2015/16 PBR Exclusions – Funding Application for Insulin Pump (Package of Care) for type 1 Diabetes Mellitus (Final version 1: Last updated 01/06/15) Before providing patient identifiable data on this form, please confirm that the patient (or in the case of a minor or vulnerable adult with the parent/legal guardian/carer) has given appropriate explicit consent for sensitive personal information on this form to be passed to the CCG and/or CSU for processing this funding request and validating subsequent invoices. Consent given: Yes Patient NHS No: Patient Hospital No: Patient birth year: Confirm patient status: (select 1 option) NHS (yyyy) Private Overseas Trust: GP Name: Consultant Making Request: Consultant Contact Details: GP code/Practice code: GP Post code: Please indicate whether patient meets the following NICE criteria Please tick 1. Patient is aged over 18 years with type 1 diabetes and seen by adult service (Note: All requests for insulin Yes No pumps in under 18’s or any patient seen in paediatric services should be directed to NHS England) 2. Please tick the most applicable statement: This patient has never used an insulin pump before and this is a new application (go to 3) This patient has an insulin pump out of warranty, a replacement pump is requested (go to 5) 3. One or both of the following applies (please tick as appropriate): Yes No Patient is experiencing disabling hypoglycaemia with multiple daily injections (MDIs) AND/OR HbA1C has remained high (8.5% / 69 mmol/mol or above) on MDI therapy despite a high level of care? 4. Please provide baseline data (i.e. prior to starting pump Baseline rate of hypoglycaemic episodes: per week therapy) Number of disabling hypoglycaemic episodes: per year Baseline HbA1c: Date: (go to 6) 5. Has use of the pump resulted in a sustained improvement in HbA1C and/or sustained decrease in the rate of hypoglycaemic episodes? Give details: Before pump therapy HbA1C Number of hypoglycaemic episodes per week Number of disabling hypoglycaemic episodes per year Date: Date: Date: 6. Is the requested insulin pump one of the following? (tick which applies) Accu-Chek Spirit Combo (Roche) Animas Vibe (Animas) Accu-Chek Insight (Roche) Cellnovo (Cellnovo) Dana Diabecare R (Advanced Therapeutics) Current Date: Date: Date: Paradigm Veo (Medtronic) MiniMed 640G (Medtronic) Yes No Yes No Contact details: Form completed by: Email: Phone: Date of completion: Additional Information: CCGs will not fund any other insulin pumps not listed above (see overleaf for comparative table of insulin pumps) unless there are patient specific exceptional clinical circumstances demonstrated. If so, a full IFR form will need to be completed and submitted for consideration to the relevant CCG. 7. The patient will receive on-going support from a specialist team (comprised of physician with specialist interest, diabetes nurse specialist and dietician) 8. Please attach a copy of the quote detailing cost of requested insulin pump and consumables including discounts (not older than 12 months). The application will not be processed without this. Only fully completed forms will be accepted by CCGs/CSUs for consideration. If the answer to any of these questions is NO, please consider if there are patient specific exceptional clinical circumstances demonstrated. If so, a full individual funding request (IFR) form will need to be completed. This may be obtained from the named contact at the relevant CCG/CSU/Trust. Please refer to the individual CCG IFR policy for further details. Yes Yes (Attached) No No (not attached) Participating CCGs: Barking&Dagenham; Barnet; Brent; Camden; Central London; City&Hackney; Croydon; Ealing; Enfield; Hammersmith&Fulham; Haringey; Harrow; Havering; Hillingdon; Hounslow; Islington; Kingston; Merton; Newham; Redbridge; Richmond; Sutton; Tower Hamlets; Waltham Forest; Wandsworth; West London. This form should be returned to the named contact at the relevant CCG/CSU Page 1 of 9 9. What is anticipated acquisition cost of consumables associated with the pump and pump (including VAT if applicable)? Please note: Devices and consumables for blood glucose monitoring including strips and continuous glucose monitoring systems are not included in the funding GPs should not be asked to prescribe any aspect of this technology apart from the insulin. Purchase of subsequent pumps requires a new application Funding approved for 12 months? Funding re-approved? (12-monthly) Yes No Yes No Consumables: £ / month Pump (one-off*): £ FOR CCG/CSU USE ONLY Funding for Insulin Pump therapy will only be re-approved if the treatment results in a sustained improvement in glycaemic control, evidenced by a fall in HbA1c levels, or a sustained decrease in the rate of hypoglycaemic episodes. Appropriate targets for improvement should be set by the responsible physician, in discussion with the person receiving the treatment or their carer. Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus (NICE TA 151: July 2008) 1.1 1.2 1.3 1.4 1.5 Continuous subcutaneous insulin infusion (CSII or ‘insulin pump’) therapy is recommended as a treatment option for adults and children 12 years and older with type 1 diabetes mellitus provided that: attempts to achieve target haemoglobin A1c (HbA1c) levels with multiple daily injections (MDIs) result in the person experiencing disabling hypoglycaemia. For the purpose of this guidance, disabling hypoglycaemia is defined as the repeated and unpredictable occurrence of hypoglycaemia that results in persistent anxiety about recurrence and is associated with a significant adverse effect on quality of life OR HbA1c levels have remained high (that is, at 8.5% or above) on MDI therapy (including, if appropriate, the use of long-acting insulin analogues) despite a high level of care. CSII therapy is recommended as a treatment option for children younger than 12 years with type 1 diabetes mellitus provided that: MDI therapy is considered to be impractical or inappropriate, and children on insulin pumps would be expected to undergo a trial of MDI therapy between the ages of 12 and 18 years. It is recommended that CSII therapy be initiated only by a trained specialist team, which should normally comprise a physician with a specialist interest in insulin pump therapy, a diabetes specialist nurse and a dietitian. Specialist teams should provide structured education programmes and advice on diet, lifestyle and exercise appropriate for people using CSII. Following initiation in adults and children 12 years and older, CSII therapy should only be continued if it results in a sustained improvement in glycaemic control, evidenced by a fall in HbA1c levels, or a sustained decrease in the rate of hypoglycaemic episodes. Appropriate targets for such improvements should be set by the responsible physician, in discussion with the person receiving the treatment or their carer. CSII therapy is not recommended for the treatment of people with type 2 diabetes mellitus. Page 2 of 9 Comparative table of all available insulin pumps (prepared by UKMi – London Medicines Evaluation Network) – April 2015 Page 3 of 9 Page 4 of 9 Page 5 of 9 Page 6 of 9 Page 7 of 9 Page 8 of 9 Page 9 of 9
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