21 September 2017

Website aims to smooth cannabis approval process

Drugs General Practice

A website is promising to ease the headache that comes with seeking TGA approval for medicinal cannabis.

The CannabisAccess portal, launched in August, offers free practical assistance to doctors who are interested in prescribing medicinal cannabis to patients.

Doctors could seek approval from the TGA directly through the website (cannabisaccess.com.au).

The website shows which cannabis products are available in Australia and directs doctors to the evidence to support their use for specific medical conditions.

CannabisAccess uses a team of specialists to help ensure the application contains sufficient evidence before being submitting to the TGA, in an effort to improve the likelihood the application will be successful.

CannabisAccess also runs a call centre to walk doctors through the process.

“A lot of these doctors haven’t been trained in cannabinoids and cannabis because it hasn’t been legal for them to prescribe it,” Giles Craig, the CEO of CannabisAccess, said.

“And we, basically, are there to help them through the process, make it more efficient, and make sure their application forms have all the materials that they are required to submit.” A spokesperson said the TGA was aware of the website but could make no comment on its appropriateness.

Doctors currently have to jump over numerous regulatory hurdles to gain approval for medicinal cannabis prescriptions in Australia. An application form has to be filled out for each individual patient under Special Access Scheme Category B. In around one-third of cases, the TGA asks the doctor for more information, delaying approval.

The most common reason the TGA initially rejected applications was gaps in information,  Mr Craig said.

“Typically, that is the value that we are adding. We vet the forms and try to make sure the doctors have submitted all the information that they should,” he said.

CannabisAccess drew on international references to support the use of medicinal cannabis but would be incorporating the TGA’s guidance to doctors, once an upcoming review of the evidence was completed, Mr Craig said.

The federal Department of Health has commissioned a review of the current clinical evidence for medicinal cannabis, drawing on the expertise of clinicians, scientists and experimental pharmacologists from universities in Queensland and NSW. The TGA’s guidance would be a high-quality resource for doctors, Mr Craig said.

Medicinal cannabis applications were also more likely to be approved if the TGA had their own references referenced back to them, he said.

In its first two months, more than 100 doctors have signed up to CannabisAccess and around 20 doctors have been taken through the approval process.

The website is not currently generating revenue; the team members are volunteering their time for free. “It is leveraging expertise that we have used in other projects,” Mr Craig said.

Although doctors would never be charged for using the website, the team would look to suppliers of cannabis products as a source of revenue in the future, he said.

The CannabisAccess team includes Mr Craig, who is a chartered accountant; medical science liaison Dr Catherine O’Sullivan, who has a PhD in neuropharmacology; and CTO Rowan McCann, an executive at cloud services company White Stratus.