Debate: Will digital therapeutics gain the required levels of awareness, adoption, reimbursement and fulfillment to become sustainable?

Can dig­i­tal ther­a­peu­tics become prof­itable? (MedTech­Dive):

In 2020, the Food and Drug Admin­is­tra­tion cleared Akili Inter­ac­tive’s video game to improve atten­tion in kids with ADHD. It was the first time that a video game for treat­ment was cleared by the agency, and is one exam­ple of a dig­i­tal ther­a­peu­tic, a class of soft­ware-based treat­ments with FDA indications.

Now, as the mar­ket is fur­ther devel­op­ing, these com­pa­nies have built up big ambitions.

Corey McCann, the CEO of Pear Ther­a­peu­tics, which has three FDA-cleared dig­i­tal treat­ments, hopes to make them the stan­dard of care and gar­ner wide­spread insur­ance cov­er­age. After going pub­lic last year, Pear aims to increase its rev­enue 30-fold by 2023, based on expec­ta­tions that more insur­ers will cov­er its prod­ucts, and more physi­cians will write prescriptions.

How­ev­er, it remains to be seen whether they will be able to achieve these goals, or sus­tain the costs that come with devel­op­ing a new class of treatments.

While get­ting FDA clear­ance was a first step, experts iden­ti­fied sev­er­al hur­dles ahead, includ­ing get­ting physi­cian uptake, build­ing path­ways to reim­burse­ment, and impor­tant­ly, devel­op­ing soft­ware that patients will want to use.

“There’s still a lot of foun­da­tion­al work that needs to be done,” said Maya Desai, direc­tor of life sci­ences for Guide­house. “There’s a lot of behav­ioral change that needs to hap­pen across the stake­hold­ers and their mind­sets to think about dig­i­tal ther­a­peu­tics as a cat­e­go­ry of its own.” » Keep read­ing excel­lent arti­cle HERE, over at MedTech­Dive

News in Context:

A con­ver­sa­tion at the fron­tier of dig­i­tal health inno­va­tion, FDA reg­u­la­tions, and cog­ni­tive health:

In terms of spurring inno­va­tion, one approach is to have a reg­u­la­to­ry par­a­digm that’s bet­ter suit­ed for these devices. Because if you set the bars in the right place, and we’re not talk­ing about chang­ing the US autho­riza­tion stan­dard of safe­ty and effec­tive­ness, but instead pro­vid­ing greater flex­i­bil­i­ty on how that stan­dard is met and bet­ter tai­lored to the tech­nol­o­gy, this cre­ates effi­cien­cies, reduces unnec­es­sary costs, and makes it more attrac­tive to have inno­v­a­tive tech­nol­o­gy come to the U.S. And I’d love to see bet­ter reim­burse­ment avail­able, as well, because we know that will dri­ve great tech­nolo­gies com­ing to the mar­ket­place … And if we can get pay­ment poli­cies to come into align­ment, I think the U.S. would be incred­i­bly attrac­tive for inno­v­a­tive tech­nol­o­gy to be devel­oped and avail­able, and that includes in the Alzheimer’s space. — Dr. Jef­frey Shuren, a behav­ioral neu­rol­o­gist who has held a vari­ety of lead­er­ship roles at the FDA and CMS

• Dig­i­tal ther­a­peu­tics pio­neer Akili Inter­ac­tive plans to go pub­lic in mid-2022 at a $1B valuation
• Pear Ther­a­peu­tics rais­es $175M and goes pub­lic via SPAC deal rais­ing the pro­file of pre­scrip­tion dig­i­tal ther­a­peu­tics (Update: shares were priced at $10 on Decem­ber 6th; they are $4.59 at end of April 20th)
• Lyra Health, Big Health and Mantra Health raise a com­bined $332M to com­mer­cial­ize dig­i­tal ther­a­peu­tics for mental/ behav­ioral health
• The Nation­al Acad­e­my of Med­i­cine (NAM) shares dis­cus­sion paper to help empow­er 8 bil­lion minds via the eth­i­cal adop­tion of dig­i­tal men­tal health and neurotech
• A call to action: We need the right incen­tives to guide eth­i­cal inno­va­tion in neu­rotech and healthcare