Proposal to fund rasagiline

Consultation Closed

We are seeking feedback on a proposal to fund rasagiline, a new treatment for people with Parkinson’s disease.

What we’re proposing

We are seeking feedback on a proposal to fund rasagiline, a new treatment for people with Parkinson’s disease from 1 August 2021, through a provisional agreement with Teva Pharma (New Zealand) Limited.

This proposal follows Apotex New Zealand Limited’s (Apotex) decision to leave the New Zealand market and cease supplying the currently funded brand of selegiline hydrochloride (Apo-Selegiline). This means that people will not be able to access funded Apo-Selegiline after current stock has been used, this is expected to occur later in 2021.

If this proposal is approved, people using selegiline would have the option of transitioning to rasagiline. No eligibility criteria have been proposed for rasagiline and it would be funded for all New Zealanders who need it.

We anticipate that Teva’s brand of rasagiline tablets (Azilect) would not have Medsafe approval at the time it is proposed to be listed on the Pharmaceutical Schedule. Teva has committed to working toward Medsafe approval for the Azilect brand of rasagiline.

You can monitor the registration status of rasagiline (Azilect) on the Medsafe website.(external link)

Consultation closes at 4 pm Monday 10 May 2021 and feedback can be emailed to consult@pharmac.govt.nz.

Your feedback

Consultation is a very important step in our process. When providing consultation feedback, you might want to think about the following:

What would the effect be?

From 1 August 2021 rasagiline would be funded for the first time for all New Zealanders who need it.

This proposal results from Apotex’s decision to leave the New Zealand market. Apotex is the current supplier of selegiline hydrochloride (Apo-Selegiline) to New Zealand. A Request for Tender was released on 1 October 2020 to secure supply of various medicines including selegiline hydrochloride and rasagiline; both these medicines may be used in treatment of Parkinson’s disease.

Following Apotex’s decision to exit the New Zealand market PHARMAC has been unable to secure supply of an alternative brand of selegiline hydrochloride.

Rasagiline is not currently supplied to New Zealand and would be funded for the first time as a result of this proposal. Clinical advice received from members of the Neurological Subcommittee is that rasagiline could be a suitable alternative treatment for people currently using selegiline hydrochloride.

If this proposal is approved people using the currently funded brand of selegiline hydrochloride (Apo-Selegiline) would have the option of transitioning to the Azilect brand of rasagiline. People who are interested in this option should discuss it with their healthcare professional.

Prescribers and pharmacists would be supported with appropriate information and implementation activities to manage the transition of people currently using the funded Apo- Selegiline brand of selegiline hydrochloride onto the Azilect brand of rasagiline.

We anticipate that there would be a period of time where both selegiline and rasagiline would be available, in order to assist patients who are transitioning from selegiline hydrochloride to rasagiline. It is the intention that no new patients would be initiated on selegiline hydrochloride once rasagiline is available.

Following the exhaustion of remaining stock, the currently funded Apo-Selegiline brand of selegiline hydrochloride would be delisted from the pharmaceutical schedule.

In order to ensure people have continued access to a treatment, we anticipate that there would be a period where the Azilect brand of rasagiline may be funded by us and provided in New Zealand as an Unapproved Medicine. Additional support from prescribers may be required to assist people on an unapproved medicine.

Who we think will be interested

  • People with Parkinson’s disease and their family, whānau or caregivers.
  • People currently using the funded Apo-Selegiline brand of selegiline hydrochloride supplied by Apotex
  • Healthcare professionals who treat people with Parkinson’s disease.
  • Hospital and community pharmacists, DHBs and wholesalers.
  • Suppliers of pharmaceuticals to the New Zealand market.

About Parkinson’s disease and rasagiline

Parkinson’s disease is a progressive, degenerative disorder of the nervous system characterised by tremors, rigidity, slow and decreased movement, postural instability, and gait abnormalities; caused by a loss of neurons and a decrease of dopamine. Rasagiline, like selegiline hydrochloride belongs to a class of medicines called monoamine-oxidase-B inhibitors and is used to treat the symptoms of Parkinson’s disease by slowing down the breakdown of dopamine.

