Step therapy, the requirement that more cost effective/inexpensive drugs and therapies must be prescribed for a patient before a more expensive/less cost-effective drug or therapy will be reimbursed, has become a common requirement by insurers over the last few decades.
Now, patients and other stakeholders are wondering if such efforts are beneficial and actually worth it in the long run for patients. One the one hand, step therapy typically provides health insurers with the leverage to negotiate lower prescription drug costs. On the other hand, however, step therapy is often burdensome and requires that a patient fail on a less costly drug before allowing for a more expensive therapy or drug.
In 2018, a study done by James D. Chambers et al., showed that step therapy is typically used for specialty pharmaceuticals and/or high cost drugs prescribed for chronic or life-threatening conditions, such as rheumatoid arthritis, multiple sclerosis, and cancer. That same study found that step edits were the most common restriction in to limit specialty drug coverage, used in nearly 75% of decisions.
In addition to commercial plans, step therapy is also used in Medicare and has been used in Medicaid formulary management for decades.
PharmacoEconomics Study
However, a recent study published in PharmocoEconomics demonstrates the potential negative impact step therapy can have on patients with rheumatoid and psoriatic arthritis.
The study looked at patients with rheumatoid arthritis or psoriatic arthritis between 18 and 64 years old that had at least one claim for a subcutaneous biologic novel disease-modifying antirheumatic drug (bDMARD) between January 1, 2014, and December 31, 2015. Both of the conditions are immune-mediated and patient outcomes have made leaps and bounds with rapid advances in novel DMARDs, due to reduced inflammation and slower disease progression.
Among 3,993 rheumatoid arthritis and 1,713 psoriatic arthritis patients, 34.2% and 35.1%, respectively, had access restrictions, of whom 70.5% and 78.9%, respectively, had plans with step therapy.
The study found that patients with psoriatic arthritis whose insurers implemented step therapy had 27% lower odds of treatment effectiveness and 29% lower odds of medication adherence, when compared to patients with the same disease without similar access restrictions.
For rheumatoid arthritis, patients whose insurers implemented step therapy had 19% lower odds of treatment effectiveness and 19% lower odds of medication adherence when compared to patients without similar access restrictions.
The study summarily concluded that when compared to patients in plans without access restrictions, rheumatoid arthritis and psoriatic arthritis patients in insurance plans with step therapy had lower odds of treatment effectiveness, largely due to lower odds of treatment adherence, during the twelve months following the start of the subcutaneous bDMARD.
While the study may be limited in scope, it points at what may be a bigger issue: in order to minimize negative patient outcomes, it is important that step therapy be used judiciously, not as an across-the-board mechanism. There is great need for more empirical evidence examining the impact of the use of step therapy on health outcomes. Pending the additional evidence, further changes may need to be made to the way step therapy is implemented.