Decisions relating to levetiracetam and lamotrigine

Medicines

Decision

PHARMAC is pleased to announce the approval of an agreement with REX Medical Ltd involving levetiracetam (used to treat epilepsy) and lamotrigine (used to treat epilepsy and mood disorder in patients with bipolar disorder).

This was the subject of a consultation letter dated 12 October 2015.

In summary, the effect of the decision is:

From 1 February 2016 there will be:

  • a reduction in net expenditure on levetiracetam tablets;
  • a name change for the funded brand of levetiracetam (the brand name Levetiracetam-Rex will change to Everet);
  • a new 1000 mg strength of levetiracetam tablet listed.

From 1 July 2016 there will be:

  • a new brand of lamotrigine dispersible tablets: 25 mg, 50 mg and 100 mg (Motrig) listed.

Details of the decision

Levetiracetam-Rex

  • Levetiracetam-Rex will remain listed in Section B and Part II of Section H of the Pharmaceutical Schedule at the following prices and subsidies (ex-manufacturer, excluding GST):
    Chemical Presentation Brand Pack size Price and subsidy
    Levetiracetam Tab 250 mg Levetiracetam-Rex 60 tablets $24.03
    Levetiracetam Tab 500 mg Levetiracetam-Rex 60 tablets $28.71
    Levetiracetam Tab 750 mg Levetiracetam-Rex 60 tablets $45.23
  • From 1 February 2016, a confidential rebate will apply to Levetiracetam-Rex, reducing the net price paid by the Funder.
  • From 1 August 2016, Levetiracetam-Rex will be delisted from Section B and Part II of Section H of the Pharmaceutical Schedule.

Everet

  • Everet, including a 1000 mg tablet strength, will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 February 2016 at the following prices and subsidies (ex-manufacturer, excluding GST):
    Chemical Presentation Brand Pack size Price and subsidy
    Levetiracetam Tab 250 mg Everet 60 tablets $24.03
    Levetiracetam Tab 500 mg Everet 60 tablets $28.71
    Levetiracetam Tab 750 mg Everet 60 tablets $45.23
    Levetiracetam Tab 1,000 mg Everet 60 tablets $59.12
  • A confidential rebate will apply to Everet, reducing the net price paid by the Funder.
  • Everet will have subsidy and delisting protection until 31 January 2019.
  • The net price of Everet will be published in the Pharmaceutical Schedule from 1 November 2018.

Note: The listing of Everet reflects a brand name change for Levetiracetam-Rex; there will be no changes to the formulation or manufacturing of the product.

Motrig

  • Motrig will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule from 1 July 2016 at the following prices and subsidies (ex-manufacturer, excluding GST):
    Chemical Presentation Brand Pack size Price and subsidy
    Lamotrigine Tab dispersible 25 mg Motrig 56 tablets $14.74
    Lamotrigine Tab dispersible 50 mg Motrig 56 tablets $24.73
    Lamotrigine Tab dispersible 100 mg Motrig 56 tablets $42.34

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 27 October 2015 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme Comment
Supported the introduction of a 1000 mg levetiracetam tablet, as this would reduce pill burden. Noted.
It would be desirable to have more than one levetiracetam brand funded. The proposal did not offer sole supply. Other suppliers of levetiracetam are welcome to make commercial proposals for listing of other brands.
Concern was expressed around patients changing brands of levetiracetam. The listing of Everet reflects a brand name change for Levetiracetam-Rex, there will be no changes to the formulation or manufacturing of the product.
Two suppliers responded that they were planning to offer competitive prices for levetiracetam via the tender. The proposal did not offer sole supply. Other suppliers of levetiracetam are welcome to make commercial proposals for listing of other brands.
Considered generic lamotrigine to be bioequivalent to Lamictal. Noted.
Concern was expressed around an additional brand of lamotrigine in the market, as in clinical practice they encourage patients to stay with one brand. There are currently four brands of lamotrigine tablets funded (Lamictal, Arrow-lamotrigine, Logem and Mogine). Mogine will be delisted from 1 April 2016, so the listing of Motrig will mean that there will continue to be four brands of lamotrigine funded.
Motrig does not contain blackcurrant flavouring or a sweetener and this may affect compliance of patients dispensed this brand. It also contains lactose which may be undesirable for lactose intolerant patients. The level of lactose contained within the tablets is unlikely to cause any adverse effects in most patients, however patients that are concerned about consuming lactose or find the Motrig flavour unpalatable should discuss these matters with their doctor.

More information

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz