美国人民愤怒了——吉利德天价丙肝药Sovaldi印度售价仅1%

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。

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.