The economics of biosimilars and challenges to biosimilar adoption in low- and middle-income countries.

INTRODUCTION: Biologics have shown marked success over the past decades in disease areas as cancer, immunology and diabetes. However, elevated costs of innovative biologic medicines have led to an inequity in accessibility across the world. While 85% of the world's population lives in low- and middle- income countries (LMIC), 80% of the sales of monoclonal antibodies are attributed to Western countries, highlighting the pronounced market imbalance. AREAS COVERED: This perspective paper draws some analogies as well as differences between biosimilars and generics, aims to address the unmet need for treatment with biologics in LMICs by reviewing possible causes, economic and social, of low access, displaying the disparity between LMICs and HIC, and suggets countermeasures for this unmet medical need in LMICs. EXPERT OPINION: It is up to all stakeholders to capitalize on the opportunity that biosimilars provide, mostly by committing to transparent collaboration, to make biotherapeutics accessible to all, regardless of region or country of residence.

Economic evaluation of polatuzumab-bendamustine-rituximab vs. tafasitamab-lenalidomide in transplant-ineligible R/R DLBCL.

AIM: Polatuzumab vedotin-bendamustin-rituximab (PBR) and tafasitamab-lenalidomide (Tafa-L) were approved recently for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in autologous stem cell transplant (ASCT) ineligible patients. We performed an industry-independent pharmacoeconomic evaluation of both regimens over a 5-year (y) time horizon (US payer perspective; 2020 USD). METHODS: Survival curves, treatment costs, and utility values were applied in a three-state Markov model (progression-free survival (PFS), post-progression survival (PPS), death) to estimate the incremental follow-up (ICER) and cost-utility ratios (ICUR). A novel metric of the incremental cost per 1% gain in the probability of achieving objective response (OR), PFS, and OS were estimated. RESULTS: Five-year Tafa-L costs ($470,119) exceeded PBR's ($249,217) by $220,902 with incremental gains of 0.71 life-years (LY) and 0.32 quality-adjusted life-years (QALY); yielding ICER of $310,041/LYg and ICUR of $694,241/QALYg. Tafa-L had favorable PFS and OS rates over PBR with adjusted differences of +19.2 and +34.1%, respectively at trial follow-up (∼2 years), with corresponding 5 years differences in survival of +7.8% in PFS and +21.4% in OS. The incremental cost per 1% gain in the probability of achieving OR, PFS and OS at follow-up were $8,479, $6,359, and $3,583; and $28,321 and $10,323 for PFS and OS at 5 years. CONCLUSION: The sustained Tafa-L treatment demonstrated better survival outcomes than 6-cycle PBR though at a greater cost. The incremental costs to gain a 1% improvement in 2 and 5 years survival outcomes with Tafa-L over PBR were modest, underscoring the longer-term benefit of Tafa-L over PBR in patients ineligible for or opting out of ASCT.

PLAIN LANGUAGE SUMMARYTwo new medication regimens were approved recently for relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL): six cycles of polatuzumab vedotin-bendamustine-rituximab (PBR) and continuous twice-monthly treatment with tafasitamab-lenalidomide (Tafa-L). Both treatments are expensive, but Tafa-L more so because it requires continuous treatment versus the maximum 6 cycles of PBR. However, Tafa-L may have better progression-free (PFS) and overall survival (OS) outcomes. Is this worth the additional money?We conducted a cost-effectiveness analysis comparing Tafa-L to PBR. After calculating the differenced in costs and the progression-free and overall survival, we determined the additional cost to gain a life year (LY) or quality-adjusted life year (QALY) over 5 years. We also introduced a novel metric: how much it would cost extra to gain, with Tafa-L treatment, an improvement in progression-free or overall survival of 1% over the survival afforded by PBR. Treatment with Tafa-L over PBR would cost an extra $220,902 for a gain of 0.71 life years (standardized, $310,041/LYgained) and 0.32 quality-adjusted life years ($694,241/QALYgained). Importantly, two years of Tafa-L treatment increased the likelihood of progression-free survival by +19.2% and overall survival by 34.1% over PBR; extending to +7.8% in progression-free survival and +21.4% in overall survival at five years. It cost an additional $28,321 per 1% gain in likelihood in progression-free survival and $10,323 per 1% gain in overall survival after 5 years. Summarized, the increased costs of Tafa-L translate into significantly better progression-free and overall survival.

Comparing jurisdiction-specific pharmaco-economic evaluations using medical purchasing power parities.

OBJECTIVES: To demonstrate how medical purchasing power parities (mPPP) may harmonize economic evaluations from different jurisdictions and enable comparisons across jurisdictions. METHODS: We describe the use of mPPPs and illustrate this with an example of economic evaluations of nab-paclitaxel with gemcitabine (Nab-P + Gem) versus gemcitabine monotherapy in the setting of metastatic pancreatic cancer. Following a literature search, we extracted data from cost-effectiveness studies on these treatments performed in various countries. mPPPs from the Organization for Economic Co-operation and Development were used to convert reported costs in the jurisdiction of origins to US dollars for the most current year using two possible pathways: (1) reported costs first adjusted by mPPP then adjusted by exchange index; and (2) reported costs first adjusted by exchange index then adjusted by mPPP. RESULTS: Despite many of the pharmaco-economic evaluations sharing similar assumptions and inputs, even after mPPP conversion, residual heterogeneity was attributable to perspectives, discount rate, outcomes, and costs, among others; including in studies conducted in the same jurisdiction. CONCLUSION: Despite the methodological challenges and heterogeneity within and across jurisdictions, we demonstrated that mPPP offers a way to compare economic evaluations across jurisdictions.