By Mathias Ask
Pharmaceutical companies are pushing back against decisions by
cash-strapped European governments to reimburse patients for drugs
that haven't been approved to treat their conditions.
National health boards and policy makers say paying for
so-called off-label drugs, which are often cheaper than their
approved rivals, is necessary to cut national health-care bills.
However, pharmaceutical companies argue that encouraging doctors to
prescribe medicines beyond their approved usage could harm patients
and may violate European Union law.
In June, Italy became the first EU country to allow its national
health system to pay for cancer drug Avastin when it is prescribed
to treat age-related macular degeneration, or AMD, an eye sickness
that can cause blindness. The European Medicines Agency hasn't
approved Avastin for treating AMD.
Although the price of drugs can vary widely from country to
country, Avastin typically sells for about EUR40 ($53.9) per
injection in Europe, while Lucentis, a drug that has been approved
to treat AMD, sells for around EUR900 per injection.
On Wednesday, France's National Assembly passed a law allowing
for the reimbursement of off-label medicine as an attached
amendment to its social-security budget. It specifically mentions
Avastin as an example of a drug that falls under this category. The
law could save the French as much as EUR200 million a year, said a
spokeswoman for Gerard Bapt, the Socialist lawmaker who proposed
it. Mr. Bapt is also a medical doctor and heart specialist.
Novartis AG, the Swiss pharmaceutical company that markets
Lucentis in Europe, has said it may challenge the French and
Italian decisions for violating the EU's regulatory framework. In a
statement, a company spokesman wrote "at this time we are carefully
considering all legal options."
A spokesman for the European Commission, the EU executive in
charge of enforcing the bloc's laws, declined to comment on the
French and Italian laws. However, he said the commission will
launch a study on off-label prescription later this year to
evaluate legal and scientific aspects.
Prescribing medications off-label is neither illegal nor
uncommon in Europe, but it is up to national regulators to place
restrictions on use. The EMA doesn't keep official statistics on
off-label use, but it is common in the fields of oncology,
pediatrics and ophthalmology.
When prescribing off-label, doctors typically rely on clinical
guidance by independent researchers if available or experience
suggesting that the drug is effective when treating a particular
illness.
Some experts say that drug companies are reluctant to invest in
clinical trials for less expensive drugs because there isn't enough
market potential. However, Roche Holding AG argues that Lucentis
was specifically designed to treat eye sickness and is a better
alternative than Avastin. Roche's subsidiary Genentech manufactured
both drugs.
The pharmaceutical industry is worried that the moves by two of
Europe's biggest economies will create a domino effect across the
continent and further encourage off-label use to control costs.
Since 2010, a number of European countries including Spain, Italy,
France, Greece and Ireland have had to cut their health-care
spending.
In May, Richard Bergstrom, the director of European Federation
of Pharmaceutical Industries and Associations, wrote a letter to
Paola Testori Coggi, director general for health and consumers at
the European Commission, expressing his concern over what he called
the promotion of off-label use by European health-care bodies. Mr.
Bergstrom asked the commission to meet with an EFPIA delegation,
which Ms. Testori Coggi accepted. A specific date for the meeting
hasn't yet been set.
Roche said it is "our obligation to inform the medical community
including physicians and patients about the known risks associated
with the off-label uses of our medicines." They said they support
the position taken by EFPIA that the decision to prescribe
off-label medications should be based on medical needs, not
financial considerations.
Roche and Novartis have come under scrutiny after Italian
antitrust authorities ruled that they were colluding to push
doctors to prescribe Lucentis rather than Avastin. Earlier this
year, the Italian government decided to seek EUR1.2 billion in
damages from the two companies. The Italian antitrust body said the
companies presented Avastin as riskier than Lucentis to increase
prescriptions for the more expensive approved drug.
Novartis strongly denied the allegations of anticompetitive
practices and Roche said the claim was groundless.
Stanimir Hasurdjiev, a board member of the European Patients
Forum, an organization that campaigns for patient safety, said
off-label drugs shouldn't be prescribed simply because a government
faces financial problems. But he said in the case of Avastin there
is sufficient proof that it can effectively treat AMD.
"We have enough data published in high-impact scientific
magazines from independent researchers showing that the product is
safe enough and an effective alternative," he said.
According to Mr. Hasurdjiev, off-label use of Avastin is
critical to countries such as his native Bulgaria, where the
national health-care provider doesn't pay for Lucentis and
patients, many of whom are old people on low state-pension income,
can't afford to pay for the more expensive drug out of their own
pockets. This leaves doctors with little choice.
"Doctors can take the risk," Mr. Hasurdjiev said. "Or wait until
the patient goes blind."
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