Value-Based Arrangements May Be More Prevalent Than Assumed

ABSTRACT

Objectives: To better understand the prevalence of US value-based payment arrangements (VBAs), their characteristics, and the factors that facilitate their success or act as barriers to their implementation.

Study Design: Surveys were administered to a convenience sample of subject matter experts who were senior representatives from payer organizations and biopharmaceutical manufacturers. These data were supplemented with qualitative interviews in a subsample of survey respondents.

Methods: Descriptive statistics, including percentages for categorical values and mean (SD) and median (interquartile range) for continuous variables, were assessed for quantitative questions. Trained reviewers collated responses to free-text survey questions and the qualitative interviews to identify themes.

Results: Of the 25 respondents, 1 manufacturer and 4 payers reported not having explored or negotiated any VBAs. Subsequently, questionnaire results from 11 biopharmaceutical manufacturers and 9 payers who had experience with VBAs were analyzed. More than 70% of VBAs implemented between 2014 and 2017 were not publicly disclosed. Furthermore, although consideration of VBAs as a coverage and payment tool is increasing, VBA implementation is relatively low, with manufacturers and payers reporting that approximately 33% and 60% of early dialogues translate into signed VBA contracts, respectively. Respondents’ reasoning for VBA negotiation process breakdowns generally differed by sector and reflected each sector’s respective priorities.

Conclusions: This study reveals that the majority of VBAs are not publicly disclosed, which could underestimate their true prevalence and impact. Given the effort required to implement a VBA, future arrangements would likely benefit from a framework or other evaluative tool to help assess VBA pursuit desirability and guide the negotiation and implementation process.

Am J Manag Care. 2019;25(2):70-76Takeaway Points

Little information is publicly available about the number and characteristics of value-based payment arrangements (VBAs) between biopharmaceutical manufacturers and payers, as well as the underlying reasons organizations do or do not enter these arrangements.

• Previous estimates of VBAs, using only publicly available data, likely underestimate how many VBAs are currently being implemented.
• Given the effort required to implement a VBA, future arrangements would likely benefit from a framework or other evaluative tool to help assess VBA pursuit desirability and guide the negotiation and implementation process.

The US health system faces increasing pressure to improve patient access to highly effective, yet costly, therapies. In line with the broader policy shift toward alternative payment models for healthcare delivery, there is ongoing interest amongpayers and manufacturers in exploring value-based payment arrangements (VBAs) for pharmaceuticals and medical devices. VBAs, also referred to as “outcomes-based contracts,” “performance-based contracts,” or “risk-sharing agreements,” link coverage, reimbursement, or payment for a product to a prespecified clinical or financial/utilization outcome or set of outcomes. VBAs can include contractual arrangements among manufacturers, payers, and providers to achieve these aims. For example, such arrangements could entail a rebate provided by the manufacturer to the payer when a drug or device does not perform as expected.¹ VBAs have been discussed in the media and in the academic literature for drugs that treat hyperlipidemia, chronic heart failure, rheumatoid arthritis, and osteoporosis, among others.^2-4

Despite growing interest in and discussion of VBAs, there is relatively limited information currently available on the extent to which these arrangements are being pursued. A lack of public knowledge of these arrangements could (1) underestimate their use in the market and (2) limit what could potentially be learned from current experience that would advance the design and implementation of successful VBAs in the future. Recent research based on publicly available information suggests that a relatively small number of VBAs have been implemented in the United States (approximately 26), pointing to a range of contractual, procedural, and regulatory barriers that could impede their pursuit and implementation.^3,4 Another study found that among 35 payers and 30 manufacturers, the average numbers of total pending/executed VBAs were 5.1 and 3.5, respectively, between 2012 and 2017.⁵ This study aimed to better understand VBAs in the United States, including both public and nonpublic arrangements, with a particular focus on gaining insights into their negotiation, operationalization, and impeding or success factors from the perspectives of manufacturers and payers.

