Appendix D(iv)

National Specialist Services Committee
NSSC /

Notes for completion of the full proposal for national commissioning and designation

4. Additional information requested at outline stage (if any)
Objectives:
To assess any additional evidence or details requested from applicants following the review of their outline proposal

Responses to this question should follow the instructions provided along with the request for additional information. If no such request has been made, the response should state “none requested”.

5. Summary of the patients’ need
Objectives:
To assess the clinical need for the proposed service

Applicants should provide the information from their outline proposal and expand their response where additional details are necessary or have since become available, or would enable NSSC more clearly to understand the proposal from the perspective of the patient or their carer(s). NSSC would welcome a ‘patient impact statement’ that describes the impact of the condition in a patient’s own words.

6. Description of the current provision
Objectives:
To compare the current commissioning and provision with the proposition

Applicants should provide the information from their outline proposal and expand their response where additional details are necessary or have since become available.

7. Description of the proposed service
Objectives:
To compare the current commissioning and provision with the proposition

Applicants should provide the information from their outline proposal and expand their response where additional details are necessary or have since become available.

If there is any change to the proposed model since the outline proposal, such as change in centres or lead clinicians, applicants should specify this here and explain the details. Additionally, they should bring this to the attention of the NPPPRG.

Questions 8.1 – 8.3 refer to the clinical benefits of the proposed service

8.1Clinical effectiveness & potential for health gain
Objectives:
-To demonstrate the clinical effects of the proposed service in terms of measurable health gain and other patient benefits
- / Examples include:
  • Reduced mortality rate/reduced severity of symptoms/improved independence scores,from randomised controlled trials
  • Number needed to treat (NNT), from randomised controlled trials
  • QALY (if formally produced)
  • Life years gained, from longitudinal studies
  • Self-reported quality of life improvements, from patient/carer surveys
  • Expert opinions
  • Anecdotal information such as informal patient, carer and family feedback and 'stories’/case studies

Applicants should provide the best available evidence demonstrating the clinical effectiveness of the proposed service. They may elaborate on any evidence provided in the outline proposal, as well as provide more recently available information.

The evidence can include qualitative and quantitative measures. The measures should be chosen appropriately to reflect the characteristics of the proposed provision.

The strongest evidence that can be provided is data from randomised controlled clinical trials (RCT) and longitudinal studies or reviews. If RCT evidence is available, it should be presented in the proposal.

RCT evidence, ideally with UK patients, will be expected for all propositions involving a pharmaceutical 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.

For diagnostic services, applicants can provide evidence of indirect improvements on quality of life from connecting patients and carers with a patient group.

Quantitative measures (preferred where available):

  • RCT data on the strength of clinical effects within the treatment group, compared to a control/baseline group.
  • The number needed to treat (NNT). (A measure of the proportion of patients who experience an improvement in their condition, compared to the total number of patients treated. For the most expensive services, this measure will be expected to approach NNT=1.)
  • Quality-Adjusted Life Years (QALYs). If a QALY has already been produced by NICE or via other routes, it should be cited in the proposal. If a QALY measure has not been formally produced, applicants will not be expected to provide estimates.
  • Data on life years gained by treatment, supported by long-term reviews or studies, where available.

In cases where the proposed service is new or recently developed, or the condition is newly diagnosed, it may not be possible to provide robust quantitative data. In these circumstances, a medical advisor should be consulted as to the most appropriate types of evidence that can be provided and whether the timing is right to proceed with the proposal. Possible alternative types of supporting information are listed below:

  • Outcome data from smaller/non-randomised trials.
  • Case studies with individual patients’ outcome data.
  • Alternative quantitative data, collected in an objective and controlled way, demonstrating improvements in quality of life or measurable utility (e.g. ability to walk independently, reduction of acute episodes, DALY etc).

Any relevant published peer-reviewed papers, supporting the quantitative evidence provided should be appended to the proposal.

Qualitative measures

This should estimate the likelihood and scale of potential health gains as a result of the interventions included in the proposed service. If the product or service is life-saving or significantly increases quality of life, the best possible evidence demonstrating these effects should be provided. This can include:

  • Information from patient and carer questionnaires collected in an objective and controlled way
  • Expert opinions of the potential benefit of the proposed services, (including any available quantitative estimates, accompanied by their assumptions where more robust evidence for calculating these is not available)
  • Anecdotal information such as informal patient, carer and family feedback, stories and case studies etc.

Comparisons with clinical alternatives:

Based on the quantitative and qualitative evidence provided above, some comparative measures of clinical effectiveness should be derived and evaluated as part of this criterion.

