STEP THERAPY ULTIMATELY HURTS PATIENTS:

 Worsening symptoms:Patient quality of life suffers with step therapy.  When an insurance company forces their patients to take medications that are not sufficient to meet their needs, it prolongs painful symptoms and inflicts long-term damage to their health.  One patient described how she was bedridden for ten years(and mute for five) due to unbearable symptoms from her Complex Regional Pain Syndrome while going through step therapy.  Another patient said she felt “blind from the pain”of migraines while she waited for her insurance company, which uses step therapy, to approve coverage for her to take a more expensive yet far more effective drug.  

Forcing patients to use treatments that are less effective:  Biologics vary in their effectiveness.  While a more expensive brand version of a Part D drug is chemically identical to and thereby as equally effective as its less expensive generic version, each Part B biologic has its own molecular makeup and is not interchangeable with other biologics, even if they are used to treat the same disease.  As such, no two biologics are equally effective and can have different side effects, but the new CMS step therapy policy ignores this important distinction and forces patients to use biologics that their doctor thinks might not be the most effective option for them.  The consequences can be severe; according to Managed Caremagazine, a college student with ulcerative colitis had no choice but to have his colon removed after his insurance company forced him to undergo step therapy instead of covering the infused biologic his gastroenterologist recommended.

 Endangering vulnerable populations: A 2010 studyof step therapy among Medicaid patients conducted by the American Journal of Pharmacy Benefits noted that step therapy can be particularly dangerous for low-income and/or elderly patients, who are more likely to need Part B-covered treatments as they age.  The study determined that step therapy increases the average number of days that Medicaid patients spend in inpatient and outpatient hospital settings by 37 and 35 percent, respectively; it also increases the share of Medicaid patients who seek out physician visits by an average of 66 percent.  

Increasing overall patient costs:  While step therapy does reduce drug prices, the practice ultimately increases patients’ overall health care costs.  Step therapy for Part B biologics can force patients to seek treatment for their persistent, worsening symptoms in the emergency room or another hospital setting; a 2009 studyin the American Journal of Managed Care concluded that step therapy increases patient costs by an average of $99 per quarter due to hospitalizations and emergency room visits, offsetting any savings patients might incur from step therapy.  

Forcing patients to use drugs that their doctor has not prescribed and that have not been approved by the FDA for that specific indication:  MA plans will be able to force the use of off-label drugs that are designed to treat an entirely separate disease.  Off-label drugs are not necessarily as effective as on-label drugs, which are required by the FDA to demonstrate their effectiveness and safety.  Forcing patients to endure ineffective treatment exacerbates their existing health issues; in 1997, for example, the FDA reported that nearly three dozen women developed heart valve diseaseafter being prescribed an off-label combination of phentermine, fenfluramine, and dexfenfluramine to treat obesity, including one 30-year-old patient who died.  

Permitting insurance companies to force the use of compounded drugs that pose a safety hazard: Off-label drugs are typically repackaged by third-party compounding centers, and the additional layer of handling that the drugs goes through increases their likelihood of contamination.  In 2011, nearly two dozen wet age-related macular degeneration (AMD) patients developed severe eye infections after being injected with contaminated off-label Avastin, which was prescribed to restore some of their vision.  Some of the patients, including veterans receiving Avastin from the VA, went blind due to the infection.  Other off-label drugs have been recalled by compounding centers, which are only loosely regulated by the FDA, due to fungal contamination; in 2012, over six dozen people died after taking steroids contaminated with fungal meningitis by the New England Compounding Center.

Lessening coverage compared to Original Medicare:  The 2012 CMS memo held that MA plans could not use step therapy because Original Medicare plans are not allowed to use step therapy, and CMS requires MA plans to offer coverage equivalent to or better than Original Medicare.  Step therapy unfairly destabilizes MA patients’ health care by subjecting their treatment regimens to scrutiny through step therapy, creating uncertainty that Original Medicare patients do not experience.