Test lim­its meet re­sis­tance

CMS seeks to re­strict new PET scans for Alzheimer’s

Modern Healthcare - - LATE NEWS - Jaimy Lee

Eli Lilly and Co. and the Alzheimer’s As­so­ci­a­tion say that the CMS’ pro­posal to limit cov­er­age of a pricey new test used to iden­tify brain plaques as­so­ci­ated with Alzheimer’s dis­ease would hin­der di­ag­no­sis.

The test uses brain beta-amy­loid imag­ing to dif­fer­en­ti­ate pa­tients with symp­toms of Alzheimer’s from those with other forms of de­men­tia. The to­tal cost of the test, which in­cludes a $1,600 drug, a PET scan and the physi­cian’s in­ter­pre­ta­tion, can range from $3,000 to $10,000.

In a July 3 pro­posed cov­er­age de­ci­sion, the CMS said Medi­care will cover one scan per pa­tient in two in­stances: ef­forts to ex­clude Alzheimer’s dis­ease in “nar­rowly de­fined and clin­i­cally dif­fi­cult dif­fer­en­tial di­ag­noses” and “to en­rich clin­i­cal tri­als seek­ing bet­ter treat­ments or preven­tion strate­gies.”

The agency also said it would in­cor­po­rate the test in the “cov­er­age with ev­i­dence de­vel­op­ment” (CED) pro­gram, which grants con­di­tional re­im­burse­ment for what it con­sid­ers promis­ing new med­i­cal tech­nolo­gies while track­ing the tech­nol­ogy’s im­pact on health out­comes.

Eli Lilly man­u­fac­tures Amyvid, the first PET tracer to be ap­proved by the Food and Drug Ad­min­is­tra­tion. The com­pany is re­quest­ing that Medi­care pay for the be­taamy­loid imag­ing class with­out the re­stric­tions that come with the CED pro­gram.

“CMS ap­pears to be chal­leng­ing the value of an ad­junc­tive tool that can as­sist physi­cians in mak­ing a more in­formed di­ag­no­sis for pa­tients with cog­ni­tive im­pair­ment,” Dr. Daniel Skovron­sky, pres­i­dent and CEO of Avid Ra­dio­phar­ma­ceu­ti­cals, the Lilly sub­sidiary that de­vel­oped Amyvid, said in a com­pany state­ment. “Re­strict­ing cov­er­age could hin­der a timely and ac­cu­rate di­ag­no­sis, which is in con­flict with the ad­vice of Alzheimer’s dis­ease ex­perts and with the ad­min­is­tra­tion’s National Alzheimer’s Pro­ject Act. In ad­di­tion, it may sti­fle fu­ture in­no­va­tion aimed at im­prov­ing di­ag­no­sis.”

How­ever, a CMS panel in Jan­uary ques­tioned whether there is ad­e­quate ev­i­dence that brain beta-amy­loid imag­ing will af­fect health out­comes for pa­tients re­port­ing early signs of

cog­ni­tive dys­func­tion. And, some physi­cians say that while they sup­port cov­er­age of the test, there are con­cerns about the de­gree to which it will be used and by what providers. “While I see great po­ten­tial in all of this, the

“The po­ten­tial to im­prove early di­ag­no­sis by tests like this is there. But it’s chal­leng­ing ... for a num­ber for rea­sons, be­cause of the false pos­i­tives and the false neg­a­tives and be­cause of the im­pact of other fac­tors like ge­net­ics.”

—Dr. Nor­man Relkin Weill Cor­nell Med­i­cal Col­lege

po­ten­tial hinges on the test be­ing used in the right con­text, in terms of the right pa­tient and by ex­perts who oth­er­wise know the fac­tors that can in­flu­ence the re­sult one way or an­other,” said Dr. Nor­man Relkin, di­rec­tor of the mem­ory dis­or­ders pro­gram in the neu­rol­ogy depart­ment at Weill Cor­nell Med­i­cal Col­lege in New York.

About 5 mil­lion Amer­i­cans have Alzheimer’s dis­ease and the num­ber is ex­pected to jump 40% to 7 mil­lion by 2025.

The di­ag­no­sis of a pa­tient demon­strat­ing signs of Alzheimer’s dis­ease usu­ally be­gins with an ex­ten­sive rou­tine eval­u­a­tion be­fore a physi­cian will or­der an MRI or a CT scan. The com­bi­na­tion of a struc­tural brain im­age and the eval­u­a­tion are of­ten enough for many pa­tients to re­ceive a di­ag­no­sis.

How­ever, about 1 in 5 pa­tients present with atyp­i­cal symp­toms or un­usual types of pro­gres­sion, Relkin said. “There are peo­ple for whom those tests are not de­fin­i­tive and for which the amy­loid imag­ing can po­ten­tially tell us whether we’re deal­ing with Alzheimer’s or an­other form of de­men­tia.”

In th­ese cases, the ad­di­tional in­for­ma­tion pro­vided by amy­loid imag­ing can aid physi­cians who are eval­u­at­ing a pa­tient with a short du­ra­tion of symp­toms or some­one with past cog­ni­tive or be­hav­ioral prob­lems that make con­ven­tional di­ag­nos­tic tech­niques less ac­cu­rate. The use of flu­o­rodeoxy-D-glu­cose, also called FDG, is an­other tool that is of­ten used.

“The po­ten­tial to im­prove early di­ag­no­sis by tests like this is there,” Relkin said. “But it’s

chal­leng­ing, and it’s chal­leng­ing for a num­ber of rea­sons, be­cause of the false pos­i­tives and the false neg­a­tives and be­cause of the im­pact of other fac­tors like ge­net­ics.”

And, un­like many other med­i­cal tests, the test does not pro­vide a yes-or-no di­ag­no­sis. Physi­cians have dis­cov­ered that some pa­tients in their 80s and 90s de­velop amy­loid de­posits, but do not de­velop Alzheimer’s dis­ease. In other cases, some pa­tients whose symp­toms align with those of Alzheimer’s dis­ease do not show amy­loid in their scans. The Alzheimer’s As­so­ci­a­tion worked with the So­ci­ety of Nu­clear Medicine and Molec­u­lar Imag­ing to de­velop ap­pro­pri­ate­ness cri­te­ria for the test in hopes that pos­i­tive re­sults would grant pa­tients ear­lier ac­cess to treat­ments and sup­port ser­vices rang­ing from build­ing a care team to fi­nan­cial plan­ning.

“The time frame at which CMS has con­ducted CED pro­cesses is wholly un­suited and un­ac­cept­able to both the pace of sci­en­tific and tech­no­log­i­cal in­no­va­tion in the Alzheimer’s field, and more im­por­tantly, the rapidly in­creas­ing needs posed by the es­ca­lat­ing Alzheimer’s epi­demic,” the as­so­ci­a­tion said in a state­ment re­spond­ing to the CMS pro­posal.

The FDA ap­proved Lilly’s Amyvid imag­ing agent in April 2012. Gen­eral Elec­tric Co. has de­vel­oped its own PET amy­loid imag­ing tracer, and an­other drug de­vel­oped by Bayer and now owned by Pi­ra­mal Health­care is also in de­vel­op­ment. The CMS will is­sue a fi­nal pay­ment de­ci­sion in Oc­to­ber.

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