Health Technology AssessmentsThe new face of Asia Pacific and the emerging role of pharma companies in the future of healthcare

By Joe Caputo, Principal, HEOR and RWE

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 authorities in Asia-Pacific countries is the basic lack of technical expertise, 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 CONVERSATIONPharma 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 invitation extended to PReMA 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

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, since data is not traditionally collected for research purposes 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 companies therefore can have a voice in promoting the role and use of HTAs and can help communicate recommendations to relevant stakeholders and ultimately help strengthen their own collaborations with HTA authorities.

Finally, there’s the never-small matter of transparency. What is the rationale 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 THOUGHTSDespite 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— preferably prior to the development and implementation of HTA processes. 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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