Are Smart Bottles the Solution to Medication Non-Adherence?

Medication non-adherence costs the health care system $300 billion about per year.

Very few patients carry through with the full process of filling a prescription, picking it up, taking every dose, and repeating the process with refills until the prescriber says they can stop. Sometimes, that non-adherence is intentional, such as when the patient decides that the medication is not necessary or that the cons (eg, the adverse effects, cost, and inconvenience, etc.) outweigh the pros. And sometimes, it is unintentional, mostly showing up as forgetfulness, leading to missed doses. In either case, we know that this is a problem. What has been missing is a solution.

In all likelihood, there never will be a magic bullet that solves the problem of non-adherence for all patients. However, there are a lot of companies out there trying to address non-adherence through the use of smart bottles, which are advanced prescription vials designed to promote adherence through the use of caregiver, health care provider, and patient alerts and reminders. The smart bottle companies also stand to improve medication persistence. Where adherence is defined as the percentage of doses taken as prescribed, persistence is the duration of time from initiation to discontinuation of therapy or to the time a patient exceeds a permissible gap.

But why do we care about improving adherence and persistence? Well, provided that the patient is prescribed the right drug, adherence is in the best interest of all stakeholders. The adage that “the most expensive drug is the one not taken" is true. Adherence is related to positive health outcomes, which obviously benefits the patient. But prescribers also want positive outcomes in order to rate well within their networks, among other reasons. And payors or insurance companies want positive outcomes, because, theoretically, medical costs should then decline. Although manufacturers and pharmacies also want positive health outcomes, it is much easier to measure how improved adherence correlates with improved revenue for payors and prescribers.

Let's look at both the costs and the data related to smart bottles.

Dollars

Because smart bottles typically are best used in the specialty market, let's look at the drug tofacitinib (Xeljanz) an oral therapy for autoimmune disorders, such as rheumatoid arthritis and ulcerative colitis. Let's look at the relationship between adherence and profit for a pharmacy. Hypothetically, let’s say a pharmacy has 10 patients on tofacitinib. Here are some made-up figures for a 30 days’ supply: At an average wholesale price (AWP) of $4000, reimbursement of AWP, minus 10%, and a pharmacy cost of $3400, the pharmacy is looking at a gross profit of $200 per dispense. Because adherence measures look at things in terms of days medication is possessed or covered (see this article on adherence measures), let's convert that to profit per day. Now, for every extra day that a patient has this medication, that translates to an extra $6.66 of gross profit for the pharmacy. Over a year’s time, a 10% improvement in adherence equates to an extra 36.5 days with medication or about an extra $250 of profit for the pharmacy per patient. Multiply this by 10 patients, and we are looking at a handsome incremental profit for helping those patients improve their adherence by 10%.

This example illustrates a starting point for evaluating return on investment (ROI) for devices geared toward improving adherence, such as smart bottles. It is helpful in answering the questions: How much can I expect intervention X to improve adherence; what does intervention X cost; and will the profit generated from improved adherence cover that cost? In the example, if the intervention were a smart bottle offering for patients taking tofacitinib and it was expected to improve adherence 10%, it could have an ROI and may be worth considering if the cost of that offering was less than $250 per patient per year.

That said, smart bottles are not cheap. Think “miniature cell phone” in terms of some of the capabilities of these bottles. By the time the cost of the bottles including the hardware and software is taken into account, the profit generated by increased adherence may not be enough to justify a smart bottle offering. This is where the value of the data must be considered.

Data

Many bottles record the dose-by-dose, or, more importantly, the missed-dose-by-missed-dose, behavior of patients that can be extracted and reported on in aggregate. And, most bottle programs are drug-specific and involve the manufacturer of that drug. The manufacturer can use the data collected by smart bottles to better understand its drugs.

Let’s consider a new oral oncolytic that was just approved. Clinical trials were completed, and the manufacturer understands the rates of adverse effects reported. But remember that those clinical trials were conducted in a vacuum. The sample size was small and subject to strict inclusion criteria compared with the eligible population that could benefit from the drug post-approval. In real life, data collected by a smart bottle and solicited during interventions prompted by the bottle could pinpoint exactly when specific adverse effects are leading to non-adherence, with or without early discontinuation. The data might even show that a rare adverse effect observed in clinical trials is occurring much more frequently post-marketing. Those adverse effects could better be addressed proactively by the dispensing pharmacies and the manufacturers, in hopes of helping patients overcome them and remain on therapy.

If the data provided by a smart bottle program could allow a manufacturer to do this, then the ROI improves as a pharmacy can add this to the fair market value of the offering when a manufacturer is sponsoring the entire program. Alternatively, the pharmacy could sell the data a la carte to interested manufacturers.