The pharmaceutical industry has recently
developed several drugs that produce remarkable benefits in certain cancers.
These include both small molecules and monoclonal antibodies or other
macromolecules. However, in some cases
these life saving drugs come with astronomical price tags of $100,000 per year
or more. Patients and insurers have long been concerned about these costs, but
now oncologists have also started to rebel (1). This began with a group of
physicians at Sloan Kettering cancer center in NY who objected to the high
price of Zaltrap®, a new drug from Sanofi. It has since spread, and many
oncologists support a commentary in the April 25 issue of the journal Blood (2) advocating for lower drug
prices. In addition to Sanofi, criticism has been leveled at Novartis the maker
of Gleevec®, as well as at other producers.
One of the problems in this area is the
increasingly fragmented nature of the cancer drug market. As studies in cancer
genomics have progressed the existence of multiple cancer subtypes has emerged,
with each potentially requiring a different therapeutic approach. One of many examples of this is the recently
published study of endometrial carcinoma (3) that has divided this disease into
four distinct categories and also revealed previously unsuspected relationships
to some forms of breast and ovarian cancers. Unlike ‘classic’ cytotoxic
anticancer drugs like doxorubicin that are used in a variety of cancers, many
of the newer agents are highly selective for particular cancer subtypes. Since
each subtype involves far fewer patients than previous broader cancer
classifications, the industry response has been to raise prices. The argument,
of course, is that this is necessary to cover R& D costs.
The issue of drug pricing came to the fore at
the recent Biotechnology Industry Association meeting in Chicago, as reported
in C&EN (4). Business oriented consults advocated that drug and biotech
companies carefully consider future value and reimbursement issues before
proceeding too far down the development pathway. However, this approach would
put profit considerations squarely in opposition to the advance of science. As
understanding of cancer (and other diseases) advances rapidly it should become
possible to design drugs that have dramatic impacts on individual disease
subtypes. Gleevec® is the current hallmark of this, since it has revolutionized
therapy of chronic myelogenous leukemia but is useful only in this disease plus
a few rarer cancers.
We seem to be coming to a sort of end game with
current models of cancer drug development.
Patients need advanced drugs but our health system cannot sustain
outrageous costs. Some new ideas about drug development strategies have been
published recently (5) and more thought needs to be given to this critical
area.
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