U.S. authorities approved the world's first digital drug, an antipsychotic pill that signals smartphones once it reaches the gut so doctors can track whether patients are taking their medication.
Tuesday's greenlight from the Food and Drug Administration means Japan's Otsuka Pharmaceutical Co. can implant a chip containing minerals like silicon, magnesium and copper inside tablets of Abilify, which is widely used to treat schizophrenia, bipolar disorder and other mental illnesses.
Once swallowed, the chip mixes with stomach acids and sends a heartbeat-like signal to an adhesive patch worn on a patient's torso. The patch records the dosage and time of ingestion and relays this to a smartphone app for patients to monitor and share with doctors and caretakers.
Otsuka spent years testing the drug with Silicon Valley company Proteus Digital Health Inc., which provided the chip technology.
The invention is intended for patients with mental illnesses who don't always take their medication or may be forgetful. Digital drugs may also solve a couple of problems facing pharmaceutical companies and insurers: lower drug sales because of missed doses and higher medical costs treating patients whose conditions worsen.
But Otsuka faces basic questions: whether patients and physicians want digital pills, and, if so, how much insurers are prepared to pay.
The Japanese drugmaker must convince doctors that digitized Abilify significantly improves patients' compliance compared with the analog pill and cheaper copies now available. Otsuka also needs to show insurers the extra cost for the high-tech drug creates savings in treatment.
Otsuka's digital pill is competing against its own alternative form of Abilify: A long acting injection that reduces the risk of patients' missing doses because it is supervised by a doctor.
An Otsuka spokeswoman said the injectable is “not appropriate for all patients,” and “so there is a need to have a number of treatment options to choose from.”
Insurers will only cover digital Abilify once they see “real world evidence that this is a better approach,” said Troyen Brennan, the chief medical officer of CVS Health Corp., which administers drug benefits for employers, insurers and some state Medicaid programs in the U.S.
Ingestible devices, such as capsules that take pictures inside the body, have been around for years. But this the first time such a device has successfully been paired with a drug. Venture capitalists are betting on digital health care.
They poured $4.2 billion into 296 such startups in the U.S. last year, a fourfold increase in investment since 2011, according to Rock Health, a San Francisco- based venture capital fund. Companies that got funding last year were engaged in wearable technologies, digital devices, big data analysis and genomic sequencing.
The smallest vial of the long-acting injectable has a list price of $1,478. It is administered once a month and covered by major U.S. insurers. Kabir Nath, who manages Otsuka's drug business in the U.S., said the company hasn't decided on a price for digitized Abilify.
Proteus, a Redwood City, Calif.- based startup that developed the chip-and-patch system, counts Otsuka, Novartis AG and Oracle Corp. among its investors. Proteus Chief Executive Andrew Thompson said the ingestible chip is safe to consume.
The pill is for patients with mental illnesses who don't always take their medication.