Background: Kenya faces significant gaps in multiple myeloma (MM) management, with available data (likely underreported) indicating 800 new cases and 677 deaths (2022). Late diagnosis, fragmented care pathways, and limited access to advanced therapies drive poor outcomes, exemplified by the AMPATH Multiple Myeloma Program (AMMP)—Kenya's sole integrated care initiative—reporting a median overall survival of just 29 months, starkly contrasting with >10-year survival in high-income settings. To dismantle systemic barriers, a landmark 2024 workshop convened national stakeholders to address diagnostic, therapeutic, and policy gaps impeding equitable care. Objectives: To (1) enhance multidisciplinary education on precision diagnostics/therapeutics, (2) develop implementation frameworks for Western Kenya's 23 counties, and (3) establish actionable pathways for bispecific antibody (BsAb) access.

Methods: Participants: 117 attendees including: Frontline providers (hematologists, nurses, pharmacists) from all 23 counties of Western Kenya with direct MM management experience. Regulatory agencies: KEMSA, Directorate of Health Products & Technology (MoH), NCCP, NHIF, PPB, NCI-K. Design: 2-day hybrid workshop: Day 1 (Education): Didactic sessions on FISH cytogenetics, flow-adapted MRD, and BsAbs (teclistamab/elranatamab), anchored to AMMP data (n=221). Day 2 (Implementation): Interactive breakouts co-designing strategies for diagnostics scale-up, BsAb safety protocols, and regulatory pathways. Evaluation: Pre/post-knowledge assessments (111 paired responses; 95% response rate) analyzed via chi-square (p<0.05 significant).

Key Findings: Diagnostics: Retrospective AMMP data (n=221) showed that 29.4% of patients had spinal cord compression at diagnosis, highlighting systemic diagnostic delays. FISH cytogenetics remains inaccessible, but AMMP is working to adapt existing lymphoma-capable flow cytometry for validation. Flow-based MRD detection (sensitivity 10⁻⁵) was identified as a transformative yet underutilized tool. While its implementation requires funding for reagents and validation studies, it could optimize therapy duration in resource-limited settings.

Therapeutic Landscape and Barriers: Bispecific antibodies (BsAbs), such as teclistamab and elranatamab, emerged as prime candidates due to their >60% overall response rate in triple-class-exposed multiple myeloma. Their subcutaneous administration and lower CRS risk (compared to CAR-T) make them suitable for Kenyan infrastructure. However, critical barriers remain, including no regional BsAb experience, prohibitive costs, and a lack of pharma-regulatory partnerships for access roadmaps.

Implementation Framework: The proposed framework includes structural, safety, and patient support strategies. Hub-and-spoke networks will leverage AMMP's ECHO tele-mentoring program. For safety, BsAb initiation will be inpatient with ICU backup, alongside mandatory infection screening (HIV/TB/HBV). Patient support includes “treatment buddy” systems and Swahili-language IEC tools.

Regulatory Hurdles: Stakeholders (KEMSA, PPB, NCCP, NHIF now SHA) identified slow novel drug registration and reimbursement uncertainty by health insurance as major challenges. There is currently no clear pathway for BsAb procurement or trials, despite workshop consensus on their urgency.

Workshop Impact and Next Steps: Post-workshop assessments showed significant knowledge gains (p<0.05) in FISH utility (Δ +42%), MRD principles (Δ +38%), and BsAb mechanisms (Δ +47%). Additionally, 96% of participants affirmed the workshop's relevance to Kenyan practice, while 94% gained critical insights into BsAbs. The unprecedented inclusion of regulators enabled direct dialogue on access barriers.

Future Directions: Adaptive strategies—such as corticosteroid-first CRS protocols, task-shifted diagnostics, and pharma co-investment in African-centric data—now define a replicable care model for resource-constrained settings. Leveraging AMPATH's infrastructure as a launchpad, the 2025 follow-up aims to convert momentum into binding agreements with regulators, payers, and manufacturers. Progress will be tracked through measurable reductions in diagnostic delays and outcome inequities across Western Kenya, with accountability anchored to a dedicated 2025 implementation summit. While systemic challenges persist, this first-of-its-kind convening has crystallized a path to translate policy dialogue into tangible patient survival gains.

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