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

Brian Godman, Anna Bucsics, Patricia Vella Bonanno, Wija Oortwijn, Celia Rothe, Alessandra Ferrario, Simone Bosselli, Andrew Hill, Antony P. Martin, Steven Simoens, Amanj Kurdi, Mohamed Gad, Jolanta Gulbinovic, Angela Timoney, Tomasz Bochenek , Ahmd Salem, Iris Hoxha, Robert Sauermann, Amos Massele, Augusto Guerra Jnr & 30 others Guenka I. Petrova, Gnosia Achniotou, Ott Laius, Catherine Sermet, Gisbert W. Selke, Vasilios Kourafalos, John Yfantopoulos, Einar Magnusson, Roberta Joppi, Margaret Oluka, Hye-Young Kwon, Arianit Jakupi, Francis Kalemeera, Joseph Fadare, Oyvind Melien, Magda Wladysiuk, Vanda Marković-Peković, Ileana Mardare, Dmitry Meshkov, Tanja Novakovic, Jurij Fürst, Dominik Tomek, Corinne Zara, Eduardo Diogene, Johanna C Meyer, Rickard Malmstrom, Bjorn Wettermark, Zinhle C. Matsebula, Stephen Campbell, Alan Haycox

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

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.
LanguageEnglish
Article number328
Number of pages21
JournalFrontiers in Public Health
Volume6
DOIs
Publication statusPublished - 5 Dec 2018

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Budgets
Rare Diseases
Costs and Cost Analysis
Pressure
Neoplasms
Decision Support Techniques
Drug and Narcotic Control
Immune System Diseases
Financial Management
Communicable Diseases
Publications
Medicine
Delivery of Health Care
Health
Research

Keywords

  • managed entry
  • health policy
  • pharmaceutical
  • financing
  • cancer
  • orphan disease
  • new model

Cite this

Godman, Brian ; Bucsics, Anna ; Vella Bonanno, Patricia ; Oortwijn, Wija ; Rothe, Celia ; Ferrario, Alessandra ; Bosselli, Simone ; Hill, Andrew ; Martin, Antony P. ; Simoens, Steven ; Kurdi, Amanj ; Gad, Mohamed ; Gulbinovic, Jolanta ; Timoney, Angela ; Bochenek , Tomasz ; Salem, Ahmd ; Hoxha, Iris ; Sauermann, Robert ; Massele, Amos ; Guerra Jnr, Augusto ; Petrova, Guenka I. ; Achniotou, Gnosia ; Laius, Ott ; Sermet, Catherine ; Selke, Gisbert W. ; Kourafalos, Vasilios ; Yfantopoulos, John ; Magnusson, Einar ; Joppi, Roberta ; Oluka, Margaret ; Kwon, Hye-Young ; Jakupi, Arianit ; Kalemeera, Francis ; Fadare, Joseph ; Melien, Oyvind ; Wladysiuk, Magda ; Marković-Peković, Vanda ; Mardare, Ileana ; Meshkov, Dmitry ; Novakovic, Tanja ; Fürst, Jurij ; Tomek, Dominik ; Zara, Corinne ; Diogene, Eduardo ; Meyer, Johanna C ; Malmstrom, Rickard ; Wettermark, Bjorn ; Matsebula, Zinhle C. ; Campbell, Stephen ; Haycox, Alan. / Barriers for access to new medicines : searching for the balance between rising costs and limited budgets. In: Frontiers in Public Health. 2018 ; Vol. 6.
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abstract = "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.",
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author = "Brian Godman and Anna Bucsics and {Vella Bonanno}, Patricia and Wija Oortwijn and Celia Rothe and Alessandra Ferrario and Simone Bosselli and Andrew Hill and Martin, {Antony P.} and Steven Simoens and Amanj Kurdi and Mohamed Gad and Jolanta Gulbinovic and Angela Timoney and Tomasz Bochenek and Ahmd Salem and Iris Hoxha and Robert Sauermann and Amos Massele and {Guerra Jnr}, Augusto and Petrova, {Guenka I.} and Gnosia Achniotou and Ott Laius and Catherine Sermet and Selke, {Gisbert W.} and Vasilios Kourafalos and John Yfantopoulos and Einar Magnusson and Roberta Joppi and Margaret Oluka and Hye-Young Kwon and Arianit Jakupi and Francis Kalemeera and Joseph Fadare and Oyvind Melien and Magda Wladysiuk and Vanda Marković-Peković and Ileana Mardare and Dmitry Meshkov and Tanja Novakovic and Jurij F{\"u}rst and Dominik Tomek and Corinne Zara and Eduardo Diogene and Meyer, {Johanna C} and Rickard Malmstrom and Bjorn Wettermark and Matsebula, {Zinhle C.} and Stephen Campbell and Alan Haycox",
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Godman, B, Bucsics, A, Vella Bonanno, P, Oortwijn, W, Rothe, C, Ferrario, A, Bosselli, S, Hill, A, Martin, AP, Simoens, S, Kurdi, A, Gad, M, Gulbinovic, J, Timoney, A, Bochenek , T, Salem, A, Hoxha, I, Sauermann, R, Massele, A, Guerra Jnr, A, Petrova, GI, Achniotou, G, Laius, O, Sermet, C, Selke, GW, Kourafalos, V, Yfantopoulos, J, Magnusson, E, Joppi, R, Oluka, M, Kwon, H-Y, Jakupi, A, Kalemeera, F, Fadare, J, Melien, O, Wladysiuk, M, Marković-Peković, V, Mardare, I, Meshkov, D, Novakovic, T, Fürst, J, Tomek, D, Zara, C, Diogene, E, Meyer, JC, Malmstrom, R, Wettermark, B, Matsebula, ZC, Campbell, S & Haycox, A 2018, 'Barriers for access to new medicines: searching for the balance between rising costs and limited budgets' Frontiers in Public Health, vol. 6, 328. https://doi.org/10.3389/fpubh.2018.00328

