Proposal to change the funded brand of labetalol tablets

Medicines

Consultation Closed

PHARMAC is seeking your feedback on the proposal to make changes to the funded brands of labetalol tablets, which are used in the treatment of hypertension in pregnancy.

  • the funded brand of labetalol tablets would change from Hybloc and Presolol (both 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 would be the only funded brand of labetalol tablets until 30 June 2024.

These changes would mean that all people currently using funded labetalol tablets would need to change to the Trandate brand in order to remain on a funded brand.

No changes are proposed for labetalol injection.

This proposal results from a competitive process 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. These changes were previously notified to the market.

As a result of the Hybloc discontinuation, stat (all-at-once) dispensing was removed from labetalol tablets from 1 March 2019. This proposal would result in the reinstatement of stat dispensing for labetalol 100 mg and 200 mg tablets from 1 April 2020.

The Hybloc brand of labetalol 50 mg tablets was delisted on 1 August 2019 as a result of the discontinuation. We have been unable to source another brand of this tablet strength and resupply of a 50 mg tablet is not part of this proposal.

Consultation closes at 4pm, Monday 16 December 2019 and feedback can be emailed to procurement@pharmac.govt.nz.

What would the effect be?

For patients

From 1 April 2020, people would have funded access to a new brand of labetalol 100 mg and 200 mg tablets (Trandate).

The currently funded Presolol brand of labetalol 100 mg and 200 mg tablets would be delisted from 1 September 2020.

People would need to change to the Trandate brand to keep accessing funded labetalol tablets from 1 September 2020.

From 1 April 2020, the stat dispensing rule would be reinstated for labetalol 100 mg and 200 mg tablets. This would allow pharmacists to dispense three months of tablets at once.

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

There would be no change to the funding of labetalol injection.

As previously notified, the currently funded Hybloc brand of labetalol 100 mg and 200 mg tablets will be delisted from 1 December 2019 and 1 February 2020 respectively.

There would be no change to the funding of labetalol injection.

For community pharmacies

As previously notified, the currently funded Hybloc brand of labetalol 100 mg and 200 mg tablets will be delisted from the Pharmaceutical Schedule on 1 December 2019 and 1 February 2020 respectively.

From 1 April 2020, the Trandate brand of labetalol 100 mg and 200 mg tablets would be listed on the Pharmaceutical Schedule.

Stat dispensing would be reinstated for labetalol tablets from 1 April 2020.

From 1 September 2020, the currently funded Presolol brand of labetalol 100 mg and 200 mg tablets would be delisted from the Pharmaceutical Schedule and Trandate would have Sole Subsidised Supply status until 30 June 2024.

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

For hospital pharmacies

Following the listing of Trandate tablets on the Pharmaceutical Schedule from 1 April 2020, hospital pharmacies could continue to purchase any brand of labetalol 100 mg and 200 mg tablets for five months, until 1 September 2020.

From 1 September 2020, the Trandate brand would have Hospital Supply Status until 30 June 2024 with a discretionary variance (DV) limit of 1%, meaning that only 1% of total purchases of the relevant presentation of labetalol tablets could be a brand other than Trandate.

No changes are proposed for the listing of labetalol injection 5 mg per ml, 20 ml ampoule.

For prescribers

Prescribers would need to support people needing to change brands of labetalol 100 mg and 200 mg tablets as a result of this proposal.

This proposal would provide continued access to a funded brand of labetalol 100 mg and 200 mg tablets. From 1 September 2020, the only funded brand of labetalol tablets would be Trandate.

This proposal would not affect the currently listed injectable labetalol 5 mg per ml, 20 ml ampoule presentation, which will remain listed and fully funded. PHARMAC has no plans to delist or otherwise limit access to the injection.

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

For DHBs

This proposal would ensure continuity of supply of labetalol tablets.

Who we think will be 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

About labetalol

Labetalol is used in the treatment of hypertension (high blood pressure). It is particularly important for managing blood pressure in people who are pregnant, where raised blood pressure will affect both the person (pregnant women) and the unborn child.

Why we’re proposing this

PHARMAC released a Request for Tenders (RFT) for the sole supply of labetalol tablets in New Zealand on 2 August 2019. This was in response to the notification of a discontinuation of the funded, registered Hybloc brand of labetalol tablets by the supplier, and advice we received from the Cardiovascular Subcommittee (one of our expert clinical advisory groups).

You can read details of the advice we received. [PDF, 125 KB]

As a result of the RFT, PHARMAC is proposing to enter into an agreement with Aspen Pharmacare for the sole supply of 100 mg and 200 mg labetalol tablets. Feedback to this consultation will help us to decide whether to enter into this agreement.

Details about our proposal

Listing

From 1 April 2020, Aspen’s Trandate brand of 100 mg and 200 mg labetalol tablets would be listed 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

Labetalol

Tab 100 mg

Trandate

100

Labetalol

Tab 200 mg

Trandate

100

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

Sole supply

From 1 September 2020 until 30 June 2024, the Trandate brand would have Sole Subsidised Supply status and Hospital Supply Status for 100 mg and 200 mg labetalol tablets in the community and for DHB hospitals.

In DHB hospitals, this would result in Trandate being the only available brand of 100 mg and 200 mg labetalol tablets, subject to a 1% DV limit (i.e. 99% of total volume of these presentations of labetalol tablets purchased by DHB hospitals would be required to be the Trandate brand).

From 1 September 2020, all other brands of 100 mg and 200 mg labetalol tablets would 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 proposal would result in the reinstatement of stat dispensing of 100 mg and 200 mg labetalol tablets from 1 April 2020.

To provide feedback

Send us an email: procurement@pharmac.govt.nz by 4pm, Monday 16 December 2019.

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.