OBJECTIVES: Since April 2017, NHS England (NHSE) has new powers to negotiate directly with pharmaceutical companies offering innovative high-value medicines. These commercial discussions can be triggered if the annual budget impact for a new technology is expected to exceed £20 million in any of the first 3 years of use and occur in parallel with the NICE technology assessment. This research systematically evaluates all innovative therapies reimbursed to date following commercial discussions with NHSE.

METHODS: NHSE press releases were screened, any innovative medicine reimbursement decision identified, and key information extracted (01/April/2017-10/Jun/2021).

RESULTS: NHSE have publicly announced successful conclusion of commercial discussions for 20 innovative therapies (4 in 2017, 3 2018, 9 2019, 2 2020 and 2 in 2021). 13/20 had NICE positive guidance: 7/13 NHSE press release and NICE FAD were on the same day, 5/13 NHSE press releases preceded the NICE FAD by a mean of 63 days [range: 44-84], and 1/13 was after NICE FAD. 3/20 successful NHSE commercial discussions were associated with negative NICE appraisals (not recommended or non-submissions), 2/20 [both in 2021] were associated with ongoing NICE assessments, 2/20 did not go through NICE (instead were subject to Clinical Commissioning Policies). Conclusion of commercial discussions were announced before or on the day of regulatory approval for 2/20, notably these represent 2 of the 3 most recent announcements. Positive guidance for 10 HST therapies have been announced since April 2017, 4/10 have had NHSE commercial discussions. These 20 include 2 CAR-T cell therapies and 2 gene therapies. The specific type of commercial agreement is not typically stated but 2 were outcomes-based agreements, 1 was budget-neutral and 1 was a portfolio-wide agreement.

CONCLUSIONS: NHSE is becoming an increasingly active and important stakeholder in UK market access of innovative therapies. Manufacturers should accordingly tailor their early engagement and pricing strategies