Decision to move to one funded brand of lamotrigine (Logem)

Medicines

Decision

PHARMAC has made a decision to approve an agreement with Mylan New Zealand Ltd for the supply of lamotrigine, a treatment used for epilepsy and some mental health conditions such as bipolar disorder.

What we’re doing

PHARMAC has made a decision to approve an agreement with Mylan New Zealand Ltd for the supply of lamotrigine, a treatment used for epilepsy and some mental health conditions such as bipolar disorder.

This decision means that:

  • from 1 October there will be only one funded brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets (Logem), rather than three different brands (Lamictal, Arrow-Lamotrigine and Logem) and people will be able to collect a three-month supply of Logem from their community pharmacy;
  • people who are not already using the Logem brand will have five months to change to it;
  • the price and subsidy of Logem will reduce.

There are no changes to the funding of lamotrigine 2 mg (Lamictal) and 5 mg (Lamictal and Arrow-Lamotrigine) dispersible tablets, except that people will be now be able to collect a three-month supply of these from their community pharmacy.

This decision results from a Request for Proposals (RFP) for the supply of lamotrigine.

PHARMAC’s job is to make sure that New Zealanders have access to the medicines they need. Making brand changes to medicines helps us achieve that by freeing up money to fund other medicines.

Reducing the number of brands of lamotrigine we fund will free up more than $30 million over the next five years; money that PHARMAC will use to fund other medicines for New Zealanders.

Further details about the transition timeframes and funding changes are detailed below.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 29 August 2018.

While there was general support for the proposal from most healthcare professionals that responded, concerns regarding the potential for loss of seizure control or mood destabilisation were raised by other responders. PHARMAC provided an update on our website after the consultation had closed advising that we needed to take more time to consider the issues raised and that this meant that a decision would not be made in time for the proposed 1 December 2018 implementation date. The implementation date is now 1 May 2019.

We sought additional clinical advice from our expert clinical advisors (the Neurological and Mental Health Subcommittees) on the concerns raised and updated evidence.

In summary, the Subcommittees concluded that there was no pharmacological reason to suggest there would be a clinical problem for patients with epilepsy or mental health conditions to change the brand of lamotrigine they use.

The Subcommittees were supportive of the proposal to move to one funded brand of lamotrigine (Logem) with appropriate implementation support. Full details of the advice we received is available on PHARMAC’s website.

In addition to the change of implementation date, there are two other changes to the proposal that we consulted on:

  1. There is an amendment to the transition process. There will now be a five-month transition period when all three currently funded brands will remain fully funded. This change was made following consultation feedback asking for the transition period to be more supportive of patients’ needs. Reference pricing will not occur as originally proposed, meaning all three currently funded brands will be fully funded until Lamictal and Arrow-Lamotrigine are delisted on 1 October 2019. 
  2. From 1 October 2019, all strengths of lamotrigine will be able to be dispensed all at once (stat dispensing) as a three-month supply, rather than the current one-month supply. This change was made following consideration of consultation feedback suggesting that adherence for some people may be improved with three-monthly dispensing.

We advised during consultation that the price and subsidy of Logem would be notified if the proposal was approved; accordingly, this information is included below.

A summary of the main issues raised in consultation feedback is at the end of this notification.

Who we think will be most interested

People currently using lamotrigine, consumer support organisations for people living with epilepsy or mental health conditions, pharmacists, nurses, clinicians involved in the management of epilepsy and/or mental health conditions, including bipolar disorder, DHBs and suppliers of lamotrigine tablets.

Detail about this decision

From 1 May 2019, the price of Mylan’s brand of lamotrigine (Logem) will be reduced in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

Chemical

Presentation

Brand

Pack size

Current Price & Subsidy

New Price & Subsidy

Lamotrigine

Tab dispersible 25 mg

Logem

56

$19.38

$2.76

Lamotrigine

Tab dispersible 50 mg

Logem

56

$32.97

$3.31

Lamotrigine

Tab dispersible 100 mg

Logem

56

$56.91

$4.40

From 1 October 2019, the other currently listed brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets, Lamictal and Arrow-Lamotrigine, will be delisted both from Section B and Part II of Section H of the Pharmaceutical Schedule.

Lamictal and Arrow-Lamotrigine will remain fully subsidised at their current prices until delisting.

From 1 October 2019, Logem will be the only funded brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets in the community until 30 June 2022. Logem will be the Hospital Supply Status brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets until 30 June 2022, with a 5% DV limit.

