ACR Issues Step Therapy, Drug Pricing Position Statements

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:

• Transparency in the policies used by pharmaceutical manufacturers, pharmacy benefit managers and health insurance companies to determine prescription drug prices
• A safe and efficient biosimilar approval pathway and marketplace to improve access to treatment by lowering costs
• Drug price proposal inclusive of the concerns of cost to the healthcare system, continuity of care, and out-of-pocket affordability for patients.

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.”