Decisions about a course of therapy that were once exclusively made by the doctor and patient are now being overturned by a common insurance practice called step therapy, or what is sometimes called “fail first.” Requiring patients to try one or more less expensive treatments first and “fail” on them before the health plan will cover the one prescribed by the doctor, step therapy harms patients both through exposure to potentially ineffective treatments and by delaying treatment. As a result, step therapy costs the nation in lost productivity and higher medical expenditures for increased disease activity, disease progression, more symptom severity, loss of function, and patients’ poorer quality of life.
Why Policy Change Is Necessary
As an insurance practice, step therapy is on the rise. Between 2005 and 2013, use of step therapy increased from 27 percent to 73 percent among employers. The rationale is step therapy keeps costs down so insurers can cover a wide range of medications, lab tests and other medical treatments.
Missing from this argument is the price in poorer outcomes for patients who are forced to take lower-cost drugs that don’t treat their diseases adequately, undergo different diagnostic tests than their physicians ordered, or wait needlessly for a medical procedure they need. Based on numerous research studies, step therapy harms patients and increases health care costs because:
Step Therapy Delays Access to the Most Effective Therapies creased Survival
Underscoring the serious harm associated with fail first policies, studies find rheumatoid arthritis patients who delayed disease-modifying treatment for approximately 4 months experienced significantly more radiologic joint damage after 2 years compared with those who were treated within 2 weeks of diagnosis. Similarly, delaying adjuvant chemotherapy by 4 weeks has been shown to decrease disease-free survival and overall survival significantly in patients with colorectal cancer.
Fail First Policies Increase the Risk of Harmful Side Effects
As one example, a study of patients with cancer and inflammatory diseases found 18 insurance plans required almost half these patients (45 percent) to first take immunologic or biologic therapies carrying an FDA “black box warning” of serious adverse events because the drugs were cheaper before paying for a more expensive but less toxic drug.
Step therapy Increases the Likelihood of Avoidable Hospitalizations and ER Visits
In one study reported in the American Journal of Managed Care examining the effects of step therapy on patients with hypertension, researchers documented an increase in hospital admissions and emergency room visits due to a reduction in antihypertensive medication days supplied. The study also showed that the cost savings to insurers were short-lived: after initially reducing medication expenses 3.1 percent, patients in step therapy incurred $99 more per user in quarterly expenditures than the comparison group.
Step therapy Increases the Costs for Medical Providers
For physicians and their staff, step therapy is extremely burdensome and leaves less time for patient-centered health care. In 2006, a study put the cost of step therapy requirements on prescribing statins and antihypertensive drugs only at $1,569 per physician per year and it is likely the price is significantly higher today.
Patients Rising NOW supports the efforts of the patient advocacy community to secure reasonable limitations on step therapy/fail first protocols so patients are able to access the initial treatments prescribed by their clinician in a timely manner. Towards this end, we champion passage of federal and state legislation that will:
- Allow physicians to override step therapy requirements when patients are stable on an existing medication
- Allows physicians to override step therapy requirements based on a medical necessity or the potential for harm (such as possible adverse reactions, previous failure of the substituted treatment)
- Prevent insurers from requiring use of a failed medication more than once
- Limit the time period for a “step” to a reasonable period (45-60 days)
- Require health plan determinations quickly – no more than 24 hours for urgent matters and within 48-72 hours for other situations
At the state level, we are working with other advocacy organizations to pass state laws that limit or reform step therapy. Already, 18 states have passed laws that mandate insurers follow strict protocols “based on high-quality studies, research and medical practice” when implementing step therapy policies, exempt patients proven stable on a prescribed drug from step therapy, and allow individuals to avoid step therapy when the clinical characteristics of the substitute drug are known to be ineffective. These state laws also ensure patients and doctors have a direct route to appeal a health plan’s action with a “clear, readily accessible and convenient process to request a step therapy exception determination.” As of April 2018, 18 states have enacted step therapy laws and more are considering passing legislation so patients can fill the prescriptions written by their doctors.
At the national level, we support passage of the Restoring the Patients Voice Act (H.R.2077) introduced by Rep. Brad Wenstrup (R-OH) and Rep. Raul Ruiz (D-CA) on April 6, 2017. Designed to give health providers increased autonomy in determining the care that is best for their patients, the bill would require employer-sponsored health plans employing step therapy to implement a clear process by which the patient (or provider) can request an exception and to make necessary forms and easy instructions for obtaining the waiver on the health plan’s website. The bill also specifies five situations when patients must be granted an automatic exception: (1) the treatment is contraindicated, (2) the treatment is expected to be ineffective, (3) the treatment will cause or is likely to cause an adverse reaction to the individual, (4) the treatment is expected to decrease the individual's ability either to perform daily activities or occupational responsibilities or adhere to the treatment plan, or (5) the individual is stable based on the prescription drugs already selected. Patients Rising NOW is working with the advocacy community to generate widespread bipartisan support for H.R. 2077 in 2018.
Cancer Drug Parity Act (H.R. 1409) to expand parity to cancer patients covered by federally-mandated plans like Medicare and employer-sponsored health plans. Introduced by Rep. Leonard Lance (R-NJ) and Rep. Brian Higgins (D-NY) in 2017, today the bill has bipartisan support from 140 cosponsors equally divided between Republicans and Democrats. Based on studies in states with oral chemotherapy parity laws such as Vermont, Texas and Indiana, passing the Cancer Drug Coverage Parity Act will have no appreciable effect on insurance premiums. One study found the cost to expand coverage to include oral chemotherapy for most benefit plans is under $0.50 per member per month (a mere 0.17 percent).
 Chung A, MacEwan J. Goldman D. Does a” One-Sized Fits All” Formulary Policy Make Sense? Health Affairs Blog. June 2 , 2016. Accessible at: https://www.healthaffairs.org/do/10.1377/hblog20160602.055116/full
 Lard LR, Visser H, Speyer I, et al. Early versus delayed treatment in patients with recent-onset rheumatoid arthritis: comparison of tow cohorts who received different treatment strategies. Am J of Med. Vol. 111’ Issue 6: 15 October 2001, Pages 446-451
 Biagi JJ, Raphael MJ, Mackillop WJ, et al. Association Between Time to Initiation of Adjuvant Chemotherpay and Survival in Colorectal Cancer: A Systematic Review and Meta-analysis. JAMA. 2011;305(22):2335-2342
 Branning G, Schaars R, Hornung J, et al. Formulary Management of Branded Drugs With and Without Boxed Warnings Within Therapeutic Categories. Value in Health. May 2015. Vol. 18, Issue 3. Page A100
 Mark TL, Gibson TB, McGuigan KA. The Effects of Antihypertensive Step-Therapy Protocols on Pharmaceutical and Medical Utilization and Expenditures. Am J Manag Care. 2009;15(2):123-131
 Ketchum JD, Epstein AJ. Which Physicians Are Affected Most by Medicaid Preferred Dug Lists for Statins and Hypertensives. PharmacoEconomics (2006) 24(Suppl 3): 27.
 Camacho FT, Wu J, Wei W, et al, Cost of oral capecitabine compared to intravenous taxane-based chemotherapy in first line metastatic breast cancer. Journal of Medical Economics.2009 Volume 12 No 3.