Originator and Biosimilar Biologic Medications: Understanding the Changes to ODB Coverage in Ontario and How to Support Patients

Background on Biologics and Biosimilars

Biosimilars are not new to Canada and we have learned much about them since the first biosimilar was marketed in 2009 (somatropin). Check out the Pharmacy Connection article “Biosimilars and Biologics: Navigating the Uncertainty in Ontario” for background information on originator and biosimilar biologics.

Ontario Drug Benefit’s Biosimilar Switching Policy

Ontario has joined other provinces and territories across Canada to implement a biosimilar switching policy. Between March 31, 2023, and December 29, 2023, the Ontario Drug Benefit (ODB) program will start transitioning coverage for certain medications to their biosimilar versions.

As new biosimilars enter the Canadian market, the Ministry of Health indicated that these biosimilars and their corresponding originator biologic medications may also be included as part of the policy change. The policy is driven by data from years of experience with the use of biosimilars and to support a sustainable drug system where cost savings realized by the switch can be reinvested into the healthcare system to fund more new drug therapies.

While the majority of patients can be transitioned successfully and safely, medically necessary exemptions to this policy may be considered through the Exceptional Access Program (EAP) on a case-by-case basis. These exemptions include patients who have tried at least two biosimilars (or the only existing biosimilar) of the originator biologic.

Pharmacists have an important role to provide patients with reliable information and to answer any questions and concerns about the transition. Details about the process for switching and supports available to pharmacy professionals to transition patients over can be found in the Executive Officer Notice: Biosimilar Policy and the Questions and Answers for Pharmacists

Interchangeability of Biologics in Ontario

The authorization of a biosimilar by Health Canada is not a declaration of bioequivalence to the originator/reference biologic drug. Each province and territory must deem that two products are interchangeable based on their own rules and regulations. In Ontario, biosimilars are not deemed to be interchangeable with the originator/reference biologic nor are they interchangeable with other biosimilar products. Therefore, a prescription must clearly identify the brand (originator or biosimilar) along with the generic name of the product to ensure a safe and efficient process for dispensing.

A pharmacy staff who receives a prescription for a biologic drug where a biosimilar biologic exists must clarify with the prescriber the intended product for use. Without this information readily available on the prescription, a patient may risk unnecessary delays with treatment initiation. An example of this is the use of filgrastim for the prevention of febrile neutropenia with systemic treatment (chemotherapy).

Within a hospital, a Pharmacy & Therapeutics Committee may recommend a substitution policy where a biosimilar biologic may be used when a biologic drug is indicated. The substitution policy serves to reduce the number of drug products on a Formulary for various reasons and is ultimately a decision by a hospital with buy-in from prescribers.

Patient Scenarios

Patient 1: Taylor

Taylor has been using pegfilgrastim for the past two cycles after dose-dense chemotherapy for early-stage breast cancer. They bring in a prescription to your pharmacy for pegfilgrastim (Lapelga®) 6 mg subcutaneous but you only see pegfilgrastim (Fulphila®) in the fridge. Can you dispense pegfilgrastim (Fulphila®)?

In Ontario, biosimilar products are not interchangeable with one another or with the originator biologic product. Therefore, pegfilgrastim (Fulphila®) cannot be interchanged with pegfilgrastim (Lapelga®). Instead, there are a couple options that a pharmacist can consider:

As this drug is used to prevent febrile neutropenia after chemotherapy treatment, it is important to clarify when the patient received their last treatment. If chemotherapy was given within the past 24 hours, the patient urgently needs pegfilgrastim as the window to use this drug in a dose-dense regimen is only 24-48 hours. A call to the Oncology or Systemic Therapy Clinic is warranted immediately. It is important not to delay the start of pegfilgrastim so clinical judgement is needed with appropriate documentation and notification to the prescriber, if the pharmacist cannot reach the prescriber in a timely manner.
The pharmacist may want to discuss with the prescriber if a substitution policy is acceptable, particularly if a drug shortage exists.

Patient 2: Kim

Kim currently has stable disease with the use of adalimumab (Humira®) 40 mg subcutaneous once every other week for rheumatoid arthritis. She presents to your pharmacy for a prescription refill which is on time with two refills remaining. She has ODB coverage. How do you proceed?

Kim has coverage for adalimumab (Humira®) 40 mg subcutaneous for rheumatoid arthritis and would be subject to the biosimilar switching policy. The pharmacist should proceed to:

Discuss with Kim her understanding of biosimilars and the switching policy in Ontario
Provide education and address any concerns and questions that Kim may have to help her confidently transition to a biosimilar product; schedule a follow-up appointment if required
Contact the prescriber for a new prescription for an appropriate biosimilar of Humira®
Dispense the biosimilar product and claim the Biosimilar Support Fee through ODB

Patient 3: Basim

man pricking his finger for diabetes test

Basim was recently diagnosed with type 2 diabetes. He brings in a prescription for insulin glargine (Basaglar®) 10 units subcutaneous every night. He has ODB coverage. How do you proceed?

