11 July 2018

Finally, medicinal cannabis is on a roll

Drugs General practice TheHill

Medicinal cannabis is putting down roots in Australia with an expansion of clinical education, federal support and the start-up of local supply due by the year’s end.

The shape of change has been evident in the past few months, after NSW became the first jurisdiction to withdraw from a two-step approval process in which states can stonewall a doctor’s application despite the TGA’s assessment of a product’s clinical suitability for a patient. 

Since March, more scripts have been authorised for cannabis-derived medicines in NSW than in the entire 20-month period following the adoption of enabling laws in 2016.  GPs in the state are now receiving approvals in significant numbers for the first time.  

Of the 211 NSW applications approved since March 2, when NSW Health Minister Brad Hazzard shook hands on the agreement, a total of 78 were for GP patients. Only 81 approvals were granted in the period from August 2016 to March 1, of which only one was a GP application.

A large cohort of the new GP patients are under the care of Dr Teresa Towpik, a GP practising in the Blue Mountains, west of Sydney, who has become a local leader in accumulating, publishing and lecturing on research into cannabis therapies.  

She is now treating 30 patients with cannabis products under the TGA’s Special Access Scheme B provision, including some patients referred to her from other doctors.

Despite the short timeframe, she observes encouraging responses in patients with a range of condition from chronic pain to post-traumatic stress disorder and depression.

“When it comes to pain reduction, there are variable results,” Dr Towpik tells The Medical Republic. “Some people’s pain goes down really well. Others have a more modest reaction. But they say even if the pain remains, it doesn’t trouble them so much.

Commonly, patients report an improved sense of hope and quality of life, she says.

“The patients who have come to me have been in total misery, zombied out on oxycodone and benzodiazepines. For them, this is a last resort.  

“Overall, what I am noticing in almost all of them is an improvement in quality of life. They sleep better and feel more relaxed.

Interestingly, no patients so far have reported any psycho–active effects despite using a product with equal ratios of tetrahydrocannabinol  (THC) and cannabidiol (CBD), she says.

“Most say their thinking is clearer, they feel more focused and motivated and they can perform better.”

Dr Towpik says she emphasises to patients the importance of working with the GP and recording everything they experience. She speaks to them every few days by phone.

Under the one-step approval system, Dr Towpik has had scripts approved in the space of a single day and, in one case, within an hour.  

Previously, she had battled NSW Health for more than a year only to be denied approval to prescribe for a patient with chronic pain.

According to Adjunct Professor John Skerritt, federal deputy secretary of health with responsibility for the TGA, the new arrangement with NSW has been “working beautifully”, with state approval “nested” within the TGA process. 

Under questioning by a Senate estimates committee on May 30, Dr Skerritt said there had been no rejections and all approvals had been processed within 48 hours of the agency receiving a doctor’s application.

“We’ll get the application electronically from the doctor,” he said.  “We’ll whiz off an email to NSW Health if it’s a Schedule-8 product, and consistently – as I said, 100 to 200 times, so they’ve kept their word – they’ll do the relevant Schedule-8 approvals.”

Dr Skerritt also held out hope of relief on costs, pointing to rising competition and the looming start of local supply.  A couple of hundred companies had applied to import product and a “couple of dozen” already had product on the market.

He was responding to a question from South Australian Senator Senator Stirling Griff, who brought up the case of a disability support pensioner who had been paying $612.50 plus $100 postage for 25ml of cannabis oil to control his seizures.  

“What I would suggest your constituent do is essentially shop around,” Dr Skerritt said. 

“There is a range of cannabis products that have been brought into the country and, because of that competition, their prices have dropped. 

“The first three crops of commercial cannabis have also been harvested in Australia and, while it will be a little time before they’re converted into products, we expect local cultivation will also result in a decrease in the price of those products.”

With the prospect of Australian growers exporting cannabis product “providing they serve all the requirements of Australian patients”, it was hoped market size and local product would pressure prices, he said. 

“In fact, just yesterday we met with a particular company that isn’t providing product in Australia but was of a view that they could provide product at about a quarter of the price of their competitors,” Dr Skerritt added.

“And we said: ‘Please submit import permit applications. Pricing is up to you, but you’d certainly get a fair bit of market share if you can do that.’”

Importers could list their product information on the Office of Drug Control’s website, so doctors could compare various cannabidiol and THC concentrations and ratios, and determine what they wanted to prescribe, he said.  The imports included a range of “dose forms”, from oils to certified raw product. 

The expectation in government was that other states would follow the NSW lead in the coming months, under strong encouragement from Federal Health Minister Greg Hunt, Dr Skerrit told the Senate Community Affairs Committee.  

Emerging from a COAG health ministers’ meeting on April 13, Minister Hunt said all states and territories had agreed to provide faster access to medicinal cannabis.  “There will be the adoption of the NSW-Commonwealth trial, and that will now be spread to all states and territories,” he said. 

“This means that the decision as to whether or not to prescribe is rightly in the hands of medical professionals, but once that decision is made, access will then be provided within what we expect to be a 48-hour period; indeed, in many cases, as low as 24 hours.”

“So now, time should not be a matter of concern once a doctor has made his or her prescription.”

GPs interested in learning about medicinal cannabis and its potential for bringing relief to their patients have also found a friend in the RACGP.  College President Dr Bastian Seidel made an important appearance at a seminar held by advocates in February, at which he described the complex regulatory regime for medicinal cannabis products as a “basket case”. 

The RACGP allotted CPD points to a two-day workshop in May hosted by the National Institute of Integrative Medicine (NIIM) in Melbourne, featuring international and Australian clinicians with expertise in medicinal cannabis.  A follow-up is slated for Sydney in September.  

The college has extended the same support to a seminar in Queensland on July 6, where clinicians will share their experience.  

One of them, Dr Towpik, says this will include practical advice, such as how to approach an initial consultation and dosing protocols and follow-ups.

The event is being held at the University of the Sunshine Coast in conjunction with Medifarm, a licensed growing and manufacturing operation based in the local region, which partners the university in research.

Medifarm expects to have locally grown product ready for market by around Christmas, according to director Adam Benjamin.

Mr Benjamin says Australia is well positioned to capitalise on the global medicinal marijuana boom, given federal backing and the country’s strengths in farming and healthcare.

“The reason is, we have a federal landscape that sets the health initiative. This gives a huge advantage over countries like America, where approvals are state-based … federally, it is not approved, and that rules out a major part of research. 

“You can research and control products here that have global application in countries where medicinal cannabis is permitted.  By the end of this year, another 30 countries will have legislated for it. 

“Another huge competitive advantage is that in order to do this well you need to be good at healthcare, but you also need to do exceptionally well at agriculture.  Medicinal cannabis is the meeting ground of the two.”

Medifarm, which had significant backing from Tikun Olam, an Israeli pioneer in medicinal cannabis, would be involved in end-to-end supply from raw product to oils, he said.

From a clinical and marketing viewpoint, Australia is off to a late start compared with the likes of Canada – where medicinal cannabis was introduced in 1999 and the number of registered users exceeded 200,000 patients in 2017.  

As of June 15, there had been only 701 script approvals under SAS-B in all of Australia, according to the TGA.  

Separately, a total of 33 Authorised Prescribers had been approved, allowing them to prescribe specific cannabis products for specific patient groups – mostly for paediatric neurology.  

Applications for prescriber status must go through an accredited medical ethics committee. 

So far, only one GP has achieved that status, for treating chronic neuropathic and cancer-related pain, in an application undertaken through the Melbourne-based NIIM.