2.0 Lamotrigine Review: Summary of findings and recommendations
Was PHARMAC’s decision making process in relation to the sole supply of lamotrigine appropriate?
- With two exceptions, PHARMAC’s process in the period leading up to the issuing of its Request for Proposals (RFP) for the sole supply of lamotrigine in June 2018 was appropriate. It was evidence based and robust.
- The two exceptions are:
- First, PHARMAC ought to have involved its Consumer Advisory Committee (CAC) at some point over this period; and, in particular, at some point after the November 2015 Neurological Subcommittee meeting. While it is unlikely that involvement of the CAC would have led to a substantive change in the proposed decision, it was clear that the proposal to move to one brand of lamotrigine would have a significant impact on consumers. The CAC’s input would likely have been useful; and involving it would have been good practice.
- Secondly, and less significantly, it would have been preferable if PHARMAC had sought further input from its Pharmacological and Therapeutics Advisory Committee (PTAC), most likely through PTAC’s Subcommittees, at a time closer to the issuing of the RFP in June 2018.
- PHARMAC’s RFP and consultation processes were appropriate.
- The PHARMAC Board’s decision making process was sound. The Board had sufficient evidence to make the decision on 29 March 2019 to move to one brand of lamotrigine; and this decision was appropriate.
Was the design and execution of PHARMAC’s implementation process for the Sole Supply Decision appropriate?
- PHARMAC’s implementation process, and risk management strategies, were of a high standard. There are two qualifications to this conclusion:
- First, PHARMAC ought to have involved its CAC in the development of its Implementation Plan prior to the Board’s decision on 29 March 2019. The CAC was not consulted until June 2019. Given the depth and robust nature of the Implementation Plan, it may be that earlier involvement of the CAC would not have resulted in any significant changes to the Implementation Plan. However, the CAC’s consumer voice on the implementation activities and risk mitigation strategies should have been heard earlier in the process.
- Secondly, the patient information leaflet was easy to read and, appropriately, encouraged patients to talk to healthcare professionals about the brand change. However, the leaflet did not mention PHARMAC’s preparedness to pay the GP’s co-payment for patients who wanted to consult their doctor about the change. While that was mentioned in other places, the patient information leaflet would have been a good place to include this important information for patients.
Given PHARMAC’s role in the heath sector, are there areas in which PHARMAC could improve its decision making and implementation processes for brand changes?
- PHARMAC’s decision making could be improved by earlier involvement of its CAC. I recommend that PHARMAC continues with the current process of reviewing the CAC and its role; and in doing so takes into account the matters referred to in this report.
- While PHARMAC’s implementation activities and risk mitigation strategies were of a high standard, PHARMAC will need to be hyper-vigilant in any future, proposed brand changes involving anti-epileptic drugs (AEDs) – including working as closely as possible with key stakeholders, other agencies, and consumer groups. The role played by the media in reporting on brand switches is significant; and it may be that there is work PHARMAC can do with the media to ensure there is good understanding of the basis of decision making.
Last updated: 16 July 2020