A Pharma company's cry: "NICE has got it wrong! What can I do?"

Background to NICE and its role

The National Institute for Health and Clinical Excellence (or NICE) was set up in 1999 to reduce the variation in the availability and quality of NHS treatments and care. In 2005 it merged with the Health Development Agency and began to develop public health guidance, so becoming the National Institute for Health and Clinical Excellence.

NICE is internationally recognised as establishing guidelines and guidance[1] for treatments and ailments from anaphylaxis[2] to zaleplon, zolphiem and zopiclone[3]; they also produce social care and staffing guidelines. NICE guidelines are prepared by committees including clinicians, researchers and NICE representatives as well as representatives of patient groups. They are also generally the subject of consultation with any interested parties. The committees take into account not only the medical evidence for the treatment but also its health economic impact. In other words, they address the NHS’s economic limitations as well as medical innovations.

Very generally speaking, if you are a patient in the UK and a treatment you want is recommended by a NICE guideline, you should be able to get it, subject to any local limitations which may be in place. NHS clinicians look to the NICE guidelines as a benchmark of the best treatment available for a patient and whilst it is not “the law” the reality is that if they do not follow the guidelines, they will have to explain why, particularly if something should go wrong.

The impact of NICE guidelines on life sciences companies

This means that your product’s sales, whether a drug or a medical device, will be impacted if it is not recommended in the relevant NICE guidelines – whether expressly ‘not recommended’ or is simply excluded.

What can be done if “NICE has got it wrong!”

It is possible that your product may be excluded from NICE guidelines because NICE have made a mistake – for example their review of the science or the health economic benefits may be flawed or they may have included irrelevant factors or excluded relevant factors in reaching their conclusions. If that’s the case, it may be possible to challenge the guidelines through NICE’s internal systems or alternatively to seek a judicial review of NICE’s decision through the Court to seek to have the guidelines changed. If the situation is urgent, it may also be possible to seek urgent injunctive relief to prevent the guidelines being published.

As part of our Life Sciences dispute resolution practice, we have advised clients on this issue and would be happy to talk to you if you find yourself saying “NICE has got it wrong!”. For further information please speak with Michael Frisby or Catherine Penny or your usual S&B contact.

[1] The difference between NICE guidelines and guidance is beyond the scope of this note and we refer simply to ‘guidelines’ in the remainder of this piece.

[2] An allergic reaction.

[3] Treatments for insomnia in adults.