Clinical Commissioning Group
INDIVIDUAL TREATMENT REQUEST FORM
GUIDE TO COMPLETION
GENERAL QUESTIONS
Why are applications for individual treatments necessary and what is the mechanism for this?
NHS Dorset CCG considers requests on an individual treatment basis in a small number of specific instances where treatment is not routinely commissioned. The purpose of this application system is to consider individual requests which have a degree of exceptionality placing them outside the normal commissioning process. The panel is not there to review, revise or reverse existing commissioning decisions. When new treatments become available application will normally be made for these to be considered in the following commissioning round; this is not the business of the panel.
Applications are made using a standardised form and are initially considered by a small Individual Treatments Team (IPTT). In many cases decisions can be made immediately based upon current policy and experience of previous requests or high quality of evidence. Where a more detailed discussion needs to be made, the case is considered at the Individual Cases Panel (ICP) comprisingaround ten members. In addition to the IPTT, members are drawn from a broad range of primary and secondary care specialties and also include Pharmacist and Public Health representation. This panel meets monthly.
Why does a form need to be completed?
In considering a request the IPTT/ICP need to be convinced that:
- The case is truly exceptional to the commissioning population – in most cases unique.
- Any commissioned treatments for the condition have either been shown to be ineffective or inappropriate.
- The treatment is in line with evidence based recommendations (e.g. NICE) or, where not available, or falling outside guidelines, there is appropriate evidence to justify its use in this patient.
- The treatment is likely to be effective
- The treatment has been appropriately discussed within the provider organisation and is supported.
- The patient has been appropriately counselled, supports the application and has consented to their case being discussed.
- The treatment is in line with the spirit and philosophy of existing commissioning decisions with respect to matters such as boundaries of provision and cost effectiveness.
By using a standard form, NHS Dorset seeks to ensure that all the relevant information is available in these areas and that requests are therefore treated in a consistent and equitable manner.
The process of completing a standard form and explicitly outlining the areas where information is required also minimises the likelihood that the IPTT will need to approach the referring clinician for information omitted from a letter requesting treatment. The use of a standard form, therefore, helps to ensure that the time taken in reaching a decision is minimised by reducing the need to seek further information.
The form is intended to provide direction to the applying clinician as to the information that is required in considering individual treatment requests. The form is necessarily generic and it is appreciated that there may be instances where a specific question may not be appropriate. However in order that the full position is known it would be anticipated that almost all questions are answered in all cases. Please note that all the boxes are designed so that they can be expanded as required. You should not consider the size of a box to be an indication of the amount of information required.
Why are applying clinicians asked to type the form?
- Legibility
- All boxes are expandable to accommodate the information given. It is unlikely that handwritten notes in the boxes supplied will contain adequate information for the panel.
How quickly will my application be processed.
NHS Dorset CCG is committed to consider requests and convey decisions within 28 days of receipt. Please make sure that the form is correctly dated so that we can measure performance against this target.
Some requests made on the basis of exceptional clinical circumstances will need to be considered by an ICP. The process for consideration by Panel and for considering requests in general is outlined in the “Policy for Individual Patient Treatment”. The ICP meets on a monthly basis.
A referring clinician can request urgent consideration of a case. Significant clinical risk must be evident in justifying consideration on an urgent basis.
Will the decision by communicated to the patient?
In cases where the individual request is considered by the ICP, the outcome will be copied to the patient unless the form specifically states that it should not. If the request is not considered by the Panel, then the decision will only be conveyed to the applying clinician along with the patients’ GP if they are not the applying clinician in which case it will be their responsibility to convey the decision.
How should the form be submitted?
Forms may be submitted by post or by email. The IPTT seeks to process requests and convey a response within 28 days from receipt. Submission by email will expedite receipt by the IPTT. However submitted, requests should be accompanied by all the relevant attachments referenced on the treatment request form.
