Individual funding request policy 

This refers to the team which maintains overall responsibility for the management, processing and triaging of funding applications received for patients registered with a GP, or if unregistered ‘usually resident’ within the Essex ICB area.

A multi-disciplinary professional group responsible for providing clinical and commissioning support to the Funding Team in the delivery of their function.

A request submitted by an NHS clinician to the Integrated Care Board to fund a treatment or intervention for an individual patient where that treatment is not routinely commissioned. An IFR must demonstrate exceptional clinical circumstances, a robust evidence base of clinical effectiveness, and that funding the intervention would represent a fair and reasonable use of NHS resources in line with national IFR policy.

A multi‑disciplinary professional group responsible for considering Individual Funding Requests and making decisions—whether to approve or decline—based on the evidence presented. The panel reviews each case to determine whether the clinical circumstances are exceptional and whether there is sufficient evidence of clinical effectiveness, cost‑effectiveness, and affordability in line with ICB policy.

There can be no exhaustive description of the situations which are likely to come within the definition of exceptional clinical circumstances. The onus is on the clinician making the request to set out the grounds for clinical exceptionality clearly for the IFR Panel.

The words “exceptional”, “exceptionality” and “exceptional clinical circumstances” bear their natural meanings as defined in the Oxford English Dictionary. However, the ICB recognises that the meaning of these words has given rise to considerable difficulty in the past and offers the following guidance to assist the IFR Team, Panel and clinicians as to how to approach the meaning of the words.

There is a difference between “individual” and “exceptional”. Every patient has features of their condition which are specific to that individual and are not likely to be repeated in other patients with the same clinical condition at the same stage of progression of the condition. Exceptionality is not the same as individuality.

‘Exceptional’ in IFR terms means a person to whom the general rule should not apply. This implies that there is likely to be something about their clinical situation which was not considered when formulating the general rule. Very few patients have clinical circumstances which are genuinely exceptional. To justify funding for treatment for a patient which is not available to other patients, and is not part of the established care pathway, the IFR Panel needs to be satisfied that the clinician has demonstrated that this patient’s individual clinical circumstances are clearly different to those of other patients, and that because of this difference, the general policies should not be applied. Ultimately, the issue is whether it is fair to fund treatment that others cannot access; social circumstances do not influence this decision. It should be stressed that an IFR is not a route to “have another look” at the general rule, or to protest that the general rule is ungenerous

To consider whether a patient has exceptional clinical circumstances the IFR Panel will focus on the following issues:

• Are there any clinical features of the patient’s case which make the patient significantly different to the general population of patients with the condition in question at the same stage of progression of the condition?
  
• Would the patient be likely to gain significantly more clinical benefit from the requested intervention than might be normally expected for the general population of patients with the condition at the same stage of the progression of the condition?

Where a ‘not for routine commissioning’ policy is in place, the ICB will have taken into account that some patients within the relevant cohort may respond better than others, and that a small minority may respond significantly better than the average. This variability should already have been considered in the development of the policy. Accordingly, in considering whether an IFR should be submitted, the clinician must consider whether the individual is likely to respond in a way that materially exceeds the response expected in the cohort covered by the policy, and whether there is evidence to support this.  Where such exceptionality is demonstrated, the request will then be assessed not only against the evidence of clinical effectiveness and cost effectiveness, but also against considerations of affordability and good stewardship of finite NHS resources-effectiveness, but also against considerations of affordability and good stewardship of finite NHS resources.

In line with the principle that patients with rare conditions should neither be advantaged nor disadvantaged simply because their condition is uncommon where treatments, devices or pieces of equipment can be used to treat various conditions, it is the presenting need that will be assessed against the same criteria as everyone else requiring the intervention.  This applies particularly to equipment requests – Examples can be found in Appendix B.

For the purposes of this policy, an Individual Patient is determined by reviewing the incidence and prevalence of the requested intervention for a particular condition at the same stage of progression of that condition. If the ICB has no policy for the intervention being requested for a particular condition, then an IFR Panel can only consider the request if both the incidence and prevalence criteria set out are met or the patient has exceptional clinical circumstances compared to the cohort of patients (however small) with the presenting condition.

An IFR application for an individual patient will be considered by the IFR Panel on its individual merits with the decision on whether to fund a requested intervention based on the evidence of clinical/cost effectiveness and affordability. 

If both the prevalence and incidence criteria are not met, then the ICB will not consider that the request represents an individual patient. In these circumstances, funding can only be provided if a decision is made by the ICB to develop a policy for the requested intervention for a group of patients, including the requesting patient; unless the patient has exceptional clinical circumstances compared to the cohort of patients (however small) with the presenting condition.

The number of new cases of a disease in a defined population within a specified period of time. The intervention for a particular condition at the same stage of progression of that condition is expected to be initiated for two or fewer patients per million population per year.

The number of cases of a disease in a defined population at a point in time. The total number of patients on the intervention for a particular condition at the same stage of progression of that condition is less than 10 patients per million population at any one time.

The Clinical Review Group will assess whether an IFR application contains sufficient information and evidence to justify consideration by the IFR Panel. This includes reviewing the case for clinical effectiveness, cost‑effectiveness and affordability, and determining whether the request meets the criteria to proceed for formal decision‑making. The Clinical Review Group does not make funding decisions.

For the purpose of this policy a cohort is a group of patients who have shared a particular event together during a particular time span.

A conflict of interest might arise as a result of an IFR Panel member’s involvement with pharmaceutical companies or membership of committees. It can also include personal experience (they, or a close relative/friend, suffer from / receive treatment for the same condition that the IFR relates to).  

Conflicts may arise if a Panel member has a personal connection to the condition or treatment under consideration, has involvement with relevant support or charitable organisations, or has recently been involved in the care of the patient. Where a Panel member identifies a potential conflict of interest, they should notify the Chair privately. The Chair, in consultation with non‑conflicted members, will determine how the conflict should be managed, which may include the member withdrawing from all or part of the discussion. To protect the privacy of the individual, the nature of the conflict does not need to be recorded in detail. The minutes will document only that a conflict was declared and how it was managed, without disclosing personal medical information or other sensitive details. Further information regarding the management of conflicts of interest is available within the Management of Conflicts of Interest Policy.

Where Panel members have a conflict of interest either by virtue of a connection with the patient or in terms of a vested interest as a potential service provider, this must be declared as soon as it becomes apparent. An alternative individual will need to be agreed to replace them (Appendix C – Terms of Reference (TOR)

The Panel will consider on an individual basis; what action is required where the Panel member knows the patient.

All Panel members should follow their local conflicts of interest policy.

The ICB Board is accountable and responsible for ensuring that the ICB has effective processes for managing IFRs in accordance with relevant legislation and best practice guidance. 

The Audit, Risk and Compliance Committee is responsible for oversight of compliance with the principles of the policy (not clinical decision making) and thus will monitor the effectiveness of the policy and receive update reports from the Funding Team.

The Chief Executive Officer of the ICB has overall accountability for the IFR Policy.

The Executive Medical Director is the Executive Board member with delegated responsibility for development and implementation of this policy. 

The Director of Pharmacy, Medicines and Clinical Policies is responsible for the monitoring and compliance with this policy, operational implementation of this policy and management of the Funding Team.

The IFR Panel is responsible for considering IFRs that, following triage, fall outside existing policy and therefore require a formal funding decision. These are cases in which clinical exceptionality has been asserted and no relevant precedent exists to support routine approval. The Panel reviews the submitted evidence and makes an independent decision—whether to approve or decline funding—in accordance with ICB policy.

Acting on behalf of the ICB, the IFR Panel makes decisions only for individual cases and within the framework of existing commissioning policy. It does not create or amend clinical commissioning policy through its decisions; its role is limited to determining whether funding should be granted for the specific patient based on the evidence presented.

The IFR Senior Officer or deputy is responsible for supporting the IFR Panel as a non-voting member to:

To provide adequate, appropriate, and transparent reporting to the ICB board and its committees, stakeholders and the public when required. 

Ensure consistency in the decision-making processes and ensuring the maintenance of a record of prior decisions to enable reference to precent where relevant.

Share experience gained in dealing with requests for individual patients within the ICB.

Ensure the Funding Team and Panel operate according to best practice with regards to this policy.

The policy author will have responsibility for reviewing and updating the policy.

The ICB will not introduce new drugs/technologies in an ad hoc basis through the mechanism of individual case funding. To do so risks inequity, since the treatment will not be offered openly and equally to all with equal need. There is also the risk that diversion of resources in this way will de-stabilise other areas of health care which have been identified as priorities by the ICB. The ICB expects consideration of new drugs/technologies to take place within the established planning frameworks of the NHS.   This will enable clear prioritisation against other calls for funding, and the development of implementation plans which will allow access for all patients with equal need. 

Drugs and technologies that are approved as the result of a NICE TA need to be implemented, usually, within three months of the appraisal being published.  The ICB will, within resource constraints, seek to ensure implementation of NICE TAs without delay but recognises that the ICB may take the full period of three months before a new commissioning policy can be brought into place where significant service change and/or development are required as part of the implementation. NICE also produces clinical guidelines which are a valuable source of good practice which the ICB will take into account in developing policy, but the ICB retains discretion and is not mandated by directions to implement such Guidance within a fixed time period or at all.

The ICB’s policy is that treatments not currently included in established care pathways—such as those outlined in the schedules to service agreements with commissioned providers or identified for funding through the commissioning process, including medicines and medicine-related devices, are not routinely funded.

For some of these treatments, the ICB has published specific policy statements that set out restrictions on access, based on evidence of clinical effectiveness or relative funding priority.

The ICB operates under a ‘Decision-Making Policy’ that governs how commissioning decisions are made, alongside a Commissioning Policy that defines the principles for restricting services. However, the absence of a treatment from these policies must not be interpreted as an indication that it will automatically be funded. (See Policy 085: Commissioning (Service Restrictions) Policy.)

Policy development is an ongoing process. Future policies on additional treatments will be produced and published in response to NICE guidance, health technology assessments, and other relevant evidence.

Specific groups of patients may fall outside ICB Commissioning Policies, including:

• Patients with conditions for which the ICB does not have an agreed policy, such as those with rare conditions or where the proposed treatment lies outside established service agreements.
  
• Patients with conditions for which the ICB does have an agreed policy but do not meet the criteria for the routinely commissioned treatment.
  
• Patients whose conditions fall under the commissioning responsibility of NHS England, including those with rare conditions or treatments outside agreed service agreements. Many of these cases are addressed by NHS England Specialist Commissioning Policies (see NHS England Commissioning Policies). Consideration of funding under these policies is outside the remit of the ICB.

In such circumstances the ICB will not have given approval in advance to fund the treatment, and approval will therefore be required under this policy. The requesting clinician should consider, before making the application, whether the requested treatment is an appropriate request judged against the ICB Commissioning Principles

The role of the IFR Panel is to make decisions on individual cases. It cannot be used as a means of ‘creeping implementation’ for new technologies. Consideration therefore needs to be given as to the likelihood of other patients having the same clinical need who could also benefit from the proposed treatment. If there are or are likely to be other patients then, properly considered, the request is for a service development and not an individual application. Where a decision may affect other patients, the application should be considered as a service development and not through the IFR process.

Patients with rare conditions should neither be advantaged nor disadvantaged simply because their condition is uncommon. This means that the same approach will be taken in applying the principles of clinical effectiveness and cost effectiveness to patients with rare conditions as should be applied to all other patients.

The ICB does not expect to provide funding for patients to continue medication/treatment commenced as part of a clinical trial. In line with the Medicines for Human Use (Clinical Trials) Regulations 2004 and the Declaration of Helsinki, the responsibility lies with those conducting the trial to ensure a clear exit strategy from a trial AND that those benefiting from treatments provided within the trial setting will have on-going access to those treatments. The initiators of the trial (provider trusts and drug companies) have a moral obligation to continue funding patients benefiting from treatment until such time as the ICB agrees to fund through the commissioning process. Where the treatment is not prioritised through commissioning, the responsibility remains with the trial initiators. The Research Ethics Committee should require this assurance as part of the approval for the trial.

A treatment may be considered experimental where any of these points apply:

• the treatment is rarely used, novel, or unknown and there is a lack of authoritative evidence of safety and efficacy. 
• the treatment is still undergoing clinical trials and/or is a drug yet to undergo a phase III clinical trial for the indication in question. 
• the treatment does not have marketing approval from the relevant government body for the indication in question. 
• the treatment does not conform to a usual clinical practice in the relevant field. 
• the treatment is being used in a way other than that previously studied or that for which it has been granted approval by the relevant government body.

A treatment may be considered unproven when it is considered “as not demonstrated by evidence or argument to be true” or “of a new method, system, or treatment; not tried and tested”.

Where the case for clinical exceptionality has been accepted but the treatment is experimental or unproven, there is a particular need to scrutinise individual funding requests the likelihood that the treatment will be clinically effective and consider carefully whether funding the treatment would be a good use of NHS resources.  This is because it is important that decisions on clinical practice and policy are based on sound clinical evidence. To ensure the effective and equitable use of NHS funding, experimental treatments have to be undertaken judiciously, responsibly and for clearly defined purposes. 

The ICB will not fund treatment in response to an IFR if it considers that it would be more appropriate for the treatment to be the subject of research trials. Primary research into novel treatments should be progressed through the usual research funding routes and will not be funded through this IFR policy.

On occasions, a request is received where a provider has commenced an unfunded treatment prior to asking for or receiving confirmation that the ICB will approve. Evidence that the patient is responding to the treatment is then presented as part of the request for ICB funding.

The provider’s decision to commence treatment in advance of any decision by the ICB is a clear risk taken by the provider and/or patient. The ICB accepts no responsibility for the decision taken by the provider in these circumstances.

In considering a request for funding the ICB will apply the criteria set out in this policy as it would for any other request and accords no special privileges because the unfunded drug was given by a provider.

The ICB policy is that, unless a decision has been taken to approve routine funding for a treatment, the treatment will only be commissioned for an individual patient in line with this policy.  The fact that a patient has responded to a drug or other treatment in a manner which was anticipated for a proportion of patients who are commenced on the treatment is unlikely to be sufficient to demonstrate exceptional clinical circumstances.

Where funding is approved, the ICB will not accept responsibility for any costs incurred for treatment that was provided prior to the date of funding approval. 

A similar approach will be adopted if a treatment has been funded initially by a pharmaceutical company or other third party.

ICB policies define which treatments the ICB routinely funds and, by implication, those it does not fund

An individual may choose to begin privately a course of treatment that would have been commissioned by the ICB. If the patient later wishes to transfer back into NHS care, an NHS clinician may request this on their behalf. In such cases, the patient is entitled, as far as reasonably possible, to receive the same treatment they would have received had they been treated within the NHS from the outset. This does not entitle the patient to any treatment or pathway that is not available to other NHS patients. Transfer to NHS care may require the patient to wait in line with normal NHS access arrangements to ensure equity

If a patient has commenced a course of treatment that the ICB does not routinely fund, the ICB will not normally assume responsibility for continuing or completing that treatment. This includes circumstances where:

• the individual can no longer afford private treatment.
• private insurance does not cover ongoing or full treatment costs.
• the patient requests NHS funding based on perceived clinical benefit from private treatment; or
• a revision procedure is required following an intervention originally carried out privately.

Where NHS funding is approved for future care, the NHS will not make any retrospective payments or reimburse any costs incurred during private treatment.

Individual funding requests must be submitted by an appropriate NHS clinician acting on behalf of the patient; patients cannot submit IFR applications directly.  The clinician must have the relevant expertise to assess the patient’s condition and believe there are exceptional clinical circumstances that justify consideration outside existing policy. IFRs should not be submitted by clinicians working outside their scope of practice. For example GPs are not expected to submit IFRs or provide specialist justification for treatments where specialist assessment is required. The ICB will review the clinical information submitted, but benefit demonstrated solely through access to private treatment will not be considered evidence of exceptionality, as this would create inequity between patients who can and cannot self‑fund.

Where the ICB has decided not to fund a treatment routinely, evidence that a patient appears to have benefited from private treatment—without other evidence of clinical exceptionality—is not a valid reason for the ICB to agree NHS funding. To do so would create differential access based on ability to pay. The ICB will therefore continue to apply the standard IFR process when considering requests relating to treatment commenced privately.

See ICB policy ‘Defining the Boundaries between NHS and private care’.

IFRs may be submitted for patients with conditions for which there is no agreed commissioning policy, for patients with rare conditions, or for patients whose proposed treatment falls outside existing commissioning policies or service agreements.  

In most cases, an IFR should be submitted by the specialist clinician who intends to provide or oversee the proposed treatment, as they are best placed to describe the clinical rationale and evidence.  Requests should only be made once the patient has been assessed within the appropriate commissioned pathway and the treating specialist advises that an IFR is clinically appropriate. GPs should not need to submit IFRs, as commissioned pathways already provide access to specialist review and treatment decisions.

IFR applications must not be used as a route to request new or expanded services (service developments) where more than one patient would reasonably be expected to benefit from the intervention.

The requesting clinician has full responsibility for ensuring that the IFR application is completed accurately, thoroughly, and with all necessary supporting evidence. Where clinical exceptionality is being asserted, the clinician must clearly set out why the patient’s circumstances differ significantly from the cohort of patients for whom the treatment is not routinely commissioned and provide adequate clinical evidence to support this position. All IFR decisions are based solely on the information submitted by the clinician. Applications that are incomplete, unclear, or fail to demonstrate clinical exceptionality may delay the assessment process or lead to the request being declined.

IFR application forms must be submitted electronically or in typed format. Forms that are handwritten or incomplete will be returned to the referring clinician and may delay the decision-making process. A patient, a non-clinical representative, or a non-NHS clinician cannot submit an IFR, as an NHS clinical sponsor is required. Where a patient contacts the ICB directly about a potential request, the Funding Team will provide guidance on the correct process and advise them to speak with their NHS clinician.

Supporting correspondence from the requesting clinician or, where appropriate, from a patient’s advocate may be submitted by email or letter, using the contact details published on the ICB website. All correspondence relating to an IFR request will be logged and recorded on the ICB’s secure case-management system by the Funding Team in accordance with information governance standards.

