美國國會(huì)即將就《立即降低藥品成本法案》(Lower Drug Costs Now Act,即H.R.3)的立法進(jìn)行辯論。一旦通過,該法案將賦予聯(lián)邦醫(yī)療保險(xiǎn)(Medicare)就降低藥品價(jià)格進(jìn)行談判的權(quán)力。重點(diǎn)是降低治療各類疾病的藥物價(jià)格,其中包括哮喘、關(guān)節(jié)炎和糖尿病。但許多人或許沒有充分認(rèn)識(shí)到該提案對降低抗癌藥物價(jià)格的威力。抗癌藥物現(xiàn)在貴得離譜,讓病人和付款人苦不堪言。
美國國會(huì)預(yù)算辦公室(Congressional Budget Office)估計(jì),這項(xiàng)法案通過限制自付藥物費(fèi)用,將在未來十年為患者節(jié)省約1500億美元,同時(shí)通過降低總體價(jià)格和減緩藥價(jià)的未來漲幅,在未來十年為納稅人節(jié)省約4500億美元。這些節(jié)余可以用來改善醫(yī)療保險(xiǎn)福利、降低保費(fèi),或者用來擴(kuò)大老年人或其他人群的醫(yī)保覆蓋范圍。
制藥業(yè)已經(jīng)開始辯稱,這項(xiàng)法案將終止創(chuàng)新,并阻撓亟需療法,特別是抗癌類藥物的研發(fā)工作。此言差矣。是的,我們能夠同時(shí)擁有創(chuàng)新療法和可承受的價(jià)格。
目前用于癌癥治療的資金是不可持續(xù)的
根據(jù)美國國家醫(yī)學(xué)研究院(National Academy of Medicine)發(fā)布的一份報(bào)告,醫(yī)療保險(xiǎn)為老年人支付了四分之三的癌癥治療費(fèi)用,主要是藥物成本;許多抗癌藥物的價(jià)格上漲速度遠(yuǎn)遠(yuǎn)超過一般的藥物和醫(yī)療費(fèi)用。這在實(shí)踐中意味著,當(dāng)用于抗癌藥物的支出增加時(shí),用于其他公共資助醫(yī)療服務(wù)和社會(huì)需求的資金就會(huì)減少。
抗癌藥物支出的其他部分由患者和商業(yè)健康計(jì)劃承擔(dān),其資金來自雇主的繳款和受保雇員的工資。隨著成本不斷上漲,這些健康計(jì)劃一直在想方設(shè)法地管理其抗癌藥物支出,著手對保險(xiǎn)覆蓋范圍施加限制,并將更多的成本轉(zhuǎn)嫁給患者。如此一來,保險(xiǎn)就無法履行其應(yīng)盡之責(zé),即為大病患者提供亟需的護(hù)理和經(jīng)濟(jì)保障。
但是,抗癌藥帶來的好處難道不值得付出這些成本嗎?盡管美國食品與藥物管理局(FDA)最近批準(zhǔn)的一些新療法可以帶來全新且重要的臨床效果,但許多療法的作用卻差強(qiáng)人意。此外,與抗癌藥物治療相關(guān)的費(fèi)用可能會(huì),也確實(shí)會(huì)迅速增長——病人每年需要多次輸液、額外就診、住院、做影像檢查、測試,可能還需要使用其他昂貴藥物配合治療。
是什么原因?qū)е驴拱┧幬飪r(jià)格奇高?
