Lilly's CDK4/6 Inhibitor Abemaciclib Slashes Price by 50% Ahead of China's National Reimbursement Drug Negotiation

Source: PharmaCube Info

Author: Feng Qiu

On September 6, the Hainan Provincial Public Resources Trading Center issued a notice on adjusting the listed procurement prices of drugs, which included Eli Lilly's abemaciclib tablets. For the 14-tablet per box packaging, the prices for the three strengths were reduced from RMB 3,342.33 (50 mg), RMB 5,681.95 (100 mg), and RMB 7,750.00 (150 mg) to RMB 1,671.16 (50 mg), RMB 2,840.98 (100 mg), and RMB 3,875.00 (150 mg), respectively, with price reductions uniformly reaching 50%. Abemaciclib was only officially launched in the Chinese market this April, yet its price has been slashed in half in less than six months.

Abemaciclib is the third CDK4/6 inhibitor approved globally and the second in China. It was first approved by the U.S. FDA in September 2017, followed by approvals in Japan and the European Union. On December 31 last year, it received approval from the National Medical Products Administration (NMPA) for marketing in China. Its indications include use in combination with an aromatase inhibitor as initial endocrine therapy for postmenopausal women with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer, or in combination with fulvestrant for the treatment of advanced or metastatic HR-positive, HER2-negative breast cancer in women whose disease has progressed following failure of initial endocrine therapy. In 2020, the annual sales of marketed CDK4/6 inhibitors exceeded USD 7 billion, and the global market size is projected to surpass USD 15 billion by 2025.

As the world's first approved CDK4/6 inhibitor, Pfizer's Ibrance (palbociclib) achieved sales of $5.392 billion in 2020. However, its growth rate slowed significantly compared to 2019, primarily due to competitive pressure from Eli Lilly's abemaciclib and Novartis's ribociclib. Since August 2020, U.S. prescription volumes for abemaciclib and palbociclib have exhibited an inverse trend. According to Eli Lilly's financial report released earlier this year, Verzenio (abemaciclib) saw a 57% increase in sales revenue in 2020, reaching $913 million. This rapid growth has allowed it to quickly distance itself from its neck-and-neck competition with Novartis's Kisqali and begin directly challenging Pfizer's Ibrance.

In the domestic market, confronted with competitive pressure from abemaciclib and generic drugs, palbociclib has not remained passive. Although first approved for marketing in China in 2018, it failed to secure inclusion in the National Reimbursement Drug List (NRDL) over two consecutive years of negotiations. In January of this year, amid the dual pressure from the approval of abemaciclib and the launch of Qilu Pharmaceutical's first generic version, palbociclib promptly implemented a price reduction of 54.14%. It is currently priced at 9,244 RMB (75 mg), 11,521 RMB (100 mg), and 13,667 RMB (125 mg) per bottle of 21 capsules.

The upcoming national medical insurance negotiations are approaching, with both palbociclib and abemaciclib included in the preliminary review list. Given that ribociclib and domestically manufactured CDK4/6 inhibitors are expected to enter the market next year, successfully securing inclusion through this year's negotiations would be the optimal choice for both products. In the absence of a national negotiation reference price for similar products, abemaciclib will initially lower its price to test the waters, aiming to successfully conclude the negotiation at a more appropriate price point.

Of course, Eli Lilly is not the only company preparing its pricing for the medical insurance negotiations. In the past two months, Janssen (Xi'an) Janssen's daratumumab injection and Pfizer's new rare disease drug tafamidis soft capsules were the first to complete price adjustments, with respective reductions of 56.81% and 61%.