General funding applications for medicinal cannabis
Pharmac does not currently fund any medicinal cannabis products.
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Clinical experts discuss medicinal cannabis
PTAC (the Pharmacology and Therapeutics Advisory Committee) discussed medicinal cannabis at its meeting in March 2021 as part of an overarching horizon scan sought by Pharmac.
They found that clinical evidence about the use of medicinal cannabis spanned a wide range of conditions. However, the evidence was generally of poor quality, did not capture long-term risks, and did not demonstrate a meaningful benefit when treating most symptoms or conditions.
PTAC thought that there was a significant potential risk of harm from medicinal cannabis if it were not prescribed and used appropriately (according to high-quality clinical evidence).
They noted that any application to fund medicinal cannabis would need to meet requirements as detailed in the Guidelines for Funding Applications to Pharmac, but in particular it would be important that any application had:
- A clearly defined patient population and symptoms (or disease)
- good quality supporting evidence (eg. randomised controlled trials)
- an appropriate comparator treatment in a patient group that could be generalised to the New Zealand population
- long-term outcome and safety data.
The Committee noted that products without Medsafe approval do not have the benefit of Medsafe’s assessment of the product’s content, quality, production, and safety; including long-term risks. The Committee therefore thought, given safety considerations, that funding applications to Pharmac should ideally be for Medsafe-approved products.
PTAC considered that applications for medicinal cannabis products should be considered on an individual basis, rather than as a class, due to variation in their manufacture, quality, and component cannabinoid compounds.
Pharmac would welcome any funding application that met these requirements.
Making a funding application for medicinal cannabis products
Who can apply
Anyone can make an application to Pharmac for funding of a medicine. They can be a patient, health professional or a pharmaceutical supplier.
Pharmaceutical companies usually make the application. They have access to the clinical information Pharmac needs to assess applications.
The same as other medicine funding applications
We would treat any application to fund a medicinal cannabis product the same as other medicine funding applications. They must meet the same regulatory standards and we’ll assess them using the same process.
- published evidence that supports the health benefits of the product.
- Information on the regulatory status of the product, such as if:
- the Medicinal Cannabis Agency has verified the product meets minimum quality standards, or
- the product is Medsafe approved as a pharmaceutical.
PHARMAC has assessed one cannabis-based product which is classified as a controlled drug for funding: Sativex (cannabidiol with tetrahydrocannabinol).
Sativex is currently the only cannabis-based product registered as a medicine for use in New Zealand.
Previous consideration of a cannabis based medicine
We considered funding Sativex for treating:
- spasticity due to multiple sclerosis (the registered indication)
- pain (including pain associated with spasticity) (off-label use)
- refractory epilepsy (off-label use).
How we assessed the application
First, we asked our Pharmacology and Therapeutics Advisory Committee (PTAC) to review Sativex.
Advice from experts is an important part of PHARMAC’s funding decision-making process. Our experts make recommendations based on published evidence.
In August 2015, PTAC considered the published evidence for Sativex’s use. PTAC found that the clinical evidence did not demonstrate that Sativex was more effective than other medicines that we already fund for the same uses.
The Committee recommended that PHARMAC decline funding for all three clinical uses listed above. When PTAC recommends we decline an application, the medicine is not usually funded.
In this case, we haven’t made a decision yet. This allows us to reconsider it for funding if new information becomes available.
Who to contact
If you have questions about making a funding applicaton, email firstname.lastname@example.org