the following: a. All of the following: (1) History of intolerance or contraindication to Epclusa (sofosbuvir/velpatasvir) (2) History of intolerance or contraindication to Harvoni (sofosbuvir/ledipasvir) (3) History of intolerance or contraindication to Mavyret (glecaprevir/pibrentasvir)

7 b. Patient is currently on Olysio Authorization will be issued for 24 weeks a State mandates may apply. Any federal regulatory requirements and the member specific benefit plan coverage may also impact coverage criteria. Other policies and utilization management programs may apply. *Defined as the management and treatment of at least 10 patients with HCV infection within the past 12 months and at least 10 HCV-related CME credits in the last 12 months. 3. Additional Clinical Rules: Supply Limits may be in place. 4. References: 1. Olysio [package insert]. Titusville, NJ: Janssen Therapeutics; May Sovaldi [package insert]. Foster City, CA: Gilead Sciences, Inc.;April American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Recommendations for Testing, Managing, and Treating Hepatitis C. Accessed September 5, 2017 Program Prior Authorization/Medical Necessity - Olysio (simeprevir) Change Control 4/2015 Coverage requirements for State of New Jersey effective 5/18/ /2015 Administrative change, Oxford New Jersey effective date reference added onto separate line. 11/2015 Changed program title to include all lines of business and language regarding documentation of liver fibrosis. 7/2016 Added Indiana and West Virginia coverage information. 8/2016 Added Epclusa to step requirement. 9/2016 Administrative change to corrected header for Section A. 10/2016 Administrative change made for clarity. 11/2016 Added California coverage information. 12/2016 Removed abstinence-based criteria and replaced with treatment readiness screening criteria. 9/2017 Updated background, revised step criteria based on new product availability, included NY prescriber requirement, removed treatment readiness screening tools and removed medical record submission requirements.