请注意，I-O玩家。百时美施贵宝以半价出售Opdivo：报道

StephenW

Take note, I-O players. Bristol-Myers to sell Opdivo in China at half-price: report
by Angus Liu | Aug 22, 2018 11:52am
opdivo
Opdivo's price in China will set a benchmark for other immuno-oncology therapies eyeing the Chinese market. (Bristol-Myers Squibb)

After Bristol-Myers Squibb won the first immuno-oncology nod in China for its PD-1 star Opdivo in June, all parties were holding their breath for its price tag. After all, it would set a bar for other I-O therapies on their way to the key market.

And now we know. Opdivo will be priced in China at half its U.S. cost, according to local reports.

The drug will come in at retail prices of 9,260 yuan ($1,354) for the 100mg/10mL vial and 4,591 yuan ($671) for the 40mg/4mL dose, local business news organization Caixin reported, following rumors that first emerged on social media Monday. In the U.S., the larger vial costs about $2,600 to $2,800, and the smaller vial runs about $1,100, according to the drug pricing website GoodRx.


A Bristol-Myers Squibb spokeswoman wouldn’t confirm the reported price, and a media aide in China Tuesday told FiercePharma that the company is “working with the government to complete” the pricing process.

“The price of Opdivo will take the value of the medicine, affordability for Chinese patients and the high unmet medical needs into consideration,” the company said in a statement. It also promised to work with payers and third parties, through various programs, to open up Opdivo to more patients.

Caixin also reported that BMS might initiate a patient assistance program—a typical move for high-cost cancer drugs in China as well as the U.S.—which will offer patients six months of free treatment after they pay for the first five.


The Chinese price will be quite a bit lower compared with other parts of Asia, according to local reports. After a round of price cuts, the drug still costs about $2,500 in Japan. Its prices in Hong Kong and Singapore each came above $2,000 per vial.

A significant discount? Yes. But even at the much lower price, the cost is still a huge burden for Chinese patients. The drug will be given as a bimonthly injection at 3mg per one kilo of the individual patient's weight. That means someone weighing 60 kg will need to pay 18,442 yuan every two weeks.

To put that in context, in Shanghai, the per capita annual disposable income in 2017 was a little below 59,000 yuan.

Opdivo could become less pricey for patients if it's included on government-run insurance programs. However, Professor Yilong Wu, who led Opdivo’s Chinese-specific phase 3 trial that led to its approval, told The Paper (Chinese) that he doesn’t expect Opdivo will be considered for that coverage.

Compared to targeted therapies, PD-1 inhibitors cannot really pinpoint the perfect patients who benefit most, said Wu.

“Clinical trial results showed that, among five patients on Opdivo, only one really benefited from it,” he said. “It’s just that the duration of the benefit was long, which is why the drug was approved.”


Last week, China’s State Medical Insurance Administration unveiled a list of 18 cancer drugs that will be part of negotiations this year for adoption by the national medical insurance scheme. While Opdivo didn’t make that list, several other newly approved therapies did, such as AstraZeneca’s lung cancer drug Tagrisso and Takeda’s multiple myeloma treatment Ninlaro, as well as ALK-positive lung cancer therapies Zykadia by Novartis and Xalkori from Pfizer.

Based on previous talks, drugs usually need to take huge price cuts to win enlistment on the National Reimbursement Drug List and thus reach more patients. Last year, for example, the 36 drugs newly added to the roster took an average 44% discount.

As for the PD-1/PD-L1 fight in China, Merck & Co. just won Keytruda approval a month ago, and all eyes will now move to its pricing strategy. Besides, local players Zhejiang Hengrui, Innovent and Junshi Biosciences have candidates under priority review at the Chinese regulators.

StephenW

请注意，I-O玩家。百时美施贵宝以半价出售Opdivo：报道
安格斯刘| 2018年8月22日上午11:52
opdivo
Opdivo在中国的价格将为其他针对中国市场的免疫肿瘤治疗奠定基准。 （Bristol-Myers Squibb）

继百时美施贵宝公司于6月份获得PD-1明星Opdivo在中国首次获得免疫肿瘤学认可后，所有各方都为它的价格而屏住呼吸。毕竟，它将为进入关键市场的其他I-O疗法设定一个障碍。

现在我们知道了。据当地报道，Opdivo将以中国的一半成本在中国定价。

据当地商业新闻机构财新报道，周一首次出现在社交媒体上的传言称，100mg / 10mL小瓶的零售价为9,260元（1,354美元），40mg / 4mL剂量为4,591元（671美元）。根据药品定价网站GoodRx的数据，在美国，较大的小瓶价格约为2,600美元至2,800美元，较小的小瓶价格约为1,100美元。


布里斯托尔 - 迈尔斯施贵宝发言人不会证实报道的价格，周二中国媒体助理告诉FiercePharma，该公司正在“与政府合作完成”定价过程。

该公司在一份声明中说：“Opdivo的价格将考虑药品的价值，中国患者的负担能力以及未满足的高医疗需求。”它还承诺通过各种计划与付款人和第三方合作，向更多患者开放Opdivo。

财新还报告说，BMS可能会启动一项患者援助计划 - 这是中国和美国的高成本抗癌药物的典型举措，它将为患者支付前五个月后的六个月免费治疗费用。


据当地报道，与亚洲其他地区相比，中国的价格会相当低。经过一轮降价，该药在日本仍然花费约2,500美元。它在香港和新加坡的价格均高于每瓶2000美元。

一个很大的折扣？是。但即使价格低得多，成本仍然是中国患者的巨大负担。该药物将以每1千克个体患者体重3mg的剂量给予双月注射。这意味着体重60公斤的人每两周需要支付18,442元。

说到这一点，在上海，2017年人均年可支配收入略低于59,000元。

如果患者被纳入政府运营的保险计划，Opdivo可能会降低患者的价格。然而，领导Opdivo中国特定阶段3试验的吴仪龙教授告诉The Paper（中国），他并不认为Opdivo会被考虑用于该报道。

吴说，与靶向治疗相比，PD-1抑制剂无法确定最有益的患者。

“临床试验结果显示，在Opdivo的5名患者中，只有一名真正从中受益，”他说。 “这只是益处的持续时间很长，这就是药物被批准的原因。”


上周，中国国家医疗保险管理局公布了18种抗癌药物清单，这些药物将成为今年谈判的一部分，供国家医疗保险计划采用。虽然Opdivo没有列出这个名单，但其他一些新批准的疗法确实如此，例如阿斯利康的肺癌药物Tagrisso和Takeda的多发性骨髓瘤治疗Ninlaro，以及诺华公司的ALK阳性肺癌治疗Zykadia和辉瑞公司的Xalkori。

根据之前的谈判，药物通常需要大幅降价才能赢得国家报销药物清单上的入伍，从而吸引更多患者。例如，去年新增加到名册上的36种药物平均折扣44％。

至于中国的PD-1 / PD-L1战斗，默克公司一个月前就获得了Keytruda的批准，现在所有的目光都将转向定价策略。此外，本土企业浙江恒瑞，Innovent和俊士生物科学有优先考虑中国监管机构的候选人。