Nigel Hawkes in the BMJ News reports: Start of cheaper technique for breast cancer is delayed in UK despite adoption elsewhere ( 2015;350:h2874 ) This type of rationing by delay of approval is very common in the health services. Its the same for new drugs whose approval is delayed until they are nearly out of patent.. GP commissioners should be demanding intra-operative radiotherapy.
A new technique that substantially reduces the burden of radiotherapy in women with early breast cancer and could save the NHS millions of pounds a year has been approved in Australia by the Medical Services Advisory Committee—the Australian equivalent of the UK National Institute for Health and Care Excellence (NICE)—ahead of its UK counterpart. Not only has it been recommended for selected patients but it is also an item in the committee’s 2015-16 budget.
In July 2014 NICE published draft guidance recommending the use of intrabeam radiotherapy, which replaces a course of 15 postoperative radiotherapy sessions with a single dose, given at the time of surgery. A randomised controlled trial led by University College London (UCL), the TARGIT-A trial, was published in 2010,1 and a five year follow-up in 2014 showed that the outcomes were not inferior to the established approach.2
At that time Carole Longson, director of health technology evaluation at NICE, said that the technique had the potential to be a much more efficient form of radiotherapy. “Unlike regular radiotherapy, with the Intrabeam Radiotherapy System only one dose is required,” she said. “The single dose is given at the same time as surgery, eliminating the need for numerous hospital visits. Regular radiotherapy typically requires numerous doses over a three week period—although some people may receive it for longer—and is performed weeks or months after surgery or chemotherapy.”
But, after comments from what NICE referred to simply as professional organisations, the final recommendation has been delayed. This delay has blighted the use of the technique in the United Kingdom, where it was developed, but it continues to be enthusiastically employed elsewhere in the world.
“It’s a terrible and shameful situation,” said Jeffrey Tobias, consultant clinical oncologist at UCL and one of the original trialists. “It was invented here—we did the first case in 1998 at the Middlesex Hospital. Now it’s being done routinely in the US, Germany, Australia, France and elsewhere but not here. A number of our patients even have had to go abroad for this treatment—it’s such a pity.”
Jayant Vaidya, professor of surgery and oncology at UCL, said, “As professionals, we can’t give our patients the treatment that’s best for them. I had to send a patient to Italy last week to get the treatment there. It’s very frustrating.” He calculated that use of the technique would save the NHS £12m to £60m (€17m to €85m; $18.5m to $92m) a year.
The technique has been adopted worldwide. At the St Gallen Breast Cancer Conference in 2011 the consensus among more than 52 breast cancer expert panellists was that TARGIT alone could be used as the only radiation treatment in selected cases after breast conserving surgery or as a boost to the bed of the tumour instead of external beam radiotherapy boost.
At the Miami Breast Cancer Conference in 2012, 91% of the audience in the surgical oncology stream echoed that view. The 2015 update of German guidelines from the Association of Gynaecological Oncology includes TARGIT intraoperative radiation therapy (IORT) during lumpectomy as a recommended option for women with T1, grade I or II, ER positive breast cancer. Over 250 centres worldwide now use the technique for treating breast cancer in the United States, Europe, Australia, the Middle East, the Far East, and South America. Some 120 centres are in Germany and the US alone, and more than 8000 patients have now been treated.
NICE told The BMJ that its decision to call for more evidence does not mean that the technique cannot be used in England and Wales, but Tobias and Vaidya both said that this has indeed been the effect of the ruling, except for patients enrolled in the National Institute for Health Research’s Health Technology Assessment TARGIT-B trial in patients with higher risk disease. In a statement NICE said, “While this NICE appraisal is ongoing, intrabeam radiotherapy can continue to be offered to NHS patients who need it. Until NICE publishes its final guidance, decisions on whether or not to fund specific treatments are the responsibility of local NHS bodies.”
NICE requested further information from the trialists, which has been provided. The appraisal committee will meet in August to look at the new evidence provided and make a further recommendation on the use of intrabeam radiotherapy, NICE said.
The new approach would greatly reduce the burden on radiotherapy departments, since women would not have to return for repeated radiotherapy sessions. It requires investment in machines to deliver the intraoperative radiation but on balance would save substantial amounts of money.