Barriers for access to new medicines : searching for the balance between rising costs and limited budgets

Godman, Brian and Bucsics, Anna and Vella Bonanno, Patricia and Oortwijn, Wija and Rothe, Celia and Ferrario, Alessandra and Bosselli, Simone and Hill, Andrew and Martin, Antony P. and Simoens, Steven and Kurdi, Amanj and Gad, Mohamed and Gulbinovic, Jolanta and Timoney, Angela and Bochenek, Tomasz and Salem, Ahmd and Hoxha, Iris and Sauermann, Robert and Massele, Amos and Guerra Jnr, Augusto and Petrova, Guenka I. and Achniotou, Gnosia and Laius, Ott and Sermet, Catherine and Selke, Gisbert W. and Kourafalos, Vasilios and Yfantopoulos, John and Magnusson, Einar and Joppi, Roberta and Oluka, Margaret and Kwon, Hye-Young and Jakupi, Arianit and Kalemeera, Francis and Fadare, Joseph and Melien, Oyvind and Wladysiuk, Magda and Marković-Peković, Vanda and Mardare, Ileana and Meshkov, Dmitry and Novakovic, Tanja and Fürst, Jurij and Tomek, Dominik and Zara, Corinne and Diogene, Eduardo and Meyer, Johanna C and Malmstrom, Rickard and Wettermark, Bjorn and Matsebula, Zinhle C. and Campbell, Stephen and Haycox, Alan (2018) Barriers for access to new medicines : searching for the balance between rising costs and limited budgets. Frontiers in Public Health, 6. 328. ISSN 2296-2565 (

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Introduction: There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growing prevalence of both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated as well as strategies to improve prescribing efficiency. However, more needs to be done. Consequently, the primary aim of this paper is to consider potential ways to optimise the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective. Methods: A narrative review of pharmaceutical policies and implications, as well as possible developments, based on key publications and initiatives known to the co-authors principally from a health authority perspective. Results: A number of initiatives and approaches have been identified including new models to better manage the entry of new medicines based on three pillars (pre-, peri-, and post-launch activities). Within this, we see the growing role of horizon scanning activities starting up to 36 months before launch, managed entry agreements and post launch follow-up. It is also likely there will be greater scrutiny over the effectiveness and value of new cancer medicines given ever increasing prices. This could include establishing minimum effectiveness targets for premium pricing along with re-evaluating prices as more medicines for cancer lose their patent. There will also be a greater involvement of patients especially with orphan diseases. New initiatives could include a greater role of multicriteria decision analysis, as well as looking at the potential for de-linking research and development from commercial activities to enhance affordability. Conclusion: There are a number of ongoing activities across countries to try and fund new valued medicines whilst attaining or maintaining universal healthcare. Such activities will grow with increasing resource pressures and continued unmet need.