Bridging the Gap: Ways to Overcome Barriers of Access to Anti-CD38 Therapies

Opinion
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An expert highlights that overcoming clinical inertia in US community settings through targeted education and patient advocacy is essential to increase frontline use of CD38 antibodies in transplant-ineligible multiple myeloma, ensuring more patients benefit from proven, life-extending therapies.

In the US, logistical and regulatory hurdles significantly limit home administration of oncology drugs, especially when compared with European models where home treatment is more common. Although subcutaneous injections may seem ideal for at-home delivery, current US practices often require these to be administered by oncology nurses in clinical settings due to safety protocols and billing structures. There is uncertainty around how new delivery systems—such as on-body injectors—will be classified and reimbursed, especially for practices relying on in-clinic administration revenue. Though these devices are likely safe after the initial cycle due to the low risk of infusion reactions, the core challenge lies not in medical concerns but in overcoming bureaucratic and reimbursement barriers.

The expansion of at-home oncology care will depend heavily on economic and logistical feasibility. Even for drugs such as subcutaneous daratumumab or bortezomib, which have been discussed for home use, real-world implementation has been minimal. As the industry begins exploring newer models such as on-body devices, it remains unclear how payer policies and practice-level economics will evolve. These considerations are particularly relevant for private practices where financial sustainability may hinge on in-office treatment delivery. Ultimately, while the medications themselves are generally safe for decentralized administration, operational realities continue to dictate how care is delivered.

Lastly, the role of patient-reported outcomes (PROs) in multiple myeloma care is gaining importance. This disease can severely impair quality of life due to symptoms such as bone pain, fatigue, and renal complications. Encouragingly, regimens such as those studied in the MAIA trial have shown not only strong efficacy, measured by progression-free survival and overall survival, but also improvements in PROs. The addition of a well-tolerated fourth drug, such as an anti-CD38 monoclonal antibody, can speed up response time and enhance overall patient well-being, making these regimens especially valuable for older or more vulnerable patients.

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