There are a number of challenges in the economic evaluation of medical devices (MDs). They are typically less regulated than pharmaceuticals, and the clinical evidence requirements for market authorization are generally lower. There are also specific characteristics of MDs, such as the device–user interaction (learning curve), the incremental nature of innovation, the dynamic nature of pricing, and the broader organizational impact. Therefore, a number of initiatives need to be taken in order to facilitate the economic evaluation of MDs. First, the regulatory processes for MDs need to be strengthened and more closely aligned to the needs of economic evaluation. Second, the methods of economic evaluation need to be enhanced by improving the analysis of the available clinical data, establishing high-quality clinical registries, and better recognizing MDs’ specific characteristics. Third, the market entry and diffusion of MDs need to be better managed by understanding the key influences on MD diffusion and linking diffusion with cost-effectiveness evidence through the use of performance-based risk-sharing arrangements.
Michael Drummond, Rosanna Tarricone, and Aleksandra Torbica
Pharmaceutical expenditure accounts for approximately 20% of healthcare expenditure across the Organisation for Economic Cooperation and Development (OECD) countries. Pharmaceutical products are regulated in all major global markets primarily to ensure product quality but also to regulate the reimbursed prices of insurance companies and central purchasing authorities that dominate this sector. Price regulation is justified as patent protection, which acts as an incentive to invest in R&D given the difficulties in appropriating the returns to such activity, creates monopoly rights to suppliers. Price regulation does itself reduce the ability of producers’ to recapture the substantial R&D investment costs incurred. Traditional price regulation through Ramsey pricing and yardstick competition is not efficient given the distortionary impact of insurance holdings, which are extensive in this sector and the inherent uncertainties that characterize Research and Development (R&D) activity. A range of other pricing regulations aimed at establishing pharmaceutical reimbursement that covers both dynamic efficiency (tied to R&D incentives) and static efficiency (tied to reducing monopoly rents) have been suggested. These range from cost-plus pricing, to internal and external reference pricing, rate-of-return pricing and, most recently value-based (essential health benefit maximization) pricing. Reimbursed prices reflecting value based pricing are, in some countries, associated with clinical treatment guidelines and cost-effectiveness analysis. Some countries are also requiring or allowing post-launch price regulation thorough a range of patient access agreements based on predefined population health targets and/or financial incentives. There is no simple, single solution to the determination of dynamic and static efficiency in this sector given the uncertainty associated with innovation, the large monopoly interests in the area, the distortionary impact of health insurance and the informational asymmetries that exist across providers and purchasers.
Ching-to Albert Ma and Henry Y. Mak
Health services providers receive payments mostly from private or public insurers rather than patients. Provider incentive problems arise because an insurer misses information about the provider and patients, and has imperfect control over the provider’s treatment, quality, and cost decisions. Different provider payment systems, such as prospective payment, capitation, cost reimbursement, fee-for-service, and value-based payment, generate different treatment quality and cost incentives. The important issue is that a payment system implements an efficient quality-cost outcome if and only if it makes the provider internalize the social benefits and costs of services. Thus, the internalization principle can be used to evaluate payment systems across different settings. The most common payment systems are prospective payment, which pays a fixed price for service rendered, and cost reimbursement, which pays according to costs of service rendered. In a setting where the provider chooses health service quality and cost reduction effort, prospective payment satisfies the internalization principle but cost reimbursement does not. The reason is that prospective payment forces the provider to be responsible for cost, but cost reimbursement relieves the provider of the cost responsibility. Beyond this simple setting, the provider may select patients based on patients’ cost heterogeneity. Then neither prospective payment nor cost reimbursement achieves efficient quality and cost incentives. A mixed system that combines prospective payment and cost reimbursement performs better than each of its components alone. In general, the provider’s preferences and available strategies determine if a payment system may achieve internalization. If the provider is altruistic toward patients, prospective payment can be adjusted to accommodate altruism when the provider’s degree of altruism is known to the insurer. However, when the degree of altruism is unknown, even a mixed system may fail the internalization principle. Also, the internalization principle fails under prospective payment when the provider can upcode patient diagnoses for more favorable prices. Cost reimbursement attenuates the upcoding incentive. Finally, when the provider can choose many qualities, either prospective payment and cost reimbursement should be combined with the insurer’s disclosure on quality and cost information to satisfy the internalization principle. When good healthcare quality is interpreted as a good match between patients and treatments, payment design is to promote good matches. The internalization principle now requires the provider to bear benefits and costs of diagnosis effort and treatment choice. A mixed system may deliver efficient matching incentives. Payment systems necessarily interact with other incentive mechanisms such as patients’ reactions against the provider’s quality choice and other providers’ competitive strategies. Payment systems then become part of organizational incentives.