Breast Cancer Patients’ Distress at Withdrawal of Kadcyla


“Terminal breast cancer patients have spoken of their distress after learning that a life-extending drug they had been told would be available to them looks set to be withdrawn.

“Advisory body NICE is reviewing drugs made available through the old cancer drugs fund, and has rejected Kadcyla for use on the NHS in England.

“It believes the price per patient set by manufacturer Roche is too expensive. Roche says discussions are continuing.”

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NICE Draft Guidance Recommends Nivolumab for Advanced Skin Cancer

“NICE recommends that nivolumab (also called Opdivo, and manufactured by Bristol Myers Squibb) is made available on the NHS as a treatment option for patients with advanced (unresectable or metastatic) melanoma.

“The independent Committee decided that a consultation on the draft recommendations was not needed for this appraisal, so the recommendations could go straight to a final appraisal determination (FAD). This happens when the Committee recommends a treatment in line with its licence.

“Professor Carole Longson, Health Technology Evaluation Centre Director said: ‘We are pleased to be able to recommend nivolumab for treating advanced skin cancer in final draft guidance. In 2011, over 13,000 people were diagnosed with melanoma in the UK, and it accounts for more deaths than all other skin cancers combined. I am sure this will be welcome news to patients and healthcare professionals alike.’ ”

NHS Patients Barred from BMS' Opdivo, Roche's Kadcyla

“NICE is planning to bar patients with a particular form of lung cancer from access to Bristol-Myers Squibb’s ground-breaking immunotherapy Opdivo on the NHS in England and Wales.

“Opdivo (nivolumab) is the first in a new class of medicines, called PD-1 immune checkpoint inhibitors, to be licensed for use in squamous pre-treated lung cancer patients, and is currently available in the UK to some patients through the Early Access to Medicines Scheme.”

UK’s NICE Proposes to Recommend GSK’s Tafinlar for Melanoma

“UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending UK pharma giant GlaxoSmithKline’s (LSE: GSK) Tafinlar (dabrafenib) for the treatment of melanoma which has spread or can’t be completely removed by surgery and tests positive for the BRAF V600 mutation.

“NICE proposes recommending dabrafenib on the basis that GSK provides the drug to the National Health Service with a discount on the list price. The size of the discount is commercial in confidence.

“Carole Longson, Centre for Health Technology Evaluation director at NICE, said: ‘For a long time the treatments available for skin cancer which has spread have been very limited. However, in recent years a number of breakthrough treatments that can potentially significantly improve the prognosis for some people with malignant melanoma have become available. NICE has already recommended vemurafenib and ipilimumab and we hope to add dabrafenib to the list of options available. The information provided by GlaxoSmithKline, who markets the drug, suggested that dabrafenib works just as well as vemurafenib which also targets melanoma with the BRAF V600 mutation. Drugs like dabrafenib are also thought to have very rapid positive effect for patients, even in those who are very unwell or bed-ridden. In some cases, it has enabled people to resume everyday activities.’ ”

Editor’s note: Tafinlar is a targeted drug used to treat patients whose melanoma has spread (metastasized) or cannot be removed by surgery, and has a mutation called BRAF V600, as detected by molecular testing.

NICE 'No' for Celgene's Abraxane in Pancreatic Cancer

The National Institute for Health and Care Excellence has published new recommendations rejecting the use of Celgene’s Abraxane (nab-paclitaxel) on the National Health Service to treat patients with advanced pancreatic cancer.

“According to the cost regulator, the drug, a novel formulation of the chemotherapy paclitaxel, is not as effective as standard therapy and is more expensive, and thereby fails to hit value-for-money criteria.

“NICE says that data provided by Celgene show that the chemo regimen FOLFIRINOX, a first-line option for patients with the disease, was actually more clinically effective than the Abraxane/gemcitabine combination. And while Abraxane/gemcitabine was more effective than gemcitabine alone, it resulted in more serious side effects.”

Prostate Drug Decision Highlights Urgent Need for Reform

“Just a week after the controversy over breast cancer drug Kadcyla, the inflexibilities within the UK’s disparate drug approval systems have been pulled into sharp focus once again.

“NICE – the organisation that tells the English and Welsh NHS which drugs it should pay for – has said that the health service should not routinely give prostate cancer drug abiraterone (aka Zytiga), to men whose disease has stopped responding to hormone treatment, before they’ve had a course of chemotherapy.

“The drug was approved for use after chemo in 2011. Today’s decision prevents its routine use earlier in men’s treatment.

“The reasons for this decision are complex, and relate to the drug’s cost, and a disagreement over whether using it before chemotherapy constitutes an ‘End of Life’ treatment (and thus able to be considered under a more flexible set of criteria) – we’ll explore these below in more detail.”

Disappointment as Breast Cancer Drug Not Approved on NHS

“The breast cancer drug trastuzumab emtansine (also known as Kadcyla) will not be made routinely available on the NHS following a failure to reach an agreement on price between the National Institute for Health and Care Excellence (NICE) and the drug’s manufacturer, Roche.

“NICE criticised the pharmaceutical company over a failure to make the drug more affordable, stating that the high price of Kadcyla makes it ‘impossible’ to recommend for widespread use in the NHS.

“The drug is licensed to treat breast cancer patients with a form of the disease known as HER2-positive breast cancer, after it has spread to other parts of the body.”

Single-Dose Radiotherapy Could Transform Breast Cancer Treatment

New single-dose radiotherapy could transform breast cancer treatment

“Tens of thousands of breast cancer patients could benefit from a new type of radiotherapy which would be delivered during surgery instead of them having to take a course of treatment.

“Intrabeam radiotherapy has been given a provisional go-ahead for NHS use by the health finance watchdog.

“In draft guidance, the National Institute for Health and Care excellence (Nice) said the treatment option should be considered for people with early stage breast cancer. A single dose of radiotherapy could be more convenient for patients, Nice said.

“Some patients have to make 15 trips to hospital for radiotherapy, but the latest treatment could be given during breast surgery, reducing ‘disruption, stress and inconvenience’, the charity Breakthrough Breast Cancer said.

“It said the ‘revolutionary’ treatment would not only cause less hassle for patients but would save the NHS time and money.”

Photograph: Rui Vieira/PA

Cancer Drugs Yervoy, Xtandi Get NICE Thumbs Up

“Cost regulators for the National Health Service in England and Wales have this morning issued guidance recommending the use of Bristol-Myers Squibb’s Yervoy (ipilimumab) for skin cancer and Astellas’ Xtandi (enzalutamide) for prostate cancer.

“First-line use of Yervoy will be funded in patients with advanced malignant melanoma when the full tumour cannot be removed or the cancer has spread to other parts of the body.

“The drug costs £3,750 per 10-ml vial or £15,000 per 40-ml vial, but B-MS has also agreed a patient access scheme with the Department of Health, in which it will be sold to the NHS at a discounted price.

“NICE analysis concluded that the most plausible cost per Quality Adjusted Life Year (QALY) was £47,900 for Yervoy compared with the chemotherapy dacarbazine and £28,600 per QALY compared with Roche’s Zelboraf (vemuraf [sic]).”