Health economics data and market access

Peter Mansell reports on how pharmacoeconomics can help define data requirements to match market access plans.

Peter Mansell reports on how pharmacoeconomics can help define data requirements to match market access plans.

It may be intensely frustrating for a company that has worked for years to develop a drug with demonstrable clinical advantages, but these advantages may not always convince as societal benefits when it comes to the allocation of finite healthcare resources and priority-setting by payers.

Since in most healthcare systems the pharmaceutical industry is not in a position to ask the patient directly what is worth paying for, it is essential companies learn to tell the right story and draw the relevant stakeholders into that story. This calls for pharmacoeconomics with a marketing mindset.

Pharmacoecomics and the marketers mindset

Pharmacoecomics may come across as a rather dry, rational discipline. Yet it still needs to be approached with a marketers mindset recognizing, above all, that there is no single customer but rather an assortment of stakeholders, driven by distinctly local needs, priorities and financial incentives.

Moreover, this range of customers and needs may vary from country to country. In the end, there is no status quo: an environmental scan in early-phase development may produce findings that are no longer relevant by the time of launch. Developing market mechanisms continuously alter the payer environment.

What is your market access strategy? Thats the question consultant Eline Kogels invariably ends up asking pharmaceutical companies that need to work up some health economics or market access data.

What's your strategy?

Kogels point is that, while the need for extra clinical and health economic data as input to secure reimbursement or a place on the local formulary may be beyond dispute, there is no future in tossing out new data and hoping it sticks. Apart from anything else, that can be a very expensive waste of time and resources. First, you must have a strategic plan that defines data requirements to match the market access approach.

A properly informed strategy will be able to address these needs from the customers perspective. And there may be a considerable gap to bridge. For example, notes Kogels, founder of Kogels Consultancy Network, it may make perfect commercial sense for a new drug to debut with its biggest indication.

From a market access viewpoint, though, this may be the worst possible approach, one that risks alienating payers and other stakeholders over the long term due to budgetary impact in isolation from any clinical benefits. You dont always get a second chance, Kogels warns.

Alternatively, some companies prefer to focus on a subset of patients for the purposes of securing reimbursement, then to expand the indication profile subsequently with new data in the marketplace. But this strategy may backfire if the regulator asks for more specific evidence from the sub-group, while all of the available core data are geared to the large indication the company is ultimately pursuing.

Know the local systems

Other factors companies need to take into account include:

data accumulated on the product so far, and whether these should be supplemented with tailored evidence for central or local payers or protocols;

the nature and political context of the payer community;

the patient community, how it views the disease in question, and its attitudes to treatment cost and value;

how the market access strategy can be transformed into a long term, sustained return on investment (ROI).

You really need to know your local systems, Kogels comments. One reason pharmaceutical companies can fall short on market access is the speed with which healthcare payers and policies have shifted towards cost-containment. That said, local reimbursement guidelines are not always helpful in pointing the way, as the application of these guidelines is heavily influenced by the personal interpretations of decision-makers.

Translating clinical benefits into a cost-benefit equation is not just hard science, Kogels observes. Quality-of-life measures used by payers to determine value may omit basic factors that are meaningful to patients, such as disease-specific symptoms (e.g. hand tremors in Parkinsons disease) or patient satisfaction.

The payers' perspective

What companies need to remember, she stresses, is that payers have their own agenda and perspective, shaped by global and local budgetary considerations as well as shifting politics and the growth of free-market mechanisms that yield new players in the healthcare arena.

Making payers enthusiastic about the data is not just spin, Kogels insists, adding: They are people, too. And it is right for companies to feel passionately that their product can improve quality of life for patients This is what they are living for. At the same time, industry must recognize that ultimately it is the payers job to find value for money.

What companies should be aiming at, Kogels says, is the best possible multi-step strategy that will enable a particular product to secure market access in a particular market at a particular time.

That means learning not just from experience in the companys own portfolio but from what has happened to dossiers in other disease areas. It means building scenarios, talking to decision-makers, isolating target groups and performing functions that are normally the preserve of marketing departments.

Health economics data are a means to the end, Kogels comments. You need to define a market access strategy to result in a long-term sustained ROI.