There are no changes to the listings of lamotrigine 2 mg (Lamictal) and 5 mg (Lamictal and Arrow-Lamotrigine) dispersible tablets.

What will the effect of this decision be?


For patients

Between 1 May 2019 and 30 September 2019 all people using the Lamictal and Arrow-Lamotrigine brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets will need to change to the Logem brand to keep accessing funded lamotrigine.  All people currently taking the Logem brand will need to stay on the Logem brand. 

From 1 October 2019, all strengths of lamotrigine will be able to be dispensed all-at-once as a three-month supply, rather than receiving one month of treatment at a time as is currently the case. If people want to stay with more frequent dispensing, they should talk to their doctor or pharmacist. 

There will be no changes for people, mainly young children, using lamotrigine 2 mg and 5 mg dispersible tablet presentations.

More information and resources will be available during the transition period for pharmacists, prescribers and clinicians on PHARMAC’s website.


For prescribers

Between 1 May 2019 and 1 October 2019, treating clinicians will need to support patients on the Lamictal or Arrow-Lamotrigine brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets to transition to the Logem brand.

There is no need to change the way prescriptions are written if clinicians are already prescribing generically. If not, the Logem brand name will need to be annotated by the prescriber on the prescription from the date the patient changes brands, to ensure that they can access the funded brand of lamotrigine.

We are aware that there could be a small number of patients who might need an additional visit to their healthcare professional to provide counselling through the brand change. Healthcare professionals can apply to PHARMAC to cover the patient’s cost of an additional visit if needed. Details will be available from PHARMAC’s website.

Prescribers will be able to apply to PHARMAC under the exceptional circumstances framework for continued funded access to their patient’s current brand of lamotrigine. This would be for people who, due to exceptional clinical difficulties, they consider would be unable to manage a change to the Logem brand, or who have not tolerated the change during the five-month transition period. There will be a specific form for clinicians to complete and it will be available on PHARMAC’s website.


For community pharmacies

From 1 May 2019, community pharmacies dispensing lamotrigine will need to support patients changing to Logem.  Pharmacies will need to manage stock of all three brands of lamotrigine during the transition.

From 1 October 2019, all strengths of lamotrigine will be able to be dispensed all-at-once as a three-month supply. Pharmacists can use their clinical discretion to dispense smaller quantities for Long Term Conditions (LTC) patients if required. All other patients who require smaller quantities would require the prescription to be endorsed accordingly by the prescriber.  

From 1 October 2019 until 30 June 2022, Logem will be the only funded brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets.

A Brand Switch Fee will apply for dispensings of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets from 1 October 2019 until 1 January 2020 for Logem. Only one fee will be paid per patient. This will be provided to pharmacists in recognition of their assistance to patients with the change.


For hospital pharmacies

From 1 October 2019 until 30 June 2022 Logem will be the Hospital Supply Status brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets subject to a 5% DV limit.

Our response to what you told us

We want to thank everyone who responded to the consultation and are really grateful for the time people took give us meaningful feedback. All consultation responses received have helped inform our decisions and will continue to guide us as we implement this brand change across the country. Common issues raised during consultation, and our comments on these, are summarised in the table below.

Theme

PHARMAC comment

Support for the proposal

 

Generally supportive, including acceptance that the products are bioequivalent and based on published literature changing brands for lamotrigine is unlikely to lead to adverse effects

This feedback is in line with the advice we received from our Subcommittees.

Continuity of supply

 

Highlighted the importance of maintaining supply of the 2 mg and 5 mg tablets

This decision will not affect the subsidy of the tab 2 mg and 5 mg presentations of lamotrigine tablets which will remain listed and fully funded.

Highlighted importance of continuity of supply if there is a sole supply arrangement for lamotrigine.

 

For many essential medicines in New Zealand, only one brand is funded, often following a competitive process. Drawing from the experience of supply security for these other medicines, PHARMAC considers that having multiple brands of a product in a market does not improve security of supply. When there is one supplier, forecasting is more accurate which helps prevent out-of-stock situations.

Suppliers also have continuity of supply obligations in their contracts with PHARMAC. In exchange for market exclusivity, we require suppliers to agree to rigorous conditions to prevent and manage potential out-of-stocks. This includes stock-holding in NZ, stock reports to PHARMAC and a commitment to source a suitable alternative to prevent any potential out-of-stock.

Implementation activities to support a brand change

 

Patients need to be supported during the transition. Some suggestions for implementation activities that could be provided by PHARMAC to help support a brand change were provided.

