Decision to fund bedaquiline and linezolid for multi-drug resistant tuberculosis
Pharmac will fund bedaquiline and linezolid for multi-drug resistant tuberculosis (MDR-TB) from 1 July 2023.
What we’re doing
We're pleased to announce that from 1 July 2023 bedaquiline and linezolid will be funded for multi-drug resistant tuberculosis (MDR-TB) for both community and hospital use. This change will enable people with MDR-TB to be treated in the community where appropriate.
Any changes to the original proposal?
This decision was subject to a consultation letter dated 23 May 2023.
We received feedback from consumers and clinicians.
We want to thank everyone who took the time to provide us with their feedback. Responses were generally supportive of the proposal, with some requests for more information about tuberculosis and wider access. We have not made any changes to the original proposal following feedback.
A summary of the feedback received and our responses to this feedback is included below.
Who we think will be most interested
- People with drug-resistant tuberculosis and their whānau
- Healthcare professionals involved in the care of people with drug-resistant tuberculosis
- Te Whatu Ora - Health New Zealand hospitals and other organisations who deliver services and support for people, and their whānau who are affected by drug-resistant tuberculosis
- Pharmacies and wholesalers
- Pharmaceutical suppliers
Detail about this decision
The following changes will occur in Section B and Part II of Section H of the Pharmaceutical Schedule.
Bedaquiline
Bedaquiline will be listed in Section B of the Pharmaceutical Schedule (community Schedule) from 1 July 2023 at the following price and subsidy (ex-manufacturer, excluding GST):
|
Chemical |
Formulation |
Brand |
Pack size |
Price and subsidy |
|---|---|---|---|---|
|
Bedaquiline |
Tab 100 mg |
Sirturo |
24 OP |
$3,084.51 |
Original pack (OP) dispensing will apply to allow pharmacies to dispense a complete pack and avoid wastage.
Bedaquiline will also be listed in Part II of Section H (hospital medicines list) of the Pharmaceutical Schedule from 1 July 2023 at the following prices (ex-manufacturer, excluding GST):
|
Chemical |
Formulation |
Brand |
Pack size |
Price |
|---|---|---|---|---|
|
Bedaquiline |
Tab 100 mg |
Sirturo |
24 |
$3,084.51 |
|
Bedaquiline |
Tab 100 mg |
Sirturo |
188 |
$24,162.00 |
The smaller 24 tablet pack will be available for use in the community and in hospitals ongoing. The larger 188 tablet pack will only be available in hospitals short-term to help use up existing stock. We expect to delist the 188 tablet pack from 1 July 2024 once stock is exhausted.
Bedaquiline (Sirturo) will have protection from delisting and subsidy reduction until 30 June 2026.
Bedaquiline will be listed in Section B subject to the following eligibility criteria:
Special Authority for Subsidy
Initial application – (multi-drug resistant tuberculosis) from any relevant practitioner.
Approvals valid for 6 months for applications meeting the following criteria:
Both:
- The person has multi-drug resistant tuberculosis (MDR-TB); and
- Manatū Hauora - Ministry of Health’s Tuberculosis Clinical Network has reviewed the individual case and recommends bedaquiline as part of the treatment regimen.
A similar restriction will apply in Part II of Section H of the Pharmaceutical Schedule.
Linezolid
Linezolid tablets and oral liquid will be listed in Section B (community Schedule) of the Pharmaceutical Schedule from 1 July 2023 at the following prices and subsidies (ex-manufacturer, excluding GST):
|
Chemical |
Formulation |
Brand |
Pack size |
Price and subsidy |
|---|---|---|---|---|
|
Linezolid |
Tab 600 mg |
Zyvox |
10 |
$276.89 |
|
Linezolid |
Oral liq 20 mg per ml |
Zyvox |
150 ml |
$1,879.00 |
Linezolid will be listed in Section B subject to the following eligibility criteria:
Special Authority for Subsidy
Initial application – (multi-drug resistant tuberculosis) from any relevant practitioner.
Approvals valid for 18 months for applications meeting the following criteria:
Both:
- The person has multi-drug resistant tuberculosis (MDR-TB); and
- Manatū Hauora - Ministry of Health’s Tuberculosis Clinical Network has reviewed the individual case and recommends linezolid as part of the treatment regimen.
The current listings of linezolid, including hospital Principal Supply Status for the tablets (ending 30 June 2024), and hospital restrictions in Part II of Section H (hospital medicines list) of the Pharmaceutical Schedule will not change.
Our response to what you told us
We’re really grateful for the time people took to respond to this consultation. Responses were largely supportive of the proposal. A summary of the main themes raised in feedback, our responses to the feedback received are available below.
|
Theme |
Comment |
|---|---|
|
Requests for wider access to bedaquiline and linezolid including susceptible M. tuberculosis complicated by intolerance to first line agents where a satisfactory regimen cannot be prescribed. |
We have not previously considered the use of these treatments for this use. Pharmac intends to seek further input from our clinical advisors on funding bedaquiline and linezolid for this group. |
|
Request that Pharmac consider the addition of pretomanid for tuberculosis treatment to the schedule per World Health Organization (WHO) guidelines. |
Pharmac is monitoring the ongoing developments in tuberculosis treatment clinical practice, at present there is no Medsafe approved pretomanid product available in New Zealand. Pharmac intends to seek further input from our clinical advisors on tuberculosis treatments. |
|
Request for further information on tuberculosis and drug-resistant tuberculosis and the scale of the issue with tuberculosis in Aotearoa New Zealand. |
Tuberculosis is one of the leading causes of infectious disease related mortality worldwide. While Aotearoa New Zealand is classified as a low-incidence country due to an effective public health response that is able to identify and treat people with tuberculosis, MDR-TB is resistant to many of the common medicines used to treat TB. Maintaining access to effective treatments to prevent spread of MDR-TB throughout Aotearoa New Zealand is therefore highly important. Detailed epidemiological information is published by the Institute of Environmental Science and Research (ESR)(external link). |
|
Request for more information on how Pharmac decides what medicines to fund and how many other medicines are waiting for funding as well as if cost-effectiveness assessment considered? |
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 660 050.