For a new service, where alternative provision currently exists for the target patients, the best available estimates of clinical effectiveness of the standard current provision (along with any assumptions) should be provided in a form that enables comparisons with the proposed intervention.

In addition to presenting the best available clinical effectiveness evidence, applicants should explain why the timing of the proposal is appropriate. This can include evidence for the potential urgency of the need for the service, as well as recent significant developments in gathering clinical effectiveness evidence.

Applicants should propose at least one clinical outcome measure by the clinical effectiveness of the service would be measured.

8.2Clinical safety & risk
Objective:
To present the safety record of the proposed service, including the NNH measure / Examples include:
  • A description of any adverse effects previously observed in relation to the proposed product, service or technology
  • Categorisation of stated adverse effects into mild/moderate/severe and mortalities
  • Number Needed to Harm (NNH) as a measure of the proportion of patients who experience an adverse reaction to the intervention, compared to the total number of patients treated
  • Any international data or qualitative information relevant to the safety record of the proposed product, service or technology

Applicants should present all available evidence relevant to the safety record of the proposed, service. This should complement the evidence for clinical effectiveness provided under Question 8.1. The types of quantitative and qualitative evidence that can be provided are the same as those outlined under Question 8.1 above.

8.3Severity and capacity to benefit
Objectives:
Explain the disability level or threat to life resulting from the target condition(s) / Examples include:
  • Proportion of patients at different levels of disability resulting from the target condition(s)
  • Mortality rates resulting from the target condition(s)
  • Proportion of patients who are unable to benefit from the proposed intervention due to the severity of their overall health condition, co-morbidities, etc

Applicants should provide any available information to explain the level of severity of the target condition(s), if the proposed service is not provided. Where available, evidence should also be provided to demonstrate the capacity of the target patients to benefit from the proposed provision.

Applicants should identify in their proposal the proportion of patients with the target condition whose severity levels would make them eligible for the proposed intervention (for example, in cases where only the most severe cases require the proposed treatment). Criteria for inclusion in this group should be provided.

In addition, applicants should specify, where applicable, if the severity levels of any patients could be too extreme for them to be able to benefit from the proposed intervention (for example, in cases where treatment would pose a greater threat to life compared to the target condition).

Questions 9.1 – 9.2 refer to the societal benefits of the proposed product, service or technology

9.1Needs of patients and society
Objectives:
To explain how providing the proposed service would help meet the needs and expectations of patients and society
To present any available information regarding the equality impact of the proposed provision / Examples include:
  • Details on any health inequalities addressed/eliminated by the proposed intervention
  • Examples of any wider (non-financial) societal benefits such as reducing the need for carers, improving family life, eliminating risks to society
  • Results from any formal equality impact assessment that has been carried of the proposed provision
  • Evidence of patient or public involvement in identifying the need for the proposed service

Applicants should describe the impact that providing (or not providing) the proposed service would have on patients and society. This should include any available information on a potential disproportionate impact on the quality or quantity of life of particular group(s) of patients and society. Whilst the primary role of NSSC is to consider proposals in the context of health budgets, it will also wish to understand any wider societal benefit/impact, for example, ability of patients to remain in, start or return to work/education following successful treatment.

For existing services, applicants should state in their proposal whether they have carried out an equality impact assessment of their existing provision. If so, they should state whether they have used a screening or a full assessment and should provide detail on the results.

In addition, applicants should provide evidence for any patient and public involvement in identifying the need for the proposed service, as well as the stated needs of the wider society.

9.2Stimulating research and innovation
Objective:
To explain the benefits from the proposed provision to clinical research and innovation in the NHS / Examples include:
  • Specific plans of how the proposed provision would enable further clinical research, e.g. through the creation of a central patient registry, concentration of a critical mass of patients, etc.
  • If the proposed intervention is new, details on its availability outside the UK

Applicants should describe the impact that providing (or not providing) the proposed service would have on:

  • Strengthening the evidence base on the clinical effectiveness and cost of the proposed intervention
  • Innovation within the NHS and the introduction of new services to the UK, if the proposed service is new. Where applicable, this should be accompanied by information regarding the availability of the proposed service in key comparator countries.

Applicants should outline any plans for the creation of a patient registry, if one does not currently exist, to enable further research into clinical effectiveness and risks.

While preparing their response, applicants should take into account that National Commissioning is not expected to fund research.

Questions 10.1 – 10.3 refer to the financial impact and affordability of the proposed service. Responses will be considered in combination with the financial and activity information presented in Appendix E. For guidance on how to complete Appendix E, please see the section on ‘Financial and activity information’ in the main document above.

