创新药落地为何困难重重

近日，国家医疗保障局正式发布《2024年国家基本医疗保险、工伤保险和生育保险药品目录调整工作方案》并于2024年7月1日启动医保目录调整工作。与去年医保目录调整方案相比，今年的方案着重明确了目录药品调出的情形，强调近三年未向医药机构供应的目录内药品以及未按照医保协议约定保障市场供应的药品将被重点考虑移除医保目录。

这一规定加强了药品进入医保目录和保障药品供应之间的联系，缓解医保目录药品短缺，推动医保药品在临床上的应用。然而，许多患者目前仍然面临药品进入了医保却买不到的难题。进入医保只是实现创新药惠及广大患者的第一步，创新药落地的“最后一公里”还存在许多障碍。

创新药“进院难”的问题

药品的主要销售渠道是医院。商务部《2022年药品流通行业运行统计分析报告》数据显示，2022年医疗机构药品销售额占总销售额68.8%，零售药品占比为31.2%。创新药进入医保目录再到进入医院、能够被患者购买到的这一过程往往充满曲折。首先，公立医院药品配备目录规定一家医院的药品种类是有限的，例如一家三甲医院原则上不能配备超过1500种不同品规的药品。然而，医保目录药品种类多达2800种，这意味着医保药品进院面临激烈的竞争，有些医保药品将不会被医院采购。

决定一款新药能否纳入医院采购取决于医院药事管理与药物治疗学委员会的决定。医疗机构药品目录遴选是一个非常复杂的过程，涉及到不同科室之间的博弈。一款药品的安全性、有效性和经济性需经过充分论证并通过药事会投票通过，才可以纳入医院采购。这就导致有些临床急需的新药不得不等待医院漫长的决策流程，才有可能纳入医院药品目录。此外，由于各省对药事会召开的时间和频率要求存在差异，同一款新药进入不同地区不同医院的时间也会有所不同，这就导致患者对新药的可及可能存在地域性差异。

“双通道”政策落实存在阻碍

作为患者获取药品的另一重要渠道，零售药店在提供便利和提升药物可及方面承担着重要的作用。为助力国谈药品落地，医保部门将零售药店纳入谈判药品供应保障体系，开辟“双通道”为国谈药品在定点零售药店提供与医疗机构相同的医保报销政策。零售药店也能够为医院药品采购与储备分担一定压力。

然而，“双通道”的落实并非理想中一帆风顺。首先，零售药店销售“双通道”药品需要配置多名执业药师以及建设电子处方流转对接系统，这无疑增加了零售药店的投入。其次，医疗机构推动处方外流至零售药店的动力不足。一方面，外流处方的用药安全问题缺少完善的保障机制。另一方面，处方外流涉及到医院和医生的利益，因此医生更倾向于患者在自己的医院药房购药。另外，有些医院在某款药品进入了当地“双通道”药品目录后，便不再考虑纳入医院的药品目录。这反而令“双通道”变成了“单通道”，出现了国谈药品无法进入医院药房，而只能在零售药店购买得到的情况。

创新药落地需要更加全面的支持

医保支付是创新药可及的重要一环，而实现创新药惠及患者需要从研发、审批、支付、合理用药等多方位全链条的政策支持。7月5日，国务院常务会议审议通过了《全链条支持创新药发展实施方案》，要求全链条强化政策保障，统筹用好价格管理、医保支付、商业保险、药品配备使用、投融资等政策，优化审评审批和医疗机构考核机制，合力助推创新药突破发展。

除了全链条政策支持之外，医疗机构和药品企业还应帮助医生和患者提升对新药的认识与接受程度。许多疾病已经形成了较为固定的治疗方案，患者对使用传统药物的依从性高。但由于对新药的了解不足，医生对开具新药处方存在顾虑，患者还是仅认同自己熟悉的药品品牌和厂家。因此需要全社会齐心协力，推动有价值的健康教育帮助患者获取医药创新信息，破除医护人员和患者对创新药有效性和创新性的信息差，更好地做出用药决策，满足各种健康需求。

Recently, the National Healthcare Security Administration (NHSA) officially released the 2024 National Reimbursement Drug List (NRDL) Adjustment Work Plan and launched this year’s NRDL adjustment on July 1, 2024. The 2024 Work Plan clarified the conditions under which NRDL medicines may be removed from the list. According to the Work Plan, medicines will be considered for removal if they: a) have not been supplied to any medical institution in the past three years, or b) have not been supplied to the market according to their NRDL negotiation contract.

