Hopes have been shattered for hundreds of women with incurable triple negative secondary breast cancer today, as the National Institute for Health and Care Excellence (NICE) has provisionally rejected Trodelvy1 for routine use on the NHS in England, leaving them with profound anxiety and uncertainty about their future treatment options.
Women living with this life-limiting disease already face the devastating reality of short prognoses and limited treatment options. But Trodelvy could offer certain patients hope of precious extra months spent with loved ones and doing what matters most to them.
With Trodelvy recommended for use on the NHS in Scotland2 last month, today’s news could see women in England left behind, as they face the prospect of being denied access to the drug in the future, unless this decision is reversed.
Breast Cancer Now’s tireless efforts to ensure all women had access to the treatment as soon as it was licensed, and ahead of the decision being reached around its routine use on the NHS, saw the charity launch its #TimeForTrodelvy campaign.
The charity worked closely with its patient advocates to successfully secure increased supply of Trodelvy through a pre-reimbursement access scheme run by biopharmaceutical company, Gilead.
In light of today’s news, the charity is calling on Gilead to guarantee their pre-reimbursement access scheme will remain open to all new eligible patients until a final decision around routine access to Trodelvy on the NHS is made by NICE, at the second committee meeting next month.
With a public consultation closing at 5pm on Friday 29 April 2022, Breast Cancer Now is calling for the public to sign our Open Letter and respond to the NICE Consultation directly.
Crucially, we are urging Gilead, NICE and NHS England to do everything in their power to ensure Trodelvy becomes routinely available on the NHS.
A key part of this is in urging Gilead to ensure it is affordable, so that all eligible patients across the UK can potentially benefit from this drug.
Baroness Delyth Morgan, Chief Executive at Breast Cancer Now, said:
"Today’s decision is a devastating blow to women with triple negative incurable secondary breast cancer in England.
"Evidence shows Trodelvy can increase time before a patient’s disease progresses and, crucially, how long they live compared to being treated with chemotherapy.
"These women, who already face devastatingly poorer prognoses and limited treatment options, deserve the chance to benefit from this new treatment option.
“We campaigned tirelessly to see eligible patients access Trodelvy.
"And earlier this year, we secured a commitment from drug company, Gilead, to expand its pre-reimbursement access scheme, to ensure more women could access the drug while we waited on NICE’s decision around its routine use on the NHS.
"But now, with a matter of weeks until NICE makes its final decision, action is needed more urgently than ever.
"Together, Gilead, NICE and NHS England must find a solution that sees this potentially life-extending drug made routinely available on the NHS, including Gilead ensuring the drug is affordable for the NHS.
“In the meantime, Gilead must guarantee that its pre-reimbursement scheme remains open to all new eligible patients as we make every effort to ensure that NICE reverses its decision."
Sign our ‘It’s Time for Trodelvy’ open letter to Gilead, NHS England and NICE, now: breastcancernow.org/trodelvy
Nicola, 42, from Bristol was diagnosed with triple negative breast cancer in July 2018. And in April 2020, she was diagnosed with secondary triple negative breast cancer. She has been on Trodelvy since November 2021. She said:
"Living with secondary triple negative breast cancer is like walking a tightrope every day. At any moment, I could take a turn for the worse and my treatment options are limited.
"Having brain metastases is especially frightening as the disease can take away who I am as a person as well as my physical abilities.
“I have now been on Trodelvy for just four months and scans have shown that it has already shrunk my tumours.
"Trodelvy is more targeted than other treatments and I believe it could give people extra quality and precious time with their loved ones, which is why today’s provisional decision is so brutal.
“I want other women to be able to have the same chance to benefit from Trodelvy.
"This drug gives me hope of more time and doing things that matter most to me, like walking my dog and spending time with my family.
"It’s absolutely vital that others get the same opportunity and that Trodelvy is now made available on the NHS."
Notes to Editor
- Sacituzumab govitecan (Trodelvy) is a targeted (biological) therapy. It delivers a chemotherapy drug straight to cancer cells which have the protein Trop-2 on their surface. This is the case in many types of cancer, including breast cancer. This treatment is suitable for patients with unresectable locally advanced or secondary triple negative breast cancer, who have had at least two prior therapies.
- Wales normally follow NICE decisions. We have written to the Northern Ireland Department of Health asking them to confirm whether they will be following the Scottish Medicines Consortium's positive recommendation.
Triple negative breast cancer
This is the name given to breast cancers that lack the three receptors which are normally used to classify breast cancers: oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2).
Around 15% of all breast cancers – over 8,000 cases a year in the UK – are triple negative.
Triple negative breast cancer is more common in:
- Women who have inherited an altered BRCA gene
- Black women
- Women who have not yet reached the menopause
- Women under 40
About Breast Cancer Now
- Breast Cancer Now is the UK’s first comprehensive breast cancer charity, combining world-class research and life-changing care.
- Breast Cancer Now’s ambition is that, by 2050, everyone who develops breast cancer will live and be supported to live well.
- Breast Cancer Now, the research and care charity, launched in October 2019, created by the merger of specialist support and information charity Breast Cancer Care and leading research charity Breast Cancer Now.
- Visit breastcancernow.org or follow us on Twitter or Facebook or Instagram.
- Anyone looking for support or information can call Breast Cancer Now’s free Helpline on 0808 800 6000.