The Client
Leading global biopharmaceutical company, AbbVie.
Challenge
We supported AbbVie with global evidence generation and an initial submission to the National Institute for Health and Care Excellence (NICE) in 2015 for a treatment for diabetic macular edema – the leading cause of sight loss in people with diabetes. The treatment received a partial recommendation from NICE in 2015, only not receiving a full recommendation due to challenges in demonstrating cost-effectiveness in a subset of patients.
The challenge was to re-submit to NICE in 2022 against the backdrop of changing standards of care in the UK since the original submission, affected patients not responding to existing therapies being prescribed by clinicians, and the availability of real world evidence since the partial recommendation obtained in 2015.
Approach
- We partnered with and advised AbbVie throughout the appraisal process, leveraging our experience from the previous appraisal and reviewing the required scope of work in response to expert advice
- Our team, including professionals who had worked on the original submission in 2015, provided strategic advice to support the case for re-appraisal within the biopharmaceutical company, and to NICE, by assessing the potential to demonstrate cost-effectiveness with the available evidence and given the evolved comparator landscape
- We also advised on evidence gaps and provided flexible input to de novo real world data collection protocols and analysis plans to provide key data to support the submission
- A dossier was developed to tell a complex value story, bringing together multiple diverse evidence sources, in a clear and understandable way
- A high standard of economic modelling support was provided; the evidence review group at NICE made no corrections to the economic model following their review
Solutions
Lumanity deployed a cross-functional team to provide end-to-end health technology assessment (HTA) services in a seamless manner to tell a comprehensive and cohesive story to NICE. Our services included:
- Economic modelling
- Systematic literature review
- Indirect treatment comparison feasibility assessment
- Submission dossier development
- Post-submission support, including mock appraisal committee meeting and strategic advice
“Lumanity has been with us on this journey from the very beginning. Their team has not only served as a service provider, but have acted as our strategic advisors in getting this important therapy a full recommendation for NICE – which is so important for this patient group which now has full access to an effective treatment.”
HTA Lead, AbbVie
Outcomes
