Proposals to widen access to progesterone, antiretrovirals and nitrofurantoin

We are seeking feedback on proposals to make medicines more widely available for a range of uses, including menopausal symptoms, human immunodeficiency virus (HIV) prevention, and urinary tract infections (UTIs).

What we’re proposing

We are proposing to make the following changes:

  • Progesterone – remove all funding restrictions at a date to be determined
    • This would significantly increase the number of people who could access funded progesterone for a range of uses, including for menopause hormone therapy. 
  • Emtricitabine with tenofovir disoproxil - Widen access from 1 July 2022
    • This would increase the number of people who could access treatment for pre-exposure prophylaxis (PrEP) of HIV.
  • Antiretrovirals - widen access from 1 July 2022
    • This would increase the number of people who could access treatment for post-exposure prophylaxis (PEP) for HIV. It would also broaden the types of prescribers who could apply for funded access.
  • Nitrofurantoin modified release – addition to the Practitioners Supply Order (PSO) list and remove the wastage claimable rule from 1 July 2022
    • This would allow relevant prescribers to hold stock of the medicine for immediate use by patients in some situations. 

Consultation closes at 5 pm on Thursday, 2 June 2022 and feedback can be emailed to consult@pharmac.govt.nz

On this page:

Progesterone – remove restrictions (open listing) 

Emtricitabine with tenofovir disoproxil – pre-exposure prophylaxis of HIV 

Antiretrovirals – post-exposure prophylaxis of HIV

Nitrofurantoin 100 mg modified release (Macrobid) – available on a Practitioners Supply Order

Progesterone

We are proposing to widen access to progesterone through Pharmac’s Annual Tender process. As the Tender process is still in progress, the brand names, pricing and timing for this change are still to be determined.

Who we think will be interested

  • People who may be treated with progesterone and their whānau
  • Support and advocacy groups with an interest in progesterone
  • Health care professionals
  • Pharmacies, DHBs and wholesalers
  • Pharmaceutical suppliers

What would the effect be?

Progesterone cap 100 mg (“progesterone”) would be funded without restriction (“open-listed”). This would mean that the funded brand of progesterone could be prescribed for any relevant use. 

We understand that the majority of use would come from people taking progesterone for menopause hormone therapy. We estimate that over 7,000 people would benefit from this wider access in the first year, increasing to over 28,000 people per year in the next five years. 

About progesterone

Progesterone is a naturally occurring progestogen. Progestogens are a type of sex hormone. Progesterone is sometimes called ‘micronised progesterone’ and has all the same properties as the progesterone made in the body. 

Currently progesterone is funded for the prevention of pre-term labour. Progesterone may be used for a range of uses, including for menopause hormone therapy (or ‘hormone replacement therapy’ (HRT), prevention of pregnancy loss or prevention of pre-term labour, and gender reaffirming hormone therapy. 

The current funded brand of progesterone, Utrogestan, is Medsafe approved for use as hormone replacement therapy in combination with oestrogen in postmenopausal women with an intact uterus. If progesterone were prescribed for other uses, it would need to be prescribed and used in accordance with section 25 of the Medicines Act 1981. 

Read more about: 

The currently funded brand of progesterone on the Medsafe website(external link) 

Section 25 of the Medicines Act 1981 on the Medsafe website(external link) 

Why we’re proposing this

We have received funding applications for progesterone for several uses (please follow the below links to Pharmac’s Application Tracker for more information on these funding proposals): 

In 2021, progesterone was recommended by the Pharmacology and Therapeutic Advisory Committee (PTAC), the Endocrinology Subcommittee and the Reproductive and Sexual Health Advisory Committee to be funded with a high priority. 

While assessing these applications, both PTAC and the Endocrinology Subcommittee recommended open-listing progesterone(external link). 

You can read more about the Committees’ assessments of the clinical evidence for each use via Pharmac’s Application Tracker link above. 

We understand that there is currently an unmet health need for people requiring progestogen treatment. Our clinical advisors have told us that in particular Māori and Pacific people experiencing menopause have a high unmet health need in this area. 

Progesterone has been shown to have a better side effect profile than currently funded treatments. We expect this would mean more people would access treatment. Open-listing progesterone would remove some of the barriers for people to be prescribed treatment and provide a more suitable treatment option. This would help to work towards more equitable access of medicines for New Zealanders. 

