Madrigal Pharmaceuticals is “off to a strong start” with its recently approved MASH drug Rezdiffra, CEO Bill Sibold said on Wednesday. The company pulled $14.6 million in the first full quarter of sales.
Coverage is in place for more than 50% of commercial patients, which is on track toward the company’s goal of 80% coverage by the end of the year, Madrigal said in its second-quarter earnings report. Sibold touted “high enthusiasm and early demand” from physicians and patients, and favorable coverage from insurers.
“Our efforts to help healthcare practices build patient care pathways are progressing well, setting the stage for future growth,” Sibold said.
Rezdiffra was approved in March for metabolic dysfunction-associated steatohepatitis, also referred to as MASH or NASH. Revenue estimates had ranged from $3.8 million to $10 million, according to a Tuesday Leerink note.
Sibold, who previously led Sanofi’s specialty drug business, has repeatedly said that Rezdiffra’s first year on the market will be about “wiring the system.” Rezdiffra is the first approved drug for MASH, a liver disease that has vexed scientists for years. Madrigal said Wednesday that it continues to focus on “building the foundation” for Rezdiffra, including through education and dialog with payers.
The drug is currently under regulatory review in Europe, and Madrigal expects a decision in mid-2025.
Few insurers require liver biopsies
The US Department of Veterans Affairs listed a liver biopsy among its criteria for use for Rezdiffra released earlier this year, despite the fact that biopsies are not required in the FDA’s prescribing information. But Madrigal said Wednesday that few patients have been impacted by such requirements.
Less than 5% of covered livers are affected by liver biopsy requirements, Madrigal said. The company emphasized last quarter that its conversations with payers have focused on the use of non-invasive tests as a means for diagnosis and monitoring.
More than 80% of MASH patients with stage 2 or 3 fibrosis are diagnosed with non-invasive tests, according to a recent survey of 30 hepatologists and gastroenterologists conducted by Cantor Fitzgerald. Most practices said they intend to use a FibroScan, a non-invasive test that measures liver stiffness, because of its availability and ease of use.
“Liver biopsy is a very invasive procedure for diagnosis, and because it’s not being done broadly in the real world, if more insurance companies start asking for this, it’s a big issue for the uptake,” Cantor analyst Prakhar Agrawal told Endpoints News.
A Madrigal spokesperson told Endpoints last month that even among the “outlier payers” requiring a liver biopsy in their prior authorization criteria, “we’ve seen examples of patients and physicians appealing successfully and the prescription being processed without a biopsy.”