Published 08 Mar.2024 14:18(KST)
Updated 08 Mar.2024 15:57(KST)
Major U.S. Pharmacy Benefit Managers (PBMs) are listing HLB's liver cancer drug in their expected prescription lists for this year.
PBMs are prescription drug management service providers that play a key role in drug distribution within the U.S. health insurance market. Since it is practically difficult to sell a drug without being listed by PBMs, it is important to be included in as many PBM insurance formularies as possible in the U.S.
PBMs contract with various insurers to select and maintain drug formularies and handle the review and payment of drug claims. They receive management fees along with rebates provided by pharmaceutical companies. Being listed in the formularies published by PBMs is crucial for extensive sales in the U.S. market.
Major PBMs such as OptumRx and CVS Caremark, which account for over 20% of the U.S. PBM market, have included Lenvatinib and Camrelizumab in their "significant predicted forthcoming drug" lists. OptumRx is a subsidiary of UnitedHealth Group, the largest health insurer in the U.S.
Upon FDA new drug approval, expectations are rising for negotiations not only with these PBMs but also with various insurers and their affiliated PBMs across the U.S. The FDA is expected to decide on the new drug approval for the Lenvatinib combination therapy by May at the latest.
The Lenvatinib combination therapy has demonstrated the longest patient survival period (22.1 months) in history through global Phase 3 trials, marking a breakthrough in liver cancer treatment. It is expected to gain an advantage not only in broad insurance formulary listings but also in negotiations for prescription prioritization.
In the first-line treatment of liver cancer, existing anticancer drugs show limitations due to patients' liver function or gastrointestinal bleeding issues, whereas the Lenvatinib combination therapy has proven consistent treatment effects on overall survival (mOS) and progression-free survival (mPFS) regardless of the patient's liver function status (ALBI grade 1 or 2). There are no gastrointestinal bleeding problems, which is why many liver cancer specialists are eagerly awaiting its rapid market launch.
In fact, Professor Amit Mahipal of Case Western Reserve University in the U.S. emphasized in an interview with the oncology media outlet ‘OncLive’ that "the Lenvatinib combination therapy presents a practice-changing treatment for first-line liver cancer therapy" and stated, "It will become the standard treatment after approval."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.