Original research
Implementing precision cancer medicine in the public health services of Norway: the diagnostic infrastructure and a cost estimate

https://doi.org/10.1136/esmoopen-2017-000158Get rights and content
Under a Creative Commons license
open access

ABSTRACT

Objective

Through the conduct of an individual-based intervention study, the main purpose of this project was to build and evaluate the required infrastructure that may enable routine practice of precision cancer medicine in the public health services of Norway, including modelling of costs.

Methods

An eligible patient had end-stage metastatic disease from a solid tumour. Metastatic tissue was analysed by DNA sequencing, using a 50-gene panel and a study-generated pipeline for analysis of sequence data, supplemented with fluorescence in situ hybridisation to cover relevant biomarkers. Cost estimations compared best supportive care, biomarker-agnostic treatment with a molecularly targeted agent and biomarker-based treatment with such a drug. These included costs for medication, outpatient clinic visits, admission from adverse events and the biomarker-based procedures.

Results

The diagnostic procedures, which comprised sampling of metastatic tissue, mutation analysis and data interpretation at the Molecular Tumor Board before integration with clinical data at the Clinical Tumor Board, were completed in median 18 (8-39) days for the 22 study patients. The 23 invasive procedures (12 from liver, 6 from lung, 5 from other sites) caused a single adverse event (pneumothorax). Per patient, 0–5 mutations were detected in metastatic tumours; however, no actionable target case was identified for the current single-agent therapy approach. Based on the cost modelling, the biomarker-based approach was 2.5-fold more costly than best supportive care and 2.5-fold less costly than the biomarker-agnostic option.

Conclusions

The first project phase established a comprehensive diagnostic infrastructure for precision cancer medicine, which enabled expedite and safe mutation profiling of metastatic tumours and data interpretation at multidisciplinary tumour boards for patients with end-stage cancer. Furthermore, it prepared for protocol amendments, recently approved by the designated authorities for the second study phase, allowing more comprehensive mutation analysis and opportunities to define therapy targets.

cost model
metastasis
molecularly targeted therapy
mutation profiling
public health services

Cited by (0)

AHR and HGR shared first authorship. GMM and KF shared last authorship.

Contributors: AHR, HGR, GAG, OCL, ALBD, GMM and KF constituted the MetAction study management. AHR, HGR, DH, SD, KB, KTH, ALBD, GMM and KF contributed to the concept and design of the study. AHR, DH, SD and KB were the study oncologists. JTØ and CJ were the study nurses. SN, LJ, CHR and EAR were the study radiologists. HGR, TS, MLI and KB were the study pathologists. IRB, VS, MS and GAG were the study laboratory engineers. EH, VN, EAR, SN and OCL were the study bioinformaticians. VN, LSP, OØ, VAF, ALBD and GMM were the study molecular biologists. AHR, EA, HL and SJS performed the cost modeling. AHR drafted the manuscript. All authors read and approved the final version.

Funding: This work was supported by the Research Council of Norway (Grant number 218325). The funding source had no role in the study design, collection, analysis and interpretation of data, or the decision to make a scientific report. All of the authors had full access to the data. AHR had the final responsibility to submit the manuscript for publication.

Competing interests: None declared.

Ethics approval: The study was approved by the Institutional Review Board at the two study centres, Oslo University Hospital-Norwegian Radium Hospital and Akershus University Hospital, the Regional Committee for Medical and Health Research Ethics of South-East Norway (reference number REK 2013/2099) and the Norwegian Medicines Agency.

Provenance and peer review: Not commissioned; internally peer reviewed.