'Step therapy' approach to lowering health-care costs raises concerns, writes law professor

February 20, 2018, Case Western Reserve University
Credit: Case Western Reserve University

To keep rising health-care costs in check, many health insurers have adopted a strategy known as "step therapy," a policy requiring patients to try cheaper drugs first—and find them to be ineffective—before approving pricier medication.

However, some health-care experts contend the approach, also known as "fail first," can yield poorer health outcomes and raises ethical and legal concerns.

In an article just published in the Food & Drug Law Journal, Sharona Hoffman, professor of law and bioethics and co-director of the Law-Medicine Center at Case Western Reserve University, argues that the practice could reduce insurers' drug costs in the short term, but could actually cost more and harm in the long run. This is because patients who do not receive the right treatment may suffer complications and need further treatment or even hospitalization.

And, she writes, the practice often hurts chronically ill patients the most. Dr. Hoffman personally encountered step therapy when her husband was initially denied coverage for a prescribed for his Parkinson's disease.

"Some insurers are less than transparent with patients about their programs," she said. "They adhere to a one-size-fits-all approach, ignoring nuanced clinical and economic evidence, and implement their policies in a discriminatory way."

Hoffman's article—among the first law journal pieces dedicated to step therapy—also points out that several states have already taken a stand through legislation that establishes step therapy limits. The article also reviews mechanisms that federal law provides to appeal adverse insurance decisions.

"Step therapy has more complicated implications than initially meet the eye," Hoffman said. "Step therapy policies should be carefully designed to achieve cost savings while remaining flexible, responsive to patients' needs and consistent with relevant clinical data."

"Insurers should be careful not to strive single-mindedly to reduce short-term costs at the expense of ignoring patients' overall well-being, physicians' treatment goals, and the prospect of increased long-term expenditures."

Hoffman further argues that states without "fail first" statutes should enact them and that federal law should address step therapy as well. Among her recommendations for such legislation are easy and fast ways to request exemptions and appeal insurance denials as well as clear and easily accessible explanations of step therapy terms.

Hoffman notes that, done well, step therapy can be a safe and effective approach to providing patients with cheaper but still appropriate drugs. She recommends that the health-insurance industry conduct further research to determine if and under what circumstances step therapy is an effective cost-reduction tool.

"Step should not constitute a bludgeon used against patients and doctors," Hoffman said. "Instead it should be a vehicle for all stakeholders to work cooperatively to reduce treatment without compromising health outcomes."

Explore further: 97 percent of insurance denials in pediatric proton patients overturned on appeal

More information: Step Therapy: Legal, Ethical, and Policy Implications of a Cost-Cutting Measure: www.fdli.org/2018/02/step-ther … ost-cutting-measure/

Related Stories

97 percent of insurance denials in pediatric proton patients overturned on appeal

August 7, 2017
Insurance companies end up covering proton therapy treatment for pediatric cancer patients in 97 percent of the cases they originally deny once those decisions are appealed. Researchers from the Perelman School of Medicine ...

Treatment costs can be another blow to cancer patients

July 27, 2017
(HealthDay)—The emotional and physical costs of cancer can be staggering. But the financial side of cancer is also a great burden, with many patients in the United States struggling to pay for treatment, new research ...

Cost of a common ER visit? Study finds most health care providers don't know

May 30, 2017
Researchers found an average of only 38 percent of emergency medicine healthcare professionals—including physicians, physician assistants, and nurse practitioners—accurately estimated the costs for three common conditions ...

Managing concerning behaviors when opioids are taken for chronic pain

December 11, 2017
Patients receiving long-term opioid therapy for chronic pain sometimes demonstrate challenging and concerning behaviors, such as using more opioid medication than prescribed or concomitant alcohol or drug use. A new study, ...

One blood pressure drug therapy associated with lower health-care costs

May 30, 2017
About half of patients diagnosed with high blood pressure will need their medication adjusted within the first year to address side effects or failure to control blood pressure properly. Among the modification options available, ...

High rate of prescriptions for new cholesterol medications never filled

September 27, 2017
In the first year of availability of the cholesterol lowering medications PCSK9 inhibitors, fewer than 1 in 3 adults initially prescribed one of these inhibitors actually received it, owing to a combination of out-of-pocket ...

Recommended for you

Shortcut strategy for screening compounds with clinical potentials for drug development

December 4, 2018
Developing a new drug often takes years and costs hundreds of millions of dollars. A shortcut has now been reported in a study led by City University of Hong Kong (CityU), which can potentially reduce the time and costs of ...

Drug wholesalers drove fentanyl's deadly rise, report concludes

December 4, 2018
Fentanyl, a powerful synthetic opioid implicated in nearly 29,000 overdose deaths in the United States last year, most likely spread because of heroin and prescription pill shortages, and also because it was cheaper for drug ...

Global review reports on administration of children's antibiotics

December 4, 2018
Researchers analyzing the sales of oral antibiotics for children in 70 high- and middle-income countries found that consumption varies widely from country to country with little correlation between countries' wealth and the ...

Opioid prescriptions from dentists linked to youth addiction risk

December 3, 2018
Teens and young adults who receive their initial opioid prescriptions from their dentists or oral surgeons are at increased risk for opioid addiction in the following year, a study from the Stanford University School of Medicine ...

Rise in meth and opioid use during pregnancy

November 29, 2018
Amphetamine and opioid use in pregnancy increased substantially over the last decade in the United States, a new Michigan Medicine-led study finds. And a disproportionate rise occurred in rural counties.

Mouse model aids study of immunomodulation

November 19, 2018
Because mice do not respond to immunomodulatory drugs (IMiDs), preclinical therapeutic and safety studies of the effects of IMiDs have not been possible in existing types of mice. This has led to an inability to accurately ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.