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进医保,能让药品销量增长多少?

小番茄 小番茄 来源:医药魔方
2019-02-02
药品销量 医保
原文

医保基金是我国医药市场最大的支付主体。进入医保目录意味着患者付费负担减轻,医院用药意愿加大,理论上自然会带动药品销量增长,对促进公司业绩增长的重要性也不言而喻。因此,在动态调整方案落地前的历次医保目录集中调整都吸引了行业的重大关注。

 

2017版国家医保目录在2017年2月23日正式公布,共收录药品2535个,相比2009版目录增加15%。其中,西药增加217种,调出61种,中成药增加251种。总体上做到稳步扩容、中西药并重,在适应症方面也更多的增加了肿瘤、心血管、呼吸系统消化系统用药,罕见病,抗感染用药也有一定扩增,进一步减轻了患者负担。

 

医药市场瞬息万变,特别是2017版新医保实施至今也已近2年,对终端销量的影响也应有所体现。回想一下,各家企业当初庆祝自己品种进入医保目录的欢声笑语依然让人记忆犹新,那么2年之后,医保目录政策的利好是否已经兑现到品种业绩上?具体品种的销量业绩又增厚多少?相信这是所有人都感兴趣的问题。

 

篇幅所限,本文以13个代表性品种为例,看一下这些品种在进入医保之后的销量和销售额变化,从中窥测一下医保目录对于药品销量的帮助作用到底有多大。


说明:本文销售额和销量数据均来源于医药魔方PharmaBI;本文所指增长率均为环比(本季度与上一季度比较)。


NO. 1 西达本胺


西达本胺是微芯生物自主研发的HDAC抑制剂类抗癌新药,通过精确控制与肿瘤细胞活动密切相关的四种酶,激活人体内抗肿瘤细胞的免疫功能,来控制肿瘤复发和转移。首个适应症是复发及难治性外周T细胞淋巴瘤的新药,在临床有效性、安全性以及使用方便性上均优于其它产品。

 

西达本胺于2014年12月23日在中国首次获批上市,价格只有同类产品的十分之一。进入医保目录前,销售业绩并不理想。在通过谈判方式进入2017国家医保目录后,价格降低,同时随着医保支付逐渐在部分省市落地,2017Q2的销量环比增幅超过700%,说明临床需求在骤然间得到了一个极大的释放。此后销量增长幅度下降,渐趋于稳定。


NO.2 来那度胺


来那度胺胶囊主要用于治疗曾接受过至少一种疗法的多发性骨髓瘤,原研厂家是美国新基公司。自2005年上市以来,瑞复美全球销售额始终保持高速增长,2017年全年销售额已超过80亿美元。虽然我国多发性骨髓癌以及骨髓异常综合征总患者基数多,市场潜力大,但是来那度胺原研药在国内的销售并不如全球市场风光,直到2017年谈判进入医保后才开始放量,特别是2018Q1相比上一季度翻倍增长。



来那度胺治疗效果好、临床应用安全、不良反应小,在NCCN2019新版指南以及2017年版《中国多发性骨髓瘤诊治指南》中被推荐为一线用药,叠加医保谈判降价效应,推动了临床使用量的明显提升。


NO.3 阿利沙坦酯

 

沙坦类降压药是国内高血压患者的一线用药,阿利沙坦酯片是信立泰开发的独家专利新药,属于血管紧张素 II 受体(ARB)拮抗剂,用于轻、中度原发性高血压的治疗治疗高血压。我国高血压患者保持着年均4%左右的增幅,虽然降压药市场空间大,但是药品种类繁多,ARB类药物更是高度竞争。

 

阿利沙坦酯片2017年销售额不到800万,通过国家谈判进入医保,28%的价格降幅也显示出了竞争力。不过由于医保落地程序繁琐,阿利沙坦酯片在2017年只进入了极少的医院,由于基数较小,2017Q3的翻倍放量跟跟医保降价相关。随着医保落地和阿利沙坦酯片进入更多的医院,2018年显示出了持续、稳定并且明显的放量效应。



