Ministers were invited to answer a very straightforward question from the Bulgarian Presidency (which has not hidden its strong dissatisfaction with aspects of the Commission initiative) on whether they support or oppose the core principle of the proposal regarding the mandatory participation in the joint clinical assessments and most importantly, the mandatory national uptake of the conclusions of these assessments. Several Ministers expressed reservations as to the mandatory uptake of the joint clinical assessments.
Why are governments suspicious of the proposal?
This mandatory-mandatory combination has polarized the conversation between Member States. Numerous governments consider this to be overstepping into sensitive national competences. In particular, they are concerned that a mandatory European HTA system will tie their hands and restrict their decision-making power on which medicines should or should not be reimbursed. The concern is that if a product gets a European HTA green light, it will be much more difficult for a national government to decline its reimbursement. Some Health Ministers wish to keep pricing and reimbursement decisions as close as possible. At the same time, others worry that the new EU HTA system will be vulnerable to capture by pharmaceutical companies who have long despised HTA as the fourth, hard-to-predict, hurdle (in addition to proving good quality, efficacy and safety) which stands between them and national coverage decisions.
Another crucial point, not raised in the EPSCO discussions, is that a new EU-wide HTA framework which is institutionalised and quite predictable would signal a step towards decentralising power, consequently reducing individual national politicians’ leverage. Where insufficient checks and balances are in place, this not only gives them more power and influence but also opens the door to possible corruption. The allegations around the recent Novartis scandal in Greece show that this isn’t just a theoretical risk.
HTA is important as a tool for governments to identify to what extent a new medicinal product is better than currently available treatments. However, another reality which needs to be openly talked about today, is that in certain cases, HTA can be exploited as a way for governments to win time against reimbursing more costly medicines that do have important added therapeutic value. It is important that HTA is not politically deployed as a mechanism to procrastinate on taking these difficult decisions.
Health Technology Assessment, the issue nobody used to talk about
The recently proposed EU Regulation has put HTA at the centre of a political discussion on the broader question of access to medicines and their affordability which has moved to the top of the European agenda in recent years. Unsurprisingly, during last week’s EPSCO, quite a few delegations linked HTA with access and affordability and expressed their concerns over the budgetary impact of some new medicines. HTA is undeniably an integral part of this political discussion while simultaneously being a technical-scientific evaluation.
HTA at its birth was heavily promoted by the pharmaceutical companies themselves. They wanted HTA to justify the very high prices of some new drugs. Nonetheless, as they have continued to hike their prices up in recent years, the project has come back to haunt them. In the face of the paralysing budget impact of numerous drugs in oncology, rare diseases, Hepatitis C (HCV), HIV and others, more and more governments began to establish new or reinforce existing HTA agencies, finding that most of these new drugs didn’t measure up to their price tags. IQWiG, the German HTA agency was strengthened in 2011, while Denmark set up its own national HTA body in January last year with the explicit objective of cost-containment and bolstering the Danish government’s position in their negotiations with pharmaceutical companies. Greece is now pursuing a similar path. HTA has thus gained prominence in recent years as European governments struggle to cope with the high prices charged and look for tools to use as gatekeepers.
HTA: a powerful ally of patients and healthcare systems
The high prices of certain drugs aside, Health Technology Assessment is a powerful ally of patients and health care systems. If used properly, HTA serves patients’ needs and interests, making the case for information and evidence which show that the new medicines offer meaningful innovation rather than imitation – and give a vital signal to steer medical R&D in that direction. HTA agencies are often falsely held responsible for the rationing of treatments, accused of stalling access or cherry-picking the data in order to help payers (statutory social insurance systems) to delay or avoid the reimbursement of certain drugs. In reality, any rationing is a direct consequence of aggressive pricing strategies pursued by pharmaceutical companies. The recent proposal is the right way to dispel this belief.
Getting it right: EPHA recommendations on how to improve the Commission proposal
EPHA has made five recommendations on the Commission proposal (highlighted). You can read the full recommendations here.
1. Complete data for informed, evidence-based decisions
2. Transparent, reliable assessments will build trust in the new EU HTA system
3. Strengthening national capacity for a truly EU-wide HTA system
4. A credible new EU HTA system resistant to regulatory capture
5. Independent from the EMA: Good fences make good neighbors
Contrary to fears, the Ministerial debate of 22 June 2018 was not the kiss of death for the HTA proposal but a fresh start for the negotiations. The real journey for the proposed Regulation starts now under the new Austrian Presidency of the EU. The Austrian Government has pledged to advance the negotiations by putting HTA on the agenda of numerous Council Working Parties until the end of their Presidency. This does not mean that the “mandatory-mandatory” principle will not be diluted. Following the EPSCO discussion, the Commission will doubtlessly have to meet Member States halfway as many of them have repeatedly called for flexibility to be built into the system. Practically, this means that the mandatory application of assessment results and the prohibition of own assessments will be modified accordingly in the coming months. In spite of the Austrian push, it is unlikely that the negotiations on this file will be concluded by the end of the European Parliament’s current term. One thing is certain, nobody in the Council currently wishes to “kill” the proposal completely. As previously discussed, the HTA negotiation is not taking place in a policy vacuum and will be used as a trade-off between the parallel ongoing discussions on other access to medicines-related issues and policies, some of which are not yet on the horizon.
Overall, although no-one is truly opposed to European collaboration in this field, there is considerable anxiety from all sides over the unknown future landscape. Payers, pharmaceutical companies and health ministries are trying to navigate unchartered waters. Both payers and health ministries do not want to see their freedom over reimbursement choices limited in any way due to a strong or weak EU-wide HTA system. Pharmaceutical companies are relatively happy with the status quo as they are used to doing business with the current fragmented European HTA landscape. Over the years, they have built up their collaboration with key HTA players in Europe, they have become familiar with national players and their specificities and know what to expect in every Member State – compared to an unknown and consequently, very uncertain EU HTA system. The fact that these discussions are taking place in the midst of growing and widespread concerns over the rising prices of medicines is only adding to the industry’s worries over how solid a gatekeeper the new HTA system will prove to be. On the other hand, the prospect of an EU-wide HTA system similar to the EMA excites pharmaceutical companies.
The discussions at the European Parliament have been relatively smooth with no major standoffs. This will not be the case in the Council. Despite the very public debate and often emotional statements by government officials and others since the launch of the proposal a few months ago, Member States have yet to show their red lines and the divisions and alliances in the Council are still being shaped. The pharmaceutical companies on the other hand have not yet mobilised their lobbying resources to the fullest as they are on standby waiting for the negotiations to get underway in the Council. One thing is certain, the text as well as Member States’ red lines will continue to evolve and will change considerably beyond the end of the Austrian Presidency in December.
Policy Manager for Universal Access and Affordable Medicines