Screen­ing for hepati­tis C raises eth­i­cal, cost is­sues

Modern Healthcare - - NEWS - By Sabriya Rice

The CMS plans to start cov­er­ing one-time uni­ver­sal hepati­tis C test­ing for ag­ing baby boomers. The con­tro­ver­sial move will add bil­lions of dol­lars to Medi­care costs to iden­tify asymp­to­matic people who carry a virus that may not need to be treated.

Un­til re­cently, hepati­tis-C (HCV) screen­ings were rec­om­mended only for high-risk pa­tients, such as users of in­jectable drugs, people on longterm kid­ney dial­y­sis, or in­di­vid­u­als who un­der­went blood trans­fu­sions be­fore 1992. Left un­treated, less than a quar­ter of people in­fected with HCV con­tract fi­bro­sis, cir­rho­sis or cancer of the liver, usu­ally many decades af­ter ex­po­sure. Ap­prox­i­mately 19,000 people die each year from HCV-as­so­ci­ated dis­ease.

In 2012, the Cen­ters for Dis­ease Con­trol and Preven­tion rec­om­mended that all baby boomers be screened. Nearly a year later, the U.S. Pre­ven­tive Ser­vices Task Force up­graded HCV screen­ing to a grade B, mean­ing the test of­fers a mod­er­ate ben­e­fit for pa­tients and pay­ers should cover it.

How­ever, treat­ments for HCV are limited and very ex­pen­sive, cost­ing about $84,000 for a full 12-course treat­ment of the lat­est drug, Gilead’s So­valdi. If all 300,000 Medi­care pa­tients pro­jected to be di­ag­nosed by 2015 were to seek treat­ment with the lat­est drug af­ter be­ing screened in the new pro­gram, the to­tal ex­pen­di­ture could ex­ceed $25 bil­lion. That does not in­clude the cost of screen­ing, doc­tor vis­its and other fees.

Doc­tors ad­min­is­ter­ing the tests also face an eth­i­cal predica­ment. While they must tell asymp­to­matic pa­tients they tested pos­i­tive, most people will not de­velop se­ri­ous ill­ness from the in­fec­tion. More­over, the avail­able treat­ments have se­vere side ef­fects.

“There is cur­rently no way of pre­dict-

“Cost for much of the care is go­ing to fall back on the tax­pay­ers, and at a time when we’re strug­gling just to get people in­sured, that is prob­lem­atic.”

—Dr. J. Mario Molina, pres­i­dent and CEO Molina Health­care

ing which pa­tients will de­velop liver dis­ease and which will not,” said Dr. J. Mario Molina, pres­i­dent and CEO of Molina Health­care, which op­er­ates man­aged care plans. “Screen­ing … raises the ques­tion of what are you go­ing to tell the pa­tient,” he said.

Medi­care’s pro­posal to cover one­time HCV screen­ing for all Medi­care ben­e­fi­cia­ries born be­tween 1945 and 1965 was opened for com­ment on the agency web­site last week. A fi­nal rule is an­tic­i­pated by June. Other pay­ers, in­clud­ing Med­i­caid, are wor­ried they will have to cover screen­ings as well.

Ap­prox­i­mately 3.2 mil­lion people in the U.S. have chronic hepati­tis C, but most have not been di­ag­nosed. HCV is “pri­mar­ily a dis­ease of the baby boomer pop­u­la­tion,” wrote the au­thors of a PLOS jour­nal study, which found that be­tween 2007 and 2009, the pop­u­la­tion of people age 65 and older di­ag­nosed with chronic HCV had in­creased to 1.19 mil­lion, ac­count­ing for 75% of all pa­tients with the dis­ease, and 83% of pa­tients with ad­vanced dis­ease.

The mass screen­ing cam­paign has al­ready drawn crit­i­cism in a leading med­i­cal jour­nal. “The de­sire to treat pa­tients to pre­vent these con­se­quences is great. But the treat­ments that we have had avail­able are not very ef­fec­tive in clear­ing the in­fec­tion, re­sult in se­ri­ous ad­verse ef­fects in­clud­ing mak­ing pa­tients feel sick dur­ing a pro­longed treat­ment course, and are ex­pen­sive,” Dr. Mitchell Katz, di­rec­tor of the Los Angeles County Depart­ment of Health Ser­vices, wrote in a JAMA ed­i­to­rial pub­lished in Fe­bru­ary. “For these rea­sons, nei­ther I nor my pa­tients have been very en­thu­si­as­tic about treat­ment.”

The call for mass screen­ing comes just as drug com­pa­nies are push­ing to bring new med­i­ca­tions to the mar­ket. Be­sides the Food and Drug Ad­min­is­tra­tion’s ap­proval in De­cem­ber of Gilead’s com­bi­na­tion an­tivi­ral treat­ment reg­i­men So­valdi, Ab­bVie an­nounced pos­i­tive re­sults for its in­ves­ti­ga­tional ther­apy at the Con­fer­ence on Retro­viruses and Op­por­tunis­tic In­fec­tions in Bos­ton last week.

The com­pany’s piv­otal phase III study showed that the ther­apy could cure 99% of hepati­tis C in­fec­tions in some pa­tients. Bris­tol-My­ers Squibb, Roche and Merck also are rac­ing to de­velop drugs.

The CDC is also col­lab­o­rat­ing with test mak­ers to de­velop di­ag­nos­tics that will more ac­cu­rately iden­tify which drugs will work best for which HCV­pos­i­tive pa­tients. Last July, the CDC and Quest Di­ag­nos­tics an­nounced a re­search pro­gram in which they would share data about di­ag­nos­tic, geno­typ­ing and vi­ral load tests clin­i­cians use to man­age treat­ment.

Med­i­caid pay­ers al­ready are fret­ting about the costs. The lat­est drugs such as So­valdi are too costly to treat ev­ery po­ten­tial pa­tient, they say. The is­sue is such a con­cern that sev­eral groups, in­clud­ing Molina Health­care, sent letters to state Med­i­caid of­fices in Jan­uary re­quest­ing “emer­gency guid­ance” on how to han­dle “ex­traor­di­nar­ily ex­pen­sive” treat­ments.

“Cost for much of the care is go­ing to fall back on the tax­pay­ers, and at a time when we’re strug­gling just to get people in­sured, that is prob­lem­atic,” Molina said. “You could prob­a­bly in­sure 25 people per year, just with what it would cost to treat one per­son with that drug.”

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.