fail first fails

Fail First is the Wrong Prescription for Patients

As policymakers and health care stakeholders consider reforms to address the cost of medications, Men’s Health Network (MHN), the leading health advocacy and education non-profit for advancing the comprehensive health of boys and men in America, urges lawmakers and regulators to reject outright policies that will prevent or constrain patients from accessing effective medications necessary to treat their diseases and improperly insert themselves into the patient-healthcare provider relationship.

One such approach that should be avoided is known as Step-Therapy but this process is more accurately termed Fail-First therapy. This approach is a complex and drawn out type procedure that requires a payer to give approval to the patient before a medication can be started (known as prior-authorization). It requires that a patient must try less expensive, usually older medications — which are frequently have a higher treatment failure rate because they are less effective, have more potential side-effects or less convenient dosing — before allowing the patient to receive the drug their health care provider recommended based on the patient’s individual needs.

As a practicing clinical pharmacist and former pharmacist educator, I have seen firsthand the potential problems this Fail-First approach to care has on patients, the lost productivity it leads to, and how it not so subtly undermines the relationship between health care providers and patients, replacing it with a third-party organization (often a for-profit entity) at the center of decision making.

Picture an adolescent child that has been diagnosed with diabetes. Their health care provider assesses the child’s specific needs, prescribes an appropriate treatment plan and recommends the best diabetes medication for them. However, the family’s health insurance won’t cover that drug, instead insisting on only paying for a different, older and less expensive option. The patient must start on this insurance company‘s “preferred” drug and wait for the drug to fail before being permitted to try the medication originally recommended by their physician. Worst of all, this cycle could happen many times over several weeks, months or even years before the patient is finally able to access the originally prescribed medication.

While most agree that a Fail-First strategy is inappropriate for so-called “life threatening” conditions it is sometimes very difficult to appreciate that even common medical conditions, such as high-blood pressure, diabetes, and lung conditions such as COPD if not treated effectively quickly are life-threatening.  Just look at the mortality figures where these four conditions are among the top 10 causes of death in the US.  The refusal of insurance companies to provide the originally prescribed drug ultimately leads to a patient receiving less efficient care, suffering longer than they need to, letting the underlying medical condition progress and causing hardship for both the patient and their caregivers. This is just not right!

This protocol cook-book approach to prescribing medications is clearly geared to saving money and profit margins for payers and not optimizing patient care.  This is short sighted and a penny wise, pound foolish policy.

Imagine if we applied such a Fail-First step approach to other areas of our lives? Imagine if airline companies were directed to use older, less effective instruments and wait for them to fail before using the newer, effective, and recommended parts. The potential catastrophes and outrage that would ensue from an approach would be overwhelming and yet, we are expected to be comfortable with that exact same approach being applied to our health.

Put simply, the Fail-First approach to selecting treatments is a fundamentally flawed and dangerous practice that values cost-cutting over the individual needs of patients, the expertise and advice of the prescriber and effective care early on in a disease process. Patients deserve the best chance of success from the very beginning of their treatment, and stakeholders must work together to make changes that improve our programs while also ensuring that patients have access to the best quality care available, without having to wait while their condition gets worse.

MHN believes that preserving patient-provider relationships and ensuring access to the full range of technologies available based on individual patient needs, not cost, must be the core principle of any health benefit plan.

Photo by Nathan Cowley from Pexels

Dr. Salvatore Giorgianni

View posts by Dr. Salvatore Giorgianni
Dr. Giorgianni is an expert in men's health, is Senior Science Advisor to Men's Health Network, and is a registered pharmacist. He is a recognized expert in drug regulatory and US pharmaceutical policy as well as in organizational reputation management and strategic alliance development. He has authored, co-authored or presented some 200 works in health care, industry regulation and business. He is an advisor and board member to several health advocacy associations including: Men's Health Network; American Osteopathic Medical Foundation; Kappa Psi Scholarship Foundation; Nurse Practitioner Health Care Foundation and the National Association for Continence. He is a founding member of the Dialogue on Men's Health, a presenter at the White House conference on Men's Health, and a contributor to the SAGE publication, American Journal of Men's Health. Dr. Giorgianni had a 26 year career with Pfizer Inc, where he held positions in the medical, regulatory, training, public policy, business planning, sales and marketing groups. Most recently he served as Pfizer's Director, External Relations. He also directed several publications, including the Pfizer Careers In Health Care series and The Pfizer Journal: Perspectives in Health Care and Biomedical Research.

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