4365 - Time to access to novel anticancer therapies in Slovenia in view of the ESMO-MCBS scores

Background

In EU, novel anticancer drugs must obtain an EMA marketing authorization (EMA MA) through a centralized procedure, while their reimbursement is not centralized, thus leading to different lag times in drug access for EU citizens. In Slovenia, the reimbursement procedure is within the jurisdiction of the National Health Insurance Institute. ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) was developed to aid oncologists and patients in informed treatment decisions, but may also assist health care authorities in decision-making. Therefore, time to EMA MA and reimbursement in Slovenia were assessed in relation to ESMO-MCBS.

Methods

Anticancer therapies for solid tumors with ESMO-MCBS scores determined by the ESMO expert panels and published until Dec 31^st 2017 were reviewed. Drugs reimbursed before Jan 1^st 2008 and before Jan 1^st 2012 for oral and parenteral drugs, respectively, were excluded due to lack of publically available data on reimbursement in Slovenia. Data on EMA MA and reimbursement were retrieved from www.ema.europa.eu and www.zzzs.si. Data lock was Mar 15^th 2018.

Results

Overall, 51 anticancer therapies were authorized by EMA: 39 targeted, 9 immunotherapy, 3 cytostatic with each drug indication evaluated separately. Until data lock, 46/51 therapies passed national reimbursement, 1 was rejected at reimbursement and 4 were pending reimbursement decision. Of the 46 reimbursed drugs, 24 had a high ESMO-MCBS score (A-B, 4-5), indicating a substantial clinical benefit, and 22 had a low ESMO-MCBS score (C, 1-3). Their median time to EMA MA was 398 d (98 - 615 d) with no difference between high vs low ESMO-MCBS (377 vs 398 d). Median time to national reimbursement was 429 d (154 - 892 d) again with no difference between high vs low ESMO-MCBS (451 vs 416 d). This resulted in a total median time to drug access of 762 d (373 – 1426 d).

Conclusions

Although most novel anticancer therapies are available in Slovenia, the median times to EMA MA and to reimbursement decision are above one year each. This is well overdue for cancer patients. Neither time seem to differ by ESMO-MCBS, possibly because the majority of drugs was not assigned a score at the time of decision-making. Hopefully, a better integration of ESMO-MCBS is forthcoming.

Clinical trial identification

Legal entity responsible for the study

All authors are responsible for the conduction of the study and its results.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

T. Cufer: Advisory boards and/or provided lectures: AstraZeneca, Boehringer-Ingelheim, BMS, Roche, MSD, Pfizer. All other authors have declared no conflicts of interest.