Postal Address:NHS Dorset Clinical Commissioning Group, Individual Patient Treatments Team,
First Floor Vespasian House, West Bridport Road, Dorchester, Dorset, DT1 1TS
Email: (ALL APPLICANTS FROM OUTSIDE DORSET)
Both emails are generic in nature and can be accessed by all members of the Team. Requests sent to personal email addresses may be left un-accessed if the individual is away from the office.
QUESTIONS RELATING TO SPECIFIC SECTIONS OF THE FORM
SECTION 2
What information do I need to give about approval by my Drug and Therapeutics Committee, MDT, Medical Director?
Where a treatment is contrary to NICE guidance or is not licensed for the purpose proposed, this is likely to raise concern within your organisation. Prior to requesting support by the IPTT, it is therefore essential to ensure that relevant individuals and committees in your trust have given their approval to the application. Please state whose approval you have sought and their level of support. Please also mention anyone whose approval you have not requested and what you are doing about that. You should also similarly discuss treatments which are not within other national/international guidance produced by specialist bodies. You will have the opportunity to discuss evidence later on the form.
SECTION 3
Why is patient consent required?
The Policy for Individual Patient Treatments stipulates that requests are made on behalf of the patient which thereby implies consent. Furthermore, the IPTTmay discuss the progress of the request with the patient if approached directly. It is therefore important that the Team are clear that the treatment has been fully discussed with the patient prior to the request being made. Any such discussion must include the pros and cons of this treatment, potential adverse effects and likely effectiveness.
Why do you need to know whether the patient has been given a TCI or been placed on a waiting list?
We would generally recommend that patients are not given a placed on a waiting list, given a TCI or a likely date to start treatment prior to the application being considered as clearly this raises expectation of treatment that may not be supported. The IPTTtherefore, seeks confirmation that the patient has not been listed for treatment in order that it can help manage patient expectations. If you have replied in the affirmative to either of these questions, it would be helpful if you would give further information on why you have done so and also what you have told the patient.
What conflicts of interest do I need to declare?
By declaring any potential interest you are protecting your own probity. It is imperative that you declare any financial interest that you may have in the treatment which you are recommending. This may be direct benefit to yourself,a spouse, relative or close friend from the treatment. You should also declare interests where you have any financial or other relationship with the provider or manufacturer of the treatment. This may, for example, include share ownership, advisory work or receipt of funding for lecturing/attending meetings.
SECTION 6
Why is the applying clinician asked about awareness of other patients for whom treatment would be sought?
If it is clear that the patient is representative of a particular cohort of patients regardless of size, then the patient is, by definition, not exceptional. It is evident in such circumstances that the request should not be considered on an individual patient basis but that a case should be made for a service development to be considered through the commissioning process for provision of the treatment to that cohort.
The Form does, however, provide the opportunity for the applying clinician to provide details of patient numbers with this condition to the Team, to provide some context to the exceptionality case. For example the applying clinician may be aware of 10 cases presenting with the condition in the previous year, all of which responded to standard commissioned treatments. The fact that the particular individual patient is refractory to the standard treatment(s) and may also be contraindicated for commissioned alternatives could therefore be highlighted to make a case for clinical exceptionality.
SECTION 7
What is meant by exceptionality and why is this important?
Exceptionality implies clinical circumstances which make the patient unique (or extremely unusual) such that the normal commissioning arrangements do not apply to that patient. It is further inappropriate for the panel to make a decision relating to a single patient where that decision could equally well apply to a significant cohort of other patients as this would predispose any future commissioning application to the CCG. In the latter case it would be more appropriate to apply to the CCG to commission the (often new) treatment directly. Where two or more similar requests are, therefore, anticipated in Dorset within a year it would be expected that the treatment request be taken forward as a service development. Treatments may not be commissioned for a variety of reasons and the basis for exceptionality will depend upon these.
In all cases the request will only be supported if it is evident that the patient is clinically exceptional. It is therefore critical that all relevant information is included in this section so that the applying clinician makes the case for exceptional status. Essentially the IPTT is looking for evidence that there is some aspect of the patients clinical presentation that makes them clinically unique and that there is something about their clinical history that indicates that they are either likely to benefit more from the treatment, or that all other commissioned established treatment options which are available to all other patients with that condition, are not available to the individual patient because of the patients unique clinical circumstances.
