by Peter O'Donnell
BRUSSELS, Feb 3 (APM) - Further views on the future of European health technology assessment reveal more divergences of opinion on how to plan, run and pay for any new system to bring some cross-border standardisation to this key element of drug pricing and reimbursement - and new concerns about smaller firms (from EUCOPE), and about smaller countries (from Ireland's HIQA), add to the complexities.
APM's review of the responses it has so far seen to the European Commission's consultation (APMMA 51365) suggests that industry, insurers, patients and official bodies have widely differing views of what should be the priorities in bringing greater order to the 50 or more HTA processes across the member states.
The European Confederation of Pharmaceutical Entrepreneurs represents mid-sized innovative pharma and biotechs and favours greater coordination, because the burden that current HTA diversity represents for "small and medium-sized enterprises (SMEs) with limited resources" creates a "discriminatory environment".
This is "particularly problematic" for the orphan medicines that many of its members develop, because of arbitrary demands from HTA agencies, says EUCOPE.
But the trade association warns against what it sees as dangers if change is not carefully planned. It expresses doubts about the feasibility of including economic assessment in joint full HTAs, including the risk of delay in patients' access to new treatment "due to the efforts to find a common denominator".
It is also anxious about increased costs arising from enhanced collaboration: "It is essential that the cooperation does not put an additional financial burden on companies, in particular SMEs," it says.
Any new system "should be financed by the EU and member states. Industry fees are only an option if there are costs offsets at member state level".
However, in sharp contrast to the views expressed by many other organisations, EUCOPE is firmly in favour of putting the system in the hands of the European Commission. This "would be the best suited institution to run the secretarial functions of such EU cooperation, to ensure coherence and neutrality in the process".
It also differs from other views - including other industry bodies - in rejecting any mandatory participation. National autonomy means that this "is not an option." It only envisages that "if stakeholders agree on participation", the results should be taken up at national level. For EUCOPE, "it is essential that any duplication of work will be avoided".
EUCOPE adds that it currently feels excluded from the discussions of HTA. Its applications to take part in the Health Technology Assessment Network and in the EUnetHTA Stakeholder Forum were rejected "due to a limited number of seats," it says.
The comments from Ireland's Health Information and Quality Authority (HIQA) are also strongly influenced by issues of size.
It says its "small team of currently approximately 10 analysts" conducts "a limited number of prioritised HTAs each year". For HIQA, "the key issue is, therefore, around prioritisation /selection of topics," and the potential for concurrent joint work is "relatively limited."
So while HIQA has contributed to some of the common assessments that have been developed at EU level over recent years, "we did not have the opportunity to include these in national reports as the topics for the most part were not national priorities".
Size also conditions HIQA's views on obligations within any new system.
It says it is "too small an organisation for mandatory participation because of the risk that without much-enhanced topic selection many topics for joint work may not match our national priorities".
"Voluntary participation with mandatory uptake serves our needs best," it says.
For HIQA, some mandatory element is essential to ensure uptake at national level of joint EU assessments, but agencies should be free to choose when they become involved in a joint assessment.
"Voluntary participation would mean that we would only contribute to joint work on topics that serve our national priorities. This avoids our involvement in joint work that does not serve our needs but guarantees that we re-use any joint work that we do contribute to."
HIQA foresees that harmonisation of methodologies and joint tools "may need to become mandatory to maximise the potential of joint work".
HIQA's views on funding favour paying for the future scheme through national and EU budgets, without industry involvement, but for pragmatic reasons rather than the fear of conflict of interest that has been frequently flagged up in other submissions.
"If pharma are asked to pay fees, then so should medical device companies - but many are SMEs for whom even producing the dossier for a European relative efficacy assessment would be prohibitively expensive."
In addition, for many other approaches - public health interventions, complex technologies such as smoking cessation interventions or surgical procedures, "there may not be a relevant commercial sponsor".
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