6.0 Implementation of the Sole Supply Decision

  1. In order to draw conclusions on the design and execution of PHARMAC’s implementation process for the Sole Supply Decision it is useful to continue the chronological overview of PHARMAC’s process. It is clear from the chronology set out above, that PHARMAC gave considerable thought to implementation issues during the decision-making process leading up to the Sole Supply Decision. That is evident from the Minutes of the Joint Subcommittees’ meeting in February 2019, the correspondence with Medsafe, and other documents.
  2. At the time PHARMAC’s Board made the Sole Supply Decision, the Board had before it PHARMAC’s implementation plan – set out in documents entitled Engagement and implementation approach to support the proposal to change brands of lamotrigine (referred to from this point as the Implementation Plan).
  3. The Implementation Plan set out four ‘key mitigation strategies’:
    1. Strengthening positive relationships with PHARMAC’s sector partners. The plan was to work with other agencies to ensure messages were aligned, and to help monitor and manage the impact. The key stakeholders identified were Medsafe, CARM, and NZTA.
    2. Supporting health professionals to change their patients’ brand of lamotrigine. The importance of prescribers and community pharmacists were identified. The strategy included:
      • providing clear information to health professionals about the change; the bioequivalence of Logem to the originator brand of lamotrigine; and activities available to help them support patients;
      • paying a brand switch fee paid to community pharmacy in recognition of the additional patient counselling that would be required during the brand change;
      • providing a mechanism to remunerate general practices for appointment fees for patients requiring extra counselling and support from their GP to manage their lamotrigine brand change;
      • providing a mechanism under PHARMAC’s ‘exceptional circumstances’ framework for prescribers to apply for their patients to remain on their current brand of lamotrigine. This would be for those patients they think would not manage this brand change.
    3. Supporting patients through the brand change. It was recognised that some patients would find the brand change challenging. The strategy included:
      • developing patient-focussed resources, including website and downloadable information, using language that would make the brand change understandable for patients;
      • developing a communications plan to support notifications and respond to any enquiries received about the change – including ensuing PHARMAC’s 0800 enquiry line is supported by pharmacists to respond to patient enquiries;
      • providing a link on PHARMAC’s website to a survey (managed by the University of Auckland) for patients taking lamotrigine to be able to provide feedback about their experience with the brand change;
      • supporting research by the University of Auckland on the brand change to assess the impact of different interventions on people’s acceptability of this brand change.
    4. Supporting consumer organisations to support their members through the brand change. The strategy was to provide Epilepsy NZ, other epilepsy consumer organisations, and organisations working to support people with mental health conditions, with information to provide their members about the brand change. Specific activities included considering providing financial support to Epilepsy NZ with an epilepsy awareness campaign that includes the importance of medication adherence to AEDs; and producing an epilepsy on-line seminar that Epilepsy NZ field officers could access to update their knowledge about the role of AEDs and medication management.
  4. PHARMAC announced its decision to move to one funded brand of lamotrigine on 11 April 2019. A standalone ‘Decision’ document was produced, published on the website, and circulated widely. It set out the implementation activities to support the brand change, and drew readers’ attention to PHARMAC’s website which would set out further details. It recorded that there would be a five month transition period, during which Lamictal and Arrow-Lamotrigine would remain fully-subsidised; but that from 1 October 2019 these two brands would be delisted and Logem would be the only funded brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets.
  5. On 11 April 2019 PHARMAC representatives had a teleconference with Medsafe representatives to discuss the notification of the change. PHARMAC’s file note records that there was discussion about the steps PHARMAC was taking, and intending to take. The file note records that Medsafe’s feedback was that the key messages ‘look good’.
  6. Throughout April and May 2019 PHARMAC circulated its decision widely, initially by email to key stakeholders, all recipients of the consultation document, and those who had provided feedback on the consultation process. On 26 April 2019 the Pharmaceutical Schedule update, confirming the change, was sent to 1,023 community pharmacies.[37] On 2 May PHARMAC released a ‘News story’, which was emailed to 1,197 subscribers to PHARMAC’s electronic mailing list. The publication outlined the change; noted the availability of the brand switch fee; and contained a hyperlink for access to a downloadable patient information leaflet.
  7. On 17 May 2019, PHARMAC emailed primary care groups informing them about PHARMAC’s preparedness to meet the costs of any GP visit co-payment. The details of the process for seeking reimbursement were provided.
  8. I note, here, that the downloadable patient information leaflet suggested that patients talk to their healthcare professionals if they had any concerns about changing brands. However, the leaflet did not state that PHARMAC would meet the costs of any GP visit co-payment. PHARMAC told me that, at this time, the reimbursement process had not been developed.
  9. On 11 June 2019, PHARMAC hosted a Facebook live “Ask me anything” event for consumers to ask about issues relating to the brand switch. The event was prompted by what PHARMAC considered to be significant misinformation circulating on social media, and in particular on Facebook.
  10. The CAC met on 12 June 2019. The Minutes of this meeting record a number of matters that are relevant for immediate purposes. First, there is reference to the previous CAC meeting that had been held on 6 March 2019. Secondly, the Minutes record that CAC members noted that there were no update papers for this meeting. Thirdly, there is reference to a review of the role of the CAC and how PHARMAC could be more effective in incorporating the consumer voice in its processes. Fourthly, the CAC received a presentation from senior PHARMAC staff on generic medicines and PHARMAC’s management of brand changes. The presentation used the current brand change of lamotrigine as an example – with details provided on the steps PHARMAC had taken as part of the implementation of the decision. The Minutes then record the following:

