Lamotrigine NPPA change

16 December 2019

[name and contact details redacted]

Dear [name redacted]

REQUEST FOR INFORMATION

Thank you for your request dated 18 November 2019 under the Official Information Act 1982 (OIA) for information relating to lamotrigine.  Your specific request covers the period between 4 – 18 November 2019 and you asked for copies of:

• All documents, reports, analysis, correspondence, emails and communications between members of the Pharmac senior leadership team in relation to the policy change to widen access to the exceptional circumstances process for lamotrigine

• All documents, reports, analysis, correspondence, emails and communications between members of the Pharmac senior leadership team and the board and chair of Pharmac in relation to the policy change to widen access to the exceptional circumstances process for lamotrigine

• All documents, reports, analysis, correspondence, emails and communications between Pharmac staff and the Minister of Health in relation to the policy change to widen access to the exceptional circumstances process for lamotrigine

• All documents, reports, analysis, correspondence, emails and communication between Pharmac staff and Mylan in relation to the policy change to widen access to the exceptional circumstances process for lamotrigine

• All documents, reports, analysis, correspondence, emails and communication between Pharmac staff and Medsafe in relation to the policy change to widen access to the exceptional circumstances process for lamotrigine

PHARMAC Response

We note that your request seeks all ‘communications’ between members of the PHARMAC senior leadership team (SLT), and in anticipation that you are seeking to understand the decision-making process leading to the announcement we think it is useful to describe the verbal engagements between SLT members that resulted in PHARMAC’s decision to widen access to the exceptional circumstances process for lamotrigine.

On 14 November 2019, PHARMAC’s Acting Medical Director, Dr Ken Clark and Director of Operations, Lisa Williams, discussed the impact of the media coverage and social media commentary that had been occurring since the publication of Medsafe advisory alert on 12 November. 

They agreed that, although PHARMAC already had in place an exceptional circumstances process to enable ongoing funding of previous brands for people unable to change and almost 90 applications had been received, in the context of the level of public concern being expressed the volume of applications had been relatively low.  They were concerned about the negative impact that anxiety could have on people using lamotrigine (i.e. that it could trigger seizures or that some people might stop using the medicine out of fear, which could have severe health impacts).  They considered that the level of anxiety being expressed by people and their families was significant and that it potentially would cause harm.   They determined that the exceptional circumstances process needed to be more broadly promoted and widened to make it easier for people on lamotrigine to stay on their current brand, if their doctor thought they should.

The Chief Executive was, at the time, overseas.  However, the Medical Director and Director of Operations telephoned her on 14 November 2019 to confirm she was comfortable with the approach; which she was.  The Director of Operations then verbally commissioned relevant staff to prepare appropriate materials to implement the decision to widen the exceptional circumstances process.

Copies of the documents and written information you requested are attached. [PDF, 13 MB]

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 material as it is outside the scope of your request.

We have also 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)); and
• 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)).

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.

Yours sincerely

Alison Hill
Director, Engagement and Implementation