The new requirement will strengthen the link between NRDL inclusion and supply guarantees, expected to alleviate NRDL drug shortages and promote their clinical use. However, many patients still face difficulties accessing medicines on the list. NRDL inclusion is only the first step; significant obstacles remain in ensuring that innovative medicines reach the patients who need them most.

Innovative Medicines Barred from Hospital Pharmacy Procurement

Hospital pharmacies are the primary sales channel for medicines in China. According to the Ministry of Commerce's 2022 Drug Distribution Industry Operation Statistical Analysis Report, drug sales in medical institutions accounted for 68.8 percent of total sales in 2022, while retail drug sales made up 31.2 percent. The process for innovative medicines – entering NRDL, being procured by hospitals, and eventually reaching patients – is often complex. Public hospitals maintain their own drug procurement lists, typically including a limited number of medicines. For example, a tertiary hospital is generally limited to stocking no more than 1,500 different medicines, despite the NRDL containing up to 2,800. Consequently, many NRDL drugs face intense competition and may not be procured by many hospitals.

The selection of new drugs for hospital procurement depends on the decision of a hospital's pharmacy management and pharmacotherapy committee. The process is complex as it must navigate potentially conflicting interests among hospital departments and involves careful evaluation of a drug’s safety, effectiveness and value. Voting within the committee is required before a drug can be approved for procurement. Consequently, some urgently needed drugs face delays due to the lengthy decision-making process. Additionally, differences in the timing and frequency of pharmacy committee meetings across provinces can lead to variations in how quickly new drugs become available in different regions, resulting in regional disparities in patient access.

Obstacles to the Implementation of the "Dual Channel" Policy

As another important channel for patients to purchase medicines, retail pharmacies play an important role in providing convenience and improving drug access. A “dual channel” policy was introduced, allowing NRDL-negotiated drugs to be sold at both medical institutions and designated retail pharmacies under the same reimbursement policy. As a result, patient access to NRDL-negotiated drugs is expected to improve, and there would be less pressure on hospitals to procure and store various NRDL drugs.

However, the implementation of the "dual channel" has not been as smooth as expected. Firstly, retail pharmacies selling "dual channel" drugs must hire additional licensed pharmacists and invest in an electronic prescription circulation system for processing prescriptions that patients obtain from other medical institutions. This will undoubtedly increase retail pharmacies’ operating costs.

Secondly, medical institutions have little incentive to direct patients to retail pharmacies. Doctors might hesitate to prescribe medications for external purchase due to safety concerns, and hospitals would rather have patients purchase drugs from their own pharmacies, as drug sales are a significant revenue source.

In addition, some hospitals may stop considering the procurement of a new drug once it is included in the local "dual channel" drug list. This may result in a situation where an NRDL-negotiated drug is only available at retail pharmacies, effectively turning the “dual channel” into a “single channel.”

Improving Access to Innovative Medicines Requires More Comprehensive Support

Inclusion in NRDL, though significant, is only one aspect of improving patient access to innovative medicines. Each stage of the pharmaceutical innovation life cycle – R&D, registration and approval, payment, and rational use – requires coherent policy support. On July 5, the State Council Executive Meeting approved the Implementation Plan for Supporting the Full Life Cycle Development of Innovative Drugs. This plan strengthens policy support for innovative medicines in drug pricing management, medical insurance payment, commercial health insurance, rational use, and investment incentives. It also aims to optimise the review and approval system and reform medical institution evaluation rules to encourage and incentivise innovative medicines.

In addition to full life cycle policy support, medical institutions and pharmaceutical companies should also work together to help doctors and patients improve their understanding and acceptance of new drugs. Many diseases have established treatment plans, and patients are loyal to traditional drugs. Doctors may be reluctant to prescribe new drugs due to lack of familiarity, while patients tend to trust familiar brands. To address this, society needs to promote robust health education, helping patients access information about pharmaceutical innovations. This will enable healthcare practitioners and patients to better understand the benefits of innovative medicines and make informed health decisions.