Decisions relating to the funded brands of some antiretroviral treatments for HIV

Medicines

Decision

We’re pleased to announce decisions to award sole supply for seven antiretroviral treatments (ARTs) used in the treatment of HIV infection.

What we’re doing

These decisions were the subject of a consultation letter dated 16 October 2018. There were no changes to the original proposal.

These decisions relate only to which brand of the treatment will be funded. There are no changes to funding criteria or the range of treatments funded.

In summary, the effect of the decisions is that:

  • The funded brands of the following four ARTs will stay the same and will be the only funded brands of these ARTs until 30 June 2022.
    Chemical Brand
    Emtricitabine 200 mg Emtriva
    Ritonavir 100 mg Norvir
    Abacavir sulphate 300 mg Ziagen
    Abacavir sulphate 600 mg with lamivudine 300 mg Kivexa
  • The funded brands of the following three ARTs will change. The new brands will be funded from 1 April 2019 and, following a transition period, they will be the only funded brands of these ARTs until 30 June 2022.
    Chemical Current Brand New Brand
    Efavirenz with emtricitabine and tenofovir disoproxil fumarate tab 600 mg with emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg Atripla Mylan
    Emtricitabine with tenofovir disoproxil fumarate tab 200 mg with tenofovir disoproxil fumarate 300 mg Truvada Teva
    Atazanavir sulphate cap 150 mg and 200 mg Reyataz Teva
  • There will be price and subsidy reductions for five of the seven ARTs noted above, which will create savings that can be used to invest in other medicines for New Zealanders.

Further details of these decisions can be found on the following pages.

Who we think will be most interested

Patients currently taking ARTs, pharmacists, doctors in general practice, gastroenterologists, oncologists, infectious disease specialists, HIV specialists, DHBs, suppliers and wholesalers.

What will the effect of this decision be?

For patients

  • Patients will continue to access funded ARTs in consultation with their prescriber.
  • Between 1 April 2019 and 1 June 2019, all patients on the following three ARTs will need to change the brand of medicine they use:
    Chemical Current Brand New Brand
    Efavirenz with emtricitabine and tenofovir disoproxil fumarate tab 600 mg with emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg Atripla Mylan
    Emtricitabine with tenofovir disoproxil fumarate tab 200 mg with tenofovir disoproxil fumarate 300 mg Truvada Teva
    Atazanavir sulphate cap 150 mg and 200 mg Reyataz Teva
  • More information and support materials will be available during the transition period from pharmacists, prescribers and PHARMAC’s website.
  • There will be no change for patients on any other funded ART.

For community pharmacies

  • From 1 April 2019, community pharmacies will need to start transitioning patients to the new brands of the three ARTs noted above.
  • From 1 June 2019, the incumbent brands of these ARTs will be referenced priced for three months and then delisted.
  • Support materials will be available to pharmacies to support patients during the brand changes.
  • A Brand Switch Fee will apply to all three brand changes.

For hospital pharmacies

  • Following the new listings on the Pharmaceutical Schedule, pharmacies will continue to purchase any listed brand of these ARTs for two months.
  • After that a discretionary variant (DV) limit of 1% will apply, meaning that only 1% of total purchases of these ARTs can be a brand other than the new listings. Note that the incumbent brands once delisted will be considered to be a DV pharmaceutical.

For prescribers

  • There are no changes to funding criteria or the range of treatments funded. Patients will continue to access funded ART in consultation with their prescriber as they do now.

Details of our decision

Sole supply and price changes for existing funded brands

From 1 July 2019 until 30 June 2022, the existing funded brands of the following four ARTs will have Sole Subsidised Supply (SSS) status in the community and Hospital Supply Status (HSS) in DHB Hospitals with a 1% Discretionary Variance (DV). The price and subsidy will also change for Ziagen and Kivexa as below:

Chemical Brand Current Price
and subsidy
Price and subsidy from 1 July 2019
Emtricitabine 200 mg Emtriva $307.20 $307.20
Ritonavir 100 mg Norvir $43.31 $43.31
Abacavir sulphate 300 mg Ziagen $229.00 $180.00
Abacavir sulphate 600 mg with lamivudine 300 mg Kivexa $427.29 $63.00

Listing of new brands

On 1 April 2019 the following brands will be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

Base chemical Brand Pack size Price and subsidy from 1 April 2019
Atazanavir sulphate 150 mg Teva 60 $141.68
Atazanavir sulphate 200 mg Teva 60 $188.91
Efavirenz 600 mg with emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg Mylan 30 $106.88
Emtricitabine 200 mg with tenofovir disoproxil fumarate 300 mg tab Teva 30 $61.15