NO.4 贝伐珠单抗


贝伐珠单抗是第一个用于转移性结直肠癌的单抗类医保药品(2018年加入了西妥昔单抗),虽然疗效确切,但高昂的价格限制了患者的使用。贝伐珠单抗在2017年底经过谈判进入国家医保,降价63%,降价后即迎来临床需求的极大释放,2017Q3的销量爆发式增长了近160%。但受制于生物药的产能供应问题,2017Q4开始一度出现环比负增长。随着产能供应跟上,贝伐珠单抗销量的环比增幅趋于稳定。



从同比来看,贝伐珠单抗在2018Q2的销量相比2017Q2增长了300%,进入医保的拉动作用是非常明显的。


NO.5 利拉鲁肽


利拉鲁肽属于人胰高血糖素样肽-1(GLP-1)类似物,具有降糖和减重的双重优势。随着多款每周1次的GLP-1受体激动剂获批上市,全球GLP-1药物市场扩容迅速。2017年之前,国内GLP-1受体激动剂市场尚不成熟,规模很小,占整个降糖药市场份额也很小。一方面因为进入市场晚,另一方面是因为价格较高,作为一种慢病用药,超出了国内患者的承受能力。利拉鲁肽通过谈判成功进入医保后,降幅43%,医保支付标准410元/支,国内的用药群体迅速扩大,在2017Q3出现了显著放量。



NO.6 曲妥珠单抗


人表皮生长因子受体-2(Her2)阳性乳腺癌占所有乳腺癌患者的大约20%,是一种侵袭性比较强的乳腺癌,在不予治疗的情况下预后极差。曲妥珠单抗是一种重组DNA衍生的人源化单克隆抗体,选择性地作用于Her2,显著提高了患者生存率,自1998年上市以后经久不衰。曲妥珠单抗在进入国家医保之前就已被多个省市地区的医保覆盖,国家谈判让其由原来的每瓶21600元降价至7600元,降价幅度高达65%。

 

2018年曲妥珠单抗又进入新版的基药目录,患者覆盖群体进一步扩大。之前有新闻报道曲妥珠单抗在进入国家医保目录后发生断货,而从销售图表可以发现,曲妥珠单抗进入医保后的放量确实非常显著,2017Q3的销量即环比增长了200%,之后因为缺货,曲妥珠单抗出现负增长;随着供应问题的解决,曲妥珠单抗的增长才慢慢恢复,并且在2018Q3再度出现明显放量。



NO.7 重组人尿激酶原


重组人尿激酶原(普佑克)是国家重大新药创制专项资助项目、国家一类生物新药,临床用于急性ST段抬高性心肌梗死的溶栓治疗,在再通率方面(85%)、安全性方面(脑出血发生率仅0.19%)和性价比方面优于瑞替普酶、阿替普酶和尿激酶等竞争对手。在国家医保谈判中重组人尿激酶原以降价11.5%进入。


2017年,普佑克样本医院销售总额约1110万元。从进入医保后的样本医院销量来看,表现不稳定,甚至出现季度负增长。一方面可能是因为急性心肌梗死的发病率存在季节性差异,夏季发病率略低。另一方面,重组人尿激酶原降价11.5%进入国家医保谈判目录,在同批次入围谈判的品种中,降幅处于偏低水平,而且医保对普佑克的报销范围限制为急性心肌梗死发病12小时内,总体增长不是特别明显。



NO.8 替格瑞洛


替格瑞洛是一种直接作用、可逆结合的血小板抑制剂,用于急性冠脉综合征。作为氯吡格雷的换代品种,对于血小板的抑制作用更强、起效更快速,能显著降低心血管死亡、心肌梗死或卒中的发生率,自上市以来已经被多部欧美治疗指南推荐为ASC患者的一线或首选抗血小板药物。

 

全球心血管疾病居高不下,带来抗血栓药市场前景广阔,2017年国内重点城市公立医院替格瑞洛销售金额超过1亿元。但2017年医保目录抗血栓用药中还增加了达比加群酯、阿哌沙班、舒洛地特、阿加曲班、依替巴肽、吲哚布芬和磺达肝癸等新品,竞争异常激烈,因此替格瑞洛的销量增长曲线整体来看还是比较顺滑的,相对本文其他品种没有出现特别明显的大起大落的情况。


