PHP21 Adoption of New Medicines in the OECD: Regulation, Innovation and Scale

Abstract

more, regulatory requirements stipulate that a new orphan status application must be submitted for each indication. Under EMA regulations, orphan and nonorphan indications cannot be granted under the same marketing authorization. Although expansions between orphan and non-orphan indications are more common in the US, no examples of expansion from a non-orphan to orphan indication were identified by the authors. CONCLUSIONS: While indication expansion between orphan indications is relatively common, examples of expansion into or out of orphan indications are less frequent due to the regulatory restrictions. Pricing and reimbursement dynamics in all cases are reflective of the trade-offs between price potential and population size across indications. OBJECTIVES:Korea introduced a new positive list system in 2007 together with a price negotiation procedure. Importantly, these two systems are run by two different, independent organizations, namely the Health Insurance Review & Assessment Service (HIRA) and the National Health Insurance Corporation (NHIC). HIRA reviews the cost-effectiveness data in submissions and makes listing decisions, then NHIC takes over and sets the reimbursement price via negotiations with manufacturers. The aim of this study is to compare the difference in price after cost-effectiveness appraisal by HIRA and price negotiation by NHIC, and to analyze the factors that NHIC has considered to determine the reimbursement price. METHODS: All 35 submissions made to the NHIC between August 2007 and June 2008 were reviewed. 19 submissions concluded with agreement, 15 failed and one case was suspended. In this review only 15 cases of successful negotiations were included. The level of the reimbursement price compared to the submitted price for both essential drugs and non-essential ones and factors affecting the final price were analyzed. RESULTS: The discrepancy between reimbursement price and costeffective price was about 12.33Ϯ11.44% on average. For 3 essential drugs, the price level was almost equal to the submitted price whereas the average level was 84.94 Ϯ11.21% of the cost-effective price for non-essential drugs. The major factors affecting negotiations to determine the final price were narrowed down to total cost of substitutes, the foreign price, and the pharmaceutical budget impact. CONCLUSIONS: Our findings have demonstrated that drug pricing within the new environment has been done independently of cost-effectiveness appraisal. The payer has exhibited limited bargaining power for essential drugs. Overall, 87.67% of the cost-effective price was accepted during price negotiations, and the total cost of substitutes, foreign prices and pharmaceutical budget impact were considered equally when fixing the reimbursement price. A limitation of this study is that the result may not be generalized because of insufficient cases. OBJECTIVES:Most OECD countries employ pricing controls to contain rising health care expenditures. The recent financial crisis has resulted in further pressure to A336

Why healthcare market needs government intervention to improve access to essential medicines and healthcare efficiency: a scoping review from pharmaceutical price regulation perspective

“…Delays in adoption reduce the net present value of research & development (R&D) investments by delaying cash flows and shortening the exclusivity period, which has been observed to reduce future R&D outlays and innovation. [ 94,95 ]…”

The Effect of Market-Based Economic Factors on the Adoption of Orphan Drugs Across Multiple Countries

“…14 For example, Dupont and Van Wilder 15 analyzed access to pharmaceutical products using the marker of product reimbursement. Similarly, Varol et al 16 analyzed speed of adoption by measuring product launch date.…”

Health systems futures: The challenges of technology, prevention and insurance

“…The development of new medical devices and pharmaceutical treatments calls into question the relevance of regulation and governmental actions. The latter is exemplified in a new study [30], which characterizes patterns of delay for new molecules from 14 different therapeutic classes in 20 major pharmaceutical markets. As Fig.…”

“…Most analysts agree that the most important factor contributing to the growth in spending in recent decades has been the emergence, adoption, and widespread diffusion of new medical technologies and services [30]. Indeed, the introduction of new treatments, primarily new drugs and the dissemination of knowledge and information on how to prevent certain conditions and surgical procedures in providing care, are large contributors to health care spending [18,22,24].…”

“…Source: Varol et al[30].2008 the correlation between the median number of years of delay and bilateral price indices is negative (the correlation is À0.47 and is significant at the 0.01 level). Findings suggest that delays are longer in lower priced markets thus decisions regarding the pricing of new pharmaceuticals impacts the speed of diffusion and adoption of new technologies.…”