Presentation (CTI)

OBJECTIVES: The value of contrast agents in CTs and MRIs is well-established; however, current contrast agents rarely underwent formal health technology assessment (HTA). Now, a new class of MRI contrast agents is navigating HTA. Benefit assessments are ongoing in several countries; key insights have emerged.
METHODS: We analyzed German and French HTA assessments for the two most recently approved MRI contrast agents (Elucirem, Vueway), focusing on HTA evidence criteria. We compared these to alternative evidence options for manufacturers and examined the subnational pricing and reimbursement (P&R) steps toward commercialization, drawing conclusions on how stakeholders can reconcile conflict between evidence requirements and feasible evidence options. This fact-based analysis and systematic review yielded practical recommendations for contrast agent benefit assessments and subnational P&R evaluations.
RESULTS: Multipurpose contrast agents are unlikely to meet national HTA evidence requirements translating to an “added clinical benefit” vs. SoC. This could hinder innovation if HTA is isolated from the interconnected subnational P&R processes. Rather than imposing stringent benefit ratings, national HTA can foster competitive dynamics in subnational P&R processes by categorizing products into classes/generations. As contrast agents are often commercialized across inpatient and outpatient reimbursement settings alongside diagnostic procedures and as standalone products, each setting can yield different net prices based on manufacturer competition.
CONCLUSIONS: National HTA should establish a product categorisation framework that benefits all P&R stakeholders and enhances competition between manufacturers. Subnational authorities (e.g. regional tender authorities [public], group purchasing organizations [private]) can better reflect cost-benefit by appropriately classifying products, while differentiating between classes/generations on meaningful criteria. HAS (France), has started moving towards recognizing the opportunity for reduced potential risks to patients with the introduction of new MRI contrast agents. In contrast, G-BA (Germany) has yet to adopt this new direction for multi-purpose contrast agents.