Breast Cancer Patients’ Distress at Withdrawal of Kadcyla

Excerpt:

“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their distress after learning that a life-extending drug they had been told would be available to them looks set to be withdrawn.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NICE Draft Guidance Recommends Nivolumab for Advanced Skin Cancer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Centre Director said: ‘We are pleased to be able to recommend nivolumab for treating advanced skin cancer in final draft guidance.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.’ ”


Breast Cancer Deaths Are Underestimated in Young Women

“An online computer programme that helps to predict the most suitable treatment for breast cancer has been found to underestimate the number of women under 40 who will die from the disease by 25 per cent, according to a study published in the British Journal of Cancer today.

“Researchers carried out an evaluation of the PREDICT computer programme which was developed after studying thousands of UK women of all ages with breast cancer.

“The programme itself has been well validated as a predictor of prognosis. However its accuracy among young women – who represent less than five percent of all breast cancer cases in the UK – might be affected by the fact that data from only a small number of young women were included when the programme was developed, and this could be making its five-year predictions for patients in this age group less accurate. The disease can behave differently in younger women compared with older patients and can sometimes be more aggressive.

“Researchers from Southampton and Cambridge, supported by Cancer Research UK and University Hospital Southampton NHS Foundation Trust, looked at how accurately the PREDICT online programme estimates the number of deaths in patients diagnosed with breast cancer before the age of 41.”


Keytruda/Pembrolizumab Is on the Fast Track for Approval in the UK

“Pembrolizumab is a treatment for advanced skin cancer and is the first medicine to be approved through the Early Access to Medicines scheme (EAMS), launched in England last April.

“The idea is to get pioneering drugs to severely ill patients much sooner.

“Drugs signed off through EAMS have been scrutinised by regulators, weighing the risks and benefits.

“A green light by the Medicines and Healthcare products Regulatory Agency (MHRA) means doctors anywhere in the UK can prescribe the drug in question before normal licensing procedures – which can take years – are complete.”


Bad News for UK Cancer Patients: NHS Denies Access to Eight Drugs

The gist: The National Health Service has decided not to fund certain cancer drugs for patients in the UK. This article lists and describes them.

“Here are eight drugs among those expected to be “delisted” so that they are not routinely funded by the NHS.

“Halaven

“Treats women with an aggressive form of breast cancer and is derived from sea sponges.

“It can extend life by almost five months on average and around half of women live longer than a year after getting the drug, which costs around £10,000 for a six-month course of treatment.

“The drug is prescribed as standard care to women in 55 countries, including all major EU members, Japan, Korea and Russia.”


Routine Genetic Testing Rolled out in Cancer Fight

“Plans for widespread DNA testing for genetic mutations will see tens of thousands of patients diagnosed and treated faster for conditions like cancer.

“Sequencing of patients’ entire genetic code is to become routine for the health service, with eleven hospitals across England already earmarked for where tests are to begin in the new year.

“The 100,000 Genome Project has been hailed as a move that will allow the UK to ‘unlock longstanding mysteries of disease on behalf of humankind’.

“Medical director of NHS England, Professor Sir Bruce Keogh, said the project would help position the health service as a world leader.

“It is hoped that mapping a person’s entire genetic code will enable scientists to better understand the DNA mutations, which cause cancer and other rare genetic conditions.”


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.”


NICE Proposes Ipilimumab as a First Treatment for Advanced Skin Cancer

“People with advanced skin cancer should be able to receive ipilimumab as a first treatment, the National Institute for Health and Care Excellence (NICE) proposes.

“In final draft guidance, NICE recommends that the drug ipilimumab (also called Yervoy and manufactured by Bristol-Myers Squibb Pharmaceuticals Limited) is made available on the NHS as a first-line treatment for patients with advanced malignant melanoma which is either unresectable (when the full tumour cannot be removed) or metastatic (the cancer has spread to other parts of the body).

“Sir Andrew Dillon, NICE chief executive, said: ‘We already recommend ipilimumab as a second-line treatment and so we are pleased to be able to propose extending that recommendation to first line treatment too.’ “

Editor’s note: The UK’s public healthcare system is required to provide funding for treatments recommended by NICE. To learn more about targeted melanoma drugs like ipilimumab, read The Basics.