An independent panel has published it’s review into the individual patient funding request (IPFR) process in Wales. An IPFR is a request to a local health board or the Welsh Health Specialised Services Committee (WHSSC) to fund an intervention, device or treatment for patients that fall outside the range of services and treatments routinely provided across Wales. Genetic Alliance UK along with a number of other stakeholders, including patients, carers and patient organisations provided evidence to the independent panel conducting the review into the IPFR process.
The report highlights a number of problems raised by Genetic Alliance UK in its submissions including the criterion of ‘exceptionality’ on which the process is based. For rare conditions, there is often limited evidence available to prove that a patient is different to a population about which little is known. The criterion puts an onus on clinicians to provide evidence that the patient’s condition is different from other patients with the same condition; that definition is usually impossible to apply to patients with rare or very rare conditions because of the very rarity of the condition.
The report has made a number of positive recommendations – particularly around the need for better commissioning processes so that the IPFR process is not used in inappropriate situations. Genetic Alliance UK will be making a formal response to the report which includes 27 recommendations. A summary of
the key recommendations can be found under seven themes below:
A lack of clarity on commissioning arrangements has led to difficulty in accessing interventions, and this has often been attributed to IPFRs. The panel made a series of recommendations to clarify and simplify the commissioning process for clinicians, to make it easier for them to access the interventions their patients need.
The “exceptionality” principle is not well understood and has been applied in circumstances where it does not make sense. The panel recommended replacing it. Whether a patient is given an intervention should depend on whether the patient will gain significant clinical benefit from the intervention, and whether the intervention offers reasonable value for money.
The panel considered whether non-clinical factors (sometimes called social factors) should be taken into account when making IPFR decisions and concluded that they should not.
Many stakeholders had concerns about the consistency of the IPFR process. The panel encountered inconsistency due to the problems with commissioning and exceptionality, and made recommendations on those subjects to reduce inconsistency. In addition, they recommended the creation of a new national IPFR quality function, to monitor IPFR panels and with a specific duty to report inconsistency or any other concern through the NHS Wales quality process. Given the costs and risks of changing the number of panels, and the panel’s confidence that they have addressed the root causes of inconsistency, they did not recommend changing the number or structure of panels.
Pharmaceutical companies should always submit their medicines for health technology appraisal (HTA) as that is the best way to assess whether they offer clinical benefit and value for money. The All Wales Medicines Strategy Group (AWMSG) offers timely appraisal for new interventions. If a pharmaceutical company could submit a medicine for HTA but chooses not to, there is inevitably less evidence that the medicine offers reasonable value for money. For IPFR panels to approve requests for the use of those medicines that could be, but have not been, submitted for HTA, they should be confident that there is clear evidence of sufficient clinical benefit to justify the cost.
More can be done to improve communications between IPFR panels, clinicians, and patients, and the panel made recommendations accordingly.
The IPFR application process should be amended in light of the recommendations, particularly those on commissioning (to ensure the IPFR process is only used when it is appropriate to do so) and on exceptionality (to amend the evidence requirements and decision-making criteria).