The National Institute for Health and Care Excellence (NICE) provides reimbursement guidance to the National Health Service (NHS) in England and Wales. The NHS is legally obliged to provide funding for medicines and treatments recommended by NICE’s health technology appraisal (HTA) programmes.

The consultation

NICE’s HTA programmes are currently funded by the United Kingdom (UK) Government. The UK Government is now proposing changes to legislation to allow NICE to charge companies for making reimbursement submissions to NICE’s HTA programmes. The intention is for NICE to be able to introduce charges from 1 April 2019.  Currently, the proposals are out for consultation with a response deadline of 14th September 2018. The Department of Health (DoH) will collate and consider all response to this consultation and publish the Minister of Health and Social Care’s response in late 2018. The intention is for the amending regulations to come into force on 1st April 2019

NICE proposes costs for large companies between £126,000 and £251,000 per submission. For small companies it proposes costs in between £94,500 and £188,000 per submission (dependent on which for of HTA programme conducted).

The options consulted on are:

Option 1 – Do nothing: NICE’s HTA programmes continue to be funded by Government.

Option 2 – Introduce charges: NICE to impose an upfront charge on an individual company calculated to recover the cost of making the recommendation for their product.  All companies will be charged the same, i.e. £126,000 to £251,000.

Option 3 – Introduce charges but with discount for small companies: NICE to impose charges for all companies but small companies get a 25% discount and may pay in instalments.

This consultation bears a number of risks especially for small companies. Therefore, especially small companies should respond to this consultation. The more companies respond the higher the likelihood to avoid charges or the options and the charging model for small companies to be reconsidered minimizing the burden for small companies and another consultation will be necessary. It is also important to respond for companies whose products are a number of years away from NICE HTAs as it is unlikely that once charges have been introduced that they will be withdrawn.

Responses can be submitted via an online consultation questionnaire, email or via post to the UK DoH.

Consultation link:

A full text version of this article can be found here:

For questions and support needed with responses please contact:

Phone: +44 7864 952 154