OBJECTIVES. Advances in oncology have led to the development of several revolutionary treatment modalities, including tumour-agnostic therapies – medicines that target specific mutations or genomic alterations across tumours. We conducted a landscape review to identify the challenges and opportunities faced by tumour-agnostic therapies entering European and Canadian health systems.

METHODS. We conducted secondary desk and interviews with country experts. The research and findings were structured around five categories: (1) stakeholder awareness; (2) government support; (3) health technology assessment (HTA) acceptance; (4) reimbursement and funding; (5) maturity of the testing landscape.

RESULTS.

(1) A common understanding and endorsement of tumour-agnostic therapies from clinical and patient representatives is necessary, as recognition of these medicines’ role in cancer treatment differs. The low disease incidence and cross-disease treatment also make it harder to mobilise awareness.

(2) Governments are becoming more aware and supportive of personalised healthcare, but there are no specific provisions for tumour-agnostic therapies. Where innovation-specific funding is available, it often limits patient access and eligibility for treatment.

(3) The methods and evidence requirements of regulatory and HTA agencies differ even more widely than for traditional medicines. Although adjustments are emerging in some geographies, tumour-agnostic therapies will likely struggle to achieve pricing and reimbursement.

(4) Many countries assess new medicines’ value relative to current standards of care, but tumour-agnostic therapies cover multiple treatment pathways, making it challenging to collect robust comparative data. Flexible commercial arrangements are needed to collect evidence and ensure access.

(5) Current diagnostic techniques focus on testing few tumours and increasingly face limited capacity and funding for expansion. Advancement in physical infrastructure, diagnostic protocols and reimbursement for high-quality next-generation sequencing will be necessary to identify the right patients.

CONCLUSIONS. Tumour-agnostic therapies will require a profound change in how cancer is managed in order to realise the promise of personalised medicine.