c*******n
发帖数: 26 | 1 我家的亲戚得了丙肝有多年，一直没有好。现在突然听说美国Gilead公司出了新药
Sovaldi能治愈丙肝。他们非常想了解一下这个药的功效，特别对于患丙肝已多年的人
（已有部分肝硬化）还有没有帮助。因为他们跑一趟美国不容易，就想让我去帮他们找
专科医生问一下。因为从没有做过咨询医生但不是自己生病，不知道这种情况如何去约
医生，医生能受理这种情况吗？还有费用是不是保险就不能cover？ 万分谢谢！如果有
人知道Sovaldi药的治愈效果怎样，就更好了... | y**s
发帖数: 563 | 2 2014年8月27日讯 /生物谷BIOON/ --丙肝治疗领域，吉利德可谓独领风骚，其明星药物
Sovaldi（sofosbuvir）在今年上半年的销售额突破58亿美元，为其带来了滚滚财源。
然而，这一格局即将打破。
近日，百时美施贵宝（BMS）丙肝新药Daklinza（daclatasvir）获欧盟批准，联合其他
药物，用于所有1、2、3、4基因型慢性丙型肝炎（HCV）成人感染者的治疗。Daklinza
是一种强效的泛基因型NS5A复制复合体抑制剂，在临床试验中，当与吉利德明星药
Sovaldi组成一种全口服、无干扰素鸡尾酒疗法（Daklinza+Sovaldi）时，取得了100%
的治愈率，包括伴有晚期肝脏疾病、基因型3 HCV及既往经蛋白酶抑制剂治疗失败的患
者群体。
目前，吉利德也在开发一种基于Sovaldi的丙肝鸡尾酒疗法ledipasvir/Sovaldi（LDV/
SOF），百时美Daklinza/Sovaldi鸡尾酒疗法的获批，对吉利德LDV/SOF鸡尾酒疗法形成
了直接威胁。
Daklinza/Sovaldi是一种每日一次、全口服、治愈率达100%的丙肝鸡尾酒疗法，为广泛
基因型HCV丙肝患者提供了一种潜在治愈的治疗选择，包括一些难治性群体，如既往治
疗失败的群体。
与Sovaldi一样，Daklinza与其他口服药物联合用药时，可排除常规注射制剂干扰素为
基础的鸡尾酒方案。目前，在美国，吉利德Sovaldi是唯一的统治者，而艾伯维（
AbbVie）和默沙东（Merck & Co）各自的全口服鸡尾酒疗法正在等待FDA的批准。
Daklinza是欧盟批准的首个NS5A复合体抑制剂，将与其他产品联用，提供一种较短治疗
时间（12或24周）的治疗方案。而目前基于干扰素和利巴韦林（ribavilin）的治疗方
案，治疗周期长达48周。Daklinza的获批，适用于欧盟所有28个成员国。此前，欧洲药
品管理局人用医药产品委员会（CHMP）已授予Daklinza加速审批资格。
Dakllinza的获批，是基于数个研究的积极数据，包括一项开放标签、随机研究，调查
了Daklinza+Sovaldi组合疗法治疗基因型1、2、3 HCV感染的疗效，包括对特拉匹韦（
telaprevir）或boceprevir无反应及伴有肝纤维化的患者群体。数据表明，Daklinza+
Sovaldi组合疗法在基因型1 HCV初治患者中的治愈率达到了99%，在既往对特拉匹韦或
boceprevir治疗失败的基因型1 HCV群体中的治愈率达100%，在基因型2和基因型3 HCV
中的治愈率分别为96%和89%。
此外，Daklinza治疗丙型肝炎的安全性，已在横跨各种不同群体中得到了证明，包括老
年患者、伴有晚期肝病群体、肝移植后受者群体及HIV/HCV共感染群体。（生物谷Bioon
.com）
英文原文：Bristol-Myers gets the approval Gilead didn't want: Daklinza +
Sovaldi for hep C
Want a window into the future of hepatitis C drug marketing? Keep an eye on
Europe. Bristol-Myers Squibb bagged European approval for its hepatitis C
fighter Daklinza (daclatasvir) Wednesday, setting the company up for head-to
-head competition with Gilead Sciences' upcoming combo drug.
The EU nod covers Daklinza treatment in tandem with Gilead's Sovaldi (
sofosbuvir), the heavyweight first entry in a new class of hep C drugs. If
you haven't been on sabbatical, you know Sovaldi raged ahead to blockbuster
status within one quarter on the market. You also know that Gilead ($GILD)
is developing a Sovaldi combo pill, using its own ledipasvir as the
companion ingredient--and that Gilead refused to team up with Bristol-Myers
($BMY) to study the Sovaldi-Daklinza combo, despite some eye-popping Phase
II data.