METHODS

Study Participants

This study used 2 data sources: an online survey and in-depth qualitative interviews. Target survey participants were subject matter experts from a cross-section of payer and biopharmaceutical companies and were identified through a snowball sampling technique based on existing working relationships, recommendations from others within the field, and internet searches. Senior representatives from 38 payer organizations and 37 biopharmaceutical manufactures were invited to participate between September 2017 and January 2018. Of those invited to participate, 26 representatives (13 each from biopharmaceutical and payer organizations) agreed to participate in the survey (response rate, 35%). Respondents were contacted for clarification when necessary to ensure validity of responses. Subsequently, 1 biopharmaceutical company’s responses were excluded due to a lack of response consistency, resulting in 25 analyzed respondents. Qualitative interviews, conducted with a subsample of survey participants, included 3 payers and 5 manufacturers. Study participants were not compensated for their participation.

Data Collection

First, we conducted an online survey using Qualtrics (eAppendix A [eAppendices available at ajmc.com]). This survey, informed by a literature review and expert opinion, was designed to assess the key characteristics and proportion of public and nonpublic VBAs pursued between 2014 and 2017, as well as the factors that led to successful or, alternatively, challenged arrangement implementation. To guide exploration of VBA pursuit, we developed a process map describing 4 phases whereby manufacturers and payers (or providers) negotiate the terms of the arrangement, including (1) internal assessment and information gathering, (2) early dialogue, (3) formal negotiation, and (4) contract implementation (eAppendix B). The process map and the survey were piloted and refined based on feedback from 5 experts representing both payer and biopharmaceutical organizations. Second, we conducted in-depth qualitative interviews with a subsample of survey respondents to expound upon key survey findings and address any gaps in information collected in the first phase of the study.

Data Analysis

Descriptive statistics were assessed for each survey question by sector, including percentages for categorical values and mean (SD) and median (interquartile range) for continuous variables. A trained senior researcher (E.R.) collated responses to free-text survey questions and the qualitative interviews to identify key themes and substantiate main findings from the quantitative analysis, which were then vetted by the research team.

RESULTS

Respondent Characteristics

Of the 25 respondents, 1 manufacturer and 4 payers reported not having explored or negotiated any VBAs. Subsequently, questionnaire results from 11 biopharmaceutical manufacturers and 9 payers who had experience with VBAs were analyzed. Manufacturer respondents included 9 large firms (≥10,000 employees and annual revenues higher than $15 billion) and 2 medium-sized firms (5000-10,000 employees and revenues between $2 billion and $10 billion). Payer respondents included 1 single-state payer, 2 regional payers, and 4 national payers covering approximately 76 million lives. Of these payers, 6 offered both commercial and Medicare Advantage plans, and 1 was a public insurance contractor. There were also 2 pharmacy benefit managers covering an estimated 103 million lives.

Existing VBA Landscape

Manufacturer and payer respondents reported implementing (phase 4) a total of 88 and 122 VBAs since 2014, respectively. However, there was considerable within-group variation in terms of the number of VBAs per firm, with manufacturers ranging from 1 to 15 implemented contracts (median of 9 contracts) and payers ranging from 1 to 40 implemented VBAs (median of 11 contracts) (Figure 1). Manufacturers and payers also reported that a majority of their company’s VBAs are not publicly disclosed (74% among manufacturers and 71% among payers). Additionally, 5 manufacturer and 2 payer respondents reported that none of their company’s VBAs are publicly disclosed (Figure 2). Respondents reported that laboratory value, medical encounter (eg, hospitalization rate/duration), financial, and drug utilization measures are the most common outcomes used in VBAs, whereas the most common payment mechanisms involved the manufacturer paying some portion of supportive product costs or providing a larger rebate or full refund to the payer if target outcomes were not achieved (Table).

Both payer and manufacturer respondents also highlighted that there were no preferred therapeutic areas for VBAs, but rather that several factors make certain therapeutic areas (eg, asthma, cardiovascular disease, multiple sclerosis, hepatitis C, and diabetes) prime for VBAs, including validated and easily measured outcomes, uncertain value for high-cost products, limited competition, and availability of a diagnostic tool (eg, genetic testing) (results not displayed).

