As legislators consider policy and regulatory options to lower the cost of prescription drugs, the American College of Rheumatology (ACR) is calling for an end to step therapy (or sometimes called “fail first” policies) as well as the switching of medications in stable patients purely for cost reasons.
As legislators consider policy and regulatory options to lower the cost of prescription drugs, the American College of Rheumatology (ACR) is calling for an end to step therapy (or sometimes called “fail first” policies) as well as the switching of medications in stable patients purely for cost reasons.
Non-medical switching in a stable patient among branded products and across therapeutic classes without the consent of the patient and the provider is inappropriate and potentially harmful, the ACR says.
“We continue to emphasize these topics because they are so critical to the well-being of millions of Americans living with rheumatic diseases, some of which can be quite debilitating and even lead to death,” says Colin Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina and chair of the ACR’s Committee on Rheumatologic Care, in a statement. “The need for patients to have access to prompt, affordable, and medically necessary treatments is ongoing and should be considered at every step of the policy making process.”
The statement comes as several bills regarding prescription prices, as well as making biosimilars more accessible, have been introduced in Congress.
One of these bills, the Medicare Negotiation and Competitive Licensing Act, would allow the HHS secretary to negotiate prices for Medicare Part D drugs directly. Another, while not directly targeting prices, aims at unraveling the patent thickets that prevent biosimilars from coming to market.
On the regulatory side, CMS is allowing the use of step therapy in Medicare Advantage plans.
The ACR’s position statement on drug pricing asks for:
ACR’s step therapy statement asks that pharmacy review committees include rheumatologists to help develop formulary benefits programs.
“Step therapy has resulted in forced drug switching, treatment gaps, and cessation of effective therapy,” the statement says. “In addition to the dangers to the patient related to loss of access to therapy and disease flares, these programs may result in immunogenicity, adverse effects, and secondary nonresponse. Downstream effects of restricted access can lead to complications such as uncontrolled disease for the patient, disabilities, and increased health care costs.”
Last year, the ACR released its first-ever Rheumatic Disease Report Card, which shows the burden of rheumatic disease in each state. The average state grade was a “C.”
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Latest Biosimilar Deals Signal Growth Across Immunology, Oncology Markets
April 14th 2025During Q1 2025, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.
Experts Pressure Congress to Remove Roadblocks for Biosimilars
April 12th 2025Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management during a recent congressional hearing.