In New York, Experts Navigate the Dichotomy of Uncertainty Amid Innovation in Cancer Care

Late February brought peaks and valleys of cancer care news: In the same week that researchers from New York University (NYU) Langone Health found that tumor samples from 9 of 10 patients with prostate cancer had microplastic levels above detection limits, the FDA expanded its accelerated approval for zongertinib (Hernexeos; Boehringer Ingelheim), including in adults newly diagnosed with unresectable or metastatic nonsquamous non–small cell lung cancer with HER2 tyrosine kinase domain–activating mutations.^1,2

So it was on February 26, 2026, as experts gathered at the Westin New York at Times Square for the Institute for Value-Based Medicine^®, where discussions covered advances in biomarker testing in lung cancer to the real-life challenges of maintaining diversity in clinical trials.

The More Testing Up Front in Lung Cancer, the Better

As the Rolling Stones’ song says, “You can’t always get what you want,” but when it comes to biomarker testing in lung cancer, there are certain “must-haves” and other “nice-to-haves.” Achieving consensus on which side of the divide a test falls is critical as more targeted therapies reach the market and neoadjuvant and perioperative treatment scenarios increase.

Salman Punekar, MD, assistant professor at NYU Langone Health, opened a discussion on biomarker testing in lung cancer by asking panelists Elaine Shum, MD, of NYU Grossman School of Medicine/NYU Perlmutter Cancer Center, as well as Efat Azizi, MD; and Amar Parikh, MD, both of New York Cancer & Blood Specialists in New York, to weigh in on this question.

Shum emphasized that comprehensive up-front testing is critical, noting that the minimum standard includes all actionable mutations—EGFR, ALK, RET, ROS1, and others with approved indications—but that a full next-generation sequencing (NGS) panel is strongly preferred to conserve tissue and avoid sequential testing. “Of course, we all want it all, but there’s a lot of physical challenges, even just if there’s going to be enough tissue for us to do it,” she said. Highlighting the zongertinib approval that had come that day,¹ she continued, “For metastatic lung cancer, it’s definitely important, just given so many new targeted therapies that have emerged in just the last couple of years…. Having all the testing results up front is extremely helpful, as we’ve been seeing more advancements in the early-stage setting for lung cancer.”

All 3 panelists agreed that full-panel NGS should be ordered for every patient regardless of stage, although early-stage testing can present insurance hurdles. Sometimes, Parikh said, patient preferences can mean less up-front testing than he might prefer. “A lot of patients I deal with are particularly hesitant toward procedures that they consider unnecessary,” he said. In particular, many are seeking alternatives to chemotherapy. “So I know that there are increased risks for coming back at some point…. If we can get insurance coverage and they’re not going to get stuck with a large bill, then I like to do all the NGS testing, if I can.”

Fortunately, Parikh said, a dedicated prior authorizations team at his practice greatly helps in navigating payer requirements, but Shum acknowledged that even academic centers struggle with surprise bills and conflicting coverage decisions—particularly when both liquid NGS and tissue NGS are ordered. Parikh said early-stage EGFR testing can get tricky as well, often requiring a peer-to-peer review. The panelists noted that large community oncology practices often establish informal financial partnerships with testing companies (such as Foundation Medicine, Tempus, or Invitae) to cap patient out-of-pocket costs, a dynamic that largely operates behind the scenes.

Who should order testing? The panel agreed that the burden for ordering biomarker testing falls disproportionately on oncologists, despite patients often being seen first by pulmonologists or interventional radiologists weeks earlier. If these clinicians ordered tests, NGS could be completed by the time the patient sees the oncologist. New York State’s informed consent requirement for molecular testing was identified as a logistical barrier, particularly for nononcology providers. Punekar noted that pathologists face legal restrictions on ordering reflex NGS due to antikickback concerns.

Punekar got into some of the nitty-gritty challenges that add time and stress for physicians and patients alike. At NYU, he said, Shum has worked to ensure that immunohistochemistry (IHC) testing is ordered reflexively on all lung cancer cases; this practice is becoming more common but is not universal. He asked Azizi how her institution handles IHC testing.

