"Gamechanging" cancer drug rejected for use on NHS

A gamechanging immunotherapy drug that can extend the life of patients with advanced head and neck cancer has been turned down for use in the NHS because of its high cost.

Nivolumab is one of a new class of drug that stimulates the patient’s own immune system to fight the cancer. Immunotherapy drugs have had some spectacular successes in some patients with some cancers. But although nivolumab can give people with advanced head and neck cancers an extra three months of life – when survival expectancy at present is around six months – the National Institute for Health and Care Excellence (Nice) has rejected it.

“The committee heard that treatment options for patients in this area are limited, and it’s important to patients that treatment extends their life and improves the quality of life. But the additional costs of nivolumab were considered to be very high in relation to its benefit to be recommended for routine NHS use at present,” said Prof Carole Longson, director of the health technology evaluation centre at Nice.

Nice will not approve drugs that cost more than its threshold of £20,000 to £30,000 per year of quality life, except for an end-of-life treatment – as this drug is – in which case the threshold rises to £50,000. But Nice believes nivolumab would cost between £66,000 to £75,000 per year of quality life.

The Institute of Cancer Research (ICR), which led the UK arm of the final phase of trials before licensing, regretted the decision. “It is disappointing and frustrating that today’s decision means doctors will not be able to offer this gamechanging immunotherapy to patients with advanced head and neck cancer,” said Prof Kevin Harrington, consultant clinical oncologist at the Royal Marsden. “Once it has relapsed or spread, the disease is extremely difficult to treat and options, including surgery and radiotherapy, are very limited.

“Nivolumab is an expensive drug but it is also the only treatment shown in a phase-III trial to improve survival for this group of patients – and it did so without worsening patients’ quality of life, and with fewer side-effects than other options. It’s crucial that talks on the drug’s availability continue and ultimately that this decision is reversed, otherwise patients face missing out on a genuinely effective treatment simply because of cost.”

The ICR’s chief executive, Prof Paul Workman, said the price of cancer drugs was too high. “This decision denies patients a genuine breakthrough treatment that makes a real difference for people with relapsed or metastatic head and neck cancer. It is another example, and a particularly stark one, of an innovative cancer therapy not being made available on the NHS because of cost. I’d urge Nice and the manufacturer to work together to reach an agreement on price so that this decision can be overturned as soon as possible.

“We need pharmaceutical companies to bring down the cost of drug development through smaller, more targeted trials, and to do much more to pass on the savings to patients. Nice for its part must take much greater account of innovation in its appraisal processes to give exciting treatments like nivolumab a better chance of reaching patients.”

"Gamechanging" cancer drug rejected for use on NHS

NHS England to expand provision of "gamechanging" stroke treatment

Thousands of stroke patients will be saved from lifelong disability after NHS England decided to invest millions of pounds in a new treatment hailed as a “gamechanger”.

About 8,000 people a year who have a stroke will benefit from a massive expansion in the number of hospitals offering mechanical thrombectomy.

Currently only a few hundred patients a year receive the treatment and just a handful of hospitals in England offer it, despite its proved effectiveness. Stroke experts say the procedure can produce remarkable results, with patients who would otherwise have ended up in a wheelchair instead able to walk out of hospital within 48 hours of having it.

“Thrombectomy is a real gamechanger which can save lives and reduce the chances of someone being severely disabled after a stroke,” said Juliet Bouverie, the chief executive of the Stroke Association.

“This decision by NHS England could give thousands of critically ill stroke patients an increased chance of making a better recovery. It could also mean more stroke survivors living independently in their own homes, returning to work and taking control of their lives again as a result,” she added.

A thrombectomy is used to remove a blood clot in someone’s brain which has not dissolved despite the patient receiving clot-busting thrombolytic drugs. It involves a doctor putting a thin tube into a patient’s artery, usually through their groin, and then feeding it up through their body to where the clot is in their brain. Once there, a wire mesh tube called a stent – usually used in heart or vascular surgery – on the top of the tube is wrapped around the clot and it is then pulled out by a doctor called an interventional neuroradiologist.

