The first FDA-ap­proved dig­i­tal pill — what it means for phar­ma

By Har­sha Madan­navar, Man­ag­ing Di­rec­tor at L.E.K. Con­sult­ing

Last year, the U.S. Food and Drug Ad­min­is­tra­tion (FDA) ap­proved what is per­haps the bold­est use of dig­i­tal tech­nol­o­gy in health­care: a pill that is in­te­grat­ed with an in­gestible sen­sor that cap­tures in­for­ma­tion about whether the pa­tient has com­plied with her med­ica­tion reg­i­men. A pa­tient in­gests the pill and it sends the da­ta to a patch worn on her tor­so, which adds var­i­ous phys­i­o­log­ic mea­sures. From there the in­for­ma­tion is wire­less­ly sent to a mo­bile phone app, al­low­ing both the pa­tient and her physi­cian to track how the pa­tient is us­ing and re­spond­ing to her med­ica­tion.

L.E.K. Con­sult­ing be­lieves that the FDA’s ap­proval of Japan-based Ot­su­ka Phar­ma­ceu­ti­cal’s Abil­i­fy MyCite for cer­tain psy­chi­atric con­di­tions — a first for dig­i­tal med­i­cine — will be seen as a land­mark in pa­tient-cen­tered care. Ap­prox­i­mate­ly 50% of pa­tients do not ad­here to their med­ica­tion as pre­scribed, tak­ing it spo­rad­i­cal­ly or with con­traindi­cat­ed foods or med­i­cines, and 20-30% of pre­scribed med­ica­tions are nev­er even picked up at a phar­ma­cy. This non­ad­her­ence prob­lem varies in acu­ity de­pend­ing on the dis­ease and the pop­u­la­tion that is af­fect­ed. The cost of this waste runs in­to the bil­lions of dol­lars in un­used med­ica­tion and, in ad­di­tion, of­ten more ex­pen­sive med­ical care.

Bridg­ing gaps in glob­al health­care

The ben­e­fits of dig­i­tal med­i­cine go be­yond the sav­ing of costs to the health­care sys­tem. Over time, we be­lieve that it can help solve three core prob­lems — we call them gaps — be­dev­il­ing the de­vel­op­ment and the de­liv­ery of health­care around the world.

Out­comes. For starters, dig­i­tal med­i­cine can bridge the out­comes gap. When physi­cians can track their pa­tients’ com­pli­ance with a pre­scribed med­ica­tion, and how pa­tients are re­spond­ing to it, they can man­age their care bet­ter. The re­sult is su­pe­ri­or health out­comes.

Physi­cians ben­e­fit by be­ing able to track their pa­tients based on ac­cu­rate, con­tin­u­ous da­ta — their heart­beat and tem­per­a­ture, whether they’re sleep­ing or walk­ing, and whether they’ve tak­en the right med­ica­tion at the right time. And pa­tients are em­pow­ered with that same da­ta to be­come more en­gaged in their over­all health. Health out­comes are most like­ly to be im­proved when health pro­fes­sion­als and pa­tients work in con­cert.

Ac­cess. In many parts of the world, in de­vel­oped coun­tries and par­tic­u­lar­ly in de­vel­op­ing coun­tries, many pa­tients live far from a mod­ern physi­cian prac­tice or a large med­ical cen­ter. Dig­i­tal med­i­cine, by en­abling the re­mote mon­i­tor­ing of a pa­tient’s med­ical ad­her­ence cou­pled with phys­i­o­log­i­cal da­ta, can alert a physi­cian to events that may re­quire in­ter­ven­tion, such as a skipped dose or an alarm­ing side ef­fect. This dra­mat­ic im­prove­ment in a pa­tient’s re­mote ac­cess to a health­care pro­fes­sion­al holds the po­ten­tial for up­grad­ing the speed and ac­cu­ra­cy of med­ical de­ci­sion-mak­ing.

Pro­teus Dig­i­tal Health (which li­censed the en­abling dig­i­tal pill tech­nol­o­gy to Ot­su­ka) has been work­ing to bring its plat­form to Chi­na. The fol­low­ing fac­tors about Chi­na make the coun­try ripe for dig­i­tal med­i­cine: A ma­jor­i­ty of the pop­u­la­tion us­es the mo­bile mes­sag­ing plat­form WeChat, and the ca­pac­i­ty of health­care ser­vices in both ur­ban and rur­al ar­eas is in­suf­fi­cient.

In­no­va­tion. Dig­i­tal med­i­cine may al­so play a role in en­sur­ing the sus­tain­abil­i­ty of in­no­va­tion. First, there is the sheer nov­el­ty of the tech­nol­o­gy: a pill joined with an FDA-ap­proved in­gestible sen­sor made of sil­i­con, mag­ne­sium and cop­per that cap­tures crit­i­cal da­ta about whether we’re com­ply­ing with our med­ica­tions. Sec­ond, it se­cure­ly and wire­less­ly sends this da­ta to a wear­able patch on the pa­tient’s side that adds phys­i­o­log­ic mea­sures and trans­mits the com­bined in­for­ma­tion to a physi­cian via the cloud.

Key chal­lenge fac­ing dig­i­tal adop­tion

The abil­i­ty of dig­i­tal med­i­cine to bridge all the above gaps and be­come a glob­al stan­dard pre­sup­pos­es that doc­tors have adopt­ed it, reg­u­la­tors are com­fort­able with it, pa­tients are de­mand­ing it and pay­ers are cov­er­ing it.

A key chal­lenge is that there is a de­gree of skep­ti­cism among phar­ma­ceu­ti­cal com­pa­nies and some physi­cians. Phar­ma­ceu­ti­cal com­pa­nies, like oth­er large or­ga­ni­za­tions, can be no­to­ri­ous­ly slow to in­te­grate in­no­v­a­tive tech­nolo­gies or plat­forms. Physi­cians, par­tic­u­lar­ly those in large hos­pi­tal sys­tems, have bare­ly enough face time with pa­tients and even less time to adapt to new care de­liv­ery mod­els or new de­ci­sion-mak­ing par­a­digms. Many of them will take a wait-and-see at­ti­tude to­ward dig­i­tal med­i­cine. A few ear­ly ap­pli­ca­tions like Ot­su­ka’s Abil­i­fy MyCite will raise aware­ness of the tech­nol­o­gy and speed its ac­cep­tance in the mar­ket.

Glob­al phar­ma’s con­tin­ued evo­lu­tion

One thing is for sure — we are en­ter­ing a brave new world of pa­tient-cen­tered dig­i­tal health. We be­lieve that dig­i­tal med­i­cines will play an im­por­tant role in the evo­lu­tion of glob­al phar­ma, from to­day’s in­dus­try that sells prod­ucts and en­ables doc­tors to pre­scribe med­ica­tions to to­mor­row’s in­dus­try that of­fers ser­vic­ing so­lu­tions and en­ables con­sumers to reach health out­comes in part­ner­ship with their care team.

Down­load the full ar­ti­cle on the L.E.K. Con­sult­ing web­site.