Drug pricing is now a regular headline feature. The past year
saw Valeant, Mylan, Pfizer and United Health receive unwanted attention around
seemingly unjustifiable increases in the prices of patent-expired medicines and
a promise from the Trump presidency that the soaring cost of medicines would be
brought under control.
Spiralling prices impact on all medical conditions, but the fair pricing of cancer drugs is particularly emotive. The six-figure
cost of newer therapies is straining public and private healthcare systems. Stiff
co-payments impose an often intolerable burden on US cancer patients and their
families and high pricing restricts access to cancer drugs in less-developed
economies.
Cancer drug development is expensive. Newer treatments target
particular mutations or other aberrations specific to certain tumour types,
with the consequence that the accessible patient population is reduced to a subset
of cancer sufferers.
Developers argue, reasonably enough, that pricing must cover
the expanding cost of development and still generate sufficient profit for
reinvestment in R&D. The costliest of cancer drugs can still represent good
value if treatment outcomes, such as increased survival or measurable
improvement in quality of life over best standard of care can be expected for the
majority of treated patients, but a large and growing body of evidence points
to a serious disconnect between cancer drug pricing, clinical efficacy and true
value.
An analysis published
this month by Vivot and colleagues compared the clinical efficacy of cancer
treatments approved by the FDA between 2000 and 2015 using measures of clinical
benefit developed by American Society of Clinical Oncology (ASCO) and the
European Society for Medical Oncology (ESMO).
Evaluation was possible for 37 of the 51 drugs approved by
the FDA. ESMO criteria indicated that just over one-third of drugs (13 or 35%)
showed “meaningful clinical benefit”. The scale of benefit obtained by applying
ASCO criteria was in the range 3.4 to 67, with a median value of 37. No
relationship was indicated between benefit and price.
A similar study by Salas-Vega and colleagues at the London
School of Economics found that cancer drugs approved in the decade to 2013
resulted in no discernible increase in overall survival for certain cancers
(breast cancer being a notable exception), with all new drugs contributing an
average gain in overall survival benefit of just under three and a half months.
Blaming the situation on drug company rapaciousness is naive,
although it’s clearly in the industry’s interest to be viewed by both governments
and the public as part of the solution. Alignment of pricing and outcome needs
a major shift in the basis for drug approval (one that may not be compatible
with President Trump’s vision of a truncated FDA approval process), along with
a better understanding on the part of prescribers, payers and patients of
cancer drug benefit in the context of toxicity, quality of life and individual
and societal cost.
Future cancer treatments may perhaps be truly
transforming, with functional cure becoming a realistic expectation. Science
aside, the challenge will be in developing equitable payment mechanisms that
reward innovation without placing cancer treatments out of reach of the
majority.
Clinical Benefit, Price and Approval Characteristics of FDA-approved New Drugs for Treating Advanced Solid Cancer, 2000-2015. A Vivot et al. Ann Oncol mdx053. https://doi.org/10.1093/annonc/mdx053. http://tinyurl.com/j4uhv3f
Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines. Sebastian Salas-Vega, Othon Iliopoulos and Elias Mossialos. JAMA Oncol. Published online December 29, 2016. doi:10.1001/jamaoncol.2016.4166. http://tinyurl.com/glo9gvz
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