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Despite Investments, Barriers Limit Access to Cutting-Edge Oncology Treatments, Survey Suggests

2023 PON survey image

NEW YORK – Major cancer centers and healthcare systems in the US are continuing to invest in molecular testing and hire experts to enable precision medicine, Precision Oncology News' fifth annual survey has found.

But as more expensive and logistically complex cell and radionuclide therapies enter the market, the survey findings also suggest the need for the entire life sciences ecosystem to address reimbursement, technological, and structural barriers within the healthcare system that are keeping many patients from getting the most cutting-edge precision oncology treatments.

Since 2019, Precision Oncology News has annually surveyed experts knowledgeable of precision oncology activities at institutions around the country to understand the investments they're making to improve patients' access to molecular testing and precision medicines — a term that comprises biomarker-informed drugs, autologous CAR T-cell therapies, and treatments designed to replace, correct, or attenuate the genetic abnormality responsible for a disease. Between August and December of 2023, Precision Oncology News reached out to individuals at small and large cancer centers, hospitals, and community practices in the US who are integrally involved in precision oncology programs and have knowledge of related activities. The 20 respondents to the 2023 survey play a role in guiding the use of precision medicine and molecular testing, including oncologists, program or cancer center directors, physician scientists, pharmacists, genetics experts, and pathologists.

Roughly a third of the 20 experts work at National Cancer Institute-designated comprehensive cancer centers, and a similar proportion work at academic institutions or cancer centers within large healthcare systems. Although some of the surveyed healthcare institutions and cancer centers do serve rural and low-income populations, most of the respondents work at healthcare organizations that are likely better resourced than many community hospitals and local, standalone private practices where most cancer patients in the US receive care.

The 2023 survey findings suggest that the top healthcare institutions in the US are continuing to invest in capabilities for delivering precision oncology to patients. When asked what investments these institutions made in the past year that improved physicians' ability to practice precision oncology, eight mentioned that doctors gained access to an internal or external molecular tumor board that reviews patients' molecular test results and provides guidance on treatment strategies. Seven respondents mentioned investments in clinical decision support and new hires with expertise in precision oncology or molecular diagnostics, while six indicated their institutions had hired support staff like nurse navigators who could enable precision oncology.

In the past year, has your institution or practice made any new investments that have improved your ability to practice precision oncology? (Select all that apply)

One person wrote in that in 2023, the institution installed updates to the electronic health records system, which made it easier to order tests and see results. Another respondent's institution had started collaborating with other health systems that furthered precision oncology access. Still another noted the recent availability of tumor/normal genetic analysis, as well as DPYD pharmacogenetic testing for predicting which patients are likely to experience severe adverse events from fluoropyrimidine-based chemotherapies. Two respondents said that their institutions already had these precision oncology-enabling resources established for more than a year.

On the other hand, because most of the respondents for this survey represent well-resourced healthcare organizations and early adopters of precision oncology, the results indicate certain access disparities that are likely far worse at organizations that do not have access to the same types of resources.

For example, new questions in this year's survey gauged the extent to which cancer patients have access to the most advanced precision medicines, such as autologous CAR T-cell therapies and radionuclides. With regard to CAR T-cell therapies, patients have experienced long wait times due to the complexity and logistics of manufacturing these n-of-1 treatments, which require harvesting T cells from patients' blood; shipping them to the drugmakers' labs to genetically engineer the T cells to make chimeric antigen receptors that can recognize and kill cancer cells; expanding the CAR T cells in the lab; and shipping the treatments back to cancer centers and hospitals for infusion in patients.

In addition to the time it takes to make these treatments, further delays can occur depending on how long patients have to travel to receive them, most likely at an academic or large healthcare facility. Reimbursement can also present roadblocks to accessing these therapies. The list prices for CAR T-cell therapies range between $373,000 and $475,000, but after accounting for the ancillary costs of delivering the treatments, typically as an inpatient service, and managing treatment-related toxicities that prolong hospital stays, the total cost of care can near $1 million and may even be as high as $2 million, according to some estimates. Since CAR T-cell therapies are currently approved only for patients with advanced, often refractory diseases, these delays can mean that patients cannot wait for CAR T-cell therapy or that they die before receiving them.