“The IHC is done often where the patient had the biopsy,” she said, “so it’s often done in the hospital, and it’s done reflexively.” Parikh described his practice’s solution: a standing “advanced-stage order packet” that automatically advances to reflex testing once consent is obtained.

The panel also touched on inpatient testing challenges, artificial intelligence (AI)–assisted pathology (including morphology-based mutation prediction and digital slide review), and the potential for AI to improve clinical trial matching.

When asked what single change would improve precision medicine in lung cancer, the panelists each described an improvement that would save time for physicians but especially reduce waiting for patients: Parikh called for a centralized digital pathology access system, Azizi suggested broader reflex IHC testing by pathologists, and Shum sought faster turnaround with guaranteed tissue adequacy. Punekar agreed.

“There’s nothing more frustrating than sending something from multiple biopsies and always getting QNS [quantity not sufficient],” Punekar said.

“So I’ll also answer the question,” he continued, “and if I had to wave my magic wand, I would say that whoever orders the biopsy, whoever obtains a tissue, needs to send the NGS testing. So if you’re a pulmonologist, you just send NGS testing. And I’ll make it easier. You don’t have to know what you’re sending to send everything [for] full-panel NGS testing, and then we’ll deal with it later. If you’re an interventional radiologist, same thing.

“Because I really think that first meeting with the oncologist, if you have that information or if you have most of that information, it really helps that initial conversation.”

Maintaining Trial Diversity as Shifts Drive Some Patients Away

More than 3 years ago, the FDA issued its initial draft guidance to industry on boosting diversity in clinical trial enrollment. Since then, a follow-up draft came in June 2024, only to be removed in early 2025 with the arrival of the Trump administration. It was returned under a court order in June 2025 and, as of early 2026, is not final.³

Industry leaders have said they remain committed to diversity in trials because it makes sense to have studies that reflect the patients who will receive therapies.⁴ But as a panel discussion chaired by Christina M. Brennan, MD, MBA, FACRP, revealed, commitments do not always match what happens on the ground.

Brennan, who is senior vice president for clinical research at Northwell Health, was joined by panelists Barbara Pro, MD, of Columbia University in New York, New York, as well as Ahmed Sawas, MD; and Sridhar Reddy, MD, who practice at different sites for New York Cancer & Blood Specialists.

Clinical trial enrollment starts with cancer screening, so the panel opened with a discussion of screening rates in the post–COVID-19 era. Sawas noted that although screenings among well-insured populations have rebounded—more so at academic institutions than in community practice—underinsured and underprivileged communities continue to lag behind. He cited trust issues, fear among immigrant populations, and the inability to take time off work as compounding factors.

“There’s been mistrust,” Sawas said. “Of course, we’re all not living in a bubble; we’re all aware of some of the policies that have driven some of these at-risk populations away.”

Reddy described the markedly different socioeconomic profiles and circumstances for patients at the 2 Brooklyn locations he serves: downtown Brooklyn and East New York.

“My East New York population is low socioeconomic status, so I do see a difference in cancer screening, as opposed to downtown Brooklyn,” he said. In downtown Brooklyn, patients have an established primary care physician and an established gynecologist and only a few patients smoke. In East New York, this is less likely.

“They tend to either be uninsured or just fall through the cracks,” Reddy said.

Vaccine hesitancy has increased, with ripple effects on health care engagement, Pro said, observing that social media has eroded trust in the scientific community broadly, affecting “all aspects of care, not only vaccination.”

The conversation then shifted to clinical trial enrollment among diverse populations. Brennan highlighted the FDA’s Drug Trial Snapshot,⁵ which, in one case, revealed that a breast cancer trial enrolled only 3 African American women—yet the drug received approval.

Columbia University has had uncommon success in enrolling patients from minority communities, which Pro attributed to several factors, beginning with its location. There is also a multidisciplinary support infrastructure, including social workers, nurse educators, and research coordinators, as well as partnerships with foundations such as Blood Cancer United, which provides translation services and helps patients navigate trial eligibility.

Reddy said that his practice benefits from a dedicated research team that proactively screens patients against available trials before they arrive for their appointment. “I was notified before I even saw the patient that this patient [was] eligible.”

