Will I have to pay?
Currently there are only two products listed on Australian Register of Therapeutic Goods (ARTG), nabiximols (Sativex) approved for the management of spasticity in people with multiple sclerosis and CBD (Epidyolex) approved for adjunctive therapy of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome which has recently been listed on the Pharmaceutical Benefits Scheme (PBS). For all other medications or indications there is no Commonwealth Government subsidy and the patient bears the full cost of the medication.
For many Australians, the cost of medical cannabis is out of their reach or significant measures, such as accessing their superannuation or selling their house, need to be taken to finance the ongoing cost of the treatment.
Why is it so costly?
Prices are set by the manufacturer and are driven by market demands. They vary depending upon the condition being treated, the product and dosage prescribed.
In addition to this, there may be importation costs (including shipping and customs fees), as well as general importer and pharmacist mark-up.
Are costs likely to ever come down?
With an increase in Therapeutic Goods Administration approvals, the cost of importing products will decrease and new medications coming to market will provide much needed competition.
An Australian based cannabis access company compared the prices of 11 suppliers and found that the prices charged by suppliers had fallen in the previous 12 months.
In Australia, doctors are not permitted to advertise that they prescribe specific medications. This is in line with the Therapeutic Goods legislation and the professional and ethical standards of the Medical Board of Australia and Australian Health Practitioner Regulation Agency (AHPRA).
For privacy reasons the details of authorised prescribers, are not publicly available. However, a number of private medical cannabis clinics have opened facilities in multiple locations across Australia, slightly easing access issues.
Many clinics accept self-referrals for screening assessments to determine if you meet the criteria to become a medical cannabis patient. Completing the relevant Medical History Form will assist your doctor with the necessary paperwork.
The fees for consults, assessments and the application process vary between clinics and it is worth exploring the clinics situated in your state or territory.
A number of hospitals also have authorised prescribers for specific medical cannabis products, often linked to a compassionate access scheme or clinical research study.
Why can’t I find suppliers advertising medical cannabis?
State and Commonwealth laws only allow the advertising of medical cannabis products to wholesale, medical and pharmaceutical professions only; not to the general public.
The Regulation specifies that price lists, advertisements and promotional material must only be accessible to the wholesale drug trade, medical or pharmaceutical professionals, or through professional or trade journals. Any advertising on a company website directed at potential patients is a contravention of the Regulation and may be subject to penalties.
The Therapeutic Goods Administrator (TGA) provides a list of medical cannabis products by active ingredient and the category of products available in Australia however this list may not include all products available in Australia.
The Office of Drug Control (ODC) publishes and regularly updates a list of manufacturers and suppliers of medical cannabis products, with links to their websites.
Unapproved medical cannabis products warehoused in Australia can only be accessed via Special Access Scheme (SAS) Category B, however, unapproved medical cannabis products not already in Australia can be imported with the appropriate Office of Drug Control permits.
How can my doctor help?
Some patients undertake extensive research before their initial discussion with their doctor and have a particular formulation or product already in mind; others look to their doctor for guidance.
Because the area of medical cannabis is reasonably new and changing rapidly, many medical practitioners have limited understating of, and experience with, cannabinoid-based therapeutics.
However, the number of medical professionals with expertise and interest in cannabinoid-based therapeutics is increasing year on year.
The endocannabinoid system, endocannabinoids (such as anandamide), CB1 and CB2 receptors and phytocannabinoids are relatively recent discoveries and many higher educational institutions are only just including this in their curriculums for medical and allied heath students.
In Australia, there are only two medical cannabis products approved and registered with the Therapeutic Goods Administration which means they have product information for both prescribers and patients.
To confidently prescribe any new medicine, doctors require high quality clinical research conducted in humans to decide if their patient would benefit from that medication.
Any doctor prescribing an unapproved therapeutic good, such as medical cannabis, takes on the legal liability for that patient’s wellbeing.
Lack of knowledge and experience with medical cannabis products and the legal liability when prescribing unapproved therapeutic goods can influence a doctor’s willingness to prescribe medical cannabis.
Doctors willing to prescribe unapproved therapeutic goods such as pharmaceutical grade medical cannabis, take on the legal liability. If they work within a hospital or within a research study, the organisation takes on that responsibility.
Patients are required to make informed decisions about their treatment in consultation with the treating doctor. Therefore, signing of a medical consent form is required.
The sample below is quoted from the Western Australian Department of Health Cannabis-based Treatment Consent Form:
My doctor has proposed using a cannabis-based product to help improve health profile. I understand:
I therefore agree:
Many people are unsure where their doctor stands in relation to medical cannabis as a medicine and it can be daunting to raise the topic with them.
