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professor and chair, department of dermatology, Director Temple Itch Center, Temple University Health System
Step therapy policies place a large administrative burden on physicians, which, in turn, takes time away from patient care. Some states are working on legislation that seeks to regulate step therapy protocols and ensure they are safe for patients.
There has been a lot of discussion, here and nationwide, with the recent changes to health care in the United States, about strategies to keep the cost of prescription medicines down and the balance required to ensure quality health care.
One such strategy, known as “step therapy” or “fail-first,” is used by payers to withhold coverage unless a healthcare provider prescribes medications in a pre-determined order. Step-protocols typically require patients to fail on one or more generic drugs, then one or more payer-preferred branded therapies, before they can get a branded therapy not preferred by the payer.
Policies of this sort are undermining the treatment of patients with psoriasis in Pennsylvania. The reasoning behind step-therapy policies is often based on financial, not medical, reasons. The requirements do not consider an individual’s medical situation or history. And there are few, if any, existing regulations that require insurers to prove the safety and efficacy of their step therapy policies. With this process, insurance companies are cutting down on costs but limiting patients’ ability to get effective and appropriate medications for their individual situation.
In some cases, patients are required to try and fail numerous medications that may be inadequate for their particular situation. Patients may be required to take medications they previously tried without success, or that are contraindicated for them based on their medical history.
As a result, step therapy policies can severely delay access to a therapy a doctor deems is best-suited for the patient. In the course of these delays, patients’ disease may worsen. For up to 20 percent of patients, step therapy can even result in not receiving treatment at all.
As a dermatologist who treats many patients with sometimes severe psoriasis, I know that finding an effective medicine with an appropriate side effect profile for a given patient is no easy process. And yet, despite my years of medical training, my medical judgement and my relationship with my patient are being undermined with step therapy.
Particularly frustrating is the requirement by some insurance companies that patients “step through” psoriasis medicines that have black box warnings - meaning they may cause potentially severe side effects, even including tuberculosis. As a physician, I have pledged first to “do no harm.” So how can I be required to prescribe these types of medicines to patients for whom they are inappropriate?
For example, I have a patient with HIV and severe psoriasis. Given his dampened immune system, I would not prescribe an immune-suppressing medicine that could lead to severe infections. Yet his insurance company refuses to cover a newer, more appropriate oral therapy that lacks these potential side effects, despite my appeals.
Or take my patient with chronic heart failure and kidney disease. Although therapies called TNF inhibitors are inappropriate for someone with these health problems, his insurance company is pushing me to prescribe them for his psoriasis.
It’s not surprising, then, that step therapy policies place a large administrative burden on physicians like me and other health care staff. We have to contact insurance companies to determine whether a prescribed medication will be covered or to file an appeal if the medication is denied. This burden, in turn, takes time away from patient care.
It’s time to do something about step therapy. Some states are working on legislation that seeks to regulate step therapy protocols and ensure they are safe for patients. Illinois, for example, is currently debating House Bill 3549, which would ensure step therapy programs are based on clinical guidelines developed by independent experts, guarantee that the exceptions process is transparent and accessible to patients and health care providers, and establish a framework for when it is medically appropriate to exempt patients from step therapy.
Pennsylvania needs to consider similar legislature.
Of course we should not be wasting our health care dollars. There has to be some regulation, or the system will be bankrupt. But final decisions should not be made by a representative of a regulatory agency who has not examined the patient and who does not understand his or her specific concerns. They should be made by the physicians who have the appropriate education, experience and knowledge.