Written by Mark Pennington, Guide Well being Economist
A Nationwide Institute for Well being and Care Excellence (NICE) advice can open the door to widespread adoption for a brand new medical system. However does getting a NICE advice require intensive proof on scientific and cost-effectiveness? Not essentially. On this submit I take a look at the necessities for the NICE Medical Know-how Analysis Programme (MTEP), and share some observations from expertise assessing firm financial submissions to MTEP because the financial lead for King’s Know-how Analysis Centre (KiTEC), an exterior evaluation centre (EAC) for NICE.
The evaluation course of typically begins with the corporate notifying NICE of their know-how. Gadgets to be assessed by MTEP are then chosen by the Medical Applied sciences Advisory Committee (MTAC). That is the committee that can finally scrutinise proof from the corporate, scientific specialists, and EAC, and make a decision on whether or not or to not suggest a know-how. Medical and financial proof submitted by the corporate kind the idea of the deliberations by MTAC.
The case for adoption rests on demonstrating a know-how will generate superior outcomes for sufferers at equal or decrease prices, or equal outcomes at decrease value. In apply, this implies scientific proof establishing the equivalence or superiority of the know-how, and financial proof indicating value parity or value financial savings related to uptake of the know-how. An necessary consideration is the function of the know-how throughout the present Nationwide Well being Service (NHS) care pathway. An efficient and low cost diagnostic know-how is probably not really helpful if analysis wouldn’t result in adjustments in NHS remedy (e.g. Neuropad).
The important thing problem for the financial submission is to show parity or value financial savings related to uptake of the brand new system. The remit of the MTEP is to make sure that suggestions don’t enhance prices on the NHS or undermine high quality of care. Nonetheless, the MTAC is reluctant to reject units which might be extremely prone to be cost-effective on the standard £20,000 per QALY threshold. Two suggestions circulation from this. Firstly, while the idea for the financial submission is a cost-minimisation evaluation, proof on cost-effectiveness will be helpful. Secondly, the MTAC will take into account proof on potential value financial savings that could be weakly supported by the literature, supplied assumptions are in keeping with scientific opinion.
A powerful financial submission is not important to safe a constructive advice. Certainly, the EAC will usually appropriate flaws in proof submissions which will prolong to intensive mannequin adjustments. Nonetheless, the EAC is not going to exit of its strategy to quantify all the potential affected person advantages and value financial savings related to a brand new system. The submission course of is the corporate’s alternative to form the scope of the analysis and guarantee it covers all features of the care course of during which uptake of the brand new system has the potential to generate value financial savings. The MTAC understands that the proof base supporting financial evaluation of units could also be very restricted in contrast with that underpinning a drug submission. The important thing to securing a constructive advice, somewhat than a ‘additional analysis wanted…’, is a well-prepared submission that features the next:
- A clearly elucidated function for the system within the present care pathway
- Nicely marshalled proof to show equivalence or superiority of outcomes with the system in contrast with at the moment used options
- A price evaluation that reveals good understanding of the care pathway and greatest use of accessible proof.
The MTAC is eager to encourage uptake of cost-effective units within the NHS. A powerful submission may help guarantee the committee and obtain a constructive advice when the proof base is weak.
If you need to study extra about well being know-how evaluation (HTA) submissions (together with systematic evaluations, well being financial modelling, and medical writing), please contact us at Supply Well being Economics, an unbiased consultancy specialising in proof technology, well being economics, and communication.
