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FDA approval is only the first hurdle for new cancer therapies. Inclusion in NCCN guidelines as a preferred regimen is the critical next step. This update validates a treatment's practice-changing potential and, more pragmatically, serves as a key signal for insurance companies to provide reimbursement.

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An industry veteran reveals that payers, wanting to keep their patient members happy, are highly sensitive to public demand. Pharmaceutical companies can leverage this by generating significant patient and physician interest, which pressures payers into providing more favorable formulary coverage.

The addition of FES-PET to NCCN guidelines is more than a clinical endorsement; it's a critical lever for overcoming access barriers. This inclusion signals to insurance payers that the imaging should be covered and prompts unfamiliar oncologists to learn about and adopt the technology, accelerating its transition into standard care.

NCCN guidelines for folate receptor alpha and HER2 in ovarian cancer allow treatment at lower expression levels than initial trials. This is driven not only by data showing activity in these groups but also by the fact that the original smaller biotech developers had limited resources for expansive trials beyond the highest-expressing cohorts, a commercial factor influencing current clinical guidance.

The Uromigos score (0-3) provides a rapid expert consensus on new treatments. It bridges the gap between slow, formal guidelines and long, unprioritized lists of approved therapies, offering a more immediate assessment of a drug's place in the standard of care.

When a highly effective therapy like EV Pembro was approved for 'cisplatin ineligible' patients, the definition of 'ineligible' became very elastic in practice. This demonstrates that when a new treatment is seen as transformative, clinicians find ways to qualify patients, putting pressure on established guidelines.

The rapid evolution of clinical evidence is reflected in ASCO guidelines. In just one year (2022 to 2023), recommendations for ESR1 testing in HR+ metastatic breast cancer changed from having insufficient data to recommending routine testing upon progression, highlighting the pace of change in oncology.

Despite lacking specific FDA approval for chemotherapy-induced thrombocytopenia (CIT), romiplostim is widely used and reimbursed. This is because the influential National Comprehensive Cancer Network (NCCN) endorsed its use based on earlier Phase II data, demonstrating how clinical guidelines can establish standard of care.

Unlike most cancers, National Comprehensive Cancer Network (NCCN) guidelines recommend clinical trials as the preferred first-line treatment for glioblastoma patients with good performance status. This rare recommendation highlights the dismal outcomes with existing therapies and the urgent need for therapeutic innovation.

Recent NCCN guidelines have fundamentally changed second-line SCLC treatment. The previous standard, which based treatment on a >6 or <6 month chemotherapy-free interval, has been eliminated. Tarlatumab is now the single, category-one recommended therapy for all second-line patients, regardless of prior treatment timing.

Don't wait until after FDA approval to think about reimbursement. Smart biotechs engage with payers early and build payer-valued outcomes directly into Phase 2/3 trials. This creates a ready-made value dossier for payers alongside the regulatory submission package.