Key Trends in Dig­i­tal Ther­a­peu­tics

Dig­i­tal med­i­cine has be­come a ma­jor com­po­nent in an ever-evolv­ing health­care en­vi­ron­ment. You’re like­ly al­ready fa­mil­iar with dig­i­tal tech­nolo­gies such as tele­health plat­forms and elec­tron­ic health records. Plus, there are hun­dreds of thou­sands of well­ness apps avail­able to any­one on smart­phone app stores.

But there’s a rea­son dig­i­tal med­i­cine and even more specif­i­cal­ly, dig­i­tal ther­a­peu­tics ex­ist in a sub­cat­e­go­ry of their own. A dig­i­tal ther­a­peu­tic is typ­i­cal­ly de­scribed as an ev­i­denced-based soft­ware so­lu­tion, which are held to the same stan­dards of reg­u­la­to­ry over­sight as more tra­di­tion­al med­ical de­vices. Dig­i­tal Ther­a­peu­tics can pos­i­tive­ly im­pact the tra­jec­to­ry of a pa­tient’s dis­ease and are ap­proved to de­liv­er spe­cif­ic clin­i­cal out­comes. In oth­er words, Dig­i­tal Ther­a­peu­tics are viewed as clin­i­cal­ly val­i­dat­ed soft­ware so­lu­tions used by clin­i­cians to treat, man­age, and pre­vent a broad spec­trum of dis­eases and dis­or­ders. This dif­fers sig­nif­i­cant­ly from con­sumer health apps that track health or aid in the care process in some way.

Al­ter­ing how health­care is de­liv­ered

Dig­i­tal ther­a­peu­tics can be en­abled by soft­ware alone, or com­bined with oth­er in­ter­ven­tions, such as med­ical de­vices or phar­ma­ceu­ti­cals. The dig­i­tal ther­a­peu­tics yield clin­i­cal out­comes, mak­ing their soft­ware pro­grams akin to med­ical de­vices. The soft­ware pro­grams used in dig­i­tal ther­a­peu­tics gen­er­al­ly have un­der­ly­ing ar­ti­fi­cial in­tel­li­gence ca­pa­bil­i­ties to an­a­lyze big da­ta sets and gen­er­ate pre­dic­tive in­sights to im­prove and ini­ti­ate care in re­al time. In this way, dig­i­tal ther­a­peu­tics can play a crit­i­cal role in ex­pand­ing ac­cess and ef­fi­cien­cies, al­low­ing pa­tients to man­age their own care with few­er vis­its to a clin­i­cian.

Prod­ucts and part­ner­ships

On the sur­face, dig­i­tal ther­a­peu­tics may ap­pear sim­i­lar to well­ness apps avail­able on the app stores, but there are sub­tle yet mean­ing­ful dis­tinc­tions. Well­doc Di­a­betes, for ex­am­ple, is a Food and Drug Ad­min­is­tra­tion (FDA)-ap­proved dig­i­tal ther­a­peu­tic avail­able to cer­tain di­a­betes pa­tients with a pre­scrip­tion. It is a vir­tu­al care plat­form that helps pa­tients track and man­age their con­di­tion us­ing ar­ti­fi­cial in­tel­li­gence to in­form clin­i­cal de­ci­sions. Well­doc has sim­i­lar of­fer­ings for pa­tients with hy­per­ten­sion, heart fail­ure, and men­tal health con­di­tions, but these arms are not con­sid­ered dig­i­tal ther­a­peu­tics be­cause the plat­form is not FDA-ap­proved for these us­es.

The part­ner­ship be­tween Chugai and Bio­four­mis is an­oth­er ex­am­ple. Chugai and Bio­four­mis de­vel­oped a dig­i­tal sys­tem to mea­sure pa­tients’ pain lev­els due to en­dometrio­sis. The sys­tem us­es wear­ables to mea­sure phys­i­o­log­i­cal mark­ers for pain and then an­a­lyzes that da­ta through ar­ti­fi­cial­ly in­tel­li­gent soft­ware to de­tect pat­terns. At the same time, pa­tients are en­cour­aged to par­tic­i­pate in ques­tion­naires through a smart­phone app with game-like el­e­ments. The pro­gram is cur­rent­ly un­der clin­i­cal in­ves­ti­ga­tion in an on­go­ing tri­al, which will hope­ful­ly im­prove our un­der­stand­ing of the re­la­tion­ship be­tween pain and en­dometrio­sis.

Gain­ing ap­proval

There are spe­cif­ic stan­dards that a prod­uct must meet to be con­sid­ered a dig­i­tal ther­a­peu­tic. Cru­cial­ly, dig­i­tal ther­a­peu­tics must have sup­port from the rel­e­vant reg­u­la­to­ry bod­ies and pro­vide a clin­i­cal­ly proven ben­e­fit through soft­ware-en­abled in­ter­ven­tions. The soft­ware must be de­signed with ro­bust pa­tient pri­va­cy stan­dards and oth­er best prac­tices. Dig­i­tal ther­a­peu­tics should be val­i­dat­ed with clin­i­cal tri­als and high-qual­i­ty, ac­cept­ed re­search.

The ap­proval process for dig­i­tal ther­a­peu­tics is not a well-worn path. Plat­forms that have re­ceived FDA ap­proval have done so through the path­way de­signed for med­ical de­vices. Cur­rent­ly, there is no path­way ex­plic­it­ly de­vel­oped for dig­i­tal ther­a­peu­tics, but the FDA is in the process of cre­at­ing one.

