Commissioning – Exceptional Funding Request
14. Before we decide if we should do a detailed investigation of a complaint, we look at whether there are signs the organisation got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not seen any signs that something has gone wrong.
15. Ms O says she has been diagnosed with interstitial cystitis (a painful bladder condition that makes you need to pass urine more often). Her GP referred her to a urologist (bladder specialist) who advised the use of D-mannose + Cranberry. Ms O says D-mannose + Cranberry did give her relief from her symptoms which had not been possible with other treatments.
16. The urologist told Ms O’s GP D-mannose + Cranberry could be prescribed for Ms O. The GP supported this and made the request to the ICB to fund this.
17. Ms O explained the ICB refused her request because D-mannose + Cranberry is available without a prescription.
18. Ms O complained to the ICB complaints team on 15 July 2022. The ICB responded by saying, ‘neither D-mannose or cranberry are medications available on prescription and {are} therefore only available for self-care.’
19. Ms O’s GP submitted Individual Funding Requests (IFRs) on 14 May, 13 September and 7 November 2022. An IFR is when a special request is made to fund a treatment that would not normally be given by the NHS.
20. The ICB referred to two points in its responses to Ms O’s GP - clinical exceptionality and published objective evidence. The IFR also referred to affordability which was not addressed by the ICB. We have addressed and explained each of these three points separately below.
Clinical Exceptionality
21. Section 5 of the IFR relates to clinical exceptionality. It says:
‘To meet the definition of exceptional clinical circumstances, your patient must demonstrate that they are clearly clinically different to other patients with the same condition at the same stage of progression and will obtain additional or different clinical benefit from the successful treatment compared to other patients.’
22. Ms O’s GP said they consider Ms O to have exceptional clinical circumstances because she is unable to tolerate any of the standard incontinence treatments due to her drug intolerance and the side effects of medications.
23. The GP explained by taking D-mannose, Ms O’s UTIs should reduce which would in turn greatly reduce her incontinence and pain.
24. The GP said Ms O had consulted with the Medicines & Healthcare products Regulatory Agency (MHRA) who confirmed that all antibiotics that would be suggested for long term UTI issues are drugs she has either been confirmed to be unable to tolerate or would be expected to be unable to tolerate them.
25. The GP explained that since Ms O stopped the D-mannose she has experienced increasing symptoms of her interstitial cystitis, which include incontinence and pain. As she is unable to take many prescribed and over the counter pain killers, she does not have any appropriate pain management strategy available to her.
26. The GP included a supporting letter from Ms O’s consultant urologist. The letter explains Ms O’s urinary symptoms have ‘not been as bad since starting the D-mannose.’
27. The ICB wrote to Ms O’s GP on 10 June 2022 with an outcome. The letter says the panel noted D-mannose is available to buy as an over-the-counter preparation for self-administration. The panel were unable to identify any clinical exceptionality in this case and agreed the reported symptoms are relatively common and not exceptional for people with Ms O’s condition.
28. The letter also explained although Ms O is reported to be intolerant to various medications, it did not consider this to be exceptional.
29. NICE guidelines confirm D-mannose is a supplement and not a medication. It says, ‘some women with recurrent UTI may wish to try D‑mannose if they are not pregnant. D‑mannose is a sugar that is available to buy as powder or tablets; it is not a medicine.’
30. The IFR policy says, ‘the fact that a patient has failed to respond to, or is unable to be provided with, all treatments available for a particular condition (either because of a co-morbidity or because the patient cannot tolerate the side effects of the usual treatment) is unlikely on its own, to be sufficient to demonstrate exceptional clinical circumstances. There are common co-morbidities for many conditions. These considerations are likely to have been taken into account in formulating the general policy’.
31. The ICB followed guidelines in assessing clinical exceptionality. The ICB acknowledged intolerance to medication is not enough to show exceptional clinical circumstances.
Published objective evidence
32. The IFR form asks for evidence which shows the patient will get additional benefit from the requested treatment. It also explains published references should be supplied in full for the panel to consider.
33. Ms O’s GP provided details of a research paper which suggests D-mannose is an effective treatment for frequent UTI with possibly similar effectiveness to antibiotics.
34. The ICB said this research paper was not enough to make a decision as it did not cover the specific circumstances of Ms O’s application.
35. The IFR policy, ‘Section 4.3, Making an application’ says:
‘It is the referring clinician’s responsibility to ensure all the appropriate and required information is provided to the CCG [clinical commissioning group] in a timely fashion. This includes full copies of all the published papers of clinical evidence that have been cited. The clinician must provide a list of the published papers that have been submitted and indicate which points within them are relevant in respect to the IFR application and criteria.’
36. The IFR stated the name and authors of a study but did not show which points within the study were relevant to the IFR application. From the information provided, in line with ICB guidelines, the IFR did not show how the study covered Ms O’s circumstances. We consider the ICB did follow guidelines relating to published information in considering Ms O’s application.
Affordability
37. The IFR says Ms O was struggling to afford good quality D-mannose as she was on a low income.
38. The supporting letter from Ms O’s urologist says Ms O had episodes of stress urinary incontinence and wore up to three small pads a day for safety. This was something she did not want to continue doing and there was also a cost linked with this.
39. The letter also says she was finding paying for the D-mannose difficult as it was helpful but expensive.
40. The ICB did not address affordability within its responses to Ms O’s GP.
41. The IFR policy says ‘the IFR process only considers clinical information’. The policy further explains it is a core value that NHS care is available or unavailable equally to all. If social factors are taken into consideration, there is a risk that patients whose non clinical and social factors are unknown may not be treated fairly.
42. The policy gives an example of a treatment being provided on the grounds that it would help someone to stay in paid work. This would potentially discriminate in favour of those working compared to people who are not working or who are retired.
43. NHS England guidance says every person has the same rights to treatment under the NHS no matter what their social, family or other circumstances are. For this reason, it is important that non-clinical factors are not considered in IFR decision making. For example, factors such as the effect of a treatment on a patient’s ability to work or study, care for dependants, or meet financial commitments cannot be considered as part of the IFR process. The decision is based on clinical circumstances only, which makes sure the IFR process is fair and does not discriminate.
44. We consider the ICB did follow procedure by not including affordability in its decision-making process. It is clear within both the ICB policy and NHS England guidance that social factors, which include affordability, should not be considered.
45. We have carefully considered all the evidence. We consider the ICB did reach its decision in line with policy.
46. We realise how difficult and upsetting this matter has been for Ms O and we thank her for bringing her complaint to us.