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Time To Stop Hiding Behind The Skirts of NICE—The UK Renal Cell Carcinoma Expert
Use of drugs prior to NICE appraisal
In the meantime, what of those new drugs that are not yet NICE appraised? In the absence of guidance, every local funding authority is individually responsible for establishing the criteria that they will use to determine whether a drug not approved by NICE is available in their patch. It is of importance however, that clinicians are involved in the decisions made about drug availability pre-NICE. To that end, strategic health authorities and primary care organisations cannot withhold funding for treatments solely on the grounds that guidance from NICE is unavailable or yet to be published; an open dialogue must be maintained between those treating patients and those responsible for funding that treatment.
With primary care trusts (PCTs) bowing under the financial burden of meeting the costs of those drugs that have already received a positive opinion, many will not consider non-NICE approved treatments for routine funding. It then becomes extremely difficult to obtain funding for these drugs—some PCTs allocate a budget every year from which requests for funding can be met; others allocate money on a case-by-case/exceptional-case basis. Frustratingly, exact information about who does what is not centrally collected, and the onus is on the clinician who wants to use a non-NICE approved drug to take the time to make a case, on behalf of their patient, to present to the commissioners via their directorate, or to put together a business case for inclusion in the local development plan, depending on local protocol. Such varying approaches to a common problem inevitably result in the unpredictable and disparate prescribing patterns (and the associated inequity of spend on cancer drugs) that it was postulated NICE would obviate. A mechanism of communication, or if not that, transparency, and hence reduced discrepancy between trusts, would surely represent a step forward. Going further, is the possibility of a lead group of PCTs working together to establish strict guidelines for the national limited use of particular drugs prior to NICE appraisal so ridiculous? Importantly, as the number of new drugs flooding onto the market continues to rise year on year, PCTs will need to be increasingly creative in delivering solutions—be that through disinvestment where appropriate, increased focus on preventions or community-based care or otherwise—for their funding.
The problem of the ‘postcode lottery’ in healthcare, it appears, has not been solved by NICE. Worryingly, the presence of NICE also stands to accelerate the development of a two-tier healthcare system, where well-informed patients who can afford to pay gain access to new treatments prior to NICE approval, while those dependent on the NHS are forced to wait for effective treatments to jump the regulatory hurdles. As well as geographical discrepancies in prescribing, a degree of discrepancy in the process, according to disease, is also apparent—the stories of two drugs illustrate this point well (though they possibly represent extreme cases); the first for breast cancer—a ‘sexy’ disease backed by high-profile lobby groups—and the second for renal cell carcinoma.
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