Proposal to change aripiprazole access and brand

1. The funded brand would change from Abilify (supplied by Otsuka) to Aripiprazole Sandoz (supplied by Novartis). Aripiprazole Sandoz would be the only funded brand in both the community and hospital settings.
2. The Special Authority and hospital restrictions currently applying to aripiprazole tablets would be removed.

Listing of Aripiprazole Sandoz on the Pharmaceutical Schedule would occur as soon as practicable following Medsafe approval.

Consultation closes at 5 pm on Monday, 14 August 2017 and feedback can be emailed to: procurement@pharmac.govt.nz.  

Please share this information with other groups you think may be interested in provided feedback.

For Patients

More patients would be able to get access to funded aripiprazole tablets. Patients currently using aripiprazole tablets would need to change brands. More information would be available during the transition period from pharmacists, prescribers and PHARMAC’s website.

For Community Pharmacies

Following listing of each strength of Aripiprazole Sandoz on the Pharmaceutical Schedule, pharmacies could continue to dispense and claim for any listed brand of that strength of aripiprazole tablets for five months (see the timeline below). After that, Aripiprazole Sandoz would be the only funded brand of that strength of aripiprazole tablets.

For Hospital Pharmacies

Following listing of each strength of Aripiprazole Sandoz on the Pharmaceutical Schedule, pharmacies could continue to purchase any brand of that strength of aripiprazole tablets for two months. After that only 1% of total purchases of that strength of aripiprazole tablets could be a brand other than Aripiprazole Sandoz.

For Prescribers

Prescribers would be able to prescribe funded aripiprazole for more patients. In particular, aripiprazole would be funded as a first-line treatment option for schizophrenia and bipolar disorder (the registered indications) as well as off-label indications where considered clinically appropriate by the prescriber and consistent with regulatory requirements.

For DHBs

Significant savings would be achieved through this proposal and more patients would have access to funded aripiprazole tablets.

Patients currently using aripiprazole tablets, pharmacists, doctors in general practice, psychiatrists, mental health care professionals, DHBs and suppliers of aripiprazole tablets.

Aripiprazole is a second-generation (atypical) antipsychotic medicine approved in New Zealand for use in treating schizophrenia and bipolar I disorder.

Aripiprazole is currently funded subject to Special Authority and hospital restrictions as a second-line treatment for schizophrenia and related psychoses and as a last-line treatment for the off-label indication of severe irritability in patients with autism spectrum disorder. Approximately 3,500 people use it, including 810 Māori and 240 Pacific patients, with 15 aged 0-9 years, 270 aged 10-19, 2780 aged 20-60, and 420 aged 60+.

Aripiprazole Sandoz is currently undergoing Medsafe regulatory approval in New Zealand. Aripiprazole Sandoz has already gained Australian Therapeutic Good Administration (TGA) approval and is listed on the Australian Pharmaceutical Benefits Scheme (PBS). Listing of Aripiprazole Sandoz on the Pharmaceutical Schedule would occur as soon as practicable following Medsafe approval.

PHARMAC released a Request for Proposals (RFP) for the supply of aripiprazole tablets to community pharmacies and DHB hospitals on 3 April 2017 to obtain the best possible pricing from suppliers of aripiprazole tablets with the goals of:

• reducing the total expenditure of the aripiprazole market; and
• determining if widening funded access to aripiprazole by removing the Special Authority and hospital restrictions would be possible from within the available budget.

As a result of the RFP, PHARMAC has entered into a provisional agreement with Novartis New Zealand Limited and feedback to this consultation will help us decide if the agreement should be confirmed.

Benefits to patients

Aripiprazole tablets (Abilify(external link) brand) are currently funded subject to restrictions for second-line treatment of schizophrenia and related psychoses and as a last-line treatment for the off-label indication of severe irritability in patients with autism spectrum disorder. As part of the agreement with Novartis, PHARMAC proposes to remove these restrictions. Removal of the restrictions would enable funded use of aripiprazole:

• as a first-line treatment option for schizophrenia and bipolar disorder (the registered indications)
• for any off-label indication where considered clinically appropriate and consistent with regulatory requirements.

Benefits to pharmaceutical expenditure

Annual expenditure on funded aripiprazole tablets is approaching $5 million per year and usage is increasing.

Substantial savings to the Combined Pharmaceutical Budget and DHB hospital pharmaceutical spend would result from this proposal. This is estimated to be approximately $4.2 million per year once the sole supply period commences (excluding confidential rebate). This would enable PHARMAC to fund more medicines for more New Zealanders.

Listing of Aripiprazole Sandoz

Following Medsafe approval, Novartis’ brand of aripiprazole 5 mg, 10 mg, 15 mg, 20 mg and 30 mg tablets (Aripiprazole Sandoz) would be listed in Section B (the Community) and Part II of Section H (the Hospital Medicines List) of the Pharmaceutical Schedule as follows:

• There would be no Special Authority restrictions or hospital restrictions applying to Aripiprazole Sandoz.
• Each strength of Aripiprazole Sandoz would be listed as soon as practicable following Medsafe approval. The listing would be unlikely to be sooner than before 1 February 2018.
• The listing of Aripiprazole Sandoz 5 mg tablet strength may be delayed up to an additional 4 months, compared with the other four tablet strengths of Aripiprazole Sandoz.

Two months after listing of Aripiprazole Sandoz

In the Community

Two months following the proposed listing of each strength of Aripiprazole Sandoz, the subsidies for the currently listed Abilify brand of that strength aripiprazole tablet would be reduced, via the application of reference pricing, to the new proposed subsidy relating to Aripiprazole Sandoz, as follows:

• If the supplier of Abilify tablets decides not to reduce the price of Abilify to match the new proposed subsidy, a manufacturer’s surcharge would apply when Abilify is prescribed.
• The Special Authority restrictions applying to Abilify in Section B would be removed once the corresponding strength of Aripiprazole Sandoz is listed.

In DHB hospitals

Two months after a strength of Aripiprazole Sandoz is listed in the Hospital Medicines List, the Abilify brand of that strength would be delisted. From this date, Hospital Supply Status (HSS) with a 1% Discretionary Variance (DV) limit would apply in DHB hospitals for that strength of Aripiprazole Sandoz. HSS would be in place for all strengths of Aripiprazole Sandoz until 30 June 2021.

Five months after listing of Aripiprazole Sandoz

In the Community

Five months after a strength of Aripiprazole Sandoz is listed, the Abilify brand of that tablet strength would be delisted from Section B of the Pharmaceutical Schedule. From this date, that strength of Aripiprazole Sandoz would have Sole Subsidised Supply and this would be in place until 30 June 2021. 

Send us an email: procurement@pharmac.govt.nz by 5 pm on Monday, 14 August 2017.

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, where 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.