NHS experts call for wider use of cancer tests with the hope of more precisely tailoring the use of new treatments for patients.
Cancer researchers want regulatory bodies and industry to work together to ensure new treatments are developed alongside biomarker tests to ensure those patients who are most likely to benefit receive treatment.
"Greater use of cancer tests is the key to tailoring use of new treatments for patients more precisely," the Institute of Cancer Research (ICR), London, said. This, they highlighted, would increase the chance of these cancer tests "being recommended for use within the NHS".
By identifying groups of patients with specific changes in their genes or protein levels that make them more likely to benefit from treatment, biomarker tests make it "easier and faster” to demonstrate that new treatments are cost-effective.
Professor Kevin Harrington, professor of biological cancer therapies at the Institute of Cancer Research, London, and consultant clinical oncologist at The Royal Marsden, commented: "Our biological understanding of some treatments, especially immunotherapies, lags behind their clinical development – which means we are struggling to get them to the right patients quickly enough. To tackle this issue, we need more and better biomarker tests."
Biomarker Development Cost Outweighs Financial Benefits
The high cost of precision medicines makes it challenging to get them recommended for use within the NHS, unless they are precisely targeted towards individuals who are most likely to benefit from them.
Biomarkers can benefit patients in two ways, explained the ICR. Firstly, they can ensure that only those who are most likely to benefit from a treatment go on to receive it. Secondly, by improving the approval rates of new treatments they reduce costs by "deploying drugs more efficiently".
Professor Harrington explained that testing for measurable indicators can help predict which patients are most likely to benefit from treatment – which, in turn, he emphasised, "allows us to evaluate new treatments in smaller, smarter and cheaper trials", making it easier to demonstrate that treatments are cost-effective.
However, the costs of developing biomarker tests currently "outweigh the financial benefits" of doing so because of "excess regulation and administrative expenses", along with uncertainty over whether tests will be recommended for use within the NHS, criticised the ICR.
Drug appraisals tend to consider companion tests as an additional cost, which can discourage pharmaceutical companies from investing in developing and bringing forward biomarker tests, as they appear less cost-effective, the ICR pointed out. In this way, new treatments with companion biomarker tests may seem less attractive, they explained, and consequently it would be harder for them to be developed and adopted.
Acceleration of Research Crucial
The ICR pointed out that most recent figures available (for 2016 to 2019) show that only around 1 in 5 (18%) cancer drugs assessed by NICE were accompanied by a biomarker test.
"The problem is that it is surprisingly hard and costly to get new biomarker tests developed, approved and accessible within the NHS," stressed Professor Kristian Helin, chief executive of The Institute of Cancer Research, London. Unnecessary regulatory barriers need to be "removed", he said, and biomarker tests need to be viewed in a different way - as a way of "treating patients more efficiently, rather than as an additional cost", he urged.
In July last year the ICR, in collaboration with other leading institutions, charities, stakeholder groups, and life-science companies, published 13 consensus statements within the Use of biomarkers in cancer research and treatment report, with the aim of driving "wider use of biomarkers and more effective use of precision medicine for cancer patients".
The consensus statements called for an "acceleration" of research to identify new biomarkers for cancer, and for changes to regulations and funding to ensure biomarker tests and molecular profiling of cancers are used more "routinely" as part of NHS care.
As part of this plan, experts from the ICR have now called upon industry and regulators to come together to encourage the development of more and better biomarker tests, "across all cancer types".
They have also called for a series of changes in the way biomarker tests are used in the UK, including: Continued incentivisation for companies and academic institutions to develop biomarker tests alongside new drugs; investment by Government in a better national infrastructure to support research into new biomarkers; and a national directory for non-genomic biomarker tests, with acceleration of the process for adding new tests.
"Biomarker tests are the key to personalised treatment – and to getting new drugs approved as quickly as possible," highlighted Prof Helin. "Tests can direct treatment precisely to the patients most likely to benefit, which in turn could improve a patient's quality of life, and additionally, be more effective for the NHS."