Step-Therapy and Forced Off-Label Prescribing

U.S. Pain Foundation – Empowering fulfillment, despite the pain

Step-Therapy & Forced Off-Label Prescribing – Frequently Asked Questions:

What is step therapy?

Step-therapy, also referred to as fail first, is a medication utilization practice commonly used by insurers. It requires patients to “fail” on one or more medications before the insurer will agree to cover the cost of the medication recommended by the patient’s own healthcare provider.

What is forced off-label prescribing?

Fail first with forced off-label prescribing occurs when insurers force patients to try and fail on one or more medications not approved by the FDA for the treatment of their medical condition – before granting access to medicines that are FDA approved to treat their condition.  

While off-label prescribing is often appropriate (for example, when treatment options are limited), the decision to prescribe off-label requires extensive medical training, clinical experience, and direct knowledge of a patient’s medical history, all of which is best understood by a patient’s own healthcare provider.

Forcing off-label use on patients through fail first protocols when FDA-approved options are available can jeopardize patient health, safety and wellbeing by exposing patients to medicines that have not been well studied for the treatment of their medical condition or in their patient population.

Why do payers force off-label use?

It is not stated, but does anyone doubt for one moment that this is motivated by profit? It seems obvious that the medications pushed on us by insurers are the cheaper ones so they can delay (indefinitely, if possible) paying for more expensive ones.

Payers often justify off-label use citing evidence found in “the medical literature.”

The problem is that information available through the medical literature is often fragmented and can be used selectively, providing only a limited understanding of – and potential misperceptions about – the off-label use and possible consequences.

Instead of mentioning the obvious motivation of greater profits, this article seems to explain away the mistreatment of patients. It frightens me that insurance companies claim that their damaging policies are due to ignorance. 

Even I know enough to understand the implications of “off-label use”. Unless it is expressly forbidden by law, corporations involved with our health care will do what it takes to make as much money from us as possible.

Some patients (and their HCPs) may be willing to accept risks associated with off-label use; others may not. A patient’s risk tolerance relative to off-label use may be situational, and is always personal. Patients should not be forced to take medicines off-label when FDA-approved options are available.

What can patients do about forced off-label prescribing?

Make insurers – and the bodies that govern them – aware that forced off-label prescribing is unacceptable. Contact your insurer, your legislators, your state’s insurance commission, and your state’s attorney general’s office to share your views.

Three states, Maryland, New Hampshire and Vermont, recently passed legislation to restrict forced off-label prescribing in step therapy protocols.

So, these legislators are trying to restrict only the use off-label medication, not this abusive policy of step-therapy itself.

Other states are considering step therapy reforms to eliminate or reduce the number of steps or “failures” a patient faces; some would stop payers from forcing patients to take medications off-label; others would allow healthcare providers to override such restrictions.


2 thoughts on “Step-Therapy and Forced Off-Label Prescribing

  1. dave

    Paul Gileno and his Foundation has done a noble job of combating step therapy in different states. I do not believe in step therapy or conservative therapy. I believe that the right treatments would be ascertained and applied asap.
    I also believe that people need direct access to treatments and diagnostics without any interference from doctors, insurers, government, etc. Furthermore government should require the development of treatments and diagnostics that are “user-friendly” or person friendly- meaning you don’t need a professional to apply the treatment. Treatments and diagnostics are based on designs that are usually require professional knowledge or skill. This is problematic in design as it forces a dependency on professionals. It is time to give people in pain more freedom and power and this requires a redesign of our system of pain care.

    Liked by 2 people

  2. painkills2

    “And since the U.S. Supreme Court upheld one sales rep’s right to discuss off-label drug uses–as protected free speech, so long as it’s truthful–the FDA has been saying it’s open to the argument. At least up to a point. The agency is working on new guidelines for pharma’s distribution of off-label information about its drugs, including journal articles and other data on unapproved uses…”

    Liked by 1 person


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