For each IFR received, the Funding Team will generate a unique reference number, and all associated documentation will be stored electronically in strict chronological order. All decisions will be fully documented, and all communication will be issued in writing, either by letter or email. Where telephone conversations occur, a contemporaneous file note will be added to the record. Both the evidence considered, and the decision reached will be clearly documented. All records will be managed, retained and securely destroyed in accordance with national and local NHS policies for confidentiality, data protection and information governance.

Cases are initially dealt with and triaged by the Funding team who will advise the requesting clinician whether the Commissioning (Service Restriction Policy), portfolio of contracts, commissioned pathways or current commissioning policies would cover the request. 

The Funding team will determine which ICB commissioning policy, if any, to be applied to each case. 

The Clinical Review Group will meet monthly as required to review all IFRs and any prior approval applications identified by the Funding Team where additional support is required.  Membership of the Clinical Review Group will include ICB commissioners e.g. acute, mental health, children and young people relevant to the cases being considered and members of the funding team.

The Clinical Review Group is able to: 

Approve the request if it is determined it is supported by an existing commissioning policy or service agreement, including Individual Prior Approval applications and IFR submissions that, on review, are found to meet the relevant policy criteria.

Ask for further information from the requesting clinician.

Signpost clinicians to specialised commissioning services if applicable

Refuse the request without reference to the IFR Panel

Refer to the IFR Panel

The criteria that are used to triage an IFR is whether there is an arguable case, based on the evidence presented in the application, that the IFR Panel could consider approving funding for the requested treatment under this policy.

The application will be refused at triage if:

• the requested treatment relates to a medical condition where there is an ICB policy, and 
• the requested treatment is not a treatment that is approved under the policy, and 
• there is no arguable case based on the information and any evidence provided in the application that the patient demonstrates exceptional clinical circumstances. 

OR

the requested treatment relates to a medical condition where there is no ICB commissioning position/policy and 

• on the evidence presented the requested intervention for that particular condition may affect other patients in the ICB population as defined in this policy
  
  and 
  
• there is no arguable case based on the information and any evidence provided in the application that the patient demonstrates exceptional clinical circumstances -which will normally be determined by comparing this patient to the cohort of patients (however small) with the presenting condition) so that the request should be properly treated as a request to change the ICB policy.
  
  Where there is uncertainty, or where a clinician submits an appeal against a refusal by the Clinical Review Group, the case will be referred to the IFR Panel provided that the appeal sets out a clear, arguable basis for review. Appeals that do not present new, relevant information; do not identify an error in the application of policy; or do not articulate a credible argument for exceptionality may be screened out by the Funding Team as not meeting the threshold for escalation.
  
• All decisions made by the Clinical Review Group, including decisions not to escalate an appeal that lacks an arguable case, will be recorded and reported to the next IFR Panel for oversight and assurance.
  

Requests for IFRs will normally be managed within a maximum of 40 working days, measured from the date the complete application is received to the date the written decision letter is issued by the Funding Team or, where applicable, the IFR Panel. 

If the Funding Team requests further information, the applicant will have 14 working days to provide the required material. Where the information is not received within this timeframe, the application will be closed and the applicant notified. A new application may be submitted at any point, provided it includes all previously requested and any additional relevant information.

Where a request is triaged as a Fast Track IFR (see Section 10.6 below), it will be managed within a maximum of 5 working days from receipt of the complete application to the date of written communication of the decision from the Funding Team.

There may be limited circumstances where the Funding Team needs to pause the 40-day timeframe, but these do not relate to delays in receiving information from the applicant, which are strictly governed by the 14-day rule. Pauses may only occur where the delay arises within the ICB’s own processes or through external processes outside the requesting clinician’s control, for example:

• waiting for confirmation of commissioning responsibility or eligibility from another NHS organisation.

• awaiting clarification from an ICB-commissioned provider regarding contractual status.
  
  The applicant will be informed when a pause is applied and when the timeframe is restarted.

Where an IFR application is found to be covered by an existing commissioning policy or service agreement, including cases suitable for Individual Prior Approval, the Funding Team will process the request under the relevant policy. The requesting clinician will be advised of the applicable policy and notified of the outcome.

If an IFR application is not covered by an existing commissioning policy/commissioned service, the Funding team will advise the requesting clinician of the next steps within the process. 

Where the case relates to an Individual Patient (as defined in this policy) and does not constitute a potential cohort or service development, the clinician may apply for funding via the IFR process on the basis of exceptionality. The IFR application must be submitted using the IFR form. Guidance notes and the patient information leaflet explaining the process are available on the ICB website.
Clinicians who are unsure whether an IFR is appropriate, or who require support in completing the form, should contact the Funding Team.

