Determination of the Value Contribution of Belantamab Mafodotin (Belamaf; BLENREP®) for the Treatment of Triple-Class Refractory Multiple Myeloma in Spain through Reflective Multi-Criteria Decision Analysis

Abstract

Background: Most patients with multiple myeloma (MM) have an initial response to treatment, however the majority will ultimately progress and develop treatment resistance to current mechanisms of action (proteasome inhibitors, immunomodulatory agents, monoclonal antibodies), evolving to Triple-Class Refractory MM (TCR-MM). Belantamab mafodotin (Belamaf) is a first-in-class immune-conjugate that binds to the B cell maturation antigen (BCMA) receptor, indicated as monotherapy for the treatment of TCR-MM. Reflective Multi-Criteria Decision Analysis (MCDA) offers a methodology that allows determination of what represents value in a given indication considering all relevant criteria for healthcare decision-making in a transparent and systematic manner and from the perspective of relevant stakeholders. The aim of this study was to determine, using reflective MCDA methodology, the relative value contribution of Belamaf for treating TCR-MM in Spain when compared to two potential therapeutic alternatives for this population: pomalidomide plus cyclophosphamide and dexamethasone [PomCyDex] and selinexor plus dexamethasone [Selinexor+Dex]. Methods: A literature review was conducted to populate an adapted MCDA framework for orphan-drug evaluation in Spain. The adapted framework included 9 quantitative criteria and 3 contextual criteria. A panel of 13 experts (haematologists, hospital pharmacists, decision-makers) were trained in MCDA methodology and scored two evidence matrices (Belamaf vs. PomCyDex and vs. Selinexor+Dex). Results: TCR-MM is considered a severe disease (4.4±0.5) with important unmet needs (4.2±0.7). Compared with PomCyDex, Belamaf is perceived to have a better efficacy profile (2.5±1.3) based on achieving similar outcomes in a population with worse prognosis. Belamaf presents a positive trend towards a better safety/tolerability profile (0.7±1.7) and a positive quality of life (QoL) profile (1.5±1.3). When compared with Selinexor+Dex, Belamaf is regarded as having a better efficacy profile (2.1±1.0) (based on improvements in duration of response, overall response rate, depth of response, and global survival). Belamaf has a better safety/tolerability profile (2.8±0.9) given the hematologic and general toxicity observed with Selinexor+Dex, and a positive QoL profile (2.3±0.9). Both direct (medical, excluding pharmacological) and indirect costs were considered similar in both treatment comparisons. Overall, Belamaf is regarded as providing a high therapeutic impact (3.5±0.8) and supported by high-quality evidence (3.1±1.0). Belamaf's global value contribution is perceived as positive when compared to PomCyDex (score: 0.44) and to Selinexor+Dex (score: 0.51). Conclusions: Based on reflective MCDA methodology and stakeholders’ experience in clinical management of TCR-MM in Spain, Belamaf is considered as adding greater benefit in terms of efficacy, safety and QoL attributes when compared with both PomCyDex and Selinexor+Dex. Expected impact on direct medical and indirect costs (without considering price) are similar in both comparisons.