Increasing Patient Access to Medicines: What Needs to Change in the U.S

Pete Wallace, Head of Federal Government Affairs

With the rising cost of prescription drugs continuing to be a top concern for Americans across the U.S. and the evolving healthcare challenges around the world, Viatris is committed to promoting public policies that remove barriers to patient access and enable people across the globe to live healthier lives. Part of that effort includes advocating for federal policies that increase access to quality, affordable medicines for all patients, including bolstering the biosimilars market, ensuring patients, regardless of circumstance, receive access to lower-cost alternatives, redesigning and modernizing Medicare Part D to incentivize generic and biosimilar utilization, and increasing transparency across the supply chain.

Over the past decade, generics and biosimilars have saved patients and the U.S. healthcare system over $2.2 trillion, with biosimilars accounting for $4.5 billion of the savings1. Biologics are some of the most expensive medicines available and treat some of the most serious medical conditions. Biosimilars are FDA-approved alternatives to biologics with no clinically meaningfully differences from their reference product and have tremendous potential for increased savings. In 2019 alone, biosimilars saved $2.2 billion2. As high-cost biologic drugs continue to lose patent exclusivity and more biosimilars receive FDA approval and enter the market, it is essential that patients have access to these lower-cost alternatives and receive the full benefits and cost-savings attributed to these products.

To ensure a robust biosimilar marketplace and increase patient access to affordable medicines, Viatris supports the following policies to incentivize utilization of biosimilars:

  • Development of a shared savings model that allows physicians to share in the financial savings attributed to prescribing biosimilars;
  • Increasing the Medicare reimbursement rate for providers who prescribe biosimilars to Average Sales Price (ASP) +8% of the reference product;
  • Reducing seniors’ out-of-pocket costs for biosimilars in Medicare Part B; and
  • Implementing a Star Ratings measurement to encourage insurers to offer lower-cost biosimilars.

Click here to learn more about Viatris’ policy proposals to address the issues in the biosimilar market and correctly align incentives to ensure patients receive the benefit of lower-cost biosimilars.

Meanwhile, despite the extensive patient and healthcare savings attributed to generic and biosimilar access, increasingly, many seniors are unnecessarily paying more for expensive brand name drugs when a more affordable, FDA-equivalent generic is available. When Part D was created, generic medicines were typically added to drug formularies immediately upon FDA approval. However, according to a recent Avalere analysis, over the last decade, generic coverage on generic formulary tiers has dropped from 93% to 45%. In fact, in 2011, 71% of generics were on a preferred generic tier; only 10% of generics are on preferred generic tiers in 20213.

It is essential that generics should always be made available and placed on a lower-tier with lower-cost sharing than their brand equivalent to reduce costs for patients. To achieve this, Viatris supports H.R. 2846, the Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021. The bipartisan legislation would require Medicare Part D plan coverage of lower-cost generic and biosimilars upon launch, ensure they are on the proper lower-cost sharing tier, and create a second specialty tier for complex generics and biosimilars with reduced cost-sharing for beneficiaries. These common-sense policies will modernize Medicare Part D and ensure that beneficiaries receive access and the savings attributed to generic and biosimilar medicines.

Click here to learn more about Viatris’ work to build healthier markets.

At Viatris, we are committed to advancing policies that will expand patient access to affordable medicines and promote a robust and competitive generic and biosimilar marketplace. As Congress and the Administration contemplate opportunities to lower drug costs and modernize Medicare, we urge policymakers to take action on these policies that will dramatically reduce patients’ out-of-pocket costs at the pharmacy counter and encourage providers, patients and insurance plans to facilitate access to generic and biosimilar medicines.

1Association for Accessible Medicine, 2020 Access and Savings Report.
3Avalere Seniors Pay More for Medicare Part D Generics Despite Stable Prices, Effect of Potential Policy Change to Part D Generic Tiering on Patient Cost Sharing and Part D Plan Costs, For the First Time, a Majority of Generic Drugs Are on Non Generic Tiers in Part D, Generic Drug Placement on Part D Generic Tiers Declines Again in 2021.