title: Pharmaco-economic aspects of sipuleucel-T.
abstract: Sipuleucel-T, a new autologous active cellular immunotherapy, is indicated for metastatic castration-resistant prostate cancer. This Commentary aims to highlight pharmaco-economic aspects relating to the clinical evidence, cost-effectiveness and reimbursement of sipuleucel-T. Today, there is still uncertainty surrounding the clinical benefit of sipuleucel-T and existing evidence relates to the efficacy of sipuleucel-T in a structured setting rather than to its effectiveness in a real-world setting. Due to the clinical uncertainty, there may be scope to introduce a 'coverage with evidence development' scheme, where sipuleucel-T is reimbursed subject to further evidence being generated about its (cost-)effectiveness. Given the high price for a modest effectiveness, sipuleucel-T is unlikely to be cost-effective. However, other societal considerations may matter such as the fact that sipuleucel-T is an end-of-life treatment. A case can be made to apply weights to quality-adjusted life years accrued in the later stages of terminal diseases, thereby improving the cost-effectiveness of sipuleucel-T. Also, risk-sharing arrangements could be considered where the manufacturer shares the risk with the third-party payer that the product may or may not be effective for a particular patient. However, the current absence of markers to identify eligible patients and to assess treatment response inhibits the implementation of a risk-sharing arrangement for sipuleucel-T.
authors.affiliation: Research Centre for Pharmaceutical Care and Pharmaco-Economics, Katholieke Universiteit Leuven, Leuven, Belgium. steven.simoens@pharm.kuleuven.be
authors.forename: Steven
authors.initials: S
authors.lastname: Simoens
mesh_terms: D019496:Cancer Vaccines / Q000008:administration & dosage* / Q000191:economics / Q000494:pharmacology; D003362:Cost-Benefit Analysis; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage* / Q000191:economics / Q000494:pharmacology; D007167:Immunotherapy / Q000191:economics / Q000379:methods; D008297:Male; D009362:Neoplasm Metastasis / Q000628:therapy*; D011471:Prostatic Neoplasms / Q000556:secondary* / Q000628:therapy*; D019057:Quality-Adjusted Life Years; D014020:Tissue Extracts / Q000008:administration & dosage* / Q000191:economics / Q000494:pharmacology; D014481:United States
chemical_list: D019496:Cancer Vaccines; D007155:Immunologic Factors; D014020:Tissue Extracts; C511774:sipuleucel-T