[Ip-health] News & Observer (NC) Biogenerics Op-ed: A cost-cutter that's missing in health bills

[Sarah Rimmington]

http://www.newsobserver.com/opinion/columnists_blogs/story/129059.html
A cost-cutter that's missing in health bills
By Laura Musselwhite
The (Raleigh-Durham, NC) News & Observer
Published Wed, Oct 07, 2009 02:00 AM



DURHAM Earlier this year, as a medical student at Duke University, I saw
a patient with Crohn's disease, an inflammatory intestinal disease
associated with substantial disability and mortality that affects over
500,000 individuals nationwide. This patient required hospitalization
for a flare she attributed to not being able to afford the month's
Humira, a biologic medicine used to treat severe, active Crohn's disease.

The drug is priced by Abbott Laboratories at a staggering $22,000 per
year. This patient would clearly have benefited from the availability of
an affordable, generic version.

In coming weeks, while considering solutions to address accelerating
health-care costs and the 40 million uninsured Americans, Congress will
be voting on proposals built in to Senate and House versions of
health-care reform that are meant to allow cheaper, generic versions of
biologic drugs, also known as "biogenerics," to come to market.

Unfortunately, the biogenerics proposal passed by the Senate Committee
on Health, Education, Labor and Pensions in July -- co-sponsored by our
very own Sen. Kay Hagan -- will do the opposite of what the bill
purports to do, by providing significant barriers to price-lowering
generic competition. A similarly ineffective proposal can be found in
the House Energy & Commerce Committee bill.

Biologics -- a special category of drugs, derived from living organisms
-- account for about 1 in 4 new medicines and include all vaccines, the
majority of new anticancer agents and many other pharmacotherapies used
to treat relatively common diseases like diabetes and multiple
sclerosis. These drugs are the fastest-growing segment of the
prescription drug market. It is projected that they will account for 50
percent of all new drugs approved by 2014.

Biologics are also among the most expensive medicines in the world,
often costing tens of thousands of dollars per patient per year.
Examples include Roche-Genentech's Herceptin, a common drug used to
treat breast cancer, which costs upwards of $48,000, and Johnson &
Johnson's rheumatoid arthritis treatment Remicade, priced at $20,000
annually. These drugs are not getting any cheaper -- within Medicare
Part D, the prices of biologic drugs have increased at a rate of 36
percent per year, compared to 22 percent for all drugs.

Generic competition is the single best proven method of bringing drug
prices down. For biologics, generic competition is estimated to reduce
costs by about 20 to 40 percent and to save Americans $71 billion over
the next decade.

Unfortunately, the biogenerics provisions in the Senate and House bills
will thwart cost containment objectives and harm patients by giving
brand-name pharmaceutical companies an unjustified 12-year marketing
monopoly on biologics from the date of FDA approval. During this period,
the FDA is precluded from approving cheaper, generic versions. This is
in sharp contrast to conventional medicines, which get a 5-year window
of data exclusivity, despite having similar costs of research and
development.

Even more concerning, companies can make relatively inexpensive and
minor modifications to a drug, such as changing dosages or combining the
drug with other therapies, and earn another 12 years of protection from
generics -- and they can do this repeatedly. This so-called
"evergreening" strategy is common and already persistently problematic
for chemically based medicines.

Not only will these indefinite monopoly protections deter generic
biologic drugs and the cost savings that could result, but these
provisions hurt innovation of new therapies. According to the Federal
Trade Commission, these protections will likely discourage innovation of
new medicines that could address unmet medical needs.

Current biologics proposals, as they stand, will undermine one of the
primary objectives of the health-care reform -- to limit costs -- by in
many instances creating almost indefinite monopolies. This will cost
billions of dollars and more importantly, will leave expensive medicines
unaffordable to the vast majority of Americans.

A solution lies in a generic biologics proposal from Rep. Henry Waxman
of California that would grant five years of data protection, the same
given to conventional drugs, and would close loopholes that allow
companies to extend these protections indefinitely. However, these
provisions have yet to be added to health-care reform bills.

Unless these meaningful changes are made, Big Pharma has won again, and
at a price Americans will not, and in fact cannot, afford to pay.


Laura Musselwhite (laura.musselwhite@duke.edu) is a Duke medical student
and member of Universities Allied for Essential Medicines.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/

Follow me on twitter at http://twitter.com/sarahrimmington