It should be noted that, although evidence of effectiveness is important, it is not, in itself, a basis for exceptionality. This includes cases where the treatment has previously been supplied on a private basis. A treatment may not be routinely commissioned because it is not cost-effective, or because it has not been prioritised against other priorities or because it is deemed to be essentially cosmetic in nature.
Social and psychological factors may not be considered in determining whether a patient is clinically exceptional. If such factors were included in the decision it becomes difficult to prevent inequity.
SECTION 8
Why does the form refer to service development?
A service development refers to any aspect of healthcare which the CCG has not historically agreed to fund and which will require the commitment of additional and predictable recurrent funding in order to provide the relevant treatment to a defined cohort of patients with a particular condition.
Where it is evident that the individual patient is not clinically exceptional but is instead representative of a cohort of similar patients it would be inappropriate to consider support for treatment on an individual patient basis. To manage new treatments by considering one patient at a time would be unfair and breaches the principle that no treatment should be offered to an individual that would not be offered to other patients with equal clinical need.
The CCG expects that all new treatments are properly assessed and prioritised through the appropriate processes in considering whether they are commissioned. Clinicians wishing to propose a new treatment for a cohort of patients should initially discuss with the relevant Trust Medical Director the appropriateness of onward referral of a business case for consideration by the CCG’s relevant Clinical Commissioning Programme.
SECTION 9
What clinical evidence should I supply?
The IPTT requires confirmation that the treatment is safe and is clinically effective for the relevant indication.
Where there are NICE guidelines in place, or national or local guidelines, these should be referenced on the application and copies attached to the application; this must be the full article and not simply an abstract. Additional articles or papers published in peer reviewed journals may also be provided, particularly where there are not national guidelines available or where the article has been published after the referenced guideline. Where the evidence provided amounts to extrapolation from a different patient group you should discuss why you think this is justified.
Whilst acknowledging that for some rare conditions evidence may be restricted to case series and studies, the CCG will broadly consider the strength evidence on the basis of conventional criteria used in systematic reviews.
SECTION 10
Why does the form request details of severity?
The severity of the condition as well as helping to provide a wider picture of the patient’s clinical circumstances also provides an indication of relative severity which may be useful when considering the suitability of alternative treatment options. In some cases national or local guidelines stipulate access criteria which may include standardised scores of severity and these may be reflected in locally commissioned pathways. Being aware of these scores, even when the patients score is outside of local criteria, may be useful in conjunction with other clinical factors recorded elsewhere on the completed form in providing a wider perspective. Where possible provide clinical interpretation of the scoring system or provide a separate document as an appendix. This will save panel members outside your specialty from having to research the topic for this purpose alone.
Why does the Team request details of alternative treatment options?
It is important for the Team to be clear about the standard / commissioned treatmentfor patients with this condition, that these treatments have been tried with inadequate results or, if not tried, the reasons for this. The time periodsover which treatments have been provided gives a chronology and also provides evidence that appropriate trials have been given. It is also important to be clear that the currently commissioned treatment remains the standard treatment for all other patients and that the individual patient for whomtreatment is sought is clinically exceptional within the cohort of general patients with this condition.
Why are questions raised about prognosis expected, response and cost?
The CCG commission’s treatment for the whole population of Dorset and needs to make commissioning decisions in a consistent manner whether they relate to the whole population, groups of patients with a specific condition, or requests for treatment made on an individual patient basis.
The guiding principles are that care and treatment is commissioned based on healthcare need, clinical evidence and national guidelines in order to achieve the greatest possible outcomes for the local population, within the resources available. The CCG therefore commissions evidence based services that are clinically and cost effective. Being aware of all the relevant variables therefore aids the process of considering a request to invest in a particular treatment whatever the number of patients that it relates to.
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