Commissioning Policy Individual Funding Request

Transcription

1 Commissioning Policy Individual Funding Request Continuous Glucose Monitors Prior Approval Policy Date Adopted: 13 October 2017 Version:

2 Document Control Title of document Continuous Glucose Monitors Policy Authors job title(s) IFR Manager Document status v Supersedes New Policy Clinical approval Date sent for clinical approval Discussion and Approval by 14 June 2017 Clinical Policy Review Group (CPRG) Discussion and Approval by CCG 01 August 2017 Board Date of Adoption 13 October 2017 Publication/issue date 08 September 2017 Review date 13 October 2020 Application Form Version Control v Equality and Impact Assessment TBC

3 TREATMENT UNDER THIS POLICY REQUIRES PRIOR APPROVAL FROM THE CCG INDIVIDUAL FUNDING TEAM THIS POLICY RELATES TO ALL PATIENTS over 18 years CONTINUOUS GLUCOSE MONITORS Policy Statement and Date of Adoption: 13 October 2017 Continuous Glucose Monitors (CGM) or Continuous Glucose Monitoring Sensors (CGMS) are not routinely funded by the CCG and are subject to this restricted policy. General Principles Funding approval will only be given in line with these general principles. Where patients are unable to meet these principles in addition to the specific treatment criteria set out in this policy, funding approval will not be given. 1. Funding approval must be secured by primary care prior to referring patients seeking treatment. Referring patients to secondary care without funding approval having been secured not only incurs significant costs in out-patient appointments for patients that may not qualify for treatment, but inappropriately raises the patient s expectation of treatment. 2. In line with the published document Guidance - Who Applies for Funding?, where referrals to secondary care are accepted without funding approval having been secured, responsibility for securing funding approval will fall to secondary care. 3. On limited occasions, the CCG may approve funding for an assessment only in order to confirm or obtain evidence demonstrating whether a patient meets the criteria for funding. In such cases, patients should be made aware that the assessment does not mean that they will be provided with the treatment as this will only be provided where it can be demonstrated that the patient meets the criteria to access treatment in this policy. 4. Where funding approval is given by the Individual Funding Panel, it will be available for a specified period of time, normally one year. 5. Funding approval will only be given where there is evidence that the treatment requested is effective and the patient has the potential to benefit from the proposed treatment. Where it is demonstrated that patients have previously been provided with the treatment with limited or diminishing benefit, funding approval is unlikely to be agreed. 6. Patients with an elevated BMI of 30 or more are likely to receive fewer benefits from surgery and should be encouraged to lose weight further prior to seeking surgery. In addition, the risks of surgery are significantly increased. (Thelwall, 2015) 7. Patients who are smokers should be referred to smoking cessation services in order to reduce the risk of surgery and improve healing. (Loof S., 2014)

4 Background Although self-monitoring of blood glucose plays an important role in achieving target glycated hemoglobin levels, few patients with Type 1 Diabetes measure glucose levels after meals or overnight (i.e. more than 4-6 times a day). Consequently, postprandial hyperglycaemia and asymptomatic nocturnal hypoglycaemia are commonly seen, even in patients with well-controlled Type 1 Diabetes who measure blood glucose several times daily with a home blood glucose meter. Continuous Glucose Monitoring Sensors (CGMS) are devices that would allow for glucose values to be visible continuously, enabling immediate therapeutic adjustments on the basis of real time glucose results. The sensor is inserted subcutaneously and measures interstitial glucose. The real-time monitor shows trends in glucose levels on an LCD display and indicates the rate of glucose change using arrows. They have predictive alarms for low or high glucose level and warn of impending hypoglycaemia or hyperglycaemia (by sounding alarm). Two types of CGMS are available under this Policy: Real time or therapeutic CGMS provide continuous interstitial glucose concentration visible to patient, allowing for strategies for adjusting therapy according to the sensor data. There is an expectation that CGMS will be worn continuously at least 70% of the time. Diagnostic CGMS measure interstitial glucose concentrations during a certain time span, usually 5-10 days; there is no contemporaneous display of sensor readings and the information is downloaded and analysed by a healthcare professional at a later time. Benefits of using CGMS Using real time CGM and either a CSII (insulin pump) or multiple daily insulin injections achieves a significant reduction in HbA1c compared with the HbA1c levels of control patients who used only blood glucose self-monitoring using meters. Using CGMS therapy would save patients frequent testing (since this neither completely prevents all episodes of severe hypoglycaemia nor episodes of hyperglycaemia) and predictive sensor alerts would forewarn them (day and night) when glucose levels are dropping hence allowing them to take preventative actions and significantly decrease frequency of moderate and severe hypoglycaemia, with their physical and social sequelae and improved quality of life. Severe hypoglycaemia, hypoglycaemia unawareness and brittle diabetes lead to increased demand on primary, ambulance and secondary care services.

