Dexcom continuous glucose monitors, Tandem insulin pump documents and emails

19 March 2021

Dear [name and contact details withheld]

REQUEST FOR INFORMATION

Thank you for your patience as we collated information relevant to your request.

Following our response sent to you on 3 December 2020, please find a further response to your request related to the FreeStyle Libre Flash Glucose Monitor (FGM), Dexcom Continuous Glucose Monitors (CGMs) and the Tandem insulin pump and its software upgrades below.

Please note, we have interpreted your request to mean applications for funding via the Pharmaceutical Schedule (Schedule) and not for individual patient funding applications via our Exceptional Circumstances Framework (eg applications submitted via the Named Patient Pharmaceutical Assessment). We have not provided any information related to applications received via our Exceptional Circumstances Framework as we have considered this out of scope of your request.

FreeStyle Libre Flash Glucose Monitor

You requested “All documentation you hold regarding the applications, meetings, advice, correspondence and decisions made regarding funding the Freestyle Libre Flash Glucose Monitoring System. If possible include the current rank on your prioritisation list.”

Further to our response sent to you on 3 December 2020, we are in the final stages of collating additional information in scope of your request and will provide you with this information as soon as possible and without undue delay. We expect to be able to provide the documentation to you by Friday 26 March 2021.

Dexcom Continuous Glucose Monitors

You requested “All documentation you hold regarding the applications, meetings, advice, correspondence and decisions made regarding funding any iteration of the Dexcom Continous Glucose Monitor. If possible include the current rank on your prioritisation list.”

Further to our response sent to you on 3 December 2020, please refer to Appendix 1, included with this response, for copies of the documentation requested.

Please note, PHARMAC recently identified the funding applications submitted for the Dexcom G5 and Dexcom G6 CGMs are not clearly identified on our Application Tracker. We are working to address this within our system. We plan to seek further clinical advice from the Diabetes Subcommittee regarding CGMs in 2021. This would include device specific advice and comparability between devices. This will inform our assessment of CGMs in line with our medicines funding process. Please note, we initially planned to seek this advice in 2020 however this was delayed due to the COVID-19 pandemic.

Tandem Basal-IQ and Control-IQ insulin pumps

You requested “All documentation you hold regarding the Tandem T:slim X2 Insulin Pump, specifically software upgrades to Basal-IQ and Control-IQ which allow the pump to integrate with the Dexcom G6 CGMS and automatically adjust insulin delivery.”

We have interpreted this request to mean copies of all documentation specifically regarding the change from the Tandem T:slim X2 to the Tandem Basal IQ or Tandem Control IQ insulin pump.

Please refer to Appendix 2, included with this response, for copies of the documentation requested.

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 some information from the attached documents, or withheld full pages from documents when all information on a page is considered out of scope of your request (ie where information does not relate to the FreeStyle Libre FGM, any iteration of the Dexcom continuous glucose monitor or the Tandem insulin pump) to ensure the information you have requested is easily identifiable and accessible.

We have also redacted a small amount of information from the documents attached, or withheld documents in full, where we consider this is necessary to:

• protect the privacy of natural persons (section 9(2)(a))
• 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 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

Yours sincerely 

Rachel Read
Manager, Policy and Government Services