Members asked about whether support information had been provided to health help lines, and practice nurses, as these tended to be first points of contact for patients?
Staff acknowledged this point, and said they would look into it.

  1. I will address this point further in the Findings section below. However, I note here, that this is the first record that I have seen of the CAC being given any information about either the proposal to move to one brand of lamotrigine, or the Sole Supply Decision itself, or the implementation strategy. When the CAC was given some details, as an example to illustrate PHARMAC’s management of brand changes generally, the CAC members raised a matter that not only appears pertinent, but was something that does not appear to have been directly considered to that point.
  2. On 21 June 2019, PHARMAC presented to Epilepsy NZ field support officers on the move to one brand of lamotrigine. PHARMAC provided almost $7,000 of funding to Epilepsy NZ to enable field support officers from around the country to attend the Auckland meeting. PHARMAC also arranged for Dr John Mottershead, a University of Otago neurologist and a member of the Neurological Subcommittee of PTAC, to attend and present on lamotrigine and the switch to one brand. PHARMAC representatives provided extensive information to the field support officers on the brand change, including practical information for patients.
  3. On 9 August 2019, Medsafe informed PHARMAC that there had been four ‘brand switch’ reports to CARM relating to lamotrigine.
  4. On 22 August 2019, Best Practice Advocacy Centre (BPAC) published its article ‘The funded brand of lamotrigine is changing’. The article was distributed to primary healthcare professionals and relevant specialist groups.
  5. This is a suitable place to interpose in the chronology and comment further on BPAC’s role and PHARMAC’ engagement with BPAC. BPAC is an independent New Zealand organisation that delivers educational and continuing professional development programmes to medical practitioners and other health professionals. Separate to the decision making relating to lamotrigine, PHARMAC has, at its own expense, engaged BPAC to develop a series of modules in relation to generic medications. BPAC has produced articles on issues including monitoring brand changes, bioequivalence and bioavailability, and generic medicines.
  6. Another, more general step PHARMAC has taken in this area is the preparation of an online, e-learning module Beyond the Brand (2017). The e-learning module traverses PHARMAC’s role, and such issues as brand changes, generic medicines and bioequivalence.
  7. On 2 September 2019, there was a telephone conference between PHARMAC and the CEO of Epilepsy NZ. This was one of many communications between PHARMAC and Epilepsy NZ during, and following, the transition period in 2019. As on other occasions, the importance of ensuring that media and other reporting did not create undue fear or anxiety for patients was emphasised. On 10 September there was a Zoom meeting between PHARMAC and Epilepsy NZ. It is clear from these, and other, records that PHARMAC was going to considerable lengths to keep open lines of communication with Epilepsy NZ.
  8. PHARMAC received the first media enquiries about the move to one brand of lamotrigine on 10 September 2019 and, over the following period, a number of media requests were made to PHARMAC.
  9. Around the same time, media were approaching NZTA. NZTA initially informed the media (RNZ) that “in light of Medsafe’s submission to PHARMAC” NZTA was reviewing its policy that the brand change was not a change in treatment that required a six month stand down from driving. NZTA subsequently stated that it would not be enforcing a mandatory stand down period from driving; but recommended a voluntary eight week stand down period for those who are changing to Logem from another brand of lamotrigine. NZTA’s advice caused concern and confusion amongst health professionals and patients.
  10. NZTA’s advice led directly to Epilepsy NZ writing to the Minister of Health, on 1 October 2019, asking for the Minister to instruct PHARMAC to make Lamictal and Arrow-lamotrigine available to people with epilepsy who are seizure-free and driving.
  11. PHARMAC convened a teleconference meeting of the Neurological Subcommittee meeting on 8 October 2019 to discuss NZTA’s position, the CARM reports, implementation activities, and other issues relating to the brand change. The Subcommittee’s Minutes note that members did not regard it as their role to interpret NZTA’s advice. The Minutes record their role as being to provide clinical and evidence based advice to PHARMAC, and their patients. The Minutes state that the brands are bioequivalent and interchangeable and therefore there should be no clinical problem with changing brands. The Subcommittee noted that patients with epilepsy will have seizures and are not at an increased risk due to a brand change.
  12. PHARMAC continued to keep the Neurological Subcommittee informed as media interest increased throughout October 2019. The Subcommittee members were also informed about the increasing CARM reports – which, by 31 October 2019, had reached 43 since 1 May 2019, including three reported fatalities.
  13. In PHARMAC’s communication with the media over this period, PHARMAC consistently emphasised, and asked the media to emphasise, the important message that people who have been prescribed Logem do not stop taking it – and that if patients have concerns they should contact their doctor, and PHARMAC would reimburse the costs.
  14. On 6 November 2019, PHARMAC’s Acting Medical Director, sent an email to primary care groups and other key stakeholders. The email noted the ability of GPs to claim reimbursement from PHARMAC for patient consultations relating to additional support because of the brand change; informed practitioners about the exceptional circumstances pathway; and provided a hyperlink to the downloadable patient information leaflets. The email also contained a hyperlink to the article prepared by BPAC New Zealand which includes practical advice on the brand change.
  15. On 12 November 2019, Medsafe issued an alert about suspected adverse reaction reports received by CARM. This included reporting that CARM had received reports of three deaths – but that the cause of death remained unknown. Medsafe’s alert triggered further media enquiries.
  16. On 14 November 2019, PHARMAC decided to widen the access criteria for other brands of lamotrigine under its ‘exceptional circumstances’ process. On 15 November 2019, by way of letter circulated to primary health providers, PHARMAC’s Acting Medical Director advised that PHARMAC would consider funding applications from prescribers who may have difficulty changing brands due to medical reasons or other concerns. This would include individuals that prescribers considered had not tolerated the changes; have had breakthrough seizures; have had mood destabilisation; where there are clinical concerns about the individual’s ability to manage the change; or where there are concerns about the ability to drive. PHARMAC provided a hyperlink to further information and the relevant, updated application forms.[38]
  17. Significant media interest, and reporting, continued throughout November and December 2019 (and in due course into 2020). As at 24 January 2020, CARM had received 191 reports for lamotrigine, of which 170 were brand related.
  18. As at the end of January 2020, more than 2000 people were confirmed on PHARMAC’s ‘exceptional circumstances’ pathway, which meant that these people were receiving a different brand of lamotrigine than Logem. At that time, PHARMAC continued to receive around 30 applications each day for ‘exceptional circumstances’ funding.