Doing that restores normal blood flow to the brain and greatly reduces damage to brain tissue, which is what causes patients to suffer long-term, often serious damage to their physical and mental functions. Patients are either sedated or under general anaesthetic during the procedure, which must be carried out within six hours of the stroke occurring.

“This major national upgrade to stroke services puts the NHS at the leading edge of stroke care internationally,” said Simon Stevens, NHS England’s chief executive. “It’s another practical example of the NHS quietly expanding innovative modern care that will really benefit patients, but which tends to be invisible in the public debate about the NHS.”

Stevens is keen that the NHS follows the lead of Germany and France, which undertake 7,500 and 3,500 thrombectomies a year respectively. While the procedure can help 10% of the 90,000 people a year in the UK who are admitted to hospital following a stroke, fewer than 600 patients a year in England have one.

Although the procedure costs about £12,000 to perform, the big savings in medical and social care for patients who would otherwise have been left seriously disabled have convinced NHS England that it represents value for money.

St George’s in London is the only hospital in the UK to offer thrombectomy around the clock every day of the week. NHS England hope the massive expansion will lead to 24 NHS trusts which are centres of excellence in neuroscience operating on the same 24/7 basis as the NHS becomes more of a seven-day service.

Dr Jeremy Madigan, a consultant diagnostic and interventional neuroradiologist at St George’s, said: “Our patients are benefiting from the thrombectomy service we provide, with an 80-90% chance of opening up blocked vessels via this technique, compared to 30% with traditional clot-busting drugs.

“Providing a thrombectomy service at all times of day, as we do at St George’s, radically improves the range and mix of interventions available to us as clinicians.”

However, Bouverie said that creating 24 centres to perform the procedure would compel the NHS to centralise acute stroke services in fewer places, which would likely prove controversial.

It would also require a big increase in the number of interventional neuroradiologists the NHS employs – currently about 90 – especially if the service is to operate around the clock.

NHS England to expand provision of "gamechanging" stroke treatment

NHS can fund "game-changing" PrEP HIV drug, court says

A leading Aids charity has won a high court battle over whether a preventative treatment for HIV that charities say is a “game-changer” can legally be funded by the NHS.

NHS England said it had received advice that it did not have the legal power to fund pre-exposure prophylaxis (PrEP), a “highly effective” anti-retroviral treatment used to stop HIV from becoming established in the event of transmission.

But Mr Justice Green, sitting in London, ruled that NHS England “has erred in deciding that it has no power or duty to commission the preventative drugs in issue”.

The ruling was a victory for the National Aids Trust (NAT), which brought the case to court.

Deborah Gold, the NAT chief executive, said: “This is fantastic news. It is vindication for the many people who were let down when NHS England absolved itself of responsibility for PrEP. The judgment has confirmed our view that it is perfectly lawful for NHS England to commission PrEP. Now NHS England must do just that.

“Over 4,000 people are getting HIV every year in the UK – we desperately need further prevention options to add to condom use. PrEP works. It saves money and it will make an enormous difference to the lives of men and women across the country who are at risk of acquiring HIV. The delay to commissioning PrEP is both unethical and expensive.”

When taken consistently, PrEP has been shown to reduce the risk of HIV infection in people who are at high risk by more than 90%.

Related: Hope for ‘end of Aids’ is disappearing, experts warn

A row erupted earlier this year after NHS England said it would not routinely fund the drug. In March, the body decided the treatment was a preventative service and was therefore not its responsibility. It has said local councils are in charge of funding preventative health services.

However, NHS England agreed to a re-evaluation after the NAT launched a legal challenge. Then in May it said it had “considered and accepted NHS England’s external legal advice that it does not have the legal power to commission PrEP”, and that under 2013 regulations “local authorities are the responsible commissioner for HIV prevention services”.

