NHS Treatments and when to use a Prior Approval or Individual Funding Request Application Form Guidance for Clinicians

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1 Situation NHS Treatments and when to use a Prior Approval or Individual Funding Request Application Form Guidance for Clinicians The Herefordshire Treatment Policy was refreshed in May 2017 which renewed interest and heightened awareness of what treatments are included in the policy and the statutory Individual Funding Requests process. Following feedback from providers, this guidance has been developed to clarify understanding of the Herefordshire Clinical Commissioning Group (HCCG) Treatment Policy; specifically the use of the new Herefordshire Prior Approval Process and CCG and NHS England Individual Funding Request process. The new Herefordshire Prior Approval process has been designed to simplify the process and should be followed by a clinician for treatments listed within Herefordshire Treatment Policy 2017 as: Restricted/criteria based treatments where the clinician is unsure whether the criteria are met, or the patient does not meet the specified criteria but may have individual exceptional clinical circumstances. Not Routinely Funded treatments where the patients clinical circumstances do not currently qualify them for funding under the existing commissioning policy but may have exceptional clinical circumstances. There is also a requirement for providers of services commissioned by HCCG to provide evidence of compliance with the Treatment Policy. This is important because there are financial implications if the provider organisation cannot show evidence of compliance. Wye Valley Trust identified a Clinical Lead to lead on the development and implementation of processes aimed at supporting clinical teams to use the Treatment Policy. Through doing this work a number of issues came to light which culminated in a constructive discussion at the Clinical Reference Group attended by medical representatives of primary care and secondary care in July Subsequent meetings have been held with consultant representatives of the concerned specialties and the CCG Clinical Lead which has led to mutually agreed changes to the policy. It is intended that the new revised version of the Herefordshire Treatment Policy will be available in December 2017 and will be reviewed annually. The Herefordshire Treatment Policy was formally known as the Low Priority Treatment Policy. Background NHS England and CCG s have finite resources, and need to make decisions about the treatments that they will and will not commission to ensure the best possible outcome for all of the patients for whom they have commissioning responsibility. The vast majority of treatments are funded (commissioned) because they have a strong evidence base, they are clinically effective and represent value for money. However, for treatments where the evidence is less certain, any decision to treat must be made in a systematic, consistent and transparent way. The aim of this is to fairly and reasonably distribute scarce resources across different patient groups, and across competing demands. To achieve this, NHS England and Clinical Commissioning Groups have Treatment policies which include a list of treatments that fall into two categories: 1. Treatments that are restricted/criteria based and that will only be commissioned if the patient meets a certain clinical criteria. 2. Treatments that are not routinely commissioned.

2 HCCG has developed the Herefordshire Treatment Policy to facilitate effective commissioning of these treatments. Click on the link below. To optimise compliance with the Treatment Policy, the CCG has produced this written guidance on when to use Prior Approval or Individual Funding Request applications. Herefordshire Treatments Policy NHS England has also developed a Manual of Prescribing for Specialist Services to facilitate the effective commissioning of specialised services. These services are commissioned directly by NHS England and not by HCCG. Click on link below. Manual for Prescribed Specialised Services Individual Funding Requests fall into three categories: 1. Exceptionality requests which seek to secure treatment for a patient whose clinical circumstances do not currently qualify them for funding under an existing commissioning policy. 2. Exceptionality requests which seek to fund an existing treatment experimentally for one or more patients with a rare clinical condition or rare clinical circumstances. 3. Requests to provide funding to enable a patient to enter into a clinical trial. NHS Commissioning Board describes what is meant by exceptional circumstances as follow and the same should be applied locally: "There can be no exhaustive definition of the conditions which are likely to come within the definition of an exceptional individual case. The word exception means a person, thing or case to which the general rule is not applicable. The IFR Panel should bear in mind that, whilst everyone s individual circumstances are, by definition, unique, very few patients have clinical circumstances which are exceptional, so as to justify funding for treatment for that patient which is not available to other patients. The following points constitute general guidance to assist the panel. However, the overriding question which the panel needs to ask itself remains: has it been demonstrated that this patient s clinical circumstances are exceptional? Herefordshire Clinical Commissioning Group - When to complete a request for funding Treatments that are restricted/criteria based: Exceptionality requests for funding for patients that do not meet the clinical criteria but where there are exceptional clinical circumstances, the clinician is entitled to request on behalf of their patient individual funding for a particular treatment this request is called a Prior Approval Request and will be assessed at the Prior Approval Panel to decide if funding will be approved. Treatments that are not routinely funded: Exceptionality requests for existing treatments for a patient whose clinical circumstances do not currently qualify them for funding under the existing commissioning policy but where there are exceptional clinical circumstances, the clinician is entitled to request individual funding using the Prior Approval Request application. This request will be assessed at the Prior Approval Panel to decide if funding will be approved. Or For requests for funding an existing treatment experimentally for one or more patients with a rare clinical condition or rare clinical circumstances or to enter into a clinical trial, the clinician is entitled to complete an Individual Funding Request which will be submitted to Individual Funding Request Panel to determine if the patient has individual circumstances are exceptional and decide if funding will be approved. Treatments that are carried out without the commissioners approval will not be funded.