In the survey, when asked what proportion of eligible patients receive CAR T-cell therapy at their institutions, out of 16 experts who answered the question, eight said more than 50 percent did and four estimated that between 10 percent and 50 percent did. At two facilities, less than 10 percent of eligible patients are receiving CAR T-cell therapy, according to respondents, while another two indicated that at their cancer center, they refer CAR T-eligible patients to a clinical trial or another facility. 

What proportion of patients deemed eligible for autologous CAR T-cell therapy receive it at your institution?

When further probed to gauge patients' wait times for CAR T-cell therapy at facilities that do offer it as part of inpatient care, only 14 out of 20 experts responded. Of these, patients at three institutions had the shortest wait times at under a month, but at nine healthcare organizations, advanced cancer patients are waiting between one and three months, and at two institutions, patients are waiting between three and six months. None of the respondents indicated wait times longer than that. 

If your institution has the in-house capability to administer autologous CAR T-cell therapy, what is the wait time for such treatment?

Meanwhile, targeted radionuclide therapies home in on receptors that distinguish cancer cells from normal ones and rely on radiation-based imaging to identify receptor-positive cancer cells in patients. Two years ago, the US Food and Drug Administration approved Novartis’ targeted radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for progressive, metastatic castration-resistant prostate cancer patients whose tumors express the prostate-specific membrane antigen. The agency has also approved two imaging products, Novartis' Locametz (gallium Ga 68 gozetotide) and Telix Pharmaceuticals' Illuccix (Ga-68 PSMA-11), to identify treatment-eligible patients with PSMA-positive lesions. The therapeutic requires the radioactive isotope lutetium 177, and the FDA-approved imaging products rely on gallium 68, though there are other imaging kits that use fluorine 18 as the radioactive isotope.

In order for an institution to offer patients timely access to Pluvicto, they must have imaging technologies to identify individuals with PSMA-positive lesions, rooms with lead walls for storing radioactive isotopes, the ability to isolate patients receiving such treatments, and experts who know how to handle and deliver these agents. In the case of Pluvicto, its short half-life provides around a five-day window for it to get from the manufacturing facility to patients and still be effective.

In 2023, delays in getting regulatory clearance for a manufacturing facility hampered Novartis' ability to keep up with patient demand for the drug and forced the company to pause new patient starts for a time. During a recent call to discuss the company's 2023 financial performance, Novartis executives assured that this is resolved and new patients are starting Pluvicto and projected that physicians will administer 250,000 radioligand therapy doses this year. Moreover, Novartis estimated there are more than 300 sites offering Pluvicto, a number the company hopes to increase to 500 this year.

The more than 300 sites Novartis has activated have the capacity to deliver all components of radioligand therapy in-house, including imaging, according to a spokesperson from the company, but most of these sites are also seeing patients who are referred from other cancer centers and hospitals and traveling "a reasonable geographic distance" to treatment centers. The spokesperson wrote in an email that Novartis considers "a reasonable distance" to be "any distance which the majority of patients can reasonably travel to and from for treatment (e.g., not requiring full/multiple days of travel)." After factoring in the number of activated treatment centers and the fact that the number of open treatment sites is just one aspect of a patient's ability to access radioligand therapy, Novartis still believes that "the vast majority" of Pluvicto eligible patients have access to it.

When Precision Oncology News asked about institutions' abilities to offer radionuclide therapy, nearly 80 percent, or 15 out of 19 respondents, said their organizations, which again, are some of the top cancer centers and healthcare systems in the country, have the resources and expertise to offer this type of treatment and that most eligible patients are receiving radionuclides in a timely fashion. Three respondents from such organizations said they are strained or lacked the ability to offer radionuclide therapies.

Please describe your institution or practice's capabilities and resources in offering patients radionuclide therapy.

