Risk Sharing Agreement Medical Devices

During this discussion, panelists described their individual experiences with value-based care from different sides of an evolving industry. Their conversation not only highlighted the role of expensive specialties in the value-based model, but also discussed measures of progress, program benefits, negative impacts, and potential opportunities for risk sharing during this change. For example, in 2016, Medtronic worked with the Catalan Agency for Health Information, Assessment and Quality to establish a procurement model that could provide more holistic and value-based healthcare to patients who received INNs.10 The agreement included a budget of €10 million for providers who were able to acquire INNs over the course of four years, and resulted in a decrease in outpatient and implant-related visits. Complications of 10%. and increased collaboration between patient care teams. Based on the success of this value-based supply agreement, other suppliers and hospitals in Catalonia are now developing similar contracts. The degree of implementation of risk-sharing agreements in Spain was high, as 90% of stakeholders said they currently have this type of contract with a pharmaceutical company and would like to renew it or sign new ones. Speakers pointed out that the most common risk-sharing arrangements take the form of a price volume. Oncology, neurology, dermatology and infectious diseases were the main medical specialties that benefited from these agreements. Financial unpredictability, depending on the type of agreement The Deloitte report also notes that CMS has not set a precedent for how it pays for medical technologies to support coverage with complementary evidence-based models or new technologies. Mutual benefit risk-sharing agreements are another pricing option that medical device companies offer to get reimbursed. With such agreements, device manufacturers offer financial advantages such as lower product prices compared to alternative devices. At the same time, cost carriers agree to share a mutually agreed percentage of cost savings or revenue gains.

Payers also often have the option of renegotiating the price of a product. Gavious A, Greenberg D, Hammerman A. Impact of a financial risk sharing system on budget impact estimation: a theoretical approach to gambling. Eur J Health Econ. 2014;15(5):553–61. [4] Siemens wins a €132 million contract for medical technology in Spain. Siemens Healthineers. 11 August 2010. Medtronic recently implemented this type of risk-sharing model for its MiniMed insulin pump system, the first closed-loop hybrid system capable of automating the delivery of insulin to patients. Self-regulating insulin pumps, including the MiniMed system, have been shown to improve clinical outcomes and reduce diabetes-related healthcare costs. However, many payers and health insurance companies refuse to cover new technologies for diabetes care, as in most cases patients are already using multiple daily insulin injections and the introduction of new insulin pumps can lead to unnecessary disruptions in care and costs.

Medtronic negotiated a risk-sharing model with Aetna in 2017, under which the MiniMed system was provided at a discounted price in exchange for patient outcome-based payments (e.g. B, the achievement of HbA1c) goals and differences in total cost of care.4 With this model, Medtronic and Aetna are able to share savings from delivering or exceeding clinical outcomes and target costs. Boggild M, Palace J, Barton P, Ben-Shlomo Y, Bregenzer T, Dobson C, Gray R. Multiple Sclerosis Risk Sharing Scheme: Two-year results of the clinical cohort study with historical comparison. Brit Med J. 2009;339(7734):1359–63. Almost all respondents (90%) felt that there was no need to amend existing legislation or adopt new rules to manage price-volume agreements, although the other contracts required new specific rules or only changes (approximately 66% and 20% respectively for payment for efficiency and 64% and 25% respectively for payment for efficiency). Regardless of the nature of the contract, stakeholders felt that these regulations should be national (59%) or regional (61%). Not all devices are created equal.

But how can device manufacturers identify the fruits at hand for risk sharing? The more characteristics a product has associated with successful risk-sharing agreements, the more likely it is that such an agreement will be successful. For example, Figure 1 shows a number of risk-sharing agreements that have been in place since 2015 in two key dimensions: product effectiveness and time spent monitoring expected results. The results are based on clinical trials of the exposed products, including nine prescription drugs (13 agreements[1]) and three medical devices (four agreements[2]). Ideally, a good candidate should have a medium or large effect size and the results should be observable and measurable in about a year. The rectangle of dotted lines in the figure captures the products that match these characteristics. One of the biggest challenges of a values-based system is to identify measurable outcomes that can be used to track success. Disagreements over these measures have indeed been one of the biggest obstacles that have slowed down the adoption of value-based contracts across the country. Measures such as patient satisfaction, value of care, or improvement in quality of life are objectively more difficult to assess than volume performance. Value-based contracts, as they are called, are a type of risk-sharing agreement in which two or more participants from an organization or other business share the financial consequences of a particular risk. In the health sector, this risk can be shared in several ways: in terms of health outcomes as the basis for any type of risk-sharing agreement, 60% of respondents pointed out that overall survival was considered the most influential parameter for signing a contract, followed by progression-free survival (22% of respondents) and quality of life (23% of respondents); other effects such as better patient monitoring, therapeutic response and better access to medicines were mentioned by 18% of participants.

To learn more about risk-sharing agreements in the Spanish context, the objective of this study is to analyze the degree of implementation of risk-sharing agreements and the relevance of several factors that determine their use as perceived by hospital pharmacists responsible for their design and monitoring. In addition, we are also investigating whether risk-sharing agreements can promote the adoption of personalized medicine and vice versa. The results of this analysis clarify the current situation of the introduction of risk-sharing contracts in Spain, as well as the prospects for their future development. The study also highlights the key elements that guide the management of these agreements. There are several examples of medical technology companies that have been successful in securing cost reimbursement through innovative agreements, primarily through the use of outcome-based risk-sharing models. An outcome-based model requires products to achieve specific and timed clinical objectives in order to be eligible for reimbursement. This model can reduce the risk of funding unsuccessful treatments with medical devices and help solve the problem of limited data to support the efficacy and safety of the product when it is launched on the market. With respect to the management effort required to process these contracts when applied to personalized medicine, stakeholders felt that they were the same for price-volume agreements as for conventional medicine; For other types of contracts, however, this effort should be greater.

Zhang H, Zaric GS. Use of price-volume agreements to manage pharmaceutical leaks and off-label promotion. Eur J Health Econ. 2015;16(7):747–61. Growth in value-based payment agreements for medical devices is expected to accelerate as regulatory constraints ease and better analytics are developed to track outcomes, according to a deloitte Center for Health Solutions study released this month. Dunlop WCN, Staufer A, Levy P, Edwards GJ. Innovative agreements on the price of medicines in five European markets: survey of stakeholders` attitudes and experiences. Health policy. 2018;122:528-232. Table 1 shows the importance of certain health and financial variables for each type of agreement, as perceived by emergency departments, which are classified according to the type of agreement signed by their hospital. . .

.