Allowing NAT’s application for judicial review, Green said on Tuesday the core of the legal challenge was about “the allocation of budgetary responsibility in the health field”.

He said: “No one doubts that preventative medicine makes powerful sense. But one governmental body says it has no power to provide the service and local authorities say they have no money.

“The claimant is caught between the two and the potential victims of this disagreement are those who will contract HIV/Aids but who would not were the preventative policy to be fully implemented.

“In my judgment the answer to this conundrum is that NHS England has erred in deciding that it has no power to commission the preventative drugs in issue.”

Alternatively, said the judge, NHS England has “mischaracterised the PrEP treatment as preventative when in law it is capable of amounting to treatment for a person with infection”.

In any event NHS England had power to commission preventative treatments because that facilitated, or was incidental to, “the discharge of its broader statutory functions”.

Campaigners have said that while the majority of gay men use condoms to prevent being infected with HIV, there is also an “ethical duty” to provide PrEP to those who do not.

And they said the drug would provide an additional defence against HIV – and would not be used simply as an alternative to safe sex.

It comes after the results of a trial, published in February 2015, suggested that rates of HIV infection could be slashed by treating actively gay men with the anti-viral drug when they are healthy.

Dr Michael Brady, medical director at the HIV/Aids charity Terrence Higgins Trust, welcomed the findings and described the drug as “a game-changer”.

He said PrEP offered “another line of defence” against HIV, alongside condoms and regular testing. Brady said: “It is not a vaccine and it won’t be for everyone, but, once approved, we expect it to significantly increase the momentum in our fight against the virus.

“We urge the government, NHS England and local authorities to make PrEP a key priority in the fight against HIV.”

NHS can fund "game-changing" PrEP HIV drug, court says

Judge to rule on NHS funding for "game-changing" HIV treatment

A high court judge is to rule on whether a preventive treatment for HIV that charities say is a “game changer” should be funded by the NHS.

Mr Justice Green, sitting in London, has heard a challenge brought by the National Aids Trust (NAT) against NHS England. The case relates to pre-exposure prophylaxis, a “highly effective” antiretroviral treatment protocol used to stop HIV from becoming established in the event of transmission.

Deborah Gold, the chief executive of NAT, told Radio 4’s Today programme that trials in the UK had produced “outstanding” results. “If it’s targeted towards people who are high risk it really does work,” she said.

Gold also defended the use of PrEP against claims that it undermined traditional safe sex messages. “There are lots of reasons why everybody, sometimes with the best will in the world, is not able to consistently use a condom every time,” she said.

“Most people, if they ask themselves honestly, if they or someone they know, if you think about the number of unplanned pregnancies there are, they often happen because with the best of intentions people can’t use a condom every time.

“You think you understand the risk … maybe you make a bad decision, maybe you are a bit drunk, and you make a decision that you wouldn’t make when you were sober. You try to do it every time, but sometimes you slip up, so PrEP is a way for people to be responsible.”

When taken consistently, Truvada, the drug used in the protocol, has been shown to reduce the chance of HIV infection in people who are at high risk by more than 90%.

Earlier this year, NHS England said it would not routinely fund the drug. In March, the body decided the treatment was a preventive service and therefore not its responsibility. NHS England has said local councils are in charge of funding preventive health services.

However, it agreed to a re-evaluation after the NAT launched a legal challenge. Then, on 31 May, the body said it had “considered and accepted NHS England’s external legal advice that it does not have the legal power to commission PrEP,” and that under 2013 regulations, “local authorities are the responsible commissioner for HIV prevention services”.

NHS England said that if it prioritised PrEP there was the risk of a legal challenge from proponents of other “treatments and interventions that could be displaced by PrEP”.

NAT, an independent charity, challenged the decision to exclude PrEP from consideration by NHS England’s clinical priorities advisory group “as part of its annual commissioning process”. The charity argued that the body has the legal power to commission the treatment.

Judge to rule on NHS funding for "game-changing" HIV treatment