Understanding business cases
A business case demonstrates that the new build project is the right choice, will deliver the required services, and provides value for money.
The NHS provides excellent resources on how to write business cases for large capital projects. Begin by reading the NHS Property Services ‘Your Guide to building a business case’ which gives a comprehensive overview of the process.
This article provides guidance to inform your own business case development for a pharmacy clean room build.
Purpose and structure
Business cases typically follow a staged approach. Each stage confirms the previous case and builds on it, incorporating more detail.
Building the business case typically includes the following stages.
Project initiation document
The project initiation document (PID) establishes the strategic context for the project proposal and presents evidence for the case for change. The PID is sometimes called the strategic outline case (SOC).
Outline business case
The Outline Business Case (OBC) reviews the PID and establishes the preferred option.
Full business case
The full business case (FBC) is the fully developed plan detailing the project, evidence of value for money and the management arrangements for delivery.
Making the ‘Five Cases’
All business cases follow a similar structure, and the headings below are typical of any business case template used in the NHS. At each stage, the structure usually follows the ‘Five Case’ model. The five cases ensure that the business case is:
- supported by a robust case for change – the strategic case
- able to deliver value for money – the economic case
- commercially viable – the commercial case
- financially affordable – the financial case
- and capable of being delivered – the management case
The strategic case
The strategic case usually consists of context, and the case for change.
Strategic context
The strategic context describes the current situation and provides an organisational overview, including:
- the size of hospital
- number of beds served
- clinical specialties served
- clinical trials involvement
- whether your hospital acts as a regional or national clinical centre for any specialty or patient group
Describe how your plan for a new pharmacy aseptics clean room suite aligns with the Trust’s business strategy and aims. Consider whether the Trust is planning to expand services for local clinical groups, and whether the Integrated Care Board has an aseptics strategy. Identify how your plan fits with current national strategies.
The case for change
The case for change explains why a new build is needed. Discuss the risks and opportunities associated with your existing arrangements, including:
- the age of the aseptic suite and whether it is still compliant with Good Manufacturing Practice (GMP)
- ability to meet current workload
- ability to meet projected demand in the context of the Trust’s clinical priorities, for example gene therapy or ATMPs
- whether the unit has an MS licence or operates under Section 10 exemption, and whether that may need to change
- potential for local collaboration
Findings from external inspection or audit reports may also support your case.
The economic case
The economic case addresses and evaluates the available options. This will usually outline several options, including do nothing, closure of the unit and use of outsourced products, refurbishment, or a new build.
Risk and benefit appraisal
Include an appraisal of the benefits and risks of each option and a rationale for the preferred option. Remember to present benefits and risks in language that your key audience will understand and care about, for example financial impact, organisational reputation and patient safety.
Options for builds
Options available may include:
- minimal refurbishment
- modular unit
- new build (options for new builds are explored in our planning a new build article (SPS page).
Regulatory model
The options should consider the two regulatory models – either a MS Specials Licence granted by the MHRA or unlicensed unit operating under the Section 10 exemption of the Medicines Act 1968. There will be different economic, operational and workforce benefits and risks for both options. The building standards and GMP requirements for an MHRA licensed unit may not be substantially different to those of a Section 10 unit, although an MHRA MS licence could give greater operational flexibility to provide products to other Trusts or customers.
The commercial case
The commercial case demonstrates that the preferred option will result in a viable procurement between the NHS organisation and the commercial providers. This requires an understanding of what is realistically achievable by the commercial clean room companies.
The procurement may be in multiple packages, for example:
- enabling works including the strip out of existing facilities, ducting and services either by the Trust Estates team or by the external contractors
- build by a specialist aseptic unit contractor
The financial case
The financial case is a detailed plan identifying and sourcing the required funding. The expected capital costs should be realistically estimated and must include contingency and risk allowance. Be clear about whether VAT is included in the estimates.
It is important to avoid delays between the planning and building stages of the project as the cost envelope is likely to increase due to inflationary cost pressures. You may find the agreed budget no longer meets to actual cost after delays.
The case may be presented under the following or other appropriate headings.
Buildings
This is likely to include both general building and specialist fit out.
Before a build begins, enabling work is usually necessary, for example demolition, stripping out of the existing suite, and installation of utilities. Other general building costs may include plant room development, installing ducting and ancillary areas such as storerooms and rest areas.
The specialist fit out usually represents the bulk of the cost and includes both the design and the building of the facility.
Equipment
Consider all equipment costs, for example:
- isolators
- unidirectional airflow (UDAF) cabinets
- industrial dishwasher
- CCTV cameras
- chairs
- intercom
- refrigerators and freezers
- environmental monitoring systems (EMS)
Professional specialist fees
The build is most likely to require additional professional services, for example a project manager, architect, quantity surveyor or structural engineer. There may also be local planning fees.
Validation
Validation costs can be substantial and may represent 5-10% of the project cost. These will include media, incubator space, creating the validation master plan and associated staffing resource, the cost of validation experts and physical validation work. It is very important to liaise with your Quality Control laboratory to ensure they have capacity to accommodate large numbers of additional samples.
Revenue
The costs for running the suite will probably change from your existing operation. This may or may not be included in the business case for capital funding but are a critical consideration in the overall affordability of the scheme. For example, there may be different arrangements for gowning if using a different room grade.
The management case
The management case demonstrates that there are sufficient managers with experience and skill in place to oversee the delivery of the scheme.
Do not underestimate the amount of management time that will be required to deliver the build project alongside the existing service. Temporary additional staffing may be needed, and different team members may be key to the delivery of different phases.
Key roles for the project team include:
- programme governance arrangements, defining roles and responsibilities within the project
- contract management arrangements
- benefits realisation assessment
- risk management arrangements
- post-implementation evaluation
Determine who needs to be included in the team to fulfil all of these roles, including specialist advisers.
Specialist advisors
Different advisors may be needed for different phases.
During the planning stages a specialist project management provider may be needed to support the development of the business case.
A specialist GMP adviser may be crucial in ensuring the build is compliant with GMP and is able to attain its relevant licence. The specialist GMP adviser will support the local team through the design process and advise on each validation stage. The cost and procurement process for engaging external advisors will need to be considered.
The SPS article on assembling a clean room design and build team (SPS page) provides additional details. Each team member will need the time and support to be able to deliver the project. New builds are often undertaken whilst existing services continue, and senior aseptic team members with operational commitments will need to plan for how conflicting priorities can be accommodated as the project develops.