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Each chemotherapy pill, capecitabine, is packed with an ingestible sensor that sends a message to a patch worn by the patient, which then transmits information, such as the time dose, the type of oral chemotherapy taken and certain physiologic responses to medication, to a mobile-friendly platform developed by Proteus.
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Edit Kovalcsik, Pharma Analyst at GlobalData, says: “This remote monitoring platform gives providers and caregivers the opportunity to help patients adhere to medication and tailor treatment regimens to individual cancer patients, based on the specific information recorded by the device.”
Proteus already has a digital pill with ingestible sensor–Abilify MyCite, which combines Otsuka Pharmaceuticals’ antipsychotic drug, Abilify (aripiprazole), approved by the US FDA in 2017 for schizophrenia, bipolar disorder and depressive disorder. However, it has demonstrated a very slow take-off as it has not yet been prescribed outside of clinical trials.
Kovalcsik adds: “Fast approval processes are critical for software-based digital health solutions because they need constant updating to keep up with the fast-evolving technology.”
As a result, software companies are employing various business strategies to gain a larger patient share where seeking reimbursement is critical to ensure greater patient access through routine prescriptions.
Kovalcsik continues: “The advantage of Proteus’ digital chemotherapy pill is that the sensor is packaged loosely within the capecitabine-containing capsule, which is prescribed routinely by physicians. Unlike in Abilify MyCite, the ingestible sensor is inserted into each capsule by the pharmacist; therefore, it does not require additional FDA approval, as Proteus’ ingestible sensor was FDA-cleared back on 30 July 2012.”
Moreover, Proteus arranged for a sort of evidence-based payment structure, where Fairview only makes payments to Proteus if the cancer patient taking the digital chemotherapy is at least 80% compliant with the medication.
Proteus is however not alone to look towards the lucrative oncology market. Voluntis, which already has FDA-cleared diabetes management software on the market, Insulia and DIABEO, also aims its pipeline products at the oncology space and has teamed up with Roche.
Kovalcsik concludes: “Nevertheless, the commercial value of these digital technologies in healthcare will be subject to the extent of their adoption by patients and physicians and the implementation of a payment structure that could save cost and resources to the healthcare system.”
