While Washington Tackles Opioid Abuse Epidemic, Hepatitis C Treatment Remains Unaffordable

If Washington wants to do something about the public health issues left behind by the opioid abuse epidemic, it might have to start doing something about prescription-drug costs.

Used syringes are discarded at a needle exchange clinic where users can pick up new syringes and other clean items for those dependent on heroin.
National Journal
Caitlin Owens
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Caitlin Owens
Aug. 18, 2015, 1 a.m.

Big names in Wash­ing­ton are in­creas­ingly join­ing the fight to com­bat the rise of opioid and heroin ab­use, but the con­ver­sa­tion around the is­sue is miss­ing half the prob­lem.

On Monday, the White House an­nounced an ini­ti­at­ive to curb heroin use by ad­dress­ing it as both a pub­lic-safety and pub­lic-health is­sue, pair­ing law en­force­ment with ac­cess to treat­ment for ad­dicts. This builds on mo­mentum with­in Con­gress and talk among 2016 pres­id­en­tial hope­fuls sur­round­ing the re­duc­tion of na­tion­al opioid drug ad­dic­tion.

But largely ex­cluded from the dis­cus­sion is what to do about those liv­ing with the con­sequences of their ad­dic­tion and the pub­lic health con­cern that presents. For many, ac­cess to treat­ment for dis­ease con­trac­ted through drug use is un­af­ford­able. Al­though there is med­ic­a­tion on the mar­ket to treat hep­at­it­is C — a dis­ease com­mon among drug users — its cost of­ten makes it un­avail­able to the sick.

“An un­qual­i­fied yes,” said Matt Salo, ex­ec­ut­ive dir­ect­or of the Na­tion­al As­so­ci­ation of Medi­caid Dir­ect­ors, when asked if state Medi­caid pro­grams are strug­gling to cov­er the cost of hep­at­it­is C med­ic­a­tions. “There isn’t a Medi­caid pro­gram in the coun­try that can af­ford to cov­er the cost of treat­ment for every pa­tient.”

If Wash­ing­ton wants to do something about the pub­lic health is­sues left be­hind by the opioid ab­use epi­dem­ic, it might have to start do­ing something about pre­scrip­tion drug costs.

Sovaldi — one of few med­ic­a­tions avail­able to treat hep­at­it­is C — costs $1,000 a pill, or about $84,000 for an en­tire course of treat­ment. And while it might be an ex­treme ex­ample, it rep­res­ents a grow­ing class of spe­cialty drugs that are in­creas­ingly driv­ing up health care costs — and an un­will­ing­ness in Wash­ing­ton to do much about it.

“When you’ve got an ef­fect­ive drug that has few or no com­pet­it­ors, its very hard for pay­ers to push back,” said Larry Levitt, seni­or vice pres­id­ent of the Kais­er Fam­ily Found­a­tion. “We are alone in the world as a coun­try that re­lies more on mar­ket forces to deal with drug prices than gov­ern­ment reg­u­la­tion.”

Hep­at­it­is C med­ic­a­tion presents an in­ter­est­ing case study of strad­dling the line between an is­sue the gov­ern­ment is keen to ad­dress — opioid use — and one it does not seem to want to touch — the cost of medi­cine.

And while private in­surers pay for the treat­ment as well, of­ten the bill falls in­to the lap of the gov­ern­ment.

“The way I look at it, hep­at­it­is C is a pub­lic-health is­sue,” said Dan Mendel­son, CEO of Avalere Health, an in­de­pend­ent con­sult­ing com­pany. “It’s a dis­ease of poverty, it’s a dis­ease of ad­dic­tion, it’s a dis­ease that comes along with needle use. That is why the hep­at­it­is C cures are be­ing pur­chased largely by Medi­caid pro­grams. And also many of them are pur­chased un­der the ex­change policy — so this is gov­ern­ment policy one way or an­oth­er.

“Ul­ti­mately, the Con­gress has to de­cide wheth­er drug price con­trols are the right an­swer. In my view, that would be a mis­take,” he ad­ded.

Cures for hep­at­it­is C on the mar­ket in­clude Sovaldi and the new­er Harvoni, both made by Gilead Sci­ences Inc. Two oth­ers were ap­proved with­in the same year, and an­oth­er was ap­proved last month, ac­cord­ing to the FDA. But oth­ers are in the pipeline to mar­ket and could present price-re­du­cing com­pet­i­tion.

“The price of Gilead’s hep­at­it­is C treat­ments re­flects the sig­ni­fic­ant clin­ic­al, eco­nom­ic, and pub­lic health value of these drugs, and is com­par­able to, or in many cases less than, the cost of older, less ef­fect­ive re­gi­mens,” the drug maker wrote in a policy po­s­i­tion on its web­site.

An ex­cep­tion to in­ac­tion in Wash­ing­ton is an in­vest­ig­a­tion launched by Sens. Ron Wyden and Chuck Grass­ley last year in­to the cost of Sovaldi, which is still pending. The sen­at­ors asked the drug­maker for de­tailed pri­cing in­form­a­tion.

“Giv­en the im­pact Sovaldi’s cost will have on Medi­care, Medi­caid, and oth­er fed­er­al spend­ing, we need a bet­ter un­der­stand­ing of how your com­pany ar­rived at the price for this drug,” the law­makers said in a state­ment last Ju­ly. “In or­der for a mar­ket­place to func­tion prop­erly, it must be com­pet­it­ive, fair, and trans­par­ent. It is un­clear how Gilead set the price for Sovaldi. That price ap­pears to be high­er than ex­pec­ted giv­en the costs of de­vel­op­ment and pro­duc­tion and the steep dis­counts offered in oth­er coun­tries. An ef­fi­cient mar­ket needs in­formed con­sumers to keep costs down.”

