The oncology market is growing rapidly, driven by advancements in diagnostic technology, new biomarker testing, and a wealth of targeted therapies. The non-small cell lung cancer (NSCLC) space is especially crowded, which should be good news for the 226,000 patients diagnosed with this disease each year.
Despite the new developments in NSCLC treatment, however, many challenges persist—along with a few new roadblocks. Both payers and oncologists still perceive high unmet need in this space, from a lack of effective drugs to a high number of non-responding patients. Payers are also skeptical about many new developments, including liquid biopsy testing and companion diagnostic tests.
Recent research from MMIT’s NSCLC Managed Care Oncology Index report indicates that payers are currently restrictive in their coverage for NSCLC testing and treatments, which limits access for patients. Let’s take a look at the data.
Wealth of New Targeted Therapies
Surgery is the primary treatment option for patients with early-stage NSCLC, followed by chemotherapy and immunotherapy treatment for patients with locally advanced disease. Patients with metastatic disease have a better chance with targeted therapies. However, there is not a gold standard of care for patients in the later stages of NSCLC, due to the variety of mutations in this disease state.
NSCLC patients can have one of ten different kinds of mutations, from the BRAF mutation to a KRAS, ALK, ROS1+, or EGFR- mutation. Approximately 50% of patients have the tP53 mutation, which is associated with poor clinical outcomes and shorter overall survival rates. For this group, immunotherapies like Keytruda, Tecentriz, Opdivo, Imfinzi, and Libtayo are patients’ only options.
Fortunately, there are more than 20 approved therapies for NSCLC that span multiple targeted mutations. In 2025 alone, there have been five new approvals in this space, all for different targeted inhibitors: Emrelis (the first-in-class for a c-Met targeted therapy), Datroway, Ibrtozi, Hernexeos, and Zegfrovy. Two other therapies, a subcutaneous version of Keytruda and a different mechanism of action (MoA) for Emrelis, will likely be approved later this year.
Despite the wealth of treatments, 86% of surveyed payers and 100% of all surveyed oncologists still perceive this space as having moderate to very high unmet need. Most say there is a lack of effective drugs in this space, as well as an unacceptably high number of non-responding patients. A majority of both payers and oncologists report a significant need for safer drug options, and many also say there are not satisfactory methods of diagnosis.
Payer/Provider Skepticism About Liquid Biopsy Testing
Providers charged with finding the right targeted treatment for a patient with NSCLC typically conduct a tissue biopsy, followed by a biomarker test, to confirm diagnosis and determine the best treatment path. However, with a patient population that is often 65+ years old, these invasive procedures are not conducive for everyone.
In recent years, liquid biopsies have emerged to fill that gap. Liquid biopsies use a simple blood draw and digital PCR (polymerase chain reaction) technology or next-generation sequencing (NGS) to analyze material shed by the tumor into the patient’s bloodstream. However, payers and prescribers are reluctant to consistently utilize liquid biopsies, as there is not yet enough data on their efficacy.
According to MMIT’s NSCLC Oncology Index report, payers representing 62% of covered commercial lives and 35% of Medicare lives say they restrict certain types of biomarker testing available for NSCLC, primarily liquid NGS. This finding is consistent with MMIT research into other oncology TAs, such as colorectal cancer. Payers are restricting NGS testing coverage due to lack of evidence of cost savings and/or the success rate of biomarker-specific treatments.
In a meta-analysis of 17 studies evaluating the diagnostic performance of liquid biopsies in identifying EGFR mutations, the authors found that although liquid biopsies show the “highest sensitivity/specificity in high-stage tumours,” the lack of “literature data, lack of optimal detection methods, together with relatively high costs make its applicability in routine diagnostics still challenging.”
Payers Reluctant to Cover Companion Diagnostic Tests for NSCLC Therapies
Many targeted therapies have been approved with a companion diagnostic test (CDx), which is a type of biomarker test that lets prescribers know if that therapy will work for a patient. Some tests, like the Guardant360 CDx or the FoundationOne Liquid CDx, are available for multiple therapies.