3 Individual Funding Request (IFR) Process On receipt of an IFR, all applications are screened for: Service development i.e. assess if there is likely to be a cohort of similar patients Incomplete submissions Submissions that ought to go to the IFR Panel. The IFR Panel (CCG and NHS England) has no responsibility for service development and does not make a service development decisions. However, HCCG and NHS England will screen each IFR request and over time it may become clear that for some treatments the circumstances are not unique and fall into another category i.e. service development for a predictable population. The respective organisation will need to take a view on how this treatment will be commissioned going forward. For more information about the Herefordshire CCG Individual Funding Request Policy or NHS England Individual Funding Request process click on the below link Herefordshire Treatment Policy NHS England Commissioning Policy: Individual Funding Request The vast majority of treatments are routinely funded. For those treatments that fall outside of the routinely funded the following three processes set out when and how to complete a Prior Approval Form or IFR: these are: 1. HCCG Prior Approval Process 2. HCCG Individual Funding Request 3. NHS England Individual Funding Request for specialised services directly commissioned by NHS England Only the first two processes relate to the treatments set out in the HCCG Treatment Policy. The overview of the commissioning of treatments for HCCG and NHS England is shown in Appendix HCCG Prior Approval Process for restricted/criteria based treatment and not routinely funded patient exceptionality only The HCCG exceptionality Prior Approval Process should be followed by a clinician for treatments listed within Herefordshire Treatment Policy as: Restricted/criteria based treatments where the clinician is unsure whether the criteria are met Or Restricted/criteria based treatments where the patient does not meet the specified criteria but may have individual exceptional clinical circumstances. Or Not Routinely Funded existing treatments where the patient s clinical circumstances do not currently qualify them for funding under the existing commissioning policy but may have exceptional clinical circumstances. The HCCG Prior Approval Form is a one sided A4 form to be completed by the requesting clinician on behalf of their patient, and with the patient s consent. The completed form should be ed to Iptpa.hccg@nhs.net. The form will be assessed in a Prior Approval Panel held weekly and the requesting clinician will be informed of the decision within 30 working days of the receipt of the Prior Approval Form or sooner if approved at the weekly Prior Approval Panel. The Prior Approval Form is included in appendix 2 or click HERE. Applications for patients not meeting the criteria will be referred for consideration by the IFR panel to determine whether the patient s clinical circumstances are exceptional. If the application is declined, there is an appeals process.

