Canada’s province of Alberta is planning to stop coverage of originator biologicals and switch patients to biosimilars for certain indications.
The new policy, if introduced, will apply to the approximately 30,000 patients in Alberta living with inflammatory bowel disease (IBD).
A similar policy was introduced in British Columbia (BC) in May 2019. Rheumatology patients in BC will have six months – until 25 November 2019 – to switch from the originator biological (Enbrel) to the etanercept biosimilar (Brenzys or Erelzi). After that time, the province’s healthcare system, PharmaCare, will no longer provide coverage for the originator biologicals for these indications, except for exceptional cases [1].
However, concerns have been raised in Alberta about the safety of such a policy to switch patients stable on their current treatment. Following a campaign of letter writing to Alberta’s government, the province’s Health Minister, Tyler Shandro, met with stakeholders on 19 November 2019.
Dr Remo Panaccione, an internationally recognized expert in IBD at the University of Calgary, urged the minister to change his mind. Dr Panaccione believes that the switch could cause patients to relapse and even put their lives at risk. He said that ‘we know from research over the last seven years that switch can harm patients. It does not harm all patients, biosimilars are good drugs. But anywhere between 20 to 30 per cent of patients in the first year may have an adverse effect’. However, the office of the Health Minister rejects the claim that biosimilars put patients’ lives at risk, saying ‘it's not warranted by the evidence from BC or other jurisdictions. All drugs have a risk of rejection by some patients; we’ll consider how to apply any change in coverage to specific groups of patients based on the evidence’.
Mina Mawani, President and CEO of Crohn’s and Colitis Canada, which was behind the letter-writing campaign, says there has not been enough research to make a major change like this. She added that patient are fearful and that ‘there’s been a lack of information, lack of consultation, lack of education and a lack of research on what happens when you’re switched’.
The Canadian Biosimilars Forum and Green Shield Canada, on the other hand, publicly commended the BC government for announcing that it will implement biosimilar transitioning. They pointed out that ‘biosimilars have been used across Europe for more than a decade and at present, 13 countries support policies to implement biosimilar transitioning. This form of policy has been supported by scientific literature as being safe and effective. It can improve access to medicines by vastly reducing healthcare spending through replacing the use of reference biologicals with cheaper biosimilars’ [2].
There is also growing evidence on the safety of transitioning patients to biosimilars. One example of such strong evidence is the Norwegian NOR-SWITCH study, which found that there was ‘no difference in disease worsening between patients that transitioned to the biosimilar compared to those that continued treatment with the originator biological’ [3, 4]. While a study published by researchers from Denmark also found that switching from originator to biosimilar infliximab had ‘no negative impact on disease activity’ [5].
A major driver for switching to biosimilars is cost. The office of Alberta’s Health Minister said that in the past decade the province’s spending on biologicals has increased from around CA$20 million per year to more than CA$200 million.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Canada’s British Columbia to switch patients to biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Policies-Legislation/Canada-s-British-Columbia-to-switch-patients-to-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Praise for Canada’s BC after it adopts biosimilar transitioning policy [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Policies-Legislation/Praise-for-Canada-s-BC-after-it-adopts-biosimilar-transitioning-policy
3. GaBI Online - Generics and Biosimilars Initiative. NOR-SWITCH study finds biosimilar infliximab not inferior to originator [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Biosimilars/Research/NOR-SWITCH-study-finds-biosimilar-infliximab-not-inferior-to-originator
4. Perks B. Randomized non-inferiority trial fails to find inferiority switching from infliximab originator to CT-P13 biosimilar. Generics and Biosimilars Initiative Journal (GaBI Journal). 2017;6(4):188-9. doi:10.5639/gabij.2017.0604.042
5. GaBI Online - Generics and Biosimilars Initiative. Danish infliximab switching study shows no difference [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Nov 22]. Available from: www.gabionline.net/Biosimilars/Research/Danish-infliximab-switching-study-shows-no-difference
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