Despite the obvious challenges, it is still abundantly clear that the time for HTA has arrived in the APAC region. Implemented correctly, it will stand not only as key component of cost containment, but also as a pivotal enabler for the efficient use of resources as governments look to provide broader access to affordable healthcare. Joe Caputo, HEOR expert in IMS Health, explains the challenges and opportunities to implement HTA successfully in APAC.

1. Health Technology Assessments
The new face of Asia Pacific and the emerging role of pharma
companies in the future of healthcare
By Joe Caputo, Principal, HEOR and RWE

2. In 1999—more than a decade after Canadian lawmakers introduced legislation designed to help evaluate
the safety and efficiency of healthcare treatments, and seven full years after Australia introduced its own
formal guidelines for pharmaceutical reimbursement—the National Institute for Health and Clinical
Excellence (NICE) was unveiled in England and Wales. As an advisory body, NICE was created “to reduce
variation in the availability and quality of NHS treatments and care” and to “help resolve uncertainty
about which medicines, treatments, procedures and devices represent the best quality care for patients
and the best value for the NHS.” It would soon become one of the most widely discussed health technology
assessment (HTA) programs in the world.
The need to control rising healthcare costs while meeting the demands
of increasing numbers of patients has forced national health authorities
around the world to respond with new cost containment measures.
Much like their western counterparts, Asia-Pacific countries have faced
significant challenges arising from the costs of caring for aging
populations, which are on the rise. In addition, the growing prevalence
of non-communicable diseases, such as cancer and diabetes, has placed a
strain on both government budgets and infrastructures. Difficult questions
have arisen; how, for example, might authorities venture beyond simple,
existing tools and put forward complex tools such as risk-sharing
schemes and HTAs?
HTAs have found advocates in the more mature Asia-Pacific countries
and have set the pace for important change. In South Korea, it was the
economic crisis of 2007/09 that forced the government to create a
national evidence-based healthcare policy. Taiwan, too, has adopted
new HTA measures, and as recently as January of 2012, Thailand
published HTA guidelines that were inspired, in large part, by the work
of NICE and similar European regulatory bodies. Today Japan and China
are joining suit, declaring their intent to develop and implement
pharmacoeconomic assessments.
Without question, passivity is not an option for those in the
pharmaceutical industry. Indeed, now is the time for the industry to
engage with payers and governments in asking the questions that
will positively shape the HTA environment: What priorities will take
precedence in the respective countries? Will transparency trump choice?
Will cost edge out quality? Will patients have a voice? Will they have
sufficient options? And how can, and should, pharmaceutical companies
proactively plan for a changing health environment?
“There’s a healthy, ongoing debate,” says Joe Caputo, HEOR Regional
Principal, Asia Pacific. “The practical issues are many, but there’s a very
real opportunity to become a valued stakeholder as such processes are
implemented across Asia-Pacific.”
One of the most profound dilemmas facing regional and national health
authoritiesinAsia-Pacificcountriesisthebasiclackoftechnicalexpertise,
with many regional authorities needing to look to countries and
organizations with already-developed processes, such as NICE, for
guidance on design and implementation of their HTA processes.
In Thailand, for example, colleagues from the Health Intervention and
Technology Assessment Program (HiTAP) asked NICE for support in
evaluating the performance of their organization. NICE obliged, offering
senior Thai academics and colleagues a chance to review key publications,
reports and data. NICE has played a similarly essential role on behalf
of the Taiwanese Bureau of National Health Insurance and the Center
for Drug Evaluation, which benefited from insights into the NICE
approach for assessing diagnostics and devices and for engaging with
constituents. NICE has additionally supported members of the Taipei HTA
division of the Center for Drug Evaluation and the Bureau of National
Health Insurance (BNHI) and offered insights to the China National
Health Development Research Center (CNHDRC) which has not yet
implemented a process but is eager for technical support.
PARTICIPATING IN THE CONVERSATION
Pharma companies must, of course, do more than just watch and wait.
Caputo urges his clients to seek direct involvement in the development
of the HTA process, especially in those places where the processes and
rules are not entirely finalized. Such conversations can be had either
alone or in concert with industry groups such as the Pharmaceutical
Research and Manufacturers of America in (PhRMA) organization (which
issued an opinion statement in 2012 with regard to HTA in Japan) or
the Pharmaceutical Research and Manufacturers Association of Thailand
(PReMA). “We’ve seen a number of doors open” says Caputo, citing an
invitationextendedtoPReMA members by those developing HTA guidelines
in Thailand as one among many recent examples.
One of the ongoing conversations revolves around the training, or the
funding of training, for HTA experts, which is essential to the successful
implementation of any HTA system. Another critical dialogue involves
the prioritization of technologies for evaluation. In Thailand, HiTAP
currently issues a survey to stakeholders to determine which
technologies should be evaluated. Since the ultimate plan is to
produce a set of criteria that will determine which technologies are
evaluated, such initiatives are important steps toward participating in the
conversation and being heard.
GATHERING THE RIGHT EVIDENCE
Then there’s the challenge surrounding the lack of local data. HTAs simply
do not work as effectively in the absence of local data, and so clinical
data on the local population is needed, particularly in populations in
which genetic differences may result in different levels of treatment
efficacy. Other necessary information is data describing healthcare
resources’ uses and costs. Without such data, countries cannot accurately
evaluate the cost-effectiveness of different treatment options relative
to the current standard of care. Consequently they cannot develop
guidelines and standards that are reliable, or ultimately helpful.
But finding that ‘real-world evidence’ is, even today, tricky. “Local
databases are rare, and even when they do exist they tend not to be
readily available,” admits Caputo. “Invariably the databases are limited

