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

Remove the Special Authority and Hospital Indication restrictions for HIV medicines

Consumers, Clinicians, Pharmacists, Suppliers, Sexual Health Services

Supportive

We appreciate the supportive feedback on this change, however, after significant feedback from clinicians and health services during consultation that highlighted concerns around the potential for insufficient support and monitoring for patients, we are reassessing potential changes to the HIV Special Authority.

Pharmac is considering this feedback carefully and will provide an update in the near future.

Academic Research Group

Supportive, noting that PrEP uptake in NZ is suboptimal and inequitably accessed by those who would benefit from it.

Approximately one in six participants (18.9%) were in the “PrEP gap”. In other words, these Men who have sex with Men (MSM) reported risk behaviours that identified them as suitable candidates to be prescribed PrEP - based on NZ clinical guidelines - and they were also willing to take PrEP, but they were not using PrEP.

We appreciate the supportive feedback on this change; however, after significant feedback from clinicians and health services during consultation that highlighted concerns around the potential for insufficient support and monitoring for patients, we are reassessing potential changes to the HIV Special Authority.

We understand more people may benefit from access to antiretrovirals for HIV prophylaxis and will continue to work to make HIV medicines more accessible.

Community prescribers

Respondents noted that at present there was no ‘prescribing for HIV’ course in NZ available to primary care clinicians and nurse practitioners.

We are reassessing potential changes to the HIV Special Authority as a result of consultation feedback and will provide an update in the near future.

While Pharmac is not responsible for training of primary care providers we will pass this feedback on to the professional colleges and BPAC, and ensure there is implementation support available if changes to the HIV Special Authority are made in the future.

Specialist clinicians, Infectious disease services

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 SA, 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.

Some considered it was important the prescribers of antiretrovirals are operating within a multidisciplinary team and have appropriate support and peer review of their practice, to ensure the patients are receiving the best possible care.

Others noted paediatric HIV management in particular is complex, and under no circumstances should treatment be initiated or prescribed by anyone other than a paediatric infectious disease specialist.

One clinician noted that they had first-hand experience of patients being provided with antiretroviral prescriptions without appropriate clinical monitoring such as viral load tests, which they considered unsafe.

We understand that care for people living with HIV can be medically complex and antiretroviral prescribing requires careful consideration by prescribers.

One of the primary concerns we received as part of consultation feedback was around initiation of HIV treatment by non-specialists. Pharmac sought further clinical advice from our Advisors who noted that there was a risk of poor patient care if people were not engaged with specialist services when they begin treatment with antiretrovirals.

In light of this feedback and clinical advice, Pharmac will investigate alternative options to removal of the HIV Special Authority in consultation with relevant stakeholders.

Pharmac will also engage with the relevant specialist colleges around appropriate guidance to their members and develop implementation support for any changes made in the future.

Clinicians

Respondents expressed concerns that removal of the Special Authority would mean a loss of prescribing data on patients receiving antiretrovirals.

Prescribing data is recorded irrespective of the presence of a Special Authority. Removal of the Special Authority would not prevent data gathering around the use of antiretrovirals.

Clinician

A clinician noted that whilst doctors have a defined scope of practice as per the Medical Council of NZ (MCNZ), this is not always the case for all prescribers and that open listing posed risks of inappropriate prescribing.

In New Zealand there are multiple types of prescribers. The MCNZ is responsible for clinicians. However, all prescribers have their own oversight body such as the Pharmacy council or Nursing Council.

Authorised prescribers can independently prescribe any medicine that relates to their area of practice. This group includes medical practitioners, nurse practitioners, optometrists, dentists, and registered midwives. We understand these groups have their own oversight bodies who manage appropriate clinical scope for their members.

Designated prescribers can only prescribe from a list of medicines published by the Director-General of Health. They are expected to prescribe in consultation with, and supervised by, an authorised prescriber. This group includes pharmacists, dietitians and registered nurse prescribers. 

Enable all at once dispensing (STAT) (3 monthly) dispensing

Consumers, Clinicians, Pharmacists, Suppliers, Sexual Health Services

Supportive

We are pleased to be able to support people living with HIV by enabling longer dispensing periods.

Pharmaceutical suppliers, Pharmacies

Supportive, however noted the short implementation timeframes and that there were ongoing Section 29 products covering supply issues in this group. Requested extension of the implementation timeframe to allow supply chains and pharmacies to adapt.

