Over the past few decades, biologic drugs have gradually been added to physicians’ therapeutic armamentarium. In the past five years, more than 60 of these new drugs have been marketed in Canada to treat a variety of serious and disabling illnesses including diabetes, immune system disorders and even cancer.
Their arrival on the market is very good news for patients as these medicines, often prescribed as a last line of treatment when other therapies have failed, keep them active and help to significantly improve their health conditions and quality of life.
However, because biologic drugs are produced from living cells rather than by chemical synthesis, the development and manufacturing processes involved are considerably more complex and, therefore, more expensive than for traditional drugs. Quality control is even more critical and complications in production potentially more catastrophic. Unlike traditional medicines, reference biologic drugs cannot be identically reproduced. Health Canada allows drugs called “biosimilars” to enter the market only after the patent on the original version of the drug has expired and the similarity of the two products in terms of both safety and efficacy has been established.
In an effort to lower pharmaceutical spending, provincial governments have recently implemented programs to artificially promote market access for these biosimilars. British Columbia set a precedent in May 2019 by becoming the first province to introduce a mandatory biosimilar switching program for non-medical reasons. Alberta will go even further. As of Jan. 15, 2021, adult patients who require a biologic medication for the first time will have to begin their therapy with a biosimilar as originators will be delisted.
Is non-medical switching well advised?
Quebec’s Institut national d’excellence en santé et services sociaux (INESSS) conducted an exhaustive literature review at the beginning of the year on the impacts of mandatory biosimilar switching policies. This review highlighted that for certain populations or certain therapeutic fields “very little or no data are available on the safety of switching a biological drug.” It urges decision-makers to be cautious by reminding that mandatory switching for non-medical reasons is generally not accepted by scientific societies and clinicians. It fears that patients who have few treatment options and whose condition is complex may be destabilized.
In the vast majority of European countries, the decision to change a patient’s medication to a biosimilar is made by the treating physician. Changing a patient’s medication to a biologic therapy for strictly economic reasons is not authorized except in a few countries. It is accepted that treating physicians are better able to assess the needs and health conditions of their patients and to prescribe the drugs most likely to adequately address them.
Mandatory switching for non-medical reasons ignores the fact that not all patients respond in the same way to medications and can lead to additional costs to healthcare networks. In Denmark, where a biosimilar switching program has been set up, researchers recently showed that healthcare use (+8 per cent) and total healthcare costs (+7 per cent) have increased for patients with chronic inflammatory diseases (treated with etanercept). A previous study by the same researchers showed that 45 per cent of the patients followed had increased healthcare use after the switch of infliximab with the biosimilar. On average, the number of service days per patient increased by 7.4 per cent after the mandatory drug switch.
The cost savings that can be generated by biosimilar drugs are also not assured when they require higher doses to achieve the same clinical endpoints. This was highlighted by Italian researchers who compared two groups of patients with renal failure requiring hemodialysis treatments. Patients who switched to the biosimilar had to receive doses an average of 40 per cent higher than those who stayed on the original biologic drug.
Unsurprisingly, patients generally prefer personalized treatment and oppose mandatory switching. Canadian researchers surveyed patients with gastrointestinal diseases and their caregivers to determine their views on the use of biologic and biosimilar drugs. Of the patients surveyed, 95 per cent said they thought it was important that the decision on the right choice of medication be determined solely by their treating physician, in collaboration with them.
Are pharmaceutical expenses out of control?
In the field of pharmaceuticals, decision-makers implementing public policy must strive to find the ideal balance between encouraging innovation and rapid access to new cutting-edge medicines and ensuring the financial sustainability of drug insurance plans.
According to some sources, this delicate balance is about to be broken as increasing availability of the more expensive biologic drugs is compromising the ability of insurance plans to meet the associated increase in costs. But is this indeed the case?
Despite the increasing availability of biologics in Canada, the growth in total pharmaceutical spending has actually slowed over the past several years. Taking inflation into account, real per capita drug expenditures have grown at an average annual rate of just 0.2 per cent in Canada since 2015 and have actually declined by 0.4 per cent in Quebec. In addition, the share of gross domestic product (GDP) devoted to prescription drug spending is also declining in Canada, going from 1.7 per cent in 2010 to 1.5 in 2019. Even in Quebec, where prescription drug spending has surpassed that of the rest of Canada for the past 20 years, these expenditures now represent a smaller share of provincial GDP in 2019 (1.9 per cent) than in 2010 (2.2 per cent).
Ultimately, the advent of biosimilars can be seen as good news for patients and physicians when it increases the range of treatment options available to them and encourages healthy competition between manufacturers.
Where reference biologics and biosimilars are allowed to co-exist without favouring one to the detriment of the other, price reductions are observed for all products. Negotiating agreements with manufacturers is also a good way to generate savings for governments without restricting choice for doctors and patients. However, government policies that force biosimilar switching for non-medical and strictly economic reasons may ultimately undermine competition, increase total healthcare costs and act as a barrier to innovation and future access to new biologic drugs for all Canadians.