Patients with autoimmune diseases like multiple sclerosis have described their conditions as feeling like their bodies are in a prison from which they are unable to escape.

Too often, that sense of imprisonment is compounded by the way in which insurers and pharmacy benefit managers (PBMs) are confining and controlling patients and medical professionals, strictly limiting their efforts to achieve greater health.

Step therapy is an ill-conceived, economically-driven practice that requires patients to try several insurer-preferred drugs before their insurer will cover the medicine that their doctors originally prescribed. This ‘fail first’ practice is an insidious mechanism, designed to save insurance companies money even though it harms those most in need of specific medications and treatments, particularly individuals with autoimmune diseases.

To help raise awareness of the harmful effects of step therapy, Let My Doctors Decide (LMDD), a national partnership of leaders across multiple therapeutic areas working to ensure that treatment decisions are left up to doctors and patients, released a set of patient principles and a petition that will be sent to federal and state/local policymakers encouraging reforms and raising awareness of the harmful ramifications of step therapy. The principles state that:

• Patients and physicians should make individual treatment choices.
• You cannot treat all autoimmune diseases the same, as responses to therapies vary widely from patient to patient.
• Patients should have access to easily understood information about their coverage: what is covered, how much it will cost them personally, and how to get coverage approved for the treatment they need.
• At the pharmacy counter, patients should receive discounts, rebates, and other insurer and non-insurer savings that help make medicines more affordable.

LMDD, among other key stakeholders and health-focused organizations, recommends that any step therapy requirements be clinically based on current evidence and used for medical reasons only, not for economic reasons. We strongly recommend prohibiting the switching of medications for non-medical reasons without the prescribers’ consent. And, we encourage exempting patients who have established stability on a physician-directed treatment from step therapy or other prior authorization requirements.

These principles and recommendations are the latest in a series of patient-focused initiatives led by LMDD to ensure decision-making treatments are made by doctors – not insurance companies and PBMs. Earlier this year, LMDD released research from Emory University that found that most private and Medicare plans are severely limiting coverage on medications for five of the most prevalent autoimmune diseases. The study looked at several coverage limitations including authorization, formulary status, tier

placement, and step therapy. Each plan was “scored,” and 86 percent of Medicare Advantage plans received an F for coverage of autoimmune drugs, while 48 percent of private insurers received an F. Within private insurers, another 50 percent of companies rated a C, and none received an A.

The evidence doesn’t stop there. In a survey by the American Medical Association, 90 percent of physicians reported that prior authorization requirements imposed by health plans have had negative clinical impacts on their patients. Other studies and surveys have found similar results, indicating step therapy does more harm than good.

And, according to survey results released last week in a white paper by Xcenda, respondents said they were concerned that step therapy diminishes the provider-patient relationship and transfers their clinical decision-making role to payers – employers and health care plans — who do not have the comprehensive, long-standing picture of the individual patient.

Escaping the madness of step therapy will be a focal point at the upcoming American College of Rheumatology Annual Meeting in Atlanta this week. LMDD will host an “escape room” – an interactive maze — to illustrate, first-hand, the frustrations associated with step therapy and “fail first” protocols. The “Escape the System” simulation is designed to demonstrate the control and confinement of step therapy, show how it second guesses providers’ expertise, interferes with the doctor-patient relationship, and negatively impacts patient health.

The clinician-patient relationship is an incredibly powerful force in our healthcare system for improving health outcomes. Treatment decisions should always be made by patients and trusted health care professionals, not insurance companies or PBMs. Ill-conceived “fail first” strategies undermine the clinician-patient relationship, harm patient health, increase the paperwork burden on clinicians, and add unnecessary costs.

There is an important distinction between sound medical protocol and economically-driven rules and processes that do not take into consideration what is best for the patient. Patients should not be required to find an escape route to receive the doctor-recommended medicines and strategies for improved health and wellness. It’s time to stop the step therapy madness.

Written by Randall Rutta

Randall Rutta is President of the American Autoimmune and Related Disease Association and Executive Director of Let My Doctors Decide.