Decision to remove the Special Authority and enable practitioners supply order (PSO) for some HIV medicines

Medicines Decision

What we’re doing

We're pleased to announce that from 1 November 2026 Pharmac will be making it easier to access all antiretroviral medicines used for HIV. This includes the following changes to the Pharmaceutical Schedule.

  • Removal of the Special Authorities (SA) and Hospital restrictions for HIV medicines (also called antiretrovirals) to resolve issues with access raised by the health sector.
  • Enabling access to two HIV medicines (emtricitabine with tenofovir disoproxil combination tablets and dolutegravir tablets) on a practitioners supply order (PSO). This will allow immediate access for these antiretrovirals for post-exposure HIV prophylaxis (PEP) for people presenting to emergency clinics and sexual health clinics across New Zealand.

These changes are not intended to change prescribing patterns, prescriber types, or move HIV treatment management into primary care. The aim is to reduce barriers and make it simpler for people to get the treatment they need.

About antiretroviral medicines and HIV

About HIV

Human immunodeficiency virus (HIV) is a virus that attacks the body’s immune system. If left untreated, it can lead to AIDS (Acquired Immunodeficiency Syndrome). With effective antiretroviral treatment, people living with HIV can live long, healthy lives.

About antiretrovirals

Antiretrovirals are medicines used for HIV in a number of different circumstances, including ongoing treatment, Post-Exposure Prophylaxis (PEP) and Pre-Exposure Prophylaxis (PrEP). Treatment of HIV occurs when a person with confirmed HIV receives a prescription for multiple antiretroviral medicines to supress the virus. HIV treatment is life-long.

PEP is used when a person who may have been exposed to HIV receives treatment with antiretroviral medicines within a 72-hour period of their possible exposure. Receiving PEP early can greatly reduce or eliminate the chance of a person contracting HIV.

PrEP is used when a person does not have HIV, but may be at risk of exposure, and takes antiretroviral medicines to reduce their risk of becoming infected with HIV.

About PSO (Practitioners Supply Order)

The PSO list is a list of pharmaceuticals that can be ordered and held by any prescriber (within their scope of practice). The purpose of the PSO is to ensure that stock is available for prescribers for:

  • emergency or urgent use
  • teaching and demonstration purposes
  • provision to certain patient groups where an individual prescription is not practical.

Why we’re doing this

Removal of the Special Authority and Hospital Indication restrictions for HIV medicines

Clinicians and pharmacists have told us the current Special Authority criteria for HIV medicines are complex and can be confusing for people and healthcare workers. This especially applies where treatment needs to be started urgently, such as PEP treatment.

HIV medicines are only used for the treatment or prevention of HIV. Because of this, removing the funding restrictions simplifies access and reduces administrative burden, without changing who can receive funded treatment. Because of this, we are removing the funding criteria for these medicines to make sure that people who would benefit are able to access them as easily as possible.

Making two HIV medicines available on a Practitioners Supply Order (PSO)

Our clinical advisors have told us that when appropriate, the sooner PEP is started the more effective it is. This change will support faster access for people after a potential HIV exposure event.

Prescribers of PEP and advocacy groups for people living with HIV have also told us that the current funding restrictions for PEP can cause delays in people accessing these medicines. At present, everyone who needs it is eligible for funded PEP and this will not change.

These medicines are generally only prescribed by infectious disease or sexual health clinicians and may not be routinely stocked by all pharmacies, which can cause difficulty and delays when people need them. Pharmac has heard from some clinicians and consumer advocacy groups that requiring people to receive a prescription, then later visit a pharmacy to receive PEP can create delays, especially during the weekend and in more rural locations. Allowing immediate supply via PSO could help avoid these delays and mean that people can access PEP more quickly when it is required.

The changes mean that prescribers who expect to encounter people needing PEP, such as clinicians working in specialist sexual health services or emergency after hours clinics, will be able to provide a course of PEP directly to patients. As PEP is not a Medsafe registered indication for these medicines, they will not be able to be supplied for this use under a standing order.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 2 October 2025 and a decision notification dated 27 November 2025. These changes were originally planned for 1 March 2026 and STAT (3 monthly) dispensing was enabled for antiretrovirals at this point. However, we received extensive feedback from clinicians and health services on the proposed removal of the HIV Special Authority and addition of PSO to some medicines.