Direct provider engagement in VBAs is limited to date; only 3 manufacturers and 1 payer reported having engaged providers directly (eAppendix B). However, 91% of manufacturers and 78% of payers believe that incorporating providers is important for the future success of VBAs. Only 1 payer and 1 manufacturer reported that they have implemented a VBA in which a patient is reimbursed out-of-pocket costs for outcome failure. In contrast, patient adherence was a VBA component used by all payers and all but 1 manufacturer. Patient adherence was most commonly incorporated into VBAs by manufacturers and payers through patient selection (VBA only includes patients who have met a certain level of adherence) (55% and 63%, respectively), outcome terms (payment is explicitly tied to improvements in adherence [eg, proportion of days covered, medication possession ratio, and discontinuation]) (27% and 25%, respectively), and payment trigger (outcomes-based component does not take effect unless a certain adherence rate is achieved in the patient population) (18% and 38%, respectively).

Characterizing the VBA Negotiation and Implementation Process

The number of VBAs by sector in each stage of the negotiation and implementation process is detailed in the Table. The attrition rate across stages was high for both sectors. Manufacturers reported that only about one-third of the early dialogues conducted (ie, where 2 parties come together to informally discuss a potential arrangement) ultimately resulted in contract implementation. Payers reported that about 60% of the early dialogues with manufacturers resulted in VBA implementation.

Understanding VBA Negotiation Breakdown and Success

Respondents’ reasoning for VBA negotiation process breakdowns generally differed by sector and reflected each sector’s respective priorities (Figure 3). For example, manufacturers cited challenges related to data collection and evidence development (73%), the availability of appropriate outcome measures (64%), and implementation costs (64%) as major reasons for negotiation failure, whereas payers cited disagreement over incentive mechanisms tying payment to outcome (56%) and financial terms associated with the arrangement (67%). Both groups (64% of manufacturers and 78% of payers) cited Medicaid Best Price (generally, that a manufacturer must offer Medicaid programs the lowest or “best price” based on what is available to other purchasers) as a major reason for negotiation failure.⁶ In their top 5 negotiation success factors, both manufacturers and payers identified (1) the availability of measurable outcomes clearly tied to product use (82% and 100%, respectively), (2) a target patient population that is easily identified in claims (73% and 63%, respectively), and (3) a reasonable administrative burden (45% and 38%, respectively) (Figure 4). Manufacturers also prioritized having partners with the necessary data collection and analysis capabilities (91%), whereas payers emphasized the potential for high budget impact (75%) and having a reasonable data collection and analysis time frame (63%).

DISCUSSION

This study aimed to gain a better understanding of the prevalence and characteristics of public and nonpublic VBAs and to assess where in the negotiation and/or implementation process these arrangements fail and why. Importantly, we found that VBAs are far more prevalent in the United States than previously estimated, based on our sample of respondents. Manufacturer and payer respondents in our convenience sample reported having implemented (phase 4) a total of 88 and 122 VBAs, respectively, between 2014 and 2017. Significant variation in the number of contracts reported by each company was observed, suggesting that some companies may have more success than others in navigating the complexities of these arrangements. Both payer and manufacturer respondents reported that a majority of these contracts are not publicly known. This demonstrates that a substantial proportion of the activity related to tying payment to outcome measures is happening behind the scenes, which should be considered when evaluating the uptake and success of the broader movement to tie payment to value. However, when contemplating policy decisions associated with value-based payment, it is also important to contextualize the magnitude and potential of VBAs compared with more traditional payer—manufacturer contracts such as rebates (eg, success of VBAs in addressing health spending if they represent only a small proportion of overall contracts).

Follow-up interviews with payers and manufacturers suggested that publicizing VBAs can be beneficial, allowing a company to signal to customers and the public at large that value is an important issue for them, that they are at the forefront of the drug pricing debate, and that they have credibility and enough experience to advance value-based payment discussion and policies. However, the high proportion of nonpublic agreements indicates that many companies believe that the risks associated with publicly announcing a VBA, such as exposure to public scrutiny or yielding competitive advantage, outweigh the benefits. Additionally, contracts between manufacturers and payers are not typically publicly announced, and companies may be unwilling to challenge this norm.