N0.9 艾瑞昔布


艾瑞昔布是恒瑞研发的骨关节炎用药,与塞来昔布相比,缓解骨关节炎作用相当,但在心血管、肾功能方面安全性更优,自2012年上市以来一直保持高速增长态势。恒瑞凭借其自身优势以及庞大的销售网络再加上新医保目录的推进,实现稳定放量,销售额一直呈现稳定的增长趋势。



NO.10 非布司他


非布司他是黄嘌呤氧化酶(XO)抑制剂,通过减少血清尿酸缓解痛风。痛风作为我国第二大代谢类疾病,患者基数庞大,但治疗用药品种却不多,国内重点城市公立医院痛风药市场主要由非布司他、苯溴马隆、别嘌醇和秋水仙碱4个药物组成。

 

2017年国内痛风药物的市场规模约10亿元,在进入2017医保目录前,非布司他虽然价格略高,但是市场占有率已经接近一半。医保报销后,非布司他在2017Q2当季即实现销量翻倍,临床需求得到释放,之后进入稳步增长阶段。截至2018Q3,非布司他的季度销量相比进入医保前的2016Q3已经同比增长了近5倍。



NO.11 康柏西普


目前我国年龄相关黄斑变性(AMD)的发病率接近发达国家,患病人群数量在360万人左右。康柏西普2017年通过谈判降价17%纳入医保,医保支付标准为5500元/支,雷珠单抗与康柏西普一同进入医保支付目录,医保支付标准为5700元/支。康柏西普相比雷珠单抗的竞争优势包括更佳的治疗效果、更少的注射次数以及以及本土制药企业销售渠道的优势,康柏西普的市场份额在未来有望超过雷珠单抗。

 

康博西普进入国家医保目录后,在2017年第四季度至2018年初陆续完成地区增补。从数据上看,在降价及医保的双重影响下,康柏西普呈现了一个稳定平稳的放量趋势。



NO.12 阿哌沙班


阿哌沙班是直接作用于凝血因子X的抗凝药,其临床效果受到广泛认可。新医保目录对其报销范围限定为下肢关节置换手术患者,所以即使在栓塞预防、深静脉栓、肺栓塞等方面有着很好的疗效,销量增长并不是特别显眼,但医保覆盖后,总体上还是带来了销量的增加。



NO.13 帕罗西汀


帕罗西汀常释剂型作为抗抑郁症一线药物进入国内后销量一直稳定增长,一度占据领头羊地位。缓释新剂型2017年通过谈判进入医保,销售迅速增长,随着人们对抑郁症危害性的认识加深,抑郁人群的增长,抗抑郁药市场前景十分广阔。帕罗西汀作为一线抗抑郁药物,临床安全性较好,市场容量大,但由于仿制药大量掠夺原研市场,竞争激烈,所以销量增长不明显。


结语

从上述品种的医院销售情况总体来看,在进入国家医保目录后,大多数品种在2017Q4之前都出现了明显的放量,特别是对于一些临床急需的、价格昂贵的抗癌药以及疗效出色的慢性病用药,销量增长显著。但是对于一些市场相对成熟,竞品较多的品种,进入医保后尚未看到销量的显著增长。

 

对于类似贝伐珠单抗、曲妥珠单抗、利拉鲁肽等生物药品种,我们透过数据可以观察到的现象是在经过2017Q3或2017Q4的极大放量后,受制于供应等问题,销量增幅出现比较明显的一个回落。来那度胺、阿利沙坦酯等小分子药物在这一点上有所不同,销量增幅回落可能主要是基数变大的因素。

 

此外,由于部分药品价格下降较多,销售额的变动幅度一般会小于销量的变化幅度,但随着相关优惠政策进一步落地,销售量增长的积极因素大于价格下降带来的不利影响,最终会实现销售额的增长。


机器翻译

The health insurance fund is the largest payee in the Chinese medicine market.Entering the health insurance catalogue means that the burden of patient payment is reduced and the willingness of hospitals to use drugs is increased. In theory, it will naturally drive the growth of drug sales, and the importance of promoting the growth of corporate performance is self-evident.Therefore, in the dynamic adjustment program before the landing of the previous health insurance list adjustment has attracted significant attention of the industry.

