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.