Sanofi promis­es mon­ey back for dis­con­tin­ued blood dis­or­der treat­ment – in some cas­es

Months af­ter Pfiz­er launched its sec­ond drug war­ran­ty pro­gram, Sanofi is hop­ping on the trend.

The French phar­ma gi­ant set up a war­ran­ty pro­gram for Ca­blivi, of­fer­ing med­ical in­sti­tu­tions a po­ten­tial re­fund if in­pa­tient treat­ment doesn’t work out. Pa­tients must re­ceive the drug in a hos­pi­tal set­ting in or­der to qual­i­fy, and Sanofi will on­ly cov­er the cost of up to six dos­es for pa­tients who don’t re­spond, or up to 12 dos­es for those who wors­en while on treat­ment.

In 2019, Ca­blivi be­came the first drug ap­proved in the US for a rare but dead­ly blood dis­or­der called ac­quired throm­bot­ic throm­bo­cy­topenic pur­pu­ra, or aTTP. Sanofi se­cured the drug, al­so known as capla­cizum­ab, in its $4.8 bil­lion Abl­ynx buy­out and won a quick ap­proval in Eu­rope short­ly af­ter. Pa­tients with aTTP suf­fer blood clots in the small ar­ter­ies that can lead to strokes, brain dam­age or death.

Sanofi set the ini­tial list price at $270,000 per course, rak­ing in €164 mil­lion ($177 mil­lion) in 2021. Sales con­tin­ued to rise through last quar­ter to €52 mil­lion ($56 mil­lion) in Q3, ac­cord­ing to the com­pa­ny’s lat­est earn­ings re­sults. Sanofi con­firmed Fri­day that the cur­rent whole­sale ac­qui­si­tion cost is $7,925 per vial.

To make that cost a bit more palat­able, the com­pa­ny is now of­fer­ing in­sti­tu­tions a re­fund of up to the full whole­sale ac­qui­si­tion cost (WAC) or ac­tu­al ac­qui­si­tion cost, whichev­er is less. The drug must be ad­min­is­tered ac­cord­ing to the la­bel and dis­con­tin­ued by a health­care provider to qual­i­fy.

“Be­cause aTTP is a life-threat­en­ing con­di­tion, Sanofi is, through this Pro­gram and oth­er ef­forts, work­ing to help re­move as many bar­ri­ers as pos­si­ble for pa­tients and the health care providers who sup­port them,” Jef­frey Schaffnit, Sanofi’s gen­er­al man­ag­er of US rare blood dis­or­ders, told End­points News in an email.

A pa­tient is deemed to have no ini­tial re­sponse if their platelet counts re­main be­low 50 × 109/L af­ter four days of com­bined treat­ment with plas­ma ex­change (PEX) and im­muno­sup­pres­sive ther­a­py. Sanofi con­sid­ers pa­tients who wors­en as those who ex­pe­ri­ence “a new drop in platelet count af­ter ini­tial platelet count nor­mal­iza­tion (>150 × 109/L), ne­ces­si­tat­ing re-ini­ti­a­tion of PEX af­ter hav­ing ruled out any caus­es for the drop in platelet count oth­er than aTTP patho­phys­i­ol­o­gy,” ac­cord­ing to the pro­gram’s web­site.

Pfiz­er sim­i­lar­ly launched war­ran­ty pro­grams for its drugs Xalko­ri and Panzy­ga, al­though those pro­grams re­im­burse pa­tients as op­posed to hos­pi­tals.

Panzy­ga was ap­proved in 2018 to treat pri­ma­ry im­mun­od­e­fi­cien­cy (PI) in pa­tients two years and old­er and chron­ic im­mune throm­bo­cy­tope­nia (cITP) in adults. It lat­er bagged an in­di­ca­tion in chron­ic in­flam­ma­to­ry de­myeli­nat­ing polyneu­ropa­thy (CIDP), a con­di­tion that’s char­ac­ter­ized by weak­ness of the arms or legs, tin­gling or numb­ness, and a loss of deep ten­don re­flex­es.

Pfiz­er said it will re­fund cer­tain CIPD pa­tients for their out-of-pock­et costs for the first four treat­ments if they must dis­con­tin­ue treat­ment for “clin­i­cal rea­sons,” up to a max­i­mum of $16,500 per treat­ment or $50,000 to­tal.

Un­der the pro­gram for its can­cer drug Xalko­ri, el­i­gi­ble pa­tients can get their out-of-pock­et costs cov­ered if they dis­con­tin­ue the drug be­fore the fourth 30-day sup­ply is ad­min­is­tered.

Oth­er com­pa­nies are join­ing the wave. Bio­Marin has pre­vi­ous­ly said it plans to of­fer an out­comes-based war­ran­ty for Roc­ta­vian, which would be “ready to im­ple­ment with pay­ers at launch” if the drug wins an ap­proval in he­mo­phil­ia A. And back in Oc­to­ber 2021, Take­da inked a deal with in­sur­ance provider Point32Health that pro­vides cer­tain lung can­cer pa­tients ac­cess to Alun­brig through an “out­comes-based struc­ture.”

“If a pa­tient cov­ered by Point32Health does not re­main on the drug for at least three months due to ef­fec­tive­ness or tol­er­a­bil­i­ty, Take­da will re­fund a sig­nif­i­cant por­tion of the drug cost to Point32Health,” Take­da con­firmed via email on Fri­day.

When asked whether Sanofi plans on ex­pand­ing the war­ran­ty pro­gram to oth­er drugs in its port­fo­lio, Schaffnit said: “Cur­rent­ly, the Pro­gram is lim­it­ed to the use of Ca­blivi in the in­pa­tient set­ting. De­pend­ing on how the Pro­gram pro­gress­es it could be ex­pand­ed.”

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