Celltrion FDA New Drug 'Jimpenetra', US Insurance Coverage Begins in Earnest

As insurance reimbursements for Celltrion's new autoimmune disease treatment drug, Jimpendra, begin in earnest in the United States, expectations for sales growth in the U.S. market are increasing.

Celltrion headquarters exterior (left) and Celltrion's new autoimmune disease treatment drug 'Jimpenetra'

Celltrion announced on the 1st that insurance reimbursements based on contracts for formulary listings with Pharmacy Benefit Managers (PBMs) for Jimpendra, launched in the U.S. last March, have started in earnest since last month.

Currently, Jimpendra is supplied under formulary listing contracts with various PBMs, including Express Scripts (ESI), one of the top three PBMs in the U.S. PBMs are the first gateway for penetrating the U.S. market. Pharmaceuticals sold in the U.S. are practically difficult to sell if they are not listed on the formulary, a drug list managed by PBMs on behalf of public and private insurers. If Jimpendra is not listed on the formulary of the insurance company the patient is enrolled in, the patient must bear the full cost of the drug. However, if Jimpendra is listed on the formulary, the insurance company reimburses the pharmacy according to a set reimbursement rate, significantly reducing the patient's out-of-pocket expenses. With the reimbursement process now fully underway, the practical effects of formulary listing have begun to appear.

Since the launch of Jimpendra, Celltrion has supplied the product free of charge through a start program to patients enrolled in PBMs where formulary listing has not yet been achieved, or supported patients without reimbursement after physicians assessed their condition and applied for prior authorization from insurers. In addition, with reimbursements now actually taking place, a foundation for substantial sales expansion has been established.

Currently, Jimpendra has secured coverage for about 40% of the U.S. private insurance market based on the number of enrollees through contracts with multiple PBMs, including ESI. As reimbursement procedures continue to start this month and considering imminent additional formulary listing contracts with other major PBMs, expectations are that Jimpendra’s sales growth will accelerate further.

In preparation, Celltrion is focusing its sales resources on maximizing Jimpendra’s sales. According to IQVIA, a pharmaceutical market research firm, the inflammatory bowel disease (IBD) market in the U.S., where Jimpendra is currently focusing, is estimated at $10.3 billion (approximately 14 trillion KRW). Celltrion aims to secure more than a 10% market share by 2025. Furthermore, if it succeeds in building a foundation for accelerated sales growth through increased conversion to subcutaneous injection formulations and a surge in registered patients, annual sales exceeding 2 trillion KRW are also expected. Considering the sales expansion of biosimilar products sold globally, achieving this year’s sales target of 3.5 trillion KRW is anticipated to be smooth.

Seo Jung-jin, Chairman of Celltrion Group (left), is conducting a Q&A session at the JP Morgan Healthcare Conference (JPMHC) held last January in San Francisco, California, USA.
[Photo by Celltrion]

Seong-Jin Seo, Chairman of the Celltrion Group, has been personally leading sales activities on the front lines in North America since the first half of this year, while the local sales workforce is also being significantly expanded. Celltrion plans to increase the current local dedicated staff of about 60 people by 1.6 times to 100.

From the second half of the year, advertising targeting the general public will begin. Unlike Korea, where advertising regulations for prescription drugs requiring a doctor’s prescription are strict, in the U.S., prescription drugs can be advertised on various platforms including terrestrial TV. Celltrion is producing TV commercials to be broadcast nationwide in the U.S. starting next month and plans to promote Jimpendra on platforms such as terrestrial TV and OTT. Additionally, they will conduct various marketing activities in collaboration with influencers on major social media channels like YouTube to raise awareness of Jimpendra and link this to actual prescription expansion.

A Celltrion official said, "With the start of insurance reimbursements for Jimpendra, a stable profit-generating foundation has been established, and a virtuous cycle of pharmaceutical supply that can continuously expand has been successfully anchored, marking the beginning of full-scale sales. We will focus on expanding the sales force in line with the timing of insurance reimbursements and actively carry out media advertising activities on TV and social media to increase local interest in Jimpendra."