HTA cooperation at EU level: From “agreeing on to doing”, from therapeutic added value to cost effectiveness

HTAThe heated debate over price transparency before the Christmas break distracted us from another important development which, being often perceived as too technical and theoretical, may in fact result in significant changes for the pharmaceutical industry: EU level cooperation on Health Technology Assessments (HTA) – the method for assessing the ways science & technology are used in healthcare with regards to their effectiveness and price, says FTI Consulting’s Emanuele Degortes.

Discussions on the Council Conclusions on Innovation for the Benefit of Patients in late November and December focused very much on the exchange of pricing information between Member States and the potential endorsement of the joint public procurement mechanism beyond cross-border health threats. On the other hand, the recommendations to “implement the HTA strategy adopted by the HTA network” and  to “further enhance joint work on HTA” have been seriously underestimated. If we look at how HTA collaboration at the EU level has developed over recent years we may however want to pay more attention to this machine which is moving slowly but continuously.

According to a Commission official closely involved in HTA discussions, the EU’s efforts on HTA have to date been focused in creating theoretical models – one of the reason why many stakeholders have not paid as much attention as they should have. So far, a number of common HTA methodologies have been produced thanks to the work conducted within EUnetHTA. The Commission’s new prerogative however is make sure Member States actually use these methodologies so as to avoid duplication of efforts and creating a more predictable business environment for companies. A number of joint pilots are currently in place but the Commission would like to be even more ambitious in this regard. As outlined in the HTA Network Strategy published in October 2014, the emphasis of the new strategy will move from “agreeing on to doing”. A reflection paper on conditions to facilitate take up and re-use at national level of joint HTA production including information and joint assessments, expected for the first half of 2015 will draw conclusions from the ongoing pilots and provide suggestions for additional ones. Another objective of the Commission will be to convene all parties involved in the process and to create more synergies between regulators and payers to ensure that the joint methodologies are effectively used and have a real impact on the final price of a medicinal product at the national and regional level.

The pharma industry in Brussels has arrived at supporting greater HTA cooperation with regards to joint assessments of therapeutic added value of drugs. Its position on the joint assessment of cost effectiveness has however been more sceptical, believing that such assessment could only be conducted at the Member State level. The overall perception was also that there was little appetite for this among Member States. The recent high-level discussions between EU Ministers on the absolute prices of pharmaceutical products have however changed this and a Commission official argued that more countries are now willing to have a closer level of collaboration, in particular around innovative (and costly) products. The Commission is in favour of this change of hearts and is willing to support those Member States who want to move in this direction without needing to stick to the lowest common denominator.

But where does the European Parliament stand in all of these discussions? So far the issue has been dealt primarily by Member States and the Commission with little involvement from the parliament but the lack of a heavy legislative agenda will leave MEPs with more time to assess European initiatives which do not necessarily fall under their scope. HTA collaboration is likely to be one of the topics they will explore in more detail and this is starting already. In December, the Coordinators of the ENVI committee have agreed to commission a study on a harmonised EU approach on the assessment of the added therapeutic value of medicines in the European Union. Knowing the default position of the European Parliament when it comes to EU integration, we can already predict that the political pressure from MEPs to the Commission will be for more HTA collaboration, not less.

All of these factors coming together should be a good enough reason to pay more attention to where HTA collaboration is going and assess what the move from “agreeing on to doing” and from the joint assessment of therapeutic added value to cost effectiveness will mean for Member States, industry and patients.

Emanuele Degortes is Senior Consultant at FTI Consulting Brussels.

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