The first targeted immunotherapy treatment for people with triple negative breast cancer has been provisionally rejected for use on the NHS.
The National Institute for Health and Care Excellence (Nice) is not recommending atezolizumab to treat people with advanced breast cancer that has spread, it said in new draft guidance.
The recommendation will be under consultation until October 24 and the Nice committee will make a final decision on the use of treatment in November.
A breast cancer care charity called the decision “extremely disappointing” and urged Nice and NHS England to work with the company to “explore every possible solution”.
Triple negative breast cancer occurs in around 15% of cases and is thought to affect around 2,000 people in England.
The body estimates about 600 people in England with a “significant unmet need” could benefit from the treatment, made by Roche, which works by blocking the activity of a protein produced in larger amounts on cancerous cells.
It is used with the chemotherapy agent, nab-paclitaxel, to treat patients who have not had prior chemotherapy for cancer which has spread and where surgery to remove the tumour is not possible.
We are committed to working with the company to try to resolve the issues identified by the committee
Evidence has shown that the combination extends the time before the disease worsens by around two-and-a-half months and increases overall survival by more than nine months, compared to a placebo plus nab-paclitaxel.
But Nice said there is no trial data directly comparing the combination with existing available treatments, and the company’s indirect comparison was “unreliable and lacked validity”.
The cost of a course of atezolizumab is £39,981 based on treatment for seven-and-a-half months, but the company offered the NHS a confidential discount.
But Nice said it “could not recommend atezolizumab plus nab-paclitaxel as a cost-effective use of NHS resources”.
It said the combination did not meet its Cancer Drugs Fund criteria because it does not “have a plausible potential to be cost effective and there is no clear evidence that further trial data would resolve the uncertainties associated with this appraisal”.
Meindert Boysen, director of the Centre for Health Technology Evaluation at Nice, said: “I know that today’s announcement will be disappointing for people with breast cancer, and for their families and carers.
“Atezolizumab provides for a new way of treating people with significant unmet need, where targeted therapies have not been available to date.
“The committee heard that the availability of a new treatment that increases progression-free survival compared with chemotherapy alone will give hope to patients because it is important to them to be able to maintain a good quality life for as long as possible.
“We are committed to working with the company to try to resolve the issues identified by the committee.”
Nice said its recommendation does not affect patients who are currently receiving the treatment.
They can continue without change to the funding arrangements in place “until they and their clinician consider it appropriate to stop”.
Baroness Delyth Morgan, chief executive at the charity Breast Cancer Now, said: “This promising immunotherapy represents a significant advance in care for hundreds of patients with triple negative breast cancer. Having raised the hopes of a patient group with very few targeted treatment options to rely on, it is completely unacceptable that Roche, NICE and NHS England have been unable to find a long-term solution to make it available to all that could benefit.
“This combination has been available in NHS clinics for six months, and to now deny new patients the hope of this potentially life-extending drug is simply not good enough. Metastatic triple negative breast cancer remains one of the biggest areas of unmet need in breast cancer, and life expectancy remains heartbreakingly short.
“The evidence suggests that this immunotherapy combination could offer substantial life-extension – precious time to live and make memories with loved ones, which we know is absolutely invaluable.
“We now urge Roche, NICE and NHS England to work together to explore every possible solution, including considering additional discounts, to ensure this treatment option can return to NHS use as soon as possible. Women diagnosed with metastatic triple negative breast cancer do not have time to wait.”