Legalization conversation adds further fuel (and urgency) to coverage debate
Medical marijuana is the hot topic of the day in health benefit plans. And the legalization conversation in Canada is adding further fuel (and urgency) to the coverage debate.
While there are many cannabinoid-related studies active in the field, there are few involving Canada. But that could change with ever-increasing flows of capital into licensed producers, and a steadily maturing medical cannabis industry in Canada.
This means we can expect a surge in evidence across different conditions as it relates to the use of medical marijuana in the years ahead. If we mix that with an ever-decreasing stigma around the use of marijuana in a medical context (and otherwise), plan sponsors are going to need to consider how to deal with medical marijuana.
There will not be a standard one-size-fits-all approach. How can there be? Policies and approaches will need to vary according to industry (such as safety-sensitive ones), and will also need to consider the financial means of a plan sponsor.
Medical marijuana is Canada’s newest specialty medication: Annual plan costs will exceed $10,000 per claimant for anyone who consumes $25 to $30 per day of medical marijuana. That equates to a daily dose of about three grams per day based on current prices. Not every employer will be in a position to make these kinds of investments.
For now, here are some key considerations for plan sponsors when it comes to making initial decisions about how their plans can responsibly address claims for medical marijuana.
Consider the evidence
Anecdotally speaking, users claim medical marijuana has beneficial impacts on a wide range of conditions ranging from irritable bowel syndrome to post-traumatic stress disorder or glaucoma. Imagine if a new traditional pharmacological agent was released to the market and costs from $2,500 to $25,000 per year and had 25 or more different indications for use — that’s what we’re dealing with here.
There are very few conditions where there is conclusive, substantial or even moderate evidence to support the use of medical cannabis. Interestingly, Shoppers Drug Mart made some buzz recently with its announcement it would cover up to $1,500 in medical marijuana per year for plan members. But the approved indications under the plan do not line up with the existing evidence base. Covering only two of the indications where there is meaningful evidence is an interesting line in the sand. I’ll be curious to see if Shoppers is challenged on that. It’s also interesting to note the $1,500 limit — that would equate to about half a gram per day at current prices.
Effective coverage of medical marijuana long-term will need to go beyond cherry-picking a couple of indications for relatively small patient populations, and allocating a fixed sum of money that may not come near to offsetting the actual financial burden to a member. If you want to make a splash in the media, that’s great and an effective way to do so, but if you are serious about responsible coverage, there is much more to it than that.
Plans need to consider the existing evidence in determining initial policies governing coverage of medical marijuana. This area will need to be actively managed moving forward. What makes sense in 2017 or 2018 may not make any sense by 2021 as evidence, clinical guidelines and dosage forms evolve.
A disease state-based approach to managing prior authorization claims for medical marijuana (in cases where plan sponsors are willing to cover medical marijuana or consider appeals for coverage) should form the foundation of a coverage policy.
Consider the dose, dosage form
Clearly, most workplaces are not going to support smoking of any kind, including that of medical marijuana, so dosage form is a major consideration.
That said, there are fascinating differences between dosage forms and their impact on users. For example, liver enzymes hydroxylate tetrahydrocannabinol (THC) to form 11-OH-THC which is a potent psychoactive metabolite that easily crosses the blood brain barrier. 11-OH-THC is more potent than THC and appears in the blood in much higher quantities when cannabis is ingested as opposed to inhaled. This should be a concern to any employer in a safety-sensitive industry.
There is also significant inter-patient variability with regards to this rate of metabolism that can lead to wide-ranging therapeutic doses when using edible cannabis.
Interestingly, preliminary guidelines for prescribing smoked cannabis for non-cancer pain being developed by the College of Family Physicians of Canada are considering dosing of 100 mg (one inhalation) up to four times daily to a maximum of 400 mg per day. That would limit quantities to 12 grams every 30 days. I’m certain many users would have something to say about a limitation of 12 grams per month. It will be interesting to see where guidelines take dosing moving forward across different conditions.
Consider drug interactions
THC is metabolized through the following liver enzymes: CYP2C9, 2C19 and 3A4. Traditional medications that significantly inhibit these enzymes can have clinically significant impact on cannabis levels and adverse effects.
Close monitoring is required for patients using certain antidepressants, stomach acid therapies, antibiotics, antifungals, blood pressure medication and protease inhibitors.
Cannabinoids are known to inhibit CYP1A1, 1A2 and 1B1 enzymes which can be a consideration for members taking therapies such as amitriptyline and granisetron.
Health Canada estimates 4.6 million Canadians aged 15 and over will use cannabis at least once in 2018, and this figure is expected to grow to 5.2 million by 2021. It is going to be impossible for plan sponsors to avoid the medical marijuana discussion in the years ahead. Sure, we all know medical marijuana does not have a drug identification number, and we all know Health Canada has not approved its use — but that isn’t going to be enough to avoid the subject as greater levels of evidence emerge for safe and responsible use of medical marijuana.
The pressure to develop policies to responsibly manage claims for medical marijuana will continue to grow. There are some interesting areas of opportunity for employers, and certainly some important risks that need to be considered and managed — not the least of which are safety and financial considerations.
Using a clinically robust, evidence-based and case-based approach to managing claims will help ensure members who benefit from therapy have access through the plan, where appropriate, and risks are properly managed.
Mike Sullivan is president and co-founder of Cubic Health in Toronto. For more information, visit www.cubichealth.ca.