6 Development

NICE's medicines and technologies programme (MTP) develops an evidence summary for each of the approved topics.

6.1 Equality and diversity considerations

Evidence summaries are developed in accordance with NICE's equality and diversity and conflict of interest policies.

6.2 Process and timescales

Table 1 shows the key steps in the development of evidence summaries. The rapid development process reflects their status as advice products as well as the timescale in which the advice is needed.

Table 1 Key steps for developing an evidence summary (with timelines)

Key step

Project time allocated

Calendar week

Agree final scope, send search request to guidance information services and contact the pharmaceutical company for data

5 days

1

Searching for evidence

10 days*

3

Sifting and selecting the evidence

Appraising and categorising the evidence

Produce initial draft

15 days*

6

Internal check of initial draft

5 days*

7

Review comments received and produce revised draft for external/specialist review

3 days*

8

Revised draft sent for review to pharmaceutical company or companies, specialist commentators, NICE guidelines team, NICE technology appraisals team and MHRA (for unlicensed or off-label use of medicines only)

10 days*

10

Review comments received and produce revised draft for technical check

2 days

10

Technical check of content by medicines adviser

4 days

11

Review comments received and produce revised draft for sign-off

3 days

12

Sign-off of content by Associate Director/ Clinical Adviser/Programme Director

5 days

13

Review comments received and produce revised draft for NICE's Guidance Executive. Pharmaceutical company invited to check for any remaining factual errors and informed of date that the evidence summary will be published

1 day

13

Final sign-off and publication of the evidence summary

Guidance Executive sign-off

3 days

14

Review Guidance Executive's comments and produce final draft for publication

5 days

15

Publication on NICE website

5 days

16

Total

76 days

Occasionally commissioners may need the evidence summary to be prioritised and developed over a more rapid time frame; key steps of the process may be carried out more quickly (*denotes where time frames may differ).

6.3 Scoping of individual topics

NHS England provides the scope for any topics they refer to NICE; the scope is then agreed by NICE.

For those topics selected by other routes, the MTP scopes each topic, supported by NICE's guidance information services. The scoping process confirms the following:

  • key contacts at the pharmaceutical company

  • key contacts at the MHRA (for unlicensed or off-label use of licensed medicines only)

  • external specialist commentators (through NICE's medicines and prescribing associates and other existing NICE networks, see section 3.3)

  • terms for a literature search to identify published data from clinical trials that reflect the indication or possible indication for the medicine

  • arrangements for identifying:

    • regulatory status

    • indication or likely indication

    • likely licensing and marketing timeline, if appropriate

    • evidence of clinical effectiveness for the condition under consideration

    • safety issues, encompassing key adverse drug reactions, precautions and contraindications with an indication of frequency of the adverse effects if possible

    • likely place in therapy

    • incidence and prevalence of condition (or likely indication), what treatment alternatives exist and an estimate of current medicine usage

    • cost of the medicine and course of treatment, and the cost of alternative treatment options.

6.4 Contacting the pharmaceutical company

NICE asks the pharmaceutical company to support the production of the evidence summary by providing any of the following data it holds:

  • key published clinical trials relating to the indication being reviewed in the evidence summary and information about ongoing or recently completed studies

  • key clinical trials that are ongoing or that have been completed but not yet published in full

  • approved name and brand name

  • the licence status within the European Union or the UK, including whether or not the pharmaceutical company expects to hold a UK marketing authorisation for the medicine for this indication within the next 2 years or knows that another pharmaceutical company is likely to have a medicine licensed in the UK for this indication within 2 years

  • the usual dose, if known, or best estimate from the available data

  • the presentation of the medicine, including form, strength and pack size.

In addition for new medicines:

  • licensed (or likely) indication

  • estimated usage

  • expected cost (for medicines not yet available).

6.5 Literature search

6.5.1 Searching for evidence

A literature search is conducted by NICE's guidance information services according to the agreed scope and strategy. The search strategy and quality assurance of the search process is documented for audit purposes.

The purpose of the literature search is to find the best available (highest quality) published evidence relating to the efficacy, safety and cost effectiveness of the medicine. In addition, explicit reference is made to information in the summary of product characteristics (if there is one) relating to precautions, warnings and undesirable effects and also to published advice from the medicine regulators. Cost information is obtained from:

6.5.2 Selecting the evidence

Evidence identified from the literature search is reviewed to find relevant primary research that addresses the use of the medicine within the defined indication and population under review. If robust randomised controlled trials or systematic reviews are available, they form the basis of the review. However, given the nature of the work, the best available evidence on which to produce the evidence summary may include evidence other than randomised controlled trials.