The National Health Insurance Catalogue (2017 Edition) was officially released on February 23, 2017, which included a total of 2,535 drugs, an increase of 15% compared with the Catalogue (2009 Edition).Among them, western medicine increased 217, call out 61, Chinese patent medicine increased 251.On the whole, make steady expansion.Both Chinese and Western medicine, in terms of indications also more increased the tumor.Cardiovascular.Respiratory system drugs, rare diseases, anti-infective drugs also have a certain expansion, further reducing the burden on patients.

The pharmaceutical market is rapidly changing, especially since the implementation of the new medical insurance in 2017 has been nearly 2 years, the impact on terminal sales should also be reflected.Recall that the laughter of companies celebrating the entry of their varieties into the Medicare Catalogue is still vivid. Two years later, has the benefits of the Medicare Catalogue Policy been honored in terms of variety performance?How much is the sales performance of specific varieties increased?Believe that this is an issue that everyone is interested in.

is limited in space. This paper takes 13 representative varieties as an example to see the changes in sales volume and sales volume of these varieties after entering the medical insurance system, from which we can see how the medical insurance catalogue helps the sales volume of drugs.

NO.1. Cetaben

Sidabenamine is a new anti-cancer drug of HDAC inhibitor independently developed by micro-core organism. It can control tumor recurrence and metastasis by precisely controlling the four enzymes closely related to tumor cell activity and activating the immune function of anti-tumor cells in human body. The first indication is a new drug for relapsed and refractory peripheral T-cell lymphoma that is superior to other products in terms of clinical effectiveness, safety, and ease of use.

Sidabenamine was first approved for listing in China on December 23, 2014, and the price is only one-tenth of that of similar products. Before entering the medical insurance catalog, the sales performance was not satisfactory. After entering the 2017 national medical insurance catalogue through negotiation, the price decreased, and as the medical insurance payment gradually landed in some provinces and cities, the sales volume of 2017Q2 increased by more than 700%, indicating that the clinical demand has suddenly been greatly released. Since then, the growth rate of sales has declined and it has gradually stabilized.

no.2 Lenalidomide

Lenalidomide Capsules is mainly used for the treatment of multiple myeloma that has received at least one therapy, and the originator is American New Base Company.Since its launch in 2005, Ruifumei's global sales have continued to grow at a high rate, exceeding $8 billion in 2017.Although the total number of patients with multiple bone marrow cancer and myelodysplastic syndrome in China is large and the market potential is large, the sales of brand-name lenalidomide in China are not as good as those in the global market. It was not until 2017 that the volume of brand-name lenalidomide began to increase, especially in 2018Q1 compared with the previous quarter.

Lenalidomide is effective.Clinical application safety.The adverse reactions were small. It was recommended as the first-line drug in the new guidelines of NCCN2019 and the Guidelines for the Diagnosis and Treatment of Multiple Myeloma in China (2017 Edition), superimposing the price reduction effect of medical insurance negotiation, which promoted the significant increase of clinical use.

NO3.Alisartan medoxomil

is the first-line drug for hypertension patients in China. Alisartan medoxomil tablets is an exclusive patented new drug developed by Xinlitai, belonging to angiotensin II receptor (ARB) antagonist, used for mild.Treatment of moderate essential hypertension.Hypertension patients in China maintain an average annual increase of about 4%, although the market space for antihypertensive drugs, but a wide variety of drugs, ARB drugs are highly competitive.

Alisartan medoxomil tablets had sales of less than 8 million yuan in 2017. Through national negotiation and entry into medical insurance, 28% price decrease also showed competitiveness.However, due to the cumbersome procedure of medical insurance landing, Alisartan Axetil Tablets only entered very few hospitals in 2017. Due to the small base, the doubling volume of 2017Q3 is related to the price reduction of medical insurance.The year 2018 has been shown to continue as Medicare and Alisartan Axetil Tablets move into more hospitals.Stable and significant volume effect.

no.4 Bevacizumab

Bevacizumab is the first monoclonal antibody for metastatic colorectal cancer (added to cetuximab in 2018), although the efficacy is definite, but the high price limits the use of patients.Bevacizumab entered the national medical insurance system through negotiation at the end of 2017, with a price reduction of 63%. After the price reduction, it ushered in a great release of clinical demand. The sales volume of 2017Q3 exploded by nearly 160%.However, subject to the problem of biological drug supply capacity, 2017Q4 began to show negative growth.Bevacizumab sales grew steadily from the previous month as capacity supply kept pace.

