OIA response: Lamotrigine brand change

24 February 2020

 

[Name and contact details withheld]

 

REQUEST FOR INFORMATION

Thank you for your request, dated 18 December 2019, to Hon Dr David Clark requesting information under the Official Information Act 1982 (OIA) relating to the lamotrigine brand change.  As parts of your request relate more closely to the functions and responsibilities of PHARMAC, under section 14 of the OIA, questions 1, 2 and 11 of your request have been transferred to PHARMAC for a response.

This letter provides answers to each of these three questions, in order below. 

Who in this Government is accountable for PHARMAC?

PHARMAC’s Board is accountable to the Minister of Health. PHARMAC provides regular reports and briefings to the Minister in line with the Crown Entities Act 2004 (and other legislation that relates to particular Crown entities).  Under section 14(2) of the Act PHARMAC must, in performing its functions, act consistently with its objective.

The Ministry of Health, acts on behalf of the Minister, to monitor PHARMAC’s performance.  PHARMAC is accountable through the Minister to Parliament for its actions. PHARMAC’s performance is also scrutinised by Parliament’s Health Select Committee. 

Why were PHARMAC allowed to ignore Medsafe and why has the switch not been properly reversed in light of the four deaths and 50+ CARM reports?

PHARMAC did not ignore Medsafe’s advice.  In fact, PHARMAC delayed a decision on the proposal following Medsafe’s consultation feedback, engaged further with Medsafe to understand its concerns, and then sought further expert advice from its Pharmacology and Therapeutics Advisory Committee’s specialist subcommittees regarding those concerns.  PHARMAC also made some changes to its implementation plans in light of Medsafe’s feedback.

These specialist subcommittees are comprised of neurologists and psychiatrists who work directly with people with epilepsy and mental health conditions.  Following careful consideration of all the evidence, the subcommittees advised that there was no pharmacological reason to suggest there would be a clinical problem with changing brand of lamotrigine for patients with epilepsy or mental health conditions.  The subcommittees were supportive of a move to one funded brand of lamotrigine, with appropriate support and reassurance provided to patients during the transition.

Further details of the advice and assessment of all the evidence are publicly available in the records of the Neurological and Mental Health Subcommittees’ meetings on the PHARMAC website.

Logem has been approved for use in New Zealand by Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, who are responsible for ensuring the quality, safety and efficacy of medicines. Logem (and Arrow-lamotrigine) are bioequivalent to the innovator brand of lamotrigine, Lamictal.  Almost 90% of people taking lamotrigine are now established on the Logem brand.

PHARMAC will consider a funding application for a specific brand of lamotrigine for patients who, due to medical difficulties or concerns, are unable to manage a change to the Logem brand of lamotrigine, or who have not tolerated the change and have been on lamotrigine prior to 1 October 2019. Duration of ongoing funding for the requested lamotrigine brand will, if granted, be determined by PHARMAC on a case by case basis.  Some people need a longer period of time to transition and we have generally been granting funding for such people for 26 weeks.  For other people, who are unlikely to be able to attempt a change, we have been granting approvals for 156 weeks (the sole supply period).

As you have noted, there have been several reported deaths of lamotrigine users since 1 May 2019.  The cause of the deaths is unknown and the cases are being investigated by the Chief Coroner.  It is well recognised that people with epilepsy have an increased risk of sudden death – this is known as Sudden Unexpected Death in Epilepsy (SUDEP).  PHARMAC is supporting the Coronial investigation.  

On what date and how do the projections differ from the initial $30m saving? 

As the transition is not complete, PHARMAC has not undertaken an analysis to calculate the pharmaceutical cost impacts to District Health Boards associated with expanding the exceptional circumstances criteria. We have not recalculated projected savings.  As we do not hold the information, your request for it is refused under section 18(e) of the OIA, on the grounds that the information requested does not exist.

Once the transition is complete, and exceptional circumstances applications for ongoing funding of Lamictal or Arrow-Lamotrigine have ceased, we may undertake this assessment.  We note that this may be difficult to quantify given uncertainties about how many applications we would have received if we had not expanded the criteria. 

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 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

 

Rachel Read
Manager, Policy