FreeStyle Libre Flash Glucose Monitor documents

26 March 2021

Dear [name and contact details withheld]

REQUEST FOR INFORMATION

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

Following our latest correspondence sent to you on 19 March 2021, we have now finalised for release the remaining documents in scope of your request related to the FreeStyle Libre Flash Glucose Monitor (FGM).

As noted in our previous correspondence, 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.”

Please refer to Appendix 3, included with this response, for copies of the FreeStyle Libre FGM documentation requested. Excerpts of records of the Diabetes Subcommittee of PTAC meetings referred to within Appendix 3 are included in Appendix 1 of our OIA response issued 18 November 2020.

 A summary of the supplier’s pharmaceutical schedule application for the FreeStyle Libre FGM is also provided within Appendix 1. Per your email response to us on 11 January 2021, you confirmed that you consider the summary of the supplier application sufficient for the purpose of this OIA request. As such, we have not included the full supplier application for the FreeStyle Libre FGM within this response.

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) 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