NICE STA submission for new drug with lifestyle but not efficacy benefit
Our clients were preparing for single technology appraisal of their new long-acting formulation drug.
The evidence base for the new drug was from non-inferiority studies, which limited the scope for the indirect treatment comparison with comparator treatments required by NICE to inform comparative effectiveness.
Long-term adherence data in the disease area was limited, as was the clinical impact of poor adherence.
Demonstrated conclusively that an indirect treatment comparison was not possible and provided evidence to support comparable effectiveness between therapies.
Built the evidence base to support the argument that the value of the novel therapy was in the mode and frequency of administration.
Extrapolated medium term adherence data to demonstrate the long-term clinical impact of poor adherence in the disease, and the adherence benefit of the novel therapy.
Supported our client in the analysis of the clinical trial utility data to show a long-term utility benefit for the novel product at every timepoint, and we designed a TTO study which suggested the clinical trial underestimated the degree of utility benefit.
Compiled the submission dossier and supported our client strategically and technically through the submission process.
Full reimbursement of the novel therapy by NICE.
This was the first recommendation of a long-acting injectable therapy in the disease area and a step change in therapy for patients with a life-impacting condition.