Decision to change Special Authority criteria for empagliflozin and dulaglutide
3 June 2021
Dear [name and contact details withheld]
REQUEST FOR INFORMATION
Thank you for your request dated 16 April 2021 under the Official Information Act 1982 (OIA) for information relating to the decision to change the proposed Special Authority criteria for funding empagliflozin and dulaglutide.
As noted in our letter to you on 5 May 2021, we extended the response timeframe for your request as we required additional time to undertake consultations for the release of the information in scope of your request. We have now completed our consultations and are able to provide you with a response to your request for information.
Any reports, emails, correspondence, briefing documents and advice produced by and for Pharmac between September 9 and December 21, 2020 relating to the decision to change the Special Authority criteria for Empagliflozin and Dulaglutide.
Also include any correspondence, emails and advice between Pharmac and the Minister of Health during the same timeframe.
On 21 December 2020, we announced a decision to fund two new medicines (empagliflozin and dulaglutide) for type 2 diabetes. A copy of the announcement can be found on our website: www.pharmac.govt.nz > News and resources > Consultations and decisions > Proposal to fund two new medicines for type 2 diabetes.
This decision was made after a consultation about the proposal which was open from 9 September to 2 October 2020.
We received a substantial amount of consultation feedback which took us some time to work through. After carefully considering the consultation feedback we made some changes to the Special Authority criteria originally proposed. These changes to the criteria aim to make sure that people with type 2 diabetes who are at high risk of heart and kidney complications can access these treatments.
A copy of all consultation feedback received, plus a summary of feedback themes and our responses, is included in the decision announcement under Our response to what you told us. We also added a list of questions and answers regarding this decision under What does this mean for people? to help prescribers and people with diabetes understand how this decision may affect them.
Your request for information under the OIA
Please find copies of the information you have requested attached with this letter.
Note: we have interpreted your request for “correspondence, emails and advice between PHARMAC and the Minister of Health during the same timeframe” to relate specifically to the change of Special Authority (SA) criteria for empagliflozin and dulaglutide.
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 as 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 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));
- maintain the effective conduct of public affairs through the free and frank expression of opinions by or between officers and employees of an organisation in the course of their duty (section 9(2)(g)(i);
- maintain legal professional privilege (section 9(2)(h));
- 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.
Additionally, we have refused to release some information and documents (such as abstracts and/or research papers, as referenced throughout the attached documents) under section 18(d) of the OIA as this information is already publicly available and may be subject to copyright restrictions.
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 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