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.

Keywords: :

• cost-effectiveness
• economic evaluation
• pharmaco-economics
• reimbursement
• sipuleucel-T

Acknowledgments

No sources of funding were used to assist in the preparation of this manuscript. The author has no conflicts of interest that are directly relevant to the content of this manuscript.