Decision to widen access to antiretrovirals and nitrofurantoin

General

Responders were supportive of the proposals

We are pleased to be funding proposals that will improve the health outcomes of New Zealanders.

Emtricitabine with tenofovir disoproxil for pre-exposure prophylaxis of HIV (PrEP)

Supportive of overall widened access to PrEP.

We are pleased to widen access to PrEP which will mean more people can benefit from treatment.

Noted that many people are uncomfortable discussing intimate details with their prescriber and removing criteria to discuss personal sexual behaviour will help reduce this barrier to access.

We are pleased to help remove this barrier to access.

Eligibility criteria and access

Many responders were supportive of the extension of the approval period for PrEP from three to 24 months.

Some respondents considered that while supportive of extension, this should not exceed six months as patients should be reviewed every three months to mitigate seroconversion risks.

We acknowledge the overall support that this change is appropriate. We consider that since a prescription period is a maximum of three months and clinical guidance for PrEP is to monitor patients at each prescription visit that these concerns would be adequately addressed by appropriate clinical practice.

Recommended amending the language of the criteria to “elevated risk of HIV”. Proposed criteria are too wide as technically, anyone having unprotected intercourse could be at risk of HIV.

This change aligns with the intent of the criteria. We have amended the criteria to include the term “elevated risk”.

Recommended the wording of PrEP ‘not at risk of HIV seroconversion’ is replaced with: “Patient has tested HIV negative, does not have signs or symptoms of acute HIV infection and has been assessed for HIV seroconversion”

Many patients at the highest risk of HIV acquisition may be at continuous or frequently recurring risk of seroconversion.

We consider the suggested change an appropriate clarification and have amended the criteria to reflect this.

Recommended replacing the usage of ‘unprotected sex’ to ‘condomless sex’ as it is a more accurate term.

This change aligns with the intent of the criteria. We have amended the criteria to include the term “condomless”.

Some respondents considered that criteria regarding testing requirements should be maintained to ensure safe and appropriate prescribing. 

Other respondents were supportive of the removal of criteria regarding testing requirements, and the removal of clinical guidance from the access criteria. Some groups noted that testing criteria would be maintained through clinical guidelines and training and considered it was appropriate that the onus is on practitioners rather than the funding criteria. 

We acknowledge the mixed feedback we received regarding the removal of education and testing requirements from the criteria. We consider that the eligibility criteria are for funding purposes rather than clinical guidance and consider that this would be able to be sufficiently managed through the available clinical guidelines. 

The removal of testing requirements from the criteria does not indicate that testing is not required, rather that it should not limit eligibility for funding. We note that PrEP has been a part of the treatment paradigm in Aotearoa for some time. We do however recognise the significant concerns raised by the Sector in relation to the removal of “safety” and “best practice” criteria and have amended the criteria to maintain the link to the ASHM guidelines(external link) to refer prescribers to where to find more information to guide safe and appropriate practice. 

We welcome ongoing discussion around this issue and will monitor how this change impacts the use of PrEP and clinical services and how we could support the sector in implementation of this change.

Concerned that the criteria did not specifically restrict use or discontinuation of emtricitabine with tenofovir disoproxil in patients with chronic hepatitis B infection.

We acknowledge that PrEP use is complicated for some patient populations. We consider appropriate and responsible prescribing practice falls within clinical guidelines which is why it is no longer included in funding criteria.

Some respondents expressed a desire to include discussion of condom use in the special authority criteria. 

Others noted the inclusion of condom discussion criteria would be redundant as this discussion is standard practice.

We appreciate the range of views regarding condom use expressed during consultation and the importance of the promotion of condom use in this context. 

We consider that the inclusion of such a criterion falls within clinical guidelines and is no longer suitable for inclusion in funding criteria. 

We have amended the criteria to include reference to the ASHM PrEP guidelines(external link).

Requested that stat dispensing be applied to allow three monthly prescriptions to be dispensed instead of monthly dispensing. 

We have applied STAT dispensing to emtricitabine with tenofovir disoproxil. This means people can collect three months’ worth of PrEP from the pharmacy all at once.

