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NICE backing for Bayer's Stivarga in GIST - PharmaTimes

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Bayer’s Stivarga is being backed by the National Institute for Health and Care Excellence as a cost-effective option for the treatment of adults with gastrointestinal stromal tumours (GIST). - News - PharmaTimes

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Murphy NM, et al.(2016)
Compliance with National Institute of Health and Care Excellence risk-based screening for Gestational Diabetes Mellitus in nulliparous women.
PMID: 26901398

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Richard Morris.(2015)
Mandatory implementation of NICE Guidelines for the care of bipolar disorder and other conditions in England and Wales.
PMCID: PMC4588679

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A drug that can extend the lives of women with advanced breast cancer has been approved for routine use on the NHS.

Charities and campaigners reacted with huge disappointment when the National Institute for Health and Care Excellence (Nice) rejected the drug, Kadcyla, on cost grounds in 2016.

But a deal has now been struck between NHS England and the manufacturer Roche, backed by Nice, to make the drug available to around 1,200 women a year in England. Until now, the drug has been funded only through the cancer drugs fund.

In clinical trials, Kadcyla, which has a full list price of £90,000 a year per patient, was shown to extend the lives of people with terminal cancer by an average of six months. It also dramatically improves quality of life, compared with other treatments, and reduces side effects.

Details of the price agreed between Roche and the NHS are being kept confidential.

Kadycla is for people with Her2+ breast cancer that has spread to other parts of the body and cannot be removed through surgery. Previous treatments, usually Herceptin, must have failed for patients to receive the drug.

Kadcyla, also called T-DM1, combines Herceptin with a potent chemotherapy agent. It works by attaching itself to the Her2 receptor on cancer cells, blocking signals that encourage the cancer to grow and spread. The chemotherapy element also goes inside the cell and causes it to die from within.

Kadcyla is given intravenously once every three weeks.

The chief executive of NHS England, Simon Stevens, speaking at the NHS Confederation conference in Liverpool, said: "NHS cancer survival rates are now at record highs, and this year we're going to be making major upgrades to modern radiotherapy treatments in every part of England.

"NHS England is also taking practical action to drive greater value from taxpayers' growing investment in modern drug treatments, and that work is beginning to bear fruit.

"Today's announcement on Kadcyla shows that for companies who are willing to work with us, there are concrete gains for them, for the NHS and, most importantly, for patients able to get new and innovative drugs.

"In this case, tough negotiation and flexibility between the NHS and Roche means both patients and taxpayers are getting a good deal."

Richard Erwin, general manager at Roche, said: "This is a positive example of how solutions can be reached when all parties show flexibility."

Delyth Morgan, chief executive of the research charity Breast Cancer Now, said: "We are absolutely delighted that tough negotiation and flexibility by Nice and NHS England, and the willingness of Roche to compromise on price, have ensured that thousands of women with incurable breast cancer will be given precious time to live.

"We want to congratulate and thank the hundreds of thousands of women, men and families across the country for their relentless campaigning to ensure this crucial lifeline drug is routinely available to those that need it.

"However, this news comes at a time when there is a real possibility that Perjeta, the first-line treatment for this group of patients, could soon be removed from NHS use, with a decision imminent.

"Perjeta's benefits are extraordinary, offering nearly 16 additional months of life to women with incurable breast cancer, and it is imperative that a solution is found to save this drug, at a cost affordable to both the NHS and the taxpayer."

Prof Carole Longson, director of the centre for health technology evaluation at Nice, said: "The committee acknowledged the comments received from patients during the consultation on the draft recommendations for trastuzumab emtansine [the generic name for Kadcyla], in particular that 115,000 people had signed a Breast Cancer Now petition urging Nice and the company to ensure that it remains available.

"We are therefore very pleased that the company and NHS England have been able to agree a deal that will achieve this."

