Recommendations

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.

Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including 'off‑label' use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

1.1 Relationships with other decision-making bodies

1.1.1 When developing or reviewing the local formulary, map and understand the functions of existing medicines‑related networks and decision‑making groups in the local and neighbouring health economies.

1.1.2 Avoid duplicating work by collaborating with other local and regional decision‑making groups, such as the Regional Medicines Optimisation Committees (RMOCs).

1.1.3 Proactively identify, discuss and implement recommendations in publications from national decision‑making bodies, such as NICE, taking appropriate actions.

1.2 Local formulary scope

1.2.1 Determine the scope of the local formulary through consultation with all locally defined stakeholders. Take account of the:

  • size of patient population to be covered

  • range of healthcare treatments to be included

  • range and number of partner organisations adopting the formulary.

1.2.2 Ensure local arrangements take account of:

  • consistency of care pathway arrangements across the patient population

  • clinical engagement

  • resources needed to operate formulary processes.

1.3 The local formulary decision-making group

1.3.1 Agree and document terms of reference for the local formulary decision‑making group. This should include:

  • clarification of budgetary responsibility

  • lines of accountability and reporting arrangements

  • members' roles and responsibilities

  • declaration of interest arrangements

  • arrangements for quoracy

  • arrangements for deputies

  • pre-meeting preparation and post‑meeting actions

  • the method by which final decisions will be made, recorded and disseminated

  • actions of the Chair

  • frequency of meetings.

1.3.2 Include a locally‑defined mix of members from partner organisations and key stakeholders, such as patients and the public.

1.3.3 Ensure that the local formulary decision making group has the range of skills and expertise needed to undertake all necessary activities.

1.3.4 Hold meetings sufficiently frequently to ensure decision‑making is robust and decisions are made in a reasonable and practical time frame.

1.3.5 Take account of the resources needed to undertake all functions of the local formulary decision‑making group, as determined by the scope and geographical coverage of the local formulary. [amended 2015]

1.3.6 If operating a local formulary covering a small population, consider sharing resources and establishing joint processes with neighbouring local formulary decision‑making groups to avoid duplicating work.

1.3.7 Ensure corporate governance arrangements are firmly established with clear lines of accountability for each partner organisation.

1.3.8 Report to relevant corporate governance bodies for each partner organisation appropriately, and as a minimum annually, and by exception when needed.

1.4 Stakeholder engagement

1.4.1 Ensure local formulary stakeholder engagement includes:

  • clinical groups and networks, especially if a formulary decision needs specific knowledge and expertise or has direct implications for a clinical practice area

  • patients or patient representative groups

  • local people and communities

  • relevant manufacturers of medicines, for example, when the company can offer additional evidence and insight that can assist with decision‑making

  • other relevant decision‑making groups.

1.4.2 Ensure stakeholder engagement is proportionate to the type of decision being made and the medicine being considered.

1.5 Processes for the adoption of medicines recommended by NICE technology appraisal guidance

1.5.1 Include NICE technology appraisals as a standing agenda item in local formulary decision‑making group meetings.

1.5.2 When a NICE technology appraisal recommends a medicine, adopt the medicine into the local formulary automatically, if clinically appropriate and relevant to the services provided by the organisation. This process should take place within 3 months. Include the medicine within the relevant care pathway(s) provided by local organisation(s), in line with NICE recommendations.

1.5.3 When a NICE technology appraisal does not recommend a medicine, focus discussions and actions on withdrawing and decommissioning the medicine if applicable, in line with NICE recommendations.

1.6 Processes for selecting medicines to be considered for inclusion in the local formulary

Recommendations for proactive identification of medicines not subject to a NICE technology appraisal for consideration

1.6.1 Ensure that there is a robust and transparent process for adopting, removing or updating medicines or indications not covered by NICE technology appraisal guidance.

1.6.2 Include horizon scanning as a standing agenda item in local formulary decision‑making group meetings.

1.6.3 Prioritise medicines not subject to a NICE technology appraisal for consideration using explicit criteria. Ensure these prioritisation criteria are well known, clear and transparent. Assess:

  • patient safety

  • impact on patient care

  • timelines for new medicines reaching the market

  • severity of disease and patient numbers affected

  • clinical effectiveness

  • gaps in treatment or other available treatments

  • cost effectiveness

  • resource impact, for example biosimilar medicines

  • inappropriate variation in local current practice.

