Implementing a Medication Switching Policy: Analysis of the Saskatchewan Biosimilars Initiative

Abstract

Key Messages

Brief Description of the Health Policy Reform

History and Context

Biologics are drugs that are produced with living cells and tissues, often with the use of advanced biotechnology (Health Canada 2022a). Biologic drugs, such as insulin, vaccines, and antibodies, are frequently used to treat a myriad of medical conditions, including anemia, diabetes, cancer, and inflammatory bowel disease (Health Canada 2022a). Compared to chemically synthesized drugs, biologics are more difficult to consistently manufacture, resulting in additional regulatory oversight by Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate (BRDD) (Health Canada 2022b). The BRDD reviews biologic drugs to ensure compliance with the requirements for market authorization for sale in Canada (Health Canada 2022b). Innovator biologic drugs authorized for sale are referred to as the “reference biologic drug” when subsequent entry biologics (SEBS) called “biosimilars” are later introduced to the Canadian market (Health Canada 2022c).

Biosimilars are biologic drugs that are structurally similar to a reference biologic drug already authorized for sale in Canada by the BRDD (Health Canada 2022c). Biosimilars are approved for sale by Health Canada after demonstrating comparable quality, efficacy, and safety to the reference biologic drug (Health Canada 2022c). Approved biosimilars are authorized for use for the same indication(s) as the reference biologic drug and therefore, per Health Canada, patients can safely switch between the reference biologic drug and biosimilars if indicated to treat the same medical condition (Health Canada 2022c). Biologics are expensive medications, accounting for $4.4 billion, or 29.4%, of total public drug program spending in 2022 (Canadian Institute for Health Information [CIHI] 2022). Therefore, a significant benefit of biosimilars is the reduced cost compared to the reference biologic drug. Biosimilars cost 15% to 50% less than the reference biologic drug (Government of British Columbia 2021).

Switching between reference biologic drugs and biosimilars is supported by literature and multiple bodies, both national and international. Several systematic reviews have demonstrated that switching between biologic drugs produces no differences in efficacy, safety, or immunogenicity (Barbier et al. 2020; de Oliveira Ascef et al. 2023). Switching between reference biologic drugs and biosimilars for various indications has been safely occurring in Europe since 2006 (Vogler et al. 2021). Subsequently, the European Medicines Agency and the Heads of Medicines Agencies produced a joint statement in support of the interchangeability of biosimilar medicines (European Medicines Agency and Heads of Medicines Agencies 2023). In Canada, switching between biologic drugs is supported by bodies such as the Arthritis Society of Canada and the Canadian Digestive Health Foundation (Arthritis Society of Canada 2020; Canadian Digestive Health Foundation 2021).

Switching between biologic drugs is not without concern. Patients report apprehension related to switching between biologic drugs, fearing destabilization of medical conditions (Chew et al. 2022). Accordingly, physicians are concerned that switching may negatively affect patients’ mental health (McClean et al. 2022). Pharmacovigilance concerns also exist due to a general lack of long-term evidence, particularly with multiple switches between biologic drugs (Allocati et al. 2022; Lasala et al. 2023).

Non-medical switching occurs when an individual stabilized on one medication switches to an alternative medication for a non-medical reason (Fleischmann et al. 2020). Governments may implement non-medical switching policies for economic reasons. With respect to biologics, by switching patients from costly reference biologic drugs to less expensive biosimilars, significant cost savings could result for provincial and territorial public insurance programs (Crosby, Tadrous, and Gomes 2020). Subsequently, medication switching policies for biosimilars have been implemented throughout Canada, with Manitoba, Nunavut, and Yukon currently existing as the only jurisdictions without a policy (Gastrointestinal [GI] Society 2023).

