In­te­grat­ed ev­i­dence gen­er­a­tion 2.0: A strat­e­gy for every stake­hold­er

Key take­aways:

• The da­ta sup­port­ing reg­u­la­to­ry ap­proval alone are of­ten in­suf­fi­cient for demon­strat­ing the added ben­e­fit of a new ther­a­py
• Plan­ning in ad­vance to con­tin­u­ous­ly de­liv­er da­ta that il­lus­trate val­ue and post-launch, to not on­ly the reg­u­la­tor, but pay­ers, health­care pro­fes­sion­als, and pa­tients re­sults in more clin­i­cal­ly mean­ing­ful ben­e­fits
• By work­ing cross-func­tion­al­ly, bio­phar­ma­ceu­ti­cal teams can un­cov­er ev­i­dence gaps and bet­ter shape reg­is­tra­tion tri­als to en­sure the needs of as many stake­hold­ers as pos­si­ble are met

The ev­i­dence-gen­er­a­tion process for bio­phar­ma­ceu­ti­cal com­pa­nies has be­come far more chal­leng­ing. The com­bi­na­tion of high sci­ence and the nu­ances of the evolv­ing land­scape has led to greater ev­i­dence gaps for a grow­ing num­ber of stake­hold­ers—from pay­ers and reg­u­la­tors to pa­tients and health­care pro­fes­sion­als—each of whom re­quires a more de­tailed un­der­stand­ing of the sci­en­tif­ic da­ta and rel­a­tive ben­e­fits com­pared with the cur­rent stan­dard of care and oth­er nov­el ther­a­pies to help them make de­ci­sions.

Drug de­vel­op­ers need to take an in­no­v­a­tive and ag­ile ap­proach to ev­i­dence gen­er­a­tion to meet the over­lap­ping needs of stake­hold­ers holis­ti­cal­ly if they are to achieve their vi­sion and en­sure nov­el ther­a­pies are max­i­miz­ing their po­ten­tial to de­liv­er pa­tient ben­e­fit and val­ue to so­ci­ety.

Ap­ply­ing a mul­ti­stake­hold­er lens to ev­i­dence gen­er­a­tion

As the phar­ma­ceu­ti­cal land­scape be­comes more com­plex, achiev­ing the vi­sion for a prod­uct re­quires all stake­hold­ers to un­der­stand, ac­cept, and adopt the prod­uct’s val­ue.

The da­ta sup­port­ing reg­u­la­to­ry ap­proval alone are of­ten in­suf­fi­cient for demon­strat­ing the added ben­e­fit of a new ther­a­py, and of­ten do not re­flect re­al-world us­age in clin­i­cal prac­tice or the im­pli­ca­tions of in­no­va­tion in de­liv­ery tech­niques or bio­mark­er test­ing re­quire­ments.

To max­i­mize op­por­tu­ni­ties at launch and en­sure suc­cess across the prod­uct life cy­cle ear­ly in the de­vel­op­ment process, bio­phar­ma­ceu­ti­cal com­pa­nies need to un­der­stand the re­quire­ments of a wider group of stake­hold­ers to fill their vary­ing in­for­ma­tion gaps and demon­strate the in­cre­men­tal val­ue of the prod­uct.

Plan­ning in ad­vance to con­tin­u­ous­ly de­liv­er da­ta that il­lus­trate the val­ue and clin­i­cal util­i­ty of the ther­a­py, post-launch, to not on­ly the reg­u­la­tor, but pay­ers, health­care pro­fes­sion­als, and pa­tients will re­sult in more clin­i­cal­ly mean­ing­ful ben­e­fits that res­onate with more stake­hold­ers across the prod­uct life cy­cle.

Cen­tral to this ap­proach is un­der­stand­ing that dif­fer­ent stake­hold­ers’ ev­i­dence re­quire­ments are of­ten in­ter­con­nect­ed.

For ex­am­ple, pay­ers re­quire a rich un­der­stand­ing of the val­ue of the prod­uct in the con­text of how it will be used, in­clud­ing how a health­care pro­fes­sion­al will pre­scribe the prod­uct in the re­al world.

Clin­i­cians of­ten col­lab­o­rate with health tech­nol­o­gy as­sess­ment (HTA) bod­ies, clin­i­cal com­mis­sion­ing groups, and for­mu­la­ry com­mit­tees at na­tion­al, re­gion­al, and lo­cal lev­els to shape pay­ers’ think­ing and un­der­stand­ing of com­plex and evolv­ing treat­ment land­scapes.

In­creas­ing­ly, pa­tients are al­so play­ing more of a role in shared de­ci­sion-mak­ing and pro­vid­ing their per­spec­tive on the val­ue of new treat­ments, shar­ing in­sights that feed in­to the HTA process. Ad­di­tion­al­ly, pay­ers and health­care pro­fes­sion­als work to­geth­er and with pa­tients to un­der­stand their ev­i­dence needs and make de­ci­sions about val­ue and re­im­burse­ment.

A 360-de­gree view of ev­i­dence needs

While the re­quire­ments for reg­u­la­to­ry ap­proval are clear and pre­scribed, the val­ue dri­vers for oth­er stake­hold­ers are more nu­anced and evolve across the cus­tomer jour­ney. So it is im­por­tant to con­sid­er these stake­hold­ers’ needs ear­ly in the prod­uct de­vel­op­ment cy­cle—be­fore com­mit­ting to piv­otal or reg­is­tra­tion tri­als.