Other funding requests

Requested funding of other key components of comprehensive HIV and STI prevention, including:

• Non-latex condoms
• So-called “female” (receptive) condom
• Lubricant gel for anal intercourse
• A wider array of latex condoms’ sizes
• HPV9 (GARDASIL 9) vaccine for MSM above the age of 27
• HBV vaccine for all sexual health clinic attendees and all MSM and gender diverse people and HAV vaccine for MSM and gender diverse people
• Tenofovir alafenamide (TAF) for people with renal adverse events due to Tenofovir DF
• A single tablet combination including an integrase inhibitor is funded in Aotearoa.
• Injectable anti-retroviral therapies (ARTs)

We have assessed funding applications for some of the products requested and they are on the Pharmac options for investment list:(external link)

• Non-latex condoms(external link)
• Internal condoms(external link)
• Water based lubricant(external link) 

We currently fund 13 different latex condom products, with a range of different sizes, flavours, colours and thickness. We would be interested to know what other products would be of interest to any consumers. 

We have not received a funding application for MSM over the age of 27. At present the vaccine is available to everyone under the age of 27. We would welcome a funding application to widen access to this group. 

At present we have not received funding application for HBV/HAV vaccines for these particular patient groups. We would welcome funding applications regarding these groups. 

Tenofovir alafenamide is under consideration for treatment of hepatitis B(external link) and treatment of HIV(external link). We have not received an application for people with renal adverse events due to Tenofovir DF. We would welcome a funding application regarding this group. 

• Tenofovir / emtricitabine / elvitegravir, and cobicistat combination(external link) has been previously considered by Pharmac and declined.
• We have not received an application for any raltegravir or cabotegravir based combination medicines.
• Dolutegravir / lamivudine(external link) is currently under under assessment by Pharmac.
• Bictegravir / Emtricitabine / Tenofovir alafenamide(external link)is currently under assessment by Pharmac. 

To date we have not received any applications for injectable ARTs. We continue to monitor the treatment space and we would welcome a funding application for injectable ARTs.

Wider feedback

Respondents were concerned regarding workload for sexual health services with widened access to PrEP and request to return the criteria to primarily MSM groups engaging in risky behaviour.

We acknowledge and appreciate the concerns regarding an increased workload for sexual health services as they may be the preferred contact for people seeking PrEP. 

We consider that this may be partially mitigated by the removal of behavioural criteria which could enable people to be more comfortable seeking PrEP from their primary care practitioners. 

We intend to engage with Health Sector partners (including Sexual Health Services) and continue ongoing dialogue regarding this change. We welcome ongoing feedback regarding impact on services and intend to be responsive to the sector.

Indicated that wider work within the sector is also needed, including:

• Improve the rainbow friendliness of general practice in NZ
• Access to PrEP prescribers and STI testing needs to be improved
• NZ guidelines for PrEP prescribing would need to be updated

We are pleased to be widening access for more people to PrEP. We acknowledge that there is sector wide work that is needed to further improve the prevention of HIV in New Zealand. 

We will share this feedback with the Ministry of Health and the interim Health New Zealand (Health NZ) agency.

Requested that savings from recent tender decision be reinvested to support additional ARVs for the purpose of treatment of HIV.

Pharmaceutical savings are not ring-fenced for a specific therapeutic area. Instead, we reinvest savings in the next best option for investment that is available across all therapeutic areas.

Concerned that widening the access to PEP and PrEP still leaves behind people at high risk, but not eligible for funded healthcare. 

Some respondents recommended that Pharmac advocates alongside the sector on this issue and explores creative ways to address this issue. 

We do not negotiate prices for medicines that are not publicly funded. We also do not set the eligibility for public health funding. We understand the disappointment expressed that access to funded PrEP is not treated similarly to HIV treatment costs being covered by public expenditure irrespective of individual eligibility for publicly funded healthcare. We will continue to raise this issue with relevant health sector partners.

Antiretrovirals for post-exposure prophylaxis of HIV

Considered that enabling a wider range of prescriber types would enable more equitable access and that it may assist in reducing wait times for timely access to PEP. 

Requested clarity regarding whether this would include nurse practitioners. 

We are pleased to be widening access to PEP, which would mean more people could benefit from treatment. 

Any relevant practitioner would be able to prescribe PEP, this would include all authorised Prescribers as per the meaning given in the Medicines Act 1981. This includes Any Practitioner (Medical Practitioner or a Dentist), Nurse Practitioner, Optometrist and Registered Midwife, a Designated Prescriber (which includes a Dietitian, Pharmacist Prescriber and Registered Nurse Prescriber).

