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Options and Expectations for Cannabis-based products

Hon Peter Dunne

Associate Minister of Health


21 February 2017 Media Statement
Dunne Outlines Options and Expectations in Letter re Cannabis-based Products

Associate Health Minister Peter Dunne has written to medical and pharmaceutical organisations clarifying the range of appropriately manufactured cannabis-based products that could be prescribed in New Zealand.

Following on from the decision to delegate decision-making responsibility to the Ministry of Health on medical decisions to prescribe cannabis-based products, MrDunne last week wrote to New Zealand’s Medical Association, Medical Council and Pharmaceutical Society outlining the list of internationally available products and his “ongoing expectation is that medical professionals consider the prescribing of cannabis-based products with an open mind.”

As anticipated, the list, prepared by the Ministry of Health, is short, illustrating the ongoing issue with product availability, which is further impacted by export restrictions on products from the United States.

“What we are seeing are new products slowly coming to market as manufacturers, such as Tilray in Canada, step up and meet the stringent requirements around Good Manufacturing Process”, said Mr Dunne.

“Unfortunately, Sativex, the one pharmaceutical-grade product that is available in New Zealand continues to be extortionately priced as big pharma continues to ignore the building resentment, both local and global, to the attitude these companies take to the sick and vulnerable.

“The government is making steady progress on the issue of cannabis-based products, an issue which generates a significant amount of interest, not always accurate or reasonable, but passionate nonetheless, and I expect to be able to make additional announcements on the issue in the coming weeks, including a response to the Expert Advisory Committee on Drugs’ advice around the legal status of cannabidiol’, said Mr Dunne.


List of products as released of Internationally available Cannabis-based Products that are either Pharmaceutical Grade or Good Manufacturing Practice (GMP) Certified

Sativex

Sativex, a pharmaceutical grade cannabis-based product with consent for distribution for the treatment of spasticity in multiple sclerosis, is available in New Zealand. It is also often prescribed for non-consented “off label” uses. It is a buccal spray with has a 1:1 ratio of tetrahydrocannabinol to cannabidiol (THC:CBD). From 1 December 2016 the prescribing of Sativex as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to multiple sclerosis has not required an application for approval to prescribe to be made. Further information on the prescribing of Sativex is available on the Medsafe website at http://www.medsafe.govt.nz/profs/riss/Sativex.asp.

Tilray Products

The Ministry has approved, on a case by case basis, Tilray TN-CT11G, an oral liquid manufactured by a Canadian company that contains a 1:1 ratio of THC:CBD. The company holds GMP accreditation for the mechanical processing and extraction of the API (active pharmaceutical ingredient(s)) and associated physical and chemical testing of their products, not the finished pharmaceutical products.

Tilray have recently advised that they have a high CBD (98%CBD), oral liquid product called CBD Max.

Cannabinoid-based Medications

The United States Food and Drug Administration (FDA) have licensed three drugs that are based on cannabinoids but manufactured synthetically rather than derived from cannabis plant material. These are:

Marinol containing dronabinol, a synthetic THC. It is clinically indicated to counteract the nausea and vomiting associated with chemotherapy and to stimulate appetite in AIDS patients affected by wasting syndrome.

Cesamet containing nabilone, a synthetic analogue of THC that has similar indications to Marinol. Marinol and Cesamet are both administered orally and have a slow onset of action

Syndros is a liquid formulation of dronabinol and has recently been approved by the FDA (July 2016) for the treatment of patients experiencing chemotherapy-induced nausea and vomiting who have not responded to conventional antiemetic therapies. It is also indicated for treating anorexia associated with weight loss in patients with AIDS.

These three products are pharmaceutical grade and can be legally exported from the United States under licence. However the Ministry has received no applications to prescribe and import these products and is unaware of the availability of these products for export.

In addition, the FDA has also approved Epidiolex, a concentrated CBD oil extracted from plant material for investigational new drug studies as an anti-seizure agent for Dravet and Lennox-Gastaut syndromes. While the clinical trials are well advanced, the manufacturer GW Pharmaceuticals have advised that this product is not anticipated to be available in New Zealand for 4-5 years.

Please note that all other cannabis-based products produced in the United States that the Ministry is aware of are not pharmaceutical grade. Cannabis-based products derived from plant material are also classified as Schedule 1 substances which means that they cannot be legally exported from the United States.

Bedrocan

Bedrocan is certified to the European Medicines Agency GMP standards in several sites in the Netherlands and certification is planned for sites in the Czech Republic and Canada. The GMP certificate covers processes from cultivation to processing and storage.

Bedrocan has a range of standardised plant material (flos and granulated plant material) products with different standardised concentrations of THC and CBD. The recommended method of administration is by using a medical vaporisation device.

The Ministry has not received an application to prescribe and import a Bedrocan product and the availability from the certified sites in the Netherlands, or elsewhere, is not known.

Assessment of Applications

Assessment of applications to prescribe cannabis-based products by the Ministry of Health against the published guidelines is undertaken by clinicians – pharmacists and senior medical practitioners – on a case by case basis and the risks associated with the particular product are weighed against potential benefits. For all applications it is expected that conventional therapy has been trialled and symptoms are still poorly controlled.

It is important for clinicians to be aware that all the medicines listed above, apart from Sativex for multiple sclerosis, are non-consented (unapproved medicines) and so the advice on the Medsafe website regarding unapproved medicines (www.medsafe.govt.nz/profs/RIss/unapp.asp) applies to prescribers regardless of any decision to authorise access. Approval to prescribe an unapproved cannabis-based product by the Ministry only authorises access to an unapproved medicine, it does not approve the product.

Further information on the prescribing of cannabis-based products is available on the Ministry of Health website at www.health.govt.nz/our-work/regulation-health-and-disability-system/medicines-control/prescribing-cannabis-based-products.

• Pharmacists need to note that Sativex and Tilray products have special storage requirements. They require both refrigeration and storage in a controlled drug safe and these factors need to be considered in coordinating the supply to patients.

• Currently no cannabis-based products are subsidised by Pharmac.

• A licence to import controlled drugs, issued by the Ministry of Health, is required to import any of the above products into New Zealand. Further information about this process can be obtained from contacting the Ministry of Health.

ends

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