[Ip-health] Politico Europe: The French defy pharma over drug pricing

Thiru Balasubramaniam thiru at keionline.org
Fri Aug 28 01:52:34 PDT 2015


The French defy pharma over drug pricing

Pharma industry objects to drug’s off-label use as French seek savings.


8/27/15, 6:23 PM CET

Updated 8/28/15, 5:51 AM CET

Drugmaker Roche lost a fight with the French government on Thursday, when
the health minister ordered reimbursement of the drug Avastin to treat a
dangerous eye condition.

Roche opposes using the drug to treat wet age-related macular degeneration,
arguing that since it is not approved for the condition, only the
alternative drug Lucentis — which costs much more — should be used. Roche
developed Lucentis but it is also marketed by drugmaker Novartis.

But doctors have been prescribing the cheaper Avastin in so-called
off-label use, and the decision “will achieve significant savings,” Marisol
Touraine, minister of health, social affairs and women’s rights, said in a

The issue highlights the burgeoning debate over the price of drugs, and
government attempts to rein in health budgets. A similar fight over the
drug took place in the U.K.

The French agency for safety of medicines and health products authorized
Avastin for the treatment of wet macular degeneration in hospitals, under
strict conditions, earlier this year. Thursday’s move goes a step further,
allowing for reimbursement.

Roche objects, noting that it did not conduct any clinical trials to test
the drug for treating the eye disease, a company spokesperson told
POLITICO. All the data being used to justify the use of Avastin for the
condition came from the Comparison of Age-Related Macular Degeneration
Treatments Trials (CATT) research group, she said.

The data do seem to prove that both Lucentis and Avastin are similar in
efficacy, said Catherine Daly, senior analyst for neurology and
ophthalmology at the GlobalData Healthcare consultancy.

“The issue that arises is safety, because Avastin is not formulated for wet
age-related macular degeneration and it has to be repackaged and with that
it increases the risk of infections,” she told POLITICO.

This happened in the U.S. a few years ago, when issues at a compounding
pharmacy led to people using Avastin for the eye condition to get
infections, she said.

Pharmaceutical industry lobbies complained to the European Commission
earlier this year that EU governments had started allowing the off-label
use of medicines purely for economic reasons, when an alternative was
already available on the market. Italy was singled out by the industry at
the time.

“In doing so, they infringe and undermine the EU’s marketing authorization
system that protects the health of the public and patients by setting
detailed standards for the quality, safety and efficacy of medicines,” the
European Federation of Pharmaceutical Industries and Associations (EFPIA),
the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the
European association for bio-industries (EuropaBio) said in a statement in

The French decision is expected to reignite the debate.

An injection containing 10 milliliters of Avastin will cost €10, according
to the French law authorizing the reimbursement. The measure will start
applying on September 1, for three years, but it can be extended
afterwards.  The Roche drug Lucentis approved for the eye condition costs
substantially more.

“There are some processes that allow for off-label usage and reimbursement
when there is no alternative and when there are high unmet needs,” Daly
said. But this is not the case here.

“The off-label use of medicines for economic purposes can dis-incentivise
biopharmaceutical companies from exploring new indications to bring ever
more innovative and safe products to patients,” the pharma industry lobbies
said earlier this year.


Carmen Paun

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