Information relating to funding continuous glucose monitors (CGMs)
Request for information on the research, feasibility studies, communication between staff members or external organisations relating to glucose monitors (CGMs).
18 November 2020
Dear [name and contact details withheld]
REQUEST FOR INFORMATION:
Thank you for your request dated 1 October 2020 under the Official Information Act 1982 (OIA) for information relating to continuous glucose monitors (CGMs). Further to our email to you on 30 October 2020, please find our complete response, including copies of requested documentation, below. You asked for:
- any information provided to Pharmac or prepared by it in regards to the funding or not of these devices. So I mean; research, feasibility studies, communication between staff members or external organisations including Diabetes NZ or anyone who makes or distributes these devices, any advice given to the minister or ministry.
PHARMAC currently has two (2) active funding applications for CGMs:
- Medtronic continuous glucose monitoring systems - Guardian 3 and Guardian Connect (Guardian); and
- Freestyle Libre flash glucose monitoring system
Please refer to the PHARMAC Application Tracker(external link) to view the status and public information of these applications, including links to related clinical advice meeting records.
In consultation with you to refine the scope of your request, we agreed to provide the following documents specifically related to the funding, or not, of CGMs (including the Freestyle Libre flash glucose monitoring system):
- all Pharmacology and Therapeutics Advisory Committee (PTAC) and Diabetes Subcommittee minutes regarding CGMs
- the Technology Assessment Report (TAR) for the Freestyle Libre flash glucose monitoring system
- any communications between PHARMAC and Diabetes NZ
- any communications between PHARMAC and PTAC and/or the Diabetes Subcommittee
- a list of research papers accessed by or provided to PHARMAC.
Please refer to Appendix 1 of this response for copies of documents related to items 1, 3 and 4 of your request.
Please refer to TAR 417, also attached with this response, for a copy of PHARMAC’s TAR for the Freestyle Libre flash glucose monitoring system (item 2). TARs are detailed analyses of new pharmaceuticals. They are used to determine the cost-effectiveness of pharmaceuticals that we are being asked to fund. PHARMAC has not yet produced a TAR for the Guardian CGMs as the assessment of this application is pending clinical advice.
A list of research papers accessed by or provided to PHARMAC (item 5)–which are not already referenced within Appendix 1–is included at the end of this letter.
Please note that PHARMAC approaches its assessment of requests for information under the OIA on the basis that, once released, the information becomes publicly available – in other words, once we release the information to you it becomes available to any other party in that exact form (whether by you distributing it to others or by virtue of us receiving the same request from a different third party).
We have redacted a small amount of information from the documents provided as we consider this information is out of scope of your request or that it is necessary to:
- protect information where the making available of the information would be likely to unreasonably prejudice the commercial position of the person who supplied or who is the subject of the information (section 9(2)(b)(ii));
- protect information which is subject to an obligation of confidence or which any person has been or could be compelled to provide under the authority of any enactment, where the making available of the information would be likely to prejudice the supply of similar information, or information from the same source, and it is in the public interest that such information should continue to be supplied (section 9(2)(ba)(i)); and
- enable PHARMAC to carry on, without prejudice or disadvantage, negotiations, including commercial negotiations (section 9(2)(j)).
As required under the OIA, we also considered whether, in the circumstances, the withholding of this information was outweighed by other considerations which render it desirable, in the public interest, to make this information available. In this case we did not consider that the public interest outweighed the reasons for withholding the information.
Please note you have the right, by way of complaint under section 28(3) of the OIA to an Ombudsman, to seek an investigation and review of our decision.
We trust that this information answers your queries. We are making our information more freely available, so we will now publish selected OIA responses (excluding personal details) on our website. Please get in touch with us if you have any questions about this.
Manager, Policy and Government Services
Research papers accessed by or provided to PHARMAC
Abbott Diabetes Care. (2017). An Evaluation of Novel Glucose Sensing Technology on Hypoglycaemia in Type 1 Diabetes (IMPACT). Retrieved from https://clinicaltrials.gov/
Charleer, S. (2018). Real-World Impact of RT-CGM Reimbursement. The Journal of Clinical Endocrinology and Metabolism, 103(3), 1224-1232.
Diabetes.co.uk. (2018, April 3). CGM use could improve HbA1c and reduce distress in adolescents with type 1 diabetes. Retrieved from https://www.diabetes.co.uk/news/2018/apr/cgm-use-could-improve-hba1c-and-reduce-distress-in-adolescents-with-type-1-diabetes
Dunn, T. (2017, February 15-18). Evidence of a strong association between frequency of flash glucose monitoring and glucose control measures during real-world useage. The 10th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2017). Paris, France.
Macaulay, G. C. (2020). Sleep and Night-time Caregiving in Parents of Children and Adolescents with Type 1 Diabetes Mellitus – A Qualitative Study. Behavioural Sleep Medicine, 18(5), 622-636.
Metcalfe, S. (2014). Self-monitoring blood glucose test strip use with diabetes medicines in people with types 1 and 2 diabetes in New Zealand. The New Zealand Medical Journal. Retrieved from https://pubmed.ncbi.nlm.nih.gov/25447249/
Miller, K. (2013). Evidence of a strong association between frequency of self-monitoring and hemoglobin A1c levers in T1D Exchange clinic registry participants. Diabetes Care, 36(7), 2009-2014.
Ministry of Health. (n.d.). Virtual Diabetes Register (VDR). Retrieved from https://www.health.govt.nz/our-work/diseases-and-conditions/diabetes/about-diabetes/virtual-diabetes-register-vdr
National Diabetes Services Scheme. (2020, February 2). Continuous Glucose Monitoring Initiative: FreeStyle Libre added and eligibility criteria streamlined from 1 March 2020. Retrieved from National Diabetes Services Scheme: https://www.ndss.com.au/news/announcement/
National Institue for Health and Care Excellence. (2008, July 23). Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus. Retrieved from https://www.nice.org.uk/guidance/ta151
New Zealand Doctor. (2018, August 22). Current and future technology for the management of type 1 diabetes. Retrieved from https://www.nzdoctor.co.nz/article/news/clinical/current-and-future-technology-management-type-1-diabetes
Onisie, O. (2019, August 16). The CGM grey market: a reflection of global access inequity. Lancet Diabetes Endocrinol 2019.
Ontario Health (Quality). (2019, December 12). Flash Glucose Monitoring System for People with Type 1 or Type 2 Diabetes: A Health Technology Assessment. Ontario Health Technology Assessment Series, 19(8). Retrieved from https://pubmed.ncbi.nlm.nih.gov/31942227/
Pedersen-Bjergaard, U. (2017, October 28). Reporting Severe Hypoglycemia in Type 1 Diabetes: Facts and Pitfalls. Current diabetes reports, 17(12), 131. doi:10.1007/s11892-017-0965-1
Robson, B. (2007). Hauora: Māori Standards of Health IV. A study of the years 2000–2005. Te Rōpū Rangahau Hauora a Eru Pōmare, School of Medicine and Health Sciences, University of Otago. Retrieved from http://www.hauora.maori.nz/
Vincze, G. (2004). Factors associated with adherence to self-monitoring of blood glucose among persons with diabetes. Diabetes Education, 30(1), 112-125.
Wagner, J. (2005). Invasiveness as a barrier to self-monitoring of bloog glucose in diabetes. Diabetes Technology & Therapeutics, 7(4), 612-619.