“The whole guideline is a major move forward in that more women than ever before now face the possibility of doing something tangible to reduce their risk of breast cancer.” Professor Gareth Evans
New NICE guidelines state tamoxifen or raloxifene should be offered on the NHS for five years to particular groups of women as a preventative measure, giving at risk British women an alternative to preventative mastectomies. Roughly 50,000 women and 400 men are diagnosed with breast cancer each year in the UK, making it the most common cancer in the country. Of these breast cancer cases, one in five will be associated with a family history of the disease while hundreds of thousands of otherwise healthy people will be at risk of developing the disease because it runs in their family.
Its estimated 3% of all women aged 35 or older in England and Wales could be eligible to receive either tamoxifen or raloxifene as a treatment to prevent breast cancer. With 16,291,025 women in this age group living in England and Wales in 2011, this would equate to roughly 488,371 women. Unlike the US, neither tamoxifen nor raloxifene are currently licensed as preventative treatments in the UK. However, as the treatments reduce a woman’s risk by a third (30-40%) the new guideline states that if a doctor wants to prescribe either of these drugs as a preventative treatment for breast cancer, they should be free to do so, so long as they follow relevant professional guidance, take full responsibility for the decision and obtain and document the woman’s informed consent.
Professor Mark Baker, Director of the Centre for Clinical Practice at NICE, said: “Currently, if someone has a family history of cancer, there are two options available to them. If they are tested and are found to have a genetic reason for their family’s cancer history, they may be eligible for annual screening so that any tumour will be detected early on. Or, they can opt for surgery to remove their breasts. These genetic mutations can also cause ovarian cancer so in some cases women may also decide to have their ovaries removed. This is major surgery and can be very traumatic for those involved.
“Our updated guideline now gives women more options in how they manage their risk of breast cancer; those with a ‘moderate’ or ‘high’ risk of developing breast cancer because of their family history but who have not had the disease themselves can now be offered tamoxifen or raloxifene for five years to prevent it. Although neither drug is licensed as a preventative treatment in the UK, clinical evidence shows they are an effective option for many women and could be preferable to surgery.”
In another major policy shift, NICE have also called for more genetic screening of both men and women in order to identify risks and offer preventative treatments at an early stage. NICE accepts this will cause an increase in referrals but these are manageable as testing is quicker and cheaper than ever before. Professor Gareth Evans, a Consultant in Clinical Genetics at St Mary’s Hospital in Manchester who helped to develop these recommendations, said: “Reducing the threshold for genetic testing will inevitably mean more men and women being seen but this is something that’s already happening in some parts of the country. Weighted against the possibility of preventing breast cancer in high-risk women, this is a cost-effective option for the NHS.”
New treatment recommendations include:
- Doctors should calculate a person’s risk of getting breast cancer by assessing their family history and using a proven method (eg BOADICEA and the Manchester scoring system) to calculate the possibility of that person carrying a BRCA1orBRCA2 mutation, whenever these methods are available in hospitals. The guideline advises doctors to use their clinical judgement when deciding whether to offer genetic testing if they have problems interpreting the results.
- Genetic testing in specialist clinics should be offered to a relative who has had breast and/or ovarian cancer if that family member has a 10% or more chance of carrying either a BRCA1 or BRCA2 genetic mutation (the threshold was previously set at 20%).
- MRI screening should be offered every year to all women aged 30-49 years who have, or have had, breast cancer and who remain at high risk of the disease. This includes those with a BRCA1 or BRCA2 mutation.
Dr Caitlin Palframan, Assistant Head of Policy at Breakthrough Breast Cancer and GDG member, said: “Today’s new guidelines are a game changer in the way we prevent breast cancer. Our strongest tool in the fight against breast cancer is prevention, and these new guidelines are a fantastic leap forward in the way we prevent breast cancer developing in those at highest risk.
“From here the next challenge is ensuring the NHS is equipped to deliver on the promise of these recommendations; more screening, genetic testing and better preventative options for those few people at highest risk, and Breakthrough will be working to ensure that patients get the benefit of these incredibly valuable guidelines.”
Questions for the Australian regulators
So when can we expect the same treatments to be available for Australian women who are at risk? With the US and the UK now both offering preventative tamoxifen, should the PBAC recommend listing the drugs for this use on the PBS? What barriers need to be addressed? Do the longer term cost savings of treating fewer breast cancer patients outweigh the costs of these drugs in the Australian context?
If you are an Australian breast cancer specialist who would like to address these questions, we’d be delighted to publish your expert commentary on this story – please get in touch if you are interested.
Click to view the NICE updated guideline on familial breast cancer.