The pres­id­ent’s budget re­quest earli­er this year in­cludes a pro­pos­al that would al­low Medi­care to ne­go­ti­ate with drug­makers over drug prices. But these ne­go­ti­ations are gen­er­ally a non­starter policy for Re­pub­lic­ans.

The heroin over­dose death rate has nearly quad­rupled over the past dec­ade, and the rise in the drug’s use is linked to the opioid paink­iller epi­dem­ic. People who are ad­dicted to opioid paink­illers are 40 times more likely to be ad­dicted to heroin.

A na­tion­al hep­at­it­is C out­break has been well doc­u­mented. Last month, The New York Times re­por­ted that in Ken­tucky, 16,000 Medi­caid re­cip­i­ents had a hep­at­it­is C dia­gnos­is last year, com­pared with only 8,000 the pre­vi­ous year (this partly re­flects a Medi­caid ex­pan­sion un­der Obama­care). Ken­tucky’s rate of hep­at­it­is C is more than sev­en times the na­tion­al av­er­age, but the state spent 7 per­cent of its Medi­caid budget treat­ing only 861 people.

While the situ­ation may be par­tic­u­larly dire in a hand­ful of states, the num­ber of cases and the cost of treat­ment is for­cing states to make dif­fi­cult de­cisions.

“States have to pri­or­it­ize treat­ment to those most in need. An ex­er­cise that would be wholly un­ne­ces­sary if the cost were af­ford­able,” Salo wrote in an email.

Gen­er­ally, “most is need” is defined as those who have already ex­per­i­enced liv­er func­tion de­teri­or­a­tion, with stage 3 or 4 liv­er fibrosis the cutoff in most states, Salo said.

It’s “harder to gauge what per­cent­age” of the pop­u­la­tion with hep­at­it­is C states can af­ford to treat, Salo wrote, “since the de­nom­in­at­or is still some­what un­known (and there are a num­ber of people who are asymp­to­mat­ic and may not even know they have it). But prob­ably safe to say it’s a fairly small per­cent­age.”

While Con­gress has not taken up any le­gis­la­tion ad­dress­ing opi­ate ad­dic­tion, the is­sue has a power­ful ad­voc­ate from Ken­tucky — Sen­ate Ma­jor­ity Lead­er Mitch Mc­Con­nell, who has made the is­sue a “ser­i­ous fo­cus … for years,” ac­cord­ing to Robert Steurer, a Mc­Con­nell spokes­per­son.

In re­sponse to hep­at­it­is C, Mc­Con­nell helped se­cure lan­guage in an ap­pro­pri­ations bill this year that would al­low states with a high in­crease in the dis­ease to work with the Cen­ters for Dis­ease Con­trol and Pre­ven­tion on us­ing fed­er­al money for needle ex­change pro­grams.

And in the House, there have been a series of hear­ings on opioid ab­use held by the En­ergy and Com­merce Com­mit­tee’s over­sight and in­vest­ig­a­tions sub­com­mit­tee.

“It is es­sen­tial to identi­fy and en­gage people who use pre­scrip­tion opioids non-med­ic­ally early be­cause the risks of be­ing in­fec­ted with HIV or hep­at­it­is C in­creases dra­mat­ic­ally once someone trans­itions to in­jec­tion drug use,” Mi­chael Bot­ti­celli, dir­ect­or of Na­tion­al Drug Con­trol Policy, wrote in a pre­pared testi­mony in May.

“It is much less ex­pens­ive to treat a per­son for just a sub­stance use dis­order early us­ing evid­ence-based treat­ment, rather than to treat a per­son with a sub­stance use dis­order and provide life­time treat­ment for HIV or a cure for hep­at­it­is C,” he ad­ded.

In blog posts dis­cuss­ing pre­scrip­tion drug spend­ing, PhRMA poin­ted that not only do new drugs help con­trol fu­ture health care costs and al­low pa­tients to live longer, health­i­er lives, but also that hep­at­it­is C treat­ments — which in­clude both Sovaldi and Harvoni and have cures rates of more than 90 per­cent — are of­ten sub­ject to steep dis­counts fol­low­ing Medi­caid ne­go­ti­ations.

While the idea of gov­ern­ment drug price ne­go­ti­ation is out there, it is not likely to be­come much more than an idea any time soon.

“There’s a sense that price reg­u­la­tion is some­what un-Amer­ic­an, even though the pub­lic is quite sup­port­ive,” Levitt said. “It in­volves a role for gov­ern­ment in the mar­ket that makes people un­com­fort­able.”

But the good news for those pay­ing for hep­at­it­is C treat­ment — and those hop­ing to ad­dress the opioid epi­dem­ic — is that its un­af­ford­ab­il­ity prob­ably won’t last forever.

“What’s in­ter­est­ing about Sovaldi is it’s a one-time treat­ment, so I think the big costs we were see­ing re­cently will drop off be­cause there was a lot of pent up de­mand for people that had hep­at­it­is C that was un­treated,” Levitt said.

But, he ad­ded, “you nev­er know when the next Sovaldi will come along either, wheth­er it’s for can­cer or heart dis­ease or HIV or MS — drug spend­ing tends to be very lumpy be­cause it’s driv­en by new block­buster drugs, which don’t come along all the time.”

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