National Specialist Services Committee
NSSC
STAGE 2
Appendix C
GUIDANCE ON HOW TO COMPLETE AN OUTLINE
PROPOSAL TO NSSC FOR NATIONAL COMMISSIONING
AND DESIGNATION
Advice to proposers
Where more than one organisation is party to the application, a joint application
must be submitted through an agreed lead, who must field questions – if necessary
– on behalf of the other bodies.
It is important that the proposers makes the case for national commissioning and
designation through Appendix C(i) in no more than 2500 words. The size of the
boxes on the attached form give an indication of the level of detail required.
Responses to the application questions should provide:


The best quality and most recent evidence, which is available
Realistic predictions of future need for the provision of the proposed
product, service or technology
All questions of the application should be completed where possible, or applicants
should explicitly state that no relevant information is available. The committee will
take a view whether the evidence provided is sufficient to enable appropriate
consideration of the application at this time, and may recommend that the application
is re-submitted at a later time in order to allow for collection of stronger supporting
evidence.
Throughout these notes, examples are given of the kind of evidence which may be
suitable. However, we recognise that different applicants may be providing
information on a diverse range of services. These lists are by no means exhaustive,
but aim to give a flavour of the type of information we would expect to receive. New
applicants will be provided with additional support by National Services Division
(NSD) as to the most appropriate evidence to provide.
Applicants should refer to the following guidance for completion of each section of
the outline application form in Appendix C(i):
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1. Full name of the proposed service
Applicants should provide the full name of the proposed service.
2. Short title for the proposed service
Applicants should provide a title that can be used for meeting papers, etc, which should be
no more than 30 characters.
3. Brief description of the proposed service
Applicants should provide a ‘lay’ description of no more than 50 words.
4. Name, title, and contact details of lead proposer
Applicants should provide the name of the lead organisation along with the name, title, and
contact details of the person acting as a lead proposer.
5. Patients’ need for the proposed service
***Applicants also need to complete the Excel spreadsheet relating to this
question***see Appendix C(iv)
Please note, the same Excel spreadsheet should be completed for sections 5 and 9
Applicants should define the target patient group and provide evidence for its size:

A clear definition of the target patient group for the proposed service. If the group is a
subset of a larger patient population, the clinical reasons for separating these
patients should also be provided.
(for example, an explanation as to why they cannot be served adequately as part of the larger
patient population)

An estimate of the total number of patients in Scotland that would be eligible for the
proposed service (i.e. the entire national caseload). This includes the prevalence and
incidence of the relevant condition(s) and, if relevant, the size of the target subset
(e.g. if only a proportion of the patients with relevant condition(s) would qualify for the
proposed intervention). Patients in England, Wales and Northern Ireland expected to
access the proposed service should also be identified where possible. In addition, for
services where there is no equivalent service elsewhere in Europe, there may be an
expectation that some EU patients may also access the service. Where such
expectation exists, it would also be helpful to provide an estimate of expected EU
patient numbers where possible.

An estimate of the number of patients currently seen by the centres applying for
national designation

The likely growth in patient numbers during the commissioning period (five
years/estimated number of patients being seen by the centre at the end of the
commissioning period. This should be supported by incidence data.
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Applicants should provide any available information on the currently unmet needs of the
patients and explain why the existing commissioning arrangements and/or existing provision
are ineffective at meeting these needs. Unmet needs could include difficulty with handling
the complexity of the condition(s), lack of effective/early diagnostics, insufficient prevention,
lack of treatment options, risks for the continuity of current provision, etc.
(Examples of supporting evidence include patient/carer surveys, statements of support for the
application from relevant patient organisations, etc.)
6. Description of the current provision
Applicants should provide detail of the current provision for the target patients, if any:

Responses should outline the capacity of the current provision, where the current
service is provided, and who undertakes the activity. This must include activity at the
applicants’ centre(s) as well as activity out with these centres. Activity at all current
providers needs to be reflected and all existing specialised centres should be
included in the application as applicants.

