A recent drug ad in the Globe and Mail raised eyebrows in the health-care community. The ad was created by a drug company called Amgen and questioned a government-initiated switch on a drug covered by the Ontario Public Drug Programs. The treatment is filgastim, a biologic drug that Amgen sells under the brand name Neupogen. Filgastim boosts white blood cells in patients undergoing chemotherapy. The OPDP – which covers people on social assistance and those over 65 – recently moved to add Grastofil to the covered drug list. It’s a generic-style version of the drug – what’s known as a biosimilar.
The OPDP decided that as of August 30, 2017, patients covered by the OPDP will be automatically given Grastofil unless they meet limited use criteria for Neupogen. Patients usually take the drug for about a week following a chemotherapy cycle, and under the new regulations, many patients would switch to Grastofil on their next cycle.
Amgen used the Globe and Mail ads to challenge the ODPD decision. The half-page ad read: “Health Canada recommends that a decision to switch a patient being treated with an original biologic drug to a biosimilar should be made by the treating physician in consultation with the patient. The impact to a patient of switching mid-treatment has not been well-studied with this biosimilar and patients may respond differently,” before going on to say that Amgen will make Neupogen available for free to people who are currently on it – but warning that “this is a short-term fix.”
Amgen said in a statement to Healthy Debate that while the company believes that biosimilars have a meaningful place in the health care system, “Our public service communication was in relation to a specific forced switch in treatment and was intended to put patient considerations first… Because biosimilars are similar but not identical to reference biologic drugs, it is Amgen’s belief that payors should ensure that physicians have the choice to prescribe medications that are in the best interest of their patients.”
With decisions like these, is it time for some counter-PR from the groups responsible for drug funding decisions – including CADTH and the provincial governments? Issuing press releases, buying advertisements, or offering plain language versions of decisions might all give the public a better sense of the rationale behind these switches.
Biosimilars an emerging issue
Canada has laws against direct-to-consumer advertising for drugs, but there are ways around this. The drug maker can name a drug in an ad, so long as it doesn’t mention what the drug is used for. Or, it can run an ad about a medical condition, so long as it doesn’t name the drug to treat it. That’s why ads that say things like “Viagra. Talk to your doctor” are legal.
The Amgen ad was unusual in that it was talking directly to patients about a recommended substitution. The government’s decision was based on a review of both drugs’ benefits and costs by the Canadian Agency for Drugs and Technologies in Health (CADTH), the national body that assesses both health technologies and drugs, including their cost-effectiveness.
Joel Lexchin, an emergency physician at the University Health Network, points out that while ads directed at the general public may be new, drug companies have been using similar tactics on physicians for decades. “In the 1970s, when generics started to be more widely used, you would see ads in medical journals from drug companies, warning doctors about the dangers of switching to generics. There was a general fear mongering campaign around their quality to doctors, and to politicians.”
Biosimilars are a bit more complicated than generics; because both biologics and biosimilars are made from living organisms, there is in fact a difference between the biologic version and its biosimilar replica. That makes substituting one for another more complex, though “it’s pretty well established that people can tolerate a certain amount of variability in the product that they’re getting, and still get the same results,” says Lexchin.
Like generics, there is a huge potential for savings here. Biologics are expensive: One common biologic for arthritis costs $1,800 a month. Biologics in general make up more than 14% of drug spending in Canada, and that amount is expected to grow substantially in the future. Biosimilars cost 20% to 30% less than the biologic drugs they replace. That’s a lot of money provincial governments and private drug plans could potentially save – and some drug companies could lose. “The companies are quite sensitive to biosimilars being used instead of the original,” says Lexchin. “That’s reflected in that [Globe and Mail] ad.”
Reaching the public
Summaries of all of CADTH’s decisions are available to the public and to practitioners, though they can be difficult for people without a medical background to understand. Other groups sometimes also weigh in on drug decisions, including Ontario’s Committee to Evaluate Drugs (they generally avoid overlap with CADTH recommendations.) The CED’s decisions are also available to the public, in more easily digestible summaries.
However, this is “a very passive approach to getting information to the general public,” says Brian O’Rourke, CEO of CADTH, adding that this is “an area that we’re starting to think about.”
Taking out counter-ads likely isn’t feasible, says O’Rourke. “It would be an extreme challenge for us to enter into a counter-PR approach with the pharmaceutical industry, just because of the cost associated with that,” he says. “We couldn’t compete with them. But I think there is probably an important role to play in getting our message out a little bit more comprehensively.”
Stirling Bryan, professor at the school of population and public health at UBC, and past-chair of the CADTH Health Technology Expert Review, says groups like CADTH are doing a good job of communicating to their primary audience: the groups that make funding decisions across Canada. But “maybe they need to start thinking about the public as an audience, too,” he offers.
Allan Grill, chair of the CED, believes the ideal way to spread a counter-message for politicized decisions is through a press release, ideally co-written by the HTA group that analyzes the drugs and by the provincial funder.
Lexchin believes that should go even further: “[I think these organizations should be] speaking to the public through press releases, websites – and also relevant patient groups, who often have much better communication routes to the individuals affected than governments do.”
Frank Gavin, a patient advocate who sat as a public member on CADTH’s Canadian Drug Expert Committee until last month, agrees. “There’s a huge need to demystify a lot of this,” he says, suggesting that every recommendation needs a plain-language version for the public, and that Health Canada might also play a role in talking about the safety of biosimilars.
In the U.K., the National Institute for Health and Care Excellence (NICE) does something similar. The institution both analyses drug decisions and makes the final call on funding. It informs the public about decisions through press releases to news organizations, their own blogs and newsletters, and they do outreach to stakeholders, such as charities organized around diseases.
Another option is to provide more general information about the process or about classes of drugs. Marc-Andre Gagnon, an associate professor at Carleton who specializes in the pharmaceutical industry, doesn’t think the public would want detailed explanations of these kinds of decisions around individual drugs, but says that there might be value in explaining and promoting the concept of opportunity cost around drugs. “We need to provide an overall rationale, for a system where people understand that drugs are only being reimbursed if they provide real therapeutic value, and if they are cost-effective,” he says.
O’Rourke says CADTH produced a document that explained generic drugs that was “very successful – it was one of our most downloaded products. I do think we have a role and could play an even greater role in getting some of that information out to the public, or out to patient groups.”
In New Zealand, PHARMAC, which makes decisions about which drugs are funded, has taken that stance. It offers general patient education around the process and the differences between, brand name drugs and generics, as well as biologics and biosimilars.
Any – or all – of these public communications projects could help counter the general feeling of the public that “government has made decisions to save money, and that care is being jeopardized” says Nav Persaud, a family physician and a member of the the CED – a feeling pharmaceutical companies are currently exploiting in their advertisements to the public. However, the public doesn’t have a very rosy view of pharmaceutical companies, either. “They are more skeptical about pharmaceutical companies than they are about government,” he says.
That means that “it is possible to counter these sorts of statements, and to gently point out that there’s a reason this company is saying this,” he says. “People are open to that.”
We just have to start saying it.
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Mark this case a clear FAIL. Health Canada and related agencies abdicated their responsibility to properly inform the public and allowed industry to manipulate and poison the biosimilar conversation. Physicians were pressured to stamp all of their biologic prescriptions with a Do Not Substitute order. Prestigious physicians wrote opinion articles disguised as evidence-based reporting that were published in medical journals advocating against substitution. And patient organizations, whether knowingly or not were parties to delivering mixed messages to patients by disseminating material and webinars produced and paid for by drug companies.
Worse still, its been reported that coercive marketing tactics by originators took advantage of many patients’ vulnerability while they were in hospital that directly interfered in and biased their treatment, resulting in the loss of their biologically naïve status and their right to choose a therapy most appropriate for them.
However, the Holy Grail of scientific evidence, such as The NOR-SWITCH Study, is now proving that biosimilars are equally effective in patients who switch.
So at this late stage of the conversation should regulators step in with a communications plan? It’s clear that fighting a rear guard action as a knee-jerk reaction would be costly and risky, both of which these bodies typically avoid like the plague.
As a warning against such an action, when the US Preventive Services Task Force (USPSTF) released its recommendations against routine prostate screening for healthy men, celebrity patients had already been lined up to challenge the population based recommendations. The result – millions of healthy men anxious that they’d lose access to screening stampeded into doctors’ offices demanding a PSA test.
It will be very easy to hijack government messaging. Tackling a well funded and subversive action, with a very restrictive communication model that government uses will only cause more problems. There is too much at stake here – we’re talking about BILLIONS of dollars and the impact on patient experience and health outcomes.
The answer: don’t wait until the sky is falling to engage with patients. We need a different approach from the get-go. Drug and treatment policy decisions can’t be made in the absence of the patient voice. All agencies involved in these decisions, and our policy leadership up to and including our federal Minister of Health, need to seriously re-evaluate and overhaul how patients and the public are being involved in health care decision-making. While intentions are well meaning, its clear from this example that current engagement practice isn’t effective in understanding the BILLION+ dollar impact of this issue.
I think it’s really about engaging the public in an informed discussion about medications, funding decisions, etc. I think you might be surprised that if presented with a complete picture, they might more fully understand and even support policy decisions made. But right now, the whole process is siloed, complex and difficult to understand to do this effectively.
Governments need to reach out to the patient communities affected by the Biosimilar and switching therapies. They know who they are as many have been providing input into drug reviews for a number of years. A dialogue about the treatments and the reasoning behind the policy would have most patients being comfortable with changing to the Biosimilar but no one has given patients the opportunity to be part of the decision making process, it’s about an informed choice and switch.