Panelists differed on when to raise the option of a trial with patients. Sawas recommended building trust first and then discussing a trial by the third or fourth visit. Pro favored raising the possibility immediately. “If you start the conversation early on, I think patients are more engaged,” she said.

Brennan then asked Reddy whether transportation issues are a barrier for clinical trial enrollment. Reddy said for those who live in East New York, “It’s not easy for them to get to the Upper East Side, to Manhattan. So when I tell them that, sometimes they’re hesitant; they ask, ‘Do we have a site in Brooklyn?’”

Later, Brennan said providing information about patient consent in other languages, travel costs, and other items all add to trial budgets.

Closing calls to action were pointed. Reddy advocated for broader public advertising to demystify clinical trials, and Pro called for simpler protocols and more flexible, home-based visit options.

Sawas was emphatic that diversity in trials must move beyond optics. “It really has to be embedded into the health care system.... Representation means generalization. It means drug safety. It means better understanding of dosing. It means better science. It’s not just about checking a box.”

Balancing Multistakeholder Partnerships in Oncology Value

How do we define value in oncology care? Marc Braunstein, MD, PhD, associate professor at NYU Langone Health, started a wide-ranging discussion with this question, which generated viewpoints on value-based care, institutional partnerships, financial toxicity, and innovation.

Panelists included Marcus Flores, PharmD, BCPS, BCOP,multiple myeloma pharmacotherapy specialist at Mount Sinai Hospital in New York, New York; Prioty Islam, MD, MSc, leukemia/chronic lymphocytic leukemia specialist at Memorial Sloan Kettering (MSK) Cancer Center in New York, New York; and Emily Park, PharmD, clinical pharmacist specialist/manager for leukemia at Icahn School of Medicine at Mount Sinai.

To start, Flores offered the classic definition of value: outcomes divided by cost, encompassing both clinical results and quality of life. Islam emphasized evidence-based decision-making and avoiding unnecessary interventions. Park offered the pharmacist’s focus.

“Value can be something as simple as reducing drug-drug interactions or monitoring for adverse effects and toxicities related to chemotherapy,” she said. “But at the end of the day, we care about the total cost of care and reducing that. Value isn’t just about reducing the cost of medication; we want to reduce admission to hospital and unnecessary visits back to the emergency department.”

Flores offered an example of how small changes can add up to big savings for both institutions and patients. He explained how evidence and recommendations from the National Comprehensive Cancer Network show that rounding doses of chemotherapy, bispecific antibodies, or biologics within 10% does not alter efficacy or safety.⁶

“But rounding from 51 mg down to 50 mg might be enough to save you a vial,” Flores said, “and that’s reducing that cost significantly of what the pharmacy has to buy and also maybe the cost that goes on to the patient.”

Collaboration counts. The panel explored multi-institutional collaboration, particularly through hub-and-spoke models. Flores, Park, and Islam agreed that academic medical centers play a critical role in initiating complex therapies, including bispecifics and chimeric antigen receptor T-cell therapy, before these patients return to their community practices.

Park and Flores both stressed the importance of standardized protocols and staff education across network sites to ensure consistent, safe administration of newer therapies. Islam offered the example of MSK’s successful partnership with New York Cancer & Blood Specialists as a model for expanding clinical trial access regionally and improving diversity in enrollment. “That’s been a really invaluable resource to our patients across the New York area,” she said. “It saves patients having to travel into Manhattan to see specialists when they have such easy access.”

Challenges with payers and PA. Financial toxicity remains a challenge for all. Islam noted that insurance companies frequently dictate treatment sequencing through prior authorization, which she finds problematic. However, she emphasized that MSK’s robust support infrastructure, from foundation grants to help with pharmaceutical patient assistance programs, has allowed her to always find a treatment pathway for patients. Flores said the adoption of biosimilars, such as rituximab and now tocilizumab—a key therapy for management of cytokine release syndrome—is a practical lever for reducing both pharmacy and patient costs.