Because of this, we decided to delay removal of the Special Authority and addition of PSO while we worked through the feedback and consulted further with the health sector.

Following further engagement with the health sector and our clinical advisors, Pharmac has included new pharmaceutical schedule notes and endorsement requirements alongside the removal of the Special Authority and Hospital Restriction criteria for these medicines (see ‘Details about this decision’ section below). Pharmac has also developed more fulsome implementation measures to ensure responsible use of these medicines, the details of these changes can be found below.

Who we think will be most interested

  • People living with HIV, their whānau, friends and caregivers
  • Healthcare professionals involved in the care of people with HIV
  • Te Whatu Ora hospitals and other organisations who deliver services and support for people, and their whānau who are affected by HIV
  • People or groups with an interest in treatments for HIV
  • Pharmacies and wholesalers

Detail about this decision

From 1 November: 

  • People will no longer need a Special Authority to receive medicines for HIV treatment.
  • People will no longer need a Special Authority to receive medicines for HIV prophylaxis.
  • Prescribers will be able to access two medicines, emtricitabine with tenofovir disoproxil (combination tablet) and dolutegravir on PSO for use in HIV post-exposure prophylaxis.
  • Notes to prompt prescribers to ensure patients are linked with specialist services will be added to all antiretroviral medicines.
  • Subsidy by endorsement criteria will be added to dolutegravir and emtricitabine with tenofovir disoproxil to limit PSO usage to PEP. 

The specific changes to the Pharmaceutical Schedule that will be made on 1 November 2026 are: 

  • Special Authorities SA2139 and SA2520 will be removed.
  • Hospital Indication Restrictions RS1898 and RS1902 will be removed.
  • The following pharmaceutical schedule note will apply to all antiretroviral medicines:

Note:
HIV treatment with antiretroviral medicines should only be initiated under the guidance of a clinician experienced in the management of HIV. Practitioners should refer to local health pathways and guidelines.

  •  The PSO rule – ‘Up to 30 tab available on a PSO’ will apply to emtricitabine with tenofovir disoproxil and dolu
  • The following endorsement criteria will apply to emtricitabine with tenofovir disoproxil and dolutegravir:

Funded on PSO for Post-Exposure Prophylaxis (PEP) only, supplied only by an authorised practitioner, and the PSO is endorsed accordingly.

  • The following additional pharmaceutical schedule note will apply to emtricitabine with tenofovir disoproxil and dolutegravir

Note:
Post-Exposure Prophylaxis (PEP) is not a registered indication for emtricitabine with tenofovir disoproxil or dolutegravir and they cannot be supplied for this use under a standing order.

Notes referring to the count of antiretrovirals required for the current Special Authority for abacavir sulphate with lamivudine, efavirenz with emtricitabine plus tenofovir disoproxil, zidovudine with lamivudine, and tenofovir disoproxil will be removed. 

Our response to what you told us

We’re grateful for the time people took to respond to the 2 October 2025 consultation on proposed changes to funding criteria for HIV medicines. A summary of the main themes raised in feedback is available on the notification webpage for the enabling of STAT dispensing for HIV medicines:

Decision to enable three monthly (STAT) dispensing for HIV medicines

Many stakeholders were supportive of the changes and their feedback is summarised in the previous notification. The consultation feedback in the table below reflects the changes we have made in response to the feedback received as part of the previous consultation process and after further engagement with the health sector. 

Stakeholder group

Theme

Pharmac response

Clinicians

A number of specialist infectious disease and sexual health clinicians noted that while they were supportive in general of simplified access to antiretrovirals, they considered that removal of the Special Authority, specifically the prescriber requirements, and open listing of antiretrovirals removed an important clinical safeguard that helped ensure people with HIV were receiving the best possible care guided by appropriate specialist oversight.

Respondents proposed Pharmac retain the current SA, or introduce an equivalent mechanism, to ensure appropriate specialist oversight of HIV treatment initiation and regimen changes.

