NICE: Beyond the process

Thursday 27th September 2018

An interactive workshop to consider how changes to the NICE STA process should influence your approach to future submissions

Pharmaceutical companies are continuously developing innovative treatments that offer dramatic benefits to patients, which is leading to a number of key challenges for successful reimbursement:

  • Decision making by HTA bodies is becoming more complex due to the limited evidence available to link the enhanced clinical efficacy to the value these novel treatments offer to healthcare systems
  • HTA bodies are rapidly evolving to assess the high number of breakthrough therapies, inevitably making the HTA process and market access more challenging for pharmaceutical companies

NICE, one of the most rigorous HTA bodies, has responded to these challenges by reshaping their approach. Their aim is to ‘do more with less’; consequently, they recently updated their STA process. The new process has the potential to reduce uncertainty and streamline negotiations but requires pharmaceutical companies to navigate through more upfront interactions with key stakeholders at NICE.

BresMed is running this interactive workshop, that draws on our experience of supporting over 100 NICE submissions. Our experts will take attendees through and beyond a summary of the new updated NICE STA process to consider:

  • The range of key stakeholders involved in the process
  • How you can most effectively engage with them to shape the outcome of your NICE assessment

The workshop will be a mixture of both presentation and group activities across a full day (10:00 – 16:00).

Agenda:

10:00-10:10 Introductions and objectives of the day

10:10:10:40
Summary of new NICE process and anticipated implications for Pharma

10:40-11:30
Key stakeholders at NICE

11:30-12:30
Step by step guidance to best prepare for key steps in new process

12:30-13:30
Lunch

13:30-15:00
Interactive group tasks – Working through an example STA

15:30-16:00
Group feedback/close

Presenters:

Professor Ron Akehurst

Ron is an Emeritus Professor and was Dean of ScHARR, University of Sheffield (1993-2010) before moving to a full-time director position in BresMed in 2012. He is a founding member of the NICE Appraisal Committee and served on the NICE Topic Selection Committee and the NICE Public Health Interventions Advisory Committee.

Dr Dan Gladwell

Dan joined BresMed in 2011. Prior to this he worked for Takeda Europe R&D, leading the pre-, peri- and post-launch HEOR planning for diabetes and obesity compounds. Dan has led the development of cost-effectiveness models and HTA submissions – providing strategic guidance on HEOR and market access.

Dawn Lee

Dawn has over 11 years of experience in economic consultancy and modelling. She has extensive experience in the development of economic models for HTA submissions, having been involved in over 60 NICE submissions.

Dr Zoe Philips

Zoe has over 20 years of experience from a career spanning academia, industry, and HEOR and market access consultancy, and has extensive experience in the areas of HTA, payer and reimbursement strategy.