First sift

The first sift reviews the title and abstract of the study against the search terms and removes evidence of low relevance.

Second sift

The second sift excludes articles that are out of scope, such as:

  • non-English language studies

  • articles with no abstract or full text freely available online

  • conference abstracts[3]

  • studies that have not been published in full[3].

The best available evidence is then selected (usually no more the 3 studies) by prioritising according to the following:

  • whether patient-oriented outcomes[4] were reported and if so, whether these were primary or secondary outcomes

  • whether an active comparator was used, and whether this reflects usual UK practice

  • whether the population in the study reflects the typical UK population for which this medicine is likely to be used (bearing in mind the licensed or proposed indication and NICE guidance)

  • the size of the available studies (such as number of study participants)

  • date of publication.

Brief details of lower priority evidence may be included in the evidence summary to add context.

The MTP records those studies that are excluded in the first and second sift. Reasons for non-inclusion of evidence from the second sift are published in the evidence summary.

6.5.3 Appraising and categorising the prioritised evidence

The MTP appraises the prioritised evidence using a NICE quality assessment checklist suitable for the type of evidence being reviewed. If a European public assessment report (EPAR) or other national public assessment report (PAR) has been published, it is used to supplement the information included in published study reports, if needed.

All included studies are appraised using a grading process where appropriate. Alternatively, a narrative of the relative quality of the evidence is provided.

6.6 Writing the evidence summary

The MTP drafts the evidence summary using a standard template, which includes sections relating to the following:

  • overview, including:

    • regulatory status

    • key points

    • framework to inform local decision-making

  • introduction and current guidance

  • product overview

    • mode of action

    • regulatory status

    • dosing information

    • cost

  • evidence review

    • clinical effectiveness

    • safety and tolerability

    • evidence strength and limitations

  • estimated impact for the NHS

    • alternative treatment(s) or medicine(s)

    • costs of alternative treatment(s) or medicines(s)

    • current or estimated usage

    • likely place in therapy

  • information for the public

  • relevance to other programmes

    • NICE guidance programmes

    • NHS England commissioning policies

  • references

  • evidence tables

  • excluded studies

  • search strategy

  • development of this evidence summary

    • expert advisers

    • declarations of interest.

6.7 Review of the draft evidence summary

The draft evidence summary is sent by the MTP to the identified external specialist reviewers, the pharmaceutical company or companies, NICE's guidelines team, NICE's technology appraisals team and the MHRA for review. The summaries are also sent to the commissioner for comment.

Any comments received are considered when revising the draft. Actions are also recorded. Feedback to commentators is available on request to NICE.

6.8 Quality assurance of the evidence summary

The evidence summary is quality assured by the MTP. This involves a detailed check of all content, to ensure all sections contain statements and conclusions that are fair and balanced. The evidence summary must accurately reflect the evidence reviewed and be substantiated by an explicit and appropriate source of evidence.

Once sign-off is received from the MTP Programme Director, Clinical Adviser or Associate Director, the pharmaceutical company is given the opportunity to review the near-final draft to check for any factual errors (1 working day) and any necessary corrections are made by the MTP.

NICE's Guidance Executive reviews the evidence summary and, if appropriate, approves the evidence summary for publication, ensuring that due process has been followed in its development. The pharmaceutical company is informed of the scheduled publication date, and may request an embargoed copy of the evidence summary to be sent to them 24 hours before publication.

6.9 Publication of the evidence summary

The final evidence summary is disseminated through the medicines and prescribing alert service, and uploaded and made available online through the guidance and advice list on the NICE website.



[3] Studies that have been reported only as conference abstracts or otherwise not reported in full are excluded because they cannot be critically appraised. However, the evidence summary may indicate if key clinical trials are ongoing or have been completed but not yet published in full.

[4] Patient-oriented outcomes are those that are of direct clinical importance, such as mortality, rates of cardiovascular events, or quality of life. This is in contrast to disease-oriented, surrogate outcomes, such as changes in blood pressure or biochemistry.