We are keen to hear what implementation activities could support greater access to progesterone, particularly for Māori and Pacific peoples experiencing menopause. 

Details about our proposal

Progesterone would continue to be listed on the Pharmaceutical Schedule, however all funding restrictions would be removed, which would widen access for those with health need. This means a prescriber could prescribe progesterone for any relevant use that they and their patient consider appropriate. 

Pharmac currently has an open tender for widened access to progesterone. Should this tender be awarded, this widening of access would apply to whichever product is successful. The funded brand and timeframes for this change would be considered as part of a tender decision. 

Currently we fund a 100 mg capsule. We have heard from our clinical advisors that a higher strength capsule would also be beneficial. We are open to considering this at a future date if access is widened.

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

Who we think will be interested

  • People who may be interested in taking PrEP and their whānau
  • The LGBTQ+ community
  • Support and advocacy groups
  • Healthcare professionals
  • Pharmacies, DHBs and pharmaceutical suppliers

What would the effect be?

From 1 July 2022, the Special Authority criteria for emtricitabine with tenofovir disoproxil for pre-exposure prophylaxis of HIV (PrEP) would be widened to allow more people access to treatment for PrEP. We propose to remove the list of behaviours and scenarios which may make a person eligible for emtricitabine with tenofovir disoproxil for PrEP. This means the criteria would only require the prescriber to confirm that the patient is HIV negative and they consider the patient is at risk of HIV exposure and use of PrEP is clinically appropriate. We understand use of PrEP would be guided by clinicians alongside clinical guidelines such as the ASHM PrEP guidelines(external link).

We also propose to extend the approval period and remove the criteria that relate to monitoring and testing. 

We estimate that initially up to an additional 3500 people per year would be able to access PrEP as a result of this proposal, increasing to 5500 people per year in the next five years. 

About emtricitabine with tenofovir disoproxil and HIV PrEP

Pre-Exposure Prophylaxis or PrEP refers to the use of HIV medication by people who are HIV-negative, in order to reduce their risk of acquiring HIV infection. When taken each day for PrEP, emtricitabine with tenofovir disoproxil significantly reduces the risk of becoming infected with HIV if a person is exposed. It is important that condoms are still used even if a person is taking PrEP.  

Emtricitabine with tenofovir disoproxil is a fixed-dose combination antiretroviral medication used to treat and prevent HIV/AIDS. It consists of a single tablet of 200 mg of emtricitabine (a nucleoside reverse-transcriptase inhibitor) with 245 mg of tenofovir disoproxil (300 mg as malleate) (a nucleotide reverse-transcriptase inhibitor) which is taken daily. It is widely used in both the treatment and prophylaxis of HIV and is both effective and well tolerated. 

You can see the current funding restrictions for PrEP in the Pharmaceutical Schedule(external link) 

Why we’re proposing this

We have received applications for widened access to emtricitabine with tenofovir disoproxil for HIV pre-exposure prophylaxis (PrEP) (please follow the below links to Pharmac’s Application Tracker for more information on these funding proposals): 

In September 2020 the Anti-Infective Subcommittee [PDF, 132 KB] recommended that the Special Authority criteria for emtricitabine with tenofovir disoproxil be updated. 

The proposed criteria in this consultation are significantly wider than the criteria recommended in 2020. We have also received feedback from consumer groups and clinicians that supports wider access to PrEP in the community. We are aware that internationally, in recent years, the HIV treatment landscape has changed towards more open and wider access to PrEP. Recent updated advice from the Anti-Infective Advisory Committee (previously Subcommittee) was supportive of wider access as per this proposal. 

Details about our proposal

The Special Authority criteria and Hospital Indication Restriction would be amended as follows from 1 July 2022: 

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid for 24 months for applications meeting the following criteria:

Both:

  1. Patient has tested HIV negative and is not at risk of HIV seroconversion; and
  2. The Practitioner considers the patient is at risk of HIV exposure and use of PrEP is clinically appropriate. 

Renewal from any relevant practitioner. Approvals valid for 24 months for applications meeting the following criteria:

Both:

  1. Patient has tested HIV negative and is not at risk of HIV seroconversion; and
  2. The Practitioner considers the patient is at risk of HIV exposure and use of PrEP is clinically appropriate. 

