The approval last week of Proteus and Otsuka’s Abilify MyCite, the world’s first pill incorporating a sensor to detect when it is absorbed, has underlined the many fields in which such a technology could be useful. One of these is in tracking patients’ use of addictive opioid painkillers, and Etectrx – the only other company in this space – has just reported data in just such a setting.
“There hasn’t been anything that provides this level of medication adherence tracking at this level of accuracy ever before,” says Etectrx’s chief executive, Harry Travis. “With the advent of ingestion event monitors from Proteus and Etectrx we’re stepping into a whole new arena.”
Etectrx’s ID-Cap technology is a gelatine capsule containing a microchip that, when swallowed, reacts with gastric acid to power a battery and send a weak radio signal through the skin to a receiver worn around the neck. This transmits the information to a smartphone app and the patient’s doctor.
Etectrx’s ID-Cap technology
The tech is being studied in a number of early pilot trials funded by the NIH and academic institutions, including one assessing its use in improving compliance with Gilead’s HIV prophylaxis product Truvada PrEP.
The trial that reported this week was a pilot study of 15 opioid-naive acute fracture patients prescribed oxycodone digital pills to take as needed, with the rest returned to the hospital a week later. It found that the patients self-administered most of the oxycodone doses within the first three days after discharge, and on average took six pills despite being given 21.
The study proved that the patients liked the technology and that it could track drug usage, though not perfectly – the digital pills recorded a total of 112 ingestion events compared with 134 based on pill count. However, all the missed ingestion events were traced back to two study participants who ingested digital pills without wearing the reader or did not interact with the reader owing to severe pain. Mr Travis says the app reminds patients to wear their reader when they take their pills.
What has not been shown yet is that the digital pills can actually improve adherence. This is also true of Proteus Digital’s similar technology and the many other devices that claim to boost compliance, such as smart pill boxes that can tell whether the patient has opened them – though not, of course, whether the patient has actually swallowed the pill.
For approval, at least, this proof is not necessary. “In general the FDA looks for equivalence to existing products that are on the market, usually from a safety and efficacy standpoint – can you detect the ingestion event? Not so much can you improve adherence,” Mr Travis says.
The FDA may not care about boosting adherence but one group of people certainly will: payers. The ID-Cap is of course more expensive to produce than a standard gelatine capsule, and if it is to be adopted payers will want to see proof that money can be saved elsewhere.
“We will need to be able to show the value of adherence,” Mr Travis says. “There will be a premium, there will be a cost for the capsule and the sensor and the system, and it is going to have to show that the adherence improvement is there. And even beyond that – that if patients are adherent there are good outcomes.”
One use of the technology that could well appeal to payers is the tracking of expensive drugs in areas like oncology. “If the patient isn’t using a high-cost medication they’re just wasting that money from the [healthcare] system,” Mr Travis says.
Reimbursement is a consideration for the future; first the company must get a sensor-drug combo to the market. Etectrx intends to submit a 510(k) clearance application for the empty capsule, using Proteus’s sensor as the predicate, in the US in the middle of next year. Approval applications in other territories will follow.
If ID-Cap gets approved as a medical device the group could partner with a pharma company to create a combination product. The pharma group would then submit that dosage form under a US NDA. This is the pattern established by Proteus, whose sensor was approved as a de novo 510(k) in 2012 but the combo was approved as an NDA – on the second time of asking (First sensor-pill combo approved, but better compliance unproven, November 14, 2017).
Alternatively Etectrx could sell the empty capsule into the pharmacy market, allowing pharmacists to use it to create a digital form of a particular drug. This could work within an adherence programme that might be offered by a health plan, insurance company or integrated delivery network, Mr Travis says.
“We don’t absolutely need a pharmaceutical partner, but clearly the market is very big and many pharmaceutical manufacturers are looking at the digital enhancement of their drugs in a number of different ways – so that is a major part of our strategy,” he says.
A huge number of therapy areas could benefit from a device that can improve patient adherence: if transplant patients take their immunosuppressive drugs they could avoid the expense of rejection treatment or subsequent operations; if tuberculosis patients comply with their antibiotic regimens the emergence of resistant strains, and the expense of countering them, will be curtailed.
Further development will be expensive, and Etectrx will be seeking venture capital funding starting in January, Mr Travis says.
The company will only be able to make a success of its technology by demonstrating that it improves outcomes and saves money. The next step, as for Proteus, will be demonstrating improved compliance.