A discrete event simulation to model the cost-utility of fingolimod and natalizumab in rapidly evolving severe relapsing-remitting multiple sclerosis in the UK

Abstract

Objective: Two disease-modifying therapies are licensed in the EU for use in rapidly-evolving severe (RES) relapsing-remitting multiple sclerosis (RRMS), fingolimod and natalizumab. Here a discrete event simulation (DES) model to analyze the cost-effectiveness of natalizumab and fingolimod in the RES population, from the perspective of the National Health Service (NHS) in the UK, is reported.

Methods: A DES model was developed to track individual RES patients, based on Expanded Disability Status Scale scores. Individual patient characteristics were taken from the RES sub-groups of the pivotal trials for fingolimod. Utility data were in line with previous models. Published costs were inflated to NHS cost year 2015. Owing to the confidential patient access scheme (PAS) discount applied to fingolimod in the UK, a range of discount levels were applied to the fingolimod list price, to capture the likelihood of natalizumab being cost-effective in a real-world setting.

Results: At the lower National Institute of Health and Care Excellence (NICE) threshold of £20,000/quality-adjusted life year (QALY), fingolimod only required a discount greater than 0.8% of list price to be cost-effective. At the upper threshold of £30,000/QALY employed by the NICE, fingolimod was cost-effective if the confidential discount is greater than 2.5%. Sensitivity analyses conducted using fingolimod list-price showed the model to be most sensitive to changes in the cost of each drug, particularly fingolimod.

Conclusions: The DES model shows that only a modest discount to the UK fingolimod list-price is required to make fingolimod a more cost-effective option than natalizumab in RES RRMS.

Keywords:

• Multiple sclerosis
• fingolimod
• natalizumab
• cost-effectiveness
• rapidly evolving severe relapsing-remitting multiple sclerosis

Transparency

Declaration of funding

This study was funded by Novartis Pharmaceuticals UK Ltd, Camberley, UK.

Declaration of financial/other relationships

NA is a paid employee of Novartis Pharmaceuticals UK Ltd, Camberley, UK. RN is a paid employee of Imperial College Healthcare NHS Trust, London, UK, and has acted as a paid consultant in the past for Biogen, Roche, Teva, Merck, and Novartis. He has also received research funds from and worked on clinical trials run by Biogen and Novartis. RN did not receive financial compensation for authorship of this manuscript. SM and JK are, and MM and DS were at the time this work was prepared, paid employees of Costello Medical Consulting Ltd, Cambridge, UK, which was contracted by Novartis to undertake some of the work. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors take full responsibility for the content of the paper. Helen Chambers, an employee of Costello Medical Consulting Ltd, Cambridge, UK, provided medical writing and editorial assistance in the preparation of this article, funded by Novartis Pharmaceuticals UK Ltd, Camberley, UK.