3. in scope, restricted to a particular locality or condition, or offer only a
subset of relevant information, such as diagnosis but no test results.”
Furthermore,sincedataisnottraditionallycollectedforresearchpurposes
it lacks consistent coding, making it all but impossible to combine the
data in ways that would yield an accurate, big-picture view of the scenario.
It’s a reality that reflects the relatively early stage of HTA programs
across the region. Certainly with time greater investments in data will
need to become a top priority.
BETTER DATA. BETTER OUTCOMES.
In the meantime, pharma companies can sponsor and/or fund the
development of new registries and databases that can represent a
win-win for the industry and healthcare providers; data can be used by
industry experts and policy makers alike to better understand the burden
of illness and the impact of treatments on patient outcomes. It can also
be used to help plan better healthcare provisions for patients. “Everyone
benefits from a greater understanding of the impact of disease,” agrees
Caputo.
Unfortunately, efficacy data and preference scores from Asian populations
are generally not available in most cases. Traditionally, therefore, the
responsible party—be it the government, a research institute, or a
pharmaceutical company—has tended to rely on foreign data. However,
this isn’t always the best solution. “It is simply not safe to use foreign
outcomes-related data without modifications, such as possible
variations in genetics among races and medical practice patterns among
countries,” explains Caputo.
Pharma companies, therefore, can play a big role here in researching and
generating such data in conjunction with academic groups and broader
stakeholders. The ultimate goal should be the refinement of the data used
to conduct health technology assessments and, ultimately, to make
decisions. Additionally, pharma companies can play a key role in
educating doctors, pharmacists, hospital management, patients, and
payers. Linking HTA and research findings with policy and practice is
imperative for the successful implementation of any HTA system. Pharma
companiesthereforecanhaveavoiceinpromotingtheroleanduseofHTAs
and can help communicate recommendations to relevant stakeholders
and ultimately help strengthen their own collaborations with HTA
authorities.
Finally,there’sthenever-smallmatteroftransparency.Whatistherationale
for the decisions that are being made? What is the degree of the
decision-maker’s influence? Critics have been outspoken in their concern
over cases in which manufacturers are invited or permitted to submit
pharmacoeconomic data, but never told how the data is actually used.
When the sweeping price cuts that are announced on a regular basis
by health ministers are added into the mix, it is no wonder that the
industry has been left feeling rattled and uneasy. Pharma companies can
play a positive role in this regard by ensuring that the data submitted to
HTA bodies is of the highest caliber, and by demonstrating that pharma
companies can be considered a trusted stakeholder.
CONCLUDING THOUGHTS
Despite the obvious challenges, it is still abundantly clear that the time
for HTA has arrived in the Asia-Pacific region. Implemented correctly, it
will stand not only as a key component of cost containment, but also as
a pivotal enabler for the efficient use of resources as governments look
to provide broader access to affordable healthcare.
And it’s not just the broader policy discussion at stake. It’s the details
and the technicalities that matter. Influencing the acceptable cost-
effectiveness threshold may, for example, be just as important as the
timing of the evaluation. “Pharma companies can’t just sit around and
wait,” concludes Caputo.
“They should be actively looking for opportunities to enter the debate—
preferablypriortothedevelopmentandimplementationofHTAprocesses.
They should be going to the table armed with as much information as
possible, determined to proactively influence the discussion.”
Once the process is implemented, the emphasis must then turn to quality
and presenting best available evidence to promote or defend products in
market. This is where pharma companies have a central role to play in
generating the best possible evidence in order to succeed.
apac.info@imshealth.com
www.imshealth.com/viewpoints/apac

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