To clarify the proposed changes, the following version shows the proposed additions shown in bold and deletions to current criteria shown in strikethrough:

Special Authority for Subsidy

Initial application from any relevant practitioner. Approvals valid for 3 24 months for applications meeting the following criteria: 

All of the following:Both

1.  Applicant has an up to date knowledge of the safety issues and is competent to prescribe pre-exposure prophylaxis (refer to local health pathways or https://ashm.org.au/HIV/PrEP/(external link) for training materials); and

2.  Patient has undergone testing for HIV, syphilis and Hep B if not immune in the previous two weeks; and

3.  Patient has had renal function testing (creatinine, phosphate and urine protein/creatinine ratio) within the last 3 months and is not contraindicated for treatment; and

4.  Patient has received advice regarding the reduction of risk of HIV and sexually transmitted infections and how to reduce those risks (e.g. Such as the importance of condom use); and

  1. Patient has tested HIV negative and is not at risk of HIV seroconversion; and
  2. The Practitioner considers the patient is at risk of HIV exposure and use of PrEP is clinically appropriate. 

Either:

6.1   All of the following:

6.1.1  Patient is male or transgender; and

6.1.2  Patient has sex with men; and

6.1.3  Patient is likely to have multiple episodes of condomless anal intercourse in the next 3 months; and

6.1.4 Any of the following

6.1.4.1 Patient has had at least one episode of condomless receptive anal intercourse with one or more casual male partners in the last 3 months; or

6.1.4.2 A diagnosis of rectal chlamydia, rectal gonorrhoea, or infectious syphilis within the last 12 months; or

6.1.4.3 Patient has used  methamphetamine in the last three months; or

6.2   All of the following:

6.2.1  Patient has a regular partner who has HIV infection; and

6.2.2  Partner is either not on treatment or has a detectable viral load; and

6.2.3  Condoms have not been consistently used. 

Renewal from any relevant practitioner. Approvals valid for 3 24 months for applications meeting the following criteria: 

All of the following: Both

1.  Applicant has an up to date knowledge of the safety issues and is competent to prescribe pre-exposure prophylaxis (refer to local health pathways or https://ashm.org.au/HIV/PrEP/(external link) for training materials); and

2.  Patient has undergone testing for HIV, syphilis and Hep B if not immune in the previous two weeks; and

3.  Patient has had renal function testing (creatinine, phosphate and urine protein/creatinine ratio) within the last 3 months and is not contraindicated for treatment; and

4.  Patient has received advice regarding the reduction of risk of HIV and sexually transmitted infections and how to reduce those risks (e.g. Such as the importance of condom use); and

  1. Patient has tested HIV negative and is not at risk of HIV seroconversion; and
  2. The Practitioner considers the patient is at risk of HIV exposure and use of PrEP is clinically appropriate.

Either: 

6.1  All of the following:

6.1.1  Patient is male or transgender; and

6.1.2  Patient has sex with men; and

6.1.3  Patient is likely to have multiple episodes of condomless anal intercourse in the next 3 months; and

6.1.4 Any of the following

6.1.4.1 Patient has had at least one episode of condomless receptive anal intercourse with one or more casual male partners in the last 3 months; or

6.1.4.2 A diagnosis of rectal chlamydia, rectal gonorrhoea, or infectious syphilis within the last 12 months; or

6.1.4.3 Patient has used  methamphetamine in the last three months; or

6.2  All of the following:

6.2.1  Patient has a regular partner who has HIV infection; and

6.2.2  Partner is either not on treatment or has a detectable viral load; and

6.2.3  Condoms have not been consistently used.

We are interested to hear feedback about:

We are interested in hearing feedback on the proposed changes to the Special Authority criteria for PrEP, specifically; 

  • Removal of the education and testing criteria.

We consider that PrEP has been a part of the treatment paradigm in Aotearoa New Zealand for some time. Practitioners are likely familiar with it and that the ASHM and other clinical guidelines provide sufficient guidance for practitioners prescribing PrEP. 

  • Extension of the approval period.

In most cases prescriptions will be for a three month period. We consider the extension of the approval period from three months to 24 months would allow practitioners to manage patients on PrEP as clinically appropriate, without needing to regularly seek Special Authority approval.

