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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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European Commission has issued the report on public consultation on cooperation between HTA agencies in Europe

16 May 2017

European Commission launched an evaluation of necessity to prolong support to cooperation between health technology assessment agencies beyond 2020, when the current EUnetHTA Joint Action 3 comes to an end) in September 2016. As part of the assessment, it launched an online public consultation in October 2016, which ended in January 2017. The objective of the consultation was to collect views of different stakeholders on the future of collaboration in the HTA field.

Here are some highlights (extracts) from the report:

  • The online public consultation and the SME consultation gathered a total of 249 replies. Of these responses, 63 are from individuals/citizens (25%) and 186 are from administrations, economic stakeholders, associations or organisations ("non-individual respondents") (75%) 

Responses from citizens (private responses)

  • Almost all respondents (98%) consider that it is useful to compare new health technologies with existing ones and assess whether they work better, equally well or worse, in order to provide guidance to decision makers
  • When asked about clinical assessment, 57% of the respondents consider that that national/regional HTA bodies should not perform clinical/medical assessments of the same health technologies in parallel, independently from each other
  • When asked a similar question about economic assessments, 44% of the individual respondents agree that there is no need of performing economic assessments separately by national and regional HTA bodies
  • The survey showed that most individuals (95%) believe that information on whether a new health technology works better, equally well or worse than a health technology already available in their country should be easily accessible to doctors to enable an informed decision when prescribing the treatment of their patients
  • In the same way, most respondents (84%) consider that information on whether a new health technology works better, equally well or worse than a health technology already available in your country should be easily accessible to patients and patients' representatives

Responses from administrators

  • Most of the respondents strongly agreed or agreed with the existence of differences in HTA processes and methodologies, from 80% on HTA methodologies for clinical assessments and 85% on HTA methodologies for economic assessments, to 91% agreement on the existence of differences in national HTA procedures
  • Representatives of pharmaceutical industry point out that, HTA procedures are very diverse across EU, and this diversity constitutes a hurdle for companies, as they have to adapt to various national requirements
  • Respondents representing medical technologies industry note that currently HTA has limited role in market access and the role and timing of HTA for medical technologies is country specific.
    • They deplore the lack of established HTA processes and expectations for medical technologies (i.e. HTA processes and methodologies are considered "pharma-biased", not always addressing the particularities of the medical technologies' sector), variable timelines and in some Member States disconnection between HTA outcomes and patient access to the technology assessed.
    • Moreover, it was stressed that compulsory HTA for all medical technologies may become a market barrier with major implications on the development of new products.
  • With reference to the differences in national HTA methodologies for the clinical assessments (i.e. REA), stakeholders note that there are different data requirements for carrying out the assessment, and also different clinical practice approaches, including choice and acceptance of comparators (e.g. indirect comparators and off-label comparators are not always accepted), selection and acceptance of endpoints (e.g. surrogate endpoints), which ultimately may explain the different outcomes of national HTA clinical reports
  • While pharmaceutical companies agree that there are elements of the methodology for the clinical assessments which vary across EU, some medical devices companies report that since their products are rarely subject to HTA, the key differences in HTA methodology for clinical and/or economic assessments are less easy to identify.
    • Additionally some contributors note that for some medical technologies (e.g. diagnostic imaging technologies) randomised clinical trials are cost-prohibitive or only indirectly linked to clinical outcomes, experimental studies can be more challenging due to ethical issues, and clinical performance often depends on end- 14 users. Therefore respondents from the medical technologies sector support the development of HTA methodology adapted to the particularities of their sector.
  • Finally, on the differences in national HTA methodologies for economic assessments, most of the stakeholders underline that these are more pronounced than those for clinical assessments. The importance of the national (regional) local socio-economic context and the need for contextual adaptation, the use of indicators such as cost/QALY or incremental costeffectiveness ratio/ICER, and the differences in the evaluation perspective (payers or societal) are quoted among the major issues which would make difficult the formulation and acceptance of an EU joint economic assessment.
  • A large majority of the respondents (87%) consider that EU cooperation on HTA should continue beyond 2020 when EUnetHTA Joint Action 3 will end
  • As regards the scope, a large majority of the respondents found useful and to some extent useful to continue EU cooperation on HTA in the field of pharmaceuticals (80%), but also in the areas of medical technologies (72%) and other technologies (54%)
  • Concerning usefulness of EU cooperation on HTA beyond 2020 in the area of medical technologies, most of the representatives of the medtech industry who support future EU cooperation on HTA (17 of the 21 contributors) indicate that the cooperation in this sector is to some extent useful (76%), while 18% see it useful and 6% consider it not useful

Full report is available here.

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