Aetna agrees to pay for Abbott pain control device

Ab­bott Laboratories is an­noun­cing new pri­vate in­sur­ance cov­er­age for a novel implantable med­i­cal de­vice to treat neu­ro­path­ic pain, a stub­born type of pain that can drive pa­tients to long-term o­pi­oid use.

The de­vice, known to­day as the Pro­claim DRG neurostimulator, was sold by Min­ne­so­ta's St. Jude Medical un­til Ab­bott ac­quired the com­pany in Jan­u­ar­y 2017. Ab­bott had cited St. Jude's line of neurostimulation de­vices, in­clud­ing its DRG stim­ul­a­tor, as a key mo­ti­va­tion for buy­ing the com­pany and bol­ster­ing its grow­ing med­i­cal de­vice thera­pies.

On Tues­day, in­sur­er Aetna un­veiled a na­tion­al cov­er­age de­ci­sion that opens up cov­er­age for Ab­bott's Pro­claim DRG neurostimulator, ex­pand­ing ac­cess to the de­vice for a­bout 22 mil­lion people in Aetna fully-insured and self-insured plans, Ab­bott said. The de­vice is also co­vered by Med­i­care, but oth­er ma­jor pri­vate in­sur­ers are still ev­alu­at­ing it for pos­si­ble cov­er­age.

"It's en­cour­ag­ing to see pri­vate pay­ers like Aetna re­view the clin­i­cal data and out­comes, then choose to pro­vide ac­cess to DRG stim­u­la­tion for their mem­bers," Ab­bott neuromodulation vice pres­i­dent Keith Boettiger said in a state­ment.

The Pro­claim DRG (pre­vi­ous­ly known as the Axium neurostimulator) works by send­ing mild e­lec­tric stim­u­la­tion to a dense clus­ter of nerves in the spi­nal col­umn called a dor­sal root gan­gli­on (DRG). Implantable neurostimulators like the Pro­claim DRG use e­lec­tric­i­ty to dis­rupt or block the nerve ac­tiv­i­ty that leads to the sen­sa­tion of chron­ic pain.

Neurostimulators have long been used to stimu­late nerves and block pain sig­nals, but the Pro­claim DRG is unique in that it tar­gets a spe­cif­ic clus­ter of neu­rons at the base of spi­nal nerves. These DRG struc­tures trans­mit sig­nals from sen­sory nerves to the brain, in­clud­ing real pain sig­nals and also the chron­ic burn­ing and shoot­ing pain that can hap­pen when nerves or sur­round­ing tis­sues are dam­aged.

The U.S. Food and Drug Administration ap­proved the de­vice in 2016 to aid in the man­age­ment of mod­er­ate to se­vere in­trac­ta­ble pain of the low­er limbs in adults with two forms of com­plex re­gion­al pain syn­drome, in­clud­ing peo­ple with con­firmed and un­con­firmed nerve in­ju­ries that cause chron­ic pain. (Pa­tients in the study that led to ap­prov­al of the de­vice were el­i­gi­ble only af­ter they failed to get re­lief from at least two drug thera­pies, and they re­mained on their phar­ma­co­log­ic thera­pies dur­ing the study.)

Ab­bott said that ex­tend­ing cov­er­age of de­vices like the Pro­claim DRG sup­ports the goals of the FDA and Med­i­care to im­prove ac­cess to non-o­pi­oid al­ter­na­tives for pain man­age­ment.

As the hu­man toll of the o­pi­oid-a­buse epi­dem­ic spreads, med­i­cal de­vice mak­ers across the na­tion have been keen to point out that their thera­pies do not rely on ad­dic­tive medi­ca­tions to achieve re­lief. Min­ne­so­ta health tech­nol­o­gy com­panies offer many dif­fer­ent non-o­pi­oid treat­ments, from con­tin­u­ous pe­riph­er­al nerve blocks to radio-frequency ab­la­tion of nerves.

E­lec­tric neuromodulation thera­pies like the Pro­claim DRG don't work for ev­er­y­one, which is part of the rea­son why com­panies like Ab­bott of­fer a noninvasive week­long tri­al de­vice for a tem­po­rary e­val­u­a­tion of the tech­nol­o­gy, be­fore committing to get­ting an implantable med­i­cal de­vice.

St. Jude's long-term implantable Axium stim­ul­a­tor, which it ac­quired by buy­ing Spi­nal Mod­u­la­tion, Inc., in 2015, was up­grad­ed and re­named in 2017 to a new plat­form that al­lows for Blue­tooth communication with an iPod Touch pa­tient con­trol­lers and iPad Mini phy­si­cian pro­gram­mers.