Richard A. Brand, M.B.A., Chief Financial Officer, BeyondSpring Pharmaceuticals

CVS Leads Trend To­ward Less Ex­pen­sive Neu­trope­nia Treat­ments

CVS Health Corp re­cent­ly an­nounced that, in its stan­dard drug plan be­gin­ning in 2017, it will re­place an ex­pen­sive brand­ed drug for the pre­ven­tion of Neu­trope­nia with a new, cheap­er copy of biotech med­i­cine. The CVS de­vel­op­ment shows the im­por­tance of price point to drug up­take. In par­tic­u­lar, CVS will be sub­sti­tut­ing Am­gen’s Ne­u­pogen with No­var­tis’s Zarxio, a cheap­er biosim­i­lar. This sur­prised the stock mar­ket.  Ne­u­pogen and G-CSF biosim­i­lars are a $1.6 bil­lion mar­ket in the U.S. alone, and the mar­ket for Am­gen’s Neu­las­ta is even big­ger at $4.1 bil­lion in sales last year in the U.S.

While most biosim­i­lars are priced at 70 per­cent of the brand­ed drug price, the price for Ne­u­pogen is $4,600 per cy­cle, and the price for G-CSF biosim­i­lars is $3,900 per cy­cle. This is 85 per­cent of the price of the brand­ed drug.

An­tic­i­pat­ing this trend, Be­yond­Spring is de­vel­op­ing a drug to pre­vent Neu­trope­nia, the same con­di­tion as Ne­u­pogen (Neu­trope­nia).  CVS’s an­nounce­ment comes as no sur­prise since pay­ers seek to min­i­mize the over­all cost of pa­tient care.  Be­yond­Spring can price its drug sim­i­lar to or low­er than biosim­i­lar G-CS­Fs, due to its marked­ly low­er cost to pro­duce its small mol­e­cule drug com­pared to the  G-CS­Fs that are more cost­ly bi­o­log­ics.

Be­yond­Spring has meet­ings sched­uled with the FDA to re­view its Neu­trope­nia pre­ven­tion pro­gram and plans to fol­low the same pro­to­col that the G-CSF biosim­i­lars uti­lized in their suc­cess­ful Phase 3 tri­als to de­vel­op a more af­ford­able drug for pa­tients around the world.

Biosim­i­lars in the U.S.

In­vestors know that biosim­i­lars do well in Eu­rope, but the U.S. has been slow to em­brace biosim­i­lars, and the ques­tion is whether biosim­i­lars will have ad­e­quate up­take in the U.S. CVS’s de­ci­sion is a ma­jor turn­ing point, as a big com­pa­ny re­placed a brand­ed drug. A change in the mind­set of a U.S. pay­er has been her­ald­ed. This fur­ther il­lus­trates the im­por­tance of price point in up­take of drug, a trend that suits Be­yond­spring’s drug very well as it is in­ex­pen­sive to man­u­fac­ture.

Be­yond­Spring’s drug, Plinab­u­lin, with a dif­fer­en­ti­at­ed mech­a­nism will come at an op­por­tune time and be wel­comed in the con­text of the on­go­ing con­ver­sa­tion around the ris­ing cost of health­care. This is al­so a drug which aug­ments the an­ti-can­cer ef­fect of chemother­a­py.

Why It’s Im­por­tant

The de­vel­op­ment of a drug for the mit­i­ga­tion of Neu­trope­nia is great­ly need­ed. Neu­trope­nia is the de­struc­tion of white blood cells, which are im­por­tant for pro­tect­ing the body against in­fec­tion. Neu­trope­nia can oc­cur in as many of 37 per­cent of pa­tients treat­ed with chemother­a­py. Pa­tients with Neu­trope­nia are more sus­cep­ti­ble to bac­te­r­i­al in­fec­tions and, with­out prompt med­ical at­ten­tion, this con­di­tion can be­come life-threat­en­ing.

Ap­prox­i­mate­ly 20 per­cent of pa­tients with chemother­a­py de­vel­op Febrile Neu­trope­nia, which is se­vere Neu­trope­nia com­bined with fever. More than 60,000 pa­tients are hos­pi­tal­ized each year for Neu­trope­nia as­so­ci­at­ed with fever, which can of­ten cause se­ri­ous in­fec­tions. In ad­di­tion, Neu­trope­nia leads to death in up to 18 per­cent of these cas­es.

Am­gen’s drugs and the GCS-F biosim­i­lars are ap­proved by the FDA for the pre­ven­tion, not for treat­ment, of chemother­a­py-caused Neu­trope­nia. A pre­ven­tion ap­proval might im­ply that 100 per­cent of pa­tients who re­ceive chemo would al­so be pre­scribed a GCS-F; how­ev­er, on­ly about 20 per­cent of pa­tients re­ceive GCS-Fs be­cause of cost and con­ve­nience con­sid­er­a­tions. Ex­pert Dou­glas W. Blayney, M.D., FACP a Pro­fes­sor of Med­i­cine (On­col­o­gy) at the Stan­ford Uni­ver­si­ty Med­ical Cen­ter and a Board mem­ber for the NC­CN guide­lines on Neu­trope­nia man­age­ment, adds that some ad­di­tion­al use of G-CSF is for treat­ment, rather than for the ap­proved pre­ven­tion in­di­ca­tion, af­ter a pa­tient has test­ed for low neu­trophils in the blood.

Da­ta from Can­cer Care On­tario in­di­cates that 40 per­cent of pa­tients re­ceiv­ing chemother­a­py for po­ten­tial­ly cu­ra­tive treat­ment of breast and colon can­cer re­quire emer­gency room hos­pi­tal vis­its to treat the con­se­quences of Neu­trope­nia. As On­tario and Cana­da at large is a sin­gle pay­er sys­tem, its da­ta cap­tures the da­ta of all pa­tients.

Trend in Neu­trope­nia Mit­i­ga­tion Drugs

CVS’s ac­tion to man­age costs by us­ing a biosim­i­lar may be the be­gin­ning of a trend from oth­er pay­ers. Be­yond­Spring’s mar­ket re­search in­di­cates strong pay­er in­ter­est in a new drug with bet­ter prod­uct char­ac­ter­is­tics at sim­i­lar prices of the G-CSF biosim­i­lars for Neu­trope­nia. The de­ci­sion by CVS demon­strates the im­por­tance of price point to drug up­take. Thus Plinab­u­lin can take ad­van­tage of this trend, be­ing an in­ex­pen­sive to make small mol­e­cule with prod­uct char­ac­ter­is­tics at least as good as or bet­ter than G-CSF.

Au­thor Richard A. Brand, M.B.A., is the Chief Fi­nan­cial Of­fi­cer of Be­yond­Spring Phar­ma­ceu­ti­cals, a clin­i­cal stage bio­phar­ma­ceu­ti­cal com­pa­ny fo­cused on the de­vel­op­ment of in­no­v­a­tive can­cer ther­a­pies, in­clud­ing a Phase 3 im­muno-on­col­o­gy com­pound and strong pipeline in col­lab­o­ra­tion with the Fred Hutchin­son Can­cer Re­search Cen­ter.

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