Fail-First Policies Are Harming Patients

Pharmaceutical CommercePharmaceutical Commerce - April 2024
Volume 19
Issue 2

Patients should not have to wait to access the medication they need.

Amy Niles

Amy Niles

Step therapy, also known as “fail first,” is a tool used by health plans to control spending on patients’ medications. And while it can be an important tool to contain the costs of prescription drugs, in some circumstances, it has negative impacts on the patients themselves. This includes delayed access to the most effective treatment, severe side effects, and irreversible disease progression.

Currently, when a physician prescribes a particular drug treatment for a patient, the patient’s insurance company may require them to try different medications and treatments, and “fail first” on those before they can access the drug originally prescribed by their physician. This protocol is known as step therapy and may ignore a patient’s unique circumstances and medical history. That means patients may have to use drugs that previously failed to address their medical issue, or—due to their unique conditions—could have dangerous side effects.

Hearing directly from patients

A recent national poll from the PAN Foundation finds that most adults (55%) who have been required to “fail first” say the policy delayed their access to the medication their healthcare provider (HCP) originally prescribed by up to 11 weeks. Other findings include:

  • 1 in 6 (16%) adults say their HCP has required them to “fail first” before authorizing drugs prescribed by their HCP.
  • The majority (59%) of adults who have been required to “fail first” say they appealed their health insurance provider’s request.
  • 1 in 5 adults who were required to “fail first” say they had to visit the emergency room (21%) or be admitted to the hospital (20%) because of the policy.

These polling results reinforce the fact that step therapy harms patients by delaying care. Because when patients are prescribed medication by their provider, they shouldn’t have to wait weeks or months to access that treatment.

Current policy landscape and call to action

While most states in the US have passed laws that address problems with step therapy, federal legislation is still needed. This will help create more transparency and ensure that more patients are protected, including those with employer-based health insurance plans regulated by the US Department of Labor.

That’s why it’s time for Congress to pass the Safe Step Act, a bill that would amend the Employee Retirement Income Security Act (ERISA) to require an exception process for any medication step therapy protocol within a group health plan. More specifically, the bill would require insurers to implement a clear and transparent exemption process for a patient or physician to request an exception to a step therapy protocol, while calling for a group health plan to respond to an exemption request within 72 hours in all circumstances, and 24 hours if the patient’s life is at risk.

The bill would also require a group health plan to grant an exemption if an application clearly demonstrates any of the following five exception situations:

  1. The patient has already tried and failed on the required drug.
  2. The required drug is reasonably expected to be ineffective, and a delay of effective treatment would lead to severe or irreversible consequences.
  3. The required drug will cause harm to the patient, meaning the treatment is contraindicated or has caused/is likely to cause an adverse reaction.
  4. The required drug will prevent a patient from working or fulfilling “activities of daily living.”
  5. The patient is stable on their current medication, which has been covered by their previous or current insurance plan.

The Safe Step Act is supported by hundreds of patient advocacy organizations and healthcare provider associations and has strong bipartisan support. In my opinion, it is a common-sense, patient-centric legislation that will safeguard patients from potential adverse medication consequences and ensure access to the treatment that is best for them. Let’s urge Congress to get this bill across the finish line and make it easier for patients to access the healthcare they need and deserve.

About the Author

Amy Niles is chief mission officer at PAN Foundation.

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