top of page

Earlier access, increased ICER thresholds, and changing rebates - 2026 ushers in sweeping changes in England's market access & reimbursement landscape

  • Writer: Kiley Trupiano
    Kiley Trupiano
  • Mar 18
  • 2 min read

Written by TruBio Consulting, LCC on March 18, 2026


Driven by converging pressures such as industry push back on skyrocketing rebates, geopolitical trade dynamics, and patient access delays, England has introduced sweeping changes to market access and reimbursement policies for the first time in years, even decades. Below, we break down the 2026 changes to England's market access & reimbursement landscape.


The MHRA-NICE Aligned Pathway


The most structurally significant change in UK market access in recent memory officially launches on April 1, 2026. The MHRA and NICE aligned pathway, announced at the NICE Conference in Manchester on March 17, 2026, is designed to bring new medicines to patients three to six months earlier by running NICE's cost-effectiveness evaluation in parallel with the MHRA's safety and efficacy review. An official announcement is scheduled for March 25th.


The aligned pathway is not mandatory, but to opt in, pharmaceutical developers must register with UK PharmaScan three years prior to expected Marketing Authorization.


Alongside the pathway, NICE and the MHRA are also launching an improved Integrated Scientific Advice service. This will offer a single-entry point, meeting, and one payment.


NICE's First Threshold Increase in 26 Years


On December 1, 2025, the UK government announced it will increase the thresholds NICE uses in evaluations of new medicines to decide which are cost-effective for use in the NHS, with the change applying from April 2026. Previous thresholds of £20,000 - £30,000 will be increased to £25,000 - £35,000. NICE believes this will increase the number of reimbursed medicines by 3-5 new medicines or indications per year.


Statutory Scheme Rate Proposed Decreases From 24.3% to 16.5%


Manufacturers outside the VPAG voluntary pricing scheme have faced an uncomfortably high rebate rates through the statutory scheme. The UK Department of Health and Social Care (DHSC) has proposed to set the repayment percentage on sales of branded prescription-only medicines to the NHS at 16.5% for 2026, a significant reduction on the current rate of 24.3%.


The VPAG payment percentage has been set at 14.5% for 2026, which is significantly lower than the statutory scheme payment percentage of 24.3%. The reduction would restore parity with the voluntary scheme returning to the longstanding principle of maintaining broad commercial equivalence between the two.


For operational purposes, the updated rate would come into force on July 1, 2026. Companies who made statutory scheme payments in the first half of 2026 at the higher rate of 24.3% would pay a lower rate of 8.7% from July 1, 2026 to December 31, 2026 to achieve a full-year average rate of 16.5%.


To schedule a consultation with us, send us a message from our contact section at the bottom of our home page linked here:



©2026 TruBio Consulting LLC. All Rights Served.


References:



 
 
 

Comments


bottom of page