How­ev­er, siloed in­ter­nal struc­tures of­ten pre­vent a holis­tic un­der­stand­ing and ac­tion­ing of stake­hold­ers’ ev­i­dence re­quire­ments. For ex­am­ple, da­ta are of­ten gen­er­at­ed through mul­ti­ple chan­nels, but re­spon­si­bil­i­ties for those chan­nels can be de­volved across dif­fer­ent func­tions.

A mul­ti­stake­hold­er ap­proach pro­vides a holis­tic un­der­stand­ing of the prod­uct val­ue and max­i­mizes re­turn on in­vest­ment. By work­ing cross-func­tion­al­ly, bio­phar­ma­ceu­ti­cal teams can un­cov­er ev­i­dence gaps and bet­ter shape reg­is­tra­tion tri­als to en­sure the needs of as many stake­hold­ers as pos­si­ble are met. In turn, help­ing man­age in­ter­nal stake­hold­ers’ ex­pec­ta­tions of the HTA out­come, in­form sce­nario plan­ning, and po­si­tion­ing at prod­uct launch.

The strat­e­gy in­volves break­ing down in­ter­nal siloes and en­sur­ing col­lab­o­ra­tion be­tween clin­i­cal de­vel­op­ment, med­ical af­fairs, mar­ket ac­cess, and health eco­nom­ics and out­comes re­search to pro­vide a com­plete view of the stake­hold­ers, iden­ti­fy over­lap­ping needs, and un­cov­er un­tapped op­por­tu­ni­ties.

It is ground­ed in cross-ca­pa­bil­i­ty col­lab­o­ra­tion and is built on clear in­sights based on deep re­search in­to each stake­hold­er group’s chal­lenges and needs.

Through this in­te­grat­ed ap­proach, op­por­tu­ni­ties can be lever­aged, and du­pli­ca­tion in ef­forts can be avoid­ed. All ev­i­dence gaps can be an­tic­i­pat­ed and pri­or­i­tized, and it is eas­i­er to un­cov­er over­lap­ping ev­i­dence re­quire­ments across stake­hold­er groups. Bio­phar­ma­ceu­ti­cal teams can then tar­get re­sources to ad­dress the most crit­i­cal ar­eas and pre­pare for the im­pact of the re­main­ing gaps.

New re­port: Rein­vent­ing val­ue

This is an ex­cerpt from Fishawack Health’s new re­port, “Rein­vent­ing Val­ue,” in which our med­ical, strate­gic, pol­i­cy, ac­cess, val­ue, and ev­i­dence spe­cial­ists have come to­geth­er to pro­vide ex­clu­sive rec­om­men­da­tions for max­i­miz­ing bio­phar­ma­ceu­ti­cal prod­uct and port­fo­lio val­ue.

Down­load the pub­li­ca­tion for more ad­vice on ap­ply­ing a mul­ti­stake­hold­er lens to your val­ue strat­e­gy and en­sur­ing your prod­uct’s ben­e­fits res­onate with every stake­hold­er.

About the Au­thors

Sarah Feaver, PhD, Se­nior Di­rec­tor, Sci­en­tif­ic Strat­e­gy
Sarah is a med­ical com­mu­ni­ca­tions spe­cial­ist with 16+ years’ agency ex­pe­ri­ence across the full breadth of med­ical af­fairs and pub­li­ca­tions sup­port.

She sup­ports nu­mer­ous clients with med­ical strat­e­gy, fo­cus­ing on med­ical plans, sci­en­tif­ic plat­forms, and ev­i­dence-gen­er­a­tion strat­e­gy plans across the full prod­uct life cy­cle.

An­drée Rose, Se­nior Di­rec­tor, Sci­en­tif­ic Strat­e­gy
An­drée col­lab­o­rates with cross‑func­tion­al med­ical af­fairs teams to pro­vide strate­gic lead­er­ship across a range of projects, in­clud­ing glob­al med­ical plans, sci­en­tif­ic nar­ra­tives/plat­forms, and in­te­grat­ed ev­i­dence-gen­er­a­tion plans. Re­cent ther­a­py area ex­pe­ri­ence in­cludes on­col­o­gy, he­mo­phil­ia and oth­er rare co­ag­u­la­tion dis­or­ders, re­nal ane­mia of chron­ic kid­ney dis­ease, and res­pi­ra­to­ry dis­ease.

Sama­ra Fer­gu­son, Ex­ec­u­tive Di­rec­tor, Mar­ket Ac­cess
Sama­ra brings near­ly 25 years’ ex­pe­ri­ence in mar­ket ac­cess and health eco­nom­ics, hav­ing worked in in­dus­try for 20 years and in con­sul­tan­cy for al­most five years, build­ing and com­mu­ni­cat­ing the val­ue of prod­ucts to glob­al pay­ers. She has worked across many dis­ease ar­eas, in­clud­ing on­col­o­gy, im­munol­o­gy, car­dio­vas­cu­lar, and me­tab­o­lism.

About Fishawack Health

Fishawack Health (FH) is a lead­ing glob­al com­mer­cial­iza­tion part­ner for the bio­phar­ma­ceu­ti­cal, med­ical tech­nol­o­gy, and well­ness in­dus­tries. The fu­ture of health is fast-paced and com­plex, de­mand­ing a dif­fer­ent ap­proach. Es­tab­lished in 2001, our 1,500+ health­care ex­perts com­bine their knowl­edge and ex­per­tise across our 4 core dis­ci­plines—Med­ical; Mar­ket­ing; Pol­i­cy, Ac­cess, Val­ue, and Ev­i­dence; and Con­sult­ing.

We imag­ine a health­i­er world and build the con­nec­tions to make it hap­pen.