Challenges and proposed solutions to value assessment and reimbursement of CAR-T therapies in Europe

Chimeric antigen receptor T-cell (CAR-T) therapy is a recently approved innovation that represents a novel approach to treating cancer. The aim of this paper is to describe some of the challenges to value assessment of CAR-Ts in Europe and put forward potential solutions to remedy these; maintaining the principles of respecting the need to accelerate broad patient access, address affordability concerns and reward innovation to maintain a sustainable life sciences industry. We explore whether the value assessment criteria employed by HTA agencies is appropriate for CAR-T therapies, considering the unique characteristics of treatment and uncertainties in the evidence base. Uncertainty is inevitable if the goal of timely patient access to innovation is to be pursued. We advocate for a more systematic inclusion of evidence from patients and carers in the HTA decision-making process, a broader perspective of value to be adopted by HTA agencies that take into account productivity gains from both patient and carers, and investment in data infrastructures to enable outcomes-based payment models. The limitations of cost-per-QALY value frameworks for CAR-T are highlighted as are their inability to capture productivity gains and solve for uncertainty. The important role that outcomes-based payment models play in enabling faster access through addressing uncertainties from an HTA perspective and payer perspective is emphasized. We conclude that multi-stakeholder collaboration across Europe is critical to ensure alignment on registries used to capture data for the regulatory mandated post-authorization study commitments and any additional data needed to support outcomes-based payment models for HTA agencies and payers.

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