Decision to change the funded brand of labetalol tablets

Medicines

Decision

PHARMAC has made a decision to make changes to the funded brand of labetalol tablets, which may be used in the treatment of hypertension in pregnancy.

This decision means that:

  • the currently funded brand of labetalol tablets will change from Presolol (supplied by Mylan) to Trandate 100 mg and 200 mg tablets (supplied by Aspen) following a five-month transition period starting on 1 April 2020.
  • from 1 September 2020, Trandate will be the only funded brand of 100 mg and 200 mg labetalol tablets until 30 June 2024.
  • From 1 April 2020, 50 mg labetalol tablets will be funded in DHB Hospitals.

Stat (all-at-once) dispensing was removed from labetalol tablets from 1 March 2019. The brand change decision will result in the reinstatement of stat dispensing for labetalol 100 mg and 200 mg tablets from 1 April 2020.

This decision results from a Request for Tender for the supply of labetalol tablets. This follows notification by the supplier of discontinuation of the Hybloc brand (50 mg, 100 mg, 200 mg tablets), and PHARMAC’s subsequent funding of the unregistered Presolol brand of 100 mg and 200 mg tablets to ensure continued access to a funded brand of labetalol tablets.

These changes were previously notified to the market

Any changes to the original proposal?

This decision was subject to a consultation letter dated 28 November 2019

One change has been made since the original proposal. This is to list labetalol tab 50 mg in part II of Section H (the Hospital Medicines List; HML) of the Pharmaceutical Schedule without a price, brand or pack size from 1 April 2020.

Who we think will be most interested

  • People currently using labetalol and their family, whānau or caregivers
  • Lead maternity carers (LMCs) and other health care professionals, including midwives and general practitioners and DHB maternity services, involved in the care of women in pregnancy, when they are patients prescribed labetalol by specialists in the treatment of hypertension and may be wanting support to change brands of labetalol tablets
  • Clinical and other groups interested in health and long-term outcomes for mothers and their babies 
  • Hospital and community pharmacists, DHBs, and wholesalers
  • Suppliers of labetalol tablets

Detail about this decision

From 1 April 2020, Aspen’s Trandate brand of labetalol 100 mg and 200 mg tablets will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

Chemical

Presentation

Brand

Pack size

Price & Subsidy

Labetalol

Tab 100 mg

Trandate

100

$14.50

Labetalol

Tab 200 mg

Trandate

100

$27.00

From 1 September 2020, Trandate will be the only funded brand of labetalol 100 mg and 200 mg tablets in both community and hospital settings until 30 June 2024. A discretionary variant (DV) limit of 1% will apply in DHB hospitals, meaning that 99% of the total volume purchases of the relevant presentation is required to be the Trandate brand.

The only exception to this is that from 1 April 2020, a 50 mg labetalol tablet will be listed in Section H of the Pharmaceutical Schedule. This listing will not state a particular brand or price, instead DHB hospitals will be able to claim for whichever brand is sourced.

From 1 April 2020, labetalol 50 mg tab will be listed in Part II of Section H of the Pharmaceutical Schedule. This means hospitals will be able to purchase any brand of 50 mg labetalol tab in any pack size.

From 1 September 2020, all other brands of labetalol 100 mg and 200 mg tablets will be delisted from Section B and Part II of Section H of the Pharmaceutical Schedule.

Stat dispensing

Stat (all-at-once) dispensing was removed on 1 March 2019, as a result of the Hybloc discontinuation. This decision will result in the reinstatement of stat dispensing of labetalol 100 mg and 200 mg tablets from 1 April 2020. This means that patients will be able to collect three months supply of labetalol tablets in a single dispensing.

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Responses were generally supportive of the proposal and a summary of the main themes raised in feedback and our responses to the feedback received are set out below. 

Theme

PHARMAC comment

Noted that it is unclear if the tablets can be halved, and that a 50 mg presentation would be required for treatment in hospital of pre-eclampsia and paediatric use

The 50 mg tablet presentation of labetalol was delisted from the Pharmaceutical Schedule in August 2019 and had been out of stock for a number of months prior to this. This was due to discontinuation by the supplier.

Feedback received from the supplier is that the tab 100mg presentation of Trandate brand labetalol does not include a score line, and cannot easily be halved. 

Although a tab 50 mg presentation of labetalol has not been sourced as a result of this process a tab 50 mg presentation of labetalol will be listed  in Section H of the Pharmaceutical Schedule as any brand from 1 April 2020 to allow DHB Hospitals to purchase any brand of  tab 50 mg labetalol if required.

PHARMAC will continue to monitor feedback on this matter and may investigate alternative options for sources of this medicine in future.

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