Pharmaceutical policies: effects of cap and co-payment on rational drug use

 

Abstract

Background

Growing expenditures on prescription drugs represent a major challenge to many health systems. Cap and co-payment (direct cost-share) policies are intended as an incentive to deter unnecessary or marginal utilisation, and to reduce third-party payer expenditures by shifting parts of the financial burden from the insurer to patients, thus increasing their financial responsibility for prescription drugs. Direct patient drug payment policies include caps (maximum number of prescriptions or drugs that are reimbursed), fixed co-payments (patients pay a fixed amount per prescription or drug), coinsurance (patients pay a percent of the price), ceilings (patients pay the full price or part of the cost up to a ceiling, after which drugs are free or available at reduced cost), and tier co-payments (differential co-payments usually assigned to generic and brand drugs).

Objectives

To determine the effects of cap and co-payment (cost-sharing) policies on drug use, healthcare utilisation, health outcomes and costs (expenditures).

Search methods

We searched the following databases and web sites: Effective Practice and Organisation of Care Group Register (date of last search: 6 September 07), Cochrane Central Register of Controlled Trials (27 August 07), MEDLINE (29 August 07), EMBASE (29 August 07), NHS EED (27 August 07), ISI Web of Science (09 January 07), CSA Worldwide Political Science Abstracts (21 October 03), EconLit (23 October 03), SIGLE (12 November 03), INRUD (21 November 03), PAIS International (23 March 04), International Political Science Abstracts (09 January 04), PubMed (25 February 04), NTIS (03 March 04), IPA (22 April 04), OECD Publications & Documents (30 August 05), SourceOECD (30 August 05), World Bank Documents & Reports (30 August 05), World Bank e-Library (04 May 05), JOLIS (22 February 06), Global Jolis (22 February 06), WHOLIS(22 February 06), WHO web site browsed (25 August 05).

Selection criteria

We defined policies in this review as laws, rules, or financial or administrative orders made by governments, non-government organisations or private insurers. We included randomised controlled trials, non-randomised controlled trials, interrupted time series analyses, repeated measures studies and controlled before-after studies of cap or co-payment policies for a large jurisdiction or system of care. To be included, a study had to include an objective measure of at least one of the following outcomes: drug use, healthcare utilisation, health outcomes or costs (expenditures).

Data collection and analysis

Two authors independently extracted data and assessed study limitations. We undertook quantitative analysis of time series data for studies with sufficient data.

Main results

We included 30 evaluations (in 21 studies). Of these, 11 evaluated fixed co-payment, six evaluated coinsurance with a ceiling, four evaluated caps, three evaluated fixed co-payment with a ceiling, three evaluated tier co-payment, one evaluated ceiling, one evaluated fixed co-payment and coinsurance with a ceiling, and one evaluated a fixed co-payment with a cap. Most of the included evaluations were observational studies and the quality of the evidence was found to be generally low to moderate.

Introducing or increasing direct co-payments reduced drug use and saved plan drug expenditures across studies. Patients responded through drug discontinuation or by cost-sharing. Investigators found reductions for life-sustaining drugs or drugs that are important in treating chronic conditions as well as other drugs. Few studies reported on the effects on health and healthcare utilisation. One study found adverse effects on health through increased healthcare utilisation when a cap was introduced in a vulnerable population. No statistically significant change in use of healthcare services was found in other studies when a cap was introduced on a drug considered over-prescribed in a vulnerable population, or following a shift from a two-tier to a three-tier system with increased co-payments for tier-1 drugs in a general population.

Authors' conclusions

We found a diversity of cap and co-payment policies. Poor reporting of the intensity of interventions and differences in setting, populations and interventions made it difficult to make comparisons across studies. Cap and co-payment polices can reduce drug use and save plan drug expenditures. However, although insufficient data on health outcomes were available, substantial reductions in the use of life-sustaining drugs or drugs that are important in treating chronic conditions may have adverse effects on health, and as a result increase the use of healthcare services and overall expenditures. Direct payments are less likely to cause harm if only non-essential drugs are included or exemptions are built in to ensure that patients receive needed medical care.

 

Plain language summary

Patient drug payment policies to ensure better use of drugs

Large amounts of health care money are spent on drugs, and these amounts are increasing. Spending more on drugs could mean less money for hospitals, doctors or even other non-health care services. There is also misuse, overuse and underuse of appropriate drugs which can lead to wasted resources and health hazards. There is therefore a pressure to ensure better use of drugs and to control the costs of drugs, but without decreasing health benefits.

This review found 21 studies that evaluated policies implemented by governments, non-government agencies and health insurance companies to improve drug use or to save (third-party) drug spending or both. Five policies were evaluated in which people pay directly for their drugs when they fill their prescription:

caps (prescription drugs are reimbursed up to a maximum amount and then after this amount people have to pay for their drugs),
fixed co-payments (people pay a fixed amount per prescription or drug),
tier co-payments (people pay a fixed amount per prescription or drug which may depend, for example, on whether the drug is a brand name or a generic name),
coinsurance (people pay a percent of the price of the drug),
ceilings (people pay for part of or full price of the drug up to a maximum amount, for example, for a year, and then people pay no or less money for drugs after that amount).

It is thought that if people have to pay directly for their drugs they may decrease their use of drugs (either overall, or for drugs considered to be over-prescribed or a less cost-effective alternative than other available treatments); they may buy cheaper drugs; or they may pay for their own drugs, or both.

This review found that cap and co-payment polices can decrease overall drug use and decrease third-party drug spending. But reductions in drug use were found for both life-sustaining drugs and drugs that are important in treating chronic conditions, as well as in other drugs. Although insufficient data on health outcomes were available, large decreases in the use of drugs that are important for peoples' health may have adverse effects. This could lead to an increased use of healthcare services and therefore, overall spending. Policies in which people pay directly for their drugs are less likely to cause harm if only non-essential drugs are included in these policies or exemptions are built into the policies to ensure that people receive needed medical care.

 

摘要

背景

藥學的政策︰ 最高限度和共同支付對合理使用藥物的影響

處方藥物的支出逐漸增加，顯示對健康系統是一項重要的挑戰。最高限度和共同支付(直接的費用分享)政策，是要作為制止不必要和邊緣的使用的一種獎勵，且藉由轉移保險業者部份的財務負擔到病人，因而增加他們的處方藥物的財務負擔，來降低第三者付款人的支出。直接的病人藥物付款政策，包括最高限度(caps，最