India's new clinical trial rules establish an accelerated pathway for new drug approvals, but affordability remains… https://t.co/uhVXDZGLfr
On the road to HTA harmonization in Europe
Last month’s proposals by the European Commission for the creation of a single, mandatory system for clinical health technology assessments was bolder and more forthright than many in the industry were prepared for. Limited changes were expected to be the order of the day, given the strength of some countries opposition to HTA convergence. Yet after years of preparation, the Commission took a brave decision to avoid the pitfalls of a cautious middle-way forward, one which accommodated the resistance of national payers and regulators, while satisfying the cries for faster and deeper HTA harmonization by pharmaceutical industry and patient advocacy groups. What the Commission actually proposed is a decisive move toward greater HTA harmonization. Aiming high was perhaps a safer bet, since the reforms face a difficult path to implementation and the real possibility that they may require careful modification in order to reach consensus with national level authorities.
The European Commission envisages a single European Union (EU) system for clinical HTAs, with mandatory cooperation between member states on clinical HTA assessments after 2020. The mandatory joint assessment will be limited to examining the clinical evidence. Pricing and reimbursement (P&R) decisions, based on these joint assessments, would remain the responsibility of national-level governments.
At the heart of the commission’s offer are substantial potential benefits for the innovative pharmaceutical sector. Alignment on clinical assessments is in theory a big win for pharmaceutical and medical device companies, as harmonization may reduce the burden of navigating the current quagmire of decentralized HTA systems that pervade the EU landscape among member states and even regions.
New medicines and medical devices would theoretically be clinically evaluated once, meaning less work for national HTA agencies with thereby the possibility to allocate increased resources to other areas, such as the faster evaluations of the socio-economic benefits of new drugs. Another advantage, is the potential for more predictable expectations for the clinical data portion of HTA throughout Europe.
The majority of EU member states are likely to be appeased by plans for national HTA authorities to continue to be responsible for pricing and reimbursement decision-making. Any pan-HTA body that emerges would only be empowered to carry out work connected with clinical evaluations. Non-clinical assessments (including the socio-economic basis for cost-effectiveness evaluation) would remain the remit of national-level authorities. At the same time, assuming the proposals are implemented in full, they would undoubtedly move the framework a step closer to a centralized HTA and P&R system in the EU. This is not an end target, but the new rules would almost certainly advance the probability of this scenario eventually coming to pass, at least over a decade long-term time horizon.
There is no question Europe is moving toward a more integrated and cohesive HTA system. Exactly how far the current reform plan will go toward enhancing HTA cooperation in this way is difficult to say. A final agreement will require compromises that dilute aspects of the proposals. But, by asking for a lot (possibly more than it expects to be able to deliver in one go), the European Commission is signaling it is prepared for these difficult conversations with member states and is determined to push its policy agenda.
The political contours of a deal on a single European HTA system are still a long way from being realized. Much could change in the discussions and negotiations that follow. However, the indicators for the pharmaceutical industry are positive that the final accord will enhance HTA cooperation to a point that improves market access for innovative medicines that should benefit patients and companies alike.
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