HTA submission success for a rare disease therapy

Case Study
We ensured HTA submission success for rare disease therapies by conducting critical appraisals, systematic reviews, and economic modelling, while addressing data gaps and validating models with key stakeholders to align with clinical practice.
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Technical Ability

We are technically astute, with experts who bring extensive healthcare strategy and clinical knowledge to every project.
HTA critical appraisal
We conducted a review of a previous NICE submission that resulted in a non-recommendation.
Systematic literature review
We performed SLR using validated Scottish Intercollegiate Guidelines Network (SIGN) and Evidence Assessment Group (EAG) filters to ensure all relevant evidence is identified.
Comparative effectiveness
We ran a de novo ITC using novel methodology fully aligned to NICE decision support unit (DSU) guidelines.
Economic modelling
We developed a de novo patient-level CEM aligned to the clinical disease, based on established surrogate outcomes to predict multiple long-term outcomes.

Practical Agility

We are practically agile, operating with a lean structure that allows seamless teamwork and swift resource deployment, ensuring efficient project completion without unnecessary bureaucracy.

Gap analysis

We assessed key data gaps and propose evidence generation recommendations to fill them.

Delphi Panel

We conducted Delphi panels to fill evidence gaps using international experts.

External validation

With patient groups and KOL stakeholders, we align the submission and economic model structure to UK clinical practice, ensuring that the model structure and results are valid, resonate, and reflect real-world use.

Relevant resources

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