[Ip-health] Guardian: Drugs watchdog condemns Roche for high price of breast cancer therapy

Thiru Balasubramaniam thiru at keionline.org
Fri Aug 8 02:08:18 PDT 2014


http://www.theguardian.com/society/2014/aug/08/drugs-watchdog-nice-roche-breast-cancer-nhs-limit

Drugs watchdog condemns Roche for high price of breast cancer therapy

Regulator Nice unable to approve £90,000 drug exceeding NHS limit, but
pharmaceuticals firm calls UK funding system 'broken'


   - *Sarah Boseley* <http://www.theguardian.com/profile/sarahboseley>,
   health editor
   - The Guardian <http://www.guardian.co.uk/theguardian>, Friday 8 August
   2014


The pharmaceuticals giant Roche has been criticised in unprecedented terms
by the government's drugs watchdog for refusing to significantly lower the
price of a breast cancer
<http://www.theguardian.com/society/breast-cancer> drug
whose £90,000-per-patient cost is well over the NHS
<http://www.theguardian.com/society/nhs>'s limit.

The National Institute for Health and Care Excellence (Nice)
<http://www.theguardian.com/society/the-national-institute-for-health-and-care-excellence-nice>,
says it cannot recommend the drug, Kadcyla, which promises extra months of
life for women with advanced breast cancer
<http://www.theguardian.com/society/cancer>, because of Roche's
inflexibility.

But the company hit back, saying the pricing row showed that the system of
cancer drug regulation was "broken".

The system set up by the coalition in 2010 means that, although hospitals
will not buy Kadcyla for their pharmacies, individual doctors
<http://www.theguardian.com/society/doctors> can apply to the separate
£600m-a-year Cancer Drugs Fund that pays for treatments Nice regards as too
expensive. As a result, some patients may get the drug because their
doctors believe in it, while others will be denied. Critics say that is
unfair and allows companies such as Roche to continue to charge high prices.

Nice had warned Roche in April that it could not sanction the drug for NHS
use because of the cost, and called on the Swiss-based company to think
again. Nice says on Friday that Roche has not made any serious attempt to
reduce the price. "Although Roche proposed a discount to the full list
price of Kadcyla, it made little difference to its value for money, leaving
it well above the top of our specially extended range of cost-effectiveness
for cancer drugs," said Sir Andrew Dillon, Nice's chief executive.

"We are really disappointed that Roche were not able to demonstrate more
flexibility to help us make a positive recommendation. The company is well
aware that we could not have recommended Kadcyla at the price it proposed."

Nice decides on whether medicines are cost-effective for the NHS to buy.
The watchdog cannot approve drugs for use in the NHS that cost more than
£30,000 per patient, but is prepared to raise that ceiling to £50,000 for
end-of-life treatments such as Kadcyla.

Breast cancer charities, which normally side with the manufacturers of new
medicines, said they regretted Nice's decision, but some said they
understood and called for drug companies to lower their prices.

"Kadcyla is a brilliant drug, but it's also incredibly expensive," said
Sally Greenbrook of Breakthrough Breast Cancer. Nice had gone "over and
above their usual processes to try to approve it", she said. "Prices set by
the pharmaceutical industry for impressive, life-extending drugs such as
Kadcyla must come down. It's impossible to put a price on life's precious
moments. But it's not impossible to put a fair price on drugs."

However, Roche's general manager, Dr Jayson Dallas, hit back at Nice,
saying the rejection "demonstrates quite simply that their current system
is broken, not fit for purpose and in need of a complete overhaul when it
comes to advanced cancer".

It was the eighth consecutive drug for advanced breast cancer rejected by
Nice, he added, noting that Kadcyla was selling at the set price in the
Nordic countries, Switzerland and Austria. But Roche is perceived by many
to be out of line with the rest of the UK pharmaceuticals industry
<http://www.theguardian.com/business/pharmaceuticals-industry>, which is
increasingly trying to work with Nice rather than against it.

Roche, whose then chief executive and lobbyists were closely involved prior
to the 2010 election in the setting up of the Cancer Drugs Fund, is the
fund's biggest beneficiary. Around a quarter of all applications to the
fund are for Roche's Avastin, a drug rejected by Nice for both breast and
bowel cancer.

The situation is unsustainable, say critics. The Cancer Drugs Fund is
overspent and effectively undermines the judgements made by Nice, because
it will pay for drugs that are rejected by its expert panels on the grounds
not just of cost but efficacy as well.

Professor Richard Sullivan, director of the institute of cancer policy at
King's College London's centre for global health, said the fund was neither
fair nor useful, because it did not collect data on the outcomes for
patients. "I have always thought it grossly unfair to other diseases that
cancer should have a short-circuit around Nice," he said. "You know - you
failed the Nice threshold but by the way, we'll still pay for it.

"I was disappointed with the charities that failed to critically look at
the issues around pricing and the failure of cancer drugs to deliver better
improvements in outcomes. Companies are setting their prices too high and
we're getting less return in terms of progression-free disease survival for
increasing cost in a small population. The fund has really missed the
point."Key to the establishment of the Cancer Drugs Fund was an inquiry,
commissioned by the Labour government just before the 2010 election, into
spending on drugs in the UK and other countries. It was chaired by cancer
tsar Sir Mike Richards jointly with John Melville, then head of Roche
Products in the UK.



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