UPDATE - Issue 21 - Spring 2005
Access To Medicines: Understanding NICE
by Dr John Graham, Consultant in Clinical Oncology
The NHS in the UK
The NHS in the UK is unique in that care is provided free at the point of use. That is to say, a patient attending an NHS hospital is able to get treatment without paying for the service on the day. This is very different to healthcare systems in many other parts of the world where patients take personal insurance for healthcare and, if they are not covered, they are not treated.
With a population over 60 million where less than 15% of people have private health insurance, the NHS is the major healthcare provider in the UK. With ever increasing demands upon the service, factors other than clinical effectiveness must be subject to scrutiny.
Background to NICE
NICE (National Institute for Clinical Excellence) was established as a Special Health Authority by the Department of Health in April 1999. One of the primary objectives of the new organisation was to address the so-called 'postcode-lottery' for accessing certain treatments. Alarming stories had emerged where a patient covered by one health authority had access to a certain treatment, whereas a patient in a neighbouring health authority did not. This 'inequity' was a clear issue that needed to be addressed. Guidelines issued by NICE would carry the remit to be adopted by all health authorities, without exception. Whilst NICE has not been developed to dictate clinical decisions, the rationale is that if NICE have approved a technology, it should be available for all patients.
NICE and Europe
NICE bases its recommendations on a critical review of both clinical and cost-effectiveness data. This is a major difference from the way the European authorities license a new product. Whilst the EMEA (European Medicines Evaluation Agency) focus on the areas of safety, efficacy and quality, NICE also consider a fourth area of cost-effectiveness.
This is a key consideration in an environment such as the NHS, where resources are not infinite. Essentially there are numerous demands placed upon the NHS and thus it is very important that interventions are not only clinically effective, but also cost-effective. Cost-effectiveness is a form of analysis that evaluates both the clinical data and the costs of the intervention. A treatment is deemed cost-effective if the balance between the costs of providing that treatment, and the benefits derived by patients and the wider society, are well-balanced.
It is important to note that decisions made by NICE do not come with funding. This is often a very difficult situation for local authorities to manage. For example, although NICE may say product 'x' is both clinically and cost-effective and should be available for use, there is no allocation of separate funding for this technology. The local authority must manage their budgets accordingly and their approach has been to prioritise technologies reviewed by NICE.
NICE Guidance
NICE produces guidance within the NHS in England and Wales in three areas of health:
- The use of new and existing medicines and treatments (technology appraisals)
- The appropriate treatment and care of patients with specific diseases and conditions (clinical guidelines)
- Whether interventional procedures used for diagnosis or treatment are safe enough and work well enough for routine use (interventional procedures)
'NICE Blight'
NICE tends to review technologies where there is likely to be a significant public health impact and cost implication. For those products not selected, there has been a scenario termed 'NICE-Blight'. What this means is that health authorities have been unable to allocate funding for a certain technology and cite the lack of a NICE recommendation as the primary reason for not prioritising this area. To address this situation the Department of Health have instructed all local authorities that the absence of NICE guidance should not be cited as a reason to withhold treatment that clinicians believe to be effective for patients.
Impact for Research
Delays in guidance do carry an impact for on-going research. Guidances provide a basis for current standard practice. New trials and research go beyond current practice but require existing standards against which they can be compared. If, in the UK environment, new technologies are not incorporated into current standards there is a consequent impact for future research and trials.
Case Study - Taxotere
Docetaxel (Taxotere) is a chemo-therapy agent that has recently been licensed by EMEA for use in patients with metastatic hormone refractory prostate cancer in combination with prednisone. Docetaxel is one of the most active chemotherapy agents available today and is also used extensively for the treatment of breast and non-small-cell lung cancer.
The new license for docetaxel in combination with prednisone has been greeted with significant enthusiasm by clinicians and patients alike. The reason has been the significant improvements observed in terms of survival, pain, PSA response and quality of life, compared to current standard treatment.
Whilst the EMEA have reviewed the data for docetaxel and provided the product a license for metastatic hormone refractory prostate cancer, guidance from NICE is still awaited. As mentioned previously, the absence of NICE guidance cannot be cited as a reason to withhold treatment. However, once NICE guidance is available it will help to address any inequalities in access to this new and important treatment for thousands of patients in the UK.
For further information about NICE you can visit www.nice.org.uk.