Health technology companies often need to demonstrate the value of their products as evidenced by economic and patient-reported-outcomes benefits to overcome reimbursement* and funding ‘hurdles’. These can be a barrier to product uptake and gaining optimal market access, even after the product has received technical approval.

To assist in providing this information, Fourth Hurdle Consulting offers the following services:
• Strategic advice on evidence planning
• Value evidence assessment
• Data collection
• Value dossier preparation
• Client support at all stages throughout any submission process

The Importance of Economics to Reimbursement

Economic evidence is required for market access in countries such as Canada, Australia, Sweden and the UK, and more countries will formalise their demands for economic evidence soon. Economic evidence is also a factor in reimbursement decisions in many other countries. Agencies, such as the National Institute for Health and Clinical Excellence (NICE) in England and Wales, have the power to recommend restrictions or expand the group of patients for whom a product may be prescribed as well as the type of physician that may prescribe the product. This means that funding and formulary access decisions can result in reduced access to the market.

Health technology companies which cannot demonstrate that their products provide good value for the money may find themselves restricted in their ability to market these products. The requirement to show the economic and humanistic value of a medical technology is often called the ‘Fourth Hurdle’.

Maximising the Likelihood of Successful Reimbursement

It is important that the economic and patient-reported-outcomes benefits of a product are clearly presented to health care decision makers. Success will depend on a number of key strategic choices in addition to price, including patient group, indication and comparator. Also, governments and payers often require assessments of a new product’s impact on service delivery as well as budget.

The preparation of the case for ‘reimbursement’ requires an in-depth understanding of health economics and outcomes research. An appreciation of the decision-making process and a solid grasp of the company’s objectives are also critical. It is important to note that the approach to data analysis in the dossier and its presentation is quite different from a Marketing Authorisation Application.

How Fourth Hurdle Consulting Can Help

Strategic Advice
We can also provide strategic advice on a company’s approach to reimbursement, including price setting, choice of population and indication. We blend expert skills in health economics with a thorough understanding of the priorities and processes in the health technology industry and in UK NHS health technology assessment. We are therefore able to understand the relevant evidence and to interpret its implications from the perspective of both the client and their customer.

Value Evidence Assessment
Fourth Hurdle Consulting are specialists in the application of economics to health care. We are therefore able to assess the strengths of a company’s evidence base and provide strategic advice. We also have hands-on knowledge of the health technology assessment process and can provide a realistic appraisal of a company’s evidence package – including the likelihood that the package will be acceptable to the relevant authorities.

Data Collection
To maximise a company’s chance of successful funding and uptake, we collect appropriate data, help generate evidence or adapt existing information to support reimbursement applications. Fourth Hurdle Consulting has extensive experience in providing economic evaluations based on clinical trials as well as adapting evaluations for different settings. We are also experts at working with observational data and economic modelling.

Value Dossier Preparation
We have extensive experience of preparation of reimbursement dossiers for health technology assessment. Fourth Hurdle Consulting has drafted submissions to the National Institute for Health and Clinical Excellence (NICE) and the Scottish Medicines Consortium (SMC) and, in collaboration with aegisnet, the International Network for Health Care Research, has worked on submissions for other agencies. As a result, we are very familiar with the technical requirements and decision-making priorities of the main European agencies.

OnGoing Process Support
The submission of a dossier is not the end of the reimbursement process, but may be followed by questions, data revisions and requests for further information. Fourth Hurdle Consulting provides a flexible, professional and responsive service to ensure that clients have the information needed to meet agency requests, are adequately briefed throughout the negotiations, and are able to meet agency timelines.

*Note: The term “reimbursement” used in this document refers to both the formal reimbursement procedures (requirements for state funding etc. Such as those found in many countries including Canada, France, Italy and Spain), as well as appraisals, evaluation and other requirements for product adoption, funding and formulary access.