Does A ‘One-Size-Fits-All’ Formulary Policy Make Sense?

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Over the last decade, insurers have increasingly used step therapy, or “fail-first,” policies as a strategy to contain pharmaceutical costs.

Step Therapy Can Delay Access To The Most Efficacious Therapies

This can increase the duration of illness and raise the total cost of health care in the long-run. Delays in receiving health care, whether caused by step therapy edits or other factors, have been shown to be significantly detrimental to patient health outcomes.

For example, breast cancer patients with a treatment delay of three months or more had a 12 percent lower five-year survival rate compared with breast cancer patients with only a zero to three month delay. Similarly, patients with rheumatoid arthritis who delayed disease-modifying treatment for approximately four months experienced significantly more radiologic joint damage after two years compared with patients who began treatment within two weeks of diagnosis.

Step Therapy Trades Prescription Spending For Time And Hospital Costs To Patients And Providers

One study reported that 28 percent of patients who had encountered a step therapy edit spent three or more hours trying to obtain second-line drugs from their physicians’ offices. Increased rates of discontinuation, along with delays in accessing treatment, can contribute to less efficient use of health care resources and increased costs over time. For example, the introduction of step therapy for schizophrenia medications initially saved Georgia’s Medicaid program $20 per member per month, but the state subsequently spent $32 per member per month on outpatient services because patients utilized ineffective medications.

Overall, the combination of prior authorization and step therapy is associated with higher inpatient spending, while formulary restrictions have been positively correlated with higher drug costs, more office visits, and higher likelihood of hospitalization among patients with certain diseases. Furthermore, drugs that require laboratory tests and monitoring can increase non-pharmacy costs that may have been avoidable with alternative therapies.

Complicated Step Therapy Rules Create Barriers To Health Care

The time and administrative burden associated with step therapy is an obstacle to access that can lead to unnecessary breaks in treatment. Indeed, depending on therapeutic class, 7 percent to 22 percent of patients did not submit any prescription claim to their insurance provider following a step edit, instead forgoing treatment.

This lack of follow-up may be due to insufficient levels of effective pharmacist involvement in the resolution of rejections, or due to the reality that more than 77 million U.S. adults have basic or below basic health literacy skills. This widespread low level of health literacy makes it challenging for patients to decipher complex policies and take appropriate action. Ultimately, the hassle patients face attempting to obtain coverage in restrictive health plans may result in lower medication utilization and adherence, with a related increase in total health care spending.

‘Fail-First’ Policies, As Their Name Suggests, Increase The Risk Of Dangerous Side Effects

For certain patients–like those who need immunologic and biologic agents—these concerns are particularly salient. Researchers found that 18 insurance plans— representing approximately 97 million insured lives—required 45 percent of beneficiaries to “step through” one or two drugs bearing an FDA “black box warning” of serious adverse events before progressing to a drug without such warning. As a result, patients may needlessly face severe health risks in disease areas that have benefited from recent advances in immunologic and biologic therapy, such as cancer and inflammatory diseases.