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the national institute for health and care excellence (nice)

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Breast cancer drug that can extend lives approved for NHS use

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A drug that can extend the lives of women with advanced breast cancer has been approved for routine use on the NHS. Charities and campaigners reacted with huge disappointment when the National Institute for Health and Care Excellence (Nice) rejected the drug, Kadcyla, on cost grounds in 2016.

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One of the cornerstones of Great Britain's National Health Service is an agency that approves and controls access to prescription drugs, the National Institute for Health and Care Excellence.

NICE recently announced a new policy that could delay and restrict access to new medicines for British citizens if the agency deems they don't pass its "budget impact test." A drug may be approved as safe and effective, but patients could still wait for years to get it if the agency believes the cost could exceed a certain total threshold.

"Thousands of patients will wait longer for treatment for conditions like heart disease, cancers and diabetes while medicines which stand to benefit the most people are caught up in the system," according to the head of the British Association of the Pharmaceutical Industry Mike Thompson.

"Use of new medicines in the UK is already poor, with [British] patients seven times more likely to get a newly launched medicine in places like Germany or France." Predictably, UK patient groups have expressed outrage and dismay, warning that this proposal will sentence thousands of patients to an early death.

Why is this relevant in the United States? NICE's intervention is made possible because this single government body has the authority to decide which medicines will be reimbursed and available to patients.

But, proponents argue, NICE can obtain lower prices for medicines. That is for the simple reason that it is the only game in town. That's what "government negotiation" means. It is the equivalent of the Godfather making "an offer you can't refuse."

The downside is that the government makes the call on when, what, and for whom treatments will be available, guided by political and budgetary considerations.

NICE shows the underside of government exercising its power to purchase or not purchase drugs and set prices.

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The Good, The Bad, And The NICE: A Cautionary Tale For Government Negotiation

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One of the cornerstones of Great Britain's National Health Service is an agency that approves and controls access to prescription drugs, the National Institute for Health and Care Excellence. NICE recently announced a new policy that could delay and restrict access to new medicines for British citizens if the agency deems they don't pass its "budget impact test."

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James Raftery.(2001)
NICE: faster access to modern treatments? Analysis of guidance on health technologies.
PMCID: PMC1121756

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A fifth of new drugs will be rationed under tighter NHS cost-cutting plans, meaning that patients will suffer longer delays for medication.

Sufferers of cancer, diabetes and asthma could have to queue for treatment as health chiefs are handed powers to restrict access to medicines to save money, even if they have been ruled cost-effective by doctors.

Drug companies say that they will no longer launch drugs early in Britain if bureaucrats are given power to stop them from reaching patients for purely financial reasons. Campaigners warned that the plans would put Britain further behind the rest of Europe in offering cutting-edge therapies and more people would die while waiting for medicines.

At present patients have a legal right to be treated with drugs that...

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A fifth of new drugs will be rationed under tighter NHS cost-cutting plans, meaning that patients will suffer longer delays for medication. Sufferers of cancer, diabetes and asthma could have to queue for treatment as health chiefs are handed powers to restrict access to medicines to save money, even if they have been ruled cost-effective by doctors.

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National Institute for Health and Care Excellence

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The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. NICE is an executive non-departmental public body, sponsored by the Department of Health and Social Care .

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nice "national institute" "health guidance" "care excellence"

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National Institute for Health and Care Excellence (NICE)

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National Institute for Health and Care Excellence (NICE)

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Welcome to the National Institute for Health and Care Excellence (NICE) YouTube channel. NICE is the independent body that provides evidence based guidance to improve health and social care.

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Patterson CM, et al.(2015)
Clinical outcomes when applying NICE guidance for the investigation of recent-onset chest pain to a rapid-access chest pain clinic population.
PMID: 25217487

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Devlin N, Parkin D.(2004)
Does NICE have a cost-effectiveness threshold and what other factors influence its decisions? A binary choice analysis.
PMID: 15127424

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Evidence-based recommendations for the health and social care sector, developed by independent committees, including professionals and lay members, and consulted on by stakeholders.

Browse guidance

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Find guidance, advice and information for health, public health and social care professionals.