Sandoz executive discusses cost savings with biosimilar insulins and challenges


2021 has been quite a 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 (Lantus reference product), the first biosimilar and interchangeable insulin. The move is expected to save the U.S. healthcare system hundreds of millions of dollars from 2020 to 2030, said Akash Patel, pharmaceutical analyst for GlobalData. Senior health 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, interviewed SME recently on the importance of the Semglee decision and other biosimilar insulin developments this year. Sandoz has biosimilar candidates for insulin aspart (Rapilin) ​​and insulin glargine (Basilin) ​​in development.

How significant is the FDA approval of the first biosimilar and interchangeable insulin to Lantus this year?

Biosimilar insulins can promote competition, potentially lowering 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) Pooled Payments for Improved Advanced Care (BPCIA) and the biosimilar pathway.

In the JMCP article, you touched on the possibility of switching between reference insulins and biosimilar insulins, and how some believe there is an increased risk of immunogenicity. However, you noted that there is no data to demonstrate this risk. Can you expand further on this topic?

Clinical and actual studies have shown that patients can effectively and safely switch from a reference biologic to a biosimilar. Insulin, in particular, has decades of clinical experience showing little or no risk of immunogenicity resulting from the use of insulin products. Despite this evidence, misinformation remains a very real barrier to widespread adoption of biosimilars.

As we continue to see trends in post-market surveillance and real data emerging on the safety and efficacy of biosimilars, raising awareness and sharing accurate information will be key to increasing access and uptake. biosimilars. Educating and combating misinformation among healthcare providers, payers and patients is an important step in encouraging the uptake of biosimilars in all therapeutic areas, including insulins.

What kinds of savings do you expect from biosimilars?

As more and more biosimilars enter the US market, it is estimated 1.2 million American patients could have 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 from 2019 to 2020, from $ 2.5 billion to $ 7.9 billion. Additional data predicts that biosimilars, if widely adopted, will generate savings of up to $ 183 billion 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?

Targeted and sensible policies that encourage the use of biosimilars are essential to maximize patient access and the savings from these life-changing drugs.

While a combination of policies would be ideal for improving the uptake of biosimilars, a few rise to the top as the most effective. Federal and state policies should ensure that all biosimilars are included on the formulas and are 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 coverage of biosimilars on forms.

Removing barriers to managing use and eliminating or reducing cost-sharing by patients also has the potential to reduce barriers to biosimilar uptake, especially as we see greater number of biosimilars covered by Medicare Part D pharmaceutical benefit and commercial plans over the next several years.

In Medicare Part B, policymakers are expected to allow a temporary additional payment to increase the use of biosimilars by healthcare providers.

What else is important to note about biosimilars?

In the years to come, increased stakeholder support and advocacy for policies that foster greater adoption will be crucial to 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 can offer significant savings to patients, thereby helping to alleviate overburdened healthcare systems.


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