10.1Average cost per patient
Objectives:
To compare the average annual cost per case/intervention of the proposed provision / Examples include:
Please see Appendix E

Applicants must complete the activity proforma E-2 in Appendix E, including activity levels and the average cost per case/intervention, for each provider and a total for the proposed service.

A summary of any current activity should also be provided on the activity proforma.

The activity proforma should be accompanied by a narrative to explain the details, particularly where any phasing of activity is planned or where a significant increase in activity is expected, compared to current provision.

10.2Affordability (including opportunity cost)
Objectives:
To enable consideration of the overall financial impact of the proposed provision and whether it is affordable / Examples include:
Please see Appendix E

Applicants should provide the details necessary to assess the overall financial impact of the proposition. The response should indicate clearly if national commissioning will result in reduced overall costs for NHS Scotland, no change in costs, or additional investment required.

Financial details of the current provisionand 5 year forward expenditure profile.

Applicants should include:

  • A summary of costs of the current standard provision (if exact figures are not available, costs can be estimated based on a typical clinical pathway within the current provision).
  • A breakdown of the total income by funding source for any current providers, based on the information on current commissioning arrangements provided under question 5. Funding sources should be grouped by size in the following groups:

£0 - £500k pa

£500k - £1,000k pa

£1,000k - £2,000k pa

£2,000k - £5,000k pa

Over £5,000k pa

Financial details of the proposed provision

Applicants should provide:

A summary of costs in the financial proforma E-1 in Appendix E. These should be broken down for each provider included in the proposal, and also summarised as a total for the whole proposition.

The financial proforma should be accompanied by a narrative to explain how the new commissioning and provision arrangements will affect costs compared to current provision. This should explain any increases in costs or direct cost savings to the NHS, expected to result from the new commissioning and provision arrangements. Applicants should also indicate if there are any health-related costs to society that could be avoided by providing the service.

(For example, in the narrative, 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 outside Scotland, elimination of costly supportive care, etc. Economies of scale could be realised, for example, through increasing numbers of patients or development of professional expertise.)

  • A breakdown of the total expected funding requirements by funding source for the proposed product, service or technology. Funding sources should be grouped by size in the following groups:

£0 - £500k pa

£500k - £1,000k pa

£1,000k - £2,000k pa

£2,000k - £5,000k pa

Over £5,000k pa

The total funding requirements should reconcile with the total costs provided above and in Appendix E.

Where available, key relevant economic papers should be appended to the proposal as supporting evidence. All appended papers should be provided in full text PDF or paper copies.

10.3Value for money compared to alternatives
Objectives:
To enable consideration of the relative value for money of the proposed provision compared to alternatives / Examples include:
  • Cost per QALY (if formally produced)
  • Cost per life year gained
  • Any other available measures

Applicants should summarise any available measures of the value per health gain of the proposed product, service or technology. They should indicate whether an improvement in value for money is expected compared to current alternatives. As supporting evidence, applicants should append existing economic papers and studies.

Applicants should also indicate where value for money is expected to vary across the different centres. The expected variations should be explained, taking into account differences that are due to different locations or models of care.

Questions 11.1 – 11.4 refer to plans for providing the proposed product, service or technology in the best possible way

11.1Best clinical practice in service delivery
Objectives:
To demonstrate that the proposed provision will be able to meet clinical best practice, quality and safety standards. / Examples include:
See text below for required information

Proposers/applicants should:

  • Explain what processes will be used for governance, and in particular how quality and clinical governance standards will be met along with delivering the business objectives of their service, in the context of their overall governance structures and processes. Responses should demonstrate that this will be a continual process that takes into account CPD, best practice, the setting and monitoring of standards and targets, benchmarking etc. Where applicable, this should be linked to national policy objectives and outcome targets.
  • Indicate the estimated levels of activity/numbers of patients to be treated at each centre and also use this information to complete the activity table in Appendix E-2. In addition, they should demonstrate that the proposed centres can, between them, provide for the entire eligible patient population.
  • Indicate the activity currencies that will be used to evaluate the service and how these will be measured. This information should also be used to complete the activity table in Appendix E-2.
  • Outline their plans for meeting the requirement for ongoing clinical research and knowledge sharing, to support the service. This includes plans to collect clinical effectiveness data and the measures that will be used to evaluate the benefits of the service over the next 5 years. Plans could include setting up patient registries, carrying out clinical trials, follow-up assessments, and/or long-term studies, administering patient questionnaires, etc.
  • Provide information on their process for how input/feedback from patients and/or carers is used to shape the planning and designing of the service, and examples of where such feedback has been used to effect changes. This should include details of any contact to date with relevant organisations of patients and/or carers and how this contact was made, for example, through a focus group.

Additionally, proposers/applicants should explain how national provision of the proposed product, service or technology would enhance: