Step therapy puts patients' health in jeopardy

On a typical day at Texas Rheumatology Care, my waiting room is filled with patients with rheumatoid arthritis, psoriatic arthritis, lupus and osteoarthritis. Quite a few of those will need a change in therapy and, in some cases, aggressive therapy. This can mean 45 minutes or more of patient education and psychological and family counseling.

Often, patients will need certain, specific types of drugs, but at the end of a given day, it's not unusual for me to be left with a sinking feeling and a stack of yellow sticky notes from my office manager: My first choice of drug for my patients will not be approved.

The reason for this is a practice known as step therapy, first introduced in 1980 by managed care organizations and pharmacy benefit managers to save money by limiting the list of drugs that may be prescribed. The practice can be beneficial for some diseases, but for specialized types of medicine — rheumatology, for example — blocking access to a specific type of drug can lead to pain, irreversible joint damage and permanent disability.

Pharmacological decision-making is nuanced to each particular patient and their medical history. Certain drugs do better with certain diseases, and patients with multiple conditions must keep vigilant watch over their various prescriptions. This is not a decision that is taken lightly, and each choice requires full comprehension of a patient’s long history.

After a doctor has decided on a certain drug, that medication needs to be authorized. The authorization process is undertaken by office managers, and it is nearly a full-time job: Reams of paperwork need to be filled out asking often-duplicitous questions and requiring a history of every drug a patient has ever taken for their condition — but very rarely allowing us to elaborate on the patient's unique condition. Texas recently introduced a standardized authorization form, but pharmacy managers use it infrequently at best.

Authorization also often involves talking to pharmacists who are unaware of the disease we're attempting to treat or the particular drug we're trying to treat it with — and who are more often than not unaware of the ramifications of arbitrary decision-making. Frequently, the process further requires a peer review — but I have never talked to a fellow rheumatologist during these reviews.

While step therapy may lead to cost savings, those savings don't extend to the patient. Far from being based on fair-market pricing of the drugs in question, prices are often based on negotiations between the manufacturer and the pharmacy board. Often, insurance will admit that a drug is part of their approved list, only for pharmacy benefit managers to remove it. Moreover, patients are forced to use a particular specialty pharmacy, with severe penalties common for not doing so.

Legislators in several states, including Indiana, Maine and Massachusetts, have recently introduced laws that would ban step therapy because of its negative effects on patients. I urge Texas to do the same.

The step therapy strategy undermines the clinical decision-making of physicians to puts insurance companies and the pharmacy managers in the driver’s seat. Prescribers should have the final say in the medicine a patient receives, and the patient's health and well being should be the focal point for every decision regarding drug treatment regimens.

Fehmida Zahabi

Founder, Texas Rheumatology Care