Bristol-Myers is running those trials solo. And now, it can say the
following in its EU approval press release: The Daklinza-Sovaldi cocktail is
an "all-oral, once-daily regimen that yields cure rates of up to 100%."
Plus, it "offers a potential cure" for a broad range of hep C patients,
including some hard-to-treat groups, such as patients who've failed on
previous therapies.
Like Sovaldi, Daklinza can squeeze out interferon-based treatment cocktails
when combined with other oral meds. That's the promise of this new class:
regimens that leave the difficult-to-tolerate interferon out. Right now,
Sovaldi is the sole "nuc" in the U.S., but AbbVie ($ABBV) and Merck ($MRK)
are looking for FDA approval for their own therapies.
And here's where it gets more interesting. We know Gilead will be leaning on
its Sovaldi + ledipasvir pill, which is up for FDA approval by Oct. 10.
AbbVie's three-drug option is under FDA review for a December decision.
Bristol-Myers might want to tout the Daklinza + Sovaldi option when (and if)
its FDA nod comes through in November.
But the FDA didn't allow the company to turn in that Sovaldi-Daklinza data
with its current app. The approval would be for Daklinza and another BMS
drug, Sunvepra (asunaprevir)--and that combo hasn't performed quite as well
as the Daklinza-Sovaldi team in trials. Sustained virological response--a
common measure in hep C trials--for the latter duo approached 100% in some
patients, as Bristol-Myers noted in its EU announcement.
For the Daklinza-Sunvepra team, a recent trial showed response rates of up
to 90%. That's way impressive--and gives the duo plenty of opportunity to
score sales, as blockbuster analyst projections show. Company execs say the
combo has been doing well in Japan, where it won approval in July. Plus,
both of those drugs belong to Bristol-Myers, so the company would be
collecting sales from two products, rather than one with the other combo.
But what might Daklinza do with Sovaldi in the U.S.?
After Gilead spurned Bristol-Myers' offer to put Sovaldi alongside Daklinza
in Phase III trials, the speculation was that doctors might prescribe the
combo off-label, once the BMS drug won FDA approval. Right now, that
prospect looks iffy. Payers are already setting up obstacles to expensive
hep C treatments. Off-label use? Patients and doctors would have to jump
through many hoops to get there, and physicians are already daunted by the
work required to get FDA-approved regimens reimbursed, a recent Decision
Resources survey found.
The market research firm also found that the hep C-treating specialists
surveyed were more likely to know about Gilead's forthcoming combo pill than
about Bristol-Myers and AbbVie's options. Half of those docs expect to
prescribe Gilead's combination therapy within 6 months after approval and
expect the combination of Sovaldi and Johnson & Johnson's ($JNJ) protease
inhibitor Olysio to hold its own. Sounds like Bristol-Myers and AbbVie's
sales-and-marketing teams have their jobs cut out for them.
But here's the kicker: "[N]ear-term competitors that offer favorable pricing
... will likely be a constraint on the uptake of [Gilead's] regimen,"
Decision Resources said. Which means that rivals that undercut Gilead's
price might move ahead in the prescribing queue. AbbVie has said it's not
interested in a price war. Maybe Bristol-Myers will be the one to step up.
【在 c*******n 的大作中提到】
: 我家的亲戚得了丙肝有多年，一直没有好。现在突然听说美国Gilead公司出了新药
: Sovaldi能治愈丙肝。他们非常想了解一下这个药的功效，特别对于患丙肝已多年的人
: （已有部分肝硬化）还有没有帮助。因为他们跑一趟美国不容易，就想让我去帮他们找
: 专科医生问一下。因为从没有做过咨询医生但不是自己生病，不知道这种情况如何去约
: 医生，医生能受理这种情况吗？还有费用是不是保险就不能cover？ 万分谢谢！如果有
: 人知道Sovaldi药的治愈效果怎样，就更好了...
