National and local guidance
The NHS Constitution for England, produced by the Department of Health in 2009 and updated 2015, provides patients with the right of medicines and treatments that have been considered by the National Institute for Clinical Excellence (NICE) through the technology appraisal process.
The Constitution states that, where appropriate, positively assessed medicines and treatments be made available to patients, and be included in the formulary adopted by the local healthcare providers and commissioners.
'You have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if your doctor says they are clinically appropriate for you.'
If a medicine has been through NICE, and given a positive assessment, then the CCG should ensure it available to appropriate patients within 90 days of the guidance being published. Click here for the list of those treatments that have been approved by NICE and, where appropriate, are available for patients locally.
Not all medicines are considered by NICE and therefore the decision to use other drugs is made on a local level.
The Constitution provides a second right for patients: Medicines (and treatments) 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, should be considered by the local NHS using a robust assessment of the best available evidence.
The Constitution states:
'You have the right to expect local decisions on funding of other drugs and treatments to be made rationally following a proper consideration of the evidence. If the local NHS decides not to fund a drug or treatment you and your doctor feel would be right for you, they will explain that decision to you.'
Locally, in the Vale of York, these decisions are made by the joint York and Scarborough Medicines Commissioning Committee. This committee is made up of a range of healthcare professionals with a special interest in commissioning medicines, including:
- CCG GP Prescribing Leads from NHS Vale of York CCG and NHS Scarborough and Ryedale CCG;
- Hospital doctors from York Hospitals Foundation Trust;
- Primary Care doctors (GPs);
- Specialist doctors e.g. from the local mental health providers;
- Hospital Pharmacists;
- Medicines Management Pharmacists.
The committee meets on a monthly basis and follows the NICE Guidance on Developing and Updating Local Formularies.
When the committee make a decision on whether a medicine should be used locally the committee considers:
- what impact the medicine has on patient care
- what are the timelines for new medicines reaching the market
- the severity of disease and patient numbers affected that the medicine is aimed at
- the clinical effectiveness of the medicine
- the effect on patient safety of the medicine
- any gaps in treatment or other available treatments
- the cost effectiveness of the medicine
- the resource impact of the medicine
The committee considers evidence available from reputable sources and individual drug manufacturers - see Useful Links page for examples.
The committee seeks the highest grade of clinical evidence available in assessing safety and cost effectiveness, for example large scale double blind randomised controlled trials of new medicines compared to established treatments. Comparisons solely against placebo or medicines that are not commonly established treatment will not be regarded as highly, nor will anecdotal reports or individual clinician opinion.
Decisions by the committee must be made in a systematic, consistent and transparent way, with the aim of fairly and rationally distributing NHS resources across different patient groups and across competing demands.
Local prescribing policies
Local prescribing policies may be developed to cover situations where there is no national guidance but there is a local demand for the treatment. A local policy will normally contain specific details about the clinical condition, the group of patients that are covered by the policy and the treatment criteria.
A formulary is a locally maintained document which lists the medicines that are deemed suitable for prescribing within the local area.
If it is agreed at the Medicines Commissioning Committee meeting that a medicine should be used locally then the medicine is added to a local joint formulary. This is published at www.yorkandscarboroughformulary.nhs.uk. The local formulary is a joint formulary between York and Scarborough Hospitals, NHS Vale of York CCG, NHS Scarborough and Ryedale CCG and other local NHS organisations for example Tees, Esk and Wear Valley NHS Foundation Trust.
All medicines that have been assessed under a NICE Technology Appraisal are added to the formulary.
Use of the medicine is generally restricted to the clinical indications that are described in the NICE guidance and so a medicine may be available for some conditions (i.e. those considered by NICE) but not for others.
The formulary also details who is responsible for the prescribing of each medicine. Many medicines accepted for use will be prescribed by GPs and hospital doctors, but some will have local restrictions on their use. Some will be prescribed in limited circumstances and some will only be prescribed in hospital settings. Some medicines won’t be included on the formulary at all.
All prescribers are expected to take into account whether the medicine they intend to prescribe is on the formulary. If a clinician wishes to apply to change the formulary – for example have a medicine added or removed for specific indications, an application must be made through the Medicines Commissioning Committee.
The CCG expects prescribing to be in line with the local formulary.
There are some circumstances where there will be a requirement to prescribe a drug that is not on the formulary and in those circumstances the CCG asks prescribers to consider the evidence and whether the circumstances are exceptional compared with those of other patients.
Prescribers can request to use a medicine that is not on the local formulary for specific patients and this request will be considered through the Medicines Commissioning Committee processes. See ‘Prescribing Guidelines for GPs’ for further information.