Germany Issues Two Major Health-System Updates: G-BA Expands Emergency-Care Tiers While IQWiG Finds Survival Benefit for Daratumumab
Germany’s healthcare regulators issued two notable updates this week, covering emergency-care reform in hospitals and the early benefit assessment of an oncology therapy. While unrelated in scope, each decision reflects the structured and evidence-driven approach of Germany’s health system, where both the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG) continue to refine standards for patient care and treatment evaluation.
What You Need To Know
- G-BA introduces a new “non-participation” tier in the emergency-care system, clarifying minimum requirements for hospitals.
- Hospitals failing to meet these criteria face future funding deductions for emergency-care participation.
- IQWiG finds no proven additional benefit for daratumumab in smoldering multiple myeloma due to inadequate comparator treatment in the AQUILA study.
- The final decision on daratumumab’s added benefit now moves to the G-BA for determination under AMNOG.
G-BA Creates New “Non-Participation” Tier in Emergency-Care System
The G-BA has expanded its tiered emergency-care framework for hospitals, introducing a fourth classification level called “non-participation.” Until now, hospitals were assigned to one of three established emergency-care tiers, basic, extended, or comprehensive care but regulatory gaps meant some facilities remained ambiguously categorized.
Under the new structure, hospitals that meet only minimal requirements for emergency readiness will be placed in the “non-participation” tier and will be allowed to participate in emergency care but will no longer be treated as qualified emergency-care centers eligible for the higher three tiers. Those failing to meet the minimum criteria will be designated as fully non-participating, resulting in future funding deductions for emergency-care reimbursement.
The minimum requirements for this tier include:
• A combination of surgical and internal medicine departments or a stand-alone specialty (e.g., ophthalmology or dermatology) that can independently manage emergencies
• On-site, always-available medical and nursing staff
• 24/7 laboratory and diagnostic imaging access
Professor Josef Hecken, chair of the G-BA, emphasized the reform’s importance in clarifying where patients can reliably receive life-saving acute care. “A hospital can only be considered an emergency care provider if it has intensive care capacity, diagnostic imaging capabilities, and medical and nursing staff available on-site at all times,” he said. The new differentiation, he added, brings “additional transparency” for patients and strengthens readiness as Germany prepares wider emergency-care reforms.
The updated guideline will take effect after the Federal Ministry of Health raises no objections and the rule is published in the Federal Gazette.
IQWiG: Evidence Remains Insufficient to Show Daratumumab Extends Life in Smoldering Multiple Myeloma
Separately, IQWiG released its early benefit assessment of daratumumab for smoldering multiple myeloma, concluding that the pivotal AQUILA study does not provide reliable evidence that early treatment meaningfully improves overall survival compared with watchful waiting.
The key methodological issue: two-thirds of patients in the control arm did not receive adequate therapy once their disease progressed to multiple myeloma. Only one-third went on to receive daratumumab or another CD38 antibody, despite CD38-based regimens being standard-of-care first-line therapy.
IQWiG states that this treatment imbalance may itself explain the observed survival differences in the study. Without an appropriate comparator, the institute concludes that the additional benefit of daratumumab is not proven for this early-stage patient population.