Eli Lil­ly’s tirzepatide — the type 2 di­a­betes can­di­date and Trulic­i­ty’s heir ap­par­ent, pro­ject­ed to be a megablock­buster drug with­in the next five years — has been wait­ing on the FDA to give it the OK. Yet ac­cord­ing to cost watch­dog ICER, there is still some doubt about just how use­ful it can be to pa­tients when com­pared to top ri­vals.

Jon Camp­bell

The In­sti­tute for Clin­i­cal and Eco­nom­ic Re­view re­leased its re­port on the drug can­di­date ear­li­er to­day, giv­ing ev­i­dence for the drug a “B+” rat­ing and say­ing “the ev­i­dence pro­vides high cer­tain­ty that tirzepatide de­liv­ers at least a small net health ben­e­fit when added to back­ground ther­a­py, with the pos­si­bil­i­ty of a sub­stan­tial net health ben­e­fit.”

How­ev­er, ICER’s Jon Camp­bell, SVP for health eco­nom­ics, said that there still is some un­cer­tain­ty.

“When com­pared to in­jectable semaglu­tide in one head-to-head tri­al, tirzepatide showed a greater de­crease in HbA1c lev­els, weight, triglyc­erides, and blood pres­sure,” Camp­bell said in a state­ment. “How­ev­er, stud­ies of car­dio­vas­cu­lar out­comes with tirzepatide have not been con­clud­ed, and there­fore there is still un­cer­tain­ty on its true com­par­a­tive clin­i­cal ef­fec­tive­ness in re­la­tion to oth­er avail­able treat­ment op­tions.”

When ICER took a vote on clin­i­cal ef­fec­tive­ness, here’s what end­ed up hap­pen­ing:

A unan­i­mous ma­jor­i­ty (13-0) found the ev­i­dence for tirzepatide is enough to demon­strate a net health ben­e­fit when tirzepatide added to back­ground ther­a­py is com­pared to back­ground ther­a­py alone.

A slight ma­jor­i­ty (7-6) found that the ev­i­dence is not ad­e­quate to demon­strate a net health ben­e­fit when tirzepatide added to back­ground ther­a­py is com­pared to in­jectable semaglu­tide, the drug name for No­vo Nordisk’s Ozem­pic.

A ma­jor­i­ty (10-2 with 1 ab­sten­tion) found that the ev­i­dence is not ad­e­quate to demon­strate a net health ben­e­fit when tirzepatide added to back­ground ther­a­py is com­pared to em­pagliflozin, which is the drug name for Boehringer In­gel­heim’s Jar­diance.

Eli Lil­ly has not yet an­nounced what the treat­ment’s US price would be if ap­proved — but in the mean­time, ICER in­tro­duced what it thinks is a rea­son­able price range for the drug. The rec­om­men­da­tion? $5,500-$5,700 a year, on the high side. The com­pa­ny pre­dict­ed that the price for the drug would be around $4,643.50, based on the price of in­jectable semaglu­tide.

So­cial im­age: Eli Lil­ly CEO David Ricks (Pho­tog­ra­ph­er: David Paul Mor­ris/Bloomberg via Get­ty Im­ages)

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”