Before you broach the topic it is worth learning as much as you can about medical cannabis, check your eligibility, complete the medical history form so your details are all in one place and consider the longer-term costs if the trial of medical cannabis makes a difference to you.
Once prepared with this information you could mention a particular news article or program about prescribed medical cannabis, you will tell from their reaction if they have an interest or not. Follow their lead and have your questions ready to discuss.
If they are interested but do not have the knowledge or experience with prescribing medical cannabis, tell them about websites like this one and accredited courses offered with RACGP. Ask if they would consider working collaboratively with another doctor who is experienced in prescribing medical cannabis in another practice or clinic.
If your doctor has a negative response, there are other doctors who would be willing to prescribe. You can contact a CanGuide Registered Nurse by emailing [email protected] or completing the form on this website. You can request a call back to discuss your options and concerns.
‘Medical cannabis clinics’ were established across Australia to fill the gap between patient demand for prescribed medical cannabis and the ability of the medical system to meet that demand. Due to the limited number of medical practitioners who were knowledgeable, experienced or willing to prescribe cannabinoid-based medicines and the time required to submit applications, clinics stepped in and streamlined their own processes and educated other practitioners in this process. Many clinics offer both in-person and telehealth appointments and have links to pharmacies that will mail the prescribed cannabinoid-based medicines to your home.
Now referred to as ‘clinics specialising in endocannabinoid dysfunction or cannabinoid-based medicines’, some clinics only supply cannabinoid-based medicines from one company whilst others offer a wide range of cannabinoid-based medicines from many different companies.
The clinic doctors prescribing cannabinoid-based medicines aim to work in collaboration with the patient’s usual General Practitioner (GP) to achieve the best outcome for the patient. If this is not possible, they will provide ongoing treatment and monitoring as required. Clinic fees vary, from Medicare only appointments to just under $450 for an initial appointment so it is important to shop around, and also assess the quality of the service.
The majority of medicinal cannabis products are unapproved therapeutic goods, which have not been assessed by the Therapeutic Goods Administration (TGA) for safety, quality or effectiveness.
To assist health care professionals in identifying and prescribing unapproved medicinal cannabis products not entered on the ARTG, the Therapeutic Goods Administration (TGA) has published a list of available products by category of active ingredient, along with sponsor details.
The Office of Drug Control (ODC) also publishes an updated list of importers and manufacturers of medicinal cannabis products on its website.’
There are a number of pathways for accessing ‘unapproved’ medicinal cannabis products, if determined to be clinically suitable for a patient.
These include the:
Authorised Prescriber Scheme: This scheme allows authorised medical practitioners to apply for authority to prescribe medicines, medical devices or biologicals not listed on the Australian Register of Therapeutic Goods (ARTG) to a group of patients within their immediate care, with a specific medical condition without requiring separate approval for each individual patient.
Authorised Prescribers must report the number of patients treated every 6 months through the SAS & Authorised Prescriber Online System.
Special Access Scheme (A and B) are application pathways where prescribers apply on behalf of a patient to access unapproved medical cannabis products. Prescribers need to provide clinical justification.
There are no restrictions on the medical conditions for which a prescriber may apply via the SAS however the prescriber needs to have knowledge on the condition and the medicinal cannabis product they wish to prescribe. Supporting evidence may be requested by the TGA.
A licence issued by the Office of Drug Control for the importation of medical cannabis for research purposes is required with the sponsor (importer) to hold the medical cannabis product until it is issued to the research institution.
Patients may request a referral or information about medical cannabis clinical trials. They can be referred to a range of sites to investigate trials for which they may meet the inclusion criteria. (see the following question)
The Australian New Zealand Clinical Trials Registry (ANZCTR) is a public online platform where clinical trials are voluntarily listed which outlines the trial objectives, design feature, sample size, recruitment status, treatments under investigation, outcomes being assessed, principal investigator and contact person.
World Health Organization International Clinical Trials Registry Platform (ICTRP) which lists trials from all Primary Registries is now cloud based and can be searched through the new ICTRP portal.
HealthMatch free patient portal to be matched to a suitable clinical trial
Clinials information and linking to clinical trials
Refer to the Research page of this website (https://canguide.org.au/mc-research/)
Therapeutic Goods Administration, Medical Cannabis, < https://www.tga.gov.au/medicinal-cannabis>
Therapeutic Goods Administration, Medical Cannabis: Role of the TGA, < https://www.tga.gov.au/medicinal-cannabis-role-tga >
Therapeutic Goods Administration, Authorised Prescribers, < https://www.tga.gov.au/form/authorised-prescribers >
Therapeutic Goods Administration, Accessing Medical Cannabis for patients < https://www.tga.gov.au/accessing-medicinal-cannabis-patient >
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