NICE has recommended the Intrabeam Radiotherapy System for people with early breast cancer in limited circumstances with additional data collection, but has rejected the use of breast cancer drug palbociclib (Ibrance) as its cost is too high in relation to its potential benefits.
Both announcements were made in draft guidance that is out for consultation now.
The recommendation regarding the Intrabeam Therapy System for further data collection was made as NICE is not yet certain whether Intrabeam, marketed by Carl Zeiss UK, is as effective as conventional radiotherapy in stopping the cancer coming back. However, the independent appraisal committee heard the risk of this happening is low in the patients who would receive Intrabeam and that people may be prepared to accept some uncertainty if it means they don’t need radiotherapy after their surgery.
For this reason, the committee has also recommended that patients are provided with information on the treatment options available, including their risks and benefits, so that they can make an informed choice about their treatment.
Regular radiotherapy typically requires numerous doses over a 3 week period, and is performed weeks after surgery when the wounds have healed.
Intrabeam is a type of targeted radiotherapy and only requires one 30 minute dose given at the same time as surgery to remove the tumour, so there is no need for repeated hospital visits for most patients (although some patients, who are found to have a higher risk of recurrence, might still need to have conventional radiotherapy after they have had Intrabeam).
The committee heard from the patient expert that this would be considered a major advantage by some patients and might outweigh the fact that much less is known about the long term outcomes of Intrabeam treatment compared with conventional radiotherapy.
Professor Carole Longson MBE, director of the centre for health technology evaluation at NICE, said: “This is a promising new way of providing radiotherapy but the evidence needs to develop and the committee therefore recommended that its use is carefully controlled and accompanied by gathering additional information on its clinical effectiveness”
The Committee also heard that Intrabeam can have better cosmetic outcomes and that the side effects of conventional radiotherapy such as local tenderness, breast pain, swelling, reduced range of movement or change in breast appearance and texture were avoided or reduced with Intrabeam.
Each machine costs £435,000 to buy and £35,000 a year to maintain, so the committee was keen to emphasise the importance of using the machines already available as effectively as possible.
Over 50,000 women and around 340 men are diagnosed with breast cancer each year in the UK. Figures suggest that about 86% of them – 43,300 people each year - will potentially have early breast cancer.
The draft guidance is open for public consultation until 1 March.
However, NICE did not recommend the use of breast cancer drug palbociclib (Ibrance) because its cost is too high in relation to its potential benefits in draft guidance out for consultation.
Palbociclib is used to treat hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer.
It can be used either before or after other treatments have been tried. NICE’s draft guidance looks at palbociclib for people who have not had any treatments for their locally advanced or metastatic breast cancer.
The committee found that palbociclib stalled the growth of the cancer for an extra 10 months on average. The committee concluded that although it was likely that this would result in some improvement in overall survival, this could not be quantified from clinical trials.
Professor Carole Longson MBE, director of the centre for health technology assessment at NICE, said: “The committee needs more evidence of the drug’s impact on overall survival of people with breast cancer. However, even when allowing for these potential benefits, it was still not enough to make palbociclib cost effective at its current price.
“The committee heard from the patient expert that delaying the progression of their cancer for as long as possible and being able to continue with normal activities, including working, is valued very highly by patients and their families.
“It also heard that by postponing disease progression, palbociclib may reduce the number of people who are exposed to the often unpleasant side effects of chemotherapy, and delay the need for such treatment in others.
“Taking the costs into account, the committee concluded that it could not recommend palbociclib for NHS use at present.”
Palbociclib is taken with an aromatase inhibitor, a type of anti-cancer drug that works by blocking the production of oestrogen, stopping the hormone’s ability to stimulate some breast cancers to grow. Given as a once-daily capsule, palbociclib is the first of a new type of drug that increases the effect of aromatase inhibitors.
A full course of treatment with palbociclib costs £79,650, with approximately 5,500 people in England would be eligible for treatment with palbociclib.
The draft guidance is open for public consultation until Friday 24 February.