The framework also includes obligations to continue to cooperate with the Association of the British Pharmaceutical Industry (ABPI) to develop commercial negotiation processes for companies that market combination therapies allowing two companies to offer NHS discounts without breaching competition law. Until then, the possibilities for improving the cost-effectiveness of a product controlled by the NICE-TA process were relatively simple; No or no passport. The introduction of Commercial Access Agreements (CAAs) and Market Access Agreements (MAAs) around 2016 offered industry additional options to propose more innovative mechanisms to obtain nice positive guidelines for technical assistance. These will be agreements submitted, verified and approved by NHS England, which can be considered as PASs by nice technology application committees. It is important that the draft trade framework also proposes when and how NHS England could agree to confidential trade agreements. NHS England could consider these agreements in the following circumstances: 4.8 The PPRS 2014 identifies 2 types of patient access schemes (see Chapter 5 of the PPRS 2014 for more details): the filing of the patient access system must be submitted to nice, either until the technical report or the closing date of the ACD consultation and, if possible, sooner. In particular, “affordability” is cited as a key principle, showing that fiscal impact, not just cost-effectiveness, is a formal factor in trade negotiations. 4.5 A commercial access agreement between a company and NHS England supports the use of a technology for which at least 1 indication is or has been considered part of the Cancer Drugs Fund. 4.12 If the evaluation committee recommends a technology with an outcome-based patient access system or commercial access agreement, it is essential that arrangements be made to collect and analyze relevant results. If the actual results differ materially from the results adopted in the initial assessment, NICE may decide to submit a review of the recommendations. In an ever-changing market access environment, the industry has a wider choice of options.
But does this further complicate the path to commercialization? 4.6 NICE can only take into account proposals for patient access schemes, flexible price proposals and commercial access agreements after formal approval by England (see Figure 6). . . .