1.0 Introduction

  1. The Pharmaceutical Management Agency (PHARMAC) is the crown entity responsible for deciding which medicines and medical devices are publicly funded in New Zealand. PHARMAC’s objectives include securing the best health outcomes that are reasonably achievable from pharmaceutical treatment and from within the amount of available funding. [1]
  2. On 29 March 2019, PHARMAC made a decision to award the sole supply of the drug lamotrigine to a single brand, Logem, supplied by Mylan (the “Sole Supply Decision”). [2]
  3. Lamotrigine is an anticonvulsant medicine used for the treatment of epilepsy and some mental health conditions. Lamotrigine is currently used by approximately 12,500 people in New Zealand. Prior to the Sole Supply Decision, three brands of lamotrigine were funded, one of which was Logem. The Sole Supply Decision meant that approximately 11,000 people would need to change the brand of lamotrigine they had been using in order to continue to receive funded lamotrigine.
  4. Following the Sole Supply Decision, PHARMAC implemented a five month transition period where the three brands of lamotrigine continued to be funded while measures were taken to support the implementation of the Sole Supply Decision. On 1 October 2019, Logem became the only funded brand of lamotrigine in New Zealand.
  5. Throughout October and November 2019 there was increasing media and public interest in the move to the one brand of lamotrigine. The Centre for Adverse Reactions Monitoring (CARM) were reporting notifications of adverse reactions relating to the switch by patients to Logem. On 12 November 2019, Medsafe issued a monitoring communication concerning suspected adverse reaction reports in relation to lamotrigine which included three deaths. Those deaths, and subsequently further deaths, have been referred to the Coroner.
  6. On 15 November 2019 PHARMAC announced that it was widening its ‘exceptional circumstances’ criteria to make it easier for patients to remain on their established brand of lamotrigine.
  7. In February 2020, I was appointed by PHARMAC to conduct an independent review of the Sole Supply Decision. The terms of reference for the review are attached as Appendix 1. The purpose of the review has been to provide an independent view on whether PHARMAC’s decision making and implementation processes in relation to the Sole Supply Decision were appropriate. I have been asked to provide findings in relation to three key questions:
    1. Was the decision making process, including preliminary steps, followed by PHARMAC in relation to the lamotrigine Sole Supply Decision appropriate?
    2. Was the design and execution of PHARMAC’s implementation process for the lamotrigine Sole Supply Decision appropriate?
    3. 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?
  8. The review is not intended to be a reassessment of the substantive aspects of the Sole Supply Decision – but I was asked to include matters such as the sufficiency of the information provided to the decision maker.
  9. Any possibility that the Sole Supply Decision has caused, or contributed to, the death of any person is a matter for the Coroner. I have neither investigated, nor formed any views on, the possibility of any such connection.
  10. Prior to commencing the review, I advised PHARMAC that I felt that I would be assisted by engaging a clinical advisor to provide me with independent clinical guidance and advice. Associate Professor Matthew Doogue, a clinical pharmacologist and endocrinologist was engaged as clinical advisor. I have received advice from A/Prof Doogue and I refer to this advice throughout this report. A/Prof Doogue’s advice is attached in full, as Appendix 2.
  11. To enable me to conduct the review, PHARMAC has given me full access to all documentation relating to the making, and implementation, of the Sole Supply Decision. During the course of the review, I have identified additional information that I have felt would benefit the review. All information that I have requested from PHARMAC has been provided.
  12. As part of the review, I have met and interviewed a number of PHARMAC representatives. A full list is set out in Appendix 3. There have been no restrictions put on me in seeking to discuss this matter with any PHARMAC representative, and all who I have spoken to have engaged with me openly and constructively.
  13. At the commencement of the review, I raised the possibility with PHARMAC that, during the course of the review, it might become apparent that discussions with interested persons outside PHARMAC may assist me. PHARMAC was willing to facilitate that, if I felt it necessary. As matters have transpired, and subject to the comments in the following paragraph, I have not felt that it is necessary to speak to any other interested persons in order to respond to the matters I have been asked to review. However, throughout the review I have been acutely aware that the issues I have considered relate to health consumers who have been directly impacted by the Sole Supply Decision. The views of some of these consumers, their families, and their representatives, have been clearly and coherently set out in the material that I have reviewed, and I have considered these views carefully.
  14. I submitted a draft report to PHARMAC on 24 April 2020. Soon after submitting the draft report, I was informed by PHARMAC that a paediatric neurologist had contacted PHARMAC and had requested that they contact the independent reviewer to discuss the lamotrigine brand change decision. I subsequently had two telephone conversations with the paediatric neurologist and received written correspondence. In reaching my final findings I have taken into account the matters raised by the paediatric neurologist.
  15. PHARMAC was given an opportunity to respond to the draft report and provided a written response. I also gave PHARMAC an opportunity to respond to the matters raised by the paediatric neurologist, and a further brief response was submitted. I have taken into account these submissions made by PHARMAC. 
  16. Finally, I have been assisted in my review by Catherine Deans, a senior lawyer who works with me at Claro. Ms Deans has participated in the interviews and has provided valuable assistance with the review generally.

Footnotes

[1] New Zealand Public Health and Disability Act 2000, s 47(a).

[2] The Sole Supply Decision related to the 25mg, 50mg, and 100mg dispersible tablets. The 2mg and 5mg dispersible tablets (mainly for paediatric use) were unaffected by the Sole Supply Decision.