May 12, 2021 at 5:00 am ET
“First, do no harm” is the vow all health care professionals abide by, yet the same oath is not required by other health system participants.
The most often implemented utilization management strategy by insurance companies to reduce drug spending is step therapy, colloquially known to patients as “fail first.” This practice results from negotiations between a drug manufacturer and an insurer or pharmacy benefit manager, leading to coverage of certain biopharmaceuticals. Unfortunately, the fail-first protocols mandate that a patient ought to fail on one or more drugs that their provider did not select for them, effectively de-prioritizing the disease management decisions made by providers and their patients.
That being said, for the past decade, patient advocacy organizations working in collaboration with provider groups and policymakers have advocated for states to regulate and reform step therapy policies by making the protocols transparent and allowing providers to request exemptions when medically appropriate. As a result, over the past dozen years, 29 states have enacted such laws.
State Step Therapy Laws Protect Very Few Patients
Despite the passage of state step therapy laws, a new study published in the journal of Health Economics Policy and Law demonstrates that the resulting legislations protect fewer than 10 percent of state populations because states do not have jurisdiction over ERISA (Employee Retirement Income Security Act) insurance plans and/or the legislation absolves state Medicaid programs.
State Step Therapy Laws Lack Regulation and Enforcement
State laws require an insurer or PBM to review, respond to and accept provider requests bypassing step therapy protocols and adhere to a list of standard medically necessary exceptions. However, only six state laws allow the most six common reasons for requesting a provider’s exemption. For example, California and Oregon state laws do not include any common exemptions in the legislative language, while Missouri, Arkansas and Colorado allow only one type of exception.
Furthermore, in 10 states, legislation language lacks regulations allowing patients and providers an appeals process if an exemption request is denied. Finally, although some state laws impose a specific time period within which the insurer or PBM must respond (e.g., 24-48 hours) to an exemption request, in nine states, insurers or PBMs have no obligation to respond to that request.
Patients Lose When Payers Block Access
There are instances when step therapy is a necessary policy, such as when a bioequivalent generic or biosimilar can be utilized prior to using a brand-name medicine to directly lower out-of-pocket costs for patients or account for a patient’s treatment history. However, serious consequences come about when providers cannot secure medically necessary exemptions of step therapy protocols for their patients rendering them to suffer through prolonged periods of inappropriate therapies.
Patients also seldom benefit from any of the cost savings through such policies.
We Can Do Better
There is no empirical evidence that step therapy reduces overall health care costs and improvements in patient outcomes short or long term. Insurers or PBMs and their clinical staff have never explained what it means to fail. Should a patient suffer from worsening disease symptoms or side effects, or maybe be hospitalized? Insurers and PBMs also unnecessarily demand that providers justify every single intervention they utilize through mounds of paperwork. ‘Isn’t it time to make insurers and PBMs provide a similar evidence level for their step therapy policies?
It is time to go back into the states to fight for more transparent, more enforceable laws that help more patients, particularly those with chronic diseases who rely on stable, affordable access to the medications prescribed by their providers.
Robert Popovian, Pharm.D., M.S., is chief science policy officer at Global Healthy Living Foundation and a senior health policy fellow at the Progressive Policy Institute.
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