NEW ! The primary care update series is a new premium content based service from bpacnz Find out more

The funded brand of lamotrigine is changing

Changes in funded brands of antiepileptic medicines can lead to concern from patients or caregivers that the medicine they are receiving is not the same and may not be as effective. Counselling in general practices and pharmacies is imperative to talk through any concerns patients may have about changing brands of medicines and to provide reassurance that although their tablets may look different, they are still receiving the same medicine.

0 comments
save
share
feedback
Log in

Published: 22 August 2019 | Updated:


Key practice points:

  • Three brands of lamotrigine (Lamictal, Arrow-Lamotrigine and Logem) are currently funded in 25 mg, 50 mg and 100 mg tablet strengths
  • From 1 October, 2019, only one brand of lamotrigine in these tablet strengths will be funded: Logem. Patients prescribed other brands will need to change to Logem; this can be done from now.
  • In addition, from 1 October all dispensings of lamotrigine will be three months stat (unless otherwise specified by the prescriber) so that patients can access their medicines with fewer visits to the pharmacy
  • Lamotrigine is also funded in 2 mg (Lamictal) and 5 mg (Lamictal, Arrow-Lamotrigine) formulations; funding arrangements for these tablet strengths will remain the same
  • Patients or caregivers require information and reassurance during a brand change as differences in the appearance of medicines may result in confusion, reduced adherence or concerns about effectiveness.
  • If an additional consultation is required to assist patients with the brand change, general practices can invoice PHARMAC for the usual patient co-payment fee, so the consultation is at no cost to the patient (invoices must be received by 31 December, 2019)
  • In exceptional circumstances, clinicians can apply to PHARMAC for a patient to continue funded use of an alternative brand of lamotrigine

N.B. This article has been distributed to primary healthcare professionals, and specialist interest groups in New Zealand (paediatric, neurology and psychology groups)

Lamotrigine is an antiepileptic medicine used in the treatment of patients with focal, generalised or absence seizures.1 In addition, it may be used in the management of some patients with bipolar disorder.2

Funding arrangements are changing

There are currently three funded brands of lamotrigine in 25 mg, 50 mg and 100 mg dispersible tablets:

  • Lamictal (innovator branded medicine)
  • Arrow-Lamotrigine (generic branded medicine)
  • Logem (generic branded medicine)

These brands have been available fully funded without restriction for over ten years (Table 1).3 Two other brands, Motrig and Mogine, have also been funded and delisted within this timeframe.3

From 1 October, 2019, funding for two of these brands will cease and Logem will be the only funded brand of lamotrigine in these formulations.4 Therefore patients currently prescribed other brands will need to change to Logem; this can be done anytime from now, when the patient is ready to change and a new prescription is due to be dispensed (prescriptions dispensed after 1 October will be for Logem).

In addition, from 1 October, 2019 lamotrigine will be dispensed as three months’ supply stat to reduce the number of visits patients need to make to a pharmacy; if this is not an appropriate arrangement for a particular patient, prescribers can indicate a more frequent dispensing interval.4

Lamotrigine is also available in 2 mg (Lamictal) and 5 mg (Lamictal or Arrow-Lamotrigine) dispersible tablets and funding arrangements and brands for these formulations will remain unchanged.4

Dispensing data show there are approximately 12,500 patients dispensed lamotrigine tablets.5 Approximately 11,000 of these patients are dispensed Lamictal or Arrow-Lamotrigine and will need to be changed to Logem.5

Many patients have already been changing brands

Dispensing data show that approximately half of patients dispensed lamotrigine have changed brands at some point, approximately one in three have changed brands two or more times and one in ten have changed brands six or more times.5, 7

Dispensing data is unable to reveal the reasons for brand change, i.e. whether a prescriber purposely intended for a patient to change brands, or whether patients were appropriately given a prescription using the generic medicine name, i.e. lamotrigine, and they were dispensed an alternative brand at the pharmacy, e.g. due to attending a different pharmacy or due to available stock. However, these data illustrate that many patients have been changing between the available funded brands, with no specific safety issues identified. Changes in pill appearance are associated with reduced adherence.8, 9 Therefore, changing brands frequently may affect adherence and a single funded brand can reduce the potential for this to happen.


