Express Scripts has excluded Lilly’s lispro authorized generic (AG) from its 2019 National Preferred Formulary. The exclusion takes effect starting July 1, 2019. Recall, on March 4, 2019, Lilly announced its intention to launch the lispro AG at a 50% WAC discount. Below, FENIX provides brief thoughts on ESI’s exclusion decision.
Sanofi hosted its Q1 ’19 earnings call but only briefly discussed its diabetes business including the recent sotagliflozin T1DM CRL. Below, FENIX provides highlights and insights from the call.
Sanofi announced that it has increased the benefits to its Valyou insulin savings program to now offer up to 10 boxes of SoloStar insulin pens and/or 10 vials of 10mL insulin for $99 per month. Previously each 10 mL vial was $99 and each box of SoloStar pens was $149. According to the press release, the program covers all Sanofi insulins (Lantus, Toujeo, Admelog, and Apidra) but not Soliqua. The program will become available starting in June 2019. Below, FENIX provides brief thoughts on the program in the context of the ongoing drug pricing debate.
Today, the Senate Finance Committee held its third hearing on drug pricing titled “Drug Pricing in America: A Prescription for Change, Part III” which focused particularly on the role of PBMs. As predicted, the PBMs largely tried to deflect attention back onto pharmaceutical manufacturers. Key themes from the hearing include: 1) PBMs blame outdated MPD legislation, PBMs do not set list prices, and PBMs do not want to provide as much transparency as manufacturers do. Below, FENIX provides highlights and insights from the hearing.
Sanofi has initiated a new Ph1 trial evaluating a U200 concentration of its bs-lispro. Below, FENIX provides thoughts on why Sanofi is pursuing U200 Admelog including its likely use in the pre-filled patch pump that is being developed in partnership with Verily and Sensile Medical.
Sanofi is reportedly set to lay off an undisclosed number of diabetes US sales reps starting in June 2019. Below, FENIX provides thoughts on the new layoffs in the context of increasing US pricing pressures on Sanofi’s insulin franchise as well as the recent sotagliflozin CRL.
Cigna and Express Scripts announced a new insulin “Patient Assurance Program” that will cap the out-of-pocket cost for a 30-day insulin supply to $25 for eligible patients on participating plans (Cigna purchased ESI in December 2018). Of note, the new savings program was announced ~1 week ahead of the third Senate Finance Committee hearing on drug pricing which is scheduled for April 9, 2019, at 10:15 AM ET. The third installment, titled “Drug Pricing in America: A Prescription for Change, Part III,” will focus specifically on the role of PBMs. Below, FENIX provides thoughts on the Cigna/ESI insulin savings program as an obvious strategy to redirect the focus away from themselves and back onto insulin manufacturers.
With the ongoing national discussion on drug pricing and increasing scrutiny particularly focused on insulin, Lilly released its 2018 Annual Transparency Report which included detailed information on Humalog pricing. Recall, Lilly recently announced the creation of a Humalog authorized generic with a list price 50% lower than Humalog. Below, FENIX provides an overview and insights on Lilly’s drug pricing transparency including Lilly’s apparent strategy to direct legislative pressure onto PBMs.
A new trial evaluating Sanofi’s biosimilar aspart (SAR341402) has been observed on CT.gov. The trial, called GEMELLI X, is an open-label, crossover design comparing SAR341402 vs. NovoLog in 184 T1DM adults who are also on glargine U100. The name of Sanofi’s Ph3 program is clever in that Gemelli is a type of pasta derived from the Italian word for “twins.” The “X” in this trial appears to reference the crossover design. Below, FENIX provides thoughts on the trial as well as insight into Sanofi’s potential strategy to delay filing until after March 23, 2020 thereby allowing for regulatory submission via the 351k biosimilar pathway.
Adocia released its Q4 ’18 earnings results, but did not have an associated webcast. Below, FENIX provides highlights from the earnings press release including 2019 pipeline activities, and thoughts on how Adocia could enter the US and EU markets.