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癌症,肝炎治疗设置为推动中国大检查药物清单   [复制链接]

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发表于 2017-1-27 16:24 |只看该作者 |倒序浏览 |打印
Cancer, hepatitis treatments set for boost as China overhauls drugs list


By Adam Jourdan |

China is set to add more than 300 new and traditional drugs to its list of medicines the state will help patients pay for, the first change in more than seven years that will boost treatments for cancer, kidney disease, hepatitis and haemophilia.

Blockbuster drugs such as GlaxoSmithKline's hepatitis drug Viread, AstraZeneca's heart drug Brilinta and Sanofi's chronic kidney disease drug Renvela were up for inclusion over the coming weeks, industry executives said, actual guaranteeing an uplift in sales.

Industry insiders and analysts said oncology drugs were also likely to be added to national and regional lists. Poor access to targeted cancer drugs is a hot-button issue in China, where patients often take on crippling debts or turn to grey markets to get treatment.

Changes to the National Reimbursement Drug List (NRDL), which determines the drugs are part-sponsored by the government, will be a welcome shot in the arm for global drug companies, most of whom saw sales growth slow or contract last year in the world's Number two pharmaceutical market.

"It's pretty much the most important list to get on. Being added can really mean sales of a drug skyrocket," said a Shanghai-based executive at a large British drugmaker.

Inclusion on the NRDL means a drug is accessible through state insurance schemes, making it affordable to mass market consumers. Any new drug approved for sale since the last update of the list in 2009 was until now substantially paid for out-of-pocket by patients .

Most additions to the list, currently just over 2,000 strong, will be traditional Chinese medicines, but roughly 130 are expected to be modern drugs.

"Inclusion on the list reduces the burden of self-pay, as drugs on the list can be reimbursed up to 80 percent depending on local implementation," said Jordan Liu, Shanghai-based associate principal at healthcare research and services company QuintilesIMS.

An executive at another global drugmaker said the list was expected to be published in the "first few months of 2017", though some analysts said it could be as early as the Lunar New Year holiday that starts later this week. There could be a further Negotiation period for high-priced drugs.

HORSE TRADING

Drug companies have spent months lobbying government advisory committees to get their drugs on the NRDL, executives said. The experts on these committees vote for which drugs to include.

The Ministry of Human Resources and Social Security (MOHRSS) and the finance ministry are then involved in a final decision, based on factors including clinical need and cost - after several industry insiders said the process was opaque and the measures used to judge criteria such as Clinical effectiveness were unclear.

Even once on the NRDL, drug makers negotiate pricing and access for their drug on separate provincial lists.

Access to the country's main lists - which includes the NRDL along with the Essential Drug List (EDL) for the most critical drugs - also comes with strings attached.

Drugmakers often have to cut prices steeply to be included, helping China's drive to lower drug prices and rein in a healthcare bill McKinsey estimates hitting $ 1 trillion by 2020.

"To gain market access, it's crucial for companies to be able to show the value of their therapies in terms of improved outcomes and optimized overall cost-of-care," added QuintilesIMS's Liu.

GlaxoSmithKline agreed to a 67 percent cut to the price of hepatitis B drug Viread in May, eyeing in return a major volume boost. GSK declined to comment for this story.

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RARE OPENING

Drugmakers say the update will improve access to medicines for Chinese patients, who often have to wait years after drugs are approved in other countries or pay for the latest drugs out-of-pocket.

"AstraZeneca is pleased that the China government has opened a review of the national drug reimbursement list, which will benefit patients in China in terms of both access and affordability of innovative and high quality drugs," said Laurence Huang, vice president of government affairs for Asia.

Analysts said local firms could benefit too. CSPC Pharmaceutical Group Co Ltd, Sino Biopharmaceutical Ltd, 3SBio Inc have drugs that have a good chance to get on to the NRDL.

Dublin-based drugmaker Shire, which specializes in Rare diseases, told Reuters in November that it hopes to get its haemophilia treatment on the main section of the NRDL as part of a drive to double its Asian sales by 2020.

