Performance-Based Risk-Sharing Arrangements (PBRSA): Is it a Solution to Increase Bang for the Buck for Pharmaceutical Reimbursement Strategy for Our Nation and Around the World?

Abstract

Due to the risks involved in not achieving desired health outcomes for the dollar spent on drugs, healthcare decision makers, including payers, providers, drug manufacturers, and patients, need a mechanism to share this financial risk among the involved parties. Performance-based risk-sharing arrangements (PBRSAs) are agreements that can potentially reduce the 'drug lag' in which patients wait for an unknown amount of time until a particular drug is covered under their health plan. In addition, PBRSAs can mitigate the risk of investing heavily in drugs that are ineffective or do not deliver good value or "bang for the buck". This review describes and evaluates PBRSAs for drugs in the USA and juxtaposes to other developed nations (i.e. Germany) that adopted PBRSAs in their healthcare model. There are different types of outcomes-based health schemes, namely conditional coverage, which can be further broken down into coverage with evidence development (CED), conditional treatment continuation (CTC), and performance-linked reimbursement, which includes outcomes guarantees. Both CED and CTC are 'conditional' on the collected evidence of the new drug's effectiveness, offering discount only if the drug delivers desirable results. The outcomes guarantee scheme offers discount or even a full refund if the outcome is less than expected, forcing the drug to meet the expected effectiveness. The USA can follow the German reference pricing model in which the assessment of new drugs is centralized and done collectively by representatives from a group of healthcare decision makers. In any shape or form, PBRSA is a clever mechanism to cope with uncertainty if drug price is scaled appropriately based on value.

Opportunities and Threats of the Legally Facilitated Performance-Based Managed Entry Agreements in Slovakia: The Early-Adoption Perspective

“…Information about the health outcome indicators that assess the product performance is mostly highly confidential, as well as most of the content of performance-based MEAs. Due to challenges such as implementing new systems as opposed to using existing data structures, experience with PB-MEA is essentially still limited [ 1 , 9 , 10 , 11 , 12 , 13 , 14 ]. The main concern for the widespread use of PB-MEA comes from a shortage of established data on parameters that indicate the performance of products, or from the lack of interpretation leading to little minimization of uncertainties in product effectiveness [ 15 ].…”

The Challenges of Outcomes-Based Contract Implementation for Medicines in Europe

“…However, the greatest achievement has been to reduce the knowledge gap between efficacy and effectiveness, stating that the therapies administered have shown the optimal benefits for which the funder is willing to pay Garattini and Casadei, 2011 [ 5 ] Understand lessons from the Italian implementation of performance-based arrangements Qualitative analysis There are a number of challenges associated with these schemes and a lack of publicly available evaluations García-Collado et al, 2021 [ 21 ] Assess the economic impact of an RSA on certolizumab pegol for rheumatoid arthritis and estimate the potential impact of an alternative agreement Quantitative analysis The RSA resulted in improved efficiency and savings in the hospital’s pharmacy service. The savings generated by the RSA would allow payment for the treatment of approximately 20% more patients Garrison et al, 2013 [ 10 ] Set out the standards that should be applied to good practices in the use of a PBRSA, encompassing questions around the desirability, design, implementation and evaluation of such an arrangement Qualitative analysis Additional evidence collection is costly, and there are numerous barriers to establishing viable and cost-effective PBRSAs: negotiation, monitoring and evaluation costs can be substantial Jarosławski and Toumi, 2011 [ 22 ] Analyse the differences between P4P and CED pharmaceutical reimbursement agreements and the motivations behind their creation Qualitative analysis While commercial agreements and P4P have the potential to reduce payers’ expenditure on costly drugs while maintaining a high list price, CED address initial uncertainty related to assessing the real-life value of new drugs and enable a final HTA recommendation or reimbursement and pricing decisions Kim et al, 2020 [ 40 ] Evaluate how PBRSAs for drug reimbursement have been used in different healthcare models Literature review PBRSAs can be used by payers, providers and manufacturers to cope with uncertainty surrounding technologies. However, the technology price should be scaled appropriately based on value Lorente et al, 2019 [ 20 ] Analyse how risk-sharing agreements have been implemented in Spain Survey and quantitative analysis Although risk-sharing agreements can promote budget control and drug management, as well as increase patients’ access to drugs, they pose specific challenges, such ...…”

Association of exogenous factors with the access to innovative pharmaceutical products in Hungary

“…While the place of our research has been confined to Hungary, we consider the findings of our study relevant to many other countries, since the exogenous factors investigated in the frame of this research are by no means exclusive to the Hungarian system of the reimbursement of pharmaceuticals [ 20 , 22 , 23 ]. Regardless of the local setting, it is important to note that policy tools for ensuring access are not mutually exclusive: from a broader, pharmaceutical policy perspective, this research implies that the legal framework of reimbursement decisions, as well as RSAs both play key roles in managing access to innovative products.…”