We have delayed the implementation of this proposal until 1 March 2026 to allow suppliers, wholesalers and pharmacies more time to adapt.

Pharmaceutical wholesaler

Not supportive, noting STAT dispensing should not be introduced as it will reduce how often people have contact with their pharmacist.

While STAT dispensing does mean that people can visit the pharmacy less often prescribers retain the capacity to issue monthly prescriptions if required for monitoring purposes.

Pharmaceutical wholesaler and Professional organisation

Not supportive, noting larger dispensing quantities can increase the risk of loss or wastage if medicines are lost or expire, or if treatment is changed or discontinued.

Pharmac has included the cost of a potential increase in medicines wastage from STAT dispensing in its analysis of this proposal. Our assessment is that the potential cost of an increase in wastage of medicines is outweighed by the advantages of people being able to receive all-at-once dispensing.

Professional organisation

Requested addition of wastage claimable for high-cost HIV medicines.

Pharmac acknowledges that wastage claimable can be useful to pharmacies for high-cost medicines. In this case we note that none of the currently funded formulations have wastage claimable, and while enabling STAT dispensing will mean the potential for more wastage on a single dispensing, the total proportion will not change.

We are not currently looking to apply wastage claimable for high-cost HIV medicines as part of this proposal. However, we will continue to monitor this and consider adding wastage if necessary in the future.

Professional organisation

Not supportive, noting here there may also be stock management pressures on community pharmacies, as sudden changes to dispensing frequency can impact inventory levels, cash flow, and ordering patterns, especially for smaller or rural pharmacies.

Pharmac acknowledges the pressures faced, especially by small and/or rural pharmacies. We have delayed the implementation of this proposal until 1 March 2026, to allow pharmacies more time to adapt stockholding and avoid any delays with supply which can occur over the new year period.

Professional organisation

Supportive but noted that reduced dispensing frequency may lessen opportunities for pharmacists to engage regularly with patients, which provides a valuable touchpoint for adherence support, side-effect monitoring, and relationship building.

Recommended that Pharmac consider implementation over a six-month transition period to allow wholesalers, prescribers, and pharmacies to adapt stock management systems and workflow processes, reducing the risk of supply disruptions.

Also recommended clear communication to both prescribers and pharmacists, reinforcing their ability to tailor dispensing frequency based on the individual patient factors such as treatment stability, adherence history, and social circumstances. 

We acknowledge the valuable role played by Pharmacists as front-line health workers and their unique ability and opportunities to engage with patients.

We have delayed the implementation of this proposal until 1 March 2026 to allow pharmacies more time to adapt to the changes.

We will also provide support to prescribers and pharmacies to make sure they have the required information and guidance around the management of people living with HIV.

Professional organisation

Supportive, however noted the proposed changes to HIV medicine access may present financial challenges for community pharmacies, particularly for smaller, independent, or rural pharmacies operating on tighter margins. 

HIV medicines can be expensive pharmaceuticals and enabling STAT dispensing will require pharmacies to purchase larger quantities upfront, while awaiting reimbursement after dispensing.  This may cause such pharmacies to adopt an ‘order as required’ approach rather than hold stock of HIV medicines, leading to a reduction in service availability. 

This risk is particularly concerning in rural and underserved communities, where it could significantly limit timely treatment access for high-risk patients, disproportionately impacting vulnerable populations and undermining national efforts to promote health equity.

Recommended Pharmac consider a zero-cost supply model for HIV medicines to pharmacies, similar to other public health initiatives.

We understand that some HIV medicines have relatively high list prices. However, placing these medicines on alternative commercial arrangements such as the arrangement for Maviret is not possible, as this requires specific commercial agreements between Pharmac and the suppliers, as well as between the supplier and individual pharmacies.

The majority of funded HIV medicines are provided under the Terms of Pharmac’s annual invitation to tender. This process does not enable the envisaged alternative funding arrangements.

We acknowledge that with the current commercial model, pharmacies can find it difficult to purchase high-cost medicines at-risk. However, discussions around changing the funding model for high-cost medicines are wider in scope than can be addressed in this consultation.

