Levels of reimbursement: what can you plan for at EU level and what needs to be done at country level?

The collaboration framework for health technology assessment in the EU will achieve a ‘common market’ in assessment of cost-effectiveness but not one in reimbursement. HTA summarises information about the medical, social, economic and ethical issues related to the use of a health technology in order to answer four key questions:

• is the technology effective?

• for whom does the technology work?

• what does it cost to use, including any associated or consequential costs such as the cost of adverse events, additional treatments, and monitoring?

• how does the technology compare (in terms of both costs and benefits) with available treatment alternatives?

Figure 1 summarises the areas in which it is more or less likely that evidence will be usable in most if not all markets. At one end evidence on clinical effectiveness can be approached at multicountry level; at the other, costing and budgets remain country-specific.

Figure 1: the pan-EU potential of elements of the evidence-based reimbursement case

HTA component	Potential for pan-European approach to evidence	Differences and similarities between EU countries
Medical (clinical effectiveness)	High	Slight differences between countries in racial mix, ethnicity, and lifestyle, generally small effect on clinical effectiveness
Social/ethical	Moderate	Social organisation similar. Some differences in ethics, particularly social judgements as to coverage and accepted ‘good practice’
Financial	Low	Unit costs and pathways (including current standard of care) differ, as does the budget available and the architecture of reimbursement and financially relevant aspects of healthcare organisation

 

Knowing which elements of your reimbursement strategy can be implemented at EU-level and which must be country-specific cuts the costs of evidence development and helps to maintain consistent positioning across markets whose payers increasingly refer to one another’s assessment.

At an early stage, ensure that pathways of care are similar in your main markets of interest. This is not often a problem but when it is this is usually because countries have adopted ‘best practice’ at different rates. This may be due to organisational inertia, professional conservatism, or budgetary constraints. As a generalisation, the German reimbursement system is more friendly to innovation than that of The Netherlands, and the UK lags behind other similar economies in cancer treatment for financial reasons. Where there are differences, you may then have to base your proposition on comparison with one or more different ‘legacy’ practices.

You need also to establish that the outcomes of interest are the same in your main markets. For example, some payers are content to consider funding anti-cancer treatment which delays progression, others may require evidence of improved survival.

Taking account of the information on pathways and outcomes of interest, you can prepare the parts of a value dossier concerned with clinical effectiveness for use across the EU. The framework for collecting costs and modelling cost-effectiveness can also be developed once. This has obvious advantages in keeping costs down, but also ensures that one person is responsible for keeping this up-to-date, as more new studies are published, or new information becomes available. This then acts as a resource which can be crafted locally to meet specific needs. Although obtaining unit costs and reimbursement figures is obviously an issue that has to be dealt with at national (or sometimes subnational) level, generating country-specific results using local data in the model is best done at multicountry level.

In each market, local intelligence is needed to place the cost-effectiveness case in a specific context to demonstrate the benefits of your product to best advantage. Hooks which may help to make your evidence-based case successful include policies, priorities, targets, disease patterns, staffing shortages, and capacity constraints.

Different skills are required to implement a successful reimbursement strategy. Pan-EU activities require knowledge of epidemiology, study design, statistics, health economists, and information science. Those at local level require networking with clinicians and payers, knowledge of local circumstances, and an appreciation of the opportunities and hurdles offered by the peculiarities of the reimbursement system. These skills usually imply people with different backgrounds and temperaments.

Strong evidence-based messages about why your product should be adopted are essential. Moulding these to the needs of each audience is also important. Whatever benefits your product offers patients, these messages need also to show that the product is cost-effective (i.e. offers value for money) and affordable. Affordability can be improved by proposing use, at least initially, in a smaller group of patients than may later be eligible, in whom results are particularly effective or cost-effective.

Relying on a strategy which aims only at securing CE-marking and hoping that traditional sales activities will succeed in securing reimbursement is increasingly risky. Investing in evidence development sufficient to support a good case that will withstand the scrutiny of an HTA review offers a better rate of return than a minimalist.