HTAs go global: What it means for market access

Richard Bergstrm, vice-chair of the EFPIAs HTA working group, talks to Peter Mansell about how the pharma industry should respond to the globalization of health technology assessment bodies.

Global problems demand global solutions. The paradox of market access for pharmaceuticals, though, is that it is both a global and a local issue.

The economic, social, cultural and political changes that come with globalization create both opportunities and challenges for the pharmaceutical industry. New markets open up, populations age, disease profiles and healthcare demands shift in line with dietary changes, industrialization or an emerging middle class.

But these trends also put enormous pressure on national healthcare systems, some of which may already be struggling to provide even the most rudimentary coverage.

Balancing cost and value

Geographical expansion and volume growth may compensate to some degree for the increasing difficulty the industry has selling innovation in established markets. At the same time, these newer territories have their own budgets to balance. And ultimately they have to make the same tough decisions about balancing cost and value in healthcare.

As the EU illustrates, regulatory harmonization can achieve something approaching a single market, while pricing and reimbursement of medicines remain firmly a national competence. This is where the critical barriers to access occur. As the worlds borders loosen, the need to rationalize healthcare provision according to national priorities only intensifies.

Nor does the story end with national decision-making. There are local or regional formulary committees, or equivalent health technology assessment (HTA) advisers, insurers and health maintenance organizations to deal with. All of them will be thinking about costs.

In this context, it is not surprising that HTA, already a well-recognized discipline in many countries and one with a growing influence on market access, has taken on a global dimension, in part through bodies such as the International Network of Agencies for Health Technology Assessment (INAHTA).

The HTAs that matter

But for Richard Bergstrm, director-general of the Swedish pharmaceutical industry association, LIF, and vice-chair of the European Federation of Pharmaceutical Industries and Associations (EFPIA) HTA working group, this is not necessarily where industry needs to focus its attention.

The more immediate influence on government policies determining market access comes from bodies such as Health Technology Assessment International (HTAi) or the International Society for Pharmacoeconomics and Outcomes Research, which tend to attract decision-makers from around the world, he suggests.

There is also EUnetHTA, and the Commission is setting up a new HTA network to address provisions in the draft Directive on the application of patients rights in cross-border healthcare.

Actively engaging stakeholders

Bergstrm contrasts the quite passive form of HTA propagated by the INAHTA with the EUnetHTA approach, which has involved actively engaging with stakeholders. Importantly for industry, EUnetHTA has a workstream on relative effectiveness, taking forward one tranche of the recommendations from the EUs multi-stakeholder Pharmaceutical Forum.

These involve a commitment to measures such as common working definitions of drug efficacy, relative efficacy, effectiveness and relative effectiveness, as well as agreed best practice principles for relative effectiveness assessment.

The recommendations also encourage information exchange between member states on relative effectiveness criteria or systems, one function of which would be to facilitate the work of the pricing and reimbursement authorities by providing them with consolidated scientific evidence.

Cost versus therapeutic value

While this makes clear that relative effectiveness assessment and the distribution of healthcare funds are inevitably linked, the High Level Pharmaceutical Forum also acknowledged the distinction between the scientific assessment of the relative effectiveness of medicinal products and health-economic assessments of their costs and benefits.

The aim of relative effectiveness assessment, it added, was to compare healthcare interventions in daily practice and classify them according to their added therapeutic value.

The point, Bergstrm explains, is that cost-effectiveness assessments are very much a business decision tied to local considerations, such as willingness to pay. The scope for harmonizing these models is restricted not just by the political vagaries of healthcare budgeting and national or local demographics, but also by cultural attitudes towards sickness and the state.

For example, Bergstrm says, the solidarity principles underlying healthcare systems in the UK or Sweden mean that, ultimately, healthcare rationing is accepted as a tool for the greater good. But this would never happen in the US or in a country with a number of healthcare systems and a large private market.

The political environment

This is a reality acknowledged by Sir Michael Rawlins, chairman of the UK National Institute for Health and Clinical Excellence (NICE).

Discussing the agencys increasing global influence, he comments: Integrating elements of cost effectiveness into healthcare systems is difficult. Its not a straightforward translation. The technical bit is relatively easy but the political environment is harder to translate. We can explain the what and the how of evaluating technologies, but the why is more complex because social values are different in different countries.

So, while industry cannot afford to ignore attempts to harmonize cost-effectiveness models, the emphasis is more on the context in which you use these, Bergstrm says.

That means accountability, full stakeholder involvement and recognizing the societal perspective, such as whether a product brings wider benefits to carers or the national economy. Economic assessment should be just one component of determining a products value to the local healthcare system, according to Bergstrm.

Meeting the needs of payers

As Bergstrm points out, there is already a lot of soul searching among health economists themselves as to whether models such as the cost per QALY (quality-adjusted life year) system employed by NICE is really a panacea. Their problem is that HTA risks being marginalized unless it adapts to the needs of payers. In the end, Bergstrm suggests, determining cost-effectiveness comes down to a pricing negotiation.

As such, he believes, industry should be looking for smarter ways of working with payers to manage uncertainty about product outcomes, such as the risk-sharing agreements reached in markets such as the UK and Italy. Early experience with this sort of agreement has not been optimal, Bergstrm notes, but it is a way forward as long as the agreements are not constructed in a way that merely transfers risk to industry.

Relative effectiveness

In the meantime, the globalization of HTA is more likely to occur in the relative effectiveness space, Bergstrm suggests. Moreover, this will not be a one shot evaluation but a new paradigm that involves making clinical assessments of a products added value both at launch and through continuous monitoring in the marketplace, in line with existing requirements for risk-management plans.

Bergstrm says he would not be surprised to see global programs for monitoring relative effectiveness in five years time, once the US has its comparative effectiveness provisions in place. Emerging tools such as patient registries will help with the monitoring process, while companies should benefit from early scientific advice, incorporating both regulator and payer perspectives, in the product development process.

But industry still has to be more proactive in shaping these developments, Bergstrm stresses. While it has spent decades communicating with regulators, there has not been much direct interaction with payers.

Pharmaceutical companies accept the need to show added value and that health systems have a right to assess that value, Bergstrm comments. So industry must ensure it understands what payers want.

Equally, though, payers must understand the uncertainties inherent in drug development. We need to be out there talking about it, Bergstrm says.

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