制藥公司經(jīng)常以藥品創(chuàng)新是一項(xiàng)高風(fēng)險(xiǎn)、高成本的事業(yè),抗癌藥物能夠顯著減低死亡率和發(fā)病率為由,為這些藥物的高價(jià)格辯護(hù)。
然而,相關(guān)證據(jù)并不支持這些說法。誠然,藥品研發(fā)以風(fēng)險(xiǎn)大、成本高和周期長著稱。然而,根據(jù)西部衛(wèi)生政策中心(West Health Policy Center)和約翰斯?霍普金斯大學(xué)彭博公共衛(wèi)生學(xué)院(Johns Hopkins Bloomberg School of Public Health)對公開會(huì)計(jì)數(shù)據(jù)的分析,制藥公司的資產(chǎn)回報(bào)率比另一些最賺錢行業(yè)的資產(chǎn)回報(bào)率高出好幾個(gè)百分點(diǎn)。此外,許多抗癌藥物的價(jià)格在上市后持續(xù)上漲,哪怕它們并沒有帶來明顯的臨床效果。
那么,如何才可以阻止制藥商動(dòng)輒就對一種抗癌藥收取100萬美元或更高的費(fèi)用呢?就我們目前的醫(yī)療體系而言,真的沒有太多辦法。大多數(shù)抗癌藥物都沒有直接的競爭對手。部分原因是,無論多么微小,新藥的臨床效果還是比現(xiàn)有藥物更好一些?;颊卟荒苁褂酶阋说奶娲幬?,因?yàn)楦揪蜎]有。
一系列旨在提高抗癌藥物價(jià)格透明度的努力,對抑制新藥的上市價(jià)格助益甚微,也沒有幫助付款人更明智地采購。
H.R.3將如何解決這些挑戰(zhàn)
H.R.3法案將授予衛(wèi)生與公眾服務(wù)部部長(Secretary of Health and Human Services)就藥品價(jià)格進(jìn)行談判的權(quán)力。它將改善癌癥患者及其家庭的負(fù)擔(dān)能力,并為付款人、雇主、工薪階層和納稅人提供亟需的開支減免。
根據(jù)該法案的規(guī)定,這些談判將以相關(guān)藥物的有效性為指針(用來證明有效性的證據(jù)主要由制藥公司自己來提供)。談判也將以病人為中心,以癌癥患者及其家屬最關(guān)心的治療結(jié)果為導(dǎo)向。
出于這些原因,這項(xiàng)提案得到了患者、保險(xiǎn)公司、雇主和創(chuàng)新者的廣泛支持。
批評者的錯(cuò)誤理由
然而,在行業(yè)組織美國藥品研究與制造商協(xié)會(huì)(PhRMA)的引領(lǐng)下,制藥業(yè)正在竭力游說,反對賦予聯(lián)邦醫(yī)療保險(xiǎn)就降低藥價(jià)進(jìn)行談判的權(quán)力。僅在2021年前三個(gè)月,前15家藥企和行業(yè)協(xié)會(huì)花費(fèi)的游說資金就超過4500萬美元。其反對理由之一是,通過限制現(xiàn)有藥物收取的高價(jià)格,這項(xiàng)提案將嚴(yán)重削弱藥企未來創(chuàng)新的動(dòng)力。
出于以下這幾個(gè)原因,我們認(rèn)為這是一個(gè)錯(cuò)誤的主張。
首先,重要的不是新抗癌藥物的總數(shù),而是新藥物創(chuàng)造的健康效益。盡管藥企大肆炒作,但目前可用的大多數(shù)藥物并不能夠治愈癌癥,而且許多藥物對患者壽命或生活質(zhì)量的提高都非常有限。
其次,癌癥預(yù)防和治療方面的許多潛在進(jìn)展仍然投資不足,因?yàn)槊绹t(yī)療體系的許多參與者認(rèn)為這種投資是不值得的。這項(xiàng)立法節(jié)省下來的資金預(yù)計(jì)將用于擴(kuò)大醫(yī)療保險(xiǎn)的覆蓋深度和廣度,除其他影響外,這將減少癌癥治療的財(cái)務(wù)毒性。
第三,規(guī)劃未來投資時(shí),創(chuàng)新者最看重其整體盈利能力。從設(shè)計(jì)上看,H.R.3將促進(jìn)那些擁有重大價(jià)值的抗癌藥物獲得更廣泛的使用,并支持這些藥物收取更高的價(jià)格,以確保公司從有價(jià)值的抗癌藥物中獲得利潤,同時(shí)減少對效果不明顯或微乎其微的藥物的支出。這項(xiàng)立法節(jié)省下來的資金將用于支持下一代創(chuàng)新抗癌藥物。
