Nadia's fight to reverse 'cruel' block on drug that could give pal lifeline
Nadia Sawalha has been left outraged after a pioneering cancer drug was blocked for use on NHS England.
The 'reeling' Loose Women star has condemned the decision by the National Institute for Health and Care Excellence (NICE), who said the cost the NHS was being asked to pay for trastuzumab deruxtecan - known as Enhertu – was "too high" in relation to its benefits. Enhertu, which received a standing ovation when its results were unveiled at a clinical trials conference in 2022, has the potential of giving the presenter's close friend, Hannah Gardner, who has secondary breast cancer, a further six months to live.
She says every minute counts with the terminal disease, which would give her precious time to make more happy memories with her 'miracle' three-year-old Lilah. Nadia is perplexed by the 'cruelty' to the breast cancer community, saying the "rug has been pulled under everybody's feet."
"I am upset, angry and scared," she declared to the Mirror. "I feel the fear of all of those women. It's scary, it's a dark shadow... this feels extra cruel to me. But it's not beyond the realms of possibility that some light can be brought in instead."
Nadia describes Hannah as having the 'kindest heart' (Hannah Gardner)
Hannah has had cancer four times (Hannah Gardner)Enhertu is the first licensed targeted treatment for patients with HER2-low breast cancer, that cannot be removed surgically or has spread to other parts of the body, also known as metastatic breast cancer. Chemotherapy is usually offered as a treatment, but if the targeted therapy had been made available, around 1,000 patients a year would have been eligible.
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Just one woman would have been Nadia's close friend, Hannah, who has been diagnosed with cancer four times.The 37-year-old, a former clinical trial manager who lives in Twickenham, London, was given her primary breast cancer diagnosis in 2013 after discovering a large lump in her left breast.
After undergoing treatment, including chemotherapy and a double mastectomy, the cancer returned twice more – once in 2017 in her chest wall and again in 2020 in her underarm. Two years later, in June 2022, Hannah was then given the devastating news she has stage 4 incurable breast cancer, specifically hormone-positive, HER2-low breast cancer, after they found it had spread to her liver.
It has been an agonising waiting game for the mother, who has seen first-hand the buzz surrounding the drug whilst in her oncology appointments. She was told at the start of the year that she could be eligible for the new treatment after finding out that her cancer had progressed, seeing her forced to pull out from the medical trial Serena-1.
Back in September, draft guidance published by NICE said it would not recommend Enhertu, which has been approved in more than 45 countries around the world - including neighbouring Scotland - 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, but on Tuesday, it was concluded without a price agreement in place.
Receiving the blow, Hannah described it as popping the balloon on her hopes and dreams. "A no deal was crushing," she told the Mirror. "I honestly, I couldn't believe it. I was in shock.
"Not that it was a dead cert, but there was so much confidence among doctors. I'd heard so much about what a great treatment it was, it's billed as game-changing, set to revolutionise how we treat breast cancer. It was great enough to stand up and clap for.
"So you hear all these things and you think there's no way they're going to say no. But that's what they did." Hannah has endured a 'choppy road' with the disease, and says she is 'burning through finite' treatment lines.
They met at a fundraising trek six years ago and since then, she has remained by Hannah's side (Hannah Gardner)
The mum-of-one has had 18 rounds of chemo over the past decade (Hannah Gardner)The average prognosis for secondary breast cancer is two to five years. Having the potential of more time with her daughter means everything to Hannah.
"The drug is meant to significantly improve how long you live, with the potential of another six months at least. Those chunks of time are huge. I want as much time as possible to be there for my little girl. For me, it means the difference between seeing my daughter into primary school or a nativity or seeing a sports day or not," she said.
While she has come to terms with the fact she is dying, Hannah admitted: "I don't want to miss out on one more kiss, one more hug, one more giggle, one more 'first' than I need to. I've been thinking of it as lifelines. Like Mario lives. I have lost a potential lifeline now. And I don't know how long I'm going to live. Without Enhertu, it's six months less than what it would have been."
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While free healthcare is available with the NHS in England and Scotland, as well as Wales, the organisations that make decisions on licenced medicines differ. In England it's NICE and in Scotland, it is the Scottish Medicines Consortium (SMC), which uses a different criteria formula.
Both Hannah and Nadia find it hard to comprehend how Scotland can think it's worth the money, but England doesn't. "How can two different bodies within the UK come to such different conclusions?" Hannah questioned. "Something doesn't add up, they've created another health inequality within the UK."
Nadia added: "This postcode lottery nonsense is a disgrace. I know it happens in loads of other drugs but we're concentrating on this right now because this is a flame, this is a fire that we are fighting now because unfortunately, people with secondary breast cancer don't have an awful lot of time. This is an opportunity for NHS England not to let them down."
After Nadia shared the dire situation for Hannah and her family on social media, the pair have been inundated with offers from kind strangers saying she can register at their addresses in Scotland in a bid to be eligible for the drug, which has "restored her faith in humanity".
But it's not just Hannah that is impacted, as the drug has the potential to extend thousands of women's lives in the years to come. "It's not just the secondary breast cancer patients that may need it now, it's women who might go on to get secondary breast cancer, there are women out there that don't even know they might benefit from it," she argued. With her experience in clinical trials, she also raises the "crazy implications" of how it could affect other drugs in the pipeline being developed and the UK's access.
