The emerging field of digital therapeutics has developed new tools with the promise to either replace or supplement traditional medical devices and therapies.
Increasingly, it appears that the general public is open to using these digital tools as part of their part of their treatment options.
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A new report from PWC found that 54 percent of surveyed consumers would be open to trying an FDA approved digital app or online tool to treat their medical condition.
What’s more is that the report found that 56 percent of physicians have brought up the potential for a digital therapy as an option for their patients, and 26 percent have discussed the option after a patient brought it up.
Some of the benefits of digital therapies are clear: treatment adherence is more easily monitored and side effects from digital therapeutics are generally less severe than in traditional treatments.
Additionally there’s been a steady rise in connected health services and the general prevalence of digital health tools. Case in point, a Rock Health report released last summer found that in 2017, around 87 percent of survey respondents adopted at least one digital health tool, which included telemedicine visits and online provider reviews.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Traditional biopharma companies have also started to put serious cash behind efforts to incorporate digital therapy solutions alongside traditional drugs.
One recent case is the partnership between smart pill startup Proteus Digital Health and Japanese pharma company Otsuka on Abilify MyCite, a digital sensor inside a pill which which records medication adherence for the anti-psychotic medication. The Silicon Valley company, which has raised nearly $500 million from investors like Novartis and Otsuka, has now entered into the oncology space with a digital version of a chemotherapy medication often used to treat breast and gastrointestinal cancers.
Digital therapies have been pitched as a possible aid when drugs and substance abuse themselves are the issue. Novartis and Pear Therapeutics teamed up on an FDA-cleared app-based therapy called reSET-O meant to increase retention for opioid addicts in outpatient treatment programs. The application is part of a larger partnership between the two companies to advance digital therapeutics supplementing Novartis drugs for schizophrenia and multiple sclerosis.
“I think we will see a lot more collaboration between pharmaceutical and technology companies to drive this forward, ultimately to the benefit of patients,” the report quotes GlaxoSmithKline Commercial Data Officer Sai Jasti as saying.
However, one instance mentioned by the PWC report, a birth control app created by Swedish company Natural Cycles illustrates some of the untested nature of the industry. The company has drawn scrutiny from Swedish authorities over its contraceptive claims and unwanted pregnancies from those using the app.
There are more than a few barriers (aside from patient interest) standing in the way of large-scale adoption of these sorts of digital tools in clinical practice.
For one, details are still being worked out Version 1.0 of the agency’s working model on the FDA’s “pre-cert” program, which is meant to create a regulatory pathway more in line with the software iteration cycle necessary to develop these kinds of technology.
The working model relies on an initial judgement of the developers of the program through a so-called Excellence Appraisal which would put companies on a pathway to more personalized regulatory review and approval. The first approvals under this new framework are expected to come sometime this year.
Still, public interest in the area has been matched by both regulatory action and potential reimbursement for remote patient monitoring and digital consults to provide the financial lift to promote adoption.
Photo: Getty Images, photo_chaz
