Proposal to fund bedaquiline and linezolid for multi-drug resistant tuberculosis

What we’re proposing

We are seeking feedback on a proposal to:

• fund bedaquiline and linezolid for treatment of people with multi-drug resistant tuberculosis (MDR-TB) for both community and hospital use, to allow people with MDR-TB to be treated in the community where appropriate, from 1 July 2023. 

Pharmac has reached a provisional agreement with the supplier of bedaquiline, Janssen-Cilag Pty Ltd (Janssen). 

Further details on the proposals, including how to provide feedback, can be found below. 

We welcome your feedback on the proposal. Consultation closes at 4pm on 7 June 2023 and feedback can be emailed to consult@pharmac.govt.nz   

Bedaquiline and linezolid for multi-drug resistant tuberculosis

What would the effect be?

From 1 July 2023 linezolid tablets and oral liquid would be listed in Section B of the Pharmaceutical Schedule (known as the community schedule) for use in the treatment of multi-drug resistant tuberculosis (MDR-TB), subject to restrictions. There would be no change to the listing of linezolid preparations in Section H of the Pharmaceutical Schedule (the Hospital Medicines List). 

From 1 July 2023 bedaquiline tablets would be listed in Sections B and H of the Pharmaceutical Schedule for use in the treatment of MDR-TB, subject to similar restrictions as linezolid. 

The 24 tablet blister pack of bedaquiline is a new presentation for New Zealand, previously only the 188 tablet bottles were available. 

We expect up to seven people would require these treatments for MDR-TB each year. 

These listings would allow people undergoing treatment for MDR-TB to receive their prescriptions from both community and hospital pharmacies. A small pack size of bedaquiline (24 tablet pack) would be available from 1 July 2023, enabling the management and dispensing of bedaquiline from community pharmacies. The listing of bedaquiline would also remove the need for people to access bedaquiline for MDR-TB via Pharmac’s Named Patient Pharmaceutical Assessment (NPPA) process.

Who we think will be 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

About Multi-Drug Resistant Tuberculosis (MDR-TB)

Tuberculosis is a serious bacterial infection caused by Mycobacterium tuberculosis complex that most often affects the lungs. 

In New Zealand, there are approximately 300 cases of tuberculosis infection diagnosed each year. New Zealand meets the World Health Organization definition of a low tuberculosis incidence country and almost four out of every five tuberculosis cases in New Zealand were diagnosed in people who were born outside New Zealand.  Our clinical advisors estimate there are three to seven cases of MDR-TB that would require treatment with bedaquiline and/or linezolid in New Zealand every year. Case numbers may rise as MDR-TB becomes more prevalent internationally. 

About a quarter of the global population is estimated to carry tuberculosis bacteria, but most people will not develop tuberculosis disease and some will clear the infection by themselves. People carrying tuberculosis bacteria have a 5–10% lifetime risk of falling ill with tuberculosis and becoming ‘active’. People with active tuberculosis infection may experience symptoms such as cough with sputum and blood at times, chest pains, weakness, weight loss, fever and night sweats. Tuberculosis infection may eventually lead to death. 

People who have an active tuberculosis infection can transmit the disease to other people. It is estimated that a person with active disease can infect 10-15 other people they have been in close contact with over the course of a year. Those with compromised immune systems, such as people living with HIV, malnutrition or diabetes, or people exposed to tobacco, have a higher risk of falling ill. 

The bacteria that cause tuberculosis can develop resistance to the antibiotic drugs used to cure the disease. MDR-TB is tuberculosis infection that does not respond to at least isoniazid and rifampicin, the two most powerful anti-tuberculosis medicines. MDR-TB can have a mortality rate as high as 40% if not properly treated. 

About bedaquiline and linezolid

Bedaquiline (brand name Sirturo) and linezolid (brand name Zyvox) are antibiotic medicines used to treat MDR-TB. Both bedaquiline and linezolid are recommended by the World Health Organization (WHO(external link)) as part of treatment regimens for MDR-TB. 

Bedaquiline is an antibiotic for a new class of medicines called diarylquinolines and is approved by Medsafe(external link) for the treatment of MDR-TB. It works by interrupting the chemical processes bacteria use to make energy and causes them to die. Bedaquiline is an oral treatment that is taken three times per week over a six month period to treat MDR-TB alongside other antibiotics. 