From the same period of last year, the sales of bevacizumab in 2018Q2 increased by 300% compared with 2017Q2, and the pulling effect into medical insurance is very obvious..

NO5. Liraglutide

Liraglutide is a human glucagon-like peptide-1 (GLP-1) analog with the dual advantages of glucose-lowering and weight-loss.With the approval of several once-weekly GLP-1 receptor agonists, the global market for GLP-1 drugs has expanded rapidly.Before 2017, the domestic market of GLP-1 receptor agonists was immature, very small, and accounted for very small market share of the whole hypoglycemic drugs.On the one hand, because of late entry into the market, on the other hand, because of higher prices, as a chronic disease medication, beyond the capacity of domestic patients.After liraglutide entered into the medical insurance through negotiation, it decreased by 43%, and the payment standard of medical insurance was 410 yuan/branch. The domestic drug use group expanded rapidly, and there was a significant increase in volume in 2017Q3.

no.6 Trastuzumab

Human epidermal growth factor receptor-2 (Her2)-positive breast cancer accounts for approximately 20% of all breast cancer patients, and is an aggressive breast cancer with a very poor prognosis without treatment. The anti-recombinant DNA-derived humanized monoclonal antibody selectively acts on Her2, significantly improving patient survival, and has been prolonged since its launch in 1998. Trastuzumab has been in the national health insurance before Covered by medical insurance in several provinces and cities, the state negotiated to reduce the price from 2,1600 yuan per bottle to 7,600 yuan, and the price reduction rate was as high as 65%.

Trastuzumab has entered the new version of base drug catalogue in 2018, and the patient coverage group has been further expanded.There was a news report that trastuzumab was out of stock after entering the national medical insurance catalogue. From the sales chart, it can be found that the volume of trastuzumab after entering the medical insurance is indeed very significant, and the sales volume of 2017Q3 is increased by 200%. Later, due to lack of stock, trastuzumab showed a negative growth; with the solution of the supply problem, the growth of trastuzumab slowly recovered, and there was a significant increase in 2018Q3.

no.7. Recombinant human pro-urokinase

The national class I biological new drugs, clinical thrombolytic therapy for acute ST-segment elevation myocardial infarction, in terms of recanalization rate (85%).In terms of safety (the incidence of cerebral hemorrhage was only 0.19%) and cost-effective than reteplase.Alteplase and urokinase and other competitors.Recombinant Human Prourokinase for Price Reduction in National Health Insurance Negotiations 11.5% entered.

In 2017, the total sales volume of Puyouke sample hospital was about 11.1 million yuan.After entering the medical insurance sample hospital sales, performance is unstable, or even quarterly negative growth.On the one hand, it may be because of seasonal differences in the incidence of acute myocardial infarction, which is slightly lower in summer.On the other hand, the price of recombinant human pro-urokinase is reduced by 11.5% entered the national medical insurance negotiation catalogue. Among the varieties that were negotiating in the same batch, the decline was at a low level, and the reimbursement scope of medical insurance for Puyouke was limited to 12 hours after the onset of acute myocardial infarction, and the overall growth was not particularly obvious.

no.8 Ticagrelor

Ticagrelor is a direct action.Reversible binding platelet inhibitors for acute coronary syndromes.As an alternative to clopidogrel, it has a greater platelet inhibition.It has a more rapid onset of action and can significantly reduce cardiovascular death.The incidence of myocardial infarction or stroke has been recommended by several European and American treatment guidelines as the first-line or preferred antiplatelet agent for patients with ASC since its launch.

The global cardiovascular disease remains high, bringing a bright future to the antithrombotic drug market. In 2017, the sales amount of ticagrelor in public hospitals in key cities in China exceeded 100 million yuan.However, the 2017 anti-thrombotic drug list also added dabigatran etexilate. Apixaban.Sulodexide.Argatroban. eptifibatide, indobufen and fondaparin, and other new products, the competition is extremely intense, so ticagrelor The overall sales growth curve is still relatively smooth, and there is no particularly obvious ups and downs compared with other varieties in this paper.