IFRs will only be fast-tracked where there is a clear clinical reason why the patient’s health will be significantly compromised by waiting until the next scheduled Clinical Review Group/IFR Panel meeting for a decision to be made. It is unlikely that IFRs will need to be dealt with in this way noting that, in line with NHS contracting arrangements, funding decisions must not preclude appropriate urgent clinical treatment by the provider.  

IFRs will not be fast-tracked on the basis that waiting until the next Clinical Review Group/IFR Panel is inconvenient or problematic for the patient or requesting clinician. The clinician submitting the funding application will need to state the clinical reason for the need fast track a case.

Where the Funding team have been notified that a case requires an urgent decision, they will fast-track that case ahead of others and convene a Clinical Review Group and/or IFR Panel at short notice if required.  It is expected that the Funding team will consult a core member of the IFR panel on the handling of any cases which are either considered as urgent by the requesting clinician or which the Funding team considers may warrant urgent consideration.

All ‘Fast Track’ cases will be considered virtually via a secure NHS‑approved platform (such as Microsoft Teams) meeting.  However, if the clinical need makes this impossible, communication via phone or e-mail will be deemed appropriate.  Decisions that are made urgently outside of a formal IFR Panel will be ratified by the IFR Panel as soon as possible. 

‘Fast-track’ Panels will also have different quoracy arrangements to facilitate them being convened at short notice. See Appendix C, IFR Panel Terms of Reference (ToR) for more information. 

Patients (supported by their clinicians) will have full access to the appeals process, (see Appendix C, IFR Panel Terms of Reference for information on External Review Panels). 

An approval letter will be sent to the requesting clinician, copied to the patient, within 5 working days after the decision has been made.

If an application is refused, a letter will be sent to the requesting clinician and the patient explaining the reasons for the decision and outlining the options that are available, including using the NHS Complaints Procedure as set out in the Complaints, Compliments and Concerns Management Policy (‘the Complaints Policy’).

The Funding team will arrange a Panel date and contact the requesting clinician to ask if they wish to attend the Panel to present the case and/or submit any further information.  The IFR Panel will normally meet virtually via a secure NHS‑approved platform (such as Microsoft Teams). Virtual meetings carry the same authority and governance requirements as in‑person meetings.

The Funding team will provide written confirmation to the Patient/Advocate to inform them that a Panel date has been scheduled to consider their application. Patients are welcome to attend the Panel hearing if they wish to do so, however this is not mandatory, and decisions will be made in their absence. 

If the patient choses to attend the Panel hearing, once the details of their case have been presented and the patient has had the opportunity to discuss their case, they will be asked to leave to allow private deliberations to enable a decision to be made. 

The patient may wish to provide written information to the Panel if preferred. If a patient wishes to provide written information, they should be directed to seek assistance from the clinician who completed the application.

The Funding team shall remind the patient that decisions can only be made on the grounds of the patient’s clinical circumstances and not on the patient’s social or personal circumstances.

The Funding team may also write to other health professionals with clinical involvement in the patient’s care (for example consultant, therapist etc.), or to others with specialist knowledge of the condition/intervention, for clarification of the patient’s needs, evidence base etc., if appropriate.

The Funding team will produce a summary of the case which will be considered by the Panel. All documentation that has been received regarding the request will be made available to the Panel members in an anonymised form to protect confidentiality unless the patient has opted to attend.

The Panel shall determine, based on the information and evidence provided, whether exceptional clinical circumstances have been demonstrated. As a prerequisite, the Panel must be satisfied that the proposed treatment has a clear and robust evidence base demonstrating clinical effectiveness. Treatments that lack objective evidence of clinical effectiveness cannot be approved and will not progress to consideration of exceptionality.

Evidence relating to clinical and cost‑effectiveness may support the overall case; however, such evidence does not in itself demonstrate exceptionality. Exceptionality must be demonstrated through the patient’s specific clinical circumstances compared with the wider cohort for whom the treatment is not routinely commissioned.

In determining whether exceptional clinical circumstances have been demonstrated, the IFR Panel will compare the patient with other patients who have the same presenting medical condition at the same stage of progression. The purpose of this comparison is to establish whether the patient differs significantly from the wider cohort for whom the treatment is not routinely commissioned. Exceptionality must relate to the patient’s clinical circumstances, not to the general effectiveness of the treatment or the patient’s personal preferences or social circumstances.