| y**s
发帖数: 563 | 3 美国人民愤怒了——吉利德天价丙肝药Sovaldi印度售价仅1%
来源：生物谷 2014-08-08 13:51
2014年8月8日讯 /生物谷BIOON/ --吉利德（Gilead）丙肝明星药物Sovaldi在2014上半
年的销售额达到了惊人的58亿美元。该药于2013年12月在美国上市，自诞生之日起便成
为行业关注的焦点，其84000美元/疗程（1000美元/片）的定价也饱受各方争议。美国
众议院、患者维权组织等机构曾强烈呼吁Sovaldi降价，而吉利德则坚持不降，并称从
长远来看，该药将为纳税人节省大笔开支。
然而，昨日接受印度时报采访时，吉利德表示，将在印度以1%的价格销售Sovaldi，即
900美元/疗程，折扣高达99%。可以预见的是，此举将令美国民众大为恼火，敢情印度
人民才是吉利德的亲爹亲娘呐！
吉利德还表示，在公司与印度本土数个仿制药商达成合作，生产药物供应印度当地市场
后，Sovaldi的售价将进一步下降。目前，吉利德仍需要在印度完成相关临床试验。
吉利德执行副总裁Gregg Alton在一份声明中称：“Sovaldi在印度的售价为300美元一
瓶（28片），这是公司面对低收入国家的定价，与埃及政府协商的价格相似。我们希望
与印度的合作者在当地生产药物，更高容量及持续的研发，将在后期使Sovaldi的售价
进一步降低。”
Alton解释称，公司在谈判时，会根据一个国家的人均收入和丙型肝炎的发病率，分为
有3种定价策略：低收入、中等收入和高收入。根据世界卫生组织（WHO），印度有1200
万慢性丙型肝炎（HCV）患者；而根据世界银行，2009-2013年，印度的人均收入仅为
1499美元，相比之下，美国的人均收入为53143美元。此外，在印度，目前丙肝的治疗
成本高达6000美元，通常需要注射具有严重副作用的药物（干扰素），治疗疗程长达24
-48周。
除开上述因素，跨国制药公司在印度对昂贵药物定价时，也会有其他的一些考虑因素。
因为印度政府有权行使强制许可权，如果认为品牌药对于本土市场太过昂过，则行使强
制许可，允许本土仿制药商生产廉价仿制药，而且印度政府目前已经在行使强制许可权
。当这种情况发生时，跨国制药公司不仅失去了在印度的直接销售，甚至有失去其产品
控制权（即专利）的风险。例如，此前印度政府就已授权本土Natco公司，生产拜耳的
抗癌品牌药多吉美（Nexavar），拜耳现在正上诉法庭，企图阻止Natco在印度以外地区
销售仿制药。而且Natco公司已要求印度专利局阻止吉利德Sovaldi在印度的专利，以便
能够自己生产该药。
然而，Sovaldi在印度和美国的售价如此悬殊，以至于即便存在上述所有因素，仍不足
以阻止美国评论家对吉利德的强烈声讨。
根据吉利德，在美国，28片/瓶装Sovaldi的批发商采购成本（WAC）费用为2.8万美元，
即每片1000美元，大多数患者需要治疗12周，即一个疗程总费用达8.4万美元。（生物
谷Bioon.com）
英文原文：The $84,000 U.S. treatment price that Gilead Sciences ($GILD) is
charging for its hepatitis C drug Sovaldi has elicited pleas from
politicians and threats from payers, who say the U.S. healthcare system
cannot bear the cost. But Gilead has held firm, insisting it will save money
for payers in the long run, even as the company is raking in billions of
dollars by the quarter. But in India, Gilead will offer it at a discount--a
99% discount.
The drugmaker has told the Times of India that the drug will cost $900 (
about 54,000 rupees) in India for a 12-week treatment. The price may drop
further after Gilead works out deals with several Indian generics makers to
produce the drug for the local market, Gilead Executive Vice President Gregg
Alton told the newspaper. The company still has to complete clinical trials
in India.
"The pricing of Sovaldi in India at $300 per bottle, is our low income
pricing, similar to the price negotiated with Egypt for its government-run
program," Alton said in a statement. "We hope with local production by our
partners in India, higher volumes and continued research & development on
the drug will lead to a further reduction in prices at a later stage."
Alton explained that the company has three pricing tiers that it uses for
negotiations, figured on the per capita income and hepatitis C prevalence of
a country: low-income, low middle-income and upper-middle income. The World
Health Organization says India has about 12 million chronic sufferers of
hepatitis C. According to the World Bank, India per capita income from 2009
through 2013 averaged $1,499. That compares with the U.S. at $53,143. The
newspaper says that current treatments for the disease in India run about $6
,000 and require a 24- to 48-week course of injectables that come with
serious side effects. So Sovaldi will be cheaper and easier to administer,
with fewer side effects and the ability to cure many of the cases.
