R. Mclaughlin (Limerick, Ireland)
Author Of 1 Presentation
- R. Mclaughlin (Limerick, Ireland)
- D. O'Reilly (Cork, Ireland)
- C. Ronayne (Cork, Ireland)
- E. Barrett (Limerick, Ireland)
- R. Kalachand (Limerick, Ireland)
- A. De Frein (Dublin, Ireland)
- B. Macanovic (Cork, Ireland)
- R. Connolly (Cork, Ireland)
- D. Power (Cork, Ireland)
- R. Bambury (Cork, Ireland)
- S. Reilly (Cork, Ireland)
- D. Collins (Cork, Ireland)
152P - Analysis of patient access to breast cancer drugs in the USA and Europe with a focus on the UK and Ireland.
Abstract
Background
Globally, there are significant disparities in patient access to breast cancer drugs. We investigate access, cost and value of these drugs in the United States (US) and Europe, focusing on the United Kingdom (UK) and the Republic of Ireland (ROI).
Methods
All breast cancer drugs approved by the FDA from 1st of January 2010 to 1st of October 2020 were included. The pathway of these drugs to license in Europe (European Medicines Agency/EMA) and reimbursement in UK and ROI was investigated. Overall survival (OS) benefit, progression free survival (PFS) benefit and cost of drugs were evaluated.
Results
There were 22 breast cancer regimens approved by the FDA since 2010. Half (n=11) of these were approved in the last 3 years. Most indications (19/22, 86%) were for metastatic disease. The majority (19/22, 86%) were also EMA approved. One in five regimens (4/19, 21%) were approved by the EMA prior to FDA. The median time from FDA to EMA approval was 6 months (Standard Deviation (SD) = 8, range -11-21). In the UK, 64% (14/22) were reimbursed and only one third were reimbursed in ROI (8/22, 36%). Median time to reimbursement in the UK and ROI following EMA approval was 11 months (SD = 10.5, Range 3-43) and 19.5 months (SD = 14.1, Range 1-46) respectively. Nine (41%) of FDA approved indications have demonstrated an OS benefit and a further 11 (50%) were approved based upon PFS benefit. Two (9%) demonstrated an overall response rate. The median price per month of all FDA approved regimens was €7608 (range €2814 – €20292). Regimens which demonstrated an OS benefit were not more expensive than those that did not (median €7608 (SD = €6112) versus €7795 (SD = €5882) respectively (p = 0.29).
Conclusions
There has been a rapid acceleration in licensing of regimens for breast cancer since 2018. Most regimens approved in the US are approved by the EMA following a 6-month time delay. Public reimbursement of these regimens is significantly limited in ROI and less so in the UK. Under half (41%) have a proven OS benefit. The absence of OS benefit is not associated with a lower drug cost. Innovative funding mechanisms are required to improve access to efficacious anticancer medications in a timely manner and at sustainable costs.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
R.A. Mclaughlin: Travel/Accommodation/Expenses: Merck; Honoraria (self): Servier; Honoraria (self): Novartis; Travel/Accommodation/Expenses: Amgen. D. O'Reilly: Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Servier. R.M. Connolly: Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Puma Biotechnology; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Merrimack; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Macrogenics; Research grant/Funding (self): Pfizer. S.O. Reilly: Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self): Roche; Honoraria (self): Pfizer; Honoraria (self): Novartis. All other authors have declared no conflicts of interest.
Presenter Of 1 Presentation
- R. Mclaughlin (Limerick, Ireland)
- D. O'Reilly (Cork, Ireland)
- C. Ronayne (Cork, Ireland)
- E. Barrett (Limerick, Ireland)
- R. Kalachand (Limerick, Ireland)
- A. De Frein (Dublin, Ireland)
- B. Macanovic (Cork, Ireland)
- R. Connolly (Cork, Ireland)
- D. Power (Cork, Ireland)
- R. Bambury (Cork, Ireland)
- S. Reilly (Cork, Ireland)
- D. Collins (Cork, Ireland)
152P - Analysis of patient access to breast cancer drugs in the USA and Europe with a focus on the UK and Ireland.
Abstract
Background
Globally, there are significant disparities in patient access to breast cancer drugs. We investigate access, cost and value of these drugs in the United States (US) and Europe, focusing on the United Kingdom (UK) and the Republic of Ireland (ROI).
Methods
All breast cancer drugs approved by the FDA from 1st of January 2010 to 1st of October 2020 were included. The pathway of these drugs to license in Europe (European Medicines Agency/EMA) and reimbursement in UK and ROI was investigated. Overall survival (OS) benefit, progression free survival (PFS) benefit and cost of drugs were evaluated.
Results
There were 22 breast cancer regimens approved by the FDA since 2010. Half (n=11) of these were approved in the last 3 years. Most indications (19/22, 86%) were for metastatic disease. The majority (19/22, 86%) were also EMA approved. One in five regimens (4/19, 21%) were approved by the EMA prior to FDA. The median time from FDA to EMA approval was 6 months (Standard Deviation (SD) = 8, range -11-21). In the UK, 64% (14/22) were reimbursed and only one third were reimbursed in ROI (8/22, 36%). Median time to reimbursement in the UK and ROI following EMA approval was 11 months (SD = 10.5, Range 3-43) and 19.5 months (SD = 14.1, Range 1-46) respectively. Nine (41%) of FDA approved indications have demonstrated an OS benefit and a further 11 (50%) were approved based upon PFS benefit. Two (9%) demonstrated an overall response rate. The median price per month of all FDA approved regimens was €7608 (range €2814 – €20292). Regimens which demonstrated an OS benefit were not more expensive than those that did not (median €7608 (SD = €6112) versus €7795 (SD = €5882) respectively (p = 0.29).
Conclusions
There has been a rapid acceleration in licensing of regimens for breast cancer since 2018. Most regimens approved in the US are approved by the EMA following a 6-month time delay. Public reimbursement of these regimens is significantly limited in ROI and less so in the UK. Under half (41%) have a proven OS benefit. The absence of OS benefit is not associated with a lower drug cost. Innovative funding mechanisms are required to improve access to efficacious anticancer medications in a timely manner and at sustainable costs.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
R.A. Mclaughlin: Travel/Accommodation/Expenses: Merck; Honoraria (self): Servier; Honoraria (self): Novartis; Travel/Accommodation/Expenses: Amgen. D. O'Reilly: Travel/Accommodation/Expenses: Pfizer; Travel/Accommodation/Expenses: Servier. R.M. Connolly: Research grant/Funding (institution): Novartis; Research grant/Funding (institution): Puma Biotechnology; Research grant/Funding (institution): Merck; Research grant/Funding (institution): Merrimack; Research grant/Funding (institution): Genentech; Research grant/Funding (institution): Macrogenics; Research grant/Funding (self): Pfizer. S.O. Reilly: Travel/Accommodation/Expenses: Roche; Travel/Accommodation/Expenses: Novartis; Travel/Accommodation/Expenses: AstraZeneca; Honoraria (self): Roche; Honoraria (self): Pfizer; Honoraria (self): Novartis. All other authors have declared no conflicts of interest.