The use of medicines in exceptional circumstances in Spain: adding perspective to early access
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The use of medicines in exceptional circumstances refers to the use of non-authorized medicines or those used outside the authorized conditions, and comprises three different situations: (1) the use of medication in research or for compassionate use; (2) the use of foreign medicines (medicines unauthorized in one country but authorized in others); and (3) off-label use (prescription of drugs for conditions other than that for which they have been officially approved). In Spain, we intend to regulate the period between authorization and pricing through the use of therapeutic positioning reports containing standard criteria. In our opinion, the key to managing this period could be restrictive access based on the therapeutic positioning reports, prespecified agreements on acquisition cost, and restrictive time framework (for use or for decision making, e.g. orphan medicines).
- 11.International Society for Pharmacoeconomics and Outcomes Research. ISPOR roadmaps. Available at: https://tools.ispor.org/htaroadmaps/. Accessed 15 May 2018.
- 12.National Institute for Health and Care Excellence. What we do. 2018. Available at: https://www.nice.org.uk/about/what-we-do. Accessed 15 May 2018.
- 13.French National Agency for Medicines and Health Products Safety (ANSM). Notice to applicants for marketing for temporary authorisation for use (ATU). 2015. Available at: http://ansm.sante.fr/var/ansm_site/storage/original/application/cadfbcf9594614d59c8915670853a28b.pdf. Accessed 15 May 2018.
- 14.The Federal Joint Committee. About us. Available at: http://www.english.g-ba.de. Accessed 15 May 2018.
- 15.Institute for Quality and Efficiency in Health Care. Responsibilities and objectives of IQWiG. Available at: https://www.iqwig.de/en/about-us/responsibilities-and-objectivesof-iqwig.2946.html. Accessed 15 May 2018.
- 16.German Institute for Medicinal Documentation and Information. HTA information system. Available at: https://www.dimdi.de/dynamic/en/further-services/health-technology-assessment/. Accessed 15 May 2018.
- 17.Care Institute of the Netherlands. Organisation. Available at: https://www.zorginstituutnederland.nl/over-ons/organisatie. Accessed 15 May 2018.
- 18.Agency for Health Technology Assessment. About us. Available at: http://www.aotm.gov.pl/www/. Accessed 15 May 2018.
- 19.Swedish Agency for Health Technology Assessment and Assessment of Social Services. Home page. Available at: http://www.sbu.se/en/. Accessed 15 May 2018.
- 20.European Medicines Agency. PRIME: priority medicines (2017). Available at: https://www.ema.europa.eu/human-regulatory/research-development/prime-priority-medicines. Accessed 15 May 2018.
- 21.European Medicines Agency: PRIME: a two-year overview (2018). Available at: https://www.ema.europa.eu/documents/report/prime-two-year-overview_en.pdf. Accessed 15 May 2018.
- 22.UK Government. Accelerated access review: final report (2016). Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/565072/AAR_final.pdf. Accessed 15 May 2018.