A brighter tomorrow as life-saving drugs in focus
The application process for drugs not offered by the NHS is going to be simplified. Health correspondent Mark Smith investigates...
HUNDREDS of new drugs and treatments are discovered every year which prove life-saving or life-changing for patients in Wales.
But as the NHS only has a set amount of money to spend, clinicians often have very difficult decisions to make about whether or not a drug should be made available. This can prove stressful and heartbreaking for patients and their families, especially if they are refused the medication on the grounds of cost.
When a patient needs a treatment not routinely available on the Welsh NHS, they can apply for it through something called an Individual Patient Funding Request (IPFR). There is an IPFR panel for each health board, each made up of top clinical experts who make these crucial decisions.
But the process has been accused of creating a “postcode lottery” in Wales after certain drugs were offered in one part of the country but not in another.
As a result, Health Secretary Vaughan Gething announced an independent review into the IPFR process in July 2016 to look at how things should be changed. It collated the opinions of leading doctors in Wales, along with a whole host of patients who’d recently struggled to navigate the system. What treatments are not routinely provided by the NHS?
A patient and NHS clinician have agreed together that they would like a treatment that is either new, novel, developing or unproven (eg. a request to use a cancer drug that has yet to be approved).
A patient and NHS clinician have agreed together that they would like a treatment that is provided by the health board in certain clinical circumstances but is not eligible in accordance with the clinical policy criteria for that treatment.
A patient has a rare or specialist condition that falls within the service remit of the Welsh Health Specialised Services Committee (WHSSC) but is not eligible in accordance with the clinical policy criteria for treatment (eg. a request for plastic surgery). What do patients have to do to make an IPFR request (as things currently stand)? If a patient can’t get access to a particular treatment, they need to contact their GP or consultant at their hospital who will submit a form to the IPFR panel on their behalf.
When making the application, the clinician will need to demonstrate why they feel the request has “exceptional” clinical circumstances. It normally takes the panel about a fortnight to make their decision. What did the review conclude? The review’s findings, published in January, found that the “exceptionality” principle was not well understood and had been applied in circumstances where it did not make sense.
The review recommended replacing this and instead basing the decisions on whether the patient will gain “significant clinical benefit” from the intervention and that it offered “reasonable value for money.”
This is arguably the most significant change to the IPFR process. What were the major problems of the current IPFR process? The review team said there is currently a lack of clarity on commissioning arrangements (ie. how they go about trying to access drugs for their patients).
Some clinicians told the review team they use the IPFR process when they don’t know how to access the treatment a patient needs. Overall, clinicians, patients, staff and the public expressed a need for transparent information on which services and interventions are routinely available within their health board. What about the number of IPFR panels? Despite concerns over the “postcode lottery” of access to drugs, the review concluded that the structure of current panels should stay the same (ie. one per health board).
Instead, it recommended the creation of a new national IPFR quality function to monitor IPFR panels and report inconsistencies. What did the Health Secretary think? Vaughan Gething AM said the review was a “helpful piece of work” that makes “thoughtful and pragmatic recommendations”.
He said: “The review has suggested improvements to the overall process to support health boards make these highly complex and sensitive decisions.
“This includes clarifying when it is appropriate to use the IPFR process, and strengthening quality assurance.”
He accepted the recommendations in full and has written to all health boards to confirm the implementation of the recommendations by September.
He added: “I believe the recommendations in this report, when implemented, will have a positive impact on the IPFR process.
“It will make the system more easily understandable and less prone to being misused. Something I’m sure the people of Wales will welcome.” What did other organisations think of the review? Claudia McVie, Tenovus Cancer Care chief executive, said: “In taking on board many of the recommendations of the IPFR review, the Welsh Government must commit to three points: clarity, consistency and criteria.
“The need for clarity and consistency is of paramount importance. If the process is to be fair and of most value to patients in Wales, it must be made clear to patients how it works and how they can apply.
“The report has recommended keeping the existing IPFR boards linked to each health board; it’s essential that the government ensures there is consistency across the country.
“Finally, the criteria for making decisions needs to be absolutely clear so that it’s easily understood by everyone, and that patients are informed of any updates to their applications.
“Tenovus Cancer Care believes the IPFR process should be reviewed on a regular basis so that the procedure remains clear, fair and equal, no matter where in Wales a patient lives.
“We must do all we can to make sure that cancer patients are kept at the heart of all decisions made about their care.”
Dr Richard Greville, director of the Association of the British Pharmaceutical Industry (ABPI) Cymru Wales, said: ““Our members are committed to submitting innovative treatments to the National Institute for Health and Care Excellence (NICE) and the All Wales Medicines Strategy Group (AWMSG), where the comprehensive evidence needed is available to support this. Where this evidence is not available, a process must exist which can enable individual patients, with the support of their clinicians, to be considered for treatments in a fair and transparent way.
“What is important now is that confidence in the IPFR process across Wales is restored through the equitable and sustainable implementation of these recommendations.”