Advice
Specialist commentator comments
Specialist commentator comments
Comments on this technology were invited from clinical experts working in the field. The comments received are individual opinions and do not represent NICE's view.
Two out of 6 specialist commentators had used Axumin before in a research setting. Two further commentators said that they were familiar with the use of other positron emission tomography (PET) tracers for prostate cancer.
Level of innovation
One commentator noted that the level of innovation depends on what is considered standard care. Compared with bone scans, CT scans and pelvic MRI alone, the technology would be considered innovative. However, pelvic MRI with 18F‑choline PET/CT has become standard care in their centre and, compared with this, Axumin would be considered an addition that may offer several benefits but would not be transformational. Two commentators agreed with this notion: 1 thought it was a minor variation on choline PET/CT, the other thought it was similar to existing PET tracers but the only 1 using an amino acid transport mechanism in prostate cancer. The remaining 3 commentators thought that Axumin was a novel concept on some level. PET/CT imaging using choline (18F- or 11C‑labelled) and prostate-specific membrane antigen (68Ga‑PSMA) tracers were identified by commentators as competing technologies currently available to the NHS. Three of the commentators considered PSMA PET/CT to be superior to Axumin PET/CT in the detection of prostate cancer because of the higher sensitivity reported for the PSMA PET tracer. Minor advantages of Axumin over choline tracers were noted by 1 commentator. One commentator thought that, because of logistical challenges with PSMA PET/CT, Axumin may be a more versatile and straightforward tracer for routine use. Another commentator noted that, unlike most competing technologies, Axumin is a licensed product and it can be used in centres without a cyclotron, generator or radiopharmacy on site. In addition, early scanning after administration of Axumin has the potential to increase patient throughput.
Potential patient impact
More accurate and earlier detection of recurrent cancer compared with bone scans and pelvic MRI was identified as a key patient benefit by most commentators. Many added that this could potentially lead to earlier and more appropriate treatment strategies for individuals, and subsequently a greater chance of disease control. Two commentators noted that the use of Axumin may help treatment planning in radiotherapy, such as identifying the optimal radiation dose and treatment field. Others noted that the use of Axumin may help to avoid the need for repeat scans and, as such, result in fewer patient visits to the hospital or their specialist. The possibility of shorter examination times were noted by 1 commentator. According to 1 commentator, Axumin is unlikely to affect decisions on whether or not to offer pelvic radiotherapy given the recent practice-changing evidence from the STAMPEDE study (Parker et al. 2018). This supports prostate radiotherapy as a standard treatment option for men with low metastatic burden (based on bone, CT or MRI staging scan results). Overall, most of the commentators agreed that the technology has the potential to improve the current care pathway or clinical outcomes in some way. Most of the commentators identified people with rising prostate-specific antigen (PSA) levels after primary therapy (radical prostectomy or radiotherapy) as the group of people who would benefit most from this technology. One commentator thought it would be particularly useful for people in whom conventional imaging had failed to locate the region of recurrence. Another commentator thought that other advanced prostate cancer states (such as high-risk, locally advanced prostate cancer; non-metastatic castrate-resistant prostate cancer, and oligometastatic hormone-sensitive and castrate-resistant prostate cancer) may also benefit although evidence to support this is lacking.
Potential system impact
Improved outcomes and better use of resources, such as a reduction in the number of additional investigations needed, and unnecessary or inappropriate treatment, were identified as system benefits by commentators. Three commentators thought that Axumin would be an addition to standard imaging. Although, 2 of these specialists added it has the potential to replace CT and bone scans in centres where this is regarded as standard care. All other commentators thought that Axumin would be a replacement, in particular, for choline PET/CT tracers. Overall, most commentators thought that Axumin would cost more than bone scans, CT scans and pelvic MRI, more than or the same as choline PET/CT, and less than PSMA PET/CT. One commentator noted however, that the cost of PSMA PET/CT can vary and that, in their centre, PET/CT scans with Axumin cost more than those with PSMA PET tracers. Despite its initial upfront cost, some of the commentators thought it had the potential for long-term cost savings as it was shown to lead to earlier detection, and to reduce the number of repeat imaging and costs associated with unnecessary therapies. Two commentators thought that it was difficult to predict the cost impact without further economic evidence. All commentators agreed that implementing Axumin PET/CT would have minimal or no resource impact. A possible increase in workload or the number of radiographers and healthcare professionals working in PET/CT was mentioned by 1 specialist. According to specialists, no facility or infrastructure changes are needed to implement the technology because it can be used by any established PET/CT department. Four commentators noted that product-specific training for healthcare professionals would be needed for them to be able to do the scans and interpret results. None of the commentators were aware of any safety concerns or regulatory issues surrounding the technology.
General comments
Most of the commentators noted that the technology was not widely or routinely used in across the NHS. Compared with standard PET/CT imaging, commentators identified no usability or practical issues with the technology. When used in a research setting, 1 of the commentators noted that Axumin was safe and easy to use. One commentator noted that a comparison with 11C‑choline is obsolete because this tracer has been replaced in most centres by 18F‑choline, which has a similar half-life to Axumin. Commentators confirmed that 18F-, rather than 11C-, choline PET/CT is considered the standard of care in the UK, and was said to be commissioned by the NHS for use in prostate cancer. The cost, NHS commissioning status and the lack of sufficient evidence to show superiority over existing choline and PSMA PET/CT tracers were identified by specialists as potential barriers to adoption for Axumin. One commentator felt that the relative diagnostic benefits of Axumin compared with PSMA are not compelling and if 18F‑labelled PSMA PET tracers become commercially available there may be less of a role for Axumin PET/CT in the management of prostate cancer. Data from a UK setting comparing the diagnostic accuracy and cost effectiveness of Axumin with that of PSMA and choline tracers were highlighted as future requirements by commentators. The need for data showing the long-term effects of the technology on patient management and survival outcomes were also identified.