Insurance approval rates for collagenase clostridium histolyticum prior to discontinuation: A Canada-wide analysis
Taekhwan Chung1, Benjamin Shiff1, Ruben Blachman-Braun2, Marc Grenier3, Ryan Flannigan4,5, Premal Patel1.
1Division of Urology, Department of Surgery, University of Manitoba, Winnipeg, MB, Canada; 2Urology, University of Miami, Miami, FL, United States; 3BioScript Solutions, Moncton, NB, Canada; 4Department of Urologic Sciences, University of British Columbia, Vancouver, BC, Canada; 5Urology, Weill Cornell Medicine, New York City, NY, United States
Introduction: Intralesional collagenase clostridium histolyticum (CCh) was the first approved non-surgical treatment for Peyronie’s disease (PD) following the results of the IMPRESS I and II trials.1 CCh was recently withdrawn from the European, Canadian, and Asian markets. The primary reason for discontinuation cited by Endo Pharmaceuticals was poor demand, partially due to lack of government reimbursement options.2 Our goal was to assess insurance approval rates and ultimately usage of CCh across Canada to better understand the factors that led to its withdrawal.
Methods: Data was obtained for all patients who had been prescribed CCh for either PD or Dupuytren’s contracture through collaboration with BioScript Solutions. Data were collected for all patients enrolled in the Xiaflex Access Program from April 2018 to June 2020. This data was used to determine the association of variables with insurance approval and prescription filling. Relationship with insurance approval and prescription filling was analyzed using univariable and multivariable-adjusted logistic regression analysis.
Results: We identified 3297 insurance coverage applications for Xiaflex from April 2018 to June 2020. Of all applications for PD, 695 (92.9%) applications were approved while 53 (7.1%) were rejected. Despite the withdrawal of CCh from Canadian markets in 2021, coverage application approval rates for 2018, 2019, and 2020 were 86.5%, 90.1%, and 89.1%, respectively. Of all 2921 approved applications, 2594 (88.8%) prescriptions were filled. However, for the 376 rejected applications, 250 (66.4%) prescriptions were filled. Overall, 90% (80–100) of the cost of Xiaflex was covered in Canada among those with extended health benefits, with an out-of-pocket expense of $210.40 (0–283.30).
Conclusions: Insurance coverage requests for Xiaflex were approved at a high rate in Canada despite some interprovincial variation. Approved patients were also very likely to proceed with therapy.
[1] Gelbard M, Goldstein I, Hellstrom WJG, et al. Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol. 2013;190(1):199-207. doi:10.1016/j.juro.2013.01.087
[2] Paladin Labs Inc. Healthcare Professional Information regarding discontinuation of XIAFLEX®. Published April 30, 2020. https://dupuytrencanada.ca/wp-content/uploads/2020/05/60841-002-Xiaflex_Discontinuation_Notice_04302020.pdf