4 HCCG Prior Approval Process The Prior Approval Process should be followed by a clinician for treatments listed within Herefordshire Treatment Policy as restricted/criteria based treatments where the clinician is unsure whether the specified criteria are met or where the patient does not meet the specified criteria. Clinician complete Herefordshire CCG Prior Approval (PA) Form (single A4). IFR Screened on arrival at the HCCG Prior Approval Form is assessed at a Prior Approval Panel held weekly. Decision The Prior Approval Process should be followed by a clinician for treatments listed within Herefordshire Treatment Policy as not routinely funded existing treatments where the patient s clinical circumstances do not currently qualify them for funding under the existing commissioning policy but may have exceptional clinical circumstances. Restricted/criteria based Not routinely funded Criteria met Criteria not met Herefordshire Individual Funding Request Panel (use the same PA form) Appeal process Funding Declined Funding Approved proceed to treatment Decision 2) HCCG Individual Funding Request process This process relates to exceptionality Individual Funding Requests for treatments listed in the Herefordshire Treatment Policy as: Not routinely funded existing treatment experimentally for one or more patients with a rare clinical condition or rare clinical circumstances Or Not routinely funded treatment to enable patients to enter into a clinical trial AND Treatments that sit outside the Herefordshire Treatment Policy and are not funded by the HCCG. For treatments that fall into this category, the clinician is entitled to submit an IFR application acting on behalf of their patient and with the patient s consent. The form should be ed to Ifr.hereford@nhs.net. The form will be assessed by a Multidisciplinary Team IFR Panel which meets monthly. This panel is part of the corporate governance process for HCCG. The requesting clinician will be informed of the decision within 30 working days of the receipt of the IFR application. Note the description of exceptional clinical circumstances on page 2. The IFR Form can be downloaded HERE

5 The Individual Funding Request form should not be used if there are likely to be other patients with similar clinical circumstances within the commissioning area who may also benefit from the treatment being requested. This constitutes a service development for a predictable population. You should discuss with your contract team how you submit a business case for consideration. Treatment listed in the Herefordshire Treatment Policy as not routinely funded specifically existing treatment experimentally for one or more patients with a rare clinical condition or rare clinical circumstances or to enter into a clinical trial but the clinician believes that the patient has exceptional clinical circumstances. Clinician completes the Herefordshire CCG Individual Funding Request application IFR Screened on arrival at the HCCG HCCG Individual Funding Request application is assessed by a MDT IFR Panel monthly. Treatment not listed in the Herefordshire Treatment Policy and not funded by HCCG but the clinician believes that the patient has exceptional clinical circumstances. Decision Funding Approved proceed to treatment Funding Declined Explanation given to the IFR clinician requestor in writing within 5 working days of the MDT IFR panel meeting Appeal process

6 3) NHS England Individual Funding Request for specialist services directly commissioned by NHS England This process relates to Individual Funding Requests for a treatment that is a Specialist service/treatment that is not routinely funded by NHS England, but the clinician acting on behalf of their patient believes that the patient has exceptional clinical circumstances. The NHS England process for handling IFR requests is completely separate from the local Herefordshire Treatment Policy process. NHS England Commissioning Board (NHS CB) is responsible for commissioning specialised services to meet a wide range of health and care needs. Specialised services are those provided in relatively few hospitals; accessed by comparatively small numbers of patients, and tend to be located in specialised hospital trusts that can recruit a team of staff with the appropriate expertise and enable them to develop their skills. These include a range of services from renal dialysis and secure inpatient mental health services, through to treatments for rare cancers and life threatening genetic disorders. For treatments that are not normally commissioned by the NHS England Commissioning Board a clinician (doctor or other health professional), on behalf of their patient, is entitled to make an Individual Funding Request to the NHS CB when it is believed that the patient is clearly different to other patients with the same condition or where the patient might benefit from the treatment in a different way to other patients. This is known as clinically exceptional. As an example, dental implants are not routinely offered by the NHS, however if a patient could not use their arms due to disability and needed dental implants to hold a pen so they could write, this might be considered an exceptional case. NHS England has developed a Manual for Prescribed Specialised Services 2016/17 to facilitate effective commissioning of specialist services which list the treatments/services that are directly commissioned by NHS England. Click on the link below. NHS England Manual of Prescribing for Specialist Services The Interim Commissioning Policy: Individual Funding Requests outlines these conditions and the criteria which are used for decision making. Click on the link below. NHS England Commissioning Policy: Individual Funding Request The IFR process is managed by NHS England within 30 working days (this period will be extended if the IFR team request further information from the requester). For additional information or IFR Form click on the links below: Guidance for clinician policy guidance link NHS England Commissioning Generic Policies Guidance for patient link NHS England Individual Funding Request - Patient Information Individual Funding Request Form link NHS England Individual Funding Request Application Form