Beyond CAR T-cell and radionuclide treatments, the survey suggested ongoing investment in molecular diagnostics needed to identify best responders to more traditional, targeted precision oncology treatments. As in surveys from 2019, 2020, 2021, and 2022, healthcare organizations in the US have access to diverse molecular test offerings from both in-house and commercial labs. Among the crop of institutions surveyed in 2023, single-gene tests, targeted next-generation sequencing, and predictive tests for immunotherapy biomarkers continued to rank among the top in-house capabilities, though oncologists may be just as likely to order these types of tests from a commercial lab. As in other years, oncologists seem to be relying mostly on commercial labs for liquid biopsy and RNA, whole-genome, and exome sequencing tests.

Please select which of the following in-house or send-out molecular testing capabilities you use to make precision treatment decisions.

As in 2022, healthcare providers are most likely to turn to an in-house lab for molecular profiling when they need results quickly and when they want to reduce out-of-pocket costs for patients. When doctors want a more customized panel or want to test patients for a large set of biomarkers, they tend to turn to a commercial lab.

If you have access to molecular testing through an internal lab but can also order from a commercial provider, when do you choose one over the other?

Likely due to the growing interest in liquid biopsy testing, survey respondents mentioned Guardant Health most often when asked which commercial labs they use for send-out molecular analysis followed by Tempus, Foundation Medicine, and Invitae — a commercial lab popular among oncologists for lower-cost molecular diagnostic testing that recently filed for bankruptcy. Other labs mentioned less frequently included Caris Life Sciences, NeoGenomics, and Myriad Genetics, while a few respondents also mentioned Natera, the Mayo Clinic, and Strata Oncology.

The proportion of early-stage cancer patients getting molecular testing continued to increase in 2023, likely spurred by the greater availability of biomarker-informed therapies for tumors when they're in a more treatable form. In 2023, 14 out of 20 respondents, or 70 percent, said that within their precision oncology programs, stage I/II patients are being offered molecular testing versus 30 percent who said that only patients with stage III/IV cancers are offered such testing. In comparison, in 2022, 55 percent said stage I/II patients were being offered molecular testing at their institutions, and 45 percent said patients were offered testing only in more advanced stages.

What is the earliest stage of disease that cancer patients at your center are offered molecular testing to explore precision oncology options?

All 20 respondents answered a question about germline testing practices, suggesting that, at least at the top healthcare organizations, cancer patients are being assessed for inherited genetic risk factors if they meet certain criteria. Similar to 2022, last year, the top reasons for institutions offering germline assessments remained patients' family history of cancer; identification of an alteration at a variant allele frequency suggesting an inherited cancer predisposition; patients with tumor types more likely to have germline pathogenic risk variants; and when germline testing can determine a patient's eligibility for an FDA-approved therapy.

At your institution/practice, when are oncologists encouraged to order germline genetic testing on cancer patients? (Select all that apply)

Studies have shown that relying too stringently on family history to decide which patients should be tested for germline risk mutations can miss a proportion of individuals with an inherited cancer predisposition. But since most payors still consider family cancer history a key criteria for determining when to cover germline genetic testing, a minority of institutions have embraced a more universal testing policy. Only four, or 20 percent, of respondents stated that all advanced cancer patients at their facility have the chance to get germline testing.

Despite the continued investment in molecular testing at cancer centers and hospitals in the US, not all eligible patients are getting tested in time to influence treatment decisions, and Precision Oncology News has used this survey over the years to explore why not. In 2023, as in 2022, tissue insufficiency remained the most oft-cited barrier, flagged by 15 out of 19 respondents, or nearly 80 percent. This was followed by more than 50 percent citing the lack of actionable biomarkers revealed by testing. Between 20 percent and 30 percent noted social, economic, and geographic disparities; lengthy test turnaround times; or patients' lack of fitness to undergo testing. Around 10 percent mentioned that insurers' prior authorization requirements can cause delays and hinder access.

At your institution or practice, what are the main reasons why a cancer patient eligible for biomarker testing may not receive it or may not have results in time to influence therapy decisions? (Select all that apply)

Cancer patients' best opportunity for precision medicine may be through a clinical trial, and 19 out of 20 respondents said biomarker-directed trials are being conducted at their institutions. At the one institution where biomarker-directed trials aren't available, the respondent said this is the case due to limited staff and operational capacity for clinical trials of this type.

