‘Lives will be cut short’ if drug not given to women with breast cancer

Health officials and pharmaceutical companies have been urged to urgently work together to make a life-extending drug available to thousands of women with incurable breast cancer.

Experts from Breast Cancer Now said that women’s lives “will be cut short” with further delays as they called for Enhertu to be made available to women in England with a certain type of breast cancer as swiftly as possible.

In March it was announced that the treatment was blocked for widespread NHS use for women with HER2-low incurable secondary breast cancer due to price issues.

The National Institute for Health and Care Excellence (Nice) said the cost the NHS was being asked to pay for trastuzumab deruxtecan – sold under the brand name Enhertu – was “too high” in relation to its benefits.

A quarter of a million people signed a petition calling for an “urgent solution” to get the treatment to women living with secondary breast cancer as soon as possible.

Enhertu is the first licensed targeted treatment for patients with HER2-low breast cancer that cannot be removed surgically or that has spread to other parts of the body, also known as metastatic breast cancer.

Breast Cancer Now said that the drugs offer women six more months to live.

Women with HER2-low incurable secondary disease in Scotland currently have access to the drug, while others across the UK do not, the charity said.

Had Nice recommended the treatment, about 1,000 patients a year would have been eligible.

Baroness Delyth Morgan, chief executive at Breast Cancer Now, said: “Over a quarter of a million people have signed our Enhertu Emergency petition, rallying behind us and keeping up pressure and momentum in calling on Nice, NHS England, Daiichi Sankyo and AstraZeneca to get back around the table to reach a solution to ensure Enhertu is made available on the NHS in England for women who desperately need it.

“This must happen urgently, or women’s lives will tragically be cut short.”

Draft guidance published by Nice in September said it would not recommend Enhertu for NHS use in England due to uncertainties in the information provided by the manufacturer and called for more details.

The spending watchdog then paused its appraisal in December while commercial talks were ongoing with pharmaceutical companies Daiichi Sankyo and AstraZeneca, but in March it was announced that the talks concluded without a price agreement in place.

Breast Cancer Now said that health leaders and pharmaceutical companies should “seize the opportunity presented by the delay to Nice’s final guidance being published” to find a solution.

It is understood that talks between parties have resumed.

A letter from NHS officials sent to MPs on the parliamentary Health Committee on Tuesday stated: “We can confirm that a further discussion with all relevant parties was held on 15th May, with an expectation of flexibility from all sides. However, at this meeting Daiichi Sankyo informed us of the withdrawal of its previous commercial offer and increased the price proposal for the drug.”

Lady Morgan added: “Nice’s delay to the publication of its final guidance on Enhertu creates a crucial window of opportunity for this heart-breaking situation to be fixed now, and women with HER2-low secondary breast cancer to be granted precious hope of more time to live and to create special moments that matter.”

NHS nurse Tracy Pratt was diagnosed with HER2-low secondary breast cancer in November 2022 after experiencing upper back pain.

The 52-year-old from Tydd St Mary, Lincolnshire, said: “When I heard the news that it had been rejected for use on the NHS, I was in shock.

“I cried, I felt completely let down and lost, sad for me, sad for my family and sad for everyone else in the secondary breast cancer community, that this decision affects.

“Enhertu would give me more quality time to enjoy my life with my family and friends, more time to live with secondary breast cancer. It would give me more time to travel and continue to work as a nurse. Ultimately it would give me hope.

“This decision does not just affect us living with secondary breast cancer now but also those that will develop it in the future. The reality is that the decision is likely to affect you or someone you love in the future. This decision must be reversed.”

A spokesperson for Daiichi Sankyo said: “Daiichi Sankyo and AstraZeneca welcomed the opportunity to provide evidence to the Health and Social Care Committee and All Party Parliamentary Group on Breast Cancer regarding Nice’s decision to not recommend Enhertu for HER2-low metastatic breast cancer, as well as highlight our concerns regarding the impact of changes to Nice’s formula on the future launch of treatments targeting late-stage cancers.

“As committed to during the meeting we have restarted the dialogue with NHS England and Nice, and the final publication of guidance has been paused while those talks are ongoing.”

The spokesperson added: “Our latest formal offer remains on the table. For the avoidance of doubt, this offer has at no point been withdrawn or increased in any way. As such, we do not recognise the assertions outlined in the letter from NHS England and Nice.

“We have entered into negotiations with NHS England and Nice in good faith to explore compromises on all sides. We intend to continue further constructive dialogue in the coming weeks and will maintain our commitment to delivering access for all eligible patients in England, Wales and Northern Ireland.

“We have secured funding for patients in 17 other countries in Europe including in Scotland in the last 12 months for this patient population.

“We are aware that an appeal of the Nice Committee’s assumptions was lodged by patient groups and clinicians on exactly the grounds referenced in the letter which was rejected by Nice without progressing to an appeal panel.”