7 The Individual Funding Request form for Specialist Services should not be used if there are likely to be other patients with similar clinical circumstances within the commissioning area who may also benefit from the treatment being requested, as this constitutes a service development for a predictable population. You should discuss with your contract team how you submit a business case for consideration. Treatments that are not routinely funded by NHS England, but the clinician acting on behalf of their patient believe the patient has clinically exceptional circumstances. Clinicians should ensure that their organisation has agreed to submission of the request. Complete Individual Funding Request form and return it in MSWord to: england.ifr@nhs.net NHS England will inform the patient and the requester of the outcome of their IFR application. If application is declined the referring clinician, or the patient, or a patient representative may make an official request to NHS England for a review of an IFR Panel decision. This must be lodged within 20 working days. Contact details: Phone: England.contacts@nhs.net Post: NHS England, PO Box 16738, Redditch, B97 9PT

8 Appendix 1 Overview of Commissioning of Treatments and Individual Funding Request for Herefordshire and NHS England Herefordshire CCG Commissioning of Services NHS England Commissioning of Services Vast majority of treatments are commissioned by Herefordshire CCG Restricted/Criteria Based Treatments HCCG Prior Approval Process Not Routinely Funded Treatments or Treatments that sit outside the Herefordshire Treatment Policy and not funded NHS England Specialist Services NHS England Individual Funding Request Process Decision Treatment Approved HCCG Individual Funding Request Panel HCCG Prior Approval Process HCCG Individual Funding Request Process

9 Appendix 2 Prior Approval Form Herefordshire Clinical Commissioning Group Treatment Policy Prior Approval Application Form The Prior Approval Form should be used by a clinician for treatments listed within Herefordshire Treatment Policy as restricted/criteria based treatments or not routinely funded existing treatments where the patient s clinical circumstances do not currently qualify them for funding under the existing commissioning policy but may have exceptional clinical circumstances. 1 Unique Identifier HCCG use only 2 Date Received by Contracts Team HCCG use only 3 NB - this form should be completed & signed by requesting GP or Consultant PLEASE COMPLETE IN TYPE 4 Urgent or Routine 5 Does the patient consent for relevant personal / clinical details to be shared with Contracts & IFR team as necessary? Yes / No 6 Patient Details First name and surname 7 Date of Birth 8 NHS number 9 Requesting Clinician Details Name, address and contact number 10 Treatment requested 11 Proposed provider 12 Details of restricted/criteria based treatments where the clinician is unsure whether the specified criteria are met. Details of restricted/criteria based treatments where the patient does not meet the specified criteria or the treatment is not routinely funded but may have individual exceptional clinical circumstances. Please provide explicit information to demonstrate that the patient s clinical circumstances are exceptional and any additional information that may inform decision making.

10 13 Signature of requesting Clinician 14 Date submitted 15 Please return this completed form to For HCCG use only 16 Funding approved Yes / No 17 Reason(s) for approval / non-approval

