Lamotrigine brand change

9 December 2019

[name and contact details redacted]

Dear [name redacted]

REQUEST FOR INFORMATION

Thank you for your request dated 15 November 2019 under the Official Information Act 1982 (OIA).  You asked for:

all and any advice or information or guidance that PHARMAC received or generated about the non-pharmaceutical healthcare and wider economic costs (eg GP and ED presentations, hospital admissions, injuries, deaths, motor vehicle accidents, time off work due to seizures, time off driving due to seizures) due to the recent change in the funded brand of lamotrigine

PHARMAC response

Any proposals considered for funding are assessed using PHARMAC’s Factors for Consideration.  Wider economic costs, outside of healthcare (such as those stated in your query), are not considered as part of the Factors.

Before making the decision to move to one funded brand of lamotrigine (Logem), PHARMAC got expert advice from healthcare professionals who work directly with people with epilepsy and mental health conditions, to make sure it would be appropriate for people to change brands of lamotrigine.

PHARMAC takes brand changes very seriously, and expert clinical advice is key to its decision making. If PHARMAC’s expert clinical advisors said it was not appropriate, we wouldn’t make a brand change.

One of the key considerations for a brand change involving an antiepileptic medicine is the likelihood of this affecting seizure control or mood stabilisation. Patients and caregivers can be reassured that the evidence has been thoroughly reviewed and concerns discussed extensively by PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) specialist Subcommittees, comprised of neurologists and psychiatrists. They concluded that there was no pharmacological reason to suggest there would be a clinical problem from switching brands of lamotrigine for patients with epilepsy or mental health conditions.

The Neurological and Mental Health Subcommittees of PTAC met in February 2019, to discuss consultation feedback that PHARMAC had received regarding the proposed change, and to review all publications and evidence regarding the clinical effects of switching lamotrigine brands. This updated a previous review conducted by the Subcommittees in November 2015.

Following careful consideration of all the evidence, PHARMAC’s clinical experts 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.

For the lamotrigine brand change PHARMAC identified the need for additional support for consumers and health professionals, so we put in place a five-month transition period to allow people time to change brands. Additionally, we created a separate exceptions process to enable continued funding for previous brands to be considered for individual patients.

Further information on the  lamotrigine change, including the responses to previous OIA requests, is available on the PHARMAC website.

You have the right, under section 28 of the Act, to seek a review or to ask the Ombudsman to review the information that has been provided to you.

We trust that this information answers your queries.  Please get in touch with us if you have any questions about this.

Yours sincerely

Alison Hill
Director, Engagement and Implementation