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

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OHE Consulting Report for PhRMA 5 January 2011 to implement systems similar to other countries. The project has not really gained much traction because the government already has tools—reference pricing and price surveillance—for controlling drug prices. It would be good if HTA could be used to establish efficient disease management or guidelines. But Taiwan needs more time to develop a consensus on how to use HTA. There are ongoing hearings on a new public law. The patient stakeholder group seems to support HTA as a rational process; however, they don’t seem to realize that it is more likely that it will be used to reduce access to new expensive, but innovative drugs. The generic drug industry is robust in Taiwan and doubts that the research-‐based industry will support HTA. This is because there is pressure on the BNHI to provide access to new breakthrough drugs, and the current median-‐based external reference pricing (with a basket of 10 countries) provides a reasonable price (from their perspective) for these drugs. The generic industry would favour HTA for these drugs because it is likely to reduce prices on branded drugs and allow more money for generics. They would also favour creating greater independence of the HTA unit from the CDE. The use of drugs is driven by the profit margin—the difference between what the NHI reimburses and what the acquisition cost from wholesalers. The generic industry is concerned about opening the market to generics made in China. Academic View Academic interviewees commented that, currently, Taiwan does not really have HTA. The only guideline is from ISPOR in Taiwan: there is no official government guideline. Neither the BNHI nor the DHTA unit in the CDE is lobbying strongly for a greater role for HTA. They do not really seem to want to be accountable to the public. DHTA currently conducts literature review and summarizes the evidence from other countries as outlined above; it does not do a local pharmacoeconomic analysis. Knowledge about this process is very limited and manufacturers have no access to this report and no opportunity to challenge it. If properly set up, HTA could help to provide a better, efficient resource allocation of health care resources. The BNHI currently exploits its monopsony power. HTA is a rational policy, and should be applied to all drugs, not just new ones. But BNHI only worries about the financial costs, and does not pay much attention to efficiency, i.e., health gain for the money spent. Reform of the NHI is under discussion but the focus is on finance and the insurance premium, not HTA. The current working on HTA is vague: the BNHI could apply it in the appraisal and pricing of new drugs. The public representatives support it as a rational and scientific approach that would also help to combat bureaucracy and corruption. 112
OHE Consulting Report for PhRMA 5 January 2011 Government View Government interviewees commented that the CDE will not rely heavily on the HTA review report. Indeed, the pilot HTA project (the DHTA) will be folded into the BNHI in the future. BNHI has other strategies for cost control, and this HTA appraisal is not necessary for that. Budget impact is the major concern. Approval and price negotiation are separate steps, and the latter step can take significant time, and drugs sometimes fail to be approved for reimbursement list. CDE is an independent assessment body and is not heavily influenced by the BNHI. Access to expensive life-‐saving drugs is supported in many cases. CDE is, however, not free to disseminate the HTA report, and sometimes CDE members question the quality of these reports, according to interviewees. Manufacturers and patient groups both have a one-‐time opportunity to participate in a DBC, but for appealed cases only, not for the first review. DBC finds time consuming to have a presentation from the manufacturers at the meeting, even for 10 minutes presentation only. Presenters get many questions from the committee members, and this ends up taking longer. Although the DOH currently funds the DHTA, they respond to requests from the BNHI. They have been internalized by the BNHI, playing a constructive role in the communication between BNHI and the industry on the submission of new drugs for listing. Comprehensive HTA in Taiwan seems unlikely in the future since the current pilot is operating quite well. Also, it would be difficult to spin off as an independent agency. Although HTA may eventually cover more than new drugs, there is little reason to review devices that are covered by virtue by being embedded in DRG payments. BNHI recently decided to make HTA summaries available to the public. Neither the government nor the companies are in favour of full public dissemination of the HTA review. Manufacturers know the information sources and processes, and can ask the CDE if they have a question. The HTA review is based on the reviews in three other countries and other database searches and focuses on indications that the company applied for. DHTA has produced meta-‐analysis guidelines and is asking manufacturers to conduct them and make a submission. 113
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The Evolution of HTA in Emerging Markets Health-Care ... - TREE

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