Drugmakers have other considerations to factor in when pricing essential but
expensive drugs in India. The government has, and has exercised, the
authority to grant a compulsory license for a drug that it considers
essential but too expensive for the Indian market, where few people have
insurance. When that happens the drugmaker not only loses direct sales in
India but also runs the risk of losing control of its product. India used
the provision to grant a license to Natco for Bayer HealthCare's cancer drug
Nexavar, and the German company is now in court trying to keep Natco from
selling it outside of India. Natco has asked the government patent office to
block Gilead's patent for the drug in that country, which would give it a
shot at producing it itself.
But all of those factors are unlikely to keep critics of Sovaldi's price in
the U.S. from pointing to India as proof that the drugmaker could do better
on price in the U.S. Gilead execs have been called to explain its pricing to
Congress after research from Georgetown University and the Kaiser Family
Foundation found that Sovaldi will increase Medicare Part D drug spending by
as much as $6.5 billion in 2015 alone. That would cause overall Medicare
drug spending to rise by 8%.
And pharmacy benefits manager Express Scripts ($ESRX), which handles drug
reimbursement for a big chunk of the U.S. private insurance market, is
trying to rally a coalition to refuse to use Sovaldi after a competitor hits
the market, which might be as early as this fall. The response to Sovaldi's
price is about the same in Europe, where 14 countries will share
information to help one another negotiate better prices for the drug even
though Gilead is likely to price it less there than in the U.S.
So far, Gilead has been able to shake off those threats and reap the rewards
of the most successful drug launch ever. In reporting its Q2 results last
month it said that since its December launch, Sovaldi has been prescribed to
80,000 patients in the U.S. and Europe. In the first two quarters this year
, it has brought in $7.8 billion. But a host of other players have competing
drugs in development or awaiting approval, and the market picture could
change dramatically in short order.
【在 c*******n 的大作中提到】
: 我家的亲戚得了丙肝有多年，一直没有好。现在突然听说美国Gilead公司出了新药
: Sovaldi能治愈丙肝。他们非常想了解一下这个药的功效，特别对于患丙肝已多年的人
: （已有部分肝硬化）还有没有帮助。因为他们跑一趟美国不容易，就想让我去帮他们找
: 专科医生问一下。因为从没有做过咨询医生但不是自己生病，不知道这种情况如何去约
: 医生，医生能受理这种情况吗？还有费用是不是保险就不能cover？ 万分谢谢！如果有
: 人知道Sovaldi药的治愈效果怎样，就更好了...
| y**s
发帖数: 563 | 4 而Sovaldi的副作用少，且治愈率高达80-90%，因此一上市便迅速获得了临床医生的青
睐。
【在 c*******n 的大作中提到】
: 我家的亲戚得了丙肝有多年，一直没有好。现在突然听说美国Gilead公司出了新药
: Sovaldi能治愈丙肝。他们非常想了解一下这个药的功效，特别对于患丙肝已多年的人
: （已有部分肝硬化）还有没有帮助。因为他们跑一趟美国不容易，就想让我去帮他们找
: 专科医生问一下。因为从没有做过咨询医生但不是自己生病，不知道这种情况如何去约
: 医生，医生能受理这种情况吗？还有费用是不是保险就不能cover？ 万分谢谢！如果有
: 人知道Sovaldi药的治愈效果怎样，就更好了...
| c*******n
发帖数: 26 | 5 万分感谢大家的回复和信息! 主要是他们对印度不太放心，而且要等到明年，现在病人
情况不太好。美国价格是高，但是如果能救命还是值得的。家庭也不是那么富裕，但是
也能承受10万左右。但是对于怎样吃这个药，还是不太清楚，比如说是只吃这种药就可
以了，还是要搭配其他药一起吃？找专科医生看的话，他们希望我能先帮他们问一下，
所以我在想是不是要我先打电话去约一个专科医生，然后去了再说不是我生病，是亲戚
，然后看专科医生能不能给点信息。如果是很positive feedback，我再叫他们到美国
来看？所以我只想问我去医生那里只是咨询为其他人的病，是不是咨询费用（不是
copay，比如医生说有另外的咨询费用）我自己的保险不会cover？他们要过来治病，肯
定是只有自费，我只是想有点更详细的信息后再让他们过来。 | s********4
发帖数: 64 | 6 这个药的效果很好，而且疗程短（12wk-24wk,根据你是哪一种type），耐受性好。但是
临床还是要和至少一种其他的药合用。每一种都非常贵。如果没有保险简直是天价。 | N**********d
发帖数: 2466 | | c******h
发帖数: 355 | 8 retail很少见。是不是走specialty pharmacy的渠道？ | c*******n
发帖数: 26 | 9 我家的亲戚得了丙肝有多年，一直没有好。现在突然听说美国Gilead公司出了新药
Sovaldi能治愈丙肝。他们非常想了解一下这个药的功效，特别对于患丙肝已多年的人
（已有部分肝硬化）还有没有帮助。因为他们跑一趟美国不容易，就想让我去帮他们找
专科医生问一下。因为从没有做过咨询医生但不是自己生病，不知道这种情况如何去约
医生，医生能受理这种情况吗？还有费用是不是保险就不能cover？ 万分谢谢！如果有
人知道Sovaldi药的治愈效果怎样，就更好了... | y**s
发帖数: 563 | 10 2014年8月27日讯 /生物谷BIOON/ --丙肝治疗领域，吉利德可谓独领风骚，其明星药物
Sovaldi（sofosbuvir）在今年上半年的销售额突破58亿美元，为其带来了滚滚财源。
然而，这一格局即将打破。
近日，百时美施贵宝（BMS）丙肝新药Daklinza（daclatasvir）获欧盟批准，联合其他
药物，用于所有1、2、3、4基因型慢性丙型肝炎（HCV）成人感染者的治疗。Daklinza
是一种强效的泛基因型NS5A复制复合体抑制剂，在临床试验中，当与吉利德明星药
Sovaldi组成一种全口服、无干扰素鸡尾酒疗法（Daklinza+Sovaldi）时，取得了100%
的治愈率，包括伴有晚期肝脏疾病、基因型3 HCV及既往经蛋白酶抑制剂治疗失败的患
者群体。
目前，吉利德也在开发一种基于Sovaldi的丙肝鸡尾酒疗法ledipasvir/Sovaldi（LDV/
SOF），百时美Daklinza/Sovaldi鸡尾酒疗法的获批，对吉利德LDV/SOF鸡尾酒疗法形成
了直接威胁。
Daklinza/Sovaldi是一种每日一次、全口服、治愈率达100%的丙肝鸡尾酒疗法，为广泛
基因型HCV丙肝患者提供了一种潜在治愈的治疗选择，包括一些难治性群体，如既往治
疗失败的群体。
与Sovaldi一样，Daklinza与其他口服药物联合用药时，可排除常规注射制剂干扰素为
基础的鸡尾酒方案。目前，在美国，吉利德Sovaldi是唯一的统治者，而艾伯维（
AbbVie）和默沙东（Merck & Co）各自的全口服鸡尾酒疗法正在等待FDA的批准。
Daklinza是欧盟批准的首个NS5A复合体抑制剂，将与其他产品联用，提供一种较短治疗
时间（12或24周）的治疗方案。而目前基于干扰素和利巴韦林（ribavilin）的治疗方
案，治疗周期长达48周。Daklinza的获批，适用于欧盟所有28个成员国。此前，欧洲药
品管理局人用医药产品委员会（CHMP）已授予Daklinza加速审批资格。
Dakllinza的获批，是基于数个研究的积极数据，包括一项开放标签、随机研究，调查
了Daklinza+Sovaldi组合疗法治疗基因型1、2、3 HCV感染的疗效，包括对特拉匹韦（
telaprevir）或boceprevir无反应及伴有肝纤维化的患者群体。数据表明，Daklinza+
Sovaldi组合疗法在基因型1 HCV初治患者中的治愈率达到了99%，在既往对特拉匹韦或
boceprevir治疗失败的基因型1 HCV群体中的治愈率达100%，在基因型2和基因型3 HCV
中的治愈率分别为96%和89%。
此外，Daklinza治疗丙型肝炎的安全性，已在横跨各种不同群体中得到了证明，包括老
年患者、伴有晚期肝病群体、肝移植后受者群体及HIV/HCV共感染群体。（生物谷Bioon
.com）
英文原文：Bristol-Myers gets the approval Gilead didn't want: Daklinza +
Sovaldi for hep C
Want a window into the future of hepatitis C drug marketing? Keep an eye on
Europe. Bristol-Myers Squibb bagged European approval for its hepatitis C
fighter Daklinza (daclatasvir) Wednesday, setting the company up for head-to
-head competition with Gilead Sciences' upcoming combo drug.
The EU nod covers Daklinza treatment in tandem with Gilead's Sovaldi (
sofosbuvir), the heavyweight first entry in a new class of hep C drugs. If
you haven't been on sabbatical, you know Sovaldi raged ahead to blockbuster
status within one quarter on the market. You also know that Gilead ($GILD)
is developing a Sovaldi combo pill, using its own ledipasvir as the
companion ingredient--and that Gilead refused to team up with Bristol-Myers
($BMY) to study the Sovaldi-Daklinza combo, despite some eye-popping Phase
II data.
