We aim to reduce the workload for the NHS and frontline staff by making commercial agreements more straightforward.
Identifying complex commercial challenges
As set out in the NHS Commercial Framework for New Medicines, a commercial access agreement (CAA) is a complex confidential agreement and is agreed at NHS England’s discretion. A CAA proposal can only be considered if a patient access scheme proposal has been fully explored with CLT.
All our activities align with key steps in the technology evaluation processes and focus on key checkpoints where commercial considerations are examined. If we identify that a technology is unlikely to be cost effective with patient access schemes alone, we’ll liaise with NHS England to assess the potential for consideration of a CAA proposal.
This may result in NHS England contacting the company directly.
We prepare a pre-appraisal committee meeting commercial summary. This confirms the commercial arrangement to be considered. It also identifies any risks relating to cost effectiveness in the evaluation or budget impact test (BIT) that may result from the arrangement.
This will be shared with the company and NHS England up to 4 weeks before the first committee meeting.
If, a topic is identified at high risk of not being cost effective with a patient access scheme alone, we’ll ask NHS England to confirm if they will consider discussing a CAA.
Further details on commercial checkpoints and our activities can be found in NICE health technology evaluations: the manual.
Commercial briefings
We attend committee meetings for topics where NHS England indicate, before the first committee meeting, that they may be willing to consider discussing a CAA.
If a company and NHS England agree to enter additional commercial discussions, we’ll provided a confidential commercial briefing with the committee's assumptions for the evaluation and the implications for the company's value proposition.
Budget Impact Test
We assess value and affordability through our technology appraisal process by considering the net budget impact of a medicine. If the net budget impact is expected to exceed £20 million per year in any of the first 3 years of use in the NHS, NHS England can engage in commercial discussions to manage the affordability.
The CLT manage the budget impact test processes and act as liaison between the technology appraisal programme, NICE resource impact assessment team, NHS England, and companies.
Further detail on the budget impact test process can be found in NICE health technology evaluations: the manual.
Information on how budget impact tests are developed can be found in the Assessing resource impact process manual.