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Biosimilar Policy Roundup: March 2021


The month of March brought intense debate and legislative action over biosimilar policies.

During March, both state and federal legislators moved forward with bills to increase access to biosimilars, biosimilar advocacy organizations made changes to their guidelines, and experts criticized current and proposed policies that they said would not improve biosimilar uptake.

Legislative Policy

The US Senate unanimously approved a bill requiring the FDA to provide the public with educational information that is supportive of biosimilar adoption. The Advancing Education on Biosimilars Act was introduced in 2019 and was initially voted on in December 2020 but required a fresh vote for 2021.

Under the bill, the FDA would develop a biosimilars education website that would include information on key statutory and regulatory terms used in reference to biosimilars, including interchangeability and biologic. The website also would be tailored to the needs of health care providers and would make comparative data for originators and biosimilars available.

Also, Minnesota state legislators introduced a bill aimed at broadening access to biosimilars by requiring health plans and pharmacy benefit managers to cover all versions of a biologic equally—biosimilars and originator products. The bill would create more opportunity for biosimilars to compete alongsideoriginators by denying payers the ability to make formulary decisions in favor of more costly biologics.

Policy Critique

In an interview with The Center for Biosimilars®, Maria Manley, LLM, a life sciences expert, discussed the hoops pharmaceutical companies had to jump through to ensure that their products could still be marketed in the United Kingdom after the country’s official departure from the European Union, which was dubbed Brexit.

In light of Brexit, many companies had to transfer product marketing authorizations from UK entites into EU entities to ensure that their products were properly domiciled. Brexit also led to the establishment of a free trade agreement without tariffs or quotas between the United Kingdom and European Union.

In a March webinar sponsored by the Biologics Prescribers Collaborative, a panel of experts discussed former president Trump’s proposed Most Favored Nations policy, which was intended to change the reimbursement structure of Medicare Part B drugs to lower drug costs. This was frowned on by the panel because it would prevent an estimated 9% of Part B patients from having access to their medications.

The methodology behind the Institute for Clinical and Economic Review’s value assessments for drugs was also criticized by the panel. They argued that the assessments are based solely on clinical trial data and are conducted prior to drugs receiving FDA approval, making the assessments less representative of how drugs would perform in real-world settings.

Additionally, a white paper noted some reasons that biosimilars are currently not achieving savings for the health care system. The authors pointed to CMS’ policy of allowing originators and biosimilars to have separate reimbursement codes and prices under Medicare Part B. The authors argued that the policy conflicts with the agency’s goal of fostering a competitive market for biologics.

Organizational Policy

AAM Policy Recommendations

  • Place generic drugs in Medicare Part D on generic formulary tiers with lower cost-sharing than brand name drugs
  • Ensure Medicare beneficiaries have access to new generics
  • Update Medicare Part D to include a dedicated specialty tier for generics and biosimilars
  • Reward Medicare health plans for encouraging use of lower-cost generics or biosimilars and eliminating barriers to access
  • End brand “rebate traps” that prevent use of generics and biosimilars
  • Increase the Medicare Part B add-on payment to providers who use biosimilars
  • Encourage adoption of biosimilars with a shared savings program
  • Repeal or amend the Medicaid drug price inflation penalty for generics

In other news, the Association for Accessible Medicines published a position paper that detailed a list of recommendations for CMS to change some of its policies. Some of the policy changes suggested were rewarding Medicare plans that encourage use of generics and biosimilars, ending “rebate traps” that prevent access to generics and biosimilars, and increasing add-on payments for physicians who prescribe biosimilars.

The National Comprehensive Cancer Network released a new set of guidelines advising health care providers to lobby for policies that avoid payer formulary preferences and create more access to biosimilars. The guidelines also addressed issues regarding biosimilar procurement and the need to stock multiple biosimilars of the same drug, which is costly and leads to errors.

Biosimilars Canada announced that it has reelected Michel Robidoux, the president and general manager of Sandoz Canada, as chair of the trade association’s board. In a statement, Robidoux praised the successes of British Columbia and Alberta’s biosimilars initiatives that require patients with chronic conditions to be switched to certain biosimilars as a mode of creating savings on biologic spending.

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