Decision to change the funded brand of aripiprazole and remove listing restrictions

7 March 2018

Medicines Decision

We’re pleased to announce the approval of an agreement with Novartis New Zealand Limited for the supply of aripiprazole tablets.

What we’re doing

We’re pleased to announce the approval of an agreement with Novartis New Zealand Limited for the supply of aripiprazole tablets.

In summary, the effect of the decision is that:

From 1 June 2018 Novartis New Zealand Ltd’s brand of aripiprazole (Aripiprazole Sandoz) will be funded, via a Sole Supply arrangement in both the community and hospital settings, without a Special Authority restriction applying.
From 1 August 2018 the Abilify brand of aripiprazole will be reference priced to the price and subsidy of Aripiprazole Sandoz, and from 1 November 2018 Abilify will be delisted. People using the Abilify brand will need to switch to Aripiprazole Sandoz to remain on a fully funded product.
Aripiprazole Sandoz will have Sole Supply Status from 1 November 2018 until 30 June 2021 and Hospital Supply Status, with a 1% DV Limit for hospitals, from 1 August 2018 until 30 June 2021.
A Brand Switch Fee will apply to dispensings of aripiprazole for three months from 1 November 2018.

Any changes to the original proposal

This decision was the subject of a consultation letter dated 20 July 2017. One change has been made to the proposal consulted on, namely that a Brand Switch Fee will be implemented for three months from 1 November 2018.

Who we think will be most interested

This decision will be of most interest to patients currently using aripiprazole, pharmacists, doctors in general practice, psychiatrists, mental health care professionals, DHBs and suppliers of aripiprazole tablets.

Detail of our decision

Listing of Aripiprazole Sandoz

From 1 June 2018 Novartis’ brand of aripiprazole 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets (Aripiprazole Sandoz) will be listed in Section B and Part II of Section H of the Pharmaceutical Schedule as follows:

Chemical	Presentation	Brand	Pack size	Price and subsidy
Aripiprazole	Tab 5 mg	Aripiprazole Sandoz	30	$17.50*
Aripiprazole	Tab 10 mg	Aripiprazole Sandoz	30	$17.50*
Aripiprazole	Tab 15 mg	Aripiprazole Sandoz	30	$17.50*
Aripiprazole	Tab 20 mg	Aripiprazole Sandoz	30	$17.50*
Aripiprazole	Tab 30 mg	Aripiprazole Sandoz	30	$17.50*

* A confidential rebate will apply to all Aripiprazole Sandoz presentations.

There will be no Special Authority restrictions or hospital restrictions applying to the Aripiprazole Sandoz brand.
The dispensing quantity rule of “No more than 1 tab per day” that currently applies to Abilify 5 mg tablets will not apply to dispensings of Aripiprazole Sandoz 5 mg tablets.

Reference pricing other listed brands of aripiprazole in the community

From 1 August 2018, the subsidy for the currently listed brand of aripiprazole (Abilify) will be reduced, via the application of reference pricing, to the subsidy for Aripiprazole Sandoz.
If the supplier of Abilify decides not to reduce the price of Abilify to match the new proposed subsidy, a manufacturer’s surcharge would apply when this brand is dispensed from 1 August 2018.
The Special Authority restrictions applying to Abilify in Section B will be removed from 1 August 2018.
The dispensing quantity rule of “No more than 1 tab per day” will be removed from Abilify 5 mg tablets from 1 August 2018.

Aripiprazole Sole Supply

In DHB hospitals

From 1 August 2018 until 30 June 2021, Aripiprazole Sandoz (tab 5 mg, 10 mg, 15 mg, 20 mg and 30 mg) will be awarded Hospital Supply Status for aripiprazole tablets in DHB hospitals. This will result in Aripiprazole Sandoz being the only available brand of aripiprazole in DHB hospitals, subject to a 1% DV limit (i.e. 99% of total volume of aripiprazole purchased by DHB hospitals will be required to be Aripiprazole Sandoz).
From 1 August 2018, the Abilify brand of aripiprazole will be delisted from Part II of Section H of the Pharmaceutical Schedule.

In the community

From 1 November 2018 until 30 June 2021, Aripiprazole Sandoz (tab 5 mg, 10 mg, 15 mg, 20 mg and 30 mg) will be awarded Sole Supply Status for aripiprazole tablets in the community.
From 1 November 2018, the Abilify brand of aripiprazole will be delisted from Section B of the Pharmaceutical Schedule.
A Brand Switch Fee will be able to be claimed on the first funded Aripiprazole Sandoz dispensing by community pharmacies, once per patient, during the three-month period from 1 November 2018 to 31 January 2019.

Our response to what you told us

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 14 August 2017 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	Comment
Support for the proposal
Four responses noted support for the proposal to remove Special Authority restrictions.	Noted
Previous experience with other atypical antipsychotic brand switches have not raised significant issues and the responder would be supportive of the switch to Aripiprazole Sandoz provided it gains regulatory approval.	Noted
Supportive of PHARMAC providing pharmacists and patients with supporting information as it will help assist with counselling patients about the brand change.	PHARMAC will develop support information for pharmacists and patients to assist counselling patients about the brand change. PHARMAC will also develop materials for primary care on the use of aripiprazole.
Concerns raised
Concerns with sole supply arrangements.	Currently there is only one brand of aripiprazole funded. PHARMAC notes that having multiple brands of a product in a market does not necessarily improve security of supply. When there is one supplier, our experience is that supplier forecasting is typically more accurate, which helps reduce the risk of out-of-stock situations. Further, in exchange for market exclusivity, the supply contracts we have in place require suppliers to agree to rigorous conditions to prevent and manage potential out-of-stocks.
Concerns with the work required by pharmacists to switch patients from one brand to another as it may be challenging to switch patients on a long-term medicine to treat schizophrenia. A Brand Switch Fee should be applied.	PHARMAC has decided to implement a Brand Switch Fee following the delisting of Abilify for a three-month period.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz or call our toll free number on 0800 66 00 50.