11 Appendix 3 ` Individual Funding Request Application (Review date Dec 2018) Treatment being Requested Condition being Treated Nature of Intervention Drug Surgical Procedure Medical Device Therapy Other (give details)... Date of Request Date Received by Commissioner NOTES FOR COMPLETION 1. This proforma is to be completed by clinicians acting on behalf of their patient to request funding from Herefordshire Clinical Commissioning Group for individual funding of drugs or therapeutic interventions not normally commissioned. It must be typed and ed together with any references in PDF format to ifr.hereford@nhs.net 2. If this request relates to oncology treatment, a response within 3 working days is required to meet national targets. 3. To minimise delays in the application process please ensure ALL fields are completed comprehensively. Incomplete forms or forms with insufficient levels of information will be returned to the requesting clinician and may result in a delay in the request being considered. 4. This form should not be used to request funding for a. NICE TAG approved treatments and/or technologies for specific indications b. Treatment requiring prior authorisation c. Consideration of potential service developments d. Approved indications where funding is already sanctioned under an existing commissioning policy and where the patient meets the treatment criteria. 5. This form should not be used if there are likely to be other patients with similar clinical circumstances within the commissioning area who may also benefit from the treatment being requested, as this constitutes a service development for a predictable population. You should discuss with your contract team how you submit a business case for consideration through the annual prioritisation round. 6. Clinicians should ensure that their organisation has agreed to submission of the request. 7. Further guidance on completion of this proforma and the nature of the request is detailed in Appendix 1. DECLARATION I confirm that it is not expected that there will be more than one patient from within the commissioning area who is or likely to be in the same or similar clinical circumstances as the requesting patient in the same financial year and who could not reasonably be expected to benefit to the same or a similar degree from the requested treatment unless similar patients are expected to be from the same family group. I affirm that I have discussed this individual funding request with my patient. This request is being made with his/her consent for treatment and consent for sharing of information regarding the case with NHS commissioner IFR management panels. To the best of my knowledge I have given the most accurate and up to date information regarding this patient s clinical condition. Type in details and scan in signature. Signed:. Designation: Telephone:.. Print Name: Organisation: .. Correspondence Address:...

12 1. Patient Details Name: Address (including postcode): Date of Birth: M or F NHS Number: GP Name: GP Practice Name: Decision to Treat Date For oncology treatment requests, please provide the decision to treat date for this requested treatment.i.e within the 31 day target. 2. Requesting Provider Details Name of Requesting Provider Trust: Type of Organisation NHS Trust GP/Dental Practice Private Sector Other Has approval of request been sought from the organisations contract team? Yes No From whom was agreement sought? Name Contact telephone number If this funding request is approved, the NHS provider will be notified. Please give details of the person who should be notified: Name Designation Contact Details Address

13 3. Diagnosis and Patient s Current Condition Diagnosis (for which the intervention is requested) Has a second consultant opinion or MDT view on the requested intervention been obtained? If YES, please give details: Current status of the patient What is the disease status? (eg. at presentation, 1 st, 2 nd or 3 rd relapse) What is the history of the disease including duration? For cancer, how advanced is the stage? Describe any disease manifestations or metastases What is the patient s clinical severity? (where possible use standard scoring systems eg. WHO, PASI, DAS, walk test, cardiac index) What are the ongoing symptoms and how does this affect the patient s well-being? What is the patient s Functional Status? ie capacity to perform Activities of Daily Living: adults- work & home, children -school or play Summary of Previous Interventions for this condition Please outline any treatment received to date (non-pharmacological, pharmacological, nonsurgical/surgical), the dates of each treatment and the outcome in chronchronological order. Dates Nature of Intervention Reason for stopping*/ response achieved *Reasons for stopping may include: Course completed No or poor response Disease progression Adverse effects/poorly tolerated Any other relevant information

14 4. About the Intervention Requested Name of Intervention Is the intervention PbR excluded Planned dose, frequency and route If the intervention forms part of a regime please document in full. Planned duration of intervention No Yes Where will the intervention be provided Indicate whether in-patient, out-patient, daycase Is the requested intervention a continuation of an existing treatment funded via another route? Is the intervention experimental, part of a trial or research? No No Yes give details of existing funding and why ceased Yes give details What are the alternative management options for this patient What other intervention might the patient receive and why is it not suitable? What intervention will the patient receive if this request is declined? What are the implications of not providing this intervention (to the patient and carer)? What is the evidence to support the requested intervention Please provide additional research information to support this application, include references or copies of clinical research papers which support or contribute to this request and attach as PDF files National and International Guidance Is there any guidance of relevance to this application? Local Guidance Has your host commissioner developed a local policy regarding this intervention?

