麻豆传媒

In 2018, the World Health Organization (WHO) released a list of what they called "." The list focused on in vitro tests and highlighted 58 tests for detection and diagnosis of common conditions, such as type 2 diabetes (T2D), and 55 tests for what WHO calls "priority" diseases such as HIV, tuberculosis, and human papillomavirus infection.

Five years on, has the list led to much of a payout in terms of testing uptake? Somewhat. For instance, at the time of the list release, WHO reported that 46% of the global adult population were estimated to have undiagnosed T2D. Three years later, a put the number of people worldwide with undiagnosed diabetes at just slightly lower, at 44.7%

But if adoption of such "simple" testing has been so slow, what chance do more sophisticated testing methods, such as next-generation sequencing (NGS), have for becoming a mainstay of real-world medicine? In cancer care, NGS and single-gene testing (SGT) have been around for at least a decade. Yet "uniform incorporation [of genetic testing] into clinical practice has been slow and inconsistent," pointed out Christopher A. Lemmon, MD, of the Taussig Cancer Institute at the Cleveland Clinic, and colleagues. "Many patients with actionable driver oncogenes (ADOs) are never identified and thus never receive targeted treatment."

Lemmon's group developed a model to compare the use of NGS with SGT, especially because a "commonly referenced barrier to NGS testing is cost of testing and the potential need for treatment with expensive targeted agents," the team wrote in . The model assumed that 80% of patients with non-small cell lung cancer (NSCLC) underwent any kind of genetic testing.

The researchers evaluated the economic impact and the potential life-years gained (LYG) that could be linked with the use of NGS in the U.S. versus SGT in patients with metastatic NSCLC. The investigators found that:

• Each incremental 10% increase in NGS testing led to an average 2,627.4 additional LYG

• The average cost savings per LYG was $75

• If SGT were replaced by NGS at the current rate of 80%, it would result in an average additional 21,09.6 LYG

• It also would reduce cost per LYG by an average of $599

Finally, if "100% of eligible patients were tested with NGS and each identified patient had matched treatment, the total average cost per LYG would be $16,641.57," Lemmon and co-authors said.

Bottom line? "Broad implementation of NGS testing for all guideline recommended [ADOs] in practices that currently perform limited genomic testing offers meaningful survival benefits to patients and is financially economical," the team concluded. "NGS testing should be performed universally for all patients with newly diagnosed advanced nonsquamous NSCLC."

But as the researchers noted, barriers to pairing patients with NGS need to be overcome. How are clinicians in other countries handling both the implementation of NGS or other costs associated with lung cancer care?

Below, a U.K. clinician discusses the challenges of genomic testing implementation in his part of the world, while a Spanish clinician outlines practical considerations for making NGS feasible, and an Australian provider takes on money matters and the delivery of radiotherapy (RT).

What are some of the hurdles related to genomic testing for lung cancer in the U.K.?

Alastair Greystoke, MBChB, MSc, PhD, University of Newcastle & Newcastle upon Tyne Hospitals NHS Foundation Trust, England: Within lung cancer, we now have eight oncogenes that we need to test for in the test directory and that lead to potential targeted treatments, with either the first- or second-line setting.

The challenge around that is that we know our tumor biopsies are often small, our patients are presenting with metastatic disease, and we need those [testing] results quickly to get them on appropriate treatment, either with a targeted therapy or using standard chemotherapy, with or without immunotherapy.

The NHS [National Health Services] went under -- at least in England -- extensive reorganization about 4-5 years ago, where we're seeing a centralization of genomic services. In England, there are seven genomic laboratory hubs, and that has led to challenges, in that there's now a very complicated pathway where the biopsy is being taken and organized by the chest team -- it's going to pathology assessing for tumor content, it's then going to a molecular laboratory to do the analysis, and then coming back even to the respiratory physician, pathologist, or the oncologist.

And there's lots of potential areas where that process can go wrong, and lots of delays can happen -- particularly if you take into account that these biopsies are small and may need to go all the way back to the beginning of the process.

I don't think there's going to be one solution that's going to fix the whole system -- I think there are some relatively simple things that we can look at. For example, the idea of a tissue coordinator who can track the tissue from the time of the biopsy to all the way through that complicated process until the result comes back. We need to be very closely monitoring our turnaround times -- not only from the time that the biopsy is taken to the time that the result is received, but look at those individual components, to try and identify roadblocks.

One of the potential solutions is that we might use a circulating tumor cell blood sample for rapid diagnostic testing, and that's got certain key advantages. It takes away some of the process that we were talking about earlier about going to a molecular laboratory and then on to [genomic] testing ().

What are some practical considerations for molecular profiling in NSCLC?

Pilar Garrido Lopez, MD, PhD, University Hospital Ramón y Cajal, Madrid: I think molecular profiling is really key for our patients. It used to be key for NSCLC patients with advanced disease. Currently, we also have the option to offer targeted treatment in this group of patients with EGFR mutation at earlier stages so the need for biomarker testing is moving to earlier stages too. But currently, according to guidelines, at least we need to know the status of different subgroups -- EGFR, ALK, ROS, BRAF. There are other subgroups [where] we have the opportunity for targeted agents in the second-line setting, such as KRAS, MEK1, and others.

Having said that, I know there are some challenges; some of them link to reimbursement, which is a challenge that we have in Spain; we know that the amount of tissue required for NGS is not always easy [to obtain] in patients with lung cancer, so we need to continue looking for new options -- for instance, liquid biopsy ().

What was the impetus for the study "Cost estimation of radiotherapy for local control and overall survival [OS] benefit of lung cancer in the Australian population?"

Shalini Vinod, MBBS, University of New South Wales, Sydney: Our group has to show that if RT is used as per evidence-based guidelines, at a population level, that there's a 12% improvement in 5-year local control, and a 6% improvement in 5-year OS. We then looked at 3 years worth of RT activities in our publicly funded RT department in Australia to determine the costs by stage. We looked at all RT activities up to the first follow-up appointment.

Basically what we found is that the average cost per treatment course for RT was $5,500 Australian dollars [about $3,600 U.S.], and the average cost for a 1-year local control benefit was $5,900 for stage I to II cancers and $11,000 for stage III cancers.

In terms of survival, the cost per 1-year survival benefit was $8,900 for stage I-II lung cancers and $16,000 for stage III lung cancers. These costs are well below the accepted cost effectiveness threshold of $50,000 a year per LYG. The overall conclusion is that RT is an inexpensive and cost-effective treatment for lung cancer ().

Read the study by Lemmon and team here.