H.R.3將幫助美國醫(yī)療體系更好地為創(chuàng)新者的努力確定一個(gè)基于價(jià)值的公允價(jià)格。
這項(xiàng)立法的目的不是要削弱制藥公司投資創(chuàng)新的能力。
相反,我們期望這些談判(如果允許其長期發(fā)揮作用的話)將創(chuàng)造一個(gè)良性循環(huán),增加新藥的可獲得性,為當(dāng)前和未來的患者提供顯著的健康益處。(財(cái)富中文網(wǎng))
本文作者雷納?康蒂是波士頓大學(xué)(Boston University)凱斯特羅姆商學(xué)院(Questrom School of Business)市場、公共政策和法律系(Department of Markets, Public Policy and Law)副教授。理查德?弗蘭克是哈佛醫(yī)學(xué)院(Harvard Medical School)衛(wèi)生經(jīng)濟(jì)學(xué)Margaret T. Morris教席教授。萊斯利?達(dá)奇是“保護(hù)我們的醫(yī)療”(Protect Our Care)的主席,曾經(jīng)擔(dān)任美國衛(wèi)生與公眾服務(wù)部部長的高級顧問。
譯者:任文科
美國國會(huì)即將就《立即降低藥品成本法案》(Lower Drug Costs Now Act,即H.R.3)的立法進(jìn)行辯論。一旦通過,該法案將賦予聯(lián)邦醫(yī)療保險(xiǎn)(Medicare)就降低藥品價(jià)格進(jìn)行談判的權(quán)力。重點(diǎn)是降低治療各類疾病的藥物價(jià)格,其中包括哮喘、關(guān)節(jié)炎和糖尿病。但許多人或許沒有充分認(rèn)識(shí)到該提案對降低抗癌藥物價(jià)格的威力??拱┧幬铿F(xiàn)在貴得離譜,讓病人和付款人苦不堪言。
美國國會(huì)預(yù)算辦公室(Congressional Budget Office)估計(jì),這項(xiàng)法案通過限制自付藥物費(fèi)用,將在未來十年為患者節(jié)省約1500億美元,同時(shí)通過降低總體價(jià)格和減緩藥價(jià)的未來漲幅,在未來十年為納稅人節(jié)省約4500億美元。這些節(jié)余可以用來改善醫(yī)療保險(xiǎn)福利、降低保費(fèi),或者用來擴(kuò)大老年人或其他人群的醫(yī)保覆蓋范圍。
制藥業(yè)已經(jīng)開始辯稱,這項(xiàng)法案將終止創(chuàng)新,并阻撓亟需療法,特別是抗癌類藥物的研發(fā)工作。此言差矣。是的,我們能夠同時(shí)擁有創(chuàng)新療法和可承受的價(jià)格。
目前用于癌癥治療的資金是不可持續(xù)的
根據(jù)美國國家醫(yī)學(xué)研究院(National Academy of Medicine)發(fā)布的一份報(bào)告,醫(yī)療保險(xiǎn)為老年人支付了四分之三的癌癥治療費(fèi)用,主要是藥物成本;許多抗癌藥物的價(jià)格上漲速度遠(yuǎn)遠(yuǎn)超過一般的藥物和醫(yī)療費(fèi)用。這在實(shí)踐中意味著,當(dāng)用于抗癌藥物的支出增加時(shí),用于其他公共資助醫(yī)療服務(wù)和社會(huì)需求的資金就會(huì)減少。
抗癌藥物支出的其他部分由患者和商業(yè)健康計(jì)劃承擔(dān),其資金來自雇主的繳款和受保雇員的工資。隨著成本不斷上漲,這些健康計(jì)劃一直在想方設(shè)法地管理其抗癌藥物支出,著手對保險(xiǎn)覆蓋范圍施加限制,并將更多的成本轉(zhuǎn)嫁給患者。如此一來,保險(xiǎn)就無法履行其應(yīng)盡之責(zé),即為大病患者提供亟需的護(hù)理和經(jīng)濟(jì)保障。
但是,抗癌藥帶來的好處難道不值得付出這些成本嗎?盡管美國食品與藥物管理局(FDA)最近批準(zhǔn)的一些新療法可以帶來全新且重要的臨床效果,但許多療法的作用卻差強(qiáng)人意。此外,與抗癌藥物治療相關(guān)的費(fèi)用可能會(huì),也確實(shí)會(huì)迅速增長——病人每年需要多次輸液、額外就診、住院、做影像檢查、測試,可能還需要使用其他昂貴藥物配合治療。
是什么原因?qū)е驴拱┧幬飪r(jià)格奇高?
