American College of Rheumatology Issues Position Statements on Drug Pricing, Step Therapy

The American College of Rheumatology (ACR) has released two statements highlighting their recommendations that health care should be affordable without sacrificing quality of care.

“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,” said Colin Edgerton, MD, chair of the ACR’s Committee on Rheumatologic Care, which presented the statements. “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.”

Drug Prices: ‘Safe, convenient and affordable access’ for Patients

The first position statement pertains to drug prices and emphasizes that rheumatology treatments should be affordable for all patients.

“All patients should have safe, convenient and affordable access to rheumatology treatments that control disease activity and prevent permanent joint and organ damage, thereby limiting disability and early death,” the statement reads.

Other key highlights include:

• Policies that will target the rising prices of rheumatologic drugs
• Transparency among pharmaceutical manufacturers, pharmacy benefit managers, and health insurance companies
• Reducing costs through the use of biosimilars
• Acknowledging cost to the healthcare system, continuity of care, and out-of-pocket affordability when targeting increasing drug prices

The development of modern medicine—particularly the use of clinical trials—has led to improved health and patient outcomes, and diseases that once carried high death rates can now be well-controlled through medications such as biologics.

“Unfortunately, these improvements have been associated with higher costs, with subsequent limitations in access for some,” according to the statement. In addition to the surge in prices of medications, the cost of insurance has increased as well.

The ACR described the process by which insured patients receive medication, involving the manufacturer, pharmacy benefit manager (PBM), and insurer—noting that what goes on behind the scenes among these three parties is often a mystery:

“The PBM acts as the ‘middleman’ in this transaction, generally deriving concessions from manufacturers (such as rebates on the drug price), in return for placing certain drugs on payer formularies. The disposition of these concessions is rarely clear, although it is clear that PBMs derive significant profit. It appears that the need for manufacturers to offer rebates on drugs increases the pressure to raise list prices.”

Notably, the price of adalimumab (Humira) has drastically increased over the last few years—outpacing inflation—without any clear evidence, such as modifications to the medication or the process by which it is made, to the patient of why their medication costs more.

Biosimilars are another area to explore in reducing drug prices, one that has been slow to catch on in the United States but has demonstrated success in Europe.

The drug prices position statement concludes by stating, “Any future changes in policy will need to give consideration to the multitude of factors that affect the cost of care. Thoughtful policy change will help ensure that all patients receive safe, convenient and affordable access to rheumatology treatments.”

ACR Does Not Support Step Therapy

According to the step therapy position statement, the ACR supports strategies to control the cost of prescription drugs but not if it means sacrificing care. Therefore, the ACR does not support step therapy.

Step therapy requires patients to try cost-effective medications and moving on to other strategies if those fail. In rheumatology, specialty medications—including biologic agents—tend to be more expensive, which could be due to fair market pricing or negotiated pricing, the statement notes: “Step therapy and related programs may reduce the use of more expensive alternatives but they have also been shown to delay appropriate therapy,” according to the ACR, citing a survey that found “up to 11% of patients who tried to fill a non-preferred drug (either a proton pump inhibitor or an NSAID) never obtained treatment.”

The position statement notes the various impacts TNF inhibitors—common medications to treat rheumatic diseases—have on different patients. Not all TNF inhibitors are the same, and prescribing one to a patient is a multi-faceted decision. With step therapy, patients are subjected to forced drug switching, treatment gaps, and termination of effective therapy, as well as the possibility of disease flares or uncontrolled disease, immunogenicity, adverse effects, secondary non-response, disabilities, and increased health care costs, the ACR notes.

In a press release the ACR said, “The ACR remains steadfast in its support of legislation that keeps drug pricing reasonable for those who need it most, while also protecting patient access to needed therapies that keep more than 54 million Americans with rheumatic diseases living well.”

American College of Rheumatology Targets Step Therapy and Drug Pricing in New Position Statements

Step Therapy.pdf

Drug Pricing Position Statement