首页 > 资讯 > 药品定价困境与仿制药计划

出自识林

2015-12-10 Lachman CONSULTANTS

我们已经看过很多药价显著上涨的例子，包括仿制药产品、短缺产品、没有竞争的老产品，甚至一些专利期或专营期已过期的产品。我们都知道Daraprim的例子（药图灵制药的抗寄生虫感染药乙胺嘧啶从13.5美元一片涨至750美元一片），我们听说至少有一家企业计划合成、配制该药，并以每片1美元的售价提供。该产品应该不会是获批药品，据说会在符合现行法规和政策的情况下配药。然而，这样的配药会与品牌咬生物等效吗？配药房会根据每位患者的处方制备药品吗？如果配药房制造已获批产品的复制品，这与FDA关于销售未经批准的处方药产品的合规政策指南直接冲突，FDA会决定施行强制执法自由裁量吗？在情况明朗之前，这是患者、从业者和监管者必须回答的一些问题。

我们必须记住，FDA不应该在做出批准或执法决定时关注定价或经济因素。FDA应基于公众健康以及安全性和有效性考量做出决定。

整个定价问题似乎集中在少量几个药品上。我们必须承认，我们生活在一个自由市场经济的时代，但还必须行使一些责任，而不是仅适用“不管怎样，市场将会承受”的哲学。我们当然不希望看到体系使患者无法获得他们急需的药品，我们不希望使个人自费患者、保险公司和地方、州、联邦政府破产。所以需要有一个平衡。我们应如何达成这样的平衡呢？1984年Hatch-Waxman法案似乎达到了理想效果，直到仿制药计划慢性资金不足与监管要求的增加引起了目前的积压，仿制药办公室正在积极努力处理的这些积压。

现在我们有了解决数年来对公众资金疏漏的仿制药使用者法案（GDUFA）。感觉到GDUFA的全面积极影响还需一些时日，但同时，联邦政府也需要采取行动和增加对计划的联邦拨款。当考虑到医疗保险(Medicare)、医疗补助(Medicaid)、现役军队和制服公务员及其家属、退伍军人事务系统和像印第安保健服务和美国国立卫生研究院(NIH)这样的项目，美国政府可能是最大的关于医疗保健的“保险公司”。我们知道，根据可靠报告，仿制药在过去十年中已经为消费者节省了1.5万亿美元。鉴于政府从节约中获得的巨大收益，人们会认为仿制药计划是联邦政府应该为之投资并增加拨款的计划。抽出3亿美元到一个每年可以节省数千亿美元的计划，似乎在长期节省方面是可靠的投资。不幸的是，美国国会并不总是这样认为。

在我看来，继续通过GDUFA计划依赖企业资金的增长是错误的，因为药品生产商会继续提高价格来弥补GDUFA的成本。GDUFA最初谈判的收费是仅给每个处方增加不超过10美分的费用。然而，在GDUFA计划的最初几年中，在许多情况下，收费已经有两位数的涨幅，而且还没有看到尽头。没有人能说出现在每个处方增加的额外费用真正是多少，仿制药公司是否会一直选择部分竞争有限的产品涨价作为弥补GDUFA所增加的成本的方式。毕竟，仿制药公司需要考虑为自己的股东和投资者负责。

所以，定价困境会有解决方案，解决方案就是时间。问题是，国会和公众愿意等待多久？我只是提醒议员不要跳进立法修正中，这将只是短期的积极影响，但导致长期负面结果。我宁愿看到国会向仿制药计划增加拨款，给GDUFA更多的时间带动竞争。请记住，Hatch-Waxman法案曾经一度被看作药品花费上涨的解决方案，并且花了一些时间来达成目的。让我们希望国会意识到这一点，并且能够利用现有立法和对仿制药计划的充分支持找到解决方案，通过公共资金使仿制药计划再次发挥作用。

Lachman CONSULTANTS - Bob Pollock先生
编译：识林-椒
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The Color of Money – Green, Always Green
By Bob Pollock | December 9, 2015

We have read a lot about the significant rising cost of some generic drug products, some shortage products, and some old products without competition, even though any period of patent or exclusivity has expired. We all know of the Daraprim example and we hear that at least one company plans to compound the drug and offer it for $1 a tablet instead of the $700 being charged. The product will not be an approved drug product and (supposedly) will be compounded in accord with the existing regulations and policy. However, will it be a bioequivalent version of the brand name product? Will the compounder be preparing the drug on a per-patient prescription basis? Will FDA decide to exercise enforcement discretion if the compounder makes a duplicate of an approved drug product, which would be in direct conflict with their Compliance Policy Guide on marketing of unapproved prescription drug products? These are some of the questions that must be answered by patients, practitioners, and regulators before the picture is clear.

We must remember that FDA is not supposed to concern itself with pricing or economics in making approval or enforcement decisions. FDA is supposed to make its decisions based on public health and safety and efficacy considerations.

The entire issue of pricing appears to be focused on a handful of drug products. We must recognize we live in a free market economy, but there must also be an element of responsibility exercised, rather than only applying the “whatever the market will bear” philosophy. We certainly don’t want to see the system keep patients from getting the drugs they desperately need and we don’t want to break the bank of private pay patients, insurers, and local, state, and federal governments. So there needs to be a balance. How do we achieve that balance? The Hatch-Waxman Act of 1984 seemed to have done the trick, until chronic under-funding of the generic program coupled with increased regulatory requirements caused the current backlog that the Office of Generic Drugs is diligently working through.

Now we have the Generic Drug User Fee Act (GDUFA) that is addressing the years of neglect in public funding. Feeling the full positive impact of GDUFA will take some time, but meantime, the Federal Government needs to also step up to the plate and increase the Federal appropriations to the program. The government is probably the biggest “insurer” relative to healthcare and drug coverage when you consider Medicare, Medicaid, the armed and uniformed services in active duty and their dependents, the VA system and programs like the Indian Health Service and NIH. We know that, based on credible reports, generic drugs have saved consumers over $1.5 trillion over the last decade. Given that the government benefits from a huge share of that savings, one would think that the generic drug program is one program in which the Federal government should invest and increase the appropriate funds. Pumping $300 million dollars into a program that saves you hundreds of billions of dollars a year seems like a good investment in long-term savings. Unfortunately, Congress does not always think that way.

Continuing to rely on industry-funded increases through the GDUFA program is, in my opinion, misguided, as the drug manufacturers will continue to raise their prices to make up for the cost of the program. GDUFA was initially negotiated to have fees that would add no more than about 10 cents to every prescription. However, over the first few years of the program, the fees (in many cases) have had double digit increases and there is no end in sight. No telling what that per-prescription cost addition really is today, or if the generic firms have been raising their prices on a select basket of products with limited competition as a way to recoup those increased costs. The generic companies do, after all, have a responsibility to their shareholders and investors to consider.

So the pricing dilemma may have a solution, and that solution may be time. The questions is – how much longer is Congress and the public willing to wait? I just caution lawmakers to not jump into a legislative fix that will have only short-term positive impact, but long-term negative consequences. I would rather see Congress increase appropriations to the Generic program and give GDUFA some more time to bring the competition along. Remember, Hatch-Waxman was once seen as the solution to rising drug product costs, and it took some time to work. Let’s hope that Congress recognizes this and can find a way to use the existing legislation, along with sufficient support of the program, through public funding to make it work again.