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Poster Discussion session - Public health policy

1147 - Major determinants of delayed access to innovative medicines for metastatic melanoma: the results of Melanoma World Society and European Association of Dermato-oncology survey


20 Oct 2018


Poster Discussion session - Public health policy


Bioethical Principles and GCP

Tumour Site



Lidija Kandolf Sekulovic


Annals of Oncology (2018) 29 (suppl_8): viii562-viii575. 10.1093/annonc/mdy297


L.O. Kandolf Sekulovic1, S.S. Agarwala2, A. Hauschild3, J. Guo4, G.A. McArthur5, P. Lorigan6, G. Cinat7, C. Caglevich8, C. Lebbé9, P.L. Rutkowski10, H. Gogas11, R. Dummer12, B. Neyns13, L. Bastholt14, A. Wainstein15, D. Herceg16, M. Banjin17, A. Zhukavets18, J. Ocvirk19, C. Garbe20

Author affiliations

  • 1 Dermatology, School of Medicine, Military Medical Academy, 11000 - Belgrade/RS
  • 2 Medical Oncology, St. Luke's Hospital & Health Network, 18015 - Bethlehem/US
  • 3 Of Dermatology, UK-SH, Campus Kiel, 24105 - Kiel/DE
  • 4 Department Of Renal Cancer And Melanoma, Beijing Cancer Hospital, 100000 - Beijing/CN
  • 5 Medical Oncology, Peter MacCallum Cancer Centre, 3000 - Melbourne/AU
  • 6 Medical Oncology, The Christie NHS Foundation Trust, M20 4BX - Manchester/GB
  • 7 Department Of Sarcoma And Melanoma, Instituto Angel H. Roffo, 1428 - Buenos Aires/AR
  • 8 Medical Oncology, Instituto Oncologico Fundacion Arturo Lopez Perez, Santiago/CL
  • 9 Paris, Hôpital St. Louis, 75010 - Paris/FR
  • 10 Surgical oncology, The Maria Sklodowska-Curie Memorial Institute and Oncology Centre, 02-781 - Warsaw/PL
  • 11 Medical Oncology, Laiko General Hospital of Athens, 115 27 - Athens/GR
  • 12 Dermatology, University Hospital Zürich-Dermatology, 8091 - Zürich/CH
  • 13 Medical Oncology, Vrije Universiteit Brussel-Campus Jette, 1090 - Brussels/BE
  • 14 Medical Oncology, Odense University Hospital, 5000 - Odense C/DK
  • 15 Surgical oncology, ONCAD, 101000 - Belo Horizonte/BR
  • 16 Medical Oncology, KBC - University Hospital Centre Zagreb, 10000 - Zagreb/HR
  • 17 Clinic Of Oncology, Clinical Centre of Sarajevo University, 71000 - Sarajevo/BA
  • 18 Oncology, N.N. Alexandrov Research Institute, 223040 - Minsk/BY
  • 19 Oncology, Institute of Oncology Ljubljana, 1000 - Ljubljana/SI
  • 20 Dermatology, University of Tuebingen-Dermatology, 72076 - Tübingen/DE


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Abstract 1147


According to data from the recent studies in Europe and worldwide, a large percentage of patients have restricted access to innovative medicines for metastatic melanoma. In the current study, major determinants of restricted and delayed access to the first-line recommended treatments were analyzed.


Web-based survey was conducted among melanoma experts from 27 European countries, USA, China, Australia, Argentina, Brazil, Chile and Mexico from September 1st to January 1st, 2018. Data on reimbursement of medicines for metastatic melanoma were correlated with: data on health expenditure per capita (HEPC), Mackenbach score of health policy performance, health technology assessment (HTA), ASCO and ESMO scores of clinical benefit market price of medicines and type of reimbursement. Regression analysis was done using SPSS software (significant correlation if p < 0.05).


The recommended BRAFi+MEKi combination and anti-PD1 immunotherapy were registered and fully reimbursed in 17/34 (50%) countries, and combination anti-CTLA4+anti-PD1 in 9/34 (26.4%) countries. In only 14/34 (41.1%) countries majority of patients (>90%) were treated according to the recommended guidelines, and estimated number of patients without access in surveyed countries was 10131 patients. Median delay in reimbursement was 871 days (0-1274 days). It was in correlation with ASCO (rho=0.819, p = 0.004), ESMO scores of clinical benefit (rho=0.933, p < 0.01), median market price (rho=0.694, p = 0.026), as well as with HEPC, health policy performance scores and HTA assessment implementation (p < 0.05). In majority of countries (64.2%) price negotiations or managed entry agreements (MEA) with national authorities were necessary for reimbursement.


