Funded by Jan Wallanders and Tom Hedelius stiftelse (Handelsbanken's research foundation).
Most newly approved cancer drugs don't have clinical data demonstrating that they make patients live longer and/or better. Instead, the approvals are increasingly based on early surrogate endpoints that are argued to predict patient-centric improvements later on. In Sweden, following the regulatory approval by EMA, an assessment is made by the Pharmaceutical Benefits Agency (TLV), which decides if the drug will be reimbursed and introduced in routine healthcare at the price set by the producer. TLV are by law mandated to consider factors such as unmet need, clinical effectiveness, and cost-effectiveness. In this project, we evaluate the clinical and cost-effectiveness data used to make such reimbursement decisions and how they relate to the price and subsequent cost to the healthcare system (and tax-payers). We also evaluate the quality of the underlying clinical trial data measurement and analysis and identify areas for improvement.
The Research Team
Mikael Svensson | Gabriella Chauca Strand | Naimi Johansson | Niklas Jakobsson | Carl Bonander
Journal Publications
Reports
Höga kostnader och låg patientnytta ‒ att värdera insatser i hälso- och sjukvård (SNS-rapport)
Talks & Conference Presentations (selection)
Division of Oncology, Sahlgrenska University Hospital (2023-12-08): Evidens för effekt och kostnadseffektivitet av nya cancerläkemedel - utmaningar från ett hälsoekonomiskt perspektiv
Program- och Prioriteringsrådet för Västra Götalandsregionen (2023-10-13, Gothenburg): (O)tillräcklig evidens kring effekt och kostnadseffektivitet av nya cancerläkemedel?
ISPOR (2023-05-08, Boston): Measurement and Analysis of Health-Related Quality of Life Data in Cancer Drug Trials: A Review of Post-Reimbursement Data
SHEA (2023-04-25, Stockholm): (O)tillräcklig evidens kring effekt och kostnadseffektivitet av nya cancerläkemedel?
EuHEA (2022-07-06, Oslo): The clinical- and cost-effectiveness evidence of reimbursed cancer drugs
Media Coverage (selection)
Forskare ifrågasätter nyttan med nya läkemedel, Svenska Dagbladet (2023-08-21)
Krävs bättre kontroll av nya cancermediciner, Sveriges Radio (2023-08-19)
Stora resurser läggs på ineffektiv vård, Svenska Dagbladet (2022-03-28)