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 The government quietly introduced the measure
allowing pharmacists to substitute prescribed brand-name biotech
drugs with cheaper, similar versions in its 2014 healthcare budget.
The move, which still needs a decree to come into effect, could cut
the cost of providing complex biological medicines to patients with
conditions like cancer, kidney disease and rheumatoid arthritis. But
it poses a threat to makers of original products that are
particularly reliant on sales of such drugs, such as Roche and
Amgen.
France is the first European country to pursue biologic
substitution, and governments across the continent, grappling with
rising healthcare costs, may be tempted to follow if the measure is
a success. But there are still major uncertainties as to whether it
will really move the dial in encouraging use of so-called
biosimilars, which have been slow to take off.
In particular, it only applies when patients are starting out on a
new course of treatment and doctors will still be able to demand the
original branded product on their prescriptions.
Nonetheless, the move goes further than efforts by other countries
to encourage use of cut-price biosimilars, including a scheme of
regional quotas for use of biosimilars in Germany.
"It's significant because it is the first such law in Europe to
specifically permit pharmacy substitution, but it remains to be seen
how much impact it will have in practice," said Maarten Meulenbelt,
a partner at law firm Sidley Austin in Brussels.
"Depending on how it is implemented, it could have a knock-on effect
by encouraging other EU member states to consider whether to do the
same."
BIG PHARMA LOBBYING
Large drugmakers including Sanofi, Roche, Amgen and Hospira, furious
not to have been consulted before the law was passed, are now
meeting with government officials, doctors and pharmacists to
discuss the decree's details.
The working group is due to give non-binding recommendations in
June, and a decree could come a few months later. A spokeswoman for
France's health administration declined to comment on how the talks
were progressing.
"The fact that the government surreptitiously introduced this
measure has deeply upset the industry," said Philippe Lamoureux,
head of French pharmaceutical trade association Leem. He said the
measure would make France a less attractive investment destination
for pharmaceutical companies.
"We often complain that France and its regulations are
incomprehensible and unpredictable, but what happened with
biosimilars is a caricature of that."
Biotech drugs are among the most expensive on the market, often
costing tens or even hundreds of thousands of dollars a year per
patient. That represents big profits but also big potential savings
if they can be swapped for cheap copies.
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Eight of the world's top 10 prescription drugs by revenue are now
biotech products, according to Thomson Reuters data. Pharmaceutical
companies have been banking on these drugs in recent years to help
offset the hit of patent losses on chemical drugs that are easier to
copy. Creating copies of biologic drugs is tricky because they are
produced in living cells, so copycat versions can only ever be
"similar", not exact replicas as with simple chemical drugs.
LIMITED SAVINGS?
For France, whose healthcare budget and public deficit have
ballooned in recent years, encouraging the use of biosimilars
costing some 20-30 percent less than the original product could mean
savings worth looking at.
Claude Le Pen, an economist at Paris-Dauphine university who works
for IMS Health, estimates biosimilars could save France between 500
million euros and 1 billion euros ($690 million -$1.4 billion) by
2020, by which time patents will have expired on a raft of biotech
drugs.
But substitution will only apply to retail pharmacies,
significantly limiting the potential for savings, since over 40
percent of biotech prescriptions are filled in hospitals.
The measure also implies cumbersome checks for pharmacists, which
could be an obstacle. Given the little incentives they have in
selling cheaper drugs, the government should instead focus on
educating prescribers and patients, says Le Pen.
"If a pharmacist tells a patient with breast cancer 'I'm going to
change the treatment your doctor prescribed', you can imagine she
might get worried," he said. "The government is putting the cart
before the horse in trying to bypass the prescriber, who is in fact
the key to success."
Paul Greenland, vice-president for biologics at Hospira, which
recently launched the first antibody-based biosimilar in Europe,
believes biosimilars will ultimately find success with time — and
practice.
"The more doctors use these products, the more confident they are
that biosimilars are really no different from the original
biologics," he said.
 ($1 = 0.7234 euros)
(Additional reporting by Ben Hirschler in London; editing by Tom
Pfeiffer)
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