Table 1: Currently funded brands of lamotrigine3,6

Brand

Date of Medsafe approval

Funded without restriction since

New Zealand sponsor or distributor

Lamictal (innovator)

Dec 1995

July 2007*

GlaxoSmithKline (NZ) Ltd

Arrow-Lamotrigine (generic)

July 2006

Feb 2007

Teva Pharma (New Zealand) Ltd

Logem (generic)

Sept 2006

June 2008

Mylan New Zealand Ltd

*Funded with Special Authority approval prior to this date

One of the key considerations for a brand change involving an antiepileptic medicine is the likelihood of this affecting seizure control or mood stabilisation. The occurrence of seizures in epilepsy or alteration of mood control in bipolar disorder can substantially impact the quality of life of patients and their families and caregivers. Factors which could contribute to this, such as a change in treatment regimen, can cause understandable concern.

Some studies have reported variations in seizure control in patients with epilepsy who change between different brands of medicine.10, 11 However, this has not been observed in all studies and the risks of changing differ between antiepileptic medicines.12 In the United Kingdom, the Medicines and Healthcare Products Regulatory Agency (MHRA) proposed a classification system to help clinicians and pharmacists make appropriate decisions when considering whether a patient could change brands (see: “The MHRA classification system”).12 Under this classification system, there was no clear evidence at the time of assessment to place lamotrigine into either a category of medicines for which there are clear differences in efficacy between brands or a category of medicines for which the potential for these differences is low.

On 7 February, 2019, as part of the process for the proposed funding changes, the Neurological and Mental Health Subcommittees of the Pharmaceutical and Therapeutics Advisory Committee (PTAC) for PHARMAC held a joint meeting to discuss the evidence and consider the feedback from the sector (see: “The clinical expert advisory assessment of lamotrigine brand changing”). The clinical advisory groups recommended that changes between approved formulations of lamotrigine produced by different manufacturers would be unlikely to result in problems for patients with epilepsy or mood disorders.7 The Subcommittees recommended that a change in the funded brand of lamotrigine should proceed, with appropriate support and reassurance provided to patients during the transition.7

Discuss the brand change and address questions and concerns

Brand changes for antiepileptic medicines can be a cause of apprehension or concern for parents or caregivers. The change in brand of lamotrigine should be discussed before issuing a prescription. A survey conducted by the Epilepsy Society in the United Kingdom in 2014 found that three-quarters of patients experienced emotions such as confusion, anxiety, worry or anger when changing to another brand of medicine.* 26 In addition, four out of ten patients were not aware they had been given a different brand until after they left the pharmacy. Although it is not clear how relevant these findings are to patients in New Zealand, they highlight the need for prior discussions and clear communication before providing patients with a different brand than they are usually prescribed or dispensed.

If the patient does not wish to change brands, they can enquire with their local pharmacy as to the cost of remaining on their preferred brand, or they may qualify for Exceptional Circumstances funding (see: In exceptional circumstances patients may continue with funded access to other brands).

* It is possible that some patients in this survey were changed to a different medicine, rather than a different brand of the same medicine

Is it safe to change brands?

Patients and caregivers can be reassured that the evidence has been thoroughly reviewed and concerns discussed extensively by the PTAC Subcommittees who concluded that there was no pharmacological reason to suggest there would be a clinical problem from changing brands of lamotrigine for the majority of patients with epilepsy or mental health conditions.7

Will the new brand be just as good?

Some patients or caregivers may worry that the formulation they are receiving will not be as safe or effective as their current brand, e.g. it’s a “cheap alternative”.16 Patients or caregivers can be reassured that the different brands of lamotrigine have been assessed as bioequivalent (see: “Bioequivalence studies of lamotrigine”), and Logem has been used in New Zealand for over ten years. There may be some differences in tablet excipients between brands, but this does not alter the clinical effect.

Is it ok for my child to change brands?

There is no published evidence about changing brands of lamotrigine in children. Three recent clinical trials concluded that different brands of lamotrigine are bioequivalent in adults with epilepsy (see: “Bioequivalence studies of lamotrigine”).17–19 There are no known reasons why these medicines would not also be bioequivalent in patients aged under 18 years with epilepsy. Therefore, the PTAC Subcommittees did not recommend an exemption for children from the brand change. If there are concerns around epilepsy control with brand change in a particular child, this can be discussed with a paediatrician or neurologist.

Can I combine brands?

Patients who are currently taking a regimen involving a combination of lower (e.g. 2 mg or 5 mg) and higher (e.g. 25 mg) strength lamotrigine will need to combine two different brands from 1 October, when Logem becomes the sole funded brand for higher strength tablets (lower strength formulations are Lamictal or Arrow-Lamotrigine brands). Patients or caregivers can be reassured that the different brands of lamotrigine have been assessed as bioequivalent, and there are no known issues with taking a regimen including two different brands of lamotrigine.

