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

What we’re proposing

PHARMAC is seeking feedback on a proposed change to the funding of lamotrigine dispersible tablets used in the treatment of epilepsy and/or bipolar disorder:

• the funded brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets would reduce from current three funded brands (Lamictal, Arrow-Lamotrigine and Logem) to just one funded brand (Logem), following a transition period; 
• from 1 May 2019, Logem would be the only funded brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets in both the community and hospital settings.

There is no proposed change to the listing of lamotrigine 2 mg (Lamictal) and 5 mg (Lamictal, Arrow-Lamotrigine) dispersible tablets, which would remain listed and fully funded.

Consultation closes at 4 pm on Wednesday, 26 September 2018 and feedback can be emailed to procurement@pharmac.govt.nz.

What would the effect be?

For patients

• From 1 December 2018, the price and subsidy of Logem, supplied by Mylan, would be reduced in the Pharmaceutical Schedule.
• During a 3-month transition period, from 1 February 2019 to 30 April 2019, the subsidy for the other currently funded brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets (Arrow-Lamotrigine, supplied by Teva, and Lamictal, supplied by GlaxoSmithKline) would be reduced. If the suppliers of those brands did not reduce their price, people using those brands would need to pay a manufacturer’s surcharge for their medicine or change to the fully funded brand (Logem). 
• From 1 May 2019, the Arrow-Lamotrigine and Lamictal brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets would be delisted.  People using these brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets would need to change to Logem to keep accessing funded lamotrigine.
• The Logem brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets would have sole supply (would be the only funded brand) from 1 May 2019 until 30 June 2022.
• This proposal would not affect the currently listed lamotrigine 2 mg and 5 mg dispersible tablet presentations, which are mainly used in children.

Prescribers, pharmacists and patients would be supported with information and implementation activities to manage any change.

For community pharmacies

Pharmacies could continue to dispense and claim for any listed brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets until 30 April 2019. The Lamictal and Arrow-Lamotrigine brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets may not be fully funded between 1 February and 30 April 2019, depending on the suppliers’ pricing. From 1 May 2019, Logem would be the only fully funded brand of those strengths of lamotrigine dispersible tablets.

A Brand Switch Fee would apply to dispensings of Logem from 1 May 2019 to 31 July 2019 (the three months following the commencement of sole supply).

For hospital pharmacies

Pharmacies could continue to purchase any brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets until 31 January 2019. After that a discretionary variant (DV) limit of 5% would apply, meaning that only 5% of total purchases of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets could be a brand other than Logem.

For prescribers

Prescribers would continue to be able to prescribe funded lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets, but the only funded brand from 1 May 2019 would be Logem.

For DHBs

From 1 December 2018 the price of Logem would be reduced on the Pharmaceutical Schedule which would allow significant savings to be achieved. These savings could be reinvested in new pharmaceutical funding to provide improved health outcomes for New Zealanders.

Who we think will be interested

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

About lamotrigine

Lamotrigine is an anticonvulsant that was first listed on the Pharmaceutical Schedule in 1994 and has been funded without restrictions since July 2007. Lamotrigine is registered for use in the treatment of epilepsy and bipolar disorder.

Multiple brands of lamotrigine are currently funded with no restrictions.

Approximately 12,000 people use lamotrigine annually, including approximately 5,000 people living with epilepsy who use lamotrigine for seizure control.

Use in epilepsy

We have received expert clinical advice from the Neurological Subcommittee of the Pharmacology and Therapeutics Advisory Committee (PTAC) that a managed switch to one brand of lamotrigine would be preferable to having multiple brands listed and that a competitive process for one brand of lamotrigine would be appropriate.

Use in bipolar disorder and other mental health conditions

We have also received expert clinical advice from the Mental Health Subcommittee of PTAC that it would not be clinically problematic from a mental health standpoint to switch patients from one brand of lamotrigine to another if necessary (that is, no more or less problematic than any other mood stabiliser brand change).

Why we’re proposing this

PHARMAC released a Request for Proposals (RFP) for the supply of lamotrigine to community pharmacies and DHB hospitals on 14 June 2018.

As a result of the RFP, PHARMAC has entered into a provisional agreement with Mylan New Zealand Limited for the supply of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets and feedback to this consultation will help us to decide if this agreement should be confirmed.

Details about the our proposal

Amendment of Logem listing

• From 1 December 2018 the price of Mylan’s brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets (Logem) would be reduced in Section B (Community) and Part II of Section H (Hospital Medicines List) of the Pharmaceutical Schedule.

• The price and subsidy would be notified should PHARMAC decide to progress the proposal following consideration of consultation feedback.

Reference pricing other listed brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets in the community 

• From 1 February 2019, the subsidies for the other currently listed brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablet (Arrow-Lamotrigine and Lamictal) in the Pharmaceutical Schedule would be reduced, via the application of reference pricing, to the subsidy for Logem.

• If the suppliers of Arrow-Lamotrigine and Lamictal decided not to reduce the price of these brands to match the new proposed subsidy, a manufacturer’s surcharge would apply when these brands are dispensed and patients would be required to make a part payment for their prescription.

Lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets Sole Supply 

In DHB hospitals

• From 1 February 2019 until 30 June 2022, Logem 25 mg, 50 mg and 100 mg dispersible tablets would be awarded Hospital Supply Status (HSS) for the relevant strengths of lamotrigine dispersible tablets in DHB hospitals.  This would result in Logem being the only available brand of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets in DHB hospitals, subject to a 5% DV limit (i.e. 95% of the total volume of each of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets purchased by DHB hospitals would be required to be Logem).

• From 1 February 2019, all other brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets would be delisted from Part II of Section H of the Pharmaceutical Schedule.

In the community

• From 1 May 2019 until 30 June 2022, Logem (25 mg, 50 mg and 100 mg dispersible tablets) would be awarded Sole Subsidised Supply status for the relevant strengths of lamotrigine dispersible tablets in the community.  

• From 1 May 2019, all other brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets would be delisted from Section B of the Pharmaceutical Schedule.

• Community pharmacies would be eligible to claim a Brand Switch Fee on the first Logem dispensing, per patient, during the three-month period from 1 May 2019 to 31 July 2019 (i.e. after the delisting the other brands of lamotrigine 25 mg, 50 mg and 100 mg dispersible tablets).

Lamotrigine 2 mg and 5 mg dispersible tablets

• No changes are proposed for the listings of lamotrigine 2 mg (Lamictal) and 5 mg (Lamictal, Arrow-Lamotrigine) dispersible tablets. These strengths and brands would remain listed and fully funded.

To provide feedback

Send us an email: procurement@pharmac.govt.nz, by 4pm on 26 September 2018.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.

PHARMAC is seeking feedback on a proposed change to the funding of lamotrigine dispersible tablets used in the treatment of epilepsy and/or bipolar disorder.

Consultation closes at 4 pm on Wednesday, 26 September 2018.