Working with you to understand whether it is appropriate to put the technology forward.
Rectifying weaknesses in your evidence base
Helping you answer the appraisal
The processes employed and the evidence base required is similar for all the organisations appraising technologies.
It is a legal requirement in most countries that products must conform to defined manufacturing standards. The EU requires manufacturers or their representatives to submit their product to a notification body, such as TUV, for assessment. These organisations have been approved to certify products conforming to the required European Standards (CE). A similar process (UL) overseen by Underwriters Laboratories occurs in the US.
These approvals unlike those for pharmaceuticals take no account of the efficacy of the technology. And like the approval process for pharmaceuticals whether they offer economic benefits to the health system or the patient.
This hasn’t posed a problem in promoting new medical technologies. Normally a company will have generated patient studies and these will be used to convince purchasers as to the usefulness of the device or procedure.
New technologies offer early adopters the opportunity to present or publish their findings. These studies usually involve limited numbers of patients but cover the range of potential applications for which the technique can be used. These become important in persuading new adopters. Clinicians weigh up this body of evidence in deciding whether to embrace the new technology. It is a qualitative process. The new technology may replace an existing technology and if it is cheaper and these benefits can be easily realised all well and good. The hospital may pay for the technology or alternatively there may be private patients happy to pay to receive diagnosis or treatment using the technology.
This was how medical technology was sold in the past but now money is more tightly controlled and those in charge of the budgets increasingly want evidence to decide on whether funding should be given to a new technology. Hospitals can’t necessarily subsidise new technologies. They depend on insurance companies or health systems to pay for or to reimburse patient treatments. A growing number of countries have organisations which assess health technologies. These include:
Health technology assessment is increasingly important in persuading payers to support a technology. Manufacturers and suppliers need to factor this into their marketing plan.
Like conformity, health technology assessment involves an external body. But unlike conformity, where the product is appraised, the health technology assessor is not interested in the product only in published evidence. The assessors are interested in whether:
Without published studies no appraisal can be made.
Each year numerous new technologies or new applications of existing technologies are introduced and therefore not all can be assessed. Technologies which are appraised are those which are expected to deliver benefits to the health system sponsoring the appraisal. These benefits are most often economic.
Assessors learn of new technologies because they are brought to their attention by users, by suppliers, by payers or by members of the public or their elected representatives. These technologies fall into two groups.
In the UK NICE carries out Health Technology assessments on behalf of the NHS. The Medical Technologies Advisory Committee (MTAC) selects the medical devices and diagnostics for which guidance is produced.
Technologies evaluated by the programme are those which have the potential to offer substantial benefit to patients and/or the NHS compared with current practice and are likely to be adopted more consistently and more rapidly if NICE develops guidance on them. They need to have clear easily understood advantages over current practice.
Clinical Commissioning Groups (CCG) are less inclined to pay for treatments and diagnostics which have not been positively appraised by NICE.
So how do I go about getting my product approved and what are the pitfalls?
The biggest risk is having the technology appraised and then rejected. But the biggest challenge is having your technology assessed. The first step is notifying NICE that you have a technology which you feel should be assessed.
While it isn’t clear which technologies are selected for assessment there are some pointers.
If you can answer yes to the following questions then it may be time to alert NICE to your technology.
Of course it is otherwise why would you have launched it!
High-quality scientific evidence will increase the likelihood of a technology being selected for evaluation. Does the body of evidence you have collected meet this threshold or do you need to improve or modify the publication strategy.
Are the costs well described? Are these placed alongside the benefits or effectiveness delivered and is the model compatible with operation within the NHS.
Is the number of patients large enough to justify the process or is there a patient group – for example a minority - which are not covered by current treatment or diagnostic algorithms. How is the condition currently managed in the NHS?
With limited capability – NICE assesses around 6 technologies each year – it less interested in revisiting old ground. Have you reviewed past submissions?
NICE needs to give everyone a look in. It is probably not a good idea to put a technology forward in a discipline in which recent appraisals have taken place. Have you reviewed current and past topics?
NICE will compile a briefing note from information which you supply and from other inputs and the Medical Technology Advisory Committee will decide whether a full appraisal should be undertaken.
If successful NICE will produce a scope which outlines the evidence which they are looking for and areas which do not need to be included. They will also appoint an assessment centre whose job it is to assess the evidence which you will provide.
The appraisal looks at the technology and a comparator, which is normally current practice and possibly an alternative technology which could be a surrogate. As the sponsor you are required to provide the evidence base on which the assessment is made.
The appraisal is in three parts.
For Part B and C published evidence needs to be identified, analysed, and presented. In addition for part C a de novo economic model needs to be derived which allows known and unknown variables to be addressed. Published meta analyses, where a number of separate studies are pooled, enhance the evidence base demanded in B. Likewise HTA assessments help in supporting the economic argument.
NICE asks that you have clinical advisors, normally NHS consultants, who can validate key aspects of the submission.
The assessment centre, which will normally be based at a UK university, will review the evidence provided; reject that which it feels is not appropriate and add additional material to produce a comprehensive appraisal.
The submission is the sponsor’s opportunity to put forward their arguments why the technology should be adopted.
Siemens put forward to NICE a new technology Virtual Touch ™ tissue quantification (VTq) which enables the elasticity of the liver to be measured by ultrasound and correlates well with the degree of fibrosis in the liver obviating the need for liver biopsy which is both invasive and expensive.
Medical Options reviewed the published literature, identified the clinical pathways and developed an economic model to show the benefit of VTq.
Siemens obtained a NICE medical technology guidance [MTG27] in September 2015.