Will I notice any difference when I change brands?

Generic medicines are designated as bioequivalent and contain the same dose of active ingredient, however, it is possible that some patients may absorb a slightly lower or higher amount of medicine when they change to a different brand due to slight differences in bioavailability which are within the accepted margin of error. Although unlikely, this could result in clinical symptoms (see: “Patient follow up”). If a patient is going to experience any symptoms as a result of the brand change, expert opinion is that these will almost certainly occur within the first eight weeks following the change. Therefore, reassure patients that they will receive support and follow-up after changing their brand to ensure they are not experiencing any difficulties.

The nocebo effect is when patients experience symptoms that are caused by anticipating adverse effects rather than actual adverse effects of a medicine. This can be influenced by extensive media coverage of an issue or discussion on social media, as well as by the language that a health professional uses when discussing symptoms and signs to be aware of.

The nocebo effect will be discussed in more detail in an upcoming article by bpacnz

If I have a seizure, was it because of the brand change?

One of the key dilemmas when changing patients with epilepsy to another brand of medicine is that if seizures occur it is difficult to determine whether a change in brand is the cause of their altered seizure control. Any seizure activity following brand change is unlikely to be because of the change, but it cannot be ruled out. Expert opinion is that seizure activity more than eight weeks following the change will not be as a result of the change. Some patients with epilepsy are likely to have seizures regardless of which formulation of medicine they are prescribed and there are many other factors which may affect seizure control, e.g. medicine adherence.

Will the brand change affect my driver licence?

For people with epilepsy who drive, it is not necessary to notify the New Zealand Transport Authority (NZTA) if they change brands of lamotrigine. The NZTA have stated that they do not regard this as a change in treatment for the purposes of a person’s fitness to drive, and consider the risk of problems from changing brands of lamotrigine to be extremely low.7 If a patient has a seizure within the first eight weeks of a medicine brand change, application can be made to NZTA for consideration of a six-month stand down period instead of the standard 12 months.

Advice at the pharmacy

When a brand change is implemented, pharmacists should check that patients are aware they are being dispensed a different brand than the medicine they may be used to, and address any questions or concerns. Discussion about an upcoming brand change is also useful to prepare patients for the change that will need to occur when their current brand is no longer funded. Keep in mind the sensitive nature of discussing changes to a patient’s medicines and offer them the option of talking in private.

Patients may notice a difference in the shape of their tablets

When a different brand is dispensed, pharmacists can show the patient what their new medicine looks like and emphasise that the active ingredient remains the same. The three currently funded brands of lamotrigine have a similar appearance, size and flavouring, with tablet shape being the main difference between brands (Table 3). Evidence suggests that changes in the appearance of a medicine may influence adherence,8, 31 therefore this is a crucial time to ensure that patients are aware of the brand change and to address any potential issues.

A patient information sheet with photos of the different tablet strengths from each brand is available at: www.pharmac.govt.nz/assets/2019-lamotrigine-brand-change-pamphlet-english.pdf


Table 3: Currently funded formulations of 25 mg, 50 mg, and 100mg lamotrigine tablets and their appearance

Logem32

Lamictal33

Arrow-Lamotrigine34

Pack size

56 tablet blister pack

56 tablet blister pack

56 tablet blister pack

Flavour

Blackcurrant

Blackcurrant

Blackcurrant

Sweetener

Saccharin and mannitol

Saccharin

Saccharin and mannitol

Writing on tablets

“LY” with dose, e.g. “25”, “50” or “100”

25 mg: “GSCL5” on one side, “25” on the other

50 mg: “GSCX7” on one side, “50” on the other

100 mg: “GSCL7” on one side, “100” on the other

Embossed with an outline similar to a PacMan with “LI” and the dose underneath, e.g “LI25” for a 25 mg tablet.

The reverse side has a line marked on it.

Tablet appearance

White to off-white

Round with a flat face

White to off-white, rounded edges with a raised centre

White to off-white

Shield-shaped

25 mg

50 mg

100 mg

Tablet size

Tablet size increases with strength. The tablet sizes for each strength are similar between brands.35

Patient follow-up

Patients should be followed up after changing from Lamictal or Arrow-Lamotrigine branded tablets to Logem to check on medicine adherence and whether patients or caregivers have any concerns regarding the alteration in medicine regimen.

If clinical symptoms and signs have emerged since the brand change, consider whether they could be caused by small differences in absorption of medicine with the new brand, or whether other factors could explain the occurrence, e.g. usual variation in the patient’s clinical condition, changes in the patient’s environment or daily activities, anxiety about the brand change and anticipation of symptoms.