Patients currently have only limited access to the drugs.

"This is a rare opening of the NRDL. It is a window of opportunity," said Peter Fang, Shire '

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发表于 2017-1-27 16:25 |只看该作者
癌症,肝炎治疗设置为推动中国大检查药物清单


作者:Adam Jourdan |

中国将在其国家将帮助患者支付的药物清单中增加300多种新药和传统药物,这是七年多以来的第一次改变,将促进癌症,肾脏疾病,肝炎和血友病的治疗。

行业高管表示,重磅药物如GlaxoSmithKline的肝炎药物Viread,AstraZeneca的心脏药物Brilinta和Sanofi的慢性肾脏疾病药物Renvela在接下来的几周内被纳入,实际保证了销售额的增长。

业内人士和分析师表示,肿瘤药物也可能被添加到国家和地区名单。难以获得靶向的癌症药物在中国是一个热门问题,在中国,患者经常遭受瘫痪的债务或转向灰色市场接受治疗。

国家赔偿药物清单(NRDL)的变化,决定了药物是由政府部分赞助的,将是全球制药公司的一个受欢迎的射击,其中大多数的销售增长缓慢或合同去年在世界第二医药市场。

一家位于上海的英国大型制药公司的执行官说:“这是一个非常重要的名单,被添加的确实意味着销售一种药物的天空。

纳入NRDL意味着药物可通过国家保险计划获得,使大众市场消费者可以负担得起。自2009年上次更新名单以来批准出售的任何新药,直到现在基本上由病人自付费用。

大多数增加的名单,目前刚刚超过2000强,将是中药,但大约130将被视为现代药物。

医疗研究和服务公司QuintilesIMS的副总裁Jordan Liu说:“列入名单可以减少自付的负担,因为列表上的药物可以报销高达80%,取决于当地的实施。

另一家全球制药商的高管表示,该名单预计将在“2017年前几个月”发布,尽管一些分析师表示,可能早在本周晚些时候开始的农历新年假期。高价药物可能有进一步的谈判期。

马交易

高管们说,药品公司花了几个月的时间游说政府咨询委员会,在NRDL上获得他们的药物。这些委员会的专家投票选择包括哪些药物。

人力资源和社会保障部(MOHRSS)和财政部然后根据包括临床需求和成本在内的一些因素参与最终决定 - 一些业内人士表示,这一过程是不透明的,并采取措施来判断标准,例如临床有效性不清楚。

即使曾经在NRDL上,药物制造商也在不同的省名单上谈判定价和获取药物。

访问国家的主要清单 - 包括NRDL以及最关键药物的基本药物清单(EDL) - 也附带了字符串。

药物制造商通常不得不大幅度降低药物价格,以帮助中国降低药物价格和控制医疗保健费用,麦肯锡预计到2020年将达到1万亿美元。

QuintilesIMS的Liu补充说:“为了获得市场准入,公司必须能够在改善结果和优化整体成本保障方面显示其治疗的价值。

葛兰素史克公司同意在5月份减少67%的乙型肝炎药物Viread的价格,目光回报一个主要的量增加。 GSK拒绝对此故事发表评论。

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罕见开放

药物制造商说,这项更新将改善中国患者获得药物的机会,中国患者通常需要在其他国家批准药物后等待几年,或者自费购买最新的药物。

“阿斯利康高兴地看到,中国政府已经开始对国家药品报销名单进行审查,这将有利于中国患者获得创新和高质量药品的可及性和可负担性,”政府事务副总裁Laurence Huang说,亚洲。

分析师说,当地公司也可以受益。 CSPC药业集团有限公司,Sino Biopharmaceutical Ltd,3SBio公司有药物有很好的机会进入NRDL。

总部位于都柏林的制药公司Shire专门从事稀有疾病,11月份告诉路透社,它希望在NRDL主要部分获得其血友病治疗,作为到2020年将亚洲销量翻一番的一部分。

患者目前只能有限地获得药物。

“这是一个罕见的NRDL开放,这是一个机会的窗口,”彼得·方,
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