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Poster display session

3137 - Impact of licensing and reimbursement discrepancies on patient access to cancer treatments across Europe and Canada


10 Sep 2017


Poster display session


Jan McKendrick


Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440


J. McKendrick1, B. Malcolm2, K. Sheahan3, I. Katsoulis1, X. Song1, J. van Loon1

Author affiliations

  • 1 Consulting, PRMA Consulting Ltd, GU51 2UZ - Fleet/GB
  • 2 Worldwide Health Economics And Outcomes Research, Bristol-Myers Squibb Pharmaceuticals Ltd, UB8 1DH - Uxbridge/GB
  • 3 Worldwide Health Economics And Outcomes Research, Bristol-Myers Squibb, 08540 - Princeton/US


Abstract 3137


The European Medicines Agency (EMA) grants licenses to safe, effective cancer treatments where access to the drug can improve and prolong life. Subsequent country-specific health technology assessment (HTA) and reimbursement decisions may restrict access to sub-populations of clinically eligible patients. This study is the first to quantify the impact of licensing discrepancies in terms of Years of Life Lost (YLL) across a range of countries.


Oncology drugs approved by the EMA for six cancers (breast, kidney, lung, multiple myeloma, melanoma, prostate) between 2006 and 2016 were identified. Associated HTA reimbursement decisions from 13 agencies (Belgium, Canada, Denmark, France, Germany, Italy, the Netherlands, Poland, Portugal, Spain, Sweden, UK) were classified by degree of restriction between the populations clinically eligible and eligible for reimbursement: “no restriction”, “partial restriction” (by percent of clinically eligible population restricted)” or “complete restriction”. Epidemiology data (GLOBOCAN 2012) and population sizes from HTA submissions informed the estimated number of patients impacted. Potential survival gains from pivotal studies were applied to quantify the YLL impact of licensing discrepancies.


Overall, 26% of published decisions resulted in complete or partial restriction; the extent of restrictions differed across countries (from 0% in Germany to 4% in Portugal and 63% in Scotland), cancer types and drugs. The restrictions impacted approximately 100,000 clinically eligible patients annually and, result in over 30,000 YLL across the scope countries. Restriction rationale was often not publically available. Results show differences between countries regardless of GDP or timing of HTA assessment.


Despite one regulatory system for the approval of new medicines, results suggest that access to cancer therapies remains inequitable across Europe and Canada. Reimbursement decisions appear fragmented, resulting in varying restrictions that impede use of effective medicines among clinically eligible patients and result in substantial YLL burden.

Clinical trial identification

Legal entity responsible for the study

Bristol-Myers Squibb Pharmaceuticals Ltd


Bristol-Myers Squibb Pharmaceuticals Ltd


J. McKendrick, X. Song: PRMA Consulting was paid to conduct the study and contribute to abstract preparation by Bristol-Myers Squibb. B. Malcolm: Employee of Bristol-Myers Squibb. K. Sheahan: Payment outside the submitted work from Bristol Myers Squibb as a Worldwide Heath Economics and Outcomes Research Fellow. I. Katsoulis, J. van Loon: Employed by PRMA Consulting who were paid to conduct the study and contribute to abstract preparation by Bristol-Myers Squibb.

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