Home Medizin Viele europäische Krebsmedikamente bieten keinen Zusatznutzen

Viele europäische Krebsmedikamente bieten keinen Zusatznutzen

von NFI Redaktion

According to a new study by the University of Utrecht in the Netherlands, many cancer drugs approved by the European Medicines Agency (EMA) between 1995 and 2020 lack evidence of added benefits.

Researchers reported that „a large proportion“ of new drug approvals offered minimal or no additional benefit, especially those approved through the accelerated „Fast-Track“ process.

These medications‘ costs could strain healthcare systems and give patients false hope, they said.

Lead researcher Francine Brinkhuis, a PhD candidate at the University of Utrecht, Netherlands, told Medscape Medical News, „About half of all new active substance drug approvals are oncology drugs, whether through standard or conditional approvals.“ She explained that the extensive drug development efforts seem to focus on specific cancer types, leading to numerous simultaneous or consecutive drug approvals that do not necessarily offer incremental innovations.

Published in the BMJ, the study retrospectively evaluated 131 oncology drugs with 166 indications, assessing their added benefits as evaluated by at least one organization during the relevant period. Health Technology Assessments (HTAs) showed that the additional benefit of the new drug was negative or unquantifiable in two-fifths of cases.

Average time to recoup R&D costs is only 3 years

The researchers found that the pharmaceutical industry claims high drug prices are necessary to recoup research and development (R&D) costs. However, their analysis of publicly available revenue data compared to published estimates of R&D costs found that the average time to recoup the average R&D cost of $684 million, adjusted to 2020 values, was only three years. Drugs with higher added benefits generally generated higher revenues.

In a linked opinion piece, the authors pointed out that the influx of innovative yet costly medications entering the market „poses increasing fiscal challenges.“

„To ensure healthcare budgets are allocated wisely, investigations on the rational use of expensive cancer drugs are necessary,“ they wrote. „Oncology drugs often not only enter the market without proven added benefits but also manage to recoup their research and development costs relatively quickly. All of this raises serious questions regarding aligning market approval and reimbursement policies with actual clinical benefits offered to patients.“

Improved alignment needed

The team highlighted that differences in evidence requirements between the EMA and HTA bodies often lead to positive risk-benefit assessments but negative added benefit evaluations. They called for better alignment between regulatory and reimbursement processes, especially for drugs approved through accelerated pathways, to promote the development of the most effective medications for patients with the greatest needs.

Global spending on cancer drugs is projected to increase from $167 billion in 2020 to $269 billion in 2025. However, the researchers write that oncology drugs are increasingly being approved based on „less robust evidence,“ raising concerns about misaligning market incentives with patient interests.

Brinkhuis said, „It needs to be discussed in which situations there is a high unmet medical need that makes approval and reimbursement based on preliminary evidence, such as single-arm studies and surrogate endpoints, acceptable to both regulatory authorities and HTA bodies.“

She added that regulatory authorities, HTA bodies, and pharmaceutical companies should engage in shared discussions about development plans for new products.

The new EU-HTA regulation will include procedures for patient involvement, with joint clinical assessments for oncology drugs starting in 2025 to better define and evaluate what is most important for patients while addressing potential conflicts of interest. „Both regulatory authorities and HTA bodies are increasingly working to actively involve the patient perspective in their decision-making,“ Brinkhuis said.

Medscape Medical News has reached out to the EMA for comment.

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