MMprofiler for prognostic risk classification in multiple myeloma

Level of innovation

All experts said MMprofiler is innovative, with 4 stating it is the first in a new class of testing. Four experts said MMprofiler finds prognostic information that is not currently found by other methods including FISH. One expert stated that FISH also finds prognostic information not found by MMprofiler, with MMprofiler plus FISH used to identify people with ultrahigh-risk multiple myeloma. One expert felt that while MMprofiler is innovative, it has not been shown to be better than standard care in terms of risk classification in multiple myeloma. Two experts described other gene expression profiling platforms but stated these were not equivalent to MMprofiler.

Potential patient impact

All experts stated MMprofiler may detect people with high-risk multiple myeloma not identified by other prognostic tests. One expert said routinely used prognostic markers are effective at risk-stratification and felt more direct comparative evidence was needed to show that MMprofiler was better. Three experts felt MMprofiler could improve people's knowledge and understanding of the prognosis of their cancer. This could improve communication between patients, healthcare professionals and carers leading to more empowerment of people in their treatment decisions and care plans. One expert stated that having better prognostic information may also help people with life plans, such as stopping work and financial planning. However, they questioned how much this additional prognostic information would affect people's decision making.

One expert felt MMprofiler has the potential to guide treatment in the future based on genetic risk scores. Two experts stated there is no evidence that the technology is a predictive biomarker. Predictive information would estimate differential responses to treatments and guide treatment decisions. All experts noted that healthcare professionals are still unsure how to manage multiple myeloma according to risk classification. They felt more research and data were needed to support the use of risk-stratified treatment for multiple myeloma. One expert noted that while the benefits of risk-stratified treatment are still unclear, most multiple myeloma experts believe that people with high-risk multiple myeloma should be treated differently.

There were few anticipated adverse events from using MMprofiler. One expert said there may be low false positive or false negative rates which may lead to the wrong risk classification in some people. They felt it was hard to estimate the potential effect of this. One expert felt that inappropriate treatment decisions could be made if the technology was used for risk-stratified treatment before evidence supporting this is mature.

Potential system impact

All experts stated that MMprofiler is not currently used in the NHS. One expert believed MMprofiler has the potential to change the current pathway by better defining genetic risk. This would allow for individualised treatment approaches like other cancers. One expert stated the improved prognostic information from combining MMprofiler with standard care prognostic tests could lead to improved allocation of resources through risk adapted management pathways. Three experts felt more data was needed to show the capability of MMprofiler to influence treatment decisions. One expert stated that while MMprofiler may have better prognostic power than standard care, they were unsure this was significantly better to justify its use without having predictive data. They added that if the technology could provide predictive information in the future, it could be adopted quickly and either replace or supplement current cytogenetic tests.

Four experts stated MMprofiler costs more than standard care. One expert believed the technology would be cost neutral when balancing test costs against the improved allocation of resources in the patient management pathway. One expert stated that while prognostic tests were being used to identify high-risk multiple myeloma, this did not result in any healthcare resource utilisation savings. Two experts stated there would be minimal resource needs because the test is done by the company on existing bone marrow samples. One expert queried the quality assurance of sample turnaround and processing of tests done at a laboratory outside of the UK. All agreed there would be no need for specific training for efficacious and safe use.

General comments

There was disagreement over where the technology would be used in the NHS. Two experts felt this would be limited to a small number of hospitals or specialist centres, while 3 experts thought it would be used by most or all district general hospitals. Four experts believed the technology could be offered to all people with newly diagnosed multiple myeloma. There are about 5,800 new diagnoses of multiple myeloma in the UK every year. The test could also be offered to more than half of people with relapsed multiple myeloma. One expert suggested use may be limited to certain groups whose treatment decisions may be more affected by genetic disease risk. These included older people and people with patient-specific factors such as frailty and comorbidities. One expert suggested use may be most relevant in younger people as the prognostic effect of tumour genetic lesions is greater in this group.

Two experts stated that it was unlikely that the technology would be universally adopted. The main factors thought to limit adoption in the NHS were the lack of mature evidence, costs, and variable uptake by healthcare professionals. All experts said further prospective research of the technology and its predictive capacity in guiding treatment decisions was needed.