Some respondents also noted they considered that prescribing antiretrovirals for children should be restricted to paediatric infectious disease specialists only due to the complexity of managing HIV in children.

We have carefully considered all options for funding restrictions for antiretroviral medicines.

Pharmac funding restrictions are criteria used by Pharmac to ensure that medicines are targeted to people who would benefit most from them and to those for whom medicines are most cost-effective. The Pharmaceutical Schedule is not designed to provide clinical advice or guidance.

Pharmac reiterates that simplified funding access does not change the need for clinicians to act within their scope of competence and sector expectations regarding the clinical management, monitoring, or specialist involvement in the care of people living with HIV. A joint statement from Pharmac and the Royal New Zealand College of General Practitioners regarding treatment of HIV positive people in primary care is attached below.

We acknowledge that Special Authority criteria for antiretrovirals have previously limited which clinicians can initiate funded treatment with these medicines, and concerns that removal of the Special Authority may therefore create potential for inappropriate prescribing.

To support the responsible use of these medicines we have added notes to antiretroviral medicines to prompt prescribers to ensure people who are HIV positive are engaged with specialist services. We have also passed this feedback on to Health New Zealand and the Specialist Colleges who are responsible for prescriber accreditation and training, and are sponsoring relevant educational articles for clinicians on the appropriate prescribing of antiretrovirals.

Clinicians

Responded proposed that New Zealand introduce a structured, mandatory national training and accreditation programme for non-specialist antiretroviral prescribers, similar to Australia’s S100 model, including ongoing HIV specific continuing professional development and specialist mentorship.

Pharmac recognises the value of clear clinical guidelines, accreditation standards, and scopes of practice.

National training and accreditation pathways for prescribers fall outside of the scope of Pharmac’s remit as the funder of medicines. However, as part of this change Pharmac has shared this feedback with Health New Zealand and the Specialist Colleges who are responsible for prescriber accreditation and training.

Clinicians

Ensure PSO supply for PEP is accompanied by clear expectations regarding assessment, baseline testing, follow‑up planning, and referral pathways.

Pharmac recognises the value of clear clinical guidelines and expectations for prescribers.

Whilst outside the scope of Pharmac’s remit, Pharmac has shared this feedback with Health New Zealand and the Specialist Colleges who are responsible for prescriber accreditation and training. We are also sponsoring relevant educational articles for clinicians on the appropriate prescribing of antiretrovirals.

Clinicians

Use of PSO minimises visible prescribing data for patients receiving PEP

Pharmac has carefully considered this concern, however we believe that that improved patient access for PEP outweighs the potential loss of detailed prescribing data for this use.

We expect that the number of people receiving PEP via PSO will be relatively low compared to the wider usage of these medicines for treatment/PrEP.

Professional organisations

The use of emtricitabine with tenofovir with or without dolutegravir, for PEP of HIV is an unapproved indication (off-label use) in New Zealand, where under the current legal and regulatory frameworks, such use requires a prescription for a specific patient, with informed consent obtained and documented.

We have considered this feedback and consulted with the Medicines regulator, Medsafe as well as the Pharmaceutical Society and Pharmacy Guild. As a result of this dolutegravir and emtricitabine with tenofovir disoproxil will receive a ‘subsidy by endorsement’ rule when used for PSO, confirming that the usage is for PEP and by an authorised prescriber. This will prevent use outside the intended scope such as via standing order.

In response to this feedback we have:

  • moved the implementation date for the proposal to 1 November 2026 so we could carry out further consultation with the health sector.
  • added notes to the schedule listing for antiretrovirals to prompt prescribers to ensure that they make sure that people who are HIV positive are engaged with specialist services.
  • worked with the Royal New Zealand College of General Practitioners (RNZCGP) to create a position statement that clearly sets out expectations for HIV prescribing in primary care.
  • planned further implementation work to communicate this change to the health sector. This includes working with the Best Practice Advocacy Centre (bpacnz) to provide resources for prescribers about what these changes mean in practice, and update resources on PEP and PrEP.

The RNZCGP position statement around this change is linked below:

Royal New Zealand College of General Practitioners position statement [PDF, 169 KB]

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