The National Institute for Health and Care Excellence (NICE) has recommended funding for advanced cervical cancer treatment with immunotherapy, representing the first new life-extending NHS treatment to be made available for incurable cervical cancer in almost 15 years.
However the treatment, with pembrolizumab (Keytruda, Merck Sharp & Dohme [MSD]), will be made available only through the Cancer Drug Fund (CDF), which will pay for the drug while data is collected on its clinical effectiveness.
"This means people can have earlier access to treatments while further clinical evidence is generated," NICE said. The data gathered will then be used when NICE re-evaluates the treatment to decide whether it is clinically and cost effective for routine NHS commissioning.
The interim decision, in NICE final draft guidance published today, was estimated to benefit potentially around 400 people who might be eligible to receive treatment through the CDF over the next 3 years.
Favourable Progression and Survival Figures but Cost-effectiveness Uncertain
NICE said that clinical trial evidence showed that people on the treatment had longer without their disease progressing than people receiving standard care. The evidence also suggested that they may live longer overall.
However, NICE said, "it is unclear how much longer it takes for their cancer to get worse, or how much longer they live for, because the trial is ongoing".
It was "difficult for the NICE committee to establish if the medicine is cost effective" because of this uncertainty, it said. "This uncertainty may be reduced by collecting and analysing data from the ongoing clinical trial."
Standard care for persistent, recurrent or metastatic cervical cancer includes chemotherapy with or without bevacizumab. Under the new ruling, pembrolizumab is recommended with chemotherapy (with or without bevacizumab) as an option for treating persistent, recurrent or metastatic cervical cancer in adults whose tumours express programmed cell death ligand 1 (PDL1) with a combined positive score (CPS) of at least 1 if the pembrolizumab is stopped at 2 years of uninterrupted treatment.
According to Helen Knight, director of medicines evaluation at NICE, women with advanced cervical cancer currently have "limited treatment options beyond standard care".
She said: "Pembrolizumab shows promise as the first effective immunotherapy. However, to ensure the best use of limited public funding, we need additional evidence to fully analyse its clinical and cost effectiveness before it can be considered for routine NHS use.
"Recommending pembrolizumab to the CDF means people have faster access to care while this further evidence is gathered."
Responding to NICE’s announcement, Dame Cally Palmer, NHS national director for cancer, said: "Making this life-extending drug available today is a significant moment for women with advanced cervical cancer, which disproportionately affects younger women, allowing them to spend more precious time with loved ones and enjoy a better and longer quality of life."
NHS England (NHSE) claimed that it had "struck a deal" to fast-track the drug through the CDF, so "making it immediately available". It said that pembrolizumab was "the first new addition to NHS treatment for incurable cervical cancer for more than 14 years". Clinical trial data suggested that adding pembrolizumab to standard chemotherapy may help extend patients' lives by up to 8 months on average compared with chemotherapy alone.
Further evidence on the exact survival benefit will be collected and analysed while the drug is accessible via the CDF.
Pembrolizumab is already offered by the NHS in England for the treatment of several other cancers, including breast, bowel, lung, and skin. It can now also be given to certain patients with cervical cancer whose disease has not responded to other treatments.
Decision Marks 'Significant Step Forward'
John Stewart, NHSE’s director of specialised commissioning and interim commercial medicines director, said: "After nearly 15 years without a new treatment for this type of advanced cervical cancer, this first immunotherapy marks a significant step forward that will provide hundreds of people with precious time with their loved ones.!
Around 2600 women are diagnosed with cervical cancer and 690 die each year in England – around two deaths per day. The disease is most often diagnosed between the ages of 30-34, according to Cancer Research UK.
In a press release from NHSE, David Long, head of oncology at MSD UK, said: "Advanced cervical cancer is an aggressive and incurable disease which has a major impact on patients and their families. It is most common in those from the most deprived backgrounds.
"Before today there were few treatment options for people with advanced cervical cancer and now MSD is incredibly proud that patients have access to a new treatment option that we hope will go some way to addressing the significant unmet need."
Asked to comment by Medscape News UK, Samantha Dixon, CEO of Jo's Cervical Cancer Trust, which contributed to NICE’s appraisal process, hailed the announcement as "fantastic news". The drug has been available to patients in Scotland since February, and Jo's Trust has been calling for pembrolizumab to be available across the UK.
"Cervical cancer affects women of all ages, many are young. They have families, children, jobs, caring responsibilities. Pembrolizumab can slow the progression of cervical cancer and the impact of this on those who are eligible for the treatment cannot be understated."
Ms Dixon said: "Treatments are far too limited for those living with advanced cervical cancer and this provides patients with valuable options, hope and, most importantly, time."