In 2018 it is absolutely standard of care that every advanced non-small cell lung cancer patient who has non-squamous histology, which is the majority of patients, need to have upfront molecular testing to identify genetic subgroups of patients that have treatments that are superior to chemotherapy or immunotherapy.
But you have to identify them using these genetic tests.
So at least four genetic tests need to be done in every single patient.
There are different ways you can do that, though.
You can do individual tests for each of the potential gene targets and then there’s a bunch of up and coming targets that can also be tested for.
Or you could do a single up-front test called next gen sequencing, or NGS, which can test for a virtually unlimited number of targets all at once.
So what we did is we constructed an economic model, looking from the payer perspective, for a hypothetical cohort of one million patients covered by a mixture of Medicare or private insurance.
We calculated how many of them were likely to get advanced lung cancer and then we tested four different testing strategies for molecular testing.
So one was up-front NGS for every patient; one was doing sequential single tests for EGFR mutations, BRAF mutations, RAS and ALK1 gene fusions; one was to do what’s called exclusionary testing where we tested for KRAS mutations, that’s the most common mutation and by identifying the 25% of people who are positive you can then exclude those patients from needing any further testing.
Then finally what we call hot spot panel testing which is a common strategy of doing all the single gene tests at once but with separate individual tests billed as separate tests.
We incorporated the variables that some patients who had single gene tests would exhaust all their tissue before they could get all the testing done, would have to have new biopsies, and we know that not every patient goes on to have that done.
Then, of course, after all of these come back negative a certain percentage will then go on to have broader NGS testing anyway to look for potential future targets.
What we found was that there was a substantial cost saving to have everyone have up-front NGS testing compared to any of the other strategies.
It was most striking in the Medicare covered population, with savings between $1.3 million and $2.1 million for this hypothetical cohort of patients.
In addition, the testing was faster so patients got the results in a shorter period of time which is very important for advanced lung cancer patients who really can’t wait more than a couple of weeks to start their treatment.
Ultimately we also were able to discover a higher percentage of patients who had targetable mutations because no-one’s tissue ran out and had to be retested afterwards.
So ultimately it was clinically better, this is something that oncologists have understood for a while – to do the best test up front – but from the payer perspective it also cost them less to do the best test.
And in terms of taking this model forwards to lobbying for policy change or lobbying for any amendments to healthcare strategies and guidelines, where does this come into play?
This is starting to happen anyway.
So very recently CMS did say that they would pay for FDA approved tests for NGS for new lung cancer patients.
But private payers are still a little bit hesitant because the up-front test costs more than the single gene tests.
But it’s a very basic concept – one better test, even if it’s more expensive, costs less than doing four and soon to be five or six individual tests that may each individually be cheaper but in aggregate are much more expensive.
And ultimately it’s the best thing to do for the patients as well.