Nadia says extra time for Hannah to be with her daughter will mean the world to her (Hannah Gardner)
The pair are now backing a Breast Cancer Now petition (Hannah Gardner)Hannah met Nadia, 59, during a Breast Cancer Now fundraising trek in the Himalayas. They shared an instantaneous bond, with Nadia feeling an overriding sense to nurture Hannah, seeing herself as an auntie figure. The TV star, along with two other friends who together call themselves the 'Fab Four', joins Hannah at her medical appointments.
Nadia has been there to witness the mum at her lowest, and has been in awe at how she has navigated her ill-health journey. "I've never met a braver, stronger person," she said. "We always say, 'why is it that Hannah doesn't catch a break?' Because Hannah is such a good, good person, she has the kindest of hearts and it has been relentless.
"She has the ability to jump into pools of happiness out of pools of absolute despair. I've seen her have amazing conversations with consultants, negotiating for her health. She was told about Enhertu, 'that would be the one for you'. There was going to be a plan, and it was coming to the NHS.
"But I feel this has been brutal for the secondary breast cancer community. There is a real sense of neglect." But the friends aren't backing down.
They're behind Breast Cancer Now's petition, which currently has more than 81,000 signatures, calling on NICE, NHS England and the drug companies Daiichi Sankyo and AstraZeneca, to do everything possible to find a solution that makes Enhertu available on the NHS.
In a direct message to readers and those involved, Nadia stated: "Every single person that signs that petition has a has a moment in the future. This could be your sister, your mother, your daughter, your grandmother.
"Every single person has an investment in signing that petition and saying, 'do you know what? No, you are not going to do this.' This is not fair. This is proven. This is a standing ovation. This is the future of cancer treatment. How dare you snatch it away?"
If she could be in a room with those negotiating, Hannah would say: "'What are you doing?' Breast cancer is one of those prolific cancers - around 55,000 women are diagnosed every year in the UK.
"It could be someone that they know. Why wouldn't you want the best possible treatments out there for them? Our lives on the line and they've just left us to it. We feel really let down so I'd ask them to get back round the table and make the deal because we're not going to go away".
Laughing, Nadia chuckled: "We'll do anything. I'll chain myself to the railings," before switching to a sombre tone, adding: "This is just the beginning." Time really is of the essence, as Hannah has her three-month scan tomorrow.
Results on Wednesday, which will be 11 years to the today of her initial diagnosis, will show whether the cancer is growing, and if so, she will be taken off her drug combination of chemo, and in another life, it would have been Enhertu next. If she were to hear that a new deal had been negotiated and it did become available, she would be "over the moon".
"The hope that has been stripped would be given back," she said. "There are some things you can't control, it's not a given how you respond to a drug, but this is something people have power over. They have the power to make that decision and actually give cancer patients a bit of good news. It felt like they dangled a carrot and pulled it away."
Helen Knight, director of medicines evaluation at NICE, said: "We are extremely disappointed not to be able to recommend Enhertu for use in the NHS for advanced HER2-low breast cancer. The backdrop to the commercial discussions was the independent appraisal committee's belief that, based on the available evidence, Enhertu represents a significant development for people with HER2-low advanced breast cancer who currently have limited chemotherapy options and most have no targeted treatments available to them.
"However, a key uncertainty in estimating Enhertu's cost-effectiveness was how much longer people on Enhertu live compared with those receiving standard treatment in the future. The independent committee carefully considered all the evidence and applied its judgement on the most clinically plausible approach on which to base its decision.
"Despite accounting for the condition's severity by applying a severity modifier, and accounting for innovation and uncaptured benefits, the cost the NHS was being asked to pay was too high in relation to the benefits it provides for it to be recommended for routine use in the NHS. Without a commercial arrangement that results in a price that represents a cost-effective use of NHS resources, NICE cannot recommend Enhertu."
Haran Maheson, vice-president and head of oncology Daiichi Sankyo UK, said: "We are extremely disappointed that patients with breast cancer in England and Wales are going to lose out on an effective treatment due to a technicality in the new formula NICE uses to assess cancer medicines.
"As we have demonstrated in Scotland, it is possible to provide access to this medicine cost-effectively within the UK. Patients now face a postcode lottery. This is the first and only licenced HER2-targeted medicine effective in HER2-low breast cancer and unfortunately NICE's approach does not adequately recognise the severity of this devastating condition. We remain determined to find a solution to deliver equitable access to patients across the UK and urge NICE to be more constructive in exercising flexibility in its assessment process."
AstraZeneca UK's President, Tom Keith-Roach, added: "This is a devastating decision and one which is out of step with other countries including Scotland. Sadly, the rigid application of a flawed methodology has here been prioritised ahead of doing what’s right for breast cancer patients in England and Wales. This sits extremely uncomfortably and we call on NICE to reverse this decision and expedite an urgent review of their disease severity modifier, in this case it clearly isn't working in the interests of patients."
An NHS spokesperson said: "NHS England expected drug companies AstraZeneca and Daiichi Sankyo to offer this treatment at a price that would enable Nice to recommend its use for patients with secondary breast cancer. We are deeply disappointed that AstraZeneca and Daiichi Sankyo have not been willing to price this treatment to enable approval, therefore denying NHS patients the opportunity to access this latest advance in care."
Breast Cancer Now is continuing to campaign on behalf of women living with HER2-low secondary breast cancer for access to Enhertu. You can sign their petition here.
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