The Of­fice of In­spec­tor Gen­er­al (OIG) of HHS re­cent­ly told No­var­tis that it can pay for low-in­come pa­tients to ac­cess its $475,000 CAR-T ther­a­py Kym­ri­ah and that those pay­ments are not il­le­gal.

While ac­knowl­edg­ing that the pay­ments might in­duce cer­tain treat­ment cen­ters and physi­cians to use the one-time gene ther­a­py, or push el­i­gi­ble pa­tients to se­lect fed­er­al­ly re­im­bursed items and ser­vices re­lat­ed to the treat­ment, the OIG prais­es the ef­fec­tive­ness of Kym­ri­ah and ex­plains how ac­cess to it is avail­able in every care set­ting, which means the pay­ments won’t in­ap­pro­pri­ate­ly steer a pa­tient to one cen­ter over an­oth­er.

OIG al­so said it rec­og­nizes that the treat­ment cen­ters and physi­cians may re­ceive a fi­nan­cial ben­e­fit un­der this arrange­ment due to pro­fes­sion­al ser­vice fees and fa­cil­i­ty fees in con­nec­tion with ad­min­is­ter­ing the free Kym­ri­ah.

But the risk of overuti­liz­ing Kym­ri­ah is re­duced here, OIG says, be­cause the CAR-T is gen­er­al­ly cu­ra­tive (re­cent da­ta showed com­plete re­mis­sions in al­most half of those with ad­vanced, treat­ment re­sis­tant non-Hodgkin lym­phoma), on­ly ad­min­is­tered once, and gen­er­al­ly on­ly for those not re­spond­ing to oth­er ther­a­pies.

No­var­tis, which brought in $474 mil­lion in Kym­ri­ah sales in 2020, told End­points News in a state­ment that its ac­cess pro­gram for the CAR-T pro­vides it for free to el­i­gi­ble, low-in­come pa­tients who do not have in­sur­ance cov­er­age or have been de­nied cov­er­age.

“Due to the na­ture of the pa­tient pop­u­la­tion, fi­nan­cial­ly needy pa­tients may need en­hanced sup­port to ac­cess their pre­scribed treat­ment. We are pleased with this out­come, as we be­lieve this pro­gram is crit­i­cal to help­ing ad­dress the unique needs of Kym­ri­ah pa­tients,” the com­pa­ny added, not­ing that as of Jan­u­ary 2021, No­var­tis has man­u­fac­tured CAR-T cells for more than 4,200 pa­tients world­wide, in­clud­ing com­mer­cial and clin­i­cal prod­uct.

OIG pre­vi­ous­ly gave No­var­tis the go-ahead to con­tin­ue with its trav­el as­sis­tance pro­gram for Kym­ri­ah too. That pro­gram helps el­i­gi­ble low-in­come pa­tients with cer­tain trav­el and lodg­ing costs and pro­vides re­im­burse­ment for oth­er re­lat­ed ex­pens­es for the pa­tient to stay near a cer­ti­fied treat­ment cen­ter af­ter the in­fu­sion of Kym­ri­ah.

Republican leaders of the House Committee on Energy & Commerce sent a five-page letter yesterday announcing an investigation into the ongoing drug shortages that have rankled the US during the pandemic and the FDA’s response to it.

The letter, signed by Chair Cathy McMorris Rodgers (R-WA), explains how shortages have become more common over the past decade, while pointing to a report from the National Academies of Science, Engineering and Medicine finding that drug shortages have been “on the rise” over the past several decades and are lasting longer, with new drug shortages in the US seeing a 30% increase from 2021 to 2022.

The US pharma giant Eli Lilly will be increasing its financial commitment to a manufacturing site in Ireland.

According to a release from Ireland’s Industrial Development Agency (IDA) on Monday, Lilly will be investing another $500 million in its manufacturing facility in Limerick, Ireland — bringing the total investment into the facility to approximately $1 billion.

In January of last year, Lilly announced it was placing a $446 million investment into the site to expand active pharmaceutical ingredient and monoclonal antibody production.