HTA: Unlocking Access to Innovative Medicines

On the 21st March, Zagreb, Croatia, welcomed a host of Health Technology Assessment (HTA) stakeholders to discuss progress of the EUnetHTA Joint Action 2, a collaborative initiative established to create a network that works to strengthen how HTAs are carried out in Europe through best practice, information sharing and increased standardisation.

HTA is often talked about these days and increasingly holds the key to access of innovative medicines for patients in Europe. They are assessments that inform policy-makers about the medical, social, economic and ethical issues related to the use of a health technology (a medicine or device, for example). At the crux is finding out whether a given health technology is clinically and cost effective in comparison to what is already available. Health authorities use HTAs to help decide whether and to what extent a medicine should be reimbursed - ultimately making a call on whether the innovative technology should be available to the likes of you and me.

More harmonization of how HTAs are carried out across Europe is crucial for making sure patients have timely access to innovative new medicines. And that's where EUnetHTA comes in. EUnetHTA is a platform that unites national authorities, regional agencies and not-for-profit organisations that produce or contribute to HTA. Together, these organisations are striving to streamline European HTA processes where currently each country independently spends its resources on evaluating the same medicines and devices resulting in considerable duplication of effort and as the methods are different can lead to different conclusions based on the same evidence which reduces the credibility of these agencies. Therefore, the HTA agencies are seeking to standardise the methodologies that they use and share the assessment workload between them to save resources and improve consistency of outcome. Ultimately, they are working to balance access of Europe's patients to new medicines with the sustainability of national health systems.

HTAs play an increasingly important role in guiding the therapy choices of both healthcare professionals and policy makers. Lilly believes that HTA systems and processes need to be transparent, objective and involve a range of stakeholders to ensure that the needs of patients and the invaluable insights of the companies developing medicines are adequately reflected.

Lilly supports some harmonization of the "clinical data package" in European HTA processes to improving quality and establish clear guidelines for the assessment clinical effectiveness. We also believe it will reduce variability and duplication of assessments by member states and reduce the cost burden to member states and industry of multiple assessments of the same information. It will also safeguard a clear and common definition and understanding of "clinical value".

We recognise that despite a need for some level of harmonisation and standardisation of the clinical assessment, the final assessment and decision making must still be undertaken by individual member states so as to accommodate their local standards of care, societal values and health care budgets. To help facilitate this, Lilly is working with the European Commission, EUnetHTA and other pharmaceutical companies to ensure that Member States use HTA appropriately so as to service their patient's best interests and to appropriately reward innovation.

Lilly firmly believes future pharmaceutical innovation, investment and growth in Europe is jeopardised by undervaluation of products during HTAs and by arbitrary price reductions and price referencing. We believe patient care and the quality of medicine will suffer by undervaluation. Some HTA's in Europe currently ignore the full range of the value that medicines can bring to society such as patient benefits associated with how they receive and use the medicine, social impacts, impacts outside the health budget such as allowing patients or caregivers to return to work, and impacts on health system efficiency. As a result innovation is neither fully recognised nor fairly valued. HTA agencies need to broaden their perspectives and be prepared to recognise appropriate innovation.