Background Given the existing evidence that the degree of response to certolizumab pegol (CZP) at Week 12 is determinant of the probability of long-term response to CZP, a risk-sharing scheme (RSS) was created and embedded in a clinical decision rationale. It also aligns with recent European treatment guidelines, emphasizing a treat-to-target approach in rheumatoid arthritis (RA) with an intensive monitoring of patients and rapid, pro-active switching in case of non-response.

Objectives Assessment of an RSS for CZP in terms of treatment response, per-patient value-for-money and affordability in the Finnish population.

Methods To evaluate the effects and costs (administration, drug, in-patient, monitoring, adverse events, travelling, productivity; 2011 real value) of biologic treatments for RA in anti-TNF-naïve patients, a literature search of American College of Rheumatology (ACR) ACR70, ACR50 and ACR20 outcomes at weeks 12 and 24, and Bayesian network meta-analyses were carried out. Per-patient cost-effectiveness and per-population budget impact were assessed in a new, hybrid stochastic Markov model, combining cost-effectiveness and budget impact analyses. Using 12-week cycles, multiple comparators (so-called treatment-mix modelling, ie. in proportion to their current market share in Finland) and a Finnish societal perspective that includes direct and indirect costs, anti-TNF therapies were compared over a 5-year horizon. If an ACR20 response was achieved at Week 12, CZP treatment was continued. Otherwise, CZP acquisition costs were refunded under a proposed RSS, and alternative treatment was initiated. Quality-adjusted life-years were estimated based on a relationship between EQ-5D and Health Assessment Questionnaire. The budget impact part assumes a rising incidence of RA during 2013–2017 in Finland and includes treatment persistence estimates.

Results The meta-analysis showed that 72.4% (95% confidence interval 64.7–80.3%) of CZP-treated patients had an ACR20 response at Week 12, compared to estimated ACR20 response at Week 12 of 60.2% with adalimumab, 52.5% with etanercept, and 55.5% with golimumab. Over the 5 years, introducing the CZP RSS for all new patients provided cost savings per patient of €4,796 together with 0.04 additional quality-adjusted life-years (with 100% cost-effectiveness probability). If using an RSS, approximately 4.7% of CZP acquisition costs would be refunded. The correspondent budget per patient-year was estimated at €27,310 under the current mix of anti-TNFs and subsequent therapies, which could be reduced to average €26,178 per patient-year if all starting patients were to receive CZP with RSS. Whereas the magnitude of the budget impact varied according to different assumptions, all the sensitivity analyses conducted were consistent and showed that CZP would reduce costs and improve patient health.

Conclusions The current analysis showed that CZP is effective and cost-effective compared to the current mix of treatments in Finland. An outcomes-based RSS would increase affordability even further.

Acknowledgements The authors acknowledge Costello Medical Consulting for editorial assistance which was funded by UCB Pharma.

Disclosure of Interest C. Asseburg Employee of: ESiOR Oy, E. Soini Shareholder of: ESiOR Oy, Grant/research support from: ISPOR, Kauneuskeskus Mona Oy, University of Eastern Finland, Consultant for: Kauneuskeskus Mona Oy, Employee of: ESiOR Oy, Paid instructor for: Kauneuskeskus Mona Oy, Speakers bureau: University of Eastern Finland, Kuopio University Hospital, K. Puolakka Consultant for: Pfizer, MSD, UCB Pharma, O. Purcaru Employee of: UCB Pharma, M. Taiha Employee of: UCB Pharma, R. Luosujärvi Speakers bureau: BMS, Abbott, Pfizer, RiLu