LONDON (AP) - Drug maker Novartis is taking legal action in
Britain to make state-run hospitals use an eye drug that costs
about 700 pounds ($1,130) per shot instead of a cheaper one that
costs 60 pounds ($97).
In a statement, Novartis said it was calling for a judicial
review "as a last resort" because it believed patient safety was
being potentially compromised.
According to the U.K.'s health watchdog, Novartis' Lucentis is
the only drug recommended to treat the eye problem macular
degeneration in the country's state-run National Health Service
However, several NHS hospitals have been prescribing the much
cheaper Avastin, a cancer drug made by Genentech Inc., a subsidiary
of Roche, for the same problem even though it has not been
A study published in the New England Journal of Medicine last
year showed Avastin worked just as well as Lucentis for treating
the eye disorder.
Lucentis and Avastin act on the same biological protein in the
body to spur blood vessel growth. In the U.S., eye doctors have
often used tiny amounts of Avastin and billed the government for
the cost, rather than buying Lucentis.
Most U.K. doctors only prescribe drugs approved by the health
watchdog, but have the discretion to use other treatments if they
believe they are warranted.
Britain's drug regulator has not approved Avastin for eye
diseases, so it has not been considered by the health service's
advisory agency, known as NICE, for this use.
NICE makes decisions based only on cost-effectiveness and agency officials said they would need help from the drug regulator to decide whether Avastin should be used for patients with macular degeneration.
Last year, four hospitals in southern England decided they would
pay for Avastin when it was prescribed by a doctor.
In a statement Tuesday, Novartis AG said it was demanding a
judicial review to make the hospitals use Lucentis rather than
Novartis said it was concerned patients and clinicians were
being pushed to use an unlicensed medicine in order to cut costs.
Britain's coalition government has mandated that its National
Health Service trim $20 billion ($31 billion) from its budget by
2015 as part of a national austerity drive.
"It is unacceptable to put the safety of patients at risk
through the widespread use of an unlicensed treatment when a
licensed medicine is available," the pharmaceutical company said.
Novartis noted there was "emerging evidence" of safety concerns
for using Avastin to treat eye problems.
Patient groups called for an independent analysis to determine
which drug should be used. "If Avastin is not as safe as Lucentis,
no one should be using it," said Helen Jackman, chief executive of
the Macular Disease Society. "If it is as good, perhaps everyone
should be using it."
Alexander Klauser, a Roche spokesman, said the company was so
far only pursuing studies for Avastin for cancer treatments, rather
than eye diseases. "No studies have been done for Avastin and
(macular degeneration) and this is not the plan."
Klauser said the company thought Avastin's biggest potential was
in cancer treatments and that there is still a large "unmet need"
for the drug. He said it was ultimately up to physicians whether to
prescribe Lucentis or Avastin.
Meanwhile, others slammed Novartis for its decision to go to the
Companies like Novartis should not be in the position to block
moves to more cost-effective treatments in order to maximize their
profits," said John Harris, of the Institute for Science Ethics
and Innovation at the University of Manchester, in a statement. He
said it was legitimate for health providers to use treatments that
were much cheaper than ones that were already licensed.
Genentech developed both Avastin and Lucentis, but Novartis has
exclusive rights on Lucentis outside the U.S.