Symptoms which could indicate that patients are absorbing an increased dose of lamotrigine include:7

  • Headache
  • Nausea
  • Tremor
  • Dizziness
  • Irritability
  • Blurred vision or visual disturbances

If these symptoms occur, consider requesting a serum lamotrigine level and discuss with a neurologist, paediatrician or psychiatrist as appropriate.

Symptoms which could indicate that patients are absorbing a reduced dose of lamotrigine or have reduced adherence include:7

  • Seizures/aura – N.B. it is now considered that aura is part of a seizure event and should be treated as such
  • Myoclonic jerks
  • Mood instability (in patients taking lamotrigine for mood disorders)

If symptoms occur, consider increasing the dose of lamotrigine by 25 mg in an adult or child aged over 12 years or by 300 micrograms/kg in a child aged 2 – 12 years, as long as the total dose remains below the recommended maximum dose, which differs depending on other anti-epileptic medicines taken and the indication for treatment: see NZF for recommended maximum doses in adults: www.nzf.org.nz/nzf_2326 or NZFC for recommended doses in children: www.nzfchildren.org.nz/nzf_2326

If the patient is already taking the maximum dose of lamotrigine or the dose increase does not improve symptoms, discuss with or refer to a neurologist, paediatrician or psychiatrist as appropriate.

Routine monitoring of serum levels is not necessary

The Neurological and Mental Health Subcommittees of PTAC considered whether monitoring serum levels of lamotrigine would aid in clinical management during a brand change, however, they concluded that based on available evidence this would be of little benefit as monitoring is generally used to check for adherence, possible toxicity or during pregnancy. Clinical trials have found that there is some dose to dose variation in serum levels of lamotrigine; importantly, these variations are similar for patients who change from the originator brand to a generic formulation of lamotrigine and patients who continue to take the originator brand.17, 36 In addition, as most patients would be expected to continue with good adherence to their regimen it is unlikely that monitoring would aid clinical decision making when patients are changed between brands of lamotrigine.7

Some patients with epilepsy are likely to have seizures regardless of which formulation they are prescribed

If a patient with epilepsy experiences a seizure after changing brands of lamotrigine, it is possible that this is related to the brand change, but also possible that this was a random occurrence or influenced by other factors, such as acute illnesses, co-morbidities, changes in daily routine or other medicines which may affect seizure control or the efficacy of antiepileptic medicines. Evidence from two randomised clinical trials report that between 7–22% of patients can have a recurrence while continuing the same antiepileptic medicine regimen even after two years without seizures.24, 25

Discuss with patients that a change in seizure control may not be related to the brand change, and it does not necessarily mean that the Logem brand should be discontinued. If appropriate, consult with a neurologist involved in managing the patient’s epilepsy.

If needed, funding to cover the cost of a follow-up appointment is available

If patients are having difficulty after being changed to Logem and require an additional appointment to discuss concerns, clinicians can invoice PHARMAC for the General Practitioner co-payment fee (i.e. in lieu of charging the patient) as long as the invoice is received on or prior to 31 December, 2019.4, 37

For further information on claiming reimbursement, see:

In exceptional circumstances patients may continue with funded access to other brands

Funding is available to assist patients in accessing a non-funded brand of lamotrigine if there are exceptional clinical difficulties. This could include a patient who clinicians believe would be unable to manage a change in brand, e.g. they have had adverse clinical effects from previous brand changes, or where a patient has changed brands to Logem and has not been able to tolerate the change.4

An application form for clinicians to apply for exceptional circumstances is available at: www.pharmac.govt.nz/assets/lamotrigine-exceptional-circumstances-form.doc

If patients wish to continue taking another brand of lamotrigine at their own personal cost after 1 October, 2019, they should discuss the price and availability of supplies with a pharmacist.4

Acknowledgement

This article was reviewed by Dr John Mottershead, Consultant Neurologist, Southern DHB, Clinical Senior Lecturer, Dunedin School of Medicine, University of Otago and member of the PTAC Neurological Subcommittee.

N.B. Expert reviewers do not write the articles and are not responsible for the final content.


There are currently no comments for this article.

Please login to make a comment.

bpacnz advocates for best practice in healthcare treatments and investigations across a wide range of health service delivery areas, and we are recognised nationally and internationally for our expertise and innovation.

Post

P.O. Box 6032
DUNEDIN 9059

Phone

03 477 5418


Made with by the bpacnz team