Cannabis-based products in NZ

Appropriately manufactured cannabis-based products can be prescribed to patients in New Zealand at the discretion of their medical specialist or GP. 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.”

Updated 23 February 2017 – More information below;

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.

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.

Internationally available Cannabis-based Products

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.
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.

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 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.

Cannabis-based products

The term cannabis-based products encompasses several types of products containing extracts of the cannabis plant that may be used to treat various medical conditions.

Cannabis-based products are Class B1 controlled drugs and Ministerial approval is required before these can be prescribed, supplied or administered, in accordance with regulation 22 of the Misuse of Drugs Regulations 1977.

Ministerial approval is now delegated to the Ministry of Health for each of the three types of cannabis-based products.

Please note that the Government does not support the use of unprocessed or partially processed cannabis leaf or flower preparations for medicinal use.

There are three types of cannabis-based products that may be considered for Ministerial approval:

  1. Pharmaceutical grade products that have consent for distribution in New Zealand. Consent for distribution means that the product has been determined by Medsafe to meet acceptable safety and efficacy requirements for distribution in New Zealand. The only product meeting this criterion currently is Sativex® for the treatment of multiple sclerosis. It may also be prescribed as a non-consented product for some other medical conditions.
  2. Pharmaceutical grade products that do not have consent for distribution in New Zealand, for example a product that has been manufactured by a pharmaceutical company overseas.
  3. Non-pharmaceutical grade products, that is products that are not manufactured to internationally recognised pharmaceutical manufacturing standards. They may, or may not, have been intended to be used as medicines.

Guidelines to assess applications for Ministerial approval to prescribe, supply and administer

The guidelines to assess applications for Ministerial approval to prescribe, supply or administer these products are listed below. There are separate application forms for each category.

If you require further information as to the appropriate form to use for an application for Ministerial approval to prescribe a cannabis-based product please email: medicinescontrol@moh.govt.nz.

Ministerial approval is now delegated to the Ministry of Health for each of the three types of cannabis-based products.

1. Pharmaceutical grade cannabis-based products that have consent for distribution in New Zealand

More information on Sativex® and the application process to prescribe Sativex® for multiple sclerosis or “non-consented conditions” can be found on the Medsafe website(medsafe.govt.nz)

2. Pharmaceutical grade cannabis-based products that do not have consent for distribution in New Zealand

The following matters are taken into account when assessing applications for Ministerial approval to prescribe pharmaceutical grade cannabis-based products without consent for distribution in New Zealand, regulated by Regulation 22 of the Misuse of Drugs Regulations 1977:

  1. application from an appropriate specialist
  2. a manufacturer has demonstrated a commitment to the development of the product as a pharmaceutical or
  3. the product has been prepared pharmaceutically and the characteristics and formulation are clearly described and defined
  4. the product has completed animal studies demonstrating proof of concept and potential clinical benefit
  5. the product is undergoing an appropriately designed Phase II clinical study or
  6. the product has completed clinical trials and is marketed overseas but is not approved for distribution in New Zealand
  7. the product is available for use
  8. the following are met where relevant:
    1. evidence that there will be close follow up of patient by a prescriber
    2. evidence that a wide range of conventional treatments have been trialled and symptoms are still poorly controlled
    3. condition is an approved condition for use or
    4. condition is one for which there is some evidence of efficacy, preferably in clinical trials
    5. Ministry clinicians assess application is appropriate if for non-approved use
    6. no history of abuse or diversion of controlled drugs
    7. the patient has no known contraindication to the use of the product
    8. initial approvals usually for 6 months
    9. baseline clinical indicators generally required and evidence of improvement before a new approval is given.

Please download, fill in and email application form to: medicinescontrol@moh.govt.nz

3. Non-pharmaceutical grade cannabis-based products

The following matters are taken into account when assessing applications for Ministerial approval to prescribe non-pharmaceutical grade cannabis-based products regulated by Regulation 22 of the Misuse of Drugs Regulations 1977:

  1. severe or life-threatening condition
  2. evidence that reasonably applicable conventional treatments have been trialled and the symptoms are still poorly controlled
  3. evidence that the risk/ benefit of the product has been adequately considered by qualified clinical specialists – that is, the risk of treatment with an unproven product is less than the risk of non-treatment and account has been taken of any evidence of potential benefit and weighed against known adverse effects
  4. application from a specialist appropriate to the medical condition being treated or the Chief Medical Officer of a District Health Board
  5. applicant or specialist prescriber has sought adequate peer review eg, Hospital Ethics Committee approval, Drug or Therapeutics Committee review, review by other specialists in the condition being treated and/or specialist colleagues involved in the treatment of the patient
  6. provision of a Certificate of Analysis, preferably from an accredited laboratory, so that the concentration of the active ingredient(s) is known
  7. patient or guardian has provided informed consent

Products that are not pharmaceutical grade or not pharmaceutically prepared will not be approved for use in clinical trials.

The guidelines to assess applications to prescribe a non-pharmaceutical grade cannabis-based product are more rigorous than the guidelines to prescribe pharmaceutical grade products with or without consent for distribution in New Zealand. This reflects the lack of authoritative quality and safety data and the lack of robust efficacy data for these products.

The use of a non-pharmaceutical grade product will not contribute meaningful data to the pool of scientific research on the safety and efficacy of cannabis-based products in the condition being treated. This is due to the inability to replicate the results (due to variation in the strength and composition of the product) and the inability to generalise results from a single patient to a broad patient group.

Please download, fill in and email application form to medicinescontrol@moh.govt.nz

Downloads

Please download, fill in and email application forms to: medicinescontrol@moh.govt.nz

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