HTA implementation, price negotiations and MEAs were associated with more timely reimbursement. Adding ASCO and ESMO scales of clinical benefit to HTA could better prioritize medicines for reimbursement at international level. Development of patient-oriented research, development, market access and reimbursement mechanisms would be necessary in the future.

Clinical trial identification

Legal entity responsible for the study

Melanoma World Society and European Association of Dermato-Oncology.


Has not received any funding.

Editorial Acknowledgement


L.O. Kandolf Sekulovic: Speakers’ fee: Roche, Novartis, BMS, MSD outside the submitted work. S.S. Agarwala: Travel, accommodations, expenses: MSD, Bristol-Myers Squibb. A. Hauschild: Consulting or advisory role, Travel, accommodations, expenses, Honoraria: Amgen, Bristol-Myers Squibb, MedImmune, Merck Serono, Merck Sharp & Dohme, Novartis, OncoSec, Roche, Nektar, Philogen, Provectus, Regeneron; Research Funding: Amgen, Bristol-Myers Squibb, Celgene, Eisai, GlaxoSmithKline, Merck Serono, Merck Sharp & Dohme, Novartis, Roche. J. Guo: Consulting or advisory role, Travel, accommodations, expenses: Roche, MSD, Bayer, Pfizer. G.A. McArthur: Research funding: Celgene, Genentech/Roche, Bristol-Myers Squibb, Amgen, Array BioPharma, Novartis/Pfizer. P. Lorigan: Consulting or advisory role: Merck Sharp & Dohme, Bristol-Myers Squibb, Novartis, Amgen, GlaxoSmithKline, NeraCare GmbH, Pierre Fabre; Speakers’ bureau: Merck Sharp & Dohme, Novartis, Bristol-Myers Squibb, Roche; Travel, accommodations, expenses: Merck Sharp & Dohme, Novartis, Bristol-Myers Squibb. G. Cinat: Consulting or advisory role: MSD, Roche, Novartis, Bristol-Myers Squibb; Research funding: Genentech, Novartis, GlaxoSmithKline, MSD, Bristol-Myers Squibb. C. Caglevich: Consulting or advisory role: MSD, Bayer, AstraZeneca, Bristol-Myers Squibb; Speakers’ bureau: MSD, Bayer, Lilly, Bristol-Myers Squibb; Travel, accommodations, expenses: Boehringer Ingelheim, Bristol-Myers Squibb; Research funding: MSD, Bayer, AstraZeneca, Bristol-Myers Squibb, Medivation, Boehringer Ingelheim, GlaxoSmithKline, Roche, Astellas Pharma. C. Lebbe: Honoraria, Consulting or advisory role, Speakers’ bureau: Roche, Novartis, MSD, Amgen, Bristol-Myers Squibbs; Research funding: Roche, Bristol-Myers Squibbs. P.L. Rutkowski: Honoraria: MSD, Novartis, Roche, Pfizer, Bristol-Myers Squibbs; Consulting or advisory role: MSD, Novartis, Amgen, Blueprint Medicines. H. Gogas: Consultant or advisory role: BMS, MSD, Amgen, Novartis, Roche, Pierre Fabre; Honoraria: BMS, MSD, Amgen, Novartis, Roche; Travel expenses: Roche, BMS; Research funding: BMS, MSD, Roche, Novartis. R. Dummer: Outside the submitted work: Research funding: Novartis, MSD, BMS, Roche, GSK; Consultant or advisory board: Novartis, MSD, BMS, Roche, GSK, Amgen, Takeda, Pierre Fabre. B. Neyns: Outside the submitted work: Consulting or advisory role: BMS, MSD, Roche, Novartis; Speakers’ fees and advisory board meetings: Novartis; Travel, Accommodations, Expenses: BMS, MSD, Roche, Novartis, Amgen; Research funding: Pfizer, Novartis, Merck KGaA; Research funding to the institution: Pfizer, Novartis. L. Bastholt: Advisory boards: Roche, BMS, Merck MSD, Novartis, Eisai; Travel, accommodations, expenses: BMS, Merck MSD, Novartis. A. Wainstein: Travel, accomodation: MSD, BMS, Roche. D. Herceg: Speakers’ fees: MSD, Novartis; Consulting or advisory role: BMS; Travel, accommodations, expenses: Roche. C. Garbe: Outside the submitted work: Speakers’ fees: Amgen, BMS, MSD, LEO, Roche, Philogen; Research funding: BMS, Novartis, Roche. All other authors have declared no conflicts of interest.

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