NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

Email received from N.I.C.E. in response to my inquiry for clarification about the anticipated timing for their guideline etc:

We are currently developing a guideline DCVax-L for treating newly diagnosed glioblastoma (https://www.nice.org.uk/guidance/indevelopment/gid-ta10143) however, it is in the very early stages of development so I am unable to advise at this stage when the guideline will publish.

This developing guideline would fall under our technology appraisal programme so the guideline can take on average between 30-43 weeks to complete, more information on our process can be found on the website (https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/process/sta-timeline).

We are asked to look at particular drugs and devices when availability varies across the country. This may be because of different local prescribing or funding policies, or because there is confusion or uncertainty over its value. Our advice ends the uncertainty and helps to standardise access to healthcare across the country. Once we published our recommendations if it is a positive recommendation then the NHS is legally obliged to fund and resource medicines and treatments recommended by NICE's technology appraisals.

The NHS Constitution states that patients have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if their doctor believes they are clinically appropriate.

When NICE recommends a treatment 'as an option', the NHS must make sure it is available within 3 months (unless otherwise specified) of its date of publication. This means that, if a patient has a disease or condition and the doctor responsible for their care thinks that the technology is the right treatment, it should be available for use, in line with NICE's recommendations.

However, if we make a negative recommendation on its use then it would be a local decision within the Trust whether they would fund the drug based on a case by case basis and this would also apply until final guidance is issued.