Exciting new medical technology which could better inform treatment decisions for cancer still needs to prove its superiority to existing prognostic tests, according to private medical insurance (PMI) providers.
Oncologists believe that the pathology tests, called cancer tumour genomic analysis, could revolutionise cancer treatment, enabling them to prescribe highly targeted therapies, avoid over-treatment and potentially save both the NHS and insurers large sums of money. However, UK insurers express caution about over-stating the benefits of the technology, as it stands.
THE US EXPERIENCE
The most well-established test – Oncotype DX – is already widely used in the US, where it has been recommended by both the National Comprehensive Cancer Network and the American Society of Clinical Oncology and approved for funding by health insurers across the Atlantic.
The manufacturer, Genomic Health, claims that the use of the test changes initial treatment determinations in approximately 30% of cases. However, although the test is not particularly expensive (about $4,000), UK insurers are yet to be convinced of its benefits, arguing that the test is still a long way off from enabling doctors to deliver truly personalised medicine.
“It is not a given that this is a panacea and insurers will see a decrease in their costs [by avoiding over-treatment],” said Dr Gary Bolger, head of medical policy at AXA PPP healthcare. “Nobody has done a study using it at the point of diagnosis where decisions are made about whether or not to use chemotherapy and then seeing what happens. They have done studies historically. That is not the same thing.
“It does not predict definitely whether or not a recurrence will occur; it is about what the risk of recurrence is. We need to look at this in practice. Does it alter what people’s decision is? Some women might want to have chemotherapy regardless of the test result.”
Although Dr Bolger has been contacted by manufacturers and laboratories seeking to promote the test, he has not seen huge demand from oncologists. He confirmed, however, that he is “open for an individual discussion” with oncologists, chiefly to determine what they plan to do with the test result. One such clinician “really had not thought about what they would do with the result”, Dr Bolger said.
Dr Doug Wright, principal clinical consultant from Aviva UK Health, another insurer, agrees that more evidence is required.
“We’re not funding it at the moment because it is not clear as to whether it drives a particular change in treatment options,” he said. “It does not give you yes or no answers but clusters people into those likely to benefit or unlikely. But there are others in the middle.”
This middle risk group is one which “nobody knows how to advise” according to Dr Virginia Warren, assistant medical director at Bupa, which will not routinely fund the test but will provide a “discretionary payment” to women participating in a current trial underway in Northern Ireland.
“The broader context is that there are already ways of helping women make decisions about whether or not to have chemotherapy,” she said, citing hormone receptor testing as an example. “New things have to prove they are as good, or better, than these.”
Nicolas Beechy-Newman, consultant surgeon and clinical director at The Harley Street Breast Clinic, agreed that for these “middle risk” patients – a sizeable number – “it hasn’t got you very far.”
“We are trying to move away from a percentage and be more individual to each patient,” he said. “One of the weaknesses of these things is that they are still not completely individualised. It’s just another percentage. What we are all aiming for is to be able to look at one patient and say ‘for you this will definitely work’.”
While Oncotype DX and similar gene profiling tests are yet to win over UK insurers, targeted therapies – and the tests required to determine their effectiveness for individual patients – are already being funded.
In fact, the speed with which private medical insurance (PMI) providers can approve such targeted therapies has enabled the industry to establish clear blue water between its offering and that of the NHS in recent years. For example, Bupa decided that it would fund Herceptin for breast cancer patients before it was licensed, because it was confident that a clinical trial had demonstrated its effectiveness. In contrast, the Health Secretary at the time Patricia Hewitt had to demand that NHS patients be given access to the drug, following patient demands.
Another drug commonly funded by PMI providers is the bowel cancer therapy cetuximab (trade name Erbitux), the effectiveness of which can be determined by testing tumours for a particular form of a certain gene. Aviva’s Dr Wright said that the insurer “took an early move” on the decision to fund such tests.
“Waiting in the wings are a whole lot more of these,” he said, pointing to recent reports in the national press that the entire genetic codes of two cancers have already been mapped. “This takes us into the next wave of development.”
While stressing the importance of supporting evidence, all three doctors advising the insurers agreed that society is entering a new dawn for cancer treatment.
“It is interesting and exciting if we can get to the position where people are only being treated because they really do need it,” said AXA PPP’s Dr Bolger. “That would be a lot better all round. The cost of the screening or the chemotherapy would not be in that consideration; it would be a good thing to do.”
WHAT IS ONCOTYPE DX?
Oncotype DX is a test can help doctors and patients decide whether or not chemotherapy should be part of a treatment plan. It is appropriate for patients with a common form (oestrogen receptor positive) of early stage breast cancer.
The test is carried out on a sample of the patient’s breast cancer tumour. The activity of 21 genes within this tumour is analysed and the results are reported as a “recurrence score” of between 1 and 100. A lower score means that there is a small chance of the patient’s breast cancer returning or spreading within 10 years of diagnosis and that she is less likely to benefit from undergoing chemotherapy. A higher score means that there is a greater chance of recurrence and more benefit to be gained from chemotherapy. The process takes 10-14 days to complete.
The score is not used to make decisions in isolation as other factors such as the patient’s age will be taken into account and the final choice remains a personal one. Women with a lower score may still decide to undergo chemotherapy.
Studies show that in early stage, oestrogen receptor positive breast cancer only four in 100 women who undergo chemotherapy derive large benefit from it.