制藥公司經(jīng)常以藥品創(chuàng)新是一項(xiàng)高風(fēng)險(xiǎn)、高成本的事業(yè),抗癌藥物能夠顯著減低死亡率和發(fā)病率為由,為這些藥物的高價(jià)格辯護(hù)。
然而,相關(guān)證據(jù)并不支持這些說法。誠然,藥品研發(fā)以風(fēng)險(xiǎn)大、成本高和周期長著稱。然而,根據(jù)西部衛(wèi)生政策中心(West Health Policy Center)和約翰斯?霍普金斯大學(xué)彭博公共衛(wèi)生學(xué)院(Johns Hopkins Bloomberg School of Public Health)對公開會(huì)計(jì)數(shù)據(jù)的分析,制藥公司的資產(chǎn)回報(bào)率比另一些最賺錢行業(yè)的資產(chǎn)回報(bào)率高出好幾個(gè)百分點(diǎn)。此外,許多抗癌藥物的價(jià)格在上市后持續(xù)上漲,哪怕它們并沒有帶來明顯的臨床效果。
那么,如何才可以阻止制藥商動(dòng)輒就對一種抗癌藥收取100萬美元或更高的費(fèi)用呢?就我們目前的醫(yī)療體系而言,真的沒有太多辦法。大多數(shù)抗癌藥物都沒有直接的競爭對手。部分原因是,無論多么微小,新藥的臨床效果還是比現(xiàn)有藥物更好一些?;颊卟荒苁褂酶阋说奶娲幬?,因?yàn)楦揪蜎]有。
一系列旨在提高抗癌藥物價(jià)格透明度的努力,對抑制新藥的上市價(jià)格助益甚微,也沒有幫助付款人更明智地采購。
H.R.3將如何解決這些挑戰(zhàn)
H.R.3法案將授予衛(wèi)生與公眾服務(wù)部部長(Secretary of Health and Human Services)就藥品價(jià)格進(jìn)行談判的權(quán)力。它將改善癌癥患者及其家庭的負(fù)擔(dān)能力,并為付款人、雇主、工薪階層和納稅人提供亟需的開支減免。
根據(jù)該法案的規(guī)定,這些談判將以相關(guān)藥物的有效性為指針(用來證明有效性的證據(jù)主要由制藥公司自己來提供)。談判也將以病人為中心,以癌癥患者及其家屬最關(guān)心的治療結(jié)果為導(dǎo)向。
出于這些原因,這項(xiàng)提案得到了患者、保險(xiǎn)公司、雇主和創(chuàng)新者的廣泛支持。
批評者的錯(cuò)誤理由
然而,在行業(yè)組織美國藥品研究與制造商協(xié)會(huì)(PhRMA)的引領(lǐng)下,制藥業(yè)正在竭力游說,反對賦予聯(lián)邦醫(yī)療保險(xiǎn)就降低藥價(jià)進(jìn)行談判的權(quán)力。僅在2021年前三個(gè)月,前15家藥企和行業(yè)協(xié)會(huì)花費(fèi)的游說資金就超過4500萬美元。其反對理由之一是,通過限制現(xiàn)有藥物收取的高價(jià)格,這項(xiàng)提案將嚴(yán)重削弱藥企未來創(chuàng)新的動(dòng)力。
出于以下這幾個(gè)原因,我們認(rèn)為這是一個(gè)錯(cuò)誤的主張。
首先,重要的不是新抗癌藥物的總數(shù),而是新藥物創(chuàng)造的健康效益。盡管藥企大肆炒作,但目前可用的大多數(shù)藥物并不能夠治愈癌癥,而且許多藥物對患者壽命或生活質(zhì)量的提高都非常有限。
其次,癌癥預(yù)防和治療方面的許多潛在進(jìn)展仍然投資不足,因?yàn)槊绹t(yī)療體系的許多參與者認(rèn)為這種投資是不值得的。這項(xiàng)立法節(jié)省下來的資金預(yù)計(jì)將用于擴(kuò)大醫(yī)療保險(xiǎn)的覆蓋深度和廣度,除其他影響外,這將減少癌癥治療的財(cái)務(wù)毒性。
第三,規(guī)劃未來投資時(shí),創(chuàng)新者最看重其整體盈利能力。從設(shè)計(jì)上看,H.R.3將促進(jìn)那些擁有重大價(jià)值的抗癌藥物獲得更廣泛的使用,并支持這些藥物收取更高的價(jià)格,以確保公司從有價(jià)值的抗癌藥物中獲得利潤,同時(shí)減少對效果不明顯或微乎其微的藥物的支出。這項(xiàng)立法節(jié)省下來的資金將用于支持下一代創(chuàng)新抗癌藥物。
H.R.3將幫助美國醫(yī)療體系更好地為創(chuàng)新者的努力確定一個(gè)基于價(jià)值的公允價(jià)格。
這項(xiàng)立法的目的不是要削弱制藥公司投資創(chuàng)新的能力。
