After Prof G's recent post about about whether Natalizumab (Tysabri) will get a first line licence , this new work is interesting
Campbell et al. Comparative effectiveness of early Natalizumab treatment in JC virus-negative relapsing-remitting multiple sclerosis. Am J Manag Care. 2013;19(4):278-285
Objectives:
To estimate the long-term comparative effectiveness of first-line
treatment in patients negative for anti-JC virus (JCV) antibodies with
glatiramer acetate (GA), fingolimod, or natalizumab for
relapsing-remitting multiple sclerosis (RRMS).
Study Design: We
developed a simulation model to estimate the average 20-year clinical
risks and benefits of GA, fingolimod, and natalizumab for RRMS patients
initially negative for anti-JCV antibodies.
Methods:
Model inputs included published natural history progressions of the
Expanded Disability Status Scale (EDSS), treatment effects from
randomized controlled trials on slowing disease progression and reducing
relapse rates, risk of progressive multifocal leukoencephalopathy
(PML), and utility preference scores. Outputs were long-term risks (PML
risk and other non-PML risks), benefits (average relapse rate and time
to disability [EDSS >7]), and quality-adjusted lifeyears (QALYs).
Results:
Compared with GA, natalizumab resulted in 4.6 fewer relapses, 0.6 more
years of disabilityfree time, 0.0165 more cases of PML per treated
patient, and an incremental 1.2 QALYs gained. Compared with fingolimod,
natalizumab resulted in 1.7 fewer relapses, 0.1 more years of
disabilityfree time, 0.0165 more cases of PML per treated patient, and
an incremental 0.4 QALYs gained. The probability that incremental QALYs
favored natalizumab over GA was 0.963 and natalizumab over fingolimod
was 0.720.
Conclusions: Average
QALYs, a measure that aggregates across risks and benefits, favored
natalizumab, suggesting more aggressive early intervention with
natalizumab in the negative anti-JCV population. For certain decision
makers, more evidence may be needed to further reduce the uncertainty in
these comparative projections prior to making population-based adoption
decisions.
It looks like the EMA do need more evidence.