In 2019, British Columbia was the first jurisdiction to implement a biosimilars switching policy (Dormuth, Fisher, and Carney 2020). To monitor for unintended effects on patient health and/or utilization of health care services, a rapid monitoring plan was implemented with the biosimilar switching policy (Dormuth, Fisher, and Carney 2020). Data from the rapid monitoring plan demonstrated that the biosimilar switching policy generally produced few unintended negative effects. However, a non-permanent increase in the utilization of health care services occurred, attributed to medical appointments related to medication switching. Additionally, there were dose escalations for some medications, attributed to multifactorial causes beyond the switching policy (Fisher et al. 2022; Fisher, Kim, and Dormuth 2022a; Fisher, Kim, and Dormuth 2022b; Fisher, Kim, and Dormuth 2023).

Switching polices also exist internationally. To take advantage of cost savings associated with the use of biosimilars, European countries have implemented a variety of policies, including medication switching (Vogler et al. 2021). For example, pricing and procurement mechanisms to reduce biologic drug costs include price link policies, tendering, or reference price systems (Vogler et al. 2021). Additionally, demand-side measures to increase uptake of biosimilars include prescribing requirements and substitution policies (Vogler et al. 2021). Utilization of biosimilars in the United States is inhibited by Medicare reimbursement policies that encourage prescription of high-cost biologics, such as innovator products (Rome and Sarpatwari 2021). Therefore, internationally trained physicians in Canada will require familiarization with jurisdictional prescribing policies of biologic drugs.

On 20 October 2022, the Saskatchewan Ministry of Health Drug Plan and Extended Benefits Branch launched the SBI, a medication switching policy that included ten biologic drugs (Drug Plan and Extended Benefits Branch 2022b). At the time, Saskatchewan was the seventh Canadian jurisdiction to implement a medication switching policy. Patients using a reference biologic drug for any indication were advised that the switch to a biosimilar must occur by 30 April 2023 to maintain ongoing medication coverage (Drug Plan and Extended Benefits Branch 2023a). Patients could request an exemption to the initiative if the use of a biosimilar drug was considered not medically possible and ongoing use of the reference biologic drug was indicated (Drug Plan and Extended Benefits Branch 2023b). Medications included in the SBI were adalimumab (Humira), etanercept (Enbrel), enoxaparin (Lovenox), filgrastim (Neupogen), glatiramer (Copaxone), infliximab (Remicade), insulin aspart (NovoRapid), insulin glargine (Lantus), insulin lispro (Humalog), and rituximab (Rituxan) (Drug Plan and Extended Benefits Branch 2022b).

The launch of the SBI had opposition from multiple groups. Patients using reference biologic drugs expressed concern that switching to a biosimilar would result in a resurgence or destabilization of their medical condition (Patterson 2023). Both Diabetes Canada and Crohn’s and Colitis Canada opposed the initiative, arguing that medication switching policies should not be implemented as they diminish shared decision-making between patients and prescribers (Crohn’s and Colitis Canada 2019; Diabetes Canada 2022). Conversely, the SBI received support from Arthritis Research Canada’s Scientific Director Emeritus Dr. John Esdaile, who highlighted the safety and efficacy of biosimilars compared to the reference biologic. Additionally, Dr. Esdaile commented that Saskatchewan should be able to implement a medication-switching policy following the success of a similar policy in British Columbia (Government of Saskatchewan 2022a). Similarly, Cheryl Koehn, the Founder and President of Arthritis Consumer Experts, provided support for the SBI as a means of ensuring the ongoing affordability of biologic drugs for individual patients and an opportunity to reinvest cost savings into the health care system to maintain and improve patient care (Joint Health Express 2022).

The Policy-Making Process

Institutions

Multiple components of the Saskatchewan government are involved with the coverage of medications through the provincial health insurance program. The Saskatchewan Ministry of Health supports several health-related programs and services for Saskatchewan residents (Government of Saskatchewan 2024b). Under the Ministry of Health, the Drug Plan and Extended Benefits Branch oversees the provision of coverage for medical and community services for Saskatchewan residents (Government of Saskatchewan 2024c). Medication coverage is provided to eligible patients by the Saskatchewan Drug Plan, the publicly funded provincial drug program (Drug Plan and Extended Benefits Branch 2023d).