Pa­tient ben­e­fits

Dig­i­tal in­ter­ven­tions of­fer po­ten­tial ben­e­fits on many lev­els. On the pa­tient side, these in­no­v­a­tive tech­nolo­gies can of­ten ful­fill un­met med­ical needs in ways that tra­di­tion­al drugs can­not. Ev­i­dence sug­gests that dig­i­tal ther­a­peu­tics can de­liv­er bet­ter out­comes, re­duced costs, and few­er med­ical in­ter­ven­tions when de­signed and im­ple­ment­ed with the high­est stan­dards. In a re­port from Frost & Sul­li­van, re­searchers found that some ex­pert-dri­ven dig­i­tal treat­ment plans re­sult­ed in a 50% re­duc­tion in av­er­age hos­pi­tal and emer­gency room ad­mis­sions.

Chal­lenges to adop­tion

When a dig­i­tal prod­uct reach­es the mar­ket, the chal­lenge be­comes get­ting providers to pre­scribe it and in­sur­ers to pay for it. Much of the lag in in­sur­er and provider ac­cep­tance stems from the nov­el­ty of the mar­ket. Providers and in­sur­ers may feel un­cer­tain about the ef­fi­ca­cy of dig­i­tal in­ter­ven­tions. Still, as the stan­dards and reg­u­la­to­ry path­ways for these prod­ucts be­come more es­tab­lished, at­ti­tudes are like­ly to shift.

The as­pects of dig­i­tal ther­a­peu­tics that make them in­no­v­a­tive and ex­cit­ing can al­so make them some­what for­eign to com­pa­nies steeped in tra­di­tion­al bio­med­ical de­vices and phar­ma­ceu­ti­cals that may not have the in-house ca­pa­bil­i­ties to de­sign soft­ware-based prod­ucts. As a re­sult, many com­pa­nies choose to bring in a part­ner with ex­per­tise in the mar­ket to as­sist with de­vel­op­ment.

The part­ner­ship be­tween No­var­tis and Bio­four­mis is a re­cent ex­am­ple. To im­prove and gain in­sight on the heart fail­ure drug Ernesto, No­var­tis want­ed to in­te­grate wear­ables in­to a dig­i­tal plat­form to ad­just dosages of the drug based on da­ta analy­sis. No­var­tis is cur­rent­ly work­ing with Bio­four­mis to de­vel­op and im­ple­ment the pro­gram. The goal is to keep pa­tients out of the hos­pi­tal and im­prove out­comes.

Mar­ket op­por­tu­ni­ties

Bio­phar­ma­ceu­ti­cal com­pa­nies are in­creas­ing­ly tak­ing no­tice of dig­i­tal ther­a­peu­tics as a new mar­ket to break in­to, with a lot of po­ten­tial. The U.S. mar­ket for dig­i­tal ther­a­peu­tics is es­ti­mat­ed to have a com­pound an­nu­al growth rate of 29.8% be­tween 2020 and 2025, ac­cord­ing to Frost & Sul­li­van.

For the bio­phar­ma in­dus­try, these tech­nolo­gies ben­e­fit a com­pa­ny’s bot­tom line be­cause they tend to cost a lot less to de­vel­op than tra­di­tion­al drugs and de­mand a sig­nif­i­cant­ly short­er reg­u­la­to­ry process be­fore they reach the mar­ket. Dig­i­tal ther­a­peu­tics al­so al­low com­pa­nies to ex­pand in­to en­tire­ly new mar­kets, of­ten by tar­get­ing con­di­tions that are ei­ther un­der­served by phar­ma­ceu­ti­cals or bet­ter treat­ed with be­hav­ioral mod­i­fi­ca­tions.

The in­for­ma­tion col­lect­ed by these dig­i­tal plat­forms can yield valu­able in­sights, such as how well a drug or treat­ment plan is work­ing and whether pa­tients are ad­her­ing to the pro­to­col. All this pop­u­la­tion-lev­el da­ta and pa­tient ac­cess en­ables com­pa­nies to adapt their strate­gies quick­ly and based on bet­ter in­for­ma­tion. The rapid ex­pan­sion of the dig­i­tal ther­a­peu­tics mar­ket will in­creas­ing­ly dri­ve com­pe­ti­tion and re­ward the in­no­v­a­tive com­pa­nies that stay ahead of the curve.

Ref­er­ences:

• Bio­four­mis Whitepa­per. “Ac­cel­er­at­ing Bio­phar­ma­ceu­ti­cal In­no­va­tion with Dig­i­tal Ther­a­peu­tics to Im­prove Pa­tients’ Qual­i­ty of Life.”
• Na­ture. “The emerg­ing world of dig­i­tal ther­a­peu­tics.” https://www.na­ture.com/ar­ti­cles/d41586-019-02873-1
• De­loitte. “How dig­i­tal health apps are em­pow­er­ing pa­tients.” https://www2.de­loitte.com/us/en/blog/health-care-blog/2021/how-dig­i­tal-health-apps-are-em­pow­er­ing-pa­tients.html
• Well­doc. “In­di­ca­tions for Use.” https://www.well­doc.com/in­di­ca­tions-for-use/
• Clin­i­cal­Tri­als.gov. “Ob­jec­tive Pain Mea­sure­ment Us­ing a Wear­able Biosen­sor and a Mo­bile Plat­form in Pa­tients With En­dometrio­sis (OPINE).” https://clin­i­cal­tri­als.gov/ct2/show/NCT04318275