Based on our analysis, successful VBAs—in which initial discussions between interested parties resulted in implementation of an arrangement—possess a range of similar characteristics, namely the availability and measurability of outcomes, uncertain value for high-cost products, and clear patient identification (eg, diagnostic tools), which have been corroborated in previous studies.^3,7,8 The considerable discrepancy in the reported proportion of early dialogues that ultimately led to contract implementation between the 2 sectors was surprising, and it is unclear why payers report a higher rate of negotiation success. This could be due to certain limitations of our study, detailed later, or differences in interpreting negotiation success, but it could also reflect the relative importance of payer buy-in to achieve VBA implementation.

Although many contracts have indeed been implemented to date, this study underscores the significant effort required to successfully progress through all 4 VBA process phases. Manufacturers and payers reported that approximately 67% and 40% of early dialogues, respectively, do not reach implementation. Next, we discuss a number of major barriers that were highlighted that impede successful negotiation and implementation of VBAs, supporting previous findings.^3-14

First, both payers and manufacturers mentioned the need for clarification, and potential reform, of certain legislation and regulation, most notably the Medicaid Drug Rebate Program’s Best Price calculation requirement.⁶ Second, both payers and manufacturers indicated that data collection and analysis issues pose a significant challenge to VBA implementation due to a lack of data infrastructure, which could be addressed through common data standard principles to allow for not only interoperability across platforms for data of the same type (eg, electronic health record [EHR] data) for aggregation, but also linking across data types (eg, EHR, laboratory, and claims data).^3-5,10-13,15 Notably, in the follow-up interviews, all respondents predicted that enhanced data sharing/analytic capabilities would result in not only more VBAs, but also more sophisticated arrangements. In the interim, and perhaps even as more advanced evidence-generation capabilities exist, respondents emphasized that contracts should be designed as simply as possible, including the data collected, outcomes measured, time horizon, and contract terms (eg, payment structure). Third, aligning with prior studies, follow-up interviews revealed that a lack of trust and understanding between payers and manufacturers can impede the negotiation process, particularly disagreement resolution.^7,9 As a result, stakeholders often partner with organizations with which they have a history of positive, successful relationships to mitigate this risk. In new partnerships, it is essential to establish mutual trust by being transparent with regard to respective goals, notably in the early negotiation stage, which may be facilitated by using frequent communications.¹² Additionally, to enhance trust, partners may consider either working with a third party to research, design, implement, and validate the VBA, or involving a greater range of stakeholders.^7,8,12 For example, we found that most VBAs are between a payer and a manufacturer, with limited provider and patient partnerships. Increased provider engagement may enhance shared accountability and data measurement, but it could also introduce conflicts between new and existing provider-risk agreements, including alternative payment models, as well as add complexities to the contract negotiation process due to lack of medical benefit/pharmacy benefit integration.

Although patient adherence was frequently used as a VBA component (eg, for patient selection), follow-up interviews suggest that there is uncertainty about whether VBAs improve patient outcomes or benefit patients more broadly, at least in terms of how they are currently designed and executed. For instance, existing VBAs appear to rarely integrate patient-reported outcomes and/or incorporate avenues for patients to share in any savings associated with the arrangement. Greater patient involvement could perhaps address this concern and align with broader efforts to mitigate high patient out-of-pocket costs. As an example, United Healthcare/OptumRx, CVS Caremark, and Express Scripts publicly announced recently that rebates would be directly shared with certain beneficiaries at the point of sale.^16-19

Overall, this study suggests that the VBA process is complex, requiring different points of alignment to successfully progress throughout all 4 of the suggested phases. As investment in these contracts by payers and manufacturers continues to increase, further research is needed to understand the scope, processes, and impact of VBAs. The study also highlights additional areas for future research, including the development and collection of VBA outcome measures, incentive mechanisms for participation, and the potential feasibility and impact of provider and patient incorporation into VBAs. However, focusing solely on publicly known VBAs greatly underestimates their prevalence and potential impact in the market, highlighting the need for research on all VBAs in a manner such that organizations can be transparent without disclosing confidential information. More transparent information exchange may also enhance trust among involved stakeholders and broaden participation in VBAs to providers and patients, where warranted. Additionally, more open discourse could help navigate the potential for overlapping contracts to enhance potential collaboration and efficiency of value-based payments.