Clinical Advisor’s advice

  1. A/Prof Doogue’s advice is that brand changes are a normal, rather than an unusual, occurrence. Implementation planning, and risk mitigation strategies, are directed at the management/social risks associated with the brand change to Logem.
  2. In A/Prof Doogue’s opinion, the guidance offered by PHARMAC around switching brands “was sufficient to inform good medicines counselling by doctors, pharmacists and nurses”. He noted that Logem was in existing use in New Zealand. This was not switching all patients from one brand to another; but consolidation to use of a single brand. A/Prof Doogue concluded by stating that:

In my opinion PHARMAC’s implementation planning and risk mitigation was of a high standard. Putting additional resources to this would have added cost and been unlikely to reduce risk.

  1. Insofar as the response to the adverse reaction notifications is concerned, A/Prof Doogue has advised:

Following reports of problems, the media reports and the reported statements of some health professionals may have further contributed to the problem. The possibility of problems was foreseen and the reasons for such problems are known. Attributing the cause of the problems to the pharmacological effects of the Logem brand risks diagnostic error and consequent management errors. This possibility cannot be excluded and needs to be investigated but apriori causality is unlikely.

  1. A/Prof Doogue advised that while the broadening, by PHARMAC, of the ‘exceptional circumstances’ criteria in November 2019 was an understandable response due to public concern, A/Prof Doogue considers that such broad criteria may not be appropriate in future, similar cases.

Footnotes

[37] PHARMAC told me that there are 900 registered pharmacies in New Zealand, and that its subscriber list may include duplicates.

[38] Both the original application form and the updated application form have been provided by PHARMAC and considered by the reviewer and the clinical advisor.