Last week’s policy signals from Germany underscored a clear regulatory theme: access increasingly hinges on comparative evidence, not just innovation or unmet need. New assessments from the Institute for Quality and Efficiency in Health Care (IQWiG) highlighted where evidence is strong enough to support added benefit, where gaps remain despite growing treatment options.
Multiple myeloma: More drugs, but not more certainty
IQWiG took a cautious stance on linvoseltamab, a bispecific antibody approved in later-line multiple myeloma, concluding that the field currently faces more unmet evidence needs than unmet medical needs.
While linvoseltamab received conditional EU approval in 2025 based on single-arm data, IQWiG questioned whether accelerated access was justified in an increasingly crowded treatment landscape. The institute noted that numerous effective therapies are already available and emphasized the lack of head-to-head comparative data against established regimens.
A randomized controlled trial comparing linvoseltamab with elotuzumab-based combination therapy is underway, but results are not expected until mid-2026. Until then, IQWiG said, the drug’s added benefit cannot be reliably assessed, placing the burden squarely on manufacturers to deliver stronger comparative evidence.
Gastric cancer: Comparative trials pay off
IQWiG reached a markedly different conclusion for trastuzumab deruxtecan in advanced HER2-positive gastric or gastroesophageal junction cancer, determining that the antibody–drug conjugate now demonstrates a considerable additional benefit.
The shift follows new data from the DESTINY-Gastric04 trial, which directly compared trastuzumab deruxtecan with the standard regimen of ramucirumab plus paclitaxel. IQWiG found that the benefits clearly outweighed harms, with improvements seen in overall survival and side-effect profiles.
The institute highlighted this case as a model for evidence generation, noting that the manufacturer initiated a suitable comparative trial before approval. IQWiG argued that this approach should become standard practice, and suggested that future reforms to Germany’s AMNOG framework should incentivize earlier comparative study planning.
Colorectal cancer screening: Modeling fills the evidence gap
IQWiG also published a preliminary report on colorectal cancer screening, examining whether screening should begin before age 50 and whether colonoscopy intervals should be adjusted.
With little direct clinical trial evidence available, IQWiG relied on decision-analytic modeling to compare multiple screening strategies, including earlier initiation using colonoscopy or fecal immunochemical testing. The institute stressed that the findings are provisional and opened the analysis for public consultation through 2 February 2026.
The review reflects growing interest among policymakers in earlier cancer detection, but also highlights how policy decisions are increasingly being made under evidence uncertainty, using modeling to inform choices when trials are not feasible or available.
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