Month Date, Year
Health Plan Addressee Line 1
Health Plan Addressee Line 2
Dear (Insert Name),
I am requesting (approval/reconsideration of your denial) of Olysio (simeprevir) plus Sovaldi (sofosbuvir) for my patient (patient name). (Patient name) has chronic hepatitis C (HCV) genotype 1 infection with stage (3 or 4) fibrosis (or compensated cirrhosis). (He/she) is unable to take an interferon-alfa (and/or ribavirin) containing regimen due to the following contraindication(s):
(one or more of: prior intolerance to interferon or ribavirin (describe), contraindication such as psychiatric disease, autoimmune disease, cardiopulmonary disease, concern about relapse with injections, anemia that cannot be corrected with iron supplementation)
Olysio+Sovaldi has shown efficacy for HCV genotype 1 patients that are treatment naïve or previous null responders (patients who had less than a 2-log decline in HCV RNA levels by 12 weeks of treatment with pegylated interferon and ribavirin), including patients with cirrhosis.
In a phase 2a study by Jacobson et al, known as COSMOS, patients from two cohorts were randomized to one of four treatment groups.[1] Cohort 1 consisted of 80 null responders with mild to moderate liver fibrosis (METAVIR F0-2). Cohort 2 consisted of 87 patients, either treatment naïve or null responders, with advanced fibrosis or compensated cirrhosis (METAVIR F3-4). Analysis was done on each cohort separately. Treatment arm 1 patients received Olysio+Sovaldi+ribavirin (RBV) for 24 weeks. Treatment arm 2 received Olysio+Sovaldi for 24 weeks. Treatment arm 3 received Olysio+Sovaldi+RBV for 12 weeks, and treatment arm 4 received Olysio+Sovaldi for 12 weeks. Table 1 displays interim sustained virological response (SVR) results for the 12 week treatment arms.
Table 1: Interim SVR results for cohort 1 and cohort 2 patients in the 12-week treatment arms of the COSMOS study1
Cohort / Treatment arm 3Olysio+Sovaldi +RBV
x12w / Treatment arm 4
Olysio+Sovaldi x12w
Cohort 1:SVR12
(Null/F0-2) / 26/27 (96%) / 13/14 (93%)
Cohort 2: SVR4
(Naïve or Null/F3-4) / 26/27 (96.3%) / 14/14 (100%)
Approved options for HCVgenotype 1 contain interferon, with the exception of Sovaldi+RBV for 24 weeks in interferon-intolerant patients, as shown in Table 2.
Table 2: Results from phase 3 studies of Olysio or Sovaldi in genotype 1, treatment naïve patients
Study name / Treatment regimen / SVR12Quest-1[2] / Olysio+peg-interferon+RBV RGT x24-48w / 80%
Neutrino[3] / Sovaldi+peg-interferon+RBV x12w / 90%
Sovaldi+peg-interferon+RBV x 12 w (patients with cirrhosis) / 80%
SPARE[4] / Sovaldi+RBV x 24 w / 68%
Olysio for 12 weeks+peg-interferon+RBV for 48 weeks was studied in 17 prior null responders in a phase 2 study (ASPIRE) and 9/17 (53%) achieved SVR[5]. There are no clinical data for Sovaldi+peg-interferon+RBV or Sovaldi+RBV in treatment experienced patients, including prior null responders. Sovaldi+RBV for 24 weeks has lower SVR rates than were seen in COSMOS and the cost of that regimen is expected to be over $176,000.
Recent data on the real world cost of treatment of HCV with peg-interferon+RBV plus telaprevir found that patients with advanced fibrosis (FIB-4>3.25) cost $256,977 per SVR[6]. These high costs were driven by low SVR rates in these difficult to treat patients as well as costs of managing adverse events, especially anemia.
In summary, Olysio+Sovaldi is the only available treatment combination that is an interferon-free regimenwith demonstrated efficacy in genotype 1 HCV. I am requesting that Olysio+Sovaldi be approved for my patient,(insert patient name) based on (his/her) advanced liver disease and contraindications to an interferon-based regimen.
Sincerely,
(Name)
(Affiliation)
[1]Jacobson IM, Ghalib,RM, Rodriguez-Torres M, et al. SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naive and prior null responder patients: the COSMOS study (AbstractLB-3). Presented at 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2013. November 1-5. Washington, DC.
[2]Jacobson IM, Dore GJ, Foster GR, et al. Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype 1 infection in treatment-naïve patients: results from QUEST-1 a phase III trial (Abstract 1425). Presented at 48thAnnual Meeting of the European Association for the Study of the Liver (EASL); 2013.April 24-28. Amsterdam, the Netherlands.
[3] Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T et al. Sofosbuvir for Previously Untreated Chronic Hepatitis C Infection. (NEUTRINO/FISSION). The New England Journal of Medicine. 2013; 368 (20). 1878-1887.
[4]Osinusi A, Meissner EG, Lee YJ, et al. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial.JAMA. 2013 Aug 28;310(8):804-11. doi: 10.1001/jama.2013.109309.
[5]Fried MW, Poordad F, Zeuzem S, et al. Safety and tolerability of TMC435 in combination with peginterferon α-2a and ribavirin for treatment of HCV genotype 1 infection in treatment-naive and -experienced patients (PILLAR and ASPIRE trials) (Abstract 769). Presented at 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) 2012; November 9-13. Boston, MA.
[6]Bichoupan K,Martel-Laferriere V, Ng M, SchonfeldEet al. Real world costs of telaprevir-based triple therapy, including costs of managing adverse events, at the Mount Sinai Medical Center, NY: $195,000 per SVR12 (Abstract 244). Presented at 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2013. November 1-5. Washington, DC.