Bristol-Myers is running those trials solo. And now, it can say the
following in its EU approval press release: The Daklinza-Sovaldi cocktail is
an "all-oral, once-daily regimen that yields cure rates of up to 100%."
Plus, it "offers a potential cure" for a broad range of hep C patients,
including some hard-to-treat groups, such as patients who've failed on
previous therapies.
Like Sovaldi, Daklinza can squeeze out interferon-based treatment cocktails
when combined with other oral meds. That's the promise of this new class:
regimens that leave the difficult-to-tolerate interferon out. Right now,
Sovaldi is the sole "nuc" in the U.S., but AbbVie ($ABBV) and Merck ($MRK)
are looking for FDA approval for their own therapies.
And here's where it gets more interesting. We know Gilead will be leaning on
its Sovaldi + ledipasvir pill, which is up for FDA approval by Oct. 10.
AbbVie's three-drug option is under FDA review for a December decision.
Bristol-Myers might want to tout the Daklinza + Sovaldi option when (and if)
its FDA nod comes through in November.
But the FDA didn't allow the company to turn in that Sovaldi-Daklinza data
with its current app. The approval would be for Daklinza and another BMS
drug, Sunvepra (asunaprevir)--and that combo hasn't performed quite as well
as the Daklinza-Sovaldi team in trials. Sustained virological response--a
common measure in hep C trials--for the latter duo approached 100% in some
patients, as Bristol-Myers noted in its EU announcement.
For the Daklinza-Sunvepra team, a recent trial showed response rates of up
to 90%. That's way impressive--and gives the duo plenty of opportunity to
score sales, as blockbuster analyst projections show. Company execs say the
combo has been doing well in Japan, where it won approval in July. Plus,
both of those drugs belong to Bristol-Myers, so the company would be
collecting sales from two products, rather than one with the other combo.
But what might Daklinza do with Sovaldi in the U.S.?
After Gilead spurned Bristol-Myers' offer to put Sovaldi alongside Daklinza
in Phase III trials, the speculation was that doctors might prescribe the
combo off-label, once the BMS drug won FDA approval. Right now, that
prospect looks iffy. Payers are already setting up obstacles to expensive
hep C treatments. Off-label use? Patients and doctors would have to jump
through many hoops to get there, and physicians are already daunted by the
work required to get FDA-approved regimens reimbursed, a recent Decision
Resources survey found.
The market research firm also found that the hep C-treating specialists
surveyed were more likely to know about Gilead's forthcoming combo pill than
about Bristol-Myers and AbbVie's options. Half of those docs expect to
prescribe Gilead's combination therapy within 6 months after approval and
expect the combination of Sovaldi and Johnson & Johnson's ($JNJ) protease
inhibitor Olysio to hold its own. Sounds like Bristol-Myers and AbbVie's
sales-and-marketing teams have their jobs cut out for them.
But here's the kicker: "[N]ear-term competitors that offer favorable pricing
... will likely be a constraint on the uptake of [Gilead's] regimen,"
Decision Resources said. Which means that rivals that undercut Gilead's
price might move ahead in the prescribing queue. AbbVie has said it's not
interested in a price war. Maybe Bristol-Myers will be the one to step up.
【在 c*******n 的大作中提到】
: 我家的亲戚得了丙肝有多年，一直没有好。现在突然听说美国Gilead公司出了新药
: Sovaldi能治愈丙肝。他们非常想了解一下这个药的功效，特别对于患丙肝已多年的人
: （已有部分肝硬化）还有没有帮助。因为他们跑一趟美国不容易，就想让我去帮他们找
: 专科医生问一下。因为从没有做过咨询医生但不是自己生病，不知道这种情况如何去约
: 医生，医生能受理这种情况吗？还有费用是不是保险就不能cover？ 万分谢谢！如果有
: 人知道Sovaldi药的治愈效果怎样，就更好了...