PHARMAC will be providing information to prescribers, pharmacists and consumers to help support the change. The implementation activities that will be provided are in line with the clinical advice we have received from the joint Neurological and Mental Health Subcommittee meeting held on the 7 February 2019. Full details of the advice provided is available on PHARMAC’s website.

Details of support for patients will be available from PHARMAC’s website.

A Brand Switch Fee will be paid to acknowledge the assistance pharmacists provide to support patients with the change. 

All patients taking lamotrigine for epilepsy should be given 3-months supply of their medication at once.

The dispensing frequency of lamotrigine will be adjusted to three months all-at-once from 1 October 2019.

There needs to be an alternative pathway for those who need to switch back to their old brand, or who are not able to change brands

Our expert external advice is that the majority of people should be able to change brands.  However, there will be a process for clinicians to apply for ongoing funding of other brands for any patients who, due to exceptionally difficult clinical circumstances, they consider would be unable to manage the change, or have not tolerated the change. Details will be available from PHARMAC’s website.

Risks of a brand change

 

A number of references to published literature and guidelines, some of which had not previously been considered by the Neurological Subcommittee, were provided to highlight concerns that a lamotrigine brand change could result in a risk of loss of seizure control and subsequent increased healthcare costs.

The Neurological and Mental Health Subcommittees of PTAC considered all of the publications provided in consultation feedback, and additional publications identified in an updated literature review undertaken by PHARMAC staff. The Subcommittees considered that there was a significant body of published evidence regarding changing between lamotrigine brands and that the majority of evidence in high quality studies reported that there were unlikely to be important clinical risks for the majority of patients from changing between brand and generic lamotrigine.

Full details of the Subcommittees’ advice and references considered are available on PHARMAC’s website.

Concern that a brand change could lead to loss of seizure control/recurrence of symptoms which could have consequences on quality of life and increased healthcare utilisation.

 

Concern about the potential for re-occurrence of currently well managed bipolar symptoms, and the potential for increased health care needs as a result.

 

 

We acknowledge that epilepsy has a significant impact on peoples’ quality of life; that activities such as employment, driving and social interaction are dependent on control of the disease; and, that consequences of uncontrolled seizures can be severe. We are aware that the chronic nature of the disease means that people with epilepsy, even on treatment, can have recurrent and spontaneous seizures.

Similarly, we recognise the significant impact that mental health conditions have on peoples’ lives.

The clinical advice we received from the Neurological and Mental Health Subcommittees is that, based on the available evidence, there is no pharmacological reason to suggest there would be a clinical problem for people with epilepsy or mental health conditions with changing brands of lamotrigine. The Subcommittees considered  that patients experience adverse events, e.g. breakthrough seizures, even when there is no brand change.

The Subcommittees considered that it would be appropriate to move to one funded brand of lamotrigine for people with epilepsy or mental health conditions, with appropriate implementation support.

Our dispensing data for 2018 shows that of all patients (12,500 patients in total) who collected a funded prescription for lamotrigine, around 50% (6,250) changed brands at least once at some point since starting lamotrigine, and around 4,000 patients have changed brands two or more times. We are not aware of, nor have we been informed of, any significant clinical impacts for these people when they changed brands.

PHARMAC sought extensive clinical advice and used the feedback to consultation to develop a comprehensive implementation plan to support:

  • people taking lamotrigine and people who care for them,
  • consumer organisations whose members are people living with epilepsy and/or mental health conditions, and
  • healthcare professionals,

through the brand change. Details will be available from PHARMAC’s website.

Other

 

A supplier raised some procedural concerns, including the fact that PHARMAC did not disclose the price of Logem at consultation, and a claim of insufficient information provided at consultation generally.

PHARMAC considers that all necessary aspects of the proposal were included in the consultation to allow for informed feedback e.g. a proposed brand change and all proposed timeframes for Schedule changes. While the price is a matter of some interest to a range of parties, it is primarily a matter for PHARMAC, which has sole responsibility for managing the pharmaceutical budget.

Pricing detail was not included to avoid the disclosure of commercially sensitive information, thereby protecting the position of the proposed supplier and any further commercial activity PHARMAC might choose to undertake in the event that PHARMAC decided not to progress the proposal. 

PHARMAC received feedback from a wide range of stakeholders and considers that the consultation process was appropriate and sufficient in all respects. 

New Zealand Transport Agency (NZTA) noted a brand change does not constitute a treatment change for purposes of driving and considered that any risks from changing would be extremely low.

This feedback is in line with the advice we received from our Subcommittees that a change to one funded brand of lamotrigine would be appropriate.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 66 00 50.