Lamotrigine review: Appendix 1 – Terms of Reference
Terms of Reference for the Independent Review of PHARMAC’s Lamotrigine Sole Supply Decision
On 11 April 2019 PHARMAC decided to award sole supply of the drug lamotrigine to a single brand, Logem, supplied by Mylan (the “sole supply decision”).  Previously, three brands of lamotrigine had been funded, including Logem. Lamotrigine is an anticonvulsant predominantly used for the treatment of epilepsy and some mental health conditions.
The decision meant that approximately 11,000 people would need to change the brand they use in order to continue receiving funded lamotrigine. Logem became the only funded brand from 1 October 2019 following a five month transition period. PHARMAC adopted a range of measures to support the implementation of the sole supply decision.
PHARMAC received a range of advice and feedback prior to making the sole supply decision. This included advice from its expert neurological and mental health subcommittees, from Medsafe (the medicines regulator), and from many other parties. A considerable amount of feedback was received via a public consultation process which commenced in August 2018. There were a range of conflicting views as to whether the proposal should proceed.
On 12 November 2019 Medsafe issued a monitoring communication concerning suspected adverse reaction reports in relation to lamotrigine which included (at that time) three deaths. Those deaths have been referred to the Coroner.
On 15 November 2019 PHARMAC announced that it was widening the criteria for its exceptional circumstances to make it easier for patients to remain on their current brand of lamotrigine where their doctor believed it was right for them.
Purpose of the review:
The Independent Review has been established to:
- Provide an independent view on whether the decision making and implementation processes followed by PHARMAC in relation to the sole supply decision were appropriate, and
- To identify any areas in which PHARMAC could improve its decision making and implementation processes for any future brand changes.
Parameters of the review:
The review is intended to be an “end to end” review of the systems and processes followed by PHARMAC in relation to the sole supply decision. In particular, it will address:
- all preliminary steps which led to the sole supply decision,
- all steps since taken to implement the decision,
- all steps responding to subsequent events.
For the avoidance of doubt, the review is not intended to be a reassessment of substantive decision making, but will include matters such as the sufficiency of the information provided to the decision maker.
The Independent Reviewer will have full access to PHARMAC’s documentation and staff as required, subject only to any reasonable restrictions for legal, commercial, or privacy reasons.
The Reviewer will engage a suitably qualified clinical advisor (to be agreed between the Reviewer and PHARMAC) to provide independent guidance and advice to the Reviewer.
The Independent Reviewer is asked to provide findings in relation to the following matters:
- Was the decision-making process, including preliminary steps, followed by PHARMAC in relation to the lamotrigine sole supply decision appropriate?
- Was the design and execution of PHARMAC’s implementation process for the lamotrigine sole supply decision appropriate?
- Given PHARMAC’s role in the health sector, are there areas in which PHARMAC could improve its decision making and implementation processes for future brand changes, and if so what are these?
The following matters are out of scope of this review:
- The specifics of any matter currently before the Coroner
- Conduct by parties outside PHARMAC
- Findings regarding adverse events experienced by individual patients
- Matters of legal liability
- Matters relating to individual staff conduct or performance
- Matters relating to PHARMAC’s statutory objective and/or the scope of PHARMAC’s current role.
Deliverables, timeframes, and reporting
The Independent Reviewer is to provide a draft report for PHARMAC comment prior to producing a final report. The intended timing for delivery of the final report is early April 2020.
 The decision related to the 25mg, 50mg, and 100mg dispersible tablets. The 2mg and 5mg dispersible tablets (mainly for paediatric use) were unaffected by the decision.
Last updated: 5 June 2020