Context
Local formularies across England vary in the number of NHS organisations covered by the formulary, the range of medicines the formulary includes, and the processes for developing and updating the formulary.
Benefits of local formularies may include:
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improving patient outcomes by optimising the use of medicines
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supporting the inclusion of patient factors in decisions about medicines
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improving local care pathways
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improving collaboration between health professionals and commissioners
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improving quality by reducing inappropriate variations in clinical care
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improving quality through access to cost‑effective medicines
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supporting the supply of medicines across a local health economy
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supporting financial management and expenditure on medicines across health communities
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supporting prescribers to follow guidance published by professional regulatory bodies in relation to medicines and prescribing.
Policy
The Department of Health and Social Care's NHS Constitution for England (2012, revised 2021), provides patients with the right that medicines that have been considered by NICE through the NICE technology appraisal process and been given a positive assessment, should be made available, where appropriate, and therefore be included in the formulary adopted by the local healthcare providers and commissioners.
The Constitution also provides a right for patients to have decisions about medicines that have not yet been considered by, or have not received a positive recommendation for use in the NHS through a NICE technology appraisal process, to be made by the local NHS using a robust assessment of the best available evidence.
After publication of the original NHS Constitution in 2009, key documents were produced to support rational local decision making. The National Prescribing Centre and Department of Health's guidance on defining guiding principles for processes supporting local decision making about medicines (2009), and the accompanying National Prescribing Centre's 2009 handbook of good practice guidance on supporting rational local decision-making about medicines (and treatments) underpin the good practice recommendations for developing and updating local formularies.
The National Prescribing Centre is now the NICE Medicines and Prescribing Centre.
Statutory responsibility
Directions issued by the Secretary of State for Health (2010) make it a statutory obligation for commissioners to make funding available within 3 months for medicines that have been recommended by a NICE technology appraisal, unless they are directed otherwise by the Secretary of State for Health.
Innovation health and wealth
The Department of Health's report on Innovation Health and Wealth: accelerating adoption and diffusion in the NHS (2011, updated 2012) sets out the aspiration for the government to support the NHS to embrace innovation to meet the current and future healthcare challenges. In particular, the NHS should ensure that local systems and processes for accessing medicines support innovation where appropriate. The report states:
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.
NICE compliance
In this report, the Department of Health introduced a NICE compliance regime for the funding direction attached to NICE technology appraisals to ensure rapid and consistent implementation throughout the NHS. The compliance regime aims to 'reduce variation and assure patients of their access to the clinically and cost‑effective technologies and medicines their doctors believe they need'. NICE has defined what constitutes compliance with a NICE‑approved medicine or treatment.
In a letter from the NHS Chief Executive in 2012 on Innovation Health and Wealth publication of NHS formularies, the Department of Health stated that all NHS organisations should publish information that sets out which NICE technology appraisals are included in their local formularies by 1 April 2013 at the very latest. The Chief Executive stated:
It is important that the publications are online, and are clear, simple and transparent, so that patients, the public and stakeholders can easily understand them.
From 1 April 2013, this became a standard term and condition in NHS standard contracts.