RSV

Res­pi­ra­tory Syn­cy­tial Virus. From http://​mikro​life​.blogspot​.com/​2​0​0​7​/​1​1​/​k​e​e​p​i​n​g​-​o​u​r​-​c​h​i​l​d​r​e​n​-​s​a​f​e​-​s​h​o​u​l​d​-​b​e​-​o​u​r​.​h​tml

You might recall that in my last episode of “Who’s Pay­ing for Health Advances?” I made brief men­tion of a drug used to treat res­pi­ra­tory syn­cy­tial virus (RSV) in chil­dren with chronic lung disease.

RSV is a sea­sonal dis­or­der that causes sig­nif­i­cant dis­ease (what doc­tors call “mor­bid­ity”) in chil­dren, espe­cially pre­ma­ture infants who have grown into chil­dren with con­gen­i­tal heart dis­ease and chronic lung dis­ease. (“Con­gen­i­tal” means “occur­ring at birth” and “chronic” means “hap­pen­ing all the time”.)

RSV is around all the time. In healthy indi­vid­u­als, it causes noth­ing more severe than a com­mon cold. How­ever, in unhealthy peo­ple (like chil­dren with lung dis­ease), it can cause the lungs to fill with mucus and fluid (severe pneu­mo­nia), even death.

Remem­ber from the ear­lier arti­cle that the immune sys­tem uses two strate­gies to fight invaders. One strat­egy is to spit out a spe­cial­ized pro­tein called an anti­body which binds to the invader and tags it for destruc­tion (if it’s a bac­te­ria) or sim­ply gums up its abil­ity to cause dis­ease (if it’s a virus).

Anti­bod­ies made by phar­ma­ceu­ti­cal com­pa­nies are in a new class of drugs called “bio­log­i­cals” or “bio­log­ics”. It’s easy to spot the ones that are anti­body mol­e­cules: the abbre­vi­a­tion for anti­bod­ies is “Ab” and so these drug names end in “-ab”. For exam­ple, anti­bod­ies against RSV are called palivizumab and are sold under the brand name Synagis™ by the drug com­pany Med­Im­mune, now part of the giant phar­ma­ceu­ti­cal com­pany AstraZeneca.

Synagis

Synagis™ (palivizumab)

Palivizumab has been shown to be remark­ably safe (caus­ing almost no side effects or adverse reac­tions) and rea­son­ably effec­tive (reduc­ing the inci­dence of RSV infec­tions in sus­cep­ti­ble per­sons to about half of what would be expected with­out use of the drug dur­ing a typ­i­cal win­ter sea­son). It sounds like a win-​​win sit­u­a­tion. What’s the problem?

Synagis™ must be given monthly dur­ing the sea­son; the length of the RSV sea­son varies by loca­tion but is typ­i­cally four to six months. Each monthly treat­ment has a cost of $1500 to $2000 for an annual cost of about $9000 per patient. The whole­sale price of Synagis™ is $1416.48 for a single-​​dose 100 mg vial that will treat a 15-​​pound child. No one knows what it costs MedImmune/​AstraZeneca to make that 100 mg, or how much of their research and devel­op­ment costs are being recov­ered with this drug. That’s of course a trade secret.

If I were an insur­ance com­pany, I would make sure that I removed any par­ents with pre­ma­ture infants from my pol­i­cy­holder list, because my busi­ness would be to max­i­mize prof­its, and lay­ing out close to $100K for Synagis™ treat­ments will break the bank if I have too many of those patients on my rolls. At present, insur­ance com­pa­nies will typ­i­cally reject any claims for Synagis™ treat­ments, despite their proven effec­tive­ness. This is just good busi­ness prac­tice. It’s good par­ent­ing to resist this good busi­ness prac­tice, so my Twit-​​friend Dr. Jen Gunter has a web­site designed to give advice on how to write an appeal let­ter to your insur­ance com­pany.

Cases like these are the root prob­lem of health care reform leg­is­la­tion. Some­how, the pool of patients needs to be large enough to spread a finan­cial risk as broadly as pos­si­ble. For exam­ple, imag­ine work­ing for a com­pany with 10 employ­ees, one of whom has two chil­dren who are sus­cep­ti­ble to RSV infec­tion. A well-​​run insur­ance com­pany will either drop this employer, or raise rates to the point where the employer can no longer afford to pay the premiums.

Roughly a half-​​million babies per year in the US alone are born pre­ma­turely, and vir­tu­ally all of these will ben­e­fit from RSV prophylaxis.

What is to be done for this? Do we ration health­care by forc­ing par­ents to write appeal let­ters? What about par­ents who are not cov­ered by insur­ance? (It should go with­out say­ing that most par­ents of pre­ma­ture infants are young adults and tend to be healthy and unin­sured.) Does this abro­gate the rights of par­ents (and their chil­dren) who may not be as good at writ­ing let­ters as oth­ers? Do we remove the abil­ity of AstraZeneca to make a profit, or reg­u­late the amount of profit they are able to make? How can we (or an insur­ance com­pany) decide who is to receive treat­ment, and who does not?

Update: Dr. Jen Gunter cor­rectly pointed out that I made a mis­take in my assump­tions about moth­ers of pre­ma­ture infants with health insur­ance. The linked arti­cle here has the sta­tis­tics: 79% of moth­ers of pre­ma­ture infants have private-​​pay health insur­ance; 21% have Med­ic­aid. As the paper notes, pre­ma­ture babies born to Medicaid-​​covered moth­ers tend to have lower Apgar scores, imply­ing that they are less healthy than pre­ma­ture babies born to moth­ers who are pri­vately insured.