| | | y**s
发帖数: 563 | 11 美国人民愤怒了——吉利德天价丙肝药Sovaldi印度售价仅1%
来源：生物谷 2014-08-08 13:51
2014年8月8日讯 /生物谷BIOON/ --吉利德（Gilead）丙肝明星药物Sovaldi在2014上半
年的销售额达到了惊人的58亿美元。该药于2013年12月在美国上市，自诞生之日起便成
为行业关注的焦点，其84000美元/疗程（1000美元/片）的定价也饱受各方争议。美国
众议院、患者维权组织等机构曾强烈呼吁Sovaldi降价，而吉利德则坚持不降，并称从
长远来看，该药将为纳税人节省大笔开支。
然而，昨日接受印度时报采访时，吉利德表示，将在印度以1%的价格销售Sovaldi，即
900美元/疗程，折扣高达99%。可以预见的是，此举将令美国民众大为恼火，敢情印度
人民才是吉利德的亲爹亲娘呐！
吉利德还表示，在公司与印度本土数个仿制药商达成合作，生产药物供应印度当地市场
后，Sovaldi的售价将进一步下降。目前，吉利德仍需要在印度完成相关临床试验。
吉利德执行副总裁Gregg Alton在一份声明中称：“Sovaldi在印度的售价为300美元一
瓶（28片），这是公司面对低收入国家的定价，与埃及政府协商的价格相似。我们希望
与印度的合作者在当地生产药物，更高容量及持续的研发，将在后期使Sovaldi的售价
进一步降低。”
Alton解释称，公司在谈判时，会根据一个国家的人均收入和丙型肝炎的发病率，分为
有3种定价策略：低收入、中等收入和高收入。根据世界卫生组织（WHO），印度有1200
万慢性丙型肝炎（HCV）患者；而根据世界银行，2009-2013年，印度的人均收入仅为
1499美元，相比之下，美国的人均收入为53143美元。此外，在印度，目前丙肝的治疗
成本高达6000美元，通常需要注射具有严重副作用的药物（干扰素），治疗疗程长达24
-48周。
除开上述因素，跨国制药公司在印度对昂贵药物定价时，也会有其他的一些考虑因素。
因为印度政府有权行使强制许可权，如果认为品牌药对于本土市场太过昂过，则行使强
制许可，允许本土仿制药商生产廉价仿制药，而且印度政府目前已经在行使强制许可权
。当这种情况发生时，跨国制药公司不仅失去了在印度的直接销售，甚至有失去其产品
控制权（即专利）的风险。例如，此前印度政府就已授权本土Natco公司，生产拜耳的
抗癌品牌药多吉美（Nexavar），拜耳现在正上诉法庭，企图阻止Natco在印度以外地区
销售仿制药。而且Natco公司已要求印度专利局阻止吉利德Sovaldi在印度的专利，以便
能够自己生产该药。
然而，Sovaldi在印度和美国的售价如此悬殊，以至于即便存在上述所有因素，仍不足
以阻止美国评论家对吉利德的强烈声讨。
根据吉利德，在美国，28片/瓶装Sovaldi的批发商采购成本（WAC）费用为2.8万美元，
即每片1000美元，大多数患者需要治疗12周，即一个疗程总费用达8.4万美元。（生物
谷Bioon.com）
英文原文：The $84,000 U.S. treatment price that Gilead Sciences ($GILD) is
charging for its hepatitis C drug Sovaldi has elicited pleas from
politicians and threats from payers, who say the U.S. healthcare system
cannot bear the cost. But Gilead has held firm, insisting it will save money
for payers in the long run, even as the company is raking in billions of
dollars by the quarter. But in India, Gilead will offer it at a discount--a
99% discount.
The drugmaker has told the Times of India that the drug will cost $900 (
about 54,000 rupees) in India for a 12-week treatment. The price may drop
further after Gilead works out deals with several Indian generics makers to
produce the drug for the local market, Gilead Executive Vice President Gregg
Alton told the newspaper. The company still has to complete clinical trials
in India.
"The pricing of Sovaldi in India at $300 per bottle, is our low income
pricing, similar to the price negotiated with Egypt for its government-run
program," Alton said in a statement. "We hope with local production by our
partners in India, higher volumes and continued research & development on
the drug will lead to a further reduction in prices at a later stage."
Alton explained that the company has three pricing tiers that it uses for
negotiations, figured on the per capita income and hepatitis C prevalence of
a country: low-income, low middle-income and upper-middle income. The World
Health Organization says India has about 12 million chronic sufferers of
hepatitis C. According to the World Bank, India per capita income from 2009
through 2013 averaged $1,499. That compares with the U.S. at $53,143. The
newspaper says that current treatments for the disease in India run about $6
,000 and require a 24- to 48-week course of injectables that come with
serious side effects. So Sovaldi will be cheaper and easier to administer,
with fewer side effects and the ability to cure many of the cases.