The Panel shall take care to avoid adopting the approach described in “the rule of rescue”. The fact that a patient has exhausted all NHS treatment options available for a particular condition is unlikely, of itself, to be sufficient to demonstrate exceptional circumstances. Equally, the fact that the patient is resistant to existing treatments where a recognised proportion of patients with same presenting medical condition at this stage are, to a greater or lesser extent, refractory to existing treatments is unlikely, of itself, to be sufficient to demonstrate exceptional circumstances.

The Panel shall be entitled but not obliged to commission its own reports from any duly qualified or experienced clinician, medical scientist or other person having relevant skills concerning the case that is being made that the treatment is likely to be clinically effective in the case of the individual patient.

The Panel is not required to accept the views expressed by the requesting clinician concerning the likely clinical outcomes for the individual patient of the proposed treatment but is entitled to reach its own views on:

• The likely clinical outcomes for the individual patient of the proposed treatment; and
• The quality of the evidence to support that decision and/or the degree of confidence that the Panel has about the likelihood of the proposed treatment delivering the proposed clinical outcomes for the individual patient.
• Cost effectiveness, acknowledging that the NHS has limited financial resources the Panel shall have a broad discretion to determine whether the proposed treatment is a justifiable expenditure of the ICB’s resources.

The IFR process is designed to consider individual patients only and cannot be used to introduce, implicitly or explicitly, a new commissioning position for a wider group of patients. If, during its deliberations, the IFR Panel concludes that the request relates in substance to a group of patients rather than an individual clinical exception, the application will fall outside the remit of the IFR process and will be declined. In such circumstances, any decision to fund the treatment for a cohort must be made through the ICB’s formal commissioning processes.

Where the Panel considers that delaying treatment may result in clinically significant harm while a potential commissioning policy change is being explored, the matter will be referred to the responsible commissioner to determine whether interim funding should be provided pending the outcome of the commissioning decision. Such interim arrangements, if approved, remain outside the IFR process and do not create a precedent.

Funding of treatment is approved

Where funding is approved, the Funding Team will inform the requesting clinician and, where appropriate, the patient or their advocate within 10 working days of the Panel meeting. The communication will outline the rationale for the decision, including an explanation of the grounds on which the patient was considered clinically exceptional.

The Funding Team will also establish an appropriate mechanism to monitor clinical outcomes to determine whether the treatment delivers the expected benefit to the patient.

Funding is not approved for treatment.

Where funding is not approved, the Funding Team will notify the requesting clinician and, where appropriate, the patient or their advocate in writing within 10 working days of the Panel meeting. The notification will set out the reasons for the decision, including whether the request was declined on the basis of lack of exceptionality or because it fell outside the remit of an individual request.

The communication will also explain the appeals process. If the clinician (or, where appropriate, the patient or their advocate) wishes to appeal the decision, they must give notice of their intention within 42 days of receiving the outcome letter. The reasons for the appeal must be clearly stated in writing. An appeal may only be convened where it is believed that:

• the IFR process was not followed correctly.
• relevant evidence was not considered; or
• the decision made by the IFR Panel was unreasonable in light of the evidence considered.

A disagreement with the Panel’s original decision, in isolation, does not constitute sufficient grounds for appeal.

Where new, relevant clinical information becomes available after an IFR decision has been issued, this cannot be used to reopen or reconsider the original case. Any additional or updated evidence must be submitted through a completely new IFR application, supported by the NHS clinician and accompanied by all relevant documentation. The new application will be assessed independently of the previous request and will follow the standard IFR process and timescales.

An appeal relates solely to whether the correct process was followed in reaching the IFR Panel’s decision; it does not revisit or reconsider the clinical decision itself. The role of the Appeals Panel is to determine whether the IFR Panel applied the policy appropriately, considered all the relevant information available at the time, and reached a decision that was fair, equitable and rational based on that evidence. The Appeals Panel does not make funding decisions and cannot substitute its own judgement for that of the IFR Panel. If new information or evidence is presented as part of an appeal, this cannot be considered by the Appeals Panel and will instead require submission of a new IFR application through the standard process.

Appeals will only be accepted from the requesting NHS clinician who submitted the original IFR, or from the patient or their advocate when acting in collaboration with that clinician. Appeals cannot be submitted independently by patients or non‑NHS clinicians, as an NHS clinical sponsor is required to confirm the basis of the appeal and ensure that any procedural concerns are appropriately articulated.

Where there are sufficient grounds for an appeal hearing—specifically, where there is evidence that the IFR Team or IFR Panel may not have followed the agreed process, may not have considered all relevant evidence, may have taken account of irrelevant or immaterial factors, or may not have applied the IFR criteria appropriately—the Appeals Panel may recommend that the case be reconsidered by an IFR Panel from a neighbouring ICB. This process, known as an External Appeal, ensures independent review and provides additional assurance regarding the fairness and robustness of the decision-making process.

