Proposal to award sole supply and change some antiretroviral brands

Medicines

Consultation Closed

What we’re proposing

PHARMAC is seeking feedback on a proposal to make several changes to funding of antiretroviral therapies (ARTs) used in the treatment of HIV infection.

  1. Award sole supply and change brands for three ARTs; and
  2. Award sole supply and maintain existing brands for four ARTs.

Brand changes would have a transition period of three months, starting 1 April 2019 and would include reference pricing. New pricing would be confirmed if PHARMAC decides to implement the proposed changes.

Incumbent brands awarded sole supply would have sole supply from 1 July 2019 until 30 June 2022.

There are no proposed changes to the Special Authority criteria for Antiretrovirals for the treatment of people with HIV infection (SA1651 [link no longer available]) or for pre-exposure prophylaxis ((PrEP) SA1714 [link no longer available]).

Consultation closes at 4 pm on Wednesday 7 November 2018 and can be emailed to procurement@pharmac.govt.nz.

What would the effect be?

For patients

Patients would continue to access funded ARTs in consultation with their doctor.

Between 1 April 2019 and 1 June 2019, all patients on the following ARTs would need to change the brand of medicine they use:

Chemical Current Brand Proposed 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 would be no change for patients on emtricitabine, ritonavir, abacavir sulphate or abacavir sulphate with lamivudine.

More information would be available during the transition period from pharmacists, prescribers and PHARMAC’s website.

For community pharmacies

Pharmacies would need to start transitioning patients to the new brands of these ARTs from 1 April 2019.

From 1 June 2019, incumbent brands would be referenced priced for three months and then delisted.

A Brand Switch Fee would apply to all three brand changes.

For hospital pharmacies

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

For prescribers

There are no proposed changes to the eligibility or prescribers access for ARTs for any indication.

Who we think will be interested

Patients currently taking ARTs, pharmacists, general practitioners, gastroenterologists, oncologists, infectious disease specialists, HIV specialists, sexual health specialists, DHBs, suppliers and wholesalers.

About antiretroviral treatments

Antiretroviral therapies (ART) are used to treat HIV infection. These medicines do not kill or cure the virus. However, when taken in combination they can prevent the growth of the virus. When the virus is slowed down, so is HIV disease. ARTs can also prevent infection through pre-exposure prophylaxis (PrEP) or post-exposure prophylaxis (PEP), which can lessen a person’s chance of contracting the virus altogether.

A large range of ARTs are currently funded subject to restrictions for people with confirmed HIV infection, for prevention of maternal transmission and for pre- and post-exposure prophylaxis. Once a patient with the infection starts antiretroviral treatment, they are required to continue treatment for the rest of their life in order to maintain undetectable viral load.

Why we’re proposing this

PHARMAC released a Request for Tender (RFT) for the supply of antiretroviral treatments in New Zealand on 6 August 2018.

Feedback to this consultation will help us to decide on awarding the Tender Items.

Details about our proposal

Award of sole supply arrangements for currently listed ARTs

The following brands would remain listed and be awarded Sole Subsidised Supply (SSS) and Hospital Supply Status (HSS) from 1 July 2019 until 30 June 2022:

Effective date of sole supply Chemical Presentation Brand Pack size HSS / SSS expiry

1 July 2019

Emtricitabine

Cap 200 mg

Emtriva

30

30 June 2022

1 July 2019

Ritonavir

Tab 100 mg

Norvir

30

30 June 2022

1 July 2019

Abacavir sulphate

Tab 300 mg

Ziagen

60

30 June 2022

1 July 2019

Abacavir sulphate with lamivudine

Tab 600 mg with lamivudine 300 mg

Kivexa

30

30 June 2022

Under this proposal there would be no change to the subsidy and price of emtricitabine or ritonavir, however the price and subsidy for abacavir sulphate and abacavir sulphate with lamivudine would be reduced on 1 July 2019. The new pricing would be notified upon confirmation of this proposal.

New Pharmaceutical Schedule Listings

The following brands would be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule from 1 April 2019, and pricing would be notified upon confirmation of this proposal:

Listing date Chemical Presentation Proposed Brand Pack size

1 April 2019

Efavirenz with emtricitabine and tenofovir disoproxil fumarate

Tab 600 mg with emtricitabine 200 mg with tenofovir disoproxil fumarate 300 mg

Mylan

30

1 April 2019

Emtricitabine with tenofovir disoproxil fumarate

Tab 200 mg with tenofovir disoproxil fumarate 300 mg

Teva

30

1 April 2019

Atazanavir sulphate

Cap 150 mg

Teva

60

1 April 2019

Atazanavir sulphate

Cap 200 mg

Teva

60

The physical details (colour, shape, etc) of the proposed brands are similar to the incumbent brands and are registered with Medsafe, any differences in presentation or markings are noted are below:

Chemical Current Brand Description Proposed Brand Description

Efavirenz with emtricitabine and tenofovir disoproxil fumarate

Atripla

debossed with 123 on one side and plain on the other

Mylan

debossed with “M” on one side of the tablet and “TEE” on the other side.

Emtricitabine with tenofovir disoproxil fumarate

Truvada

debossed with GILEAD on one side and 701 on the other

Teva

no markings

Atazanavir sulphate 150 mg

Reyataz

blue/powder blue capsule printed "BMS 150 mg" on one half and with "3624" on the other half.

Teva

dark blue capsuleprinted “150”

Atazanavir sulphate 200 mg

Reyataz

white printed "BMS 200 mg" / "3631" on each half.

Teva

blackprinted “200”

Reference pricing and delisting of incumbent brands

In the Community

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

Chemical and presentation Current Brand Date of reference pricing Date of Delist  & start of SSS New Brand Date of SSS expiry

Efavirenz 600 mg with emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tab

Atripla

1 June 2019

1 September 2019

Mylan

30 June 2022

Emtricitabine 200 mg with tenofovir disoproxil fumarate 300 mg tab

Truvada

1 June 2019

1 September 2019

Teva

30 June 2022

Atazanavir sulphate cap 150 mg

Reyataz

1 June 2019

1 September 2019

Teva

30 June 2022

Atazanavir sulphate cap 200 mg

Reyataz

1 June 2019

1 September 2019

Teva

30 June 2022

In DHB Hospitals

Chemicals with brand changes

From 1 June 2019 the incumbent brands would be delisted from Part II of Section H of the Pharmaceutical Schedule and Hospital Supply Status (HSS) with a 1% Discretionary Variance (DV) limit would then apply in DHB hospitals. HSS would apply until 30 June 2022 as below:

Chemical and presentation Current Brand Date of Delist & start of HSS New Brand Date of HSS expiry

Efavirenz 600 mg with emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg tab

Atripla

1 June 2019

Mylan

30 June 2022

Emtricitabine 200 mg with tenofovir disoproxil fumarate 300 mg tab

Truvada

1 June 2019

Teva

30 June 2022

Atazanavir sulphate cap 150 mg

Reyataz

1 June 2019

Teva

30 June 2022

Atazanavir sulphate cap 200 mg

Reyataz

1 June 2019

Teva

30 June 2022

Prescriber restrictions for PrEP

In January 2018 PHARMAC widened access to fund emtricitabine/tenofovir fixed dose combination tablets for pre-exposure prophylaxis (PrEP) to individuals meeting certain criteria. PHARMAC continue to consider a proposal to allow a wider group of clinicians to access PrEP Special Authority initial applications; no changes to the criteria are proposed at this time.

To provide feedback

Send us an email: procurement@pharmac.govt.nz, by 4pm on 7 November 2018.

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

Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.

We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. PHARMAC will give due consideration to any such request.