Reference pricing and delisting of incumbent brands

In the Community

From 1 June 2019 the subsidies of the following brands will be reduced, via the application of reference pricing, for a period of three months. Following reference pricing these brands will be delisted from Section B of the Pharmaceutical Schedule, at which time the new brand will have SSS status until 30 June 2022, as below:

Chemical and presentation Current Brand Current subsidy and price Date of reference pricing Subsidy
(price)
Date of delisting
Atazanavir sulphate 150 mg Reyataz $568.34 1 June 2019 $141.68
($568.34)
1 September 2019
Atazanavir sulphate 200 mg Reyatax $757.79 1 June 2019 $188.91
($757.79)
1 September 2019
Efavirenz 600 mg with emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tab Atripla $237.52 1 June 2019 $106.88
($237.52)
1 September 2019
Emtricitabine 200 mg with tenofovir disoproxil fumarate 300 mg tab Truvada $190.02 1 June 2019 $61.15
($190.02)
1 September 2019

If the suppliers of Reyataz, Atripla or Truvada decide not to reduce their price to match the new subsidy, a manufacturer’s surcharge will apply when these brands are dispensed.

On 1 September 2019, Reyataz, Truvada and Atripla will be delisted from Section B of the Pharmaceutical Schedule and the new brands of these ARTs will have SSS until 30 June 2022, meaning that they will be the only subsidised brands until 30 June 2022.

A Brand Switch Fee will apply to dispensings of atazanavir sulphate, efavirenz with emtricitabine and tenofovir disoproxil and emtricitabine with tenofovir disoproxil fumarate from 1 June 2019 until 1 September 2019.

In DHB Hospitals

On 1 June 2019 the Reyataz and Truvada brands will be delisted from the Hospital Medicines List (HML) and Teva’s brand of these ARTs will have HSS until 30 June 2022 with a 1% DV limit.

On 1 June 2019, Atripla will be delisted from the HML and Mylan’s brand of this ART will have HSS until 30 June 2022 with a 1% DV limit.

Our response to what you told us

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 7 November 2018 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme PHARMAC staff comment
Access criteria
Several responders requested changes to the Special Authority criteria to broaden the types of prescribers who can make applications for pre-exposure prophylaxis (PrEP) to include sexual health physicians, nurse practitioners and general practitioners who have undertaken appropriate training. Amendments to the criteria for ART did not form part of this RFT. However, we are pleased to have received this feedback and consideration of this issue remains on our work programme.
Several responders requested funding of ARTs for PrEP for various other patient groups. We would welcome funding applications to widen funded access to ARTs for PrEP for other patient groups. Details about how to make a funding application can be found on PHARMAC’s website.
Continuity of supply
Responders requested reassurance that the supply chain is guaranteed because of the essential nature of the medicines. We agree that continuity of supply is important. PHARMAC’s agreements with suppliers include various obligations on suppliers to supply, and to continue to supply, the pharmaceuticals.
Impact on patients and community pharmacy
Some patients may have concerns about the brand changes; pharmacies should be supported with the provision of patient-focused information. We acknowledge that brand changes can be concerning for patients. We will work with New Zealand Aids Foundation to ensure that appropriate materials are produced to support the brand change for patients. These materials will be available to pharmacies to help support the brand change and a brand switch fee for pharmacy will apply.
The wastage rule should be applied to the newly listed brands under high cost medicines greater than $150. Applying wastage to these formulations would not be consistent with other ART listings. We consider that the pack sizes for each presentation are sufficient for a month of treatment and, therefore, it is unlikely that pharmacies would be left with a part pack. We note also that most of the pack prices will be changing to less than $150.
Funding of other antiretroviral treatments
Responders advocated for tenofovir alafenamide (TAF), and fixed dose combinations containing TAF, to be funded as a replacement for tenofovir disoproxil fumarate (TDF) due to better tolerability with co-morbid medical conditions. This decision results from an RFT that did not request tender bids for TAF. These RFT decisions do not prevent PHARMAC from considering funding other treatments such as TAF.
Responders proposed that additional strengths or combinations of currently funded medicines, such as lamivudine 300 mg, atazanavir 300 mg, dolutegravir/lamivudine fixed dose combination, be funded. This decision results from an RFT that sought tender bids for currently funded formulations and some additional fixed dose combinations. This decision would not prevent PHARMAC from funding different formulations or fixed dose combinations in the future.

Enquiries

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 66 00 50.