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ACP Releases Policy Paper on Step Therapy and Nonmedical Drug Switching Policies

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If not appropriately implemented, these policies could restrict access to effective treatments, interfere with patient-physician relationship

Dec. 4, 2020 (ACP) – The American College of Physicians is warning insurers about potential negative consequences of step therapy and nonmedical drug switching, two policies that could drive a wedge between physicians and their patients instead of encouraging beneficial cost savings.

“These measures are potential barriers to appropriate care when they aren't applied in a transparent manner that puts patients first. The concern is that insurers are trying to replace the physician's judgment,” said Dr. Jacqueline W. Fincher, president of ACP. “We've gotten involved because we're hearing from members about how these measures are hampering our ability to provide the best care.”

In a policy paper released on Nov. 30, ACP warns that step therapy and nonmedical drug switching policies have drawn fire for “restricting patient access to effective treatments, putting patient health and safety in jeopardy by subjecting patients to potential adverse effects, interfering with the patient-physician relationship, and absorbing practice resources with burdensome approvals and documentation requirements.”

Step therapy – also known as “fail first,” tiering and sequencing – mandates that physicians go through several levels of medications for specific treatments. The insurer Cigna explains the policy this way: “Though the Step Therapy requirements vary by condition, in general, you are required to try at least one Step 1 medication before a Step 2 medication is eligible for coverage without prior authorization. And likewise, you are required to try a Step 2 medication before a Step 3 medication is eligible for coverage without prior authorization.” Step 1 medications, Cigna says, are typically generics.

Nonmedical drug switching is a similar strategy. As explained in the ACP policy paper, it mandates that patients go off their current therapies for no reason other than to save money. Tactics to promote nonmedical drug switching include increasing out-of-pocket costs, moving treatments to higher-cost tiers or terminating coverage of a particular drug.

ACP is not calling for the policies to be eliminated. “Price-based step therapy and drug switching protocols can save costs by encouraging the use of cost-effective biosimilars, generics, or other drugs,” ACP notes in the policy paper.

Instead, ACP warns that the policies can hurt patients and harm the patient-physician relationship if they are not implemented carefully. As Fincher explained, physicians are delighted to prescribe cheaper options such as generics when appropriate: “We want our patients to have effective, safe medicines at a cost they can afford.”

But mandates can spell trouble. “The physician knows the patient and their other comorbid conditions. Based on that, they may decide that the usual approach may jeopardize the patient's safety and is not the best approach. There needs to be certain flexibilities built into the process for them to be able to do that, and that is unfortunately not currently the case,” she said.

In the policy paper titled “Mitigating the Negative Impact of Step Therapy Policies and Nonmedical Switching of Prescription Drugs on Patient Safety,” ACP makes the following recommendations:

  • All step therapy and medication switching policies should aim to minimize care disruption, harm, side effects and risks to the patient.
  • All step therapy and nonmedical drug switching policies should be designed with patients at the center, while accounting for unique needs and preferences.
  • All step therapy and nonmedical drug switching protocols should be designed with input from frontline physicians and community pharmacists; feature transparent, minimally burdensome processes that consider the expertise of a patient's physician; and include a timely appeals process.
  • Data concerning the effectiveness and potential adverse consequences of step therapy and nonmedical drug switching programs should be made transparent to the public and studied by policymakers. Alternative strategies to address the rising cost of prescription drugs that do not inhibit patient access to medications should be explored.

As these policies are increasingly implemented by public and private insurers, ACP recommends that insurers, pharmacy benefit managers, and policymakers implement the recommendations put forth in this paper. Doing so will help ensure reasonable guardrails are in place to help protect patient safety while minimizing unnecessary burden and costs on physician practices.

The paper, Mitigating the Negative Impact of Step Therapy Policies and Nonmedical Switching of Prescription Drugs on Patient Safety, is available on the ACP website. 

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Back to the December 4, 2020 issue of ACP Advocate