2018-12-10 Atomoxetine Consultation

CONSULTATION

Proposal to open access to atomoxetine and change funded brand 10 December 2018

What we’re proposing PHARMAC is proposing to remove all funding restrictions from all presentations of atomoxetine, and change the funded brand of atomoxetine from Strattera to a brand supplied by Generic Partners (NZ) Limited.

The Generic Partners brand of atomoxetine would be listed from 1 July 2019, and the community and hospital funding restrictions on atomoxetine would be removed at the same time. There would then be a transition period, detailed below, after which Strattera would be delisted.

The Generic Partners brand of atomoxetine would be awarded sole supply from 1 December 2019 until 30 June 2022, meaning that it would be the only funded brand of atomoxetine during this time.

Consultation closes at 5 pm on Friday, 18 January 2019 and feedback can be emailed to alexander.rodgers@pharmac.govt.nz.

Who we think will be interested

  

 Patients with attention deficit hyperactivity disorder (ADHD)  Family and whānau of patients with ADHD, and ADHD support groups Clinicians involved with ADHD treatment Suppliers of atomoxetine or other ADHD treatments DHBs, pharmacists, and wholesalers.

About atomoxetine Atomoxetine is a noradrenaline reuptake inhibitor. It is indicated only for treatment of ADHD. Atomoxetine has been funded for ADHD since 2009, subject to Special Authority funding restrictions. The current restrictions require the patient to have tried another funded agent or for other funded agents to otherwise be unsuitable. The funding restrictions also prevent atomoxetine from being funded in combination with a funded stimulant such as methylphenidate.

Details and why we’re proposing this A1208240

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PHARMAC released a Request for Tender (RFT) on 17 August 2018 for the supply of atomoxetine to community pharmacies and DHB hospitals.

As a result of the RFT, PHARMAC has entered into a provisional agreement with Generic Partners (NZ) Limited for the supply of atomoxetine.

If this agreement is approved, the Generic Partners brand of atomoxetine would become the only funded brand of atomoxetine (after a transition period), and this sole supply period would last until 30 June 2022.

There would be a five-month transition period where both Strattera and the Generic Partners brand would be listed. During the first two months, both Strattera and the Generic Partners brand would be listed fully funded. Following this, there would be a three-month period of reference pricing, during which the subsidy for Strattera would be reduced to equal the subsidy for the Generic Partners brand. At the end of the five-month transition period, Strattera would be delisted. A brand switch fee would apply.

What would the effect be?

The Generic Partners brand of atomoxetine would be listed from 1 July 2019. At the same time, all funding restrictions on atomoxetine would be removed, regardless of which brand is prescribed. This means there would no longer be a Special Authority on atomoxetine, nor any Hospital Indication Restrictions.

For two months, both Strattera and the Generic Partners brand would be listed fully funded. After those two months, from 1 September 2019, Strattera would be reference priced. This means that the subsidy for Strattera would be reduced to match the subsidy for the Generic Partners brand. It would be the decision of Strattera’s supplier (Eli Lilly) whether to lower its price to match the subsidy or to have a manufacturer’s surcharge. Three months after reference pricing, on 1 December 2019, Strattera would be delisted entirely and the Generic Partners brand would be the only funded brand of atomoxetine.

The proposal would reduce the price of atomoxetine, resulting in savings that could be used to fund other medicines for New Zealanders.

The Generic Partners brand of atomoxetine would be awarded sole supply until 30 June 2022. This means that it would be the only funded brand of atomoxetine and PHARMAC could not list any other brand of atomoxetine until that date.

For patients Patients would continue to access funded atomoxetine in consultation with their prescriber.

Patients currently on atomoxetine would need to switch brands to stay on a funded treatment. This transition would need to be made between 1 July and 1 December 2019.

We know that changing a brand of medicine can be difficult for patients and we would provide resources to support them through any proposed brand change of atomoxetine – for example, patient information leaflets that would be available from their community pharmacy.

Patients not currently on a treatment for ADHD would have access to more treatment options, particularly for first-line treatment, as there would be no restrictions on the funding of atomoxetine from 1 July 2019.

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For community pharmacies Pharmacies would need to start transitioning patients to the Generic Partners brand of atomoxetine from 1 July 2019. Pharmacists have an important role to play in facilitating successful transition of patients to a different brand. Both brands are capsule formulations and are similar in appearance. The Strattera brand is the reference product used for the Medsafe registration of the Generic Partners brand, and these two brands are considered to be bioequivalent.

A brand switch fee would apply. We have a suite of resources that would be provided to community pharmacy to enable them to support patients through a brand change of atomoxetine.

For clarification, repeat dispensings of a prescription for the Strattera brand of atomoxetine would be fully subsidised where the initial dispensing of the prescription was before 1 September 2019, up until the start of the sole supply period (1 December 2019).

For further questions about the brand change, pharmacists would be able to contact PHARMAC on 0800 66 00 50 or email enquiry@pharmac.govt.nz.

For hospital pharmacies Following the listing of the Generic Partners brand of atomoxetine on the Pharmaceutical Schedule, pharmacies could continue to purchase any listed brand of atomoxetine for two months. After that a discretionary variant (DV) limit of 1% would apply, meaning that only 1% of total purchases of atomoxetine could be a brand other than the Generic Partners brand. Note that the Strattera brand, once delisted, would be considered to be a DV pharmaceutical.

For prescribers This proposal would open access to atomoxetine by removing the need to apply for a Special Authority. This would allow atomoxetine to be prescribed and funded for any patient where the prescriber considered atomoxetine to be clinically appropriate. For example, atomoxetine could be prescribed regardless of whether or not the patient has tried any other treatments and could be prescribed in combination with a stimulant if considered appropriate by the prescriber.

Prescribers have an important role in advising and reassuring existing patients about switching brands. The Generic Partners brand is considered to be bioequivalent to Strattera, and both brands are similar in appearance.

Prescribers would be informed in a timely manner about any brand changes and would be provided with appropriate resources for them to support patients through a brand change of atomoxetine.

To provide feedback Send us an email: alexander.rodgers@pharmac.govt.nz by 18 January 2019.

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 A1208240

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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.

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