Even though the majority of surveyed institutions had the capability to enroll patients into clinical trials for precision drugs, only a minority of patients are getting access to such treatments through a trial. In 2023, 11 out of 18 respondents, around 60 percent, said less than 10 percent of cancer patients are enrolled in a drug trial based on a molecular marker. Six respondents, or 33 percent, estimated the proportion of patients getting on precision oncology trials to be in the range of 10 percent to 20 percent, while only one respondent said between 20 percent and 30 percent are enrolling into such studies.

What percentage of your current patients are enrolled in precision oncology trials based on a molecular marker?

Of the 17 respondents who noted that 20 percent or fewer cancer patients enrolled in a precision oncology trial, the most commonly cited reason was restrictive enrollment criteria, which was also the top reason in 2022. In 2023, around 65 percent noted that not enough precision oncology trials are open for patients to join, followed by patients' refusal to travel to faraway trial sites (30 percent).

If you answered 10-20 percent or lower, what are the main barriers to enrolling more patients into trials? (Select all that apply)

When asked to flag the biggest institutional challenge to implementing precision oncology, five out of 20, or 25 percent, cited insurance coverage for off-label treatments informed by biomarker testing in 2023. Other barriers cited in 2023 included limited access to clinical trials (20 percent), difficulties keeping up with fast-paced science (20 percent), and the inability to easily access biomarker results within the electronic medical records system (15 percent).

What is the biggest challenge for oncologists at your institution or practice in implementing precision oncology? (Select one)

In 2023 and 2022, only one respondent noted payors' restrictive coverage policies for biomarker testing as the biggest hindrance in precision oncology compared to five respondents, or 25 percent, in 2021. This may be a sign that while reimbursement challenges may still exist on the testing side, the situation may be improving, helped by a national coverage determination from Medicare and the lobbying efforts of cancer-focused advocacy groups to change state laws and improve coverage for biomarker tests that meet certain evidentiary criteria.

This survey's findings suggestive of access disparities in precision oncology echo the findings of other groups. Analysis by diagnostics data analytics firm Diaceutics and the advocacy organization Personalized Medicine Coalition has found that around two-thirds of non-small cell lung cancer patients aren't getting precision treatments due to inefficiencies in the healthcare system that hinder patients from getting tested and matched to the right therapies based on the results. And community oncologists interviewed for another survey discussed challenges with managing the testing process, pressures of keeping up with rapidly advancing science, and the cost of testing and treatments as barriers in precision oncology.

Each year, Precision Oncology News asks participants how their institutions are identifying and addressing gaps in biomarker testing and precision oncology treatment access. In 2023, a quarter of respondents said their organizations didn't have systems in place for tracking such access gaps, but the rest of the surveyed institutions do. Among respondents from organizations that do, most mentioned using tumor boards, followed by electronic medical records systems. Several respondents noted that their institutions are tracking and sharing metrics with doctors on the proportion of patients getting biomarker testing and precision treatments, or that they employ nurse navigators to flag potentially missed biomarker testing opportunities. One respondent wrote in that precision medicine and molecular pathology teams work together to "identify and overcome gaps" in care.

What resources does your institution or practice have to identify and address gaps in biomarker testing and precision oncology treatment access? (Select all that apply)

Lastly, when asked what metrics institutions used to gauge the success of precision medicine programs, as in 2022 and 2021, respondents most often mentioned they looked at the number of patients enrolled in clinical trials or that received treatment based on biomarker test results. Others mentioned tracking the proportion of patients receiving genomic testing, another metric popularly cited in past years' surveys, followed by the number of patients undergoing molecular tumor board review or receiving treatments recommended by the board.

What metrics do you use to gauge the success of your precision medicine program? (Select all that apply)

However, by tracking such metrics, these institutions and the broader healthcare community are none the wiser about the extent to which precision oncology approaches are helping patients live longer and better lives. In 2023, eight individuals, or 40 percent, mentioned that their organizations are tracking patients' outcomes on molecularly informed treatments. Five respondents, or 25 percent, said their institutions don't have any metrics for tracking the success of precision oncology programs.

We'd like your feedback! Precision Oncology News conducts this survey annually. Please contact us if you are interested in participating in next year's survey or if you have ideas for additional themes or questions.