National Institute for Health and Clinical Excellence (NICE)
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Improving access to NICE-approved drugs

NICE is to produce a best practice guide to help trusts develop local formularies, as part of a move to ensure that all patients in England have access to clinically and cost-effective drugs.

Local formularies provide a list of selected or preferred drugs available to local prescribers and have an important role in underpinning safe and effective use of medicines.

However, there is currently no standard process or advice for putting together a local formulary which has led to variations across the country.

A recent report into innovation in healthcare by The Department of Health has highlighted that not all local formularies are including all of NICE's technology appraisals. This can lead to a postcode lottery where patients miss out on drugs approved by NICE.

In some cases, local formularies are duplicating NICE assessments and challenging appraisal recommendations, acting as a barrier to the uptake of NICE-approved medicines.

The report states that the Department of Health is “committed to ensuring that NHS patients have access to clinically and cost-effective drugs and technologies, and that NICE appraisal guidance is promptly delivered throughout the NHS.

“There should be no local barriers to accessing technologies recommended in NICE appraisals, beyond a clinical decision relating to an individual patient.”

The report recommends that formulary processes should proactively consider the impact of new NICE Technology Appraisals, and all NICE Technology Appraisal recommendations should - where clinically appropriate - be automatically incorporated into local formularies.

This process should take place within 90 days to support compliance with the three month funding direction and the NHS Constitution ensuring that these medicines are available for clinicians to prescribe, should they choose to, in a way that supports safe and clinically appropriate practice.

To help achieve this, NICE will develop a best-practice guide covering the creation and review of local formularies to assist local trusts and clinical commissioning groups.

Dr Gillian Leng, Deputy Chief Executive of NICE said: “NICE will embark on a specific piece of work to look at how local formularies are put together. At the moment there is no standard process for them and there tends to be a lot of variation and inconsistencies across England. This has been flagged up in the recent NHS Innovation report.

“NICE will produce a best-practice guide on how to develop a local formulary. We will be holding a workshop to develop the guide, which will then go out to consultation before being published later this autumn.”

“NICE-approved drugs should not be excluded from local formularies on the grounds of cost. We want all patients to have access to medicines that we consider to be effective,” added Dr Leng.

Elsewhere, the report outlines plans to introduce, within three months, a NICE Compliance Regime for the funding direction attached to NICE technology appraisals to ensure rapid and consistent implementation throughout the NHS.

The Department of Health will also establish a NICE Implementation Collaborative (NIC) to support the implementation of NICE guidance. The NIC will bring together the NHS Commissioning Board, NICE, the Chief Pharmaceutical Officer, the main industry bodies, the NHS Confederation, the Clinical Commissioning Coalition and the Royal Colleges.

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