Outcome-Based Pricing Feasibility in Oncology Drugs
Research type
Research Study
Full title
Making Outcome-Based Pricing a Reality in the UK – A Retrospective Comparison of Price-Based vs Outcome-Based Pricing for Trastuzamab Emantisine (Kadcyla) in Metastatic Breast Cancer.
IRAS ID
328635
Contact name
Karim Hussien El-Shakankery
Contact email
Sponsor organisation
London School of Economics
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
The availability of new systemic anti-cancer therapies (SACT) has boomed in the last 15 years, for all cancer types. As new therapies become increasingly available, they also become increasingly expensive to fund. Managed entry agreements (MEAs) are useful when decision makers express uncertainty about longer-term outcomes/benefit of medications or have concerns around drug pricing. They limit financial risk for decision-makers, alongside facilitating timely delivery of previously unaffordable medications to patients. MEAs also grant further time to collect data on uncertain outcomes.
Outcome-based pricing (OBP), a form of MEA, has been given increasing attention in recent years in both England and Scotland. With OBP, a discounted price is negotiated with the manufacturer/drug company, alongside an arrangement whereby the value of the drug would be reimbursed if the treated patient does not achieve the expected/predicted outcome. The OPB model represents an alternative to cost-based pricing (CBP), where a price (usually discounted from the list price) is paid for each unit of the drug purchased from the manufacturer, regardless of the treated patient’s outcome.
Support for OBP has been recently growing in both Scotland and England. Published literature supports its use, arguing that now our electronic health records are advanced enough to facilitate easier collecting of required outcome data. Of particular importance, the University of Edinburgh and DATA-CAN are running a feasibility project investigating the retrospective and prospective feasibility of implementing such a system in our UK healthcare systems. For both retrospective and prospective feasibility studies, haematological lymphoid malignancies are used as examples (ie not solid malignancies).
This project aims to assess, using the example of trastuzumab emtansine (T-DM1; Kadycla) in the metastatic breast cancer setting, if OBP represents a feasible funding modality for drug reimbursement in the English and Scottish National Healthcare Systems.
REC name
North of Scotland Research Ethics Committee 2
REC reference
23/NS/0060
Date of REC Opinion
11 Aug 2023
REC opinion
Further Information Favourable Opinion