The information exchanged between the suppliers has to be “limited to what is strictly necessary to reach the commercial agreement and to implement the mechanism for the contribution payment”.
The Table below shows which information can and cannot be shared under the framework:
| May share | May not share |
| Proposed combination therapy and expected indication | Confidential net prices agreed with the NHS for the component drugs |
| NICE evaluation timelines and requirement for a response, for example confirming the backbone company is willing to engage during the evaluation process | Information allowing confidential net prices to be calculated through reverse-engineering |
| Clinical data / model assumptions pertaining only to the NICE assessment of the indication being evaluated | Pricing and discount information for products unrelated to the combination |
| Treatment pathway / line of therapy, including comparators / standard of care | Clinical data and model assumption unrelated to the assessment of the therapy being evaluated |
| Expected patient population numbers for the indication and assumed duration of treatment (including extrapolation analyses if applicable) | Development plans for competitive drugs unrelated to the combination therapy |
| The sum (£) the add-on company requires per patient to make its own (confidential) discount sufficient for a positive NICE evaluation and commercially viable. This includes details of what the 'per patient' amount is based on (i.e., per patient initiated on therapy, per cycle, patient weight, vial size, vial sharing, wastage etc.) | Commercialisation and product positioning plans for competitive drugs unrelated to the combination therapy |
| Proposed implementation of the agreement: data to be shared, source, and analysis of data; frequency of payments | |
| Proposed scoping meeting date, venue, agenda, terms of engagement if a discussion about the commercial agreement is required | |
| Proposed duration of agreement and any conditions for termination | |
| Public information, and any additional information that is reasonably necessary for the component suppliers to agree the contribution payments |
Additional requirements
Not all commercial agreements between drug manufacturers on combination therapies will be automatically clear of antitrust scrutiny. The following conditions must also be met:
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