A proposal to fund bedaquiline was previously consulted upon and a decision was made in 2016 to list it in the Pharmaceutical Schedule for treatment of Extensively Drug-Resistant Tuberculosis (XDR-TB). However, the large pack size (one bottle contained a full six month course of 188 tablets) and high list price meant that community pharmacies would have difficulty with stocking bedaquiline and there was the potential for significant wastage. Instead, funding of bedaquiline for XDR-TB is currently managed via Pharmac’s Named Patient Pharmaceutical Assessment (NPPA) process. 

Linezolid is an antibiotic from a group of antimicrobials called oxazolidinones. It stops bacteria making proteins and so prevents their growth. It is Medsafe approved(external link) for the treatment of susceptible infections. Linezolid is available in tablet, oral liquid and injectable form and all three formulations are currently listed on the Hospital Medicines List(external link). When used to treat MDR-TB it is usually taken once per day for a minimum six month period. 

Why we’re proposing this

We have received funding applications for bedaquiline for the treatment of Multi-Drug Resistant Tuberculosis (MDR-TB) and Extensively Drug-Resistant Tuberculosis (XDR-TB)

• Bedaquiline for XDR-TB(external link)
• Bedaquiline for MDR-TB(external link)

As noted above, bedaquiline for XDR-TB has been funded via NPPA since the decision to fund it in 2016. 

Our clinical advisors on the Anti-Infective Advisory Committee (AIAC) and the Pharmacology and Therapeutics Advisory Committee (PTAC) reviewed the evidence for bedaquiline in 2014 (AIAC), 2020 (PTAC) [PDF, 588 KB], 2020 (AIAC) [PDF, 132 KB] and recommended it be funded with a high priority for the treatment of MDR-TB. 

The Anti-Infective Advisory Committee noted that in making the above recommendation, it was important to consider the recent update in MDR-TB treatment guidelines from the World Health Organization, which included bedaquiline as one of the Group A agents in the MDR-TB treatment regimen and linezolid as one of the Group B agents. Bedaquiline and linezolid are part of all-oral treatments for MDR-TB which allows people to receive treatment in the community instead of needing infusions in a clinic or hospital throughout the treatment period which is at least 6 months. 

In light of this, in 2020 the Anti-Infective Advisory Committee recommended that [PDF, 132 KB], based on the updated WHO and national guidelines, linezolid be funded in the community alongside bedaquiline with a high priority for the treatment of MDR-TB. 

Pharmac first prioritised bedaquiline for MDR-TB as an option for investment in June 2020. 

You can read more about the Committees’ assessments of the clinical evidence for bedaquiline and linezolid via Pharmac’s Application Tracker(external link). 

While linezolid is already funded for use in hospitals, to allow effective treatment of MDR-TB in the community both bedaquiline and linezolid need to be funded for both hospital and community use. Treatment of MDR-TB requires them to be taken alongside other antibiotics for a minimum of six months. We understand that the availability of both medicines from community pharmacy is important to support community based treatment for people with tuberculosis. 

We are proposing to fund bedaquiline and widen access to linezolid now as we have reached a provisional agreement with Janssen, the supplier of bedaquiline. The new smaller pack size of bedaquiline would resolve previous concerns with managing the large and high-cost pack of bedaquiline through community pharmacies and makes it possible to progress a proposal for community funding.  

Details about our proposal

Linezolid

Linezolid tablets and oral liquid would 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): 

Linezolid would be listed in Section B subject to the following eligibility criteria:

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 would not change. 

Bedaquiline

Bedaquiline would 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):

Original pack (OP) dispensing would apply due to the high cost-per-tablet of bedaquiline, which would allow pharmacies to dispense a complete pack and avoid wastage.

Bedaquiline would 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):

The smaller 24 tablet pack would be available for use in the community and in hospitals ongoing. The larger 188 tablet pack would 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. 

Sirturo would have protection from delisting and subsidy reduction until 30 June 2026.

Bedaquiline would be listed in Section B and Section H subject to the following eligibility criteria:

The proposed eligibility criteria are in line with the expert advice received from our advisory committees. The difference in Special Authority approval periods between bedaquiline and linezolid is due to the very long half-life of bedaquiline which means that it should be stopped before the other medicines in a MDR-TB treatment regimen. 

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm on 7 June 2023

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.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity. 

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