Exceptionality. It must be demonstrated that: Patient is significantly different to the general population of patients with condition in question (this contrasts the most common scenario where the patient’s needs are not unique and the patient is, in fact, one of a larger group of patients none of whom would be offered the treatment sought under existing policy). As a guiding principle, patients will be regarded as ‘significantly different’ where estimated prevalence of a condition is less than 1 per 100,000, per annum. Patient is likely to gain significantly more benefit from the intervention than might be expected for the average patient with the condition The fact that a treatment is likely to be efficacious for a patient is not, in itself, a basis for exceptionality If a patient’s clinical condition matches the ‘accepted indications ’for a treatment that is not funded, they are, by definition, not exceptional [This would contrast the situation where the patient has such unusual needs that these could not have been predicted and planned for by NHS BEN, however, this scenario is very uncommon as most conditions can be predicted]. Exceptionality is therefore determined on the basis of likelihood of benefit from an intervention. An individual’s personal or social circumstances are not considered when making a decision on exceptionality. Funding will not be made available for poorly evidenced treatments on the basis that the patient has progressive or persistent disease (however serious) despite exhausting the currently funded treatment options. The responsibility for demonstrating exceptionality lies with the requesting clinician.
