{"subscriber":false,"subscribedOffers":{}} Variation In The Use Of Step Therapy Protocols Across US Health Plans | Health Affairs
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Variation In The Use Of Step Therapy Protocols Across US Health Plans

Doi: 10.1377/forefront.20180912.391231

The Centers for Medicare and Medicaid Services recently sent shudders through the specialty drug market by authorizing Medicare Advantage Plans to use step therapy protocols for Part B drugs. The policy, which launches January 2019, is intended to help address rising drug spending by allowing Medicare Advantage plans more flexibility and leverage when negotiating with product manufacturers. Health plans use step therapy protocols to optimize prescribing (and control costs) by requiring that patients try a cheaper alternative before gaining access to a more expensive option. However, a concern is that “fail first” approaches can impede access to important treatments and require patients to use therapies that previously proved ineffective. 

The advent of Medicare’s new policy draws attention to commercial payers’ experiences with step therapy protocols. We recently reported that such protocols are the most common type of coverage restriction applied by US commercial payers for specialty drugs. Here we examine variation in the use of such protocols across plans and diseases, highlighting potential issues for the new Medicare policy. 

Specialty Drug Evidence And Coverage Database

We used the Specialty Drug Evidence and Coverage (SPEC) Database, a database developed by researchers at Tufts Medical Center, to examine trends in US commercial health plan specialty drug coverage. Information in SPEC is extracted from publicly available coverage decisions issued by 17 of the 20 largest commercial health plans relevant to their commercial lines of business. SPEC includes information on how plans cover specialty products and the evidence that plans cite in their coverage decisions. Roughly one in four coverage decisions in SPEC includes a step therapy protocol (1,208 of 4,809 decisions). (Decisions are current as of August 2017). 

Some Health Plans Apply Step Therapy Protocols More Often Than Others

We found wide variation in the frequency with which health plans apply step therapy protocols in their specialty drug coverage decisions, ranging from 2 percent to 49 percent across the included plans (Exhibit 1). 

Exhibit 1: Frequency That Health Plans Apply Step Therapy Protocols In Their Specialty Drug Coverage Decisions

Source: Authors’ analysis of the Tufts Medical Center Specialty Drug Evidence and Coverage Database. 

Some Step Therapy Protocols Are More Burdensome Than Others

Some step therapy protocols are more onerous than others. For example, of the 1,208 coverage decisions that include a step therapy protocol, 761 (63 percent) require patients to step through a single therapy, while 447 (37 percent) require stepping through multiple therapies. Moreover, 181 (15 percent) of protocols include three or more steps, and some require patients to fail up to five treatments before patients can gain access to a particular therapy. For example, before covering certolizumab pegol for ankylosing spondylitis (a form of inflammatory arthritis that affects the spine), one plan requires that patients have inadequate clinical benefit or adverse effects to at least one non-steroidal anti-inflammatory drug, three preferred anti-tumor necrosis factor (TNF) agents (a class of biologics), and secukinumab (a non-anti-TNF biologic). 

Even when plans require the same number of steps, some protocols are more involved than others. For example, two plans require two treatment steps before covering abatacept for rheumatoid arthritis. One requires failure of a non-biologic disease-modifying antirheumatic drug (DMARD) and a biologic DMARD, while the second requires patients to have failed two biologic DMARDs (a more onerous step therapy protocol). 

Some health plans also impose step therapy for a specified duration. An example is the coverage decisions for omalizumab for moderate to severe asthma. Some plans require that a patient’s symptoms be inadequately controlled, despite a three-month trial of a corticosteroid and a long-acting beta-agonist. Another dictates that patients persist with similar prior treatments for at least six months. 

Use Of Step Therapy Protocols Varies Across Diseases

Health plans use step therapy protocols differently for drugs indicated for different diseases. For instance, plans apply protocols in 5 percent of decisions for cancer treatments and 36 percent of decisions for non-cancer indications. They apply step protocols in 13 percent of decisions for orphan drugs, and 33 percent for non-orphan indications. One reason may be that drugs indicated for cancer or rare diseases typically have fewer therapeutic substitutes than drugs indicated for other diseases. Indeed, as our recent research highlights, plans are more likely to restrict coverage of drugs with more than three treatment alternatives. 

The findings provide a window into the kind of step therapy protocols we might see in Medicare Advantage plans. The wide variation in how and when protocols are applied also suggests a lack of strong evidence underlying protocols. 

Is Variation In Specialty Drug Coverage A Problem?

Variation in health plans’ use of step therapy protocols is not inherently problematic. Still, as the Dartmouth Atlas Project raises questions about factors underlying geographic variation in health spending patterns, our findings raise questions about reasons for observed differences in step protocols and the consequences for patients’ access to specialty drugs, health outcomes, and systemwide efficiencies. 

Because plans independently judge the strength of a product’s evidence and value, and tailor drug coverage decisions to their own enrollees and situations, some variation in plan behavior is expected. Moreover, how aggressively plans manage specialty drugs is presumably influenced by negotiated prices, available financial resources, the degree of competition within a plan’s operating region, and local practice patterns. Nonetheless, the extent of the variation seems notable and, at the very least, raises questions about whether they are grounded in sound clinical evidence. Looking forward, it will be important to track the consistency of Medicare’s and commercial plans’ coverage decisions. 

A Call For Transparency And Evidence-Based Decisions

Health plans face a formidable challenge in balancing access to effective but expensive specialty drugs and spending resources judiciously. Given the stakes, plans should better communicate the rationale and evidence base for their decisions. Our prior research has found health plans lacking in this regard. Ideally, plans should appeal to principles for good practice for step therapy protocols advanced by researchers and medical professional societies and to account for sufficient clinician input. It will be important to monitor Medicare’s implementation of the policy and how the agency communicates the basis for its decisions. 

Is Legislation Warranted?

Legislation may also have a place. For example, a requirement that plans provide reasonable provisions for physicians who request exceptions in clinically appropriate situations might be considered, as would requirements that such exceptions be processed expeditiously. Legislation that protects patients who switch health plans from losing coverage of a drug that has stabilized their condition may also make sense. Indeed, almost two dozen states have enacted laws to regulate health plans’ application of step therapy protocols through similar provisions, and Congress is deliberating similar legislation. The challenge is to balance the benefits of such provisions against the risks that excessive regulation could make an already complex process more difficult. 

Step therapy protocols vary considerably across health plan and disease, highlighting issues for Medicare’s new policy allowing such protocols for specialty drugs in Medicare Advantage plans. It will be important to monitor implementation of the policy and to emphasize the need for transparent and evidence-based decisions.