Recommendations for reactive identification of medicines by health professionals for consideration

1.6.4 Applications to consider a medicine or new indication for inclusion in the local formulary should be submitted by a health professional, although manufacturers may support evidence gathering.

1.6.5 Provide information to the applicant to explain the process for considering a medicine or new indication for inclusion in the local formulary and ensure application forms are readily available. Think about inviting the applicant to a meeting to allow for constructive discussion.

1.6.6 Ensure the following information is included in application forms to consider a medicine or new indications:

  • details of the health professional making the application, including a declaration of interests

  • local patient population

  • details of the medicine, including strength, formulation, therapeutic drug class, indication, monitoring requirements and cost

  • evidence submission with relevant supporting literature, including efficacy, safety and cost effectiveness

  • comparison with existing treatments

  • likely place in therapy

  • recommendation for the decommissioning of a current formulary medicine, if applicable

  • resource impact, for example biosimilar medicines.

1.7 Setting decision criteria

1.7.1 Clearly define and consistently apply standard criteria for decision‑making. Develop and/or apply a multi-criteria decision tool, which should include:

  • patient safety

  • clinical effectiveness

  • cost effectiveness or resource impact

  • strength of evidence

  • place in therapy relative to available treatments

  • national guidance and priorities

  • local health priorities

  • equity of access

  • stakeholder views.

1.8 Evidence and information gathering

1.8.1 When there is a NICE technology appraisal for a medicine, do not duplicate NICE's evidence assessment or challenge the technology appraisal recommendations.

1.8.2 When there is no NICE technology appraisal for a medicine, use NICE guidelines and advice, and other sources of high‑quality information produced by national and regional horizon scanning organisations, if available. Ensure these are relevant to the medicine and indication being considered. Avoid duplicating effort locally.

1.8.3 If local critical appraisal and evidence synthesis is needed, ensure that evidence‑gathering strategies comprehensively reflect the requirements set out in the local formulary's decision‑making criteria.

1.8.4 If local critical appraisal and evidence synthesis is needed, ensure that individuals with specialist skills and competencies are available. This includes skills in:

  • literature searching

  • critical appraisal

  • interpreting and contextualising evidence.

1.9 Incorporating new information from regulatory authorities

1.9.1 Incorporate medicines safety advice from regulatory authorities routinely into the local formulary. This could be achieved by having patient safety as a standing agenda item.

1.10 Assessing the financial and commissioning impact when making decisions

1.10.1 Routinely engage with commissioning and financial managers at an appropriate level of seniority and align local formulary decisions within the framework of clinical commissioning.

1.10.2 Consider addressing barriers that may delay the speed of adoption of medicines into the formulary, such as multiple applications to different decision‑making groups, delayed or absent business planning, budget identification or service design. [amended 2015]

1.11 Deliberating and reaching decisions

1.11.1 Use explicit principles that are formally documented to guide deliberation in the local formulary decision‑making group, such as mission statements, terms of reference, decision criteria and legal and ethical frameworks.

1.11.2 Support members of the local formulary decision‑making group in deliberation and decision‑making by providing appropriate training and constructive feedback.

1.11.3 Determine explicitly how local formulary decision‑making groups reach final decisions.

1.12 Documentation

1.12.1 Document the deliberations and actions from local formulary decision‑making group meetings, the outcomes of decisions, the rationale for each decision and all formulary policies.

1.12.2 Use a standard format for notes and minutes of local formulary decision‑making group meetings, which ensures that the key points are summarised for all decisions. Ensure secretariat functions are sufficiently competent so that technical information is accurately recorded.

1.13 Developing decision outputs to support local formulary decisions

1.13.1 Develop decision outputs with stakeholders (including clinical groups and networks) and other local decision‑making groups in a timely manner, to prevent delays in access to treatment.

1.13.2 Develop decision outputs related to a NICE technology appraisal within a time frame that does not delay the adoption of the medicine into the formulary beyond the statutory requirements.

1.14 Communicating and disseminating information about the local formulary

1.14.1 Publish all relevant local formulary information online, in a clear, simple and transparent way, so that patients, the public and stakeholders can easily understand it. This includes formulary policies, minutes of meetings, decision outcomes and associated decision outputs.

1.14.2 Publish information that sets out which NICE technology appraisals are included in the local formulary, in line with the NHS Chief Executive's 2012 letter Innovation, Health and Wealth publication of NHS formularies.