For services that involve laboratory input, applicants should state whether the
laboratory is CPA accredited.

For services that involve genetic input, applicants should state whether the genetic
test(s) in question have an approved UKGTN gene dossier with testing criteria and
the year of approval.
Responses should include a description of the funding arrangements for the current
provision.
7. Description of the proposed service
Applicants should provide details on the proposed scope of provision, including:

A list of all components of the proposed service(s) included in the application.
(This might include diagnostics, therapeutic interventions, medicines, follow-up assessments,
patient care, etc)

A list of all proposed centres and lead clinicians
Applicants should provide details of the proposed delivery model, including:

The proposed activity numbers for each centre over the full commissioning period,
until the service has to be reviewed for re-commissioning (5 years).

Any planned growth in activity to demonstrate that the proposed centres can,
between them, provide for the national caseload (as defined in Question 5). This
should include any anticipated growth of product usage, if the proposed model
includes the provision of high-cost products. Applicants should aim to take into
account as far as possible age changes in the patient group that may require
increases in product dosages.
Applicants should detail how all components of the proposed service(s) (as stated above)
will work together. This should include an outline of:

The defined clinical pathway for all patients within the target group, including any
subgroups. This should begin with diagnostics and include all proposed components
of provision.

The process and criteria for referring patients to the proposed centres and between
its different components.
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
How the proposed components of provision will be coordinated. For conditions which
require the involvement of more than one clinical specialty, applicants should explain
how clinicians from the different specialties will collaborate to provide an integrated
service.
(Examples include maintaining a shared patient registry, joint diagnostics, multi-disciplinary
clinics, gathering shared clinical data, sharing of knowledge and learnings, etc.)
Applicants should outline their plans for making the service accessible to all eligible patients.
This includes information on:

The known geographic spread of the target patient population

Rationale for the choice of location and number of proposed centres, including any
existing or planned referral routes to each centre

Any supplementary measures in areas with less coverage

Linkage with local services
(Examples include patient transport, travelling clinics, collaborative arrangements with local
providers, home care, etc.)
8. Clinical benefits over current NHS alternatives
Applicants should provide evidence that the proposed product, service or technology can
deliver better clinical outcomes than any current NHS alternatives. The evidence for clinical
effectiveness of the proposed service should include any available clinical trial data:

Randomised clinical trial evidence, ideally with UK patients, will be expected for all
propositions involving a high-cost product or technology, where presenting such
evidence is required for the licensing process. In other cases, the best available other
evidence should be presented.

For service propositions involving very rare conditions, where randomised trials may
be difficult to conduct, the next best available evidence should be submitted. This
could include trials in comparable patient populations using the same or a similar
service model.
(Examples include data from service provisions in other countries, trials involving patients of
other age/gender, etc).
Applicants should list all potential clinical benefits from the national commissioning and
concentrated provision of the proposed service:

The application should explain how national commissioning and concentrated
provision will better meet the clinical needs of the patients, which are unmet by the
current commissioning arrangements and models of care (as stated under Question
5).
(Examples of benefits include: reduction in complication and mortality rates, significantly
improved patients’ quality of life, enabling preventive care through early diagnostics,
concentration of clinical expertise and other highly specialised resources, more timely
provision of care, more seamless patient journeys, improvements in the accessibility of care,
etc.)
Any relevant research papers can be appended to the application as supporting evidence
and should be discussed with the NSD medical director or nursing advisor prior to
submission. All papers appended to the application should be provided in full text PDF or
paper copies.
Applicants should also give details of three measures that the service will use to monitor the
stated clinical benefits throughout the commissioning period (5 years). The measures should
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be chosen appropriately to reflect the characteristics of the proposed provision, and should
be measurable and reportable.
(Examples include time from referral to delivery of care, complication rate, severity of chronic
symptoms, survival rate, etc.)
9. Financial impact
***Applicants also need to complete the Excel spreadsheet relating to this question**
see Appendix C(iv).
Please note, the same Excel spreadsheet should be completed for sections 5 and 9
Applicants should explain what ‘added value’ a national commissioning approach will bring.
The application should demonstrate that national provision will be more cost effective and/or
make more effective/efficient use of NHS resources in other ways, compared to the current
standard provision.
As supporting evidence, applicants should provide:

Total spend for all current providers, based on the information on current
commissioning arrangements provided under question 6. This should be given to the
nearest £m if the total is greater than £2m, or otherwise to the nearest £0.1m (a)

Split of income between NHS and non-NHS, with explanation of any non-NHS
funding sources for this (b). In total this should be equal to the identified spend on the
existing service.

Estimated spend on this service/patient group elsewhere in the health service (to the
nearest £0.1m), with a brief explanation of what this covers (e.g. local outpatient
attendances, emergency admissions, alternative procedures). This should be based
on the information provided in section 6. (c)
An estimate of the total expected funding requirement for the proposed service by the end of
the commissioning period, to cover the anticipated activity detailed under question 5. This
should be given to the nearest £m if the total is greater than £2m, or otherwise to the nearest
£0.1m(d)Applicants should indicate if national commissioning will result in reduced overall
costs for NHS Scotland, no change in costs, or additional investment, (the difference
between (d) above and ((a)-(b))+(c))
In addition, applicants should explain how the new commissioning and provision will affect
costs compared to current provision. This should include any increases in costs or direct
cost savings, expected to result from the new commissioning and provision.
(For example, applicants should indicate if any increases in unit costs are expected or if the number
of referrals is expected to increase in order to include currently unmet need. The financial implications
of any new models of care should also be explained, such as a new clinical pathway and new
interventions.
In terms of cost savings, applicants should explain the basis on which there may be efficiency savings
or economies of scale over time in the service. Efficiency savings could include the elimination of
ineffective or duplicated services, elimination of unnecessary treatment through early diagnostics and
prevention, elimination of travel costs to provision centres abroad, elimination of costly supportive
care, etc. Economies of scale could be realised, for example, through increasing numbers of patients
or development of professional expertise.)
Where available, key relevant economic papers can be appended to the application as
supporting evidence for the stated financial benefits. All appended papers should be
provided in full text PDF or paper copies.
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10. Support for the application
Applicants should outline what support the application has from relevant professional and
patient groups. If there is a relevant patient group for the target condition(s), the expectation
is that applicants should seek, and present in their application, evidence for its support for
the proposed provision. If there is no organised patient group, patient feedback could be
presented.
Examples of supporting evidence from patient groups might include patient/carer surveys,
statements of support for the application from relevant patient organisations, etc.
In addition, as part of the application process, NSSC will formally seek views from
organisations such as Regional Planning Groups, NHS Boards and relevant professional
bodies.
11. Potential opposition to the application
Applicants should outline what opposition there might be to the application, the reason(s) for
this and how this/these might be overcome.
12. Other relevant information
Applicants should outline any further relevant information not captured in the other
questions.
Applications that include genetic tests
In the event that an applicant is successful at Outline Application stage and is invited to
submit a Full Application, they will need to demonstrate that any genetics tests and testing
centres included in their application have been approved through the UK Genetic Testing
Network (UKGTN) gene dossier process by providing a copy of the approved gene dossier.
Where genetic tests or testing centres have not been through this process, applicants will be
asked to submit gene dossiers as part of the Full Application. The UKGTN will evaluate the
gene dossiers, in consultation with the Scottish Genetics Laboratory Consortium, and
provide a recommendation to NSD to inform evaluation of the Full Application.
More information about the UKGTN gene dossier process can be found at:
http://www.ukgtn.nhs.uk/gtn/Home
Appendix C(ii) – Outline Application proforma for support of the host NHS Board’s Chief
Executive
Appendix C(iii) – Outline Application proforma for centre information – must each be
completed for each centre that wishes to be nationally designated.
Please ensure Appendix C(ii) is signed and submitted with the application.
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