相反,我們期望這些談判(如果允許其長期發(fā)揮作用的話)將創(chuàng)造一個(gè)良性循環(huán),增加新藥的可獲得性,為當(dāng)前和未來的患者提供顯著的健康益處。(財(cái)富中文網(wǎng))
本文作者雷納?康蒂是波士頓大學(xué)(Boston University)凱斯特羅姆商學(xué)院(Questrom School of Business)市場、公共政策和法律系(Department of Markets, Public Policy and Law)副教授。理查德?弗蘭克是哈佛醫(yī)學(xué)院(Harvard Medical School)衛(wèi)生經(jīng)濟(jì)學(xué)Margaret T. Morris教席教授。萊斯利?達(dá)奇是“保護(hù)我們的醫(yī)療”(Protect Our Care)的主席,曾經(jīng)擔(dān)任美國衛(wèi)生與公眾服務(wù)部部長的高級顧問。
譯者:任文科
Congress is about to debate legislation—the Lower Drug Costs Now Act (H.R.3)—that would give Medicare the power to negotiate for lower drug prices. The bill focuses on lowering prices of drugs that treat a wide range of diseases including asthma, arthritis, and diabetes. But less well appreciated is the power of the proposal applied to cancer drugs. The prices of cancer drugs are now exceptionally high, harming patients and payers.
The Congressional Budget Office estimates the legislation will save patients about $150 billion overall over 10 years by capping their out-of-pocket drug costs, while saving taxpayers about $450 billion over 10 years by lowering overall prices and slowing future price increases of drugs. These savings can be used to improve Medicare benefits, reduce premiums, or expand insurance coverage for seniors or others.
The drug industry is already arguing that the bill will end innovation and stop the development of needed cures, particularly in the cancer arena. That is wrong. We can have both innovative treatments and affordable prices.
The current financing of cancer treatment is unsustainable
According a report released by the National Academy of Medicine, Medicare pays for three-quarters of drug-based cancer treatment for seniors, and many cancer drugs have prices that are rising far faster than the cost of drugs and medical care in general. What this means in practice is that when spending on cancer drugs goes up, there is less money for other publicly funded medical services and societal needs.
