Decision to fund rasagiline
What we’re doing
We're pleased to announce the decision to fund rasagiline (Azilect) a new treatment for people with Parkinson’s disease from 1 August 2021 through an agreement with Teva Pharma (New Zealand) Limited (Teva). Rasagiline will be fully funded for people without restriction.
The Azilect brand of rasagiline will not have Medsafe approval at the time it is proposed to be listed on the Pharmaceutical Schedule. From 1 August 2021 it will need to be prescribed and supplied under Section 29 of the Medicines Act. Teva has committed to working toward Medsafe approval for its Azilect brand of rasagiline.
Selegiline hydrochloride is being discontinued by Apotex. Rasagiline is being listed as an alternative treatment option for people currently taking selegiline. We have secured a small amount of an alternative brand of selegiline hydrochloride to assist patients to transition to suitable alternative treatments. It is anticipated that from April 2022 selegiline hydrochloride will no longer be available in New Zealand.
What does this mean for people and prescribers
The funding of rasagiline provides a treatment option for people with Parkinson’s disease.
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. It is used to treat the symptoms of Parkinson’s disease by slowing down the breakdown of dopamine.
This decision follows Apotex New Zealand Limited’s (Apotex) decision to consolidate its international presence and leave the New Zealand market. Apotex currently supplies the funded brand of selegiline hydrochloride (Apo-Selegiline). Clinical advice received from members of the Neurological Subcommittee of PTAC is that rasagiline may be a suitable alternative treatment for people currently using selegiline hydrochloride.
We have secured approximately six months’ supply of the Eldepryl brand of 5 mg selegiline hydrochloride tablets. This will be listed from 1 September 2021. This is in addition to the remaining stock of Apo-Selegiline. This provides more time for people taking selegiline hydrochloride to transition to a suitable alternative treatment.
No new patients will be able to start on selegiline hydrochloride from 1 August 2021.
The Azilect brand of rasagiline will not have Medsafe approval at the time it is proposed to be listed on the Pharmaceutical Schedule, however Teva has committed to working toward Medsafe approval for it.
You can monitor the approval status of rasagiline (Azilect) on the Medsafe website(external link).
Any changes to the original proposal?
This decision was subject to a consultation letter dated 21 April 2021. There have been no major changes to the proposal. As a result of feedback received the following changes have been made to the proposal:
- we have sourced six months’ worth of the Eldepryl brand of 5 mg selegiline hydrochloride tablets which will be listed from 1 September 2021.
- PHARMAC will pay the patient GP co-payment for one visit for each patient using selegiline hydrochloride to support patients through this change.
Who we think will be most interested
- People with Parkinson’s disease and their family, whānau or caregivers.
- People currently using selegiline hydrochloride
- Healthcare professionals involved in supporting the treatment of people with Parkinson’s disease.
- Hospital and community pharmacists, DHBs and wholesalers.
- Suppliers of pharmaceuticals to the New Zealand market.
Detail about this decision
Rasagiline will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 August 2021 as follows:
Tab 1 mg
A funded brand of rasagiline is not currently available in New Zealand. The Azilect brand of rasagiline would not have Medsafe approval at the time it is listed on the Pharmaceutical Schedule.
Teva has committed to working toward Medsafe approval for this medicine.
Rasagiline will be funded as an alternative treatment option to selegiline hydrochloride, which is currently supplied by Apotex and will be discontinued.
We were unable to secure long term supply of an alternative brand of selegiline following Apotex’s decision to exit the New Zealand market. Clinical advice received from members of the Neurological Subcommittee is that rasagiline may be a suitable alternative treatment for people currently using selegiline hydrochloride.
From 1 August 2021 the Azilect brand of rasagiline will be listed in Section B and Part II Section H of the Pharmaceutical Schedule. The Azilect brand of rasagiline will have Sole Subsidised Supply status and Hospital Supply Status from 1 January 2022 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 Teva.
In DHB hospitals, Azilect will be 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 will be required to be the Azilect brand). The Azilect brand will have Hospital Supply Status from 1 January 2022 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 Teva.
To support the transition away from selegiline hydrochloride we have secured approximately six months supply of the Eldepryl brand of 5 mg selegiline hydrochloride tablets. The Eldepryl brand is supplied by Aspen Pharmacare. The Eldepryl brand of 5 mg selegiline hydrochloride tablets will be listed on the Pharmaceutical Schedule from 1 September 2021 alongside the Apo-Selegiline brand of selegiline hydrochloride tablets. The two brands of selegiline hydrochloride will remain listed on the Pharmaceutical Schedule until stock has been exhausted, we anticipate this will occur in April 2022.
From 1 August 2021, no new patients will be able to access funded selegiline hydrochloride. A subsidy by endorsement will be applied to selegiline hydrochloride where subsidy will only apply for patients who were taking selegiline hydrochloride prior to 1 August 2021 and the prescription must be endorsed accordingly. Pharmacists may annotate the prescription as endorses where there exists a record of prior dispensing of selegiline hydrochloride.
Our response to what you told us
We’re really grateful for the time people took to respond to this consultation. A summary of the main themes raised in feedback, our responses to the feedback received, and changes we have made after listening to you are covered below.
Support of the proposal
Respondents supported the proposal and noted that rasagiline may offer some benefits compared to selegiline hydrochloride.
Guidance and support for transition
Respondents noted that due to the nature of the condition being treated and the proposed prescriber restrictions this would be a complex transition, which would require additional resource and significant support from all the people involved in the patients care.
Education, support and resources were requested to support people transitioning from selegiline hydrochloride to rasagiline.
We understand that this could be a complex transition for some patients.
To support the successful implementation of this change we will support the development of guidance for primary care on how to change patients from one chemical to another.
We will also cover the cost of one GP patient co-payment visit per patient to support patients through this change.
Long term supply of selegiline hydrochloride
Requests that long term supply of selegiline hydrochloride is secured for patients who are unable to change to an alternative treatment.
We have been unable to secure ongoing supply of selegiline hydrochloride tablets. However, we have secured short term supply of this medicine to allow additional time for people to be transitioned to an alternative treatment.
Concerns were raised regarding the funding of unapproved medicines.
Currently no reversible monoamine oxidase inhibitors have Medsafe approval. In our view Azilect is the best available option for supply of an alternative product to selegiline tablets which is considered of high importance by our clinical advisors.
We acknowledge there are some drawbacks to funding an unapproved product, However, we consider progressing this to be appropriate as:
If you have any questions about this decision, you can email us at enquiry@Pharmac.govt.nz; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.