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–health care provider relationship. 

One approach that should be avoided is known as Step Therapy.  This process is more accurately termed Fail-First therapy.  This approach is a complex and drawn out type 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 try less expensive, usually older medications — which frequently have a higher treatment failure rate because they are less effective and have more potential side-effects or less convenient dosing — before allowing the patient to receive the drug his 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 who has been diagnosed with diabetes.  His health care provider assesses his specific needs, prescribes an appropriate treatment plan, and recommends the best diabetes medication.  However, the family's health insurance won't cover that drug, instead insisting on 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 his 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 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 ten causes of death in the U.S.  The refusal of insurance companies to provide the originally prescribed drug ultimately leads to a patient receiving less efficient care, suffering longer than he needs to, letting the underlying medical condition progress, and causing hardship for both the patient and his 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 shortsighted 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 such an approach would be overwhelming, yet we are expected to be comfortable with that exact same approach being applied to our health.  

Put simply, Fail-First 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 conditions get 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.

Dr. Salvatore J. Giorgianni, Pharm.D. is senior science adviser, Men's Health Network.