The Evolution of HTA in Emerging Markets Health-Care ... - TREE

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OHE Consulting Report for PhRMA 5 January 2011 Figure 3. Taiwan Drug Review Process A3.7 Pricing of New Drugs Doherty, et al. (2004) note that there are, at least, three methods used to determine the price of new pharmaceuticals: (1) the international median price of 10 countries, (2) the international price ratio using treatment comparators and (3) the treatment course or daily cost using treatment comparators. Advantages or disadvantages of new products, along the dimensions of efficacy, dosage form and pharmacokinetic profile, are considered in decisions to increase or reduce price. Pharmaceutical companies provide evidence to experts invited by the BNHI and a drug benefit committee. Evidence from RCTs are required (with preference for head-‐to-‐head comparisons of efficacy and safety) whilst submission of pharmacoeconomic evidence is encouraged in 2008. In 2010, a new “Pricing Principles” document was issued by the Bureau of National Health Insurance (BNHI, 2010). A distinction is made between Category I and Category II new drugs, and the reference pricing benchmarks and pricing rules are different for the two categories. For a new drug to be in Category I, drug license holders must justify a “substantial clinical improvement” via head-to-‐head or indirect comparison. Category 2A new drugs exhibit at “moderate improvement, while Category 2B new drugs have similar clinical outcomes as therapeutic reference class products. Category I drugs are priced (i.e., reimbursed) at the median of 10 reference countries (with a 10% premium if a Taiwanese trial of a reasonable scale has been done). The pricing of Category II drugs 100
OHE Consulting Report for PhRMA 5 January 2011 uses a complicated set of rules that has the median reference price as a ceiling, including getting the lowest price among the reference countries. Interestingly, up to a 10% premium might be given for “having pharmacoeconomics results in Taiwan.” According to Doherty, et al. (2004), as of that time, if the estimated market of a new product was expected to exceed NT$100 million per year (New Taiwan dollars), then a price-‐volume negotiation could be considered. The BNHI could negotiate the price of new product with the supplier for 3 years, and at the end of the third year, a pharmacoeconomic study (on Taiwanese populations) would have been conducted and the results of that study used to negotiate a price. If a new product were first introduced into the Taiwan market, the BNHI could request HTA evidence. Pharmacoeconomic evidence could be referenced from overseas literature in cases where there is lack of local data or (physician) experience. Generally speaking, it appeared that HTA, as of that time, had been well embraced by academia, industry and healthcare decision-‐makers in Taiwan (Doherty et al., 2004). This interest in HTA looked ever more appropriate when one considers evidence that drug (reimbursement) price is not the primary driver of increased spending in Taiwan. More recently, however, circumstances have changed. Apparently, the BNHI never actually announced this threshold to the public, and they did not necessarily follow it. Some products with budget impact of less than NT$100million have been required to sign a price-‐volume agreement to enable the drug to be reimbursed. However, BNHI has recently mentioned that they will consider setting a threshold for encouraging or requiring a price-‐volume agreement, maybe higher than NY$100million, but this is not yet decided and announced. Also, with regard to the aim to conduct a pharmacoeconomic study by the end of the 3 year agreement, it is an outdated practice that has not been followed. A3.8 Health Technology Assessment in Taiwan Overview The Division of Health Technology Assessment (DHTA) was established in 2007 as a pilot program in the CDE, a private, not-‐for-‐profit, non-‐governmental organization, and fully sponsored by the Department of Health. The purpose of the HTA group is to support the BNHI by providing evidence-based evaluations of the merits or drawbacks of new healthcare technologies. Currently, there are four types of new drug applications that are sent to the HTA division for review: new chemical entities, new indications, new dosage forms, and new combinations. When the HTA group receives these new drugs for review, they assign each case to 2 experts who search independently for evidence from CADTH (Canada), NICE (United Kingdom), PBAC (Australia), SMC (Scotland), the Cochrane library, PubMed, EMBASE, etc. A typical report is completed and verified within 42 days upon which it is disseminated to the BNHI for the DBC meeting. 101
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The Evolution of HTA in Emerging Markets Health-Care ... - TREE

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