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

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OHE Consulting Report for PhRMA 5 January 2011 Figure 4: DHTA Organization Chart (Source: adapted from -‐ http://www.taspor.org/wp-content/uploads/2010/04/huaxia-‐12.pdf). Yang (2009) reports that the Taiwan Society of Pharmacoeconomics and Outcomes Research (TASPOR) has published a guideline for economic evaluation of health technologies but unlike the KPEG (‘Guidelines for Economic Evaluation of Pharmaceuticals in Korea’), which is the equivalent set of HTA guidelines employed in South Korea, it is not an official guideline. A3.9 Role of HTA At the moment (2010), the BNHI does not mandatorily require evidence for r pharmacoeconomic results from new drug submission; however, it provides an incentive for a manufacturer to conduct local PE study by giving a 10% mark-‐up of the reimbursement price. It is entirely voluntary for manufacturers of health technologies to provide this information. The HTA assessment report will contain the international evidence from the literature or other HTA agencies. If the BNHI needs economic evidence, it asks the CDE. This means under the voluntary HTA scheme run by Taiwan, there is an incentive for manufacturers to submit locally conducted economic evidence to justify a higher reimbursement price. Also, there is a trend toward having HTA play a larger role in the drug review process. In 2010, HTA/CDE held an educational seminar on HTA methodology and asked pharmaceutical companies to conduct systematic reviews. The main driver behind this push toward HTA has been the introduction of new drugs into the NHI formulary: the more important issue is allocative efficiency of health technology adoption decisions (Hsieh and Sloan, 2008). However, Hsieh and Sloan (2008) note that, although adoption of new health technologies puts pressure on healthcare budgets, the estimated benefits (this includes quantified health benefits) far exceed the costs. In a strict economic sense, the adoption of expensive, new health technologies is not necessarily ‘costly’. The issue is not so much about the absolute level of spending on health technologies but on what the money buys. 102
OHE Consulting Report for PhRMA 5 January 2011 HTA would therefore be helpful in determining adoption of health technologies, for which the marginal/incremental health benefits (in monetary terms), exceeds the marginal/incremental costs. A3.10 Future of HTA in Taiwan: Findings and Issues Despite its increased importance in the drug review process, HTA is still currently a pilot project. There are about ten employees to conduct synthesis of evidence and analysis of new drugs. All projects done by DHTA are currently delegated by BNHI, so they are subordinate to the DOH and BNHI. It is, however, financially independent from the BNHI, and aims to make an unbiased, independent assessment of the evidence. According to Jirawattanapisal, et al. (2009), there is no legislative instrument backing the use of HTA in pharmaceutical reimbursement decisions in Taiwan although some progress has been made. In 2007, the Minister of Health established an HTA system under the Centre for Drug Evaluation (CDE). The CDE acts as an adviser to the BNHI – which is the single payer for all beneficiaries – in all matters relating to HTA. The BNHI (specifically the Drug Benefit Committee (DBC) of BNHI) takes consideration of HTA evidence as part of the information arsenal for pharmaceutical reimbursement decision-‐making. The CDE is thus not a healthcare payer as in the case of HIRA (the National Health Insurance Review and Assessment, which is agency within the NHI) in South Korea: it is an independent evaluator. This independence, however, doesn’t guarantee complete lack of bias: HTA deliberations and discussions are not made public in Taiwan. Few people outside of the BNHI and DBC members have access to their reports. (It is the BNHI’s decision not to disclose the assessment report, not the HTA group.) Currently, the new law regarding the “second generation” of NHI is under review in the legislative Yuan, and is expected to be completed in early December of 2010. There are two clauses related to HTA. First, it states that BNHI “can” conduct HTA analysis in appraising new drug as opposed to stating that they “should”; this clause has not yet been approved, which means that HTA’s function or role is still not specified in the new law. The second clause was approved and stipulates the following: if the BNHI cannot complete HTA analysis on a new drug within 90 days of the submission, the BNHI has to directly accept the inclusion of new drug in the reimbursement list. There can be no delay in the approval process due to tardiness from an HTA report. It is noteworthy that the HTA assessment report for BNHI has been completed within 42 days since the beginning, and has never been delayed. The decision on reimbursement and pricing is by DBC, so that is the reason for any delay. The HTA assessment report does not recommend the listing and pricing: it is given to the appraisal committee members to review before the DBC meeting, and they make the recommendation. The BNHI spends about 25% of its budget on drugs. However, this important statistic is somewhat misleading. The fact that the reimbursement level is higher than the acquisition cost means that providers are paid more by government than the amount they pay to purchase the drugs. This gives them an incentive to prescribe more. Understanding the role that HTA will, can, or should play in Taiwan requires an appreciation of the fact that a centralized health care system can behave as a monopsony buyer, negotiating in the case of innovative branded drugs with a monopoly seller-‐-‐the manufacturer. The price outcome of such a “bilateral monopoly” negotiation is indeterminate (in terms of its relation to marginal cost), 103
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The Evolution of HTA in Emerging Markets Health-Care ... - TREE

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