Drugmakers have other considerations to factor in when pricing essential but
expensive drugs in India. The government has, and has exercised, the
authority to grant a compulsory license for a drug that it considers
essential but too expensive for the Indian market, where few people have
insurance. When that happens the drugmaker not only loses direct sales in
India but also runs the risk of losing control of its product. India used
the provision to grant a license to Natco for Bayer HealthCare's cancer drug
Nexavar, and the German company is now in court trying to keep Natco from
selling it outside of India. Natco has asked the government patent office to
block Gilead's patent for the drug in that country, which would give it a
shot at producing it itself.
But all of those factors are unlikely to keep critics of Sovaldi's price in
the U.S. from pointing to India as proof that the drugmaker could do better
on price in the U.S. Gilead execs have been called to explain its pricing to
Congress after research from Georgetown University and the Kaiser Family
Foundation found that Sovaldi will increase Medicare Part D drug spending by
as much as $6.5 billion in 2015 alone. That would cause overall Medicare
drug spending to rise by 8%.
And pharmacy benefits manager Express Scripts ($ESRX), which handles drug
reimbursement for a big chunk of the U.S. private insurance market, is
trying to rally a coalition to refuse to use Sovaldi after a competitor hits
the market, which might be as early as this fall. The response to Sovaldi's
price is about the same in Europe, where 14 countries will share
information to help one another negotiate better prices for the drug even
though Gilead is likely to price it less there than in the U.S.
So far, Gilead has been able to shake off those threats and reap the rewards
of the most successful drug launch ever. In reporting its Q2 results last
month it said that since its December launch, Sovaldi has been prescribed to
80,000 patients in the U.S. and Europe. In the first two quarters this year
, it has brought in $7.8 billion. But a host of other players have competing
drugs in development or awaiting approval, and the market picture could
change dramatically in short order.
【在 c*******n 的大作中提到】
: 我家的亲戚得了丙肝有多年，一直没有好。现在突然听说美国Gilead公司出了新药
: Sovaldi能治愈丙肝。他们非常想了解一下这个药的功效，特别对于患丙肝已多年的人
: （已有部分肝硬化）还有没有帮助。因为他们跑一趟美国不容易，就想让我去帮他们找
: 专科医生问一下。因为从没有做过咨询医生但不是自己生病，不知道这种情况如何去约
: 医生，医生能受理这种情况吗？还有费用是不是保险就不能cover？ 万分谢谢！如果有
: 人知道Sovaldi药的治愈效果怎样，就更好了...
| y**s
发帖数: 563 | 12 而Sovaldi的副作用少，且治愈率高达80-90%，因此一上市便迅速获得了临床医生的青
睐。
【在 c*******n 的大作中提到】
: 我家的亲戚得了丙肝有多年，一直没有好。现在突然听说美国Gilead公司出了新药
: Sovaldi能治愈丙肝。他们非常想了解一下这个药的功效，特别对于患丙肝已多年的人
: （已有部分肝硬化）还有没有帮助。因为他们跑一趟美国不容易，就想让我去帮他们找
: 专科医生问一下。因为从没有做过咨询医生但不是自己生病，不知道这种情况如何去约
: 医生，医生能受理这种情况吗？还有费用是不是保险就不能cover？ 万分谢谢！如果有
: 人知道Sovaldi药的治愈效果怎样，就更好了...
| c*******n
发帖数: 26 | 13 万分感谢大家的回复和信息! 主要是他们对印度不太放心，而且要等到明年，现在病人
情况不太好。美国价格是高，但是如果能救命还是值得的。家庭也不是那么富裕，但是
也能承受10万左右。但是对于怎样吃这个药，还是不太清楚，比如说是只吃这种药就可
以了，还是要搭配其他药一起吃？找专科医生看的话，他们希望我能先帮他们问一下，
所以我在想是不是要我先打电话去约一个专科医生，然后去了再说不是我生病，是亲戚
，然后看专科医生能不能给点信息。如果是很positive feedback，我再叫他们到美国
来看？所以我只想问我去医生那里只是咨询为其他人的病，是不是咨询费用（不是
copay，比如医生说有另外的咨询费用）我自己的保险不会cover？他们要过来治病，肯
定是只有自费，我只是想有点更详细的信息后再让他们过来。 | s********4
发帖数: 64 | 14 这个药的效果很好，而且疗程短（12wk-24wk,根据你是哪一种type），耐受性好。但是
临床还是要和至少一种其他的药合用。每一种都非常贵。如果没有保险简直是天价。 | N**********d
发帖数: 2466 | | c******h
发帖数: 355 | 16 retail很少见。是不是走specialty pharmacy的渠道？ | b********0
发帖数: 13 | |
|