An External Appeal Panel will reach one of two possible outcomes:

• Confirm that the IFR Panel followed the correct process, applied the IFR policy appropriately, considered all relevant evidence, and reached a decision that was fair, rational and within the range of decisions a reasonable panel could make. In this case, the original decision stands.
  
• Refer the case back for reconsideration by an IFR Panel, where the External Appeal Panel identifies that:

• the decision may not have been consistent with the ICB’s Commissioning Principles; or
• the IFR Panel may not have taken account of all relevant evidence; or
• the IFR Panel may have taken account of irrelevant or immaterial factors; or
• the IFR Panel may have reached a decision that no reasonable panel, properly directing itself under the policy, could have reached.

Where a case is referred back, the External Appeal Panel will set out the specific procedural or reasoning concerns that require review but will not comment on or predetermine the clinical merits of the request.

If the original Panel decision is upheld, the Funding team will inform the requesting clinician, patient/advocate, of their remaining options – either to pursue a complaint through the relevant ICB Complaints Procedure or to take their case to the Parliamentary and Health Service Ombudsman. The ICB Complaints Policy may be used to review the decision making process for an individual case and may result in the matter being reconsidered by the Panel.

If the External Appeal Panel determines that the IFR Panel needs to reconsider the case, a Panel date will be scheduled and consist of different panel members where possible.  The IFR Panel will reconsider its decision and in doing so will formally address the detailed points raised by the External Appeal Panel. The IFR Panel is not bound to change its decision as a result of the case being referred for reconsideration, but if it confirms its original decision, then reasons will be given for not agreeing to fund the treatment request.

Clear, standardised operating procedures will be maintained for all stages of the IFR process, including triage, Panel operations, communication protocols, appeal pathways and record management, ensuring consistent application across all cases.

A dedicated Funding Team will oversee receipt, logging, triage and processing of IFR applications and related correspondence, supported by a secure case-management system for document handling, tracking and audit.

Panel membership will be maintained to ensure the availability of an appropriate quorum of trained individuals for every meeting. Contingency arrangements will be in place to ensure Panels can continue to function during periods of staff absence or operational pressure.

Mechanisms will be established to access external or specialist clinical advice where necessary to support decision-making, particularly in rare or highly complex cases.

The Audit, Risk and Compliance Committee will receive regular reports on IFR activity, outcomes and policy compliance. Feedback loops will ensure that learning from IFR decisions informs commissioning, pathway development and policy updates.

The ICB will ensure that clinicians, providers and other stakeholders are aware of the IFR process by providing clear guidance, accessible documentation and regular updates following any policy changes.

These implementation arrangements will ensure that the IFR process operates effectively, consistently, and in line with the ICB’s statutory duties and commissioning principles.

The policy sets out a transparent, fair and consistent process for handling Individual Funding Requests (IFRs) within Essex ICB. Its aim is to ensure that decisions about funding treatments outside routine commissioning are made safely, lawfully and consistently. The intended outcome for staff is that clinicians and IFR team members have a clear, structured framework to follow, enabling them to make well-informed decisions based on evidence, commissioning principles and the assessment of clinical exceptionality.

To assess how this policy may impact on protected groups, we reviewed available equality and demographic information for the Essex population, including local patterns of deprivation, ethnic diversity, disability prevalence, and the mobility of specific communities such as migrants and travelling families. We also considered intelligence from previous IFR activity within the Essex system, national evidence on healthcare access barriers for protected groups, and feedback from clinical and commissioning colleagues familiar with local population needs. This allowed us to identify where groups in Essex—particularly people with disabilities, those with communication needs, and transient populations—may face challenges engaging with the IFR process, and to ensure appropriate mitigations are built into the policy.

We consulted clinical and senior staff within the Medical Directorate.  Wider public consultation was not undertaken because the IFR policy is a clinician-led operational policy governing internal funding decisions rather than a patient-facing service redesign. The policy does not change access to commissioned services but clarifies the decision-making process for exceptional, individual cases; therefore, targeted internal consultation was proportionate.

We will monitor outcomes for protected groups by routinely collecting equality and demographic information as part of the IFR application process and analysing these data to identify any disparities in access or outcomes. This will include reviewing the proportion of IFR applications and approvals across protected characteristics and comparing these with the wider Essex population profile. Feedback from clinicians and patients will also be reviewed to identify any barriers experienced by particular groups. Findings will be reported through the IFR annual report and used to inform improvements to the policy and process, ensuring that no protected group is disadvantaged.

Every 2 years as a minimum and earlier if there are any significant changes in legislation, policy or good practice.

N/A