[Ip-health] Guardian: Health secretary urged to tear up patent on breast cancer drug

Thiru Balasubramaniam thiru at keionline.org
Wed Sep 30 20:52:56 PDT 2015


Health secretary urged to tear up patent on breast cancer drug

Medics and campaigners call on Jeremy Hunt to act after NHS decides Kadcyla
treatment is too expensive

Sarah Boseley Health editor

Thursday 1 October 2015 00.01 BST

The health secretary, Jeremy Hunt, has been challenged by a coalition of
cancer patients, clinicians and campaigners to effectively tear up the
patent on a breast cancer drug that has been dropped from the NHS because
of its cost and allow the import or manufacture of a cheap generic copy.

The radical demand is reminiscent of what happened with Aids drugs in the
early 2000s. The cocktail of antiretroviral medicines that now keeps
millions of people with HIV alive was unaffordable in the developing world
until a legal loophole was found enabling generics companies in India to
make cheap copies.

The drug, Kadcyla, known generically as T-DM1, will not be available to new
patients with advanced breast cancer from November on the NHS, although
those already on it will be able to continue getting it.

It has been turned down for NHS use by the National Institute for Health
and Care Excellence (Nice). Recently NHS England dropped it from the list
that the Cancer Drugs Fund – set up to pay for drugs Nice rejected – is
willing to reimburse.

Kadcyla offers an extra six months of life to women with the HER2 type of
breast cancer for whom Herceptin no longer works. However, the price tag is
seen as excessive. Nice said the cost was £90,000 a year, although the
manufacturer, Roche, claimed it was closer to £70,000. Either way, the cost
is well above the ceiling deemed acceptable by Nice even for end-of-life

Cancer charities condemn NHS England for axing medicines

Read more

The Coalition for Affordable T-DM1 sent its letter to Hunt as the UK’s
biggest breast cancer charity launched a petition appealing to Roche to
bring the price of Kadcyla down.

Breast Cancer Now said the Cancer Drugs Fund’s decision had led to distress
and despair from patients who may need Kadcyla in the future. It is thought
that about 1,500 women could benefit from it each year.

“Time is running out for patients living with incurable secondary breast
cancer for whom Kadcyla would be their next treatment option,” said Lady
Morgan, the chief executive of Breast Cancer Now.

“The situation is becoming increasingly desperate – it’s time for Roche to
act, and make this one-of-a-kind treatment available at a price that the
NHS can afford.


“We need a completely overhauled system of pricing and access, but until
this is finally in place, Roche must do the right thing and take steps to
keep this amazing drug available through the Cancer Drugs Fund.”

The letter from the coalition calls for measures that would allow access
not only to Kadcyla but also to other expensive drugs at a lower price in
the future.

“We propose an approach that addresses the effects of a drug’s monopoly,
when prices are unreasonable and/or unaffordable as a result, and which
creates a more sustainable model for innovation and access going forward,
as the population of the UK ages, and medical science provides new hope for
treating disease,” it says.

The letter argues that the UK government can invoke crown use provisions in
the Patents Act 1977 to disregard the patent on the drug in the national
interest. It could allow the generic manufacture or import of Kadcyla
without the permission of Roche, subject to affordable compensation for the

“The time has come to challenge pharmaceutical manufacturers charging ever
higher prices for important medicines because they can,” said Philippa
Saunders of the Union for Affordable Cancer Treatment.

“This proposal achieves something subtle but significant: it creates a
choice. The status quo is no longer simply the default, it becomes an
explicit decision which must be justified,” said Chris Redd of the
Peninsula College of Medicine and Dentistry in Plymouth.

“It becomes a decision with which the British public can hold the
government to account.

“There are 1,500 UK citizens living with breast cancer right now who could
be kept alive by this medication. The solutions are all there in the
document. The only question that remains is whether our government is more
interested in protecting its citizens or the shareholders of a
multinational drug company.”

In response to the Breast Cancer Now petition, Deborah Lancaster, the
director of Roche Products, said it was still negotiating with NHS England.

“Although we understand the financial pressures NHS England is under,
patients in the UK should not be denied access to innovative and clinically
effective medicines that are routinely available to patients in Europe,”
she said in a statement.

She said Roche had offered NHS England £15m of savings on four medicines
that the Cancer Drugs Fund currently pays for and called for its reform.

“We need to work together to put in place a pragmatic, flexible and
sustainable system – one that puts patients first and one that works for
clinicians, government, the NHS, patient groups and companies,” she said.

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