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

OHE Consulting Report for PhRMA
5 January 2011
Whilst MoHRSS does not have price setting power, which is reserved for NDRC, it can work on the
drug procurement process. Traditionally, there is a 35% -­‐ 50% mark up between the manufacturer's
wholesale price and the retail price, and drugs typically go through many "middle men" wholesalers
before finally reaching the pharmacy department in hospitals. The EDL arrangements include
Provincial procurement to replace individual hospital buying.
A2.6 The role of HTA in China
Chen, Banta and Tang (2009) note that there has been, in China, a long interest in the adoption of
HTA dating back to the 1980’s when The World Bank gave strong encouragement for its adoption.
However, there seems to be no clear path for the implementation of HTA in China (nor does it seem
to be a priority for decision-­‐makers).
Doherty, et al (2004) reports that HTA is rarely used in either the public or private sectors as
pharmaceutical policy and medical decision-­‐making is still based on traditional approaches of
establishing efficacy, safety and quality, and then using cost-­‐based price controls. The authors note
that a survey of HTA literature on China showed that researchers in government agencies or industry
did not seem to play much role in the conduct of the studies identified. Studies were conducted by
independent academic groups.
Tarn, et al (2008) noted that pharmacoeconomics is a newly developed discipline in China and a
systematic review of 380 pharmacoeconomics and outcome research articles relating to China
showed that approaches and methods for conducting HTA are not standardized. The authors also
report that pharmacoeconomic data have not been widely used in management of hospital
formularies. However, whilst pharmacoeconomic data have not been used as a decision-­‐making
criterion in China, as we noted above, an increasing number of (international) pharmaceutical
companies in China have started using pharmacoeconomic evaluations as supportive evidence in
drug reimbursement applications, and in marketing activity.
The use of HTA is conceptually accepted in government’s documents (for example documents from
the NRDC, MoHRSS and MoH) but nothing has been outlined as to the specifics of HTA. Academics
have been active in proposing a formal guideline, and in 2005 some general principles for HTA were
put forward by the Chinese Medical Doctor Association. In 2008, a Pharmacoeconomics Specialist
Committee was formed, which is charged with the task of updating the principles and pushing it into
the policy making arena. More recently, in late 2010, we understand that revised guidelines
developed at Peking University have been circulated, and a number of stakeholders including some
government agencies and officials have been involved in discussions about them. HTA, in China, is
therefore not formally conducted in a systematic fashion and therefore there is no formal
arrangement for the financing of HTA. Currently HTA projects are sponsored by manufacturers on a
small scale and the use of HTA is limited and based on short study horizons. Many HTA projects are
organised by drug manufacturers through contracts with academia, with outputs for ‘internal’
company use.
The MoH considers cost-­‐effectiveness and HTA analysis as part of its modus operatus. The MoH has
signed a Memorandum of Understanding (MoU) with the UK National Institute for Health and
Clinical Excellence (NICE). According to the NICE web site “with UK Department for International
Development (DFID), WHO and World Bank support, NICE is looking to help the MoH build capacity
(institutional and technical) and to pilot the development/adaptation of evidence informed clinical
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