Another Patient Access Milestone Met

The first meeting of the EU 'HTA Network' of national authorities and bodies responsible for health technology assessment (HTA) took place on October 16, 2013. This is another key step forward toward safeguarding measures that will ensure Member States use HTAs to deliver on patients' best interests.

This collaboration promises to save healthcare expenditure through enabling the sharing of information and workload and by the establishment of common clinical guidelines for assessment. Reducing extensive duplication of assessment, where currently each individual Member State conducts its own HTA review of essentially the same evidence, could also be fairer for patients. The diversity in outcomes of clinical appraisals by Member States that occur due to the current variability in quality and methods used for evidence assessment, can result in a location lottery for citizens of Europe for approved healthcare.

For those in the dark about the complex HTA process, check out the below to see how it fits into the laboratory to patient journey:

Thumbnail image for Focus of an HTA process.png

Archetype of an HTA process.jpg

Simplifying the way HTAs are conducted and connected across Europe is a key focus of the current work of EUnetHTA. Lilly has always maintained that greater harmonization of clinical data requirements across Europe will speed local processes, which is crucial for making sure patients have timely access to innovative new medicines.

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.

We believe 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. In general, the provision of guidance about HTA requirements is very important to enable appropriate development plans and we are supportive of agencies coming together to discuss with us our development plans in an open and constructive fashion.

We are supportive of multi-HTA advice as this provides a mechanism where we can seek guidance on our products in development from multiple HTAs. While the process is not intended to seek consensus amongst the agencies, understanding the differences in their requirements (and the reasons why) is just as important as identifying common ground.

To help facilitate the discussions, Lilly is offering its expertise and advice, working with the European Commission, EUnetHTA and other pharmaceutical companies to ensure that Member States use HTA appropriately so as to service their patients' best interests and to appropriately reward innovation.