Basim was recently diagnosed with type 2 diabetes and is therefore considered treatment-naïve. The pharmacist should proceed to:

Provide education and address any concerns and questions so that Basim can confidently start the biosimilar product insulin glargine (Basaglar®) 10 units subcutaneous every night; schedule a follow-up appointment if required
Dispense the biosimilar product (note that the pharmacist is not entitled to claim the Biosimilar Support Fee in this case as the patient is not transitioning from an originator biologic)

Education for Patients and Healthcare Providers

When the European Medicines Agency (EMA) introduced the first biosimilar in 2006 (human growth hormone somatropin), an emerging theme that came to the forefront was the importance of education for healthcare providers and patients (Oskouei ST, 2021). A similar theme was noted in Canada. In February 2014, the Canadian Rheumatology Association surveyed its members and found that in a treatment-naïve patient who would benefit from a biologic (where cost was not an issue), 72% of clinicians would be unlikely, or very unlikely to select a biosimilar as initial therapy (Grabowski D, 2015).

Similarly, at the Ontario Health-Cancer Care Ontario’s (OH-CCO) Biosimilar Summit in 2018, participants highlighted the importance of educating healthcare providers first to ensure that information provided to patients is consistent and evidence-informed. Patients place a lot of trust in their healthcare providers and a lack of confidence on the providers’ side can impact patients’ confidence in biosimilars. The lack of knowledge or confidence regarding biosimilars continues to serve as a barrier to adoption (Cohen HP, 2020).

Education for patients and their caregivers is also important to minimize the nocebo effect which can negatively impact the perception of a biosimilar’s efficacy and safety (Colloca L, 2019; Kristensen LE, 2018). This phenomenon is documented in the literature and can also negatively impact the uptake of biosimilars. Education for patients should be clear and concise while taking into consideration their health literacy. Selected resources for pharmacists and patients include:

The Leslie Dan Faculty of Pharmacy, in collaboration with OH-CCO, recently launched two new courses on biosimilars. The courses are hosted on edX and are delivered as massive open online courses (MOOCs).
- Foundations of Originator and Biosimilar Biologics: For Patients and Caregivers, which launched on April 25, 2023, focuses on providing education for patients and caregivers but is also appropriate for students and healthcare providers who may want to get a basic understanding of originator and biosimilar biologics.
- Advanced Knowledge and Skills of Originator and Biosimilar Biologics: For Health Care Providers, which starts on May 30, 2023, focuses on healthcare providers and aims to enhance knowledge and communication skills.
- Two streams are available: Audit, which is free of charge, and Professional Certificate, which provides CE credits and is offered for $200.
Health Canada recently published the Handbook for Healthcare Professionals on Biosimilar Biologic Drugs. This resource addresses the regulation of biosimilars in Canada including monitoring for safety and effectiveness, access and uptake, communication strategies and also includes case studies to further enhance learning.
As part of the OH-CCO’s pan-Canadian Oncology Biosimilars Initiative, the Education Working Group developed various resources for patients and healthcare providers. Ontario Health also developed a disease agnostic resource for the healthcare community.

As there are likely many resources available on the internet, it is important to ensure that the information provided to patients and caregivers is evidence-informed and consistent amongst all healthcare providers.

References

Biosimilar biologic drugs in Canada: Fact Sheet. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/fact-sheet-biosimilars.html Accessed April 26, 2028.

Cancer Care Ontario. Position Statements for the Implementation of Oncology Biosimilars from the pan-Canadian Clinical Operations Working Group, August 2019. Available at: https://www.cancercareontario.ca/en/guidelines-advice/types-of-cancer/60296. Accessed April 26, 2023.

Cohen HP, McCabe D. The importance of countering biosimilar disparagement and misinformation. BioDrugs. 2020;34(4):407–414. doi: 10.1007/s40259-020-00433-y.

Colloca L, Panaccione R, Murphy TK. The clinical implications of nocebo effects for biosimilar therapy. Front Pharmacol. 2019;10:1372. doi: 10.3389/fphar.2019.01372.

Health Canada’s Handbook for Healthcare Professionals on Biosimilar Biologic Drugs, 2023. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/biosimilar-biologic-drugs/handbook-healthcare-professionals.html. Accessed April 28, 2023.

Grabowski D, Henderson B, Lam D, Keystone EC, Thorne C, Jamal S, et al. Attitudes towards subsequent entry biologics/biosimilars: a survey of Canadian rheumatologists. Clin Rheumatol. 2015;34(8):1427–1433. doi: 10.1007/s10067-014-2835-4.

Kristensen LE, Alten R, Puig L, Philipp S, Kvien TK, Mangues MA, et al. Non-pharmacological effects in switching medication: the nocebo effect in switching from originator to biosimilar agent. BioDrugs. 2018;32(5):397–404. doi: 10.1007/s40259-018-0306-1.

Ministry of Health Biosimilar Policy: Q&A for Pharmacists, March 10, 2023. Available at: https://www.health.gov.on.ca/en/pro/programs/drugs/opdp_eo/notices/exec_office_eligibility_20230310.pdf. Accessed April 26, 2023.

Oskouei ST, Kusmierczyk AR. Biosimilar Uptake: The Importance of Healthcare Provider Education. Pharmaceut Med. 2021 Jul;35(4):215-224. doi: 10.1007/s40290-021-00396-7. Epub 2021 Aug 22. PMID: 34420201; PMCID: PMC8421278.