Park said that formulary access challenges, particularly for inpatient use of newer agents, can delay care. “I practice primarily in the inpatient setting, and one of the biggest challenges…is getting unfamiliar medications,” she said. Institutions have different approaches, but in general, outpatient approval is prioritized as a cost-saving measure before patients can receive the therapy as an inpatient. “That process can be time-consuming and sometimes delays the care. So that’s where charity comes in [as well as] support from the pharmaceutical companies.”

Braunstein invited panelists to highlight an innovation that would improve value. Flores advocated for a centralized portal to enable patients to simultaneously apply to multiple financial assistance programs. Islam called for broader visibility into the cost of diagnostics, not just medications. Park proposed integrating specialty pharmacy data into the electronic health record (EHR) to streamline insurance tracking and drug access. MSK’s recent transition to Epic was noted as a significant step toward enabling AI-assisted care coordination and cross-institutional record sharing.

For his own recommendation, Braunstein called for greater cost transparency at the point of care. “When we order a routine test, like a complete blood count, it shows the cost of it, but it doesn’t really mean much…. When it comes to treatments that have equipoise and decisions between them, we don’t really know for that individual patient what the difference in cost to them is,” he said. “Maybe a separate tumor board or conference about the cost for different patients would be helpful to really understand what the bottom line is to those patients, because they may not always bring it up even in conversation.”

Medically Integrated Pharmacy Offers Time Savings, Less Waste

What is medically integrated dispensing? As the name suggests, the practice of giving the clinical pharmacist an inside view of how physicians and nurses are delivering care cuts down on confusion and waste, saving time and bringing better outcomes. Medically integrated pharmacies (MIPs) are especially important in oncology care, where therapies have grown more complex and expensive. Thus, sharing information through the EHR across the team is crucial for physicians and patients alike.

Scott Freeswick, PharmD, MS, vice president and chief pharmacy officer of MSK, served as moderator for this final session, which also featured insights from Marina Barsoum, PharmD, BCOP, clinical pharmacy lead at NewYork-Presbyterian Hospital in New York, and Mary Nauffal, PharmD, MS, BCOP, clinical pharmacy specialist in bone marrow transplant and cellular therapies at MSK.

Freeswick recently coauthored a joint paper from the American Society of Clinical Oncology (ASCO) and the Network for Collaborative Oncology Development & Advancement (NCODA) that updated MIP dispensing standards.⁷ He openedwith a foundational overview of what MIPs are, why they matter, and how they contribute to coordinated, patient-centered care. He also walked the audience through how different distribution channels work, depending on the drug; how many patients they reach; and whether they are limited to distribution at 1 or 2 specialty pharmacies or available more broadly.

Unlike mail-order pharmacies, which are affiliated with pharmacy benefit managers (PBMs), he said, MIPs provide faster access to medications, enhanced real-time communication between patients and care teams, and proactive management of adverse effects.

Freeswick advocates for oncology-optimized limited distribution, which excludes PBM-affiliated pharmacies and gives MIPs a greater opportunity to fill prescriptions. Under this model, MIPs fill prescriptions in 1 to 2 days on average compared with up to 18 days for PBM-owned pharmacies.

“Sometimes,” he said, even when the MIPs cannot fill the prescription, “they do all the prior [work] of a lot of the prework, and they hand the prescription over to the PBM home pharmacy, and that helps expedite the fill. At the end of the day, the patient still benefits, which is great.”

Barsoum said ASCO and NCODA call for “MIPs being integrated and also improving clinician and patient and provider experiences.”

She described exactly how MIPs cut down on waste. Pharmacists “can see the process of where the prescription is. They can see the notes as well, so they can see when a patient has a script discontinued or when they’re in the process of switching therapies.”

This allows a discontinued communication to be sent to the pharmacy, something she said is not possible with the PBM because it has no access to the EHR.

Nauffal focused on patient outcomes, citing findings from a Moffitt Cancer Center study showing that patients with prostate cancer who filled oral androgen receptor inhibitors through MIPs experienced a significant reduction in adverse effects, faster medication access, better adherence, and reduced hospitalizations.⁸ She also shared a compelling real-world example: A patient from Connecticut with a prolonged hospital stay who had undergone a transplant urgently needed his specialty medication on a Friday evening, before the weekend. Because the patient was connected to an MIP, the medication was delivered to his bedside that same afternoon.