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

In: Frontiers in Public Health, Vol. 6, 328, 05.12.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Barriers for access to new medicines

T2 - Frontiers in Public Health

AU - Godman, Brian

AU - Bucsics, Anna

AU - Vella Bonanno, Patricia

AU - Oortwijn, Wija

AU - Rothe, Celia

AU - Ferrario, Alessandra

AU - Bosselli, Simone

AU - Hill, Andrew

AU - Martin, Antony P.

AU - Simoens, Steven

AU - Kurdi, Amanj

AU - Gad, Mohamed

AU - Gulbinovic, Jolanta

AU - Timoney, Angela

AU - Bochenek , Tomasz

AU - Salem, Ahmd

AU - Hoxha, Iris

AU - Sauermann, Robert

AU - Massele, Amos

AU - Guerra Jnr, Augusto

AU - Petrova, Guenka I.

AU - Achniotou, Gnosia

AU - Laius, Ott

AU - Sermet, Catherine

AU - Selke, Gisbert W.

AU - Kourafalos, Vasilios

AU - Yfantopoulos, John

AU - Magnusson, Einar

AU - Joppi, Roberta

AU - Oluka, Margaret

AU - Kwon, Hye-Young

AU - Jakupi, Arianit

AU - Kalemeera, Francis

AU - Fadare, Joseph

AU - Melien, Oyvind

AU - Wladysiuk, Magda

AU - Marković-Peković, Vanda

AU - Mardare, Ileana

AU - Meshkov, Dmitry

AU - Novakovic, Tanja

AU - Fürst, Jurij

AU - Tomek, Dominik

AU - Zara, Corinne

AU - Diogene, Eduardo

AU - Meyer, Johanna C

AU - Malmstrom, Rickard

AU - Wettermark, Bjorn

AU - Matsebula, Zinhle C.

AU - Campbell, Stephen

AU - Haycox, Alan

PY - 2018/12/5

Y1 - 2018/12/5

N2 - 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.

AB - 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.

KW - managed entry

KW - health policy

KW - pharmaceutical

KW - financing

KW - cancer

KW - orphan disease

KW - new model

UR - https://www.frontiersin.org/journals/public-health

U2 - 10.3389/fpubh.2018.00328

DO - 10.3389/fpubh.2018.00328

M3 - Article

VL - 6

JO - Frontiers in Public Health

JF - Frontiers in Public Health

SN - 2296-2565

M1 - 328

ER -