ACR calls for abolishing step therapy in letter to Congress, CMS
The American College of Rheumatology has called for the removal of step therapy, ranked medications and fail-first policies that are based solely on cost.
The call to abolish step therapy is one of several recommendations issued by the ACR regarding drug pricing and access. The recommendations were included in two position papers recently sent to members of Congress, CMS, pharmacy benefit management companies and others.
“Step therapy is an enormous barrier between patients and the prescription medicines they and their doctor decide on — and a very frequent problem for people with rheumatologic diseases,” Angus B. Worthing, MD, FACP, FACR, chairman of the ACR government affairs committee, told Healio Rheumatology. “It erodes patient and physician autonomy by covering preferred drugs that benefit the insurer and pharmacy benefit manager most instead of what is best for the patient.”
“Step therapy prolongs suffering from arthritis, lupus and other rheumatic diseases while patients wait for their prescriptions even if they are covered,” he added. “It forces people to take medicines that may not work for all parts of their disease or may be pose risks to comorbid conditions. In short, it can be the worst part of living with rheumatic disease: To finally have a diagnosis and treatment plan — which many patients wait months or years for— only to wait weeks or months for relief.”
Each of the four-page policy statements contains several recommendations and positions that, according to the press release, the ACR hopes legislators and other administration officials will “consider as they continue to explore policy and regulatory options to make drugs more affordable and accessible.”
The ACR statement on drug pricing included the following recommendations and policy positions:
- All patients should have safe, convenient and affordable access to rheumatology treatments that reduce disability and early death;
- Rational policies should limit rapid increases in rheumatology drug costs;
- Drug manufacturers, pharmacy benefit managers and insurance companies should be transparent in how they set drug prices;
- A safe and efficient approval process for biosimilars will lower costs and improve treatment access;
- Any proposal aimed at reducing drug costs must address the cost to the health care system, continuity of care and patients’ out-of-pocket costs; and
- The rheumatologist’s role in providing specialized care, as well as patients’ access to physician-administered medication, should be supported.
The position paper on step therapy similarly declares six policy statements, including:
- The ACR supports lowering drug costs but opposes cost savings plans that “compromise quality of care or safe clinical practices;”
- Step therapy should be removed;
- Unnecessary barriers should not stand between patients and clinically necessary medications;
- The formulary decision making process should be transparent for all health care stakeholders;
- Pharmacy review committees should include rheumatologists in the drafting of formulary benefit programs; and
- Nonmedical switching in medically-stable patients, based solely on cost and without the consent of the patient or their physician, is potentially harmful to patient health.
“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,” Colin Edgerton, MD, a rheumatologist at Low Country Rheumatology in South Carolina, and chairman of the ACR Committee on Rheumatologic Care, said in a press release announcing the position papers. “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.”
According to Worthing, the ACR is currently working to reform step therapy in several states as well as at the federal level, with Virginia and Georgia being the most recent examples. In Washington, D.C., the ACR is collaborating with U.S. Rep. Brad Wenstrup, a Republican from Ohio, who is also a podiatrist, as well as Rep. Raul Ruiz, a Democrat and physician from California.
The pair plan to reintroduce a step therapy reform bill in the House of Representatives that previously gained bipartisan support in 2018. The ACR is also pushing for a companion bill in the Senate.
“While these steps will not end step therapy, if enacted, they will allow patients to bypass step therapy if their doctor expects the step therapy treatment to be ineffective, or cause side effects or disabilities, among other exemptions,” Worthing said. “It will be an important step to boost patients’ access to treatment. These efforts have a lot of traction, and I encourage rheumatologists to stay tuned for an email campaign coming soon to the ACR Legislative Action Center so they can tell Congress to act on this.” – by Jason Laday