5 Policy - Criteria to Access Treatment is subject to Prior Approval by the IFR Team The Commissioner will commission the use of a Continuous Glucose Monitor only when the following criteria have been met: 1. The patient must have Type 1 Diabetes. 2. The patient must be using, or will begin using, insulin pump therapy with an Animas Vibe or a Medtronic Veo or a 640g insulin pump. 3. The patient must have: a. documented evidence of at least 2 episodes of hypoglycaemia requiring 3 rd party assistance (i.e. resulting, for example, in the loss of driving licence) OR b. recurrent episodes of hypoglycaemia, hypoglycaemia unawareness or night-time hypoglycaemia not amenable to usual therapeutic interventions* 4. The patient/family/carer must be highly motivated to use a CGM more than 70% of the time. 5. The patient must have documented agreement from an Insulin Pump Multi-Disciplinary Team (MDT) that criteria for use are met. The Commissioner will commission the use of a diagnostic CGMS for the duration of 5 days (and a maximum of 3 weeks in exceptional circumstances) when the following criteria have been met: 1. The patient must have Type 1 Diabetes (on CSII or Multiple Daily Insulin Injections) one of the following indicators: 2. Episodes of hyper/hypoglycaemia after all other issues have been addressed, for example - injection sites/technique, appropriate insulin regime, diabetes education update OR 3. Severe hypoglycaemia and/or hypoglycaemia unawareness OR 4. Nocturnal hypoglycaemia is suspected and difficult to confirm using capillary blood glucose readings OR 5. To demonstrate to the patient that current treatment/insulin regime is not achieving optimal control or if the patient has firm belief that they have recurrent hypoglycaemia with no objective supporting information OR 6. During preconception and pregnancy in a select group of patients.

6 *Strategies and Therapeutic Interventions to Prevent Hypoglycaemia. (Seaquist, E. R. et al. Hypoglycaemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care 36, (2013). Patient education Recognition of hypoglycaemia symptoms Effective treatment of hypoglycaemia Discussion of hypoglycaemia at review consultations, including: Frequency Severity Symptoms and awareness Analysis of events (cause, timing, role of alcohol, etc.) Knowledge of pharmacokinetics of medications Formal training programmes Hypoglycaemia identification training (impaired awareness) Dietary measures Knowledge of carbohydrate content of foods Predictable meal plan Flexible manipulation of insulin regimen and/or dosage Carry fast-acting carbohydrate to treat hypoglycaemia Physical exercise Recognition of potential risk factors (type, duration and timing of exercise) Glucose monitoring related to exercise Prophylactic snacks Insulin dose adjustment Glucose monitoring Routine and ad hoc testing, with records kept in a diary, log or memory facility of glucose meter Capillary blood glucose monitoring Diagnostic and/or real time continuous glucose monitoring (with pre-set alarm) Commencement of CSII, if still on Multiple Daily Insulin Injections Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. Individual cases will be reviewed at the CCG s Individual Funding Request Panel upon receipt of a completed application form from the patient s GP, consultant or clinician. Applications cannot be considered from patients personally. If you would like further copies of this policy or need it in another format, such as Braille or another language, please contact the Patient Advice and Liaison Service on or

7 Connected Policies This policy has been developed with the aid of the following references: BIBLIOGRAPHY Loof S., D. B. (2014). Perioperative complications in smokers and the impact of smoking cessation interventions [Dutch]. Tijdschrift voor Geneeskunde, vol./is. 70/4( Thelwall, S. P. (2015). Impact of obesity on the risk of wound infection following surgery: results from a nationwide prospective multicentre cohort study in England. Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,, vol. 21, no. 11, p e1. Approved by (committee): Clinical Policy Review Group Date Adopted: 13/10/2017 Version: Produced by (Title) Commissioning Manager Individual Funding EIA Completion Date: TBC Undertaken by (Title): Review Date: Earliest of either NICE publication or three years from approval. CATEGORY VERSION CATEGORY VERSION CATEGORY VERSION Bristol Prior Approval North Somerset Prior Approval South Gloucestershire Prior Approval