http://healthaffairs.org/blog/2016/11/04/regulatory-legal-uncertainties-are-barriers-to-value-based-agreements-for-drugs/

The past several years have seen an increasing number of new and innovative therapies entering the drug market. Many of these are precision medicines developed to treat a narrowly defined patient population, often with a previously unmet need. These treatments have demonstrated success in improving quality of life and other important health outcomes among indicated patients in clinical trials, but there is uncertainty about patient response rates in real-world settings. These uncertainties have led payers to express concerns about the costs of some new medicines and to implement policies to control patients’ access to those medicines, such as higher cost sharing, health technology assessments, and step therapy (which requires patients to try certain, often less expensive medications before progressing to costlier drugs). This creates a potential problem, as delays in receiving health care, whether due to step therapy or other factors, can be detrimental to patient health outcomes.

Performance-based risk-sharing arrangements (PBRSAs) and value-based agreements (VBAs) have received attention of late because of the flexibility they give private payers, providers, and biopharmaceutical companies to better understand the value of new medicines and align payment with it. By tying payment to real-world outcomes, these arrangements—collectively referred to in this post as VBAs—have the potential to support patients’ prompt and affordable access to new, innovative treatments while also addressing payers’ cost concerns.

Despite considerable interest from stakeholders on both sides of the negotiations, there were few successful examples of VBAs in the U.S. until very recently: Between 1993 and 2013, there were fewer than 20 VBAs executed in the U.S. However, more of these arrangements have recently been announced, although they remain rare, and payers are expressing increased interest.

The academic literature provides information about some of the existing agreements and suggests possible barriers to their execution, but it leaves many questions unanswered. We conducted two-part interviews with a group of five stakeholders regarding their experience with these types of contracts. All respondents had direct experience developing and negotiating VBAs, four as representatives of private insurers and pharmacy benefit managers, and one on behalf of a large pharmaceutical firm launching branded products.

The interviews focused on respondents’ overall perceptions and expectations of VBAs, barriers to adoption, and possible solutions to those barriers (see note 1). In order to solicit unbiased responses, the interviews were double blinded: the sponsor of the research was not revealed to interviewees, and the identity of respondents is not known by the sponsor. We conducted the initial interviews during the summer of 2015 and followed up with the respondents this fall (2016) to understand how perception of VBAs and the barriers to them may have shifted.