Sanofi

Putting Patients First by Reining In Prior Authorization and Step Therapy

Published on: June 29, 2026
A patient speaks to a pharmacist at the pharmacy counter. A title reads: Utilization Management: Roadblocks for Patients.
Utilization management practices need reform to work most effectively for patients and the entire health system.

By Adam Gluck, Head, U.S. and Specialty Care Corporate Affairs

Every day, patients across the United States are told to wait, or to try a different medication, before their insurer will approve the medication their doctor prescribed. These hurdles fall under utilization management (UM) requirements applied by insurers and pharmacy benefit managers (PBMs), commonly in the form of prior authorization and step therapy.

Like many policies, when used as originally intended, both tools can promote clinically accurate and cost-effective prescribing. But over time, both have inappropriately expanded and evolved into medically unjustified barriers that can routinely delay, disrupt, or deny access to badly needed care. The evidence is clear, the burden is measurable, and the harm to patients is real.

Prior Authorization: A Tool That Has Grown Beyond Its Purpose

Prior authorization was originally designed to ensure that high-cost or high-risk therapies were being prescribed appropriately. However, insurers and PBMs now apply prior authorization broadly, often to routine, well-established medications. This can create layers of administrative burden that physician offices must navigate before patients can receive the care they need. Too often, repeated denials of FDA-approved treatments leave patients feeling frustrated and hopeless — with a potentially effective treatment identified but still out of reach.

Patients are feeling the impact. A recent survey found that prior authorization is the “single biggest burden” when it comes to accessing treatments or medications, and nearly 60% of insured adults with chronic conditions report that their access to care has been denied, delayed, or altered in the past two years. That is not an isolated frustration: It is the daily reality for millions of Americans managing serious, chronic health conditions.

Physician offices face real consequences too, spending considerable time gathering documentation, submitting requests, and following up repeatedly on approvals instead of caring for patients.

The fragmented prior authorization process often pushes patients toward paying out of pocket for medicines their doctor has determined they need. More troubling, a majority of physicians report that previously stable patients have been destabilized as a direct result of prior authorization disruptions to their care.

The evidence is clear, the burden is measurable, and the harm to patients is real.
Adam Gluck

Adam Gluck

Head, U.S. and Specialty Care Corporate Affairs

Step Therapy: When “Fail First” Puts Patients at Risk

Step therapy, commonly called “fail first,” requires patients to try one or more insurer- or PBM-preferred medications before gaining access to the treatment their doctor originally prescribed. Like prior authorization, the use of step therapy protocols has ballooned in recent years, sometimes tied to financial incentives (such as rebates for PBMs), and can increase patient costs.

Behind every step therapy protocol is a person waiting for the treatment their physician deemed most appropriate — victims of a system built to manage costs that too often ends up managing patient access instead.

For patients with chronic, progressive, or complex diseases, delays can mean disease progression or avoidable side effects that lead to emergency care. For patients changing health plans, it can mean restarting a protocol from scratch for no medical reason. For medically underserved patients, it adds yet another layer to an already difficult process. And for physicians, it replaces individualized clinical judgment with rigid administrative requirements that ignore each patient’s unique medical history and needs.

Reasonable Reforms Are Within Reach

Applied appropriately and transparently, tools like prior authorization and step therapy can serve a legitimate purpose in the healthcare system. However, policy reforms are needed to address unjustified growth and abuse while reducing the clinical and administrative burdens of these practices on patients and healthcare providers.

A group of people, including one health professional, work together to assemble a large puzzle.

Reform is within reach when stakeholders work together for the same common goal.

That means returning prior authorization to its original scope, modernizing information exchange so clinical information moves efficiently across the healthcare system, and protecting patients from financial burdens while waiting for a decision.

For step therapy, it means exempting stable patients and those with documented contraindications and preventing repeat protocols.

The bottom line is simple: utilization management should support patient-centered care, not create unnecessary barriers that delay treatment, undermine physician judgment, and place people at risk of avoidable harm.

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