HIQA concerns on proposed EU regulation on HTA

The Health Information and Quality Authority (HIQA) welcomes a proposed new EU regulation on health technology assessments (HTA), but has a number of concerns as to how it will operate in practice, writes Dr Máirín Ryan, HIQA Deputy Chief Executive and Director of Health Technology Assessment (HTA).

Dr Máirín Ryan
Dr Máirín Ryan

What Is The Regulation?

The proposed regulation, put forward by the European Commission earlier this year, will reinforce cooperation amongst EU Member States for the clinical assessment of new medicines and medical devices. The proposal will enable Member States to use common HTA tools, methodologies and procedures when conducting joint clinical assessments and joint scientific consultations. EU countries will also work together to identify emerging health technologies, and to assess health technologies outside the scope of mandatory cooperation, for example HTAs of public health programmes.

HIQA

HTA is a multidisciplinary, research-based activity that generates information for policy makers and service providers about the clinical and cost-effectiveness of health technologies such as drugs, medical equipment, surgical procedures and public health programmes. HTAs typically address clinical aspects of the technology, cost-effectiveness, budget and resource impacts, as well as issues of an ethical, social or medico-legal nature.

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HIQA’s HTAs serve to provide independent and robust advice to the Minister of Health or the HSE to inform national health policy and health service decisions, i.e. a decision on investment in a new health technology. Some of HIQA’s HTAs to date have looked at HPV testing for cervical cancer screening, smoking cessation interventions and mechanical thrombectomy for stroke.

Since its establishment, HIQA has been an active participant at the international level, representing Ireland in the Health Technology Assessment Network and on the executive board of the European Network for Health Technology Assessment (EUnetHTA). By uniting with other European HTA agencies, HIQA multiplies Ireland’s small HTA capacity by providing access to the HTAs already completed by our European neighbours.

This international cooperation has worked on a purely voluntary basis up until now; however, the new EU regulation will provide the basis for more permanent and sustainable cooperation in the area of HTA when the current arrangement expires in 2020. The proposal will see cooperation among member states on the production of joint relative effectiveness assessment reports, which are reports focused only on the clinical aspects of a particular technology. These reports can then be used by individual member states as the basis of their economic assessments, which in turn would inform decisions on investment or pricing and reimbursement.

The new EU regulation will provide the basis for more permanent and sustainable cooperation in the area of HTA when the current arrangement expires in 2020.

Joint HTAs of medicines and high-risk medical devices will increase the availability of reviews of the international evidence on the clinical effectiveness and safety of relevant technologies. The availability of joint clinical assessments will make HIQA’s processes more efficient by obviating the need for one of the key steps in the production of HTAs on topics falling within the scope of the proposed regulation.

Concerns

While HIQA broadly welcomes the proposed regulation, there are five main issues that HIQA would like to see clarified before it enters into force.

Firstly, consideration should be given to the addition of in vitro diagnostic devices to the scope for joint clinical assessments. These technologies, which included self-testing diagnostics, are becoming increasingly important.

Secondly, what are the implications should a health technology developer refuse to comply with a request for information and documentation on a health technology that is due to undergo a joint clinical assessment? What course of action should followed?

The Commission will have up to three months to approve such requests, which is prohibitive and could lead to unnecessary delays in the albeit rare occurrence of public health emergencies.

The proposed regulation also specifies that the European Commission shall publish joint clinical assessment reports where it considers that the report complies with the substantive and procedural requirements of the regulation. In our view, any assessment of the substantive nature of a HTA report should be conducted by experts from national HTA agencies.

The proposed regulation specifies that Member States, within 30 days, should notify the European Commission of the outcome of a HTA on a health technology that has been subject to a joint clinical assessment. It is unclear what exactly is meant here — does the Commission require notification that the national HTA has been published, what the recommendations of the HTA are, or what investment decision has been taken based on the HTA recommendations.

Article 21(1) states that the Commission will publish the summary reports of all clinical assessments carried out by individual Member States that are outside the scope of the regulation. Will these summary reports be subject to a quality assessment prior to publication? And will the reports be published in a common language, i.e. English? Meeting both of these criteria will enhance the usefulness to HIQA of HTA work carried out in other Member States.

Finally, the proposal foresees that Member States may conduct clinical assessments using means other than those set out in the regulation on the grounds of public health protection. However, the Commission will have up to three months to approve such requests, which is prohibitive and could lead to unnecessary delays in the albeit rare occurrence of public health emergencies.