The Canadian ideal of universal healthcare isn’t all it’s cracked up to be for the estimated 80,000 – 100,000 Ontarians living with chronic hepatitis B. For many of these patients, getting access to the most effective treatments to delay the progress of their disease is impossible – the drugs are expensive and they’re not covered by the province.
Hepatitis B is a disease that attacks the liver and can lead to cirrhosis, liver transplants or even liver cancer. It’s a complicated condition to treat, but research advances have led to a range of new antiviral medications that can be used to stop the progression of the disease and prevent complications.
In fact, clinical practice guidelines (which physicians use to determine the recommended course of treatment) advise that a wide range of treatment options are needed to effectively control the disease in all patients. Different responses and the development of resistance to the antiviral medication means that all possible options need to be available. Unfortunately, one size does not fit all!
The Ontario government has decided not to heed the advice of Canadian and international experts regarding the availability and use of treatments for hepatitis B. Ontario’s Drug Benefit Program (ODB) only covers the cost of the older and less effective treatments.
The problem? An estimated 75 per cent of patients develop resistance to those drugs within five years, and for those with higher viral loads (levels of virus in their body), resistance develops even sooner. When resistance develops the drug is no longer effective, and the disease progresses. By contrast, the most potent of the new drugs result in resistance in only 1.9 per cent of patients within five years. The newer medications are also 100 to 1000 times more effective at controlling the virus and preventing disease progression.
An institution called the Common Drug Review (CDR) makes recommendations to the provinces about which drugs they should pay for and which are too expensive or not effective enough. The CDR has recommended two of the new hepatitis B drugs be paid for, but with restriction. Most provinces will follow suit. Ontario, however, has ignored the reality that using an inferior drug that is associated with a high rate of resistance is bad medicine. This would never be contemplated in patients with HIV or TB or a bacterial infection. Secondly, the strategy recommended by CDR - of waiting until a patient is resistant to a drug and has possibly developed serious complications - is actually the most expensive of all possible strategies.
So far the Ontario government has not approved even the limited access that CDR recommends. Why is this? It’s hard to say. The B.C. government recently moved to improve access to treatments for hepatitis B, and Quebec also offers a more diverse range of treatments to its residents. Ontario seems to acknowledge that there might be an issue with current treatment options as the province decided to approve reimbursement for a treatment for hepatitis B patients resistant to currently approved medications. However, the drug is not yet licensed for use in hepatitis B, has no long-term efficacy data to support its use, and has an unknown rate of resistance over the long-term. The province chose this agent instead of another medication, that is more expensive, but which is licensed, has considerable experimental data available that indicates the best way to use this drug, and which, when used properly has good long term efficacy.
Some have argued that the newer drugs are “me too” drugs, with equivalent efficacy. Under these circumstances the increased price is not justifiable. However, this is not the case for these new medicines. They represent a quantum increase in our ability to control this disease. It’s time that the Government of Ontario steps up to the plate and recognizes that patients with chronic hepatitis B are at risk of dying from their disease and that this can be prevented by good treatment. These patients have a right to the best treatments available to manage the disease and save lives, just as is the case for patients with HIV, hepatitis C, diabetes or other chronic diseases. Failure to provide access to good care for these patients is discriminatory. Physicians and patients are tired of making decisions between the best treatment and the treatment the province is willing to pay for.
Dr. Morris Sherman is a clinical hepatologist at the University Health Network, Toronto; Associate Professor or Medicine, University of Toronto; and Chairman of the Canadian Liver Foundation Medical Advisory Committee.