The Saskatchewan Drug Plan provides coverage for medications listed on the Saskatchewan Formulary. Medications are added to the Formulary by the Minister of Health, who is advised by the Drug Advisory Committee of Saskatchewan (Drug Plan and Extended Benefits Branch 2024a). Additionally, certain medications are only covered by the Saskatchewan Drug Plan through the Exception Drug Status (EDS) program. Medications included within the EDS Program require confirmation of patient eligibility and approval by the Minister of Health before coverage is provided (Drug Plan and Extended Benefits Branch 2024a). Approval is granted to patients that meet the medication-specific EDS criteria for use.

The Saskatchewan Ministry of Health’s Drug Plan and Extended Benefits Branch, with consideration of the Saskatchewan Drug Plan, Saskatchewan Formulary, and EDS program, implemented the SBI. The biologic drugs included in the initiative were all listed within the EDS program prior to its implementation (Drug Plan and Extended Benefits Branch 2024b). Per the SBI, to maintain coverage for a biologic drug through the EDS program, patients must obtain a prescription for a biosimilar product by 30 April 2023 or apply for an exemption to use a reference biologic (Drug Plan and Extended Benefits Branch 2022b).

Interests

The mission of the Drug Plan and Extended Benefits Branch can be summarized as the promotion of citizen-centred service through rational and appropriate use of medications and extended benefits; the pursuit of value strategies such as low-cost policies, product listing agreements, standing offer contracts, and generic and drug pricing policies; and the provision of information to stakeholders and the public regarding policies, benefit assessments, and program utilization (Drug Plan and Extended Benefits Branch 2024c). The implementation of the SBI, as a means of producing cost savings while maintaining rational medication use, aligns with this mission.

In particular, the Saskatchewan Ministry of Health was interested in the potential for cost savings resulting from the implementation of the policy. Paul Merriman, the Health Minister at the time of the SBI’s implementation, announced that the policy would contribute to the overall sustainability of the Saskatchewan Drug Plan’s coverage of essential medications. Merriman stated that cost savings from the implementation of the SBI would be reinvested into the province’s drug plan to support access to other drugs and extended benefits (Government of Saskatchewan 2022a). The Saskatchewan Ministry of Health’s interest in identifying cost-saving strategies may have been influenced by growing expenses, totalling $457.1 million above projected in the 2021-2022 fiscal year (Government of Saskatchewan 2022b). Among other causes, the increased expenditures were attributed to prescription drug plan utilization pressures (Government of Saskatchewan 2022b).

Ideas

The literature has repeatedly demonstrated the potential cost savings associated with the use of biosimilars and medication-switching policies. A 2019 study that retrospectively analyzed Canadian drug store and hospital purchasing data of infliximab, insulin glargine, and filgrastim found that the current utilization of biosimilars saved $46 million in drug costs, but exclusive use of biosimilars could have saved up to $1 billion (Mansell et al. 2019). Similarly, an Ontario-based study estimated that non-medical switching of etanercept, infliximab, and adalimumab would save $645.9 million over three years (Gomes et al. 2021).

At the time the SBI was announced, the use of medication-switching policies were already implemented in Europe, the United States, and six other Canadian jurisdictions. Medication-switching policies were in existence in Europe by 2016 and real-world evidence suggests these policies increase drug access by improving affordability without significantly reducing medication safety or efficacy (Noce and Ernst 2018). As a result of biosimilar-switching policies in Europe, a 2020 report found that drug budgets were reduced by 5% since 2014 (Troein, Newton, and Scott 2020). In the United States, a 2021 report from the Association of Accessible Medicines found that cost savings resulting from biosimilar usage totalled $8 billion in 2020, with projected savings of $133 billion by 2025 (Association of Accessible Medicines 2021). Prior to the implementation of medication-switching policies across Canadian jurisdictions, the usage of the biosimilars infliximab, etanercept, insulin glargine, and filgrastim saved Canadians an estimated $93.9 million in 2018 (Patented Medicine Prices Review Board 2020). Recent data suggests that generic- and biosimilar-switching policies reduced drug costs by $171 million in 2021-2022 (Patented Medicine Prices Review Board 2023).

Implementation and Evaluation

Conclusion

Strengths, Weaknesses, Opportunities, Threats

References