Successful Implementation of Pre-Communication Demonstration for the Second Batch of Medical Insurance Reference Drugs in 2026 2026年第二批医保参照药预沟通论证顺利实施

Another 28 "reference drugs" have quietly completed the pre-consultation process, and the feedback from the NHSA has been delivered to pharmaceutical companies. The news itself is as mundane as water—like a routine official notification. Yet beneath this calm surface, an undercurrent of anxiety is surging across the entire pharmaceutical industry. Behind these 28 names lie tangible investments in R&D, the earnest expectations of clinicians, and the hanging fate of countless patients. Now, everything points toward the upcoming 2026 adjustment of the National Medical Insurance Drug List—a grander and more ruthless endgame.

The "reference drug" system was undoubtedly well-intentioned. It seeks to introduce pharmacoeconomic perspectives early in a drug’s lifecycle, providing a more scientific anchor for future price negotiations and preventing both parties from engaging in extreme haggling. However, in practice, it has evolved into a complex "qualifying round" and a "game of expectation management." Companies go through the pre-consultation process only to receive not a commitment, but something akin to a "diagnosis report" or "potential assessment." The outcome of expert evaluation determines whether your "reference system" is recognized or challenged—directly impacting the starting line for future negotiations. Thus, the core anxiety of companies subtly shifts from "Is my drug the best?" to "Did I choose the right reference drug?" This is a nuanced, technical form of internal friction.

Even more intriguing is the statement: "If there are objections to the evaluation results of the first two batches... the reference drugs will be determined through the established process during the comprehensive evaluation stage of the drug list adjustment." This leaves a "backdoor" for dissatisfied companies, but the threshold is extremely high and the risks are immense. It means that disputes from the pre-consultation phase must be dragged into the decisive comprehensive evaluation for another round of debate. This requires immense courage—or perhaps a desperate strategy. It implicitly acknowledges that pre-consultation evaluations are not final and may not be entirely objective. Companies that failed to convince the expert panel must now decide whether to continue accumulating data in hopes of a turnaround or silently accept the predetermined "role" and adjust their market strategies accordingly. This rule stretches the chain of the game further, amplifying uncertainty.

Consider the industry ecosystem behind these 28 drugs. On one side, multinational pharmaceutical companies armed with global data and mature experience attempt to defend their value systems using "international reference pricing." On the other, domestic innovative drug companies—having barely emerged from the red ocean of me-too drugs and just beginning to show signs of innovation—now face the challenge of measuring themselves against the yardstick of "Chinese pharmacoeconomics." The composition of the expert panel—spanning clinical medicine, pharmacy, pharmacoeconomics, and healthcare security management—is itself a battlefield of value prioritization. Whose voice carries greater weight? Does the "indispensability" of clinical value override all else, or does the pharmacoeconomic "cost-effectiveness" calculation hold the final verdict? The evaluation process of this list is, in itself, a micro-debate on "what constitutes a good drug" and "what makes a drug worth its price."

The drums of war are already sounding for the 2026 drug list adjustment. The final determination of reference drugs is merely a small-scale reconnaissance before the larger battle. For pharmaceutical companies, the real test lies in whether they can craft a narrative that transcends the "reference drug" framework—a complete story about unmet clinical needs, overall treatment cost savings, and societal value. Merely fixating on whether reference drugs are upgraded or downgraded reveals a narrow vision. The top-level design of medical insurance is pushing the industry to shift from "price competition" to "value competition." Those players who rely solely on "high-quality imitation" and "incremental innovation" will find their survival space increasingly constrained under this increasingly refined evaluation system. This is not a hundred-meter sprint but a weighted cross-country endurance race—demanding not only explosive power but also resilience and strategic foresight. The tides are reshaping the riverbeds of value: some are already building dams, while others are still arguing over the quality of shells on the beach.

又一个28个“参照药”静悄悄地走完了预沟通的流程，国家医保局的反馈已送达企业手中。消息本身平淡如水，就像一份例行公事的公文通报。但在这份平淡之下，一股焦灼的暗流正在整个医药行业涌动。这28个名字的背后，是真金白银的研发投入、是临床医生的殷切期望，更是无数患者的命运悬丝。而现在，一切又指向了那个即将开启的2026年医保目录调整——一场更为宏大、也更残酷的终局游戏。

“参照药”这个制度设计，初衷无疑是好的。它试图在药品上市早期就引入药物经济学的视角，为未来的价格谈判提供一个更科学的锚点，避免到时候双方漫天要价、坐地还钱。但实际操作中，它正在异化为一种复杂的“资格赛”和“预期管理游戏”。企业费尽心思提交预沟通，拿到的不是一个承诺，而更像是一份“诊断报告”或“潜力评估”。专家论证的结果，决定了你的“参照系”是被认可还是被挑战。这直接关系到未来谈判时的起跑线在哪。于是，企业焦虑的核心从“我的药是不是最好的”悄然转变为“我的参照药选对了没有”。这是一种微妙的、技术性的内耗。

更值得玩味的是那句“对前两批论证结果有异议……参照药将在目录调整综合评审阶段按流程论证确定”。这为心有不甘的企业留下了一道“后门”，但门槛极高，风险极大。它意味着你必须将预沟通阶段的争议，拖入到决定生死的综合评审大考中再辩一次。这需要莫大的勇气，也可能是一种绝望的策略。它变相承认了，前期的预沟通论证并非终局，甚至可能并非百分之百客观。那些未能说服评审专家的企业，是在接下来的时间里继续积累数据、寻求翻盘，还是默默接受既定的“人设”，调整自己的市场策略？这条规则，让博弈的链条被拉得更长，充满了不确定性。

看看这28个药品背后的行业生态吧。一边是跨国药企带着全球数据和成熟经验，试图用“国际参照价”来捍卫自己的价值体系；另一边是本土创新药企，好不容易从me-too的红海里挣扎出来，刚露出一点创新的苗头，就面临着如何用“中国药物经济学”标尺来衡量自己的难题。专家库的构成——临床、药学、药物经济学、医保管理——本身就是一个价值排序的战场。谁的话语权重更大？是临床价值的“不可或缺性”压倒一切，还是药物经济学的“性价比”计算拥有最终裁决权？这份名单的论证过程，本身就是一场关于“何为好药、何为值钱的药”的微观辩论。

2026年的目录调整已闻战鼓。参照药的最终确定，不过是这场战役前一次小规模的火力侦察。对药企而言，真正的考验在于，你是否能讲一个超越“参照药”框架的故事——一个关于临床未满足需求、关于整体治疗成本节约、关于社会价值的完整叙事。单纯纠结于参照药是升是降，格局小了。医保的顶层设计正在倒逼行业从“价格竞争”转向“价值竞争”。那些只会做“高仿”和“微创新”的玩家，在这套日益精细化的评价体系下，生存空间将越来越逼仄。这不是一场百米冲刺，而是一场负重越野，拼的不仅是爆发力，更是耐力和战略眼光。潮水正在重新划分价值的河床，有些人已在筑坝，有些人还在沙滩上争论贝壳的成色。