The FDA made a landmark decision in November 2017 when it rubberstamped the first trackable, sensor-embedded pill that connects to a smartphone. But a comprehensive review of the FDA’s process reveals that the digital pill was approved based on sparse evidence, and it doesn’t augment medication compliance, according to a study published in The BMJ.
There’s no evidence that patients using pharma giant Otsuka’s Abilify MyCite — the digital version of Abilify, which is used to treat bipolar disorder and schizophrenia — were any better at sticking to their medication regimens than those taking the traditional form of the drug.
This adds weight to the concerns that have bubbled up since the smart pill garnered FDA approval — and could pump the brakes on smart pills’ advancement in medicine.
Here’s why the FDA’s approval of Abilify MyCite held promise for drug uptake in the US:
- The smart pill was celebrated as a “Band-Aid” to the US’ costly medication adherence problem. The idea was: Keeping tabs on when patients take their meds via smart pills’ integrated sensors could help payers vacuum up costs of members who don’t follow their regimens. The US pours out up to $300 billion annually on medication nonadherence — a portion of which is spent on patients who might qualify for Abilify MyCite and have lousy medication adherence rates. Patients with schizophrenia have among the lowest adherence rate, with only 50% taking their medications as instructed in some studies, per Bright Quest.
- We originally postulated that Abilify MyCite would serve as a launching pad for other pharma firms to create digital medication for other conditions with low medication adherence. Drug companies that developed drugs for conditions that don’t generate symptoms — like high cholesterol — could have benefitted from creating digital versions since patients with asymptomatic conditions have low adherence rates, for example.
Payers likely won’t warm to smart pills like Abilify MyCite while evidence of their benefits remains meager — but smart pills aren’t doomed just yet.
- Abilify MyCite is priced at $1,650, while generic Abilify costs $20, Forbes notes. If the smart pill adds no value to the medication and can’t promise cost reductions, it’s unlikely insurers will purchase the costlier digital version.
- But other smart pills have cropped up that might win payers’ trust. Proteus Digital Health, the company behind Abilify MyCite’s tech, also designed a digital chemotherapy pill — and because the sensor isn’t embedded in the active medication of the pill, FDA approval wasn’t necessary, Stat reports. This treatment also differs from Abilify MyCite in that it costs insurers no more than standard pills.
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