Why we’re proposing this

Following Apotex’s announcement that it is leaving the New Zealand market, PHARMAC released a closed Request for Tenders on 1 October 2020. As a result of this procurement process and our analysis of the tender bids received, we have entered into a provisional agreement with Teva for the supply of rasagiline.

This proposal would ensure a suitable medicine would continue to be available for New Zealanders who need it.

Feedback to this consultation will help us to decide whether to enter into the agreement with Teva.

Background to this proposal

In June 2020 we released a Registration of Interest for various pharmaceuticals currently supplied by Apotex, following the announcement that it is leaving the New Zealand market.

This registration of interest was open for all suppliers to express interest in supplying any, or all of the medicines to the New Zealand market. As a result of this process suppliers were shortlisted to participate in a closed Request for Tenders process, which was released on 1 October 2020.

On 19 February 2021 we released a public consultation that included 15 of the pharmaceuticals included in the 1 October 2020 Request for Tenders.

The proposal to award supply of rasagiline to Teva is the latest proposal to arise from the 1 October 2020 Request for Tenders.

Details about our proposal

Rasagiline would be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 August 2021 as follows:

The price and subsidy for the Azilect brand of rasagiline would be notified should PHARMAC decide to progress the proposal following consideration of consultation feedback.

Chemical

Presentation

Brand

Pack size

Rasagiline

Tab 1 mg

Azilect

30

A funded brand of rasagiline is not currently available in New Zealand. We anticipate that the Azilect brand of rasagiline would not have Medsafe approval at the time it is listed on the Pharmaceutical Schedule.

This means that Azilect would need to be prescribed under Section 29 of the Medicines Act 1981.(external link)

Teva has committed to working toward Medsafe approval for this medicine.

Rasagiline would be funded as an alternative treatment option to selegiline hydrochloride, which is currently supplied by Apotex. An alternative brand of selegiline has not been able to be secured following Apotex’s decision to exit the New Zealand market. Clinical advice received from members of the Neurological Subcommittee is that rasagiline could be a suitable alternative treatment for people currently using selegiline hydrochloride.

From 1 August 2021 the Azilect brand of rasagiline would be listed in Section B and Part II Section H of the Pharmaceutical Schedule. The Azilect brand of rasagiline would have Sole Subsidised Supply status and Hospital Supply Status until at least 30 June 2024, with an optional extension period of three years until 30 June 2027 to be exercised by mutual agreement between PHARMAC and the proposed supplier. The Azilect brand of rasagiline would only be eligible for the three-year extension period if it receives Medsafe approval prior to, or during the initial term, ending 30 June 2024.

In DHB hospitals, this would result in Azilect being the only funded brand of 1 mg rasagiline tablets, subject to a 1% DV limit (ie 99% of total volume of the 1 mg presentation of rasagiline tablets purchased by DHB hospitals would be required to be the Azilect brand). Following the exhaustion of remaining stock, the currently funded brand of selegiline hydrochloride would be delisted from the pharmaceutical schedule.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 4pm Monday 10 May 2021.

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.

Your feedback may be shared

Feedback we receive is subject to the Official Information Act 1982 (OIA). Please be aware that we may need to share your feedback, including your identity, in response to an OIA request. This applies to anyone providing feedback, whether they are providing feedback themselves or for an organisation, in a personal or professional capacity.

We can only keep feedback confidential as allowed under the OIA and other related laws. If you want any part of your feedback treated as confidential, you need to tell us. Please let us know if you want to keep part of your feedback confidential, and why. Is it commercially sensitive, confidential or proprietary, or personal information? Clearly state this and tell us which parts of your feedback you want to keep confidential for these reasons. We will consider your request under our OIA requirements.