Time to access to novel anticancer drugs and the correlation with ESMO-Magnitude of Clinical Benefit Scale in Slovenia

ABSTRACT

Objectives: Timely access to novel anticancer drugs is challenging and value frameworks such as the European Society of Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) could assist in drug prioritization. We assessed the overall time to access to novel anticancer drugs in Slovenia and its correlation with ESMO-MCBS scores.

Methods: Anticancer drugs with European Medicines Agency marketing authorization (EMA MA), applying for national reimbursement approval (NRA) in the period 2008–2018 with assigned ESMO-MCBS score, were included. Publically available data from EMA and the Slovenian National Health Insurance Institute were used for time calculations.

Results: Among 53 studied drugs; a majority (47) of them obtained reimbursement approval within the observed time. The median time to EMA MA was 397 (range 98–615) days with the NRA requiring additional 422 (range 154–892) days. Neither time to EMA MA nor NRA correlated with ESMO-MCBS substantial clinical benefit (p = 0.332 and p = 0.965, respectively).

Conclusions: In Slovenia, time to access to novel anticancer drugs exceeds two years and, more importantly, is equally long for drugs with or without substantial clinical benefit. Integration of the ESMO-MCBS into reimbursement deliberations could improve access to drugs with substantial clinical benefit.

KEYWORDS:

• Anticancer drugs
• value frameworks
• ESMO-MCBS
• reimbursement decision
• drug access

Article highlights

• The rapidly increasing number of expensive anticancer drugs with variable clinical benefit challenges the sustainability of healthcare systems. Value frameworks, such as the European Society of Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS), facilitate the assessment of drugs’ clinical benefit and may assist healthcare authorities in prioritizing drugs for regulatory and reimbursement review.

• This study found that median time to access to novel anticancer drugs in Slovenia exceeds two years; requiring in median 397 days (range 98 – 615 days) for European Medicines Agency’s marketing authorization (EMA MA) and additional 422 days (range 154 – 892 days) for national reimbursement approval (NRA).

• Most importantly, no correlation between EMA MA or NRA times and substantial vs. non-substantial clinical benefit scores according to ESMO-MCBS was found.

• For cancer patients an average two years lag time between development and access to novel anticancer drugs, as reported herein, is not acceptable. To ensure rapid access to clinically relevant drugs while maintaining the sustainability of healthcare systems, more stringent reimbursement considerations should be applied for drugs lacking substantial clinical benefit while the review of drugs with substantial clinical benefit should be expedited.

Declaration of interest

T Cufer discloses honoraria for lectures and advisory boards from AstraZeneca, Roche, Pfizer, MSD, BMS, Boehringer Ingelheim, outside the submitted work. U Janzic discloses honoraria for lectures and advisory boards from Pfizer, Astra Zeneca, outside the submitted work. L Knez discloses honoraria from Lek, Novartis and Pfizer, outside the submitted work. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Conception and design: UJ, LK, TC. Analysis and interpretation of the data: UJ, LK, AJ, TC. Drafting of the paper: UJ, LK. Revising critically for intellectual content: AJ, TC. Final approval of the version to be published: UJ, LK, AJ, TC. All authors agree to be accountable for all aspects of the work.

Additional information

Funding

This paper was not funded.