The remainder of spending on cancer drugs is borne by patients and by commercial health plans, funded by the contributions of employers and the wages of insured employees. As costs have mounted, these plans have looked for ways to manage their spending on cancer drugs, imposing restrictions on coverage and pushing more costs onto patients. Insurance would then fail to do its job of providing access to needed care and financial protection to patients when facing dread disease.
But aren’t the benefits worth the costs? Alas, no. While some recent FDA-approved new therapies embody treatment approaches that offer important new clinical benefits, many offer few, if any, benefits. Moreover, costs associated with cancer drug treatment can and do add up quickly, with multiple infusions required each year, additional visits, hospital stays, imaging, tests, and treatments with other expensive drugs.
What accounts for extraordinarily high cancer drug prices?
Pharmaceutical companies commonly cite the high-risk, high-cost enterprise of drug innovation and significant gains to mortality and reductions in morbidity to justify high cancer drug prices.
However, the evidence does not support these claims. To be sure, drug development is risky, costly, and takes time. However, publicly reported accounting data analyzed by researchers from the West Health Policy Center and Johns Hopkins Bloomberg School of Public Health shows that returns on assets for pharmaceutical companies exceed those of the most profitable industries by several percentage points. For many cancer drugs, prices also continue to increase after launch without demonstrated increases in benefit.
So what is to stop companies from charging a million dollars or more for a cancer drug? In our current system, not much. Most cancer drugs have no direct competitors, due in part to the fact that new drugs offer benefits, however small, over existing drugs. Patients can’t use the cheaper alternative because there isn’t one.
Efforts to improve the transparency of cancer drug prices have done little to tame the launch prices of new drugs, nor helped payers shop smarter.
How H.R.3 will resolve these challenges
H.R.3 would grant the Secretary of Health and Human Services the authority to negotiate drug prices. It will improve affordability for cancer patients and their families and also provide much needed spending relief to payers, employers, wage earners, and taxpayers.
Under the provisions of the bill, negotiations would be guided by the effectiveness of the drugs in question (supported by evidence that is largely generated by the drug companies themselves). The negotiations would also be patient-centric, guided by the outcomes that matter to cancer patients and their families.
For these reasons, the legislation has garnered widespread support among patients, insurers, employers, and innovators.
A false choice from critics
Nevertheless, the pharmaceutical industry, led by PhRMA, its lead trade association, is lobbying hard against giving Medicare the power to negotiate for lower drug prices. The top 15 drug companies and trade associations spent over $45 million in just the first three months of 2021 on lobbying, arguing in part that restrictions on the high prices charged for existing drugs would blunt incentives for future innovation.
This is a false choice for several reasons.
First, what matters is not the total number of new cancer drugs, but the health benefits created by new drugs. Despite the hype, most currently available cancer drugs are not cures, and many provide very limited gains to patients’ quantity or quality of life.
Second, many potential advances in cancer prevention and treatment remain underinvested in because various members of the U.S. system do not view such investments as worth the costs. Savings from this legislation are expected to be used to expand the depth and breadth of coverage that will among other impacts reduce the financial toxicity of cancer treatment.
Third, what matters to innovators when planning future investments is their overall profitability. By design, H.R.3 will support more widespread use and premium pricing for cancer drugs that provide significant value, ensuring company profits from valuable cancer drugs while reducing spending on drugs whose benefits are modest or negligible. Savings from this legislation will be used to support the next generation of innovative cancer drugs.
H.R.3 will help our system better arrive at a fair, value based price for innovators’ efforts.
This legislation does not aim to undermine the ability of pharmaceutical companies to invest in innovation.
Rather, we expect these negotiations, if allowed to work over time, will create a virtuous circle and increase the availability of new drugs that offer significant health benefits to current and future patients.
Rena Conti is associate professor in the Department of Markets, Public Policy and Law at Questrom School of Business, Boston University. Richard Frank is the Margaret T. Morris Professor of Health Economics at Harvard Medical School. Leslie Dach is the chair of Protect Our Care and a former senior counselor to the Secretary of Health and Human Services.