Sativex - guidelines for use
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Sativex® is a cannabis-based product classified as a Schedule 2, Part 1 (Class B1) controlled drug product under the Misuse of Drugs Act 1975 and ministerial approval is required before Sativex® can be prescribed by a New Zealand registered medical practitioner.
Currently in New Zealand, Sativex® is approved only for use as an add-on treatment for symptom improvement in patients with moderate to severe spasticity due to Multiple Sclerosis. Any other use of Sativex® is an unapproved use of this medicine in New Zealand. Note that Sativex is currently not funded by Pharmac (http://www.medsafe.govt.nz/profs/Datasheet/s/sativexspray.pdf)
Unapproved use of Sativex in New Zealand
To apply for Ministerial approval to prescribe Sativex® for an unapproved use for a specified patient, practitioners must complete the following application form:
The application requires the endorsement of a medical specialist - limited to oncologists, neurologists, anaesthetists and palliative care specialists who normally provide medical care to the patient.
The patient must have one of four specified conditions:
- nausea, anorexia and wasting (cachexia) associated to cancer and AIDS; or
- chronic pain (including cancer pain) for which other pain relief treatments are ineffective or have significant/severe adverse side-effects; or
- neuropathic pain (associated with conditions including multiple-sclerosis, stroke, cancer, spinal cord injury, severe physical trauma, and peripheral neuropathy resulting from diabetes); or
- muscle spasm and spasticity associated with spinal cord injury.
To be eligible for approval to prescribe Sativex® for an unapproved use the patient must have trialled adequate doses of standard treatments for the specified condition for appropriate periods of time without sufficient therapeutic benefit, or the standard treatments are not tolerated by the patient, or are contraindicated in the patient.
To allow Paediatric Haematologists/Oncologists within the National Child cancer Network to fulfil their professional obligations, it is necessary for the Paediatric Palliative Care team (directly or via their regional centre surrogates) to be involved in the management of the symptoms for which the Sativex is being applied for. Only when there is acknowledgement from the Palliative Care Specialist, as an expert in symptom management, that all conventional options have been explored and been unsuccessful, will an application for Sativex be made by either the Oncologist or Palliative Care Specialist.
Families may wish to use Sativex in the belief that the drug has clinically significant activity against a particular cancer. There is a great deal of anecdotal information available online describing how successful and efficacious the cannabinoids are in treating cancer, amongst other claims. However, robust clinical data is not currently available to support the use of cannabinoids where the goal is to induce a clinical response in the cancer. We thus cannot justify prescribing Sativex for this indication on both clinical and legal grounds.
This policy will be reviewed if the legal framework or application process surrounding Sativex application in New Zealand changes.
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- Date first published: 13 February 2017
- Date last published: 13 February 2017
- Document type: Clinical Guideline
- Services responsible: National Child Cancer Network
- Author(s): Stephen Laughton
- Owner: Stephen Laughton
- Review frequency: 2 years
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