Product information and disease description Place of product in therapy Disease description Burden of RAF-altered pediatric low-grade glioma requiring first-line systemic therapy

Economic impact of diagnostic testing

10 evidence topics · 6 sources

Summary: cost of molecular testing for BRAF alterations

Tovorafenib use in relapsed or refractory pLGG requires a BRAF fusion or rearrangement or BRAF V600 mutation, and FoundationOne CDx (a tissue-based next-generation sequencing test of 324 genes) was approved by the FDA as its companion diagnostic in January 2025. The Medicare advanced diagnostic laboratory test payment for FoundationOne CDx (code 0037U) was $3,500.00 during its initial period (July 1, 2018 to March 31, 2019); a current 2026 payment rate was not retrieved. No U.S. cost-effectiveness analysis of molecular testing for tovorafenib eligibility was identified.

Reported per-sample costs in other settings were US$1,000 for an outsourced RNA pan-cancer NGS panel (Jordan, 32 pediatric CNS tumors) and, for 82 pediatric LGGs, an average of $405 with a tiered approach (immunohistochemistry, targeted fusion panel or FISH, then targeted RNA sequencing) versus $745 with upfront targeted RNA sequencing. A Canadian microsimulation cost-utility analysis of BRAF fusion testing at diagnosis (100,000 simulated patients; 2018 Canadian dollars; targeted therapies not modeled) found testing dominant, with a gain of 0.38 quality-adjusted life-years (QALYs) and a $1,384 reduction in lifetime costs, driven by avoided radiation-related adverse events.

Companion diagnostic: FoundationOne CDx for tovorafenib

“FoundationOne®CDx is the first and only companion diagnostic for OJEMDA” (opens the source at this quote in a new tab)
“Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes in a patient’s tumor.” (opens the source at this quote in a new tab)

Medicare payment for FoundationOne CDx under the Clinical Laboratory Fee Schedule

Field	Quoted record
Test code	“0037U”
Test name	“FoundationOne CDx”
New ADLT initial period	“7/1/18 - 3/31/19”
Payment amount during new ADLT initial period	“$3,500.00”

Cost-utility of BRAF fusion testing at diagnosis in pLGG (Canadian microsimulation)

“We performed a model-based cost-utility analysis comparing two strategies: molecular testing to determine BRAF fusion status at diagnosis against no molecular testing. We developed a microsimulation to model the lifetime health and cost outcomes (in quality-adjusted life years (QALYs) and 2018 CAD, respectively) for a simulated cohort of 100,000 patients newly diagnosed with PLGG after their initial surgery.” (opens the source at this quote in a new tab)
“Our findings indicate that patients who received molecular testing at diagnosis experienced a 0.38 (95% CI: 0.08;0.77) gain in QALYs and $1384 (95% CI: $-3486; $1204) reduction in costs over their lifetime. Cost and QALY benefits were driven primarily by the avoidance of long-term adverse events (stroke, secondary neoplasms) associated with unnecessary use of radiation.” (opens the source at this quote in a new tab)
“Molecular testing was defined as screening glioma tumor samples for BRAF fusion alterations using the NanoString assay (NanoString Technologies, Seattle, WA).” (opens the source at this quote in a new tab)
“We did not include targeted therapies as a possible treatment for PLGG.” (opens the source at this quote in a new tab)

Per-sample cost of tiered molecular characterization versus upfront targeted RNA sequencing in pediatric glioma

“We used a tiered testing pipeline of immunohistochemistry (IHC), customized fusion panels or fluorescence in situ hybridization (FISH), and targeted RNA sequencing in pediatric gliomas.” (opens the source at this quote in a new tab)
“The average cost per sample was more affordable when using the tiered approach as compared with up-front targeted RNA sequencing in LGG ($405 US dollars [USD] v $745 USD) and HGGs ($282 USD v $745 USD). The average TAT per sample was also shorter using the tiered approach (10 days for LGG, 5 days for HGG v 14 days for targeted RNA sequencing).” (opens the source at this quote in a new tab)

Cost and turnaround of outsourced RNA NGS panel for pediatric CNS tumors (middle-income country)

“We reviewed our experience with NGS testing (TruSight RNA Pan-Cancer-seq panel) for pediatric CNS tumors at KHCC/Jordan (March/2022–April/2023).” (opens the source at this quote in a new tab)
“The median turnaround time from samples’ shipment to receiving the results was 23.5 days (range, 15–49 days) with a median laboratory processing time of 16 days (range, 8–39 days) at a cost of US$1,000/sample.” (opens the source at this quote in a new tab)

U.S. commercial cost or cost-effectiveness of BRAF testing to select tovorafenib in first-line pLGG

No evidence found.

Molecular testing treated as a routine cost already incurred in a pLGG cost-effectiveness model

“No testing costs are included in this economic evaluation because patients diagnosed with glioma are routinely tested for common driver mutations, including BRAF V600 mutations, via next-generation sequencing panel testing.” (opens the source at this quote in a new tab)

Unit cost of each tier in the tiered molecular testing pipeline

“To demonstrate the cost benefit of our tiered approach, the mean running cost (including labor cost and consumables) of testing per sample was calculated for the 86 LGG and 18 HGG samples in US dollars (USD), including failed and unsolved samples. The cost of Tier 1 testing is based on a minimum of 3 IHC stains per sample equaling $75 USD. The cost of running the Tier 2 tests is $100 USD per sample, and the cost of running Tier 3 (targeted RNA sequencing) is $745 USD per sample.” (opens the source at this quote in a new tab)

Infrastructure required before a tiered testing approach lowers per-sample cost

“It should be noted, however, that a basic infrastructure is required for such an approach including the availability of a laboratory equipped with at least Tier 1 testing and a trained molecular pathologist. The initiation of such infrastructure requires additional up-front nonrecurring costs.” (opens the source at this quote in a new tab)

Distribution of samples across testing tiers, which is what produces the cost difference

“Tier 1, Tier 2, and Tier 3 testing was performed on 98%, 41%, and 35% of samples, respectively. Collectively, 64% underwent either Tier 1 testing alone or Tier 1 and 2 testing, with 64% (52 of 82) not requiring Tier 3 testing (Fig 2A).” (opens the source at this quote in a new tab)
“Using our tiered approach, 95% (78 of 82) of LGGs were successfully molecularly characterized.” (opens the source at this quote in a new tab)