Evidence Project - Mikael Svensson

Project Overview

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 (for prescription cancer drugs) 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.

Research Team

Mikael Svensson Principal Investigator
Gabriella Chauca Strand PhD Student • University of Gothenburg
Naimi Johansson Co-Investigator • Karolinska Institute
Niklas Jakobsson Co-Investigator • Karlstad University
Carl Bonander Co-Investigator • University of Gothenburg

Journal Publications

Analyses of Quality of Life in Cancer Drug Trials - A Review of Measurements and Analytical Choices in Post-Reimbursement Studies
Mikael Svensson, Gabriella Chauca Strand, Carl Bonander, Naimi Johansson and Niklas Jakobsson
BMC Cancer, 2024, 24: 311
Assessment of the clinical and cost-effectiveness evidence in the reimbursement decisions of new cancer drugs
Gabriella Chauca Strand, Carl Bonander, Niklas Jakobsson, Naimi Johansson and Mikael Svensson
ESMO Open, 2022, 7: 100569
Cancer Drugs Reimbursed with Limited Evidence on Overall Survival and Quality of Life: Do Follow-Up Studies Confirm Patient Benefits?
Gabriella Chauca Strand, Naimi Johansson, Niklas Jakobsson, Carl Bonander and Mikael Svensson
Clinical Drug Investigation, 2023, 43: 621-633

Reports

Höga kostnader och låg patientnytta ‒ att värdera insatser i hälso- och sjukvård
SNS Report, 2022

Selected Presentations

Division of Oncology, Sahlgrenska University Hospital (2023-12-08): Evidens för effekt och kostnadseffektivitet av nya cancerläkemedel - utmaningar från ett hälsoekonomiskt perspektiv
ISPOR, Boston (2023-05-08): Measurement and Analysis of Health-Related Quality of Life Data in Cancer Drug Trials: A Review of Post-Reimbursement Data
SHEA, Stockholm (2023-04-25): (O)tillräcklig evidens kring effekt och kostnadseffektivitet av nya cancerläkemedel?
EuHEA, Oslo (2022-07-06): The clinical- and cost-effectiveness evidence of reimbursed cancer drugs

Media Coverage (Selection)