1.14.3 Develop a local communication framework for the local formulary, in consultation with stakeholders, reviewed annually, to:

  • disseminate targeted, concise information to other decision‑making groups and key stakeholders, including patients and the public who need to know about the decision

  • routinely communicate with neighbouring local formulary decision‑making groups to share practice, particularly when there are cross‑boundary patient flows

  • anticipate media response to decisions.

1.15 Reconsidering and appealing local formulary decisions

1.15.1 Establish a robust and transparent process for reconsideration or appeals of decisions made by the local formulary decision‑making group. Ensure relevant information is clear and easily accessible.

1.15.2 Clearly define the criteria for a health professional to request a reconsideration of a decision made by the local formulary decision‑making group. This should include circumstances in which:

  • significant new information such as a medicines safety alert has become available, which requires a reconsideration of the evidence

  • the decision was based on inaccurate or incomplete information.

1.15.3 Clearly define the acceptable grounds for a health professional to appeal a decision made by the local formulary decision‑making group. This should include circumstances in which the local formulary decision‑making group is judged not to have followed the published process.

1.15.4 Ensure the validity of a formal appeal is assessed by an independent appeals panel. The appeals panel should inform the health professional, in writing, if the appeal does not satisfy the defined grounds. The appeals panel should direct appeals that do satisfy the defined grounds to the most appropriate decision‑making group for further consideration.

1.15.5 Ensure the appeals panel has a clear statement of purpose. Members should together have the skills and expertise necessary to enable them to make the decisions being asked of them.

1.15.6 Consider collaborating with neighbouring groups to ensure that adequate training and resources for the appeals process are available. This may include providing independent cross‑organisational appeals panels. [amended 2015]

1.16 Reviewing and updating the local formulary

1.16.1 Establish a robust and transparent process for reviewing and updating the local formulary. This includes:

  • ensuring new positive NICE technology appraisal recommendations are incorporated into the formulary automatically

  • ensuring that when a NICE technology appraisal does not recommend a medicine, the medicine is withdrawn from the formulary, in line with NICE recommendations

  • responding to important new evidence on all medicines included in the formulary in a timely manner, including withdrawing or amending the position of a medicine in the care pathway(s)

  • responding promptly to important new information on medicines safety, such as serious adverse effects

  • reviewing and updating associated decision outputs

  • ensuring requests to review and reconsider the evidence are evaluated in a timely manner

  • responding promptly to the identification of technical errors

  • responding promptly to the outcome of appeals

  • establishing a rolling schedule of structured formulary review.

1.16.2 Collaborate effectively with relevant stakeholders, including health professionals and other local decision‑making groups, when reviewing and updating the local formulary.

Terms used in this guideline

Biosimilar medicines

A biosimilar medicine is a medicine that is developed to be similar to an existing biological medicine. Biosimilar medicines have the potential to offer the NHS considerable cost savings, especially as they are often used to treat long‑term conditions. NICE has published a position statement and process for developing guidance and advice for these medicines.

Decision output

A locally developed output that is aligned to local formulary decisions. Examples include implementation policies, prescribing guidelines, treatment protocols, shared care agreements, patient care pathways, patient information and recommendations to commissioners and other decision‑making groups.

Local formulary

For the purposes of this guideline, a local formulary is defined as 'the output of processes to support the managed introduction, utilisation or withdrawal of healthcare treatments within a health economy, service or organisation'.

Local formulary decision-making group

A formally constituted group that makes decisions relating to medicines to be included within a local formulary. The name of the group and its relationship with other local policy committees may vary. Examples of local formulary decision‑making groups include trust formulary groups, drug and therapeutics committees, interface formulary groups and area prescribing committees.

Medicine

The term 'medicine' includes all healthcare treatments that may be considered in local formularies. Examples include wound care products, appliances and vaccines.

Multi-criteria decision tool

A tool that is used to aid decision‑making, where decisions are based on more than one criterion, which make explicit the impact on the decision of all the criteria applied and the relative importance attached to them.

Robust and transparent

Robust and transparent processes, including sharing of information and appropriate collaboration with relevant stakeholders, aim to improve the consistency of decision‑making about medicines and ensure that patient safety is not compromised. This should reduce inappropriate variation in patient care when decisions are made due to inconsistent, inadequate or unsafe processes and policies.

You can also see this guideline in the NICE Pathway on local formulary development.

To find out what NICE has said on topics related to this guideline, see our web page on medicines management.

  • National Institute for Health and Care Excellence (NICE)