Why it’s time to make Naltrexone more accessible in Ontario

By Chantal Braganza - Published on May 04, 2016
Naltrexone and acamprosate have a large body of evidence backing their effectiveness in treating alcohol addiction.



Last fall, Dr. Sheryl Spithoff and a group of like-minded addictions specialists got together to make a formal request to the Ministry of Health and Long-Term Care for a change that would significantly improve their addictions medicine practice: put two drugs long proven to effectively treat severe alcohol addiction on Ontario’s general Drug Benefit Program.

Naltrexone and acamprosate are available by prescription generally paid for out-of-pocket. The province covers the drugs in exceptional circumstances through an approval process that specialists believe is a barrier to care.

Getting a drug onto the general Ontario Drug Benefit plan is a process largely instigated by the pharmaceutical companies that apply for it. The province then reviews supporting evidence of the drug’s effectiveness to treat specific ailments and whether funding it publicly is cost effective.

As a doctor who works in both primary care and at an addictions practice at Women’s College Hospital in Toronto, Spithoff sees stark differences in the way addiction is treated in the two fields. For one, general practitioners are often not the ones to diagnose it in the first place, since medical school residencies don’t focus on addiction management. “They’re already not comfortable screening for and managing it in general,” she says. Second, and more specific to her specialty, is the relative discomfort and absence of knowledge general practitioners have about medications proven to help treat addiction to more common substances such as alcohol.

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While the spectrum of alcohol addiction is wide, statistics suggest its effects on both Canada’s population and its health care systems also run deep. Statistics Canada estimates social costs such as health care and lost productivity associated with alcohol abuse totalled $14.6 billion in 2002; all costs associated with impaired driving totalled $20.2 billion from 2000 to 2010. As the health care website Healthy Debate noted last year, 40 per cent of Canadian adults reported drinking above and beyond the national low-risk guidelines in 2015, and alcohol has been cited as a factor in at least seven per cent of premature deaths annually in the country.

While a number of medications have proven useful in helping people recover from alcohol use disorders in the past few years, naltrexone and acamprosate have the largest body of evidence backing their effectiveness. Tara Gomes, a researcher at the Ontario Drug Policy Research Network at St. Michael’s Hospital in Toronto, says that with evidence available at the time both medications were submitted for consideration and recommended to the Exceptional Access Program in the mid-1990s and 2007 respectively. The program helps patients obtain drugs not on Ontario’s drug benefit program. Since their initial development, says Spithoff, more clinical studies attesting to their usefulness in alcohol addiction treatment have become available.

The current status of these drugs creates a challenge: such medications require a weeks-long process to get funding for individual patients, and aren’t particularly cheap.

“It’s a little bit of a chicken and an egg,” says Gomes. “Right now it’s rarely used, so other drug companies haven’t started to produce it — so patients aren’t taking it.”

Naltrexone, which was originally developed as an opioid addiction treatment in the mid-1980s, has since shown to be effective in blocking the euphoric effect of alcohol on the brain. “People enjoy alcohol less,” says Dr. Spithoff, and as a result will often drink less alcohol in one sitting, or fewer times during the week. What makes it particularly helpful for severe addiction treatment is that it doesn’t require abstinence while being taken. On the other hand, acamprosate is more commonly prescribed after a patient has stopped drinking. Both medications, sold respectively as ReVia and Camprol, are taken in pill form and cost about $200 to $240 a month.

Even for patients able to afford the treatment, or who typically spend more than that amount per month on alcohol itself, prospects of a family doctor recommending pharmaceutical treatment for alcohol addiction are relatively slim. A 2015 study found that as little as 29 per cent of Ontario doctors felt knowledgeable enough in  addictions medicine to prescribe drugs for addiction treatment. Research co-led by Spithoff in that same year noted that only 36 of an identified 16,000 Ontario patients diagnosed with alcohol addiction were receiving publicly funded prescriptions for naltrexone or acamprosate. The treatment can last for six to 12 months, depending on the patient’s circumstances.

“What we usually find is that when people are doing well, they can come off the medication when other things have settled down in their life,” sometimes through counselling or therapy, she says. “They might have to address other things driving the behaviour in the first place. The medication is just to get them to a point where they don’t need or crave alcohol as much anymore.”

Spithoff currently has patients on naltrexone in both her family medicine and addiction specialist practices. At the latter, patients are mostly referred through family doctors. In both cases, if a patient can’t afford the monthly cost of pharmaceutical treatment, they must apply for coverage through the Ministry of Health’s Exceptional Access Program, which covers an approved list of drugs not included in Ontario’s Drug Benefit Program.

The application process involves a doctor meeting with the patient, filling out application forms on their behalf, ensuring they fit the Exceptional Access Program’s criteria for that particular drug (it requires, for example, that acamprosate patients have been alcohol abstinent for a number of days and be receiving psychological treatment), and waiting a couple of weeks for approval. For both medications, funding approval must be renewed every six months.

For both general practitioners and addiction specialists alike, this lengthy process is a treatment barrier. “In addictions [two weeks] is important. In that time someone can relapse and not come back and see me,” Spithoff says.

Dr. Bernard Le Foll, head of the Alcohol Research and Treatment Clinic at the Centre for Addiction and Mental Health and a professor at the University of Toronto, says one of the barriers in pushing for wider access to pharmaceutical treatments for alcohol dependence is also a misguided perception on the part of drug companies.

“It’s not seen as a big market, and some companies don’t want to be associated with the stigma of drug addiction,” he says, noting that the reality of the market — is that large populations of people could benefit from such drugs as a treatment — is quite the opposite. He also says much of the pioneering research on pharmaceutical approaches to treating alcohol addiction has been conducted by academic researchers as opposed to drug companies, partially because of this market misconception.

One example he mentions is topiramate (also known as Topamax), a medication developed to treat seizures. “Despite some clear evidence — we have several clinical trials that demonstrate its utility —[some] of the companies that market this product will not market it as a treatment for alcohol use disorder. The situation is likely to stay like this.” Le Foll says it’s possible that a pharmaceutical company will never ask for this to be covered by drug benefits.

What’s largely required on the part of both government and drug companies, Le Foll says, is a cultural shift in how the health care costs of addiction are perceived. “We’re still willing to invest money to treat the consequences of addiction,” he says. “We’ll pay hundreds of thousands of dollars for cancer or cardiovascular problems, but we could avoid large fractions of those costs if we could reduce the impacts themselves.”

Correction, May 6: A previous version of this article incorrectly stated that naltrexone doesn’t conflict with opioids if taken as an alcohol addiction treatment. The medication is, in fact, instructed to be taken with abstinence from opioid medication. TVO.org regrets the error.

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