According to MMIT’s NSCLC Oncology Index report, only one-third of surveyed payers cover all CDx tests, while another 53% only cover some CDx tests. Nearly one-half require test results for all NSCLC therapies associated with a CDx, while another 47% require test results for only specific NSCLC therapies. Most surveyed oncologists confirm that CDx results are required only for specific agents.
While most payers say they will restrict the authorization of an NSCLC therapy if the same CDx used in clinical trials is not utilized by the prescriber, 88% of surveyed oncologists say that NSCLC agents are still approved based off of non-trial CDx results.
Payers that do not restrict any CDx tests say that there is a clinical rationale for each, as mutations must be detected for the patient to have the best treatment options over time. As one payer noted, “This testing is important to ensure the drugs will be effective for a particular patient. They actually facilitate tighter UM of the drugs, which is where the real cost is. The cost of the testing is quite small in comparison to the cost of the drugs.”
Payer Preferences on Route of Administration for NSCLC Therapies
Many payers also have preferences on the route of administration (RoA) for NSCLC therapies. Recently, subcutaneous (SubQ) versions of immunotherapies like Tecentriq and Opdivo have gained FDA approval, and Keytruda’s SubQ version is expected later this year.
According to our research, payers are split on whether the development of more SubQ therapies is beneficial to their organization, with some arguing that they are not worth covering if there is no significant clinical advantage. Payers that do not perceive potential cost savings from preferring SubQ versions of NSCLC agents say that they are the same price as IV versions, and the reduction in chair time is not meaningful. A few other large payers say that IV biosimilars are where the real cost savings will be seen.
Other payers and PBMs believe that SubQ therapies provide cost savings in addition to ease of use for the patient. As one payer noted, “SubQ self-administered versions are easier on patients and will see administration on pharmacy benefit.” Another large PBM agreed, stating, “Opportunity for coverage under the pharmacy benefit, which allows for coverage policies that fall in line with other existing therapies and ability to apply similar UM and criteria. Additionally, this will cut down on ancillary costs associated with the administration of IV counterparts.”
In MMIT’s Payer Message Monitor, one large specialty pharmacy noted that the main factor in their decision-making is the pricing of these subQ therapies. This echoes payer sentiment in our May 2025 payer research, in which half of surveyed payers said they were likely to prefer SubQ versions over IV versions of an oncology therapy if is less costly and has the same efficacy and safety; 45% of payers said they would cover the SubQ version at parity.
Improving Access for Biomarker-Specific Treatments
Despite the emergence of new diagnostic testing methods and more targeted therapies in NSCLC, there are many market access challenges ahead for pharma companies. As in all therapeutic areas, the development of new products and technologies does not automatically equal easier patient access. Indeed, new developments in an indication often translate to more restrictive coverage, until such time as payers and providers believe in the strength of the data.
To improve coverage and uptake, manufacturers of NSCLC therapies should provide both payers and oncologists with as much clinical evidence of their drug’s efficacy as possible. Peer-reviewed studies, clinical trial data, and comparative studies will help persuade both providers and payers of the advantages of targeted therapies for the right patients.
Most importantly, manufacturers should engage payers to raise awareness of the critical role biomarker testing plays in enhancing care efficiency and reducing overall treatment costs. This is especially true for the evaluation of NSCLC therapies that incorporate new additions to a patient’s existing treatment regimen.
As one PBM noted in MMIT’s Payer Message Monitor, “One of the biggest challenges seen with targeted therapy is patients/clinicians not completing comprehensive biomarker testing. The clinical and cost data do show value in completing this testing, and it improves care management efficiency as the most effective treatments are selected.”
While time may be the biggest factor, presenting clinical and cost-efficacy data to payers should help convince them of the value of performing diagnostic testing and providing coverage for targeted treatments.
For key insights on current and future access restrictions within oncology TAs, learn more about MMIT’s Oncology Index.