“I can’t enforce how much this improves our experience,” Nauffal said. “It’s just something you look forward to: working with people who are going to help make things faster vs, honestly, calling and waiting on [the] line for a long time.”

Barsoum emphasized the financial and operational advantages of MIPs, particularly through EHR integration. She described how external pharmacies on automatic refill can inadvertently ship expensive discontinued medications to patients, creating waste that MIPs prevent through full EHR visibility. High-cost prescriptions are more likely to be abandoned, and these costs climb to $2000. Her team at NewYork-Presbyterian processes prescriptions within hours of receipt and completes fills in 2 to 3 days.

The time wasted processing prescriptions with outside pharmacies is simply unacceptable, Barsoum said. “We don’t have the luxury of having those 40-minute wait times and calls every single day,” she said. “The MIPs really do help when they’re integrated into our EHR to speed that process.”

Freeswick underscored that even when a MIP cannot fill a prescription, it completes much of the prior authorization legwork before handing it off to a PBM, ultimately benefiting the patient regardless. He also referenced a recent joint ASCO/NCODA paper establishing updated MIP dispensing standards. Barsoum described the paper’s thrust: “It was advocating for MIPs being integrated and also improving clinician and patient and provider experiences.”

The panel reached a consensus that when MIPs are embedded in a shared EHR ecosystem, they represent a measurably superior model for oncology pharmacy care, from first fill through long-term adherence monitoring and toxicity management. Panelists described examples of patients’ oral medication being brought to them and adjustments made to oral chemotherapy.

“We recently started, at our hospital, a supportive care clinic that is run by the pharmacist in our oncology clinic, and they get referrals for really complex patients or patients who are having adverse effects that need closer follow-up,” Barsoum said. Patients cannot always see a provider every month or address toxicity issues, so this fills that gap.

“It’s constant communication and then also a handoff to the MIP that says, ‘These are the toxicities they’re having. Follow up with them, let us know,’” she continued. “We can see their notes based on the conversations they had with the patients. So it’s really helpful to have those experiences.”

References

1. FDA grants accelerated approval to zongertinib for unresectable or metastatic non-squamous non-small cell lung cancer. FDA. February 26, 2026. Accessed March 7, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zongertinib-unresectable-or-metastatic-non-squamous-non-small-cell
2. NYU Langone Health in the news—Thursday, February 26, 2026. New York University Langone Health. February 26, 2026. Accessed March 8, 2026. https://nyulangone.org/news/nyu-langone-health-news-thursday-february-26-2026
3. Grossi G. FDA quietly removes draft guidance on diversity in clinical trials following executive order on DEI. AJMC. January 31, 2025. Accessed February 26, 2026. https://www.ajmc.com/view/fda-quietly-removes-draft-guidance-on-diversity-in-clinical-trials-following-executive-order-on-dei
4. Caffrey M. Trump’s stance doesn’t end need for diversity in clinical trials. AJMC. April 11, 2025. Accessed March 9, 2026. https://www.ajmc.com/view/trump-s-stance-doesn-t-end-need-for-diversity-in-clinical-trials
5. Drug Trial Snapshots. FDA. Updated March 4, 2026. Accessed March 9, 2026. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots
6. Fahrenbruch R, Kintzel P, Bott AM, Gilmore S, Markham R. Dose rounding of biologic and cytotoxic anticancer agents: a position statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018;14(3):e130-e136. doi:10.1200/JOP.2017.025411
7. Raez LE, Gregg XT, Doshi GK, et al. Medically integrated dispensing pharmacy: ASCO-Network for Collaborative Oncology Development & Advancement standards update. JCO Oncol Pract. 2025;21(11):1567-1581. doi:10.1200/OP-25-00279
8. Simonelli M, Bautista B, Marte F, Alfonso S. Impact of medically integrated specialty pharmacy services on outcomes in metastatic prostate cancer patients receiving androgen receptor pathway inhibitors. Poster presented at: American Society of Health-System Pharmacists Midyear Clinical Meeting; December 7-10, 2025; Las Vegas, NV. Poster 2-234.