- As the healthcare industry grapples with growing prescription drug costs, patients are feeling the burden with higher patient financial responsibility. Step therapy has long been one strategy to quell those growing costs, but what are the implications for patient care access?
Step therapy is the practice of trying lower-cost drugs – biosimilars or generics, for example – to test clinical effectiveness before beginning a regimen using a costlier drug or brand name drug. If the patient responds well to the lower-cost option, the patient, provider, and payer will continue that prescription.
Health payers implement step therapy as a cost-cutting strategy, according to Blue Cross Blue Shield of Michigan.
“Just because something's expensive doesn't mean it's the best,” the payer writes on its website. “If you're a smart shopper, you find an option that costs less and works just as well. That's the idea behind step therapy. We use it to make sure you're getting the most effective and reasonably-priced drug available. It keeps costs down for everyone.”
When a patient doesn’t follow step therapy for a drug for which the practice is required, she may not receive coverage for the medication from her payer.
Ideally, step therapy is supposed to garner cost savings for both payer and patient. Patients who use less expensive drugs should yield lower costs for payers, which in turn should be returned to patients.
That logic has been applied to a recent decision from the Centers for Medicare & Medicaid Services (CMS). The agency will now allow Medicare Advantage plans to practice step therapy on Part B and some Part D drugs. This practice will allow the public payer to negotiate drug costs with drug manufacturers, ideally leading to cost savings that Medicare is required to share with patients.
“As soon as next year, drug prices can start coming down for many of the 20 million seniors on Medicare Advantage, with more than half of the savings going to patients,” HHS Secretary Alex Azar explained in a statement. “Consumers will always retain the power to choose the plan that works for them: If they don’t like their plan, they don’t have to keep it. We look forward to seeing the results of tougher negotiation within Medicare, and expanding successful negotiation tools throughout our programs.”
Step therapy is indeed a common practice at private healthcare payers. However, the practice and other cost-cutting prior authorization measures have been called into question because of potential patient care access issues.
Many providers say step therapy can keep patients from accessing the drug they truly need. At best, the strategy delays care for patients, and at worst keeps patients from seeing their desired treatment altogether.
“Step therapy policies are generally inappropriate in oncology due to the individualized nature of modern cancer treatment and the general lack of interchangeable clinical options,” the American Society for Clinical Oncology says of step therapy “Medically appropriate cancer care demands patient access to the most appropriate drug at the most appropriate time.”
The fundamental issue with step therapy is efficiency, according to a report from the American Medical Association (AMA). In a consensus statement between AMA, America’s Health Insurance Plans (AHIP), the Blue Cross Blue Shield Association (BCBSA), American Hospital Association (AHA), APhA, and Medical Group Management Association, the industry professionals asserted the need for streamlined step therapy processes.
Specifically, step therapy processes must be digitized to expedite the process. Additionally, information about step therapy requirements should be digitally available for patients and providers at the point of care. This will allow patients and providers to begin the process as soon as possible as to ensure patients get speedy access to needed treatments.
However, some industry experts question the true cost savings gained through step therapy. In a statement to Politico following the recent announcements about Medicare Advantage and step therapy, PhRMA expressed concern about the program.
“PhRMA has serious concerns with the new CMS guidance regarding Medicare Advantage coverage of Part B medicines and the implications for patients suffering from complex conditions,” Nicole Longo, public affairs director for PhRMA, told Politico.
A separate 2010 study showed that although step therapy can reduce insurers’ short-term costs, it can hinder patient health and indirectly cause increased long-term costs.
There is little evidence suggesting that any cost savings benefit the patient.
More research is necessary to better understand how step therapy impacts the patient experience of care. Industry leaders must determine strategies to ensure timely patient access to care when participating in step therapy. Additionally, these programs must be designed in such a way that payers yield cost savings that may be passed onto beneficiaries, reducing the burden of high prescription drug costs.