Considering the various barriers along the path to implementation, it may also be beneficial to develop a tool or guidance document that can help manufacturers and payers assess the desirability of pursuing a VBA and optimize the difficult negotiation process. In particular, such a planning or evaluation tool could outline key components of a VBA (eg, technology characteristics, data collection and outcome measurement plan, level of risk) to consider at different phases of the process, with a view to highlight those features known to facilitate success. Furthermore, given the current diversity in VBAs, including how they are defined and conceptualized, a guidance document or the like could support greater consistency and quality across arrangements, reduce administrative burden, and increase adoption of VBAs throughout the healthcare system. As more information on VBAs becomes publicly available, such a tool or guidance can be refined and/or expanded to accommodate different types of VBAs.

Strengths and Limitations

Although there are several strengths to this study—including that it is the first study, to our knowledge, that focuses on understanding the extent to which these arrangements are being fully disclosed to the public and made transparent —there are limitations. Generalizability of these results may be limited because the questionnaire was administered to a small convenience sample with a low response rate, and the follow-up interviews were conducted on a selection of this sample. Next, although we provided a definition of VBAs and a framework for the negotiation and implementation process, there may be heterogeneity in respondents’ interpretations. Additionally, the questionnaire collected information only on newer VBAs administered from 2014 to 2017 to provide a feasible and realistic range for respondent recall. However, given that we collected information only from 2014 to 2017, we likely have not captured the full trajectory of previous or impending VBAs. Finally, the extent to which there was overlap between the contracts reported by manufacturers and the contracts reported by payers is unknown. To address this limitation, we surveyed a sample of both payers and manufacturers independently to cross-check validity and corroborate responses.

CONCLUSIONS

As VBAs are still broadly in the experimental stage, their ability to deliver on their promise (ie, increased value and/or improved patient outcomes) is yet to be determined. However, it is important to recognize the progress made in transitioning from volume- to value-based payment. This study reveals that the majority of VBAs are not publicly disclosed. Focusing solely on publicly known VBAs greatly underestimates the prevalence and potential impact of these arrangements in the market, highlighting the need for research on the proportion of VBAs among more traditional rebate contracts in a manner such that organizations can be transparent without disclosing confidential information. Although many negotiations never lead to a signed agreement, pursuit of these arrangements increasingly occurs between payers and manufacturers, highlighting that value considerations are being incorporated into stakeholder decision making. Our study identified several opportunities to address outstanding barriers to VBAs and further accelerate the transition toward value-based payment for biopharmaceuticals. Given the amount of work required, future negotiations would likely benefit from a framework or other evaluative tool that can help manufacturers and payers to assess the desirability and feasibility of pursuing a VBA for a product.Author Affiliations: Duke-Margolis Center for Health Policy, Washington, DC (NM, ER, GWD, JQ), and Durham, NC (CS, HC, MM); UNC Eshelman School of Pharmacy (NM), Chapel Hill, NC; National Pharmaceutical Council (LB, KW, RWD), Washington, DC.

Source of Funding: This work was funded by the National Pharmaceutical Council.

Author Disclosures: Dr Mahendraratnam was a University of North Carolina—Bristol Myers Squibb Worldwide Health Economics and Outcomes Predoctoral Fellow during the completion of this work. Dr Daniel receives consulting fees from AbbVie. Ms Buelt, Ms Westrich, and Dr Dubois are employees of the National Pharmaceutical Council, a policy research organization supported by the major research-based pharmaceutical companies in the United States. Dr McClellan is a board member of Johnson & Johnson, Cigna, and Alignment Health Care, LLC. The remaining authors report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Authorship Information: Concept and design (NM, CS, GWD, LB, KW, JQ, HC, MM, RWD); acquisition of data (ER, GWD, JQ, HC, MM); analysis and interpretation of data (NM, CS, ER, GWD, LB, KW, JQ, MM); drafting of the manuscript (NM, ER, GWD, LB, KW, JQ, MM, RWD); critical revision of the manuscript for important intellectual content (CS, GWD, LB, KW, JQ, MM, RWD); statistical analysis (NM, JQ); provision of patients or study materials (MM); obtaining funding (GWD, MM); administrative, technical, or logistic support (JQ, HC, MM); and supervision (GWD, KW, MM).

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