NICEs Highly Specialised Technologies Process

NICE’s Highly Specialised Technologies Process


By 2024 orphan drugs are estimated to represent over a third of the pharma pipeline worldwide!*

With many anticipated new medicines for rare diseases, countries are beginning to prepare appropriate market access pathways to ensure that patients can access life-saving treatments as quickly as possible.

In the UK, NICE have introduced the Highly Specialised Technologies (HST) process to do just that. Below you can find the 3 key considerations to keep in mind if you’re looking to take up the HST:

  1. Qualifying criteria
    The qualifying criteria for the HST program is changing, and is likely to become stricter. Pay close attention to the upcoming NICE process update to understand if your product will qualify​​
  2. Significance of non-health benefits
    The HST has more focus on the significance of non-health benefits than the STA. Fully understanding the costs and benefit of your product outside of the NHS and personal/social services is important and should be considered.
  3. Patient Access Schemes (PAS)
    While the HST has a higher ICER threshold (£100,000 per QALY), a patient access scheme will still likely be required to reach cost-effectiveness. Actively planning for a PAS will ensure a smoother submission process.

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