A temporary add-on payment in the Part B program should be considered as a way to increase biosimilar uptake, says Sandoz’s Afton Wagner.
2021 has been quite the year for the advancement of biosimilars and biosimilar insulin, in particular.
In addition to increased use of biosimilar insulins, the FDA in August approved Semglee (reference product Lantus), the first biosimilar and interchangeable insulin. That decision is expected to save the U.S. healthcare system hundreds of millions of dollars from 2020 to 2030, Akash Patel, a pharma analyst for GlobalData, told Managed Healthcare Executive in an interview in August.
Afton Wagner, Pharm.D.,director of federal policy for Sandoz, and one of the authors of a recent Journal of Managed Care & Specialty Pharmacy article on biosimilar insulins, spoke with MHE recently about the importance of the Semglee decision and other biosimilar insulin developments this year. Sandoz has candidate biosimilars for insulin aspart (Rapilin) and insulin glargine (Basilin) under development.
What is the significance of FDA's approval of the first biosimilar and interchangeable insulin to Lantus this year?
Biosimilar insulins can promote competition, potentially decreasing both drug and health care costs and increasing patient access. Having the first biosimilar insulin in the US introduces more competition, which is in line with the intent of (CMS’) Bundled Payments for Care Improvement Advanced (BPCIA) and biosimilar pathway.
In the JMCP article you addressed the ability to switch between reference and biosimilar insulins, and how some believe there is an increased risk of immunogenicity. However, you noted that no data demonstrate this risk. Can you expand on this?
Clinical and real-world studies have shown that patients can effectively and safely switch from a reference biologic to a biosimilar. Insulin, specifically, has decades of clinical experience showing low or no risk of immunogenicity from the use of insulin products. Despite this evidence, misinformation is still a very real barrier to the widespread adoption of biosimilars.
As we continue to see trends in post-marketing surveillance and real-world data emerge on the safety and efficacy of biosimilars, awareness and accurate information sharing will be critical to increasing access to and adoption of biosimilars. Educating and combating misinformation among healthcare providers, payers and patients is an important step to encourage biosimilar adoption in all therapeutic areas, including insulins.
What kind of cost savings do you expect from biosimilars?
As more biosimilars enter the US market, an estimated 1.2 million US patients could gain access to biologics by 2025. In addition to treating more patients, the US healthcare system has the potential to benefit from cost savings from biosimilars. A recent report found that biosimilars more than tripled their savings in 2019 to 2020 from $2.5 billion to $7.9 billion. Additional data anticipates that biosimilars, if widely adopted, will generate as much as $183 billion in savings by 2025.
What needs to change in federal policy, as well as with Medicare and private insurers, to ensure increased access to biosimilars and biosimilar insulin?
Focused, commonsense polices that incentivize the use of biosimilars are key to maximizing patient access and savings from these life-changing medicines.
While a combination of policies would be ideal to improve adoption of biosimilars, a few rise to the top as the most effective. Policies at a federal and state level must ensure that all biosimilars are included on formularies and not disadvantaged by products with the interchangeable designation.
In Medicare Part D and Medicare Advantage, regulatory guidance from the Centers for Medicare and Medicaid Services (CMS) is needed to encourage the coverage of biosimilars on formularies.
Removing utilization management hurdles and eliminating or reducing patient cost sharing also have the potential to reduce barriers to biosimilar adoption, especially as we will see a larger number of biosimilars covered under the Medicare Part D pharmacy benefit and in commercial plans in the next few years.
In Medicare Part B, policymakers should authorize a temporary add-on payment to increase healthcare providers’ utilization of biosimilars.
What else is important to note about biosimilars?
In the coming years, increased stakeholder support and advocacy for policies that promote greater adoption will be crucial for improving the lives of patients around the world. Biosimilars, including biosimilar insulins, play an important role in enabling more patients to access biologic medicines and may offer significant savings for patients, helping to alleviate overburdened healthcare systems.