Antiretrovirals for post-exposure prophylaxis of HIV (PEP)

Who we think will be interested

  • People who may be exposed to HIV
  • People who are involved in a HIV sero-discordant relationship (ie. where only one person in the relationship is HIV+)
  • People who may experience non-percutaneous exposure to HIV at work (ie. sex workers)
  • The LGBTQ+ community
  • Support and advocacy groups
  • Healthcare professionals
  • Pharmacies, DHBs and pharmaceutical suppliers

What would the effect be?

From 1 July 2022, the funding restrictions for nPEP for all antiretrovirals would be widened to include more scenarios where a person may be exposed to HIV and require nPEP. The name would change to post-exposure prophylaxis (PEP), removing reference to non-occupational exposure as this proposed criteria is intended to cover all high-risk exposure events. The separate criteria for specific percutaneous exposure(external link) would not change.  

We are also proposing to widen the types of prescribers who can apply for funded access for antiretrovirals for nPEP to remove barriers and improve access for people at risk. 

We estimate that 50-100 additional people per year would have access to nPEP via this proposal.

About antiretrovirals and HIV nPEP

A large range of antiretrovirals are currently funded subject to restrictions for people with confirmed HIV infection, for prevention of maternal transmission, for percutaneous exposure (for example needlestick exposure) to blood known to be HIV positive, and for post-exposure prophylaxis following non-occupational exposure to HIV. 

You can see the current funding restrictions and the list of currently funded treatments in the Pharmaceutical Schedule(external link)

Prophylaxis (or prophylactic treatment) is when a medicine or course of treatment is given to prevent a new disease or infection developing rather than to treat one that already exists. Non-occupational HIV Post-Exposure Prophylaxis (nPEP) refers to giving HIV medication to people who may have been exposed to HIV and are at risk of developing HIV infection. For example, this may include activities such as unprotected sexual intercourse with someone who is HIV positive. 

Treatment for nPEP usually includes 2 or 3-drug therapy with a combination of antiretrovirals. The most common combination is emtricitabine with tenofovir disoproxil and dolutegravir. When used for nPEP, medicine is given within 72 hours of potential exposure to reduce the risk of transmission of HIV and prevent subsequent infection in those exposed. The intent of nPEP is to prevent the transmission of HIV to people who may have been exposed. 

Why we’re proposing this

We have received an application for widened access for emtricitabine with tenofovir disoproxil for non-occupational post-exposure prophylaxis (nPEP) (please follow the below link to Pharmac’s Application Tracker for more information on this funding proposal): 

Emtricitabine with tenofovir disoproxil - HIV Post-Exposure Prophylaxis (nPEP)(external link)

In 2019 the Anti-Infective Subcommittee considered an application from the New Zealand AIDS Foundation on widening access to nPEP. The Subcommittee recommended that prescriber types be widened and new criteria be added to make access to nPEP easier. 

We understand that the current prescriber restrictions for nPEP may contribute to inequities in access to treatment, particularly in locations where there is limited access to antiretroviral specialists. 

Details about our proposal

The Special Authority criteria for non-occupational post-exposure prophylaxis (nPEP) of HIV would be amended to widen access as recommended by the Anti-Infective Subcommittee [PDF, 386 KB]. 

The name would change to post-exposure prophylaxis (PEP), removing reference to non-occupational exposure as this proposed criteria is intended to cover all high-risk exposure events. The separate criteria for specific percutaneous exposure(external link) would not change.  

The Special Authority criteria and Hospital Indication Restriction would be amended as follows from 1 July 2022 (additions shown in bold, deletions shown in strikethrough, affected criteria shown only):

Special Authority for Subsidy

Initial application — (post-exposure prophylaxis following non-occupational exposure to HIV) from a named specialist any relevant practitioner. 

Approvals valid for 4 weeks for applications meeting the following criteria: 

Both:

  1. Treatment course to be initiated within 72 hours post exposure; and
  2. Any of the following:
    1. Patient has had unprotected receptive anal intercourse or receptive vaginal intercourse with a known HIV positive person with an unknown or detectable viral load greater than 200 copies per ml; or
    2. Patient has had unprotected anal intercourse with a person from a high HIV prevalence country or risk group whose HIV status is unknown; or
    3. Patient has shared intravenous injecting equipment with a known HIV positive person; or
    4. Patient has had non-consensual intercourse and the clinician considers that the risk assessment indicates prophylaxis is required. 

