The Society’s Position on Biosimilars
The Society strives to increase access to personalized, affordable and high-quality healthcare for those affected by MS. This is reflected in our mission statement: We will cure MS while empowering people affected by MS to live their best lives. Biosimilar medications approved by the FDA are safe and effective. As biosimilars are emerging within the DMT market, this can lead to an increase in access to affordable medicines, improve adherence and help contain healthcare costs.
The Society:
- Supports empowering people with MS to participate in shared decision-making with their provider
- Supports the implementation of rigorous and efficient pathways towards regulatory approval of biosimilar DMTs to accelerate and enhance approvability
- Supports improving communication, education and awareness efforts to enhance utilization of biosimilar DMTs
- Supports detailed notification and tracking by all pharmacists, providers and people with MS when biosimilar DMTs are administered and used
- Supports incentivizing the use of biosimilars through the creation of sustainable biosimilar DMT pricing policies, implementation of transparent insurance coverage guidelines and reimagining specialty formulary tiers
- Supports a healthcare system where everyone collaborates on strategies leading to early and ongoing treatment
Incorporating biosimilar DMTs into healthcare
Each person has a role in a patient-centered approach to incorporating biosimilar DMTs into patient care. Below is an outline of key responsibilities.
People living with MS:
- Review health plan options carefully
- Use trusted resources, such as the FDA, when researching information
- Track and share health changes, outcomes and treatment experiences with care team
Providers:
- Educate people living with MS about biosimilars, including the FDA approval process and the safety and efficacy of biosimilars
- Discuss barriers to starting a treatment and adherence with your patients
- Consider initial treatment with a biosimilar if an option of the appropriate biologic treatment exists
- Contribute to tracking and long-term pharmacovigilance data to better understand the implications associated with cross-switching among biosimilars
- Stay up to date with ongoing research of follow-on products and best practices in prescribing biosimilars
Pharmacists:
- Provide individualized education and support to people living with MS, including treatment option information, cost resources and resolution of coverage issues
- Direct people living with MS to reputable educational resources about biosimilars (i.e., the FDA, the National MS Society)
Policymakers:
- Remove access barriers to biosimilars for both providers and people living with MS
- Ensure that people living with MS receive cost-sharing protections for biosimilars, including but not limited to the use of financial assistance
Health plans:
- Provide advanced notification to both patient and providers before any formulary change
- Share cost information in a transparent manner
- Create formulary structures that result in out-of-pocket cost savings by people living with MS
- Implement policies that discourage frequent switching (i.e., cross-multiple-switching) between biosimilars
- Ensure policies do not require use of a reference product first before allowing access to the biosimilar for that reference product
Manufacturers:
- Label products clearly, indicating whether a biosimilar is interchangeable with the reference biologic
- State all indications for which a biosimilar is approved, specifying whether supporting clinical data for the indication are derived from studies of the biosimilar or the reference biologic
- Offer financial assistance programs
- Communicate clearly with the public and offer unbiased educational information
To report a side effect related to a medication, please use MedWatch, the FDA’s medical product safety reporting program.
If you are a person living with MS or carepartner to someone living with MS, connect with an MS Navigator Monday through Friday, 9:00 a.m. to 5:00 p.m. ET, at 800-344-4867. If you are a provider and have questions about biosimilars, email HealthProf_info@nmss.org. Additionally, you can reach out directly to the FDA at druginfo@fda.hhs.gov.
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