Supportive of the name change from nPEP to PEP noting that this is non-discriminatory on context of exposure.

We are pleased to confirm the name change to Post-exposure prophylaxis (PEP), removing reference to non-occupational exposure as this criteria is intended to cover all high-risk exposure events.

Eligibility criteria

Considered PEP should not be prescribed where there is no risk of sexual transmission and to include a criterion that PEP is not required when the source is a person with HIV using ART with a viral load consistently less than 200 copies.

We considered this feedback in the context of including prescribers who may be less familiar with PEP and appropriate guidance in the Special Authority. 

We consider this would represent clinical guidance and note that the current criteria exclude patients whose HIV exposure was from a source with <200 copies per ml. 

To address the concerns raised we have amended the criteria to include a reference to ASHM guidelines(external link) as a note below the criteria.

Considered that the requirement to ascertain sensitive details about potential exposure discourages people seeking support. 

Requests were made to align PrEP and PEP criteria via adjusting PEP criteria to mirror PrEP criteria.

We consider that to make the requested changes to the Special Authority criteria for PEP we would require further clinical advice from our advisors to understand the impact of these changes. 

We plan to seek further advice at the next Anti-infective Advisory Committee meeting later in 2022 and further changes would then be considered as appropriate.

Requested amendments/removal of the notes section for PEP (as consulted on) defining unprotected vaginal sex due to the language excluding some transgender individuals/creating ambiguity about eligibility for transgender and intersex people.

We appreciate the feedback. The intent of the criteria is not to exclude transgender and non-binary people. We have since removed the notes section included in the criteria consulted on.

Requested that the criteria to explicitly state condom use should be encouraged.

We have considered the feedback on the inclusion of specific clinical criteria to assist prescribers who may be less familiar with PEP.

To address the concerns raised we have amended the criteria to include a reference to ASHM guidelines(external link) as a note below the criteria.

Requested to replacement of the usage of ‘unprotected sex’ to ‘condomless sex as it is a more accurate term.

We consider that this change aligns with the intent of the criteria. We have amended the criteria to include the term “condomless”.

Requested differentiation between the use of two and three drug courses for low and high-risk patients per the ASHM guidelines.

We note that the current and new criteria enable the clinician to select the most appropriate treatment combination for each individual requiring PEP. 

Further information to support clinical practice is available in the linked ASHM guidelines(external link). 

We plan to seek further advice at the next Anti-infective Advisory Committee meeting later in 2022 regarding this request and Further changes would then be considered as appropriate.

Requested widened access to include any “vaginal intercourse with a person from a high HIV prevalence country or risk group whose HIV status is unknown.” 

It was also requested to include people who have insertive vaginal sex with known HIV positive partners or partners with unknown HIV status from either a high HIV prevalence country or high-risk group. 

It was noted that funding for this group was particularly important for victims of sexual assault (more likely to be female), including sex workers who experience stealthing(external link).

We consider that the proposed change to include “vaginal intercourse with a person from a high HIV prevalence country or risk group whose HIV status is unknown” goes beyond the scope supported by current clinical advice and that the risk profile of the group has previously been considered to be low.

In addition, we consider that people who have “insertive vaginal sex with known HIV positive partners or partners with unknown HIV status from either a high HIV prevalence country or high-risk group” would include heterosexual male partners. This group has previously been considered to be of lower risk by the Anti Infectives Subcommittee and that clinical advice at present specifically excludes insertive vaginal sex (Anti-infective Specialist Advisory committee record 5.12, May, 2019(external link)).

We do however plan to seek further advice regarding PEP at the next Anti-infective Advisory Committee meeting later in 2022.

We acknowledge that criterion 2.3 would appropriately cover individuals who have experienced sexual assault and are at risk of contracting HIV.

Nitrofurantoin modified release 100mg

Supportive of placement of nitrofurantoin 100mg MR on PSO

We are pleased to receive positive feedback regarding the proposal to place nitrofurantoin MR on PSO.

Requested an increase in the amount of capsules for nitrofurantoin MR available on PSO to align with the availability of trimethoprim on PSO.

We note that the current allowance of 15 tablets is in line with the courses of nitrofurantoin 50mg currently available via PSO. We would consider changing this amount in the future if feedback from the health sector indicates that this is insufficient.