Original Title: Avis: Évaluation des systèmes de pompes à insuline chez les patients atteints du diabète de type 1

Authors' objectives: The Institut national d’excellence en santé et en services sociaux (INESSS) was mandated by the Ministère de la Santé et des Services sociaux (MSSS) to evaluate insulin pumps and their public coverage for adult patients with type 1 diabetes (T1D). With a view to promoting an informed decision-making process, the INESSS also conducted a clinical and economic assessment of the insulin pumps available to the pediatric population.

Authors' results and conclusions: RESULTS: (1. EFFICACY): Results of the studies considered in the review illustrate the limited effects of using a CSII on HbA1c, the common parameter used to evaluate blood sugar management. Moreover, there was no impact on the frequency of hypoglycemic episodes compared with multiple insulin injections, with or without a CGM device. Results were similar for both adult and pediatric populations. (2. SAFETY): Few safety data is available on insulin pumps in the literature. No benefits on the frequency of hypoglycemic episodes, regardless of severity, or ketoacidosis have been reported for these systems. • Studies have mentioned certain technical problems with devices, and very limited instances of infections or skin reactions at the cannula insertion site, but none of these were of major concern. (3. QUALITY OF LIFE): No clinically significant benefits in terms of quality of life were revealed by validated questionnaires completed by users of insulin pump systems in clinical studies. In addition, results do not enable quantifying any decrease in the burden on patients and their loved ones of both the disease and the necessary daily management. • On the other hand, qualitative analyses have shown numerous benefits to users, including improved health, improved quality of life and greater flexibility and freedom. This type of system can, however, prove complex and demanding, requiring a high degree of involvement and decision-making from patients or caregivers. (4. EXPERT OPINIONS): The experts consulted were of the opinion that HCL pump systems have clinically significant benefits for both the adult and pediatric populations. They also acknowledged that these systems allow for fine-tuning and refining blood sugar management strategies. The scope of the impact of HCL systems, given the experts’ clinical experience with these systems, are likely underestimated in study findings. (5. PATIENT AND CAREGIVERS OPINIONS): The patients and caregivers consulted described insulin pump systems as necessary technological tools. These systems notably represent an opportunity of living a normal life as well as improving flexibility and freedom and significantly decreasing mental load. • As for the pediatric population, caregivers mentioned a reduction in the burden on the people close to the patient. The reduction in glycemic variability made possible by insulin pump systems also has the advantage of reducing the stress associated with hypoglycemic episodes. (6. IMPACT ON THE HEALTH SYSTEM): In Québec, the Insulin Pump Access Program allows for reimbursing the costs of systems available to the pediatric population with T1D. These pediatric patients will continue to be covered once they become adults if they continue to meet the program’s eligibility criteria. However, an adult who is diagnosed with T1D after turning 18 is not eligible for the program. Québec is the only province in Canada which, limits the coverage of pump systems to its pediatric population. • The public reimbursement of CGM devices and pumps is ensured by two different modalities. Concerns as to equity could arise should access to the various devices differ based on the reimbursement model.

Authors' recommendations: Based on the available data, the Institut national d’excellence en santé et en services sociaux (INESSS) considers that: 1) Public reimbursement of hybrid closed loop (HCL) insulin pump systems for adults with type 1 diabetes could be a fair and reasonable option, conditional on: • manufacturers helping to alleviate the economic burden; • the use of pump systems being overseen by a team of specialists with experience handling these devices and who would offer pump system user’s advice regarding nutrition, lifestyle and exercise. 2) Public coverage of simple insulin pumps with no tubing could be a fair and reasonable option for adults with type 1 diabetes who encounter significant difficulties or are unable to use a pump with tubing. 3) The current eligibility criteria for public coverage of insulin pump systems for pediatric patients with type 1 diabetes should not be modified. 4) Similar eligibility criteria should be introduced for the adult population. The INESSS would specifically like to call the Minister’s attention to the following elements: • The availability of trained resources is essential to ensuring treatment adherence and the appropriate use of these types of devices. • Certain legal considerations may limit the reimbursement by private insurers of devices not included in the Public Prescription Drug Insurance Plan’s List of medications, one of these being insulin pump systems. • Given the rapid evolution of insulin pump systems and the uncertainty surrounding available clinical parameters, manufacturers must be responsible for providing an adequate level of evidence for future assessments. The INESSS specifically notes that: – the absence of a validation for the correlation between time in glycemic range and long-term complications highlights the need for manufacturers to provide more data in this regard; – seeing as the validated questionnaires regarding quality of life are unable to reflect obvious benefits of diabetes technology on daily life as reported by patients, additional tools should be created to address this shortcoming.

Authors' methods: The evaluation was performed by adopting an approach based on the overall assessment of value favoured by the INESSS. A quick review of the literature was done, to obtain evidence-based data and supplement the information provided by manufacturers. Background and experience-based knowledge were gathered by reaching out to experts, patients and caregivers, as well as users and non-users of the technology in question. All of the information obtained, once integrated, was submitted to the Comité scientifique de l’évaluation des médicaments aux fins d'inscription (CSEMI) so that recommendations could be developed.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/evaluation-des-systemes-de-pompes-a-insuline-chez-les-patients-atteints-du-diabete-de-type-1.html

Year Published: 2022

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/evaluation-des-systemes-de-pompes-a-insuline-chez-les-patients-atteints-du-diabete-de-type-1.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec