For those following the debate over drug pricing, a new phrase may have entered your awareness, step therapy. Simply put, you begin with the simplest of medications and titrate to more complex medications or protocols based on patient response. The admin types and marketers would tell you that this was a form of precision medicine, fitting the prescription to the individual patient; in truth, it is how physicians have or should have been prescribing treatment. Do no harm often begins with simple measures.
Step therapy in the world of drug pricing is also about titrating medication to patient need, but its basis is on the least costly medication providing a satisfactory response. The emphasis on cost over efficacy is the sticking point in the debate. And to be fair, while the price is an issue we need to take into account, compliance, and effectiveness in the decision matrix. Insurance companies worry about the cost today, not the cost of non-compliance later on. Temporal discounting, the economic term for short-term thinking, is a bias to which all of us are susceptible.
A far bigger clinical issue, especially for the most ill and therefore vulnerable is step therapy’s opposite, polypharmacy. The term refers to taking several drugs at the same time, treating several different medical issues. A Canadian study that looked at the problem estimated that two-thirds of patients take five or more medications daily and that a quarter of patients take more than ten a day. Polypharmacy is as significant a problem for patients in the US. Leave aside the issue of cost, consider taking five different medications on 3 or more different schedules daily. There is a lot of room for error, and a big market in date labeled pill bottles or the latest e-version, Amazon’s newly acquired PillPack – a mail order pharmacy that prepackages your meds by both date and time.
The driving force behind polypharmacy are the increasing co-morbidities we have, rarely do we have one condition, we often have two, three or more. And there is a tendency to prescribe and forget, once the patient is on a workable dose, we give no further thought to their needs, needs that change. That is why I found my 90-year-old mother on a statin, she was put on the medication ten years earlier, and when her life and circumstances changed, the prescription was never re-evaluated in light of those changes.
To combat this, patients admitted to hospitals are often evaluated by the hospital-based pharmacist to down-prescribe medications. As a result of where this evaluation takes place, it reaches one of the populations at highest risk, the frail. The review seeks to eliminate drugs that are no longer indicated, that have adverse interactions with other medications the patient is taking or that no longer “align” with patient goals, as was the case for my mother. Unfortunately, the evidence that these changes make a long-term impact are weak, but this may be due to a short time frame and the difficulty in quantifying endpoints.
A newly published guideline from the American College of Allergy, Asthma, and Immunology suggest that physicians consider a step down for asthma medications. The goal, to maintain current wellness while reducing the “burden” of treatment be that cost or compliance. It is an excellent reminder to physicians that disease is not static and that what gets worse can get better. It also signals that the need to have feedback on therapeutic efficacy is necessary for chronic diseases as much as it is for acute infectious diseases. [1]
Step therapy, whether in increasing or decreasing the intensity and complexity of medication is an important role, one that is, parenthetically, more possible when there is continuity in care. It is too important a subject to be treated solely as a financial measure imposed by payers. It is an area where physicians can do better, where we can make use of the pharmacy members of the care team, and which may, as an unintended but welcomed consequence, reduce costs.
[1] Standard of care for infection would allow initial empiric therapy with a re-evaluation at 48-72 hours to redirect treatment based upon a patient’s response, cultures and antibiotic sensitivities.
Source: The Asthma Controller Step Down Yardstick Annals of Allergy, Asthma, and ImmunologyDOI:10.1016/j.anai.2018.12.004