…Cassels from p.5
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ing better treatments for hepatitis C has long been in the industry’s sights. As to how well the drug performs, I turned to the Oregon Health and Science University, which issued an assessment on Sovaldi this past May. Visit www. ohsu.edu/xd/ Search for sofosbuvir and then Click on Medical Evidence Based Decisions and scroll down to Sofosbuvir for the Treatment of Hepatitis C. This report reminds us that only about five to 20% of the people infected by hepatitis C will ever go on to develop liver disease. About 1-5% of those will die of cirrhosis or liver cancer. It’s a slow growing disease and up to 25% of those infected will clear it spontaneously. When the Oregon folks looked for all available research on Sovaldi, they found 10 studies, all of which were considered to have “a high risk of bias.” In fact, none of the studies could really apply to the real world and only one compared Sovaldi to a comparative drug currently used. Nor were the patients in the studies really representative of ‘real world’ patients – healthier, mostly white, etc. – who would likely use the drug and because Sovaldi wasn’t compared against the standard triple therapy used now, we can’t really say for sure if it’s any better than what is currently used.
If you have private insurance through your employer, get ready to pay a whopping big increase in your premiums. As for long-term effects or harms involved in the new treatment, the reviewers noted the Sovaldi studies weren’t big enough or long enough to see if it made much of a difference. The worst part is many of the studies were designed in a way that left the manufacturer, Gilead, in charge of monitoring adverse effects. We know this leads to under-reporting and as one commentator noted, “Reporting of adverse events is often incomplete.” One of the most prominent studies of Sovaldi found that about 3% of patients experienced severe adverse effects, compared to 1% of comparable patients taking peg-interferon. The group Adverse Events, which tracks side effects of drugs, said, “There really was no clear evidence that Sovaldi was really a miracle drug.” In other words, it couldn’t cure most people with fewer side effects compared to what is currently used. But what to do about the thousands of hepatitis C patients clamouring for the new drug because the hype around the $1,000 pill has been so extraordinary? While threatening to make many capitalists rich – including the CEO of Gilead who will be a billionaire according to Bloomberg. Visit www.bloomberg.com and search for Gilead CEO becomes billionaire – it will make the rest of us a little poorer. Do we need to be treating people who carry the hepatitis C virus? Some, absolutely. Do we need to be bankrupting our health care system to do so? Absolutely not. The drug has been approved in Canada and so far only Quebec has agreed to pay for it. The other provinces are still trying to figure out what to do. If you have private insurance through your employer, get ready to pay a whopping big increase in your premiums next time you renew the policy. Here at home in BC, our provincial Drug Benefits Council, whose job is to advise the government on funding decisions, is hearing from physicians, patients, caregivers, patient groups and, of course, the manufacturers. If you have an opinion, maybe you’d like to weigh in (Google: Pharmacare, Your Voice) and you can join the likes of HepC BC, the local hepatitis C advocacy group supported by at least six drug companies, including Gilead, the maker of Sovaldi. We should never be so naïve as to think this is an unbiased process. What should insurers do in the face of such potential calamity? Not an easy answer, but the best place to start is by doing what any good drug plan in the world does: play hardball with the manufacturers on price and limit coverage to only those very few patients for whom there is evidence of effectiveness and for whom it is working. And refuse to see yourself as a hostage. Will we let a single drug destroy Canada’s drug insurance system? We could or we could act rationally and make the tough decisions we need to ensure we all have the insurance we need to keep us healthy. j Alan Cassels is a drug policy researcher in Victoria. You can follow him on Twitter @AKECassels.
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common ground
July 2 014