Enable access to two HIV medicines on a practitioners supply order (PSO) to allow immediate access for these antiretrovirals for post-exposure HIV prophylaxis (PEP)

Consumers and clinicians

Supportive

We appreciate the supportive feedback on this change but have decided to pause adding these medicines to the PSO list due to feedback from clinicians and health services highlighting concerns around the potential for insufficient support and monitoring for patients.

Pharmac will provide updates when this work is complete.

Pharmaceutical wholesaler

Not supportive, noting they considered making HIV medicines available on PSO is necessary. Wholesalers have both medications available and many pharmacies stock these medications.

We have received requests from multiple health sector partners for this change and consultation feedback was generally supportive. Pharmac has also received correspondence from the health sector that noted cases of existing delays, including a health and disability commission report noting delays for one specific incident.

Infectious disease service

Respondents noted that while supply of HIV PEP medications (emtricitabine with tenofovir and dolutegravir) via PSO may reduce access delays for some people, PEP is complex, and provision is not as straightforward as simply providing a person with a supply of medication.

Supply of PEP should also include initiation of tasks such as baseline STI testing and a plan for follow-up.

We understand that there are concerns around appropriate provision of these medicines.

Pharmac is considering this feedback carefully and will provide an update in the near future.

Clinicians

Respondents were supportive but considered that Pharmac should put in place restrictions to ensure that only appropriate sites such as ED/ urgent care/inner city GP surgeries / sexual health clinics/ SAATS services stocked PEP medicines via PSO.

Pharmac acknowledges that there are limited sites for which it would be appropriate to stock these medicines for PSO use.

Pharmac is considering this feedback carefully and will provide an update in the near future.

Professional organisation

PSO supply mechanisms inherently break the direct link between individual patients and dispensing records, making it difficult to verify who received treatment or support appropriate follow-up or pharmacovigilance.

We acknowledge that PSO usage would impact prescribing data gathering. PSO usage would only be a very small proportion of total usage of these medicines.

Pharmac is considering this feedback carefully and will provide an update in the near future.

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.

Supplying this medicine via a PSO could potentially expose both the prescriber and the supplying pharmacist to regulatory or professional risk.

Pharmac has sought advice from Medsafe and Pharmac’s internal legal team. Any changes to the funding restrictions will account for the non-registered status of these medicines for PEP and be designed to mitigate the risk of use outside the intended scope.

Pharmac is considering this feedback carefully and will provide an update in the near future.

Professional organisation

We recommend that a national monitoring and reporting framework be established through the NZePS, Conporto, or a similar digital platform to record PSO utilisation data and ensure transparency, traceability and accountability across all points of supply.

This will help to identify patterns of utilisation, detect inappropriate or excessive supply, and support evidence-based policy refinement, along with enhancing the ability to link PSO data with national prescribing and dispensing datasets. 

We understand that while there would be benefits to the monitoring system described, establishment of a new prescribing data system is outside the scope of this proposal.

Professional organisation

Respondents requested Pharmac ensure the ability for whole pack quantities of PEP medications to be supplied through the PSO route.  Given the high cost of dolutegravir, it is unreasonable to expect pharmacies to absorb the financial burden of unused portions. 

The PSO limit for both dolutegravir and emtricitabine with tenofovir is proposed to be set at the size of 1 pack (30 tabs). This will avoid pharmacies having to cover the cost of any unused tablets as they would dispense the whole pack on PSO.

This size also aligns with the normal usage of PEP as a one-month supply.

Other

Clinicians

Respondents noted support for the planned change to allow prescribing for up to 12 months of medications for chronic conditions.

We are pleased to be able to simplify peoples access to medicines via extending prescribing times.

Clinicians

Respondents noted a clinical need for new anti-retroviral medications to be funded to improve choice for people with HIV the same regimen is not necessarily suitable for each individual.

Respondents noted international arrivals with HIV who previously had a far greater selection of single tablet regimens than are funded in New Zealand.

Respondents also noted there was a need for need new long-acting injectable HIV medicines for treatment and PrEP.

We acknowledge that there are antiretrovirals medicines available internationally that could be funded for HIV. We would welcome funding applications for these medicines.

Make a funding application

At present there are no Medsafe registered long-acting injectable medicines and Pharmac is yet to receive a funding application for one.

Pharmac continues to engage with suppliers of antiretrovirals medicines regarding potential funding applications to increase the number of funded antiretrovirals medicines.