Notes: For the purpose of 2.1 above, ‘unprotected receptive vaginal sex’ refers to intercourse between an HIV positive male and a HIV negative female 

Special Authority for Subsidy 

Renewal — (post-exposure prophylaxis following non-occupational exposure to HIV) from a named specialist any relevant practitioner. 

Approvals valid for 4 weeks for applications meeting the following criteria: 

Both:

  1. Treatment course to be initiated within 72 hours post exposure; and
  2. Any of the following:
    1. Patient has had unprotected receptive anal intercourse or receptive vaginal intercourse with a known HIV positive person with an unknown or detectable viral load greater than 200 copies per ml;
    2. Patient has had unprotected anal intercourse with a person from a high HIV prevalence country or risk group whose HIV status is unknown; or
    3. Patient has shared intravenous injecting equipment with a known HIV positive person; or
    4. Patient has had non-consensual intercourse and the clinician considers that the risk assessment indicates prophylaxis is required. 

Notes: For the purpose of 2.1 above, ‘unprotected receptive vaginal sex’ refers to intercourse between an HIV positive male and a HIV negative female

Nitrofurantoin Modified Release 

Who we think will be interested

  • People who experience urinary tract infections (UTIs) and their whānau
  • Health care professionals
  • Pharmacies, DHBs and wholesalers

What would the effect be?

  • Nitrofurantoin 100 mg modified release capsules would be available on Practitioners Supply Order (PSO) from 1 July 2022
  • The wastage claimable rule would be removed from nitrofurantoin 100 mg modified release capsules 

By adding nitrofurantoin modified release on to the PSO list, we estimate that up to 6000 more people would access nitrofurantoin modified release every year. We consider that this use would come from people taking the modified release presentation instead of the immediate release 50 mg nitrofurantoin presentation which is currently available via PSO. This would improve access to a product that may improve adherence, and patient outcomes.

About Nitrofurantoin 100 mg Modified Release

Nitrofurantoin 100 mg modified release is an antibacterial agent used for the treatment of uncomplicated urinary tract infections (UTIs). Urinary tract infections are caused by bacteria in any part of the body’s urinary system. 

Currently nitrofurantoin modified release can be accessed via a prescription and is only available on Practitioners Supply Order (PSO) for rural areas. 

When Pharmac originally listed the product, in October 2020 there was a 30-day expiry date after opening the bottle. We temporarily introduced the wastage claimable rule in March 2021 to help manage this. Wider access via PSO was not funded at that time due the amount of product that may need to be disposed of. The shelf life of nitrofurantoin 100 mg modified release is now 24 months. 

Why we’re proposing this

Practioners Supply Order (PSO) is a mechanism for general practice to maintain a supply of particular medicines on premises for emergency use, teaching and demonstration purposes, and for provision to certain patient groups where an individual prescription is not practicable. 

We have received feedback from the health sector that having nitrofurantoin modified release available via PSO is important as it would assist with managing antimicrobial resistance issues. It is important that when prescribed a full course of nitrofurantoin is both taken regularly and completed. Improving access to the modified release product via PSO (like the immediate formulation currently is), is expected to improve outcomes for people with urinary tract infections. This proposal would bring the availability of nitrofurantoin modified-release in line with nitrofurantoin immediate release. 

We are also proposing to remove the wastage claimable rule. The in-use shelf-life restrictions have been removed for this medicine, therefore significant wastage is no longer expected. You can read more about the change in shelf life restrictions here(external link).  

Details about our proposal 

  • Nitrofurantoin 100 mg modified release capsules would be made available on Practitioners Supply Order (PSO) from 1 July with a limit of 15 tablets. This would allow relevant registered prescribers to order, hold and dispense up to 15 tablets of nitrofurantoin 100 mg modified release.
  • Practioners Supply Order (PSO) is a mechanism for general practice to maintain a supply of particular medicines on premises for emergency use, teaching and demonstration purposes, and for provision to certain patient groups where an individual prescription is not practicable.
  • The wastage claimable rule would be removed from nitrofurantoin 100 mg modified release from 1 July 2022. 

To provide feedback

Please send us an email: consult@pharmac.govt.nz by 2 June 2022. 

All feedback received before the closing date will be considered by Pharmac’s Board (or its delegate) prior to making a decision on these proposals. 

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