N0.9 Ericsib

Ericoxib is an osteoarthritis drug developed by Hengrui. Compared with celecoxib, it relieves osteoarthritis, but it is cardiovascular. Renal function is safer and has been growing at a high rate since its launch in 2012.With its own advantages and a huge sales network coupled with the advancement of the new health insurance catalog, Hengrui achieved stable volume, sales have been showing a steady growth trend.

no.10 Febuxostat

Febuxostat is a xanthine oxidase (XO) inhibitor that relieves gout by reducing serum uric acid.As the second largest metabolic disease in China, gout has a large number of patients, but there are not many varieties of therapeutic drugs. The market for gout drugs in public hospitals in key cities in China is mainly from febuxostat. Benzbromarone.Allopurinol and colchicine are four drugs.

 

In 2017, the market size of domestic gout drugs was about 1 billion yuan. Before entering the 2017 medical insurance catalogue, although the price of febuxostat was slightly higher, the market share was nearly half.After medical insurance reimbursement, febuxostat achieved sales doubling in the current quarter of 2017 Q2, clinical demand was released, and then entered a steady growth phase.By Q3, sales of febuxostat had increased nearly fivefold in the quarter to 2016Q3, the year before Medicare.

no.11 Compaqip

At present, the incidence of age-related macular degeneration (AMD) in China is close to that of developed countries, and the number of patients is about 3.6 million. In 2017, Conbercept was included in the medical insurance through negotiation to reduce the price by 17%, and the payment standard for medical insurance was RMB 5,500/piece. Ranibizumab and Conbercept entered the medical insurance payment list together, and the payment standard for medical insurance was RMB 5,700/piece.Composing's competitive advantage over ranibizumab includes better therapeutic results.Conbercept's market share is expected to surpass that of ranibizumab in the future due to fewer injections and the advantages of local drug companies' sales channels.

After Combacept enters the National Medical Insurance Catalogue, the regional supplement will be completed successively from the fourth quarter of 2017 to the beginning of 2018.At present, the incidence of age-related macular degeneration (AMD) in China is close to that of developed countries, and the number of patients is about 3.6 million. From the data point of view, under the dual influence of price reduction and medical insurance, Compaqip presents a stable and stable Volume trend.

no.12 Apixaban

Apixaban is an anticoagulant that acts directly on factor X, and its clinical effects are widely recognized. The new health insurance list limits its reimbursement to patients undergoing lower limb joint replacement surgery, so even in embolism prevention.Deep vein thrombosis. Pulmonary embolism and other aspects have a very good effect, sales growth is not particularly conspicuous, but after the coverage of medical insurance, the overall increase in sales.

no.13 Paroxetine

As a first-line antidepressant drug, paroxetine has been growing steadily as a first-line drug for antidepressants. It has once occupied a leading position. The new release formulation has entered the medical insurance through negotiations in 2017, and sales have grown rapidly, with people's awareness of the dangers of depression. Deepening, the growth of depressed population, the market prospect of antidepressants is very broad. Paroxetine as a first-line antidepressant, clinical safety is good, the market capacity is large, but because the generic drugs plunder the original market, the competition is fierce, so the sales growth is not obvious .

Conclusion

From the overall sales situation of the above-mentioned hospitals, after entering the national medical insurance catalogue, most varieties showed significant volume before 2017Q4, especially for some clinically urgent needs. Sales of expensive anticancer drugs and highly effective drugs for chronic diseases have increased significantly.However, for some of the relatively mature and more competitive products, no significant increase in sales has been observed after entering the medical insurance system.

for similar bevacizumab.Trastuzumab. Liraglutide and other biopharmaceutical varieties, we can observe through the data that after the significant volume of 2017Q3 or 2017Q4, subject to supply and other issues, the sales growth rate has a significant decline Small molecule drugs such as lenalidomide and alisartanide differ in this point. The decline in sales growth may be mainly due to the increase in the base.

 

In addition, due to the decline in the price of some drugs, the change in sales is generally smaller than the change in sales. However, as the relevant preferential policies are further implemented, the positive factors of sales growth are greater than the adverse effects of price decline, and will eventually be realized. The increase in sales.

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