Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
Ozanimod shows moderate benefit over current care, evidenced by its ability to reduce the annualized relapse rate and brain lesions compared to interferon beta-1a. However, the uncertainty regarding its effect on disability progression limits the strength of the evidence.
Cost effectiveness
The cost-effectiveness estimates for ozanimod are higher than what NICE typically considers acceptable, indicating poor value for the Healthcare. The committee noted that the estimates did not align with their preferred assumptions.
Quality of life
While the document discusses the importance of quality of life, it does not provide specific data on HRQoL improvements associated with ozanimod, indicating a lack of demonstrated benefit in this area.
Supporting Domains
Safety and Adverse Effects
Ozanimod has a very good safety profile with mostly mild or moderate adverse events. The document indicates that serious adverse events are rare, supporting a favorable safety assessment.
Comparator Selection
The company initially limited comparators to only oral treatments, excluding relevant options like ocrelizumab. The committee concluded that a broader range of comparators should be considered, indicating suboptimal comparator selection.
Patient Population and Subgroups
The trial populations are generally representative of the Healthcare population with active relapsing-remitting multiple sclerosis, although some concerns about diversity exist. Overall, the population is well-defined for the intended use.
Care Pathway Integration
Ozanimod can be integrated into existing treatment pathways with minor adjustments, as it is an oral treatment option that many patients prefer, facilitating its adoption in clinical practice.
Resource Use and Cost Implications
The document indicates a high resource burden associated with ozanimod, raising concerns about its affordability and potential need for restrictions in use.
Evidence Quality and Robustness
The evidence is based on phase 3 trials with a robust design, although some methodological concerns and biases were noted. Overall, the evidence quality is acceptable.
Uncertainty, Sensitivity, and Broader Impacts
There is significant uncertainty regarding the cost-effectiveness and clinical outcomes of ozanimod, particularly concerning its impact on disability progression, which may limit its broader acceptance.