15 Anticipated costs (inc VAT) (per year/cycle/course etc) Estimated costs Are there any offset costs? Describe the type & value of offset costs Funding difference being applied for What is the expected outcome for the intervention being requested? How does this compare with the expected outcome from the alternative (standard) management option? How will effectiveness of the intervention be monitored? Include timeframe and type of investigation to determine effectiveness. when how 5. Basis of Request On which basis are you making this request? See annex 1 for guidance Individual requests eg where the intervention is not normally funded or there is no local policy in place describe Exceptional Clinical Circumstances For all requests, please describe why this patient s condition or clinical presentation is different to others with the same condition, such that they would benefit more from this treatment/therapy than any other patient. Rarity of condition or presentation (individuality) Potential patient numbers: What is the incidence for this condition? For endorsed clinical trial funding requests please ensure that a copy of the trial protocol is included and outline the importance of the trial, the robustness of the trial and the benefits of this trial to the patient. Additional Views/Comments made by requesting clinician in support of application: For example, the number per 100,000 population. Please with supporting information to: Herefordshire CCG ifr.hereford@nhs.net Annex 1

16 Guidance for Requesting Clinicians Individual Requests Exceptionality Requests Almost all of these requests will relate to experimental treatments: either a request to access an experimental treatment, enter a patient into a trial or to use a treatment off-label for a rare clinical condition or situation. Trial Requests: For requests to enter patients into a trial (whether to fund to enter the trial or pick up post trial funding) a copy of the trial protocol will need to be forwarded with your application the key questions are: 1. whether or not the trial is strategically important for the programme area 2. whether or not all the trial data will be in the public domain 3. whether or not the trial protocol is robust (e.g. can assess improvements in important clinical outcomes) Off label use for rare clinical circumstance the key questions are: Is there evidence of cost effectiveness for this treatment? It is biologically plausible that this treatment will work in this clinical situation? Where the treatment is a drug please indicate its UK license status. An exceptionality request is only relevant where there is an existing general or treatment specific policy and where the responsible commissioner has already taken the decision not to fund either the treatment or some categories of patients or NICE have already taken the decision not to approve either the treatment or some categories of patients for the request you are making. The key question that has to be addressed under these circumstances is on what clinical grounds can the PCT justify funding this patient when other patients with the same condition will not? In making a case therefore the clinician must specify how this patient is clinical different from others currently excluded from treatment either in reference to the clinical picture or the expected benefit or both. General Guidance Please note that if there are similar patients the request essentially represents a request for a policy variation to be made i.e. expand access to a subgroup of patients and as such should be treated as a service development and the IFR process not used. Applications need to include the following additional information: A comprehensive and balanced clinical picture of the history and present state of the patient s medical condition, 1. The nature of the treatment requested and the anticipated benefits of the treatment. 2. The degree of confidence of the Clinical Team that the outcomes will be delivered for this particular patient. 3. Previous treatments/interventions this patient has received for this condition and the outcome of these for the patient. 4. Details of standard NHS treatment that this requested treatment will replace if any. 5. Expected benefits and risks of treatment. 6. Any additional material considered to be relevant. The Clinical Team should refer to, and preferably include, copies of any clinical research material which supports, questions or undermines the case that is being made that the treatment is likely to be clinically effective in the case of the individual patient. In all cases affordability and relative priority compared to other unfunded developments remain key considerations. The directly relevant commissioning policies are: Individual Funding Request Operating Procedure o WM/1 Ethical Framework to underpin priority setting and resource allocation within collaborative commissioning arrangements o WM/9 Individual funding requests o WM/14 Experimental and proven treatments o NICE IPG guidance where this exists. Please access this link for Herefordshire policies:

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