Objective: Fingolimod has been shown to be more efficacious than interferon (IFN) beta-1a, but at a higher drug acquisition cost. The aim of this study was to assess the cost-effectiveness of fingolimod compared to IFNbeta-1a in MSers diagnosed with relapsing-remitting multiple sclerosis (RRMS) in the United States (US).
Methods: A Markov statistical model comparing fingolimod to intramuscular IFN beta-1a using a US societal perspective and a 10-year time horizon was developed. The investigators assumed a cohort of 37-year-old patients with RRMS and a EDSS score of 0-2.5. Data sources included the Trial Assessing Injectable Interferon versus FTY720 Oral in Relapsing-Remitting Multiple Sclerosis (TRANSFORMS) and other published studies of MS. Outcomes included costs in 2011 US dollars, quality-adjusted life years (QALYs), number of relapses avoided and incremental cost-effectiveness ratios (ICERs).
Results: Compared to IFN beta-1a, fingolimod was associated with fewer relapses (0.41 versus 0.73 per patient per year) and more QALYs gained (6.78 versus 5.95), but at a higher cost ($565,598 vs. $505,234).This resulted in an ICER of $73,975 per QALY. Results were most sensitive to changes in drug costs and the disutility of receiving IFN beta-1a. Monte Carlo simulation demonstrated fingolimod was cost-effective in 35% and 70% of 10,000 iterations, assuming willingness-to-pay thresholds of $50,000 and $100,000 per QALY, respectively.
Limitations: Event rates were primarily derived from a single randomized clinical trial with one-year duration of follow-up and extrapolated to a 10-year time horizon. Comparison was made to only one disease modifying drug - intramuscular IFN beta-1a.
Conclusion: Fingolimod use is not likely to be cost-effective compared to IFN beta-1a unless fingolimod cost falls below $3,476 per month or a higher than normal willingness-to-pay threshold is accepted by decision makers.
Limitations: Event rates were primarily derived from a single randomized clinical trial with one-year duration of follow-up and extrapolated to a 10-year time horizon. Comparison was made to only one disease modifying drug - intramuscular IFN beta-1a.
Conclusion: Fingolimod use is not likely to be cost-effective compared to IFN beta-1a unless fingolimod cost falls below $3,476 per month or a higher than normal willingness-to-pay threshold is accepted by decision makers.
"What is a QALY?"
Definition: The quality-adjusted life year (QALY) is a measure of disease burden, including both the quality and the quantity of life lived. It is used in assessing the value for money of a medical intervention.
"The fact that fingolimod was so much more expensive than IFNbeta in the UK is why it had such a hard time getting NICE approval. Obviously the price the NHS now pays for fingolimod has made it cost-effective. At some point payers in other countries, including the USA, will wake-up to the impact NICE is having on drug pricing and start demanding price reductions. It's inevitable!"
"There will still enough fat in the bottom line for pharma business to remain profitable. However, in certain higher risk areas a financial carrot may need to be use to incentivise Pharma to invest and take the necessary risks to address the need."
Additional reading: Bandolier - evidence-based thinking about healthcare
CoI: multiple