Innovative Contracts: A Solution to Manage the ATMPs Associated Uncertainty

OBJECTIVES: Advanced Therapy Medicinal Products (ATMPs) are cutting-edge therapeutic drugs for human use derived from genes, tissues, or cells, offering substantial clinical benefits. As the field of ATMPs experiences rapid growth, it faces significant challenges, particularly due to the high costs associated with these therapies. To ensure patient access and to address the uncertainties regarding their long-term effectiveness and financial impact on both manufacturers and payers, innovative contracting models have been developed.

METHODS: A targeted literature review was conducted on PubMed and supplemented by grey literature searches and conference abstracts. The review included publications released between 2005 and 2023 and covered Europe and the United States.

RESULTS: A total of 193 articles were reviewed and 57 were included. Results showed that depending on the country, innovative contracts can take different forms. Most of contracts described were performance-based arrangements with most of them being outcome-based contracts (OBC). OBC included both performance-linked reimbursement contracts and conditional coverage contracts, with the first type being predominant. These risk sharing agreements could be with deferred or non-deferred payment and had for general aim to reduce payer uncertainty about clinical outcomes while compensating manufacturers for their product’s value.

CONCLUSIONS: Innovative contracts demonstrate a collective commitment from all parties to enhance access to ATMPs despite the limitations they present. Further efforts in collecting and utilizing real-world data could significantly improve the effectiveness and implementation of these contracts.