Health Economics of Biopsy for Suspected Lung Cancer

Intuitive presents three Health Economics and Outcomes Research (HEOR) studies describing the current landscape of biopsies for lung cancer. See results that quantify biopsy frequency, delays, complications, and associated costs on the path to lung cancer diagnosis.

Capturing biopsy frequency prior to diagnosis

This study describes the frequency and distribution of biopsy procedures for patients diagnosed and treated for primary lung cancer.¹

46% of patients had multiple biopsies prior to diagnosis
An average of 1.7 biopsies were performed per patient prior to diagnosis
53% of the first biopsies performed were percutaneous
For those with multiple biopsies, the time lag between procedures could add up to 90 days to the patient journey prior to treatment
Complication rates for those undergoing multiple biopsy procedures was not substantially different than those undergoing a single procedure.

This study concludes, in part, that the impact on treatment and lives can be significantly impacted if interventions are offered to diminish the number and subsequently the time between abnormality, diagnosis, and treatment. Further analysis is required to better understand the order and frequency of the diagnostic test and the intervals of time in between diagnostic work up and treatment plans to identify potential process improvements in current patient pathways. See study limitations.

Publication summary

Understanding delays in the journey to lung cancer diagnosis

This study documents the patient pathway to diagnosis of lung cancer and reports the pattern of procedures and physician visits in two cohorts of patients.²

69.2% of patients in the lung cancer cohort had stage III or IV disease.
Only 66.6% of patients in the single pulmonary nodule cohort (SPN) received follow-up care for 1 year
10% of patients in the SPN cohort had no workup at all.

In the study’s conclusions it’s suggested that more aggressive screening and referral coupled with timely diagnosis of earlier stage lung cancer and more aggressive follow-up of SPN will have the largest impact on patient outcomes. See study limitations.

Publication summary

Cost impact of multiple biopsies

This study examines the costs of biopsy and complications in patients with lung cancer.³

Repeat biopsies of the same type increased costs by 40–80%
29% of all biopsies were inpatient but accounted for 81% of total costs
Complications associated with biopsies accounted for 13% of total costs

In the study’s conclusion it’s stated that multiple biopsies add substantially to the cost burden of lung cancer diagnosis, leaving an opportunity for technological advancements that increase accuracy and effectiveness, leading to fewer repeat biopsies. See study limitations.

Publication summary

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Zhang Y, Shi L, Simoff MJ, J Wagner O, Lavin J. Biopsy frequency and complications among lung cancer patients in the United States. Lung Cancer Manag. 2020;9(4):LMT40. Published 2020 Aug 17. doi:10.2217/lmt-2020-0022. https://www.futuremedicine.com/doi/full/10.2217/lmt-2020-0022

Study limitations

The MarketScan claims data come mostly from large employers providing coverage for their employees and dependents. Thus, the results may not be generalizable to the population as a whole.
The analytic files are based on payors who submit claims data and may not be representative of certain regions or the entire country.
A single primary diagnosis of lung cancer was used as evidence of lung cancer and did not have a confirmed pathological diagnosis of cancer as no chart extraction was used for this evaluation or for the records included in the analysis.
There are also limitations when defining an episode of care for analysis. The analysis focused on a 12 month episode of care; therefore, the biopsy procedure performed could have been for a re occurrence of disease, thus affecting the purpose of the biopsy, especially in a patient with suspected late stage disease.

Zhang, Y., Simoff, M.J., Ost, D. et al. Understanding the patient journey to diagnosis of lung cancer. BMC Cancer 21, 402 (2021). https://bmccancer.biomedcentral.com/articles/10.1186/s12885-021-08067-1

Study limitations

This is a retrospective study that is associated with confounding factors for biopsies and treatment procedures.
The patient population comes from two Louisiana healthcare systems and the patient pathways from nodule identification to diagnosis may not be generalizable to other healthcare systems throughout the country.
Linking of data from REACHnet with the Louisiana Tumor Registry resulted in many patients being excluded from the final cohort per protocol.
Results may not be generalizable to patient populations outside of Louisiana healthcare systems.

Chiu YW, Kao YH, Simoff MJ, Ost DE, Wagner O, Lavin J, Culbertson RA, Smith DG. Costs of Biopsy and Complications in Patients with Lung Cancer. Clinicoecon Outcomes Res. 2021 Mar 17;13:191-200. doi: 10.2147/CEOR.S295494. PMID: 33762834; PMCID: PMC7982449. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7982449/

Study limitations

The study population does not include persons who are uninsured, publically insured other than by Medicare, or persons without continuous enrollment.
Claims data are focused on administrative rather than clinical information (i.e. staging information).
30% of those diagnosed with lung cancer in the IBM Marketscan Database did not have continuous insurance enrollment, which is typically indicative of a change in employment status or a company’s change in insurance provider.
This study likely excludes low income individuals and may not be generalizable to the broader U.S. population.
Many patients, 5434 (19.2%), were observed to have lung cancer therapy with no evidence of biopsy.
A single diagnosis of lung cancer in the primary diagnosis position was used as evidence of lung cancer, however, claims data does not provide a pathological diagnosis of lung cancer.
While authors attempted to separate diagnosis and treatment claims, they may have included some costs associated with treatments if claims for diagnosis and treatments were combined. This is particularly a concern for patients with inpatient admissions.
This analysis also excluded patients who received multiple biopsy types, a population subset that may have more complications, limiting the scope of the analysis.
Complications (excluding prolonged air leak and abscess of the lung) were only considered to be biopsy related if they occurred within a day immediately following the biopsy, which may underrepresent the complication rates.

Disclosures and important safety information

Important safety information
As with any bronchoscopic procedure under general anesthesia, serious complications may include bleeding, pneumothorax (collapsed lung), cardiac-related complications, respiratory failure, air embolism, or death. For summary of the risks associated with bronchoscopy refer to www.intuitive.com/safety.

For risks, cautions, and warnings and full prescribing information, refer to the associated Ion System user manual(s) or visit https://manuals.intuitivesurgical.com/market.

Individuals’ outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics, and physician experience.

Ion endoluminal system
The Ion endoluminal system (Model IF1000) assists the user in navigating a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures. The Ion endoluminal system enables fiducial marker placement. It does not make a diagnosis and is not for pediatric use.

Information provided by the Ion endoluminal system or its components should be considered guidance only and not replace clinical decisions made by a trained physician.

The Flexision Biopsy Needle is used with the Ion Endoluminal System to biopsy tissue from a target area in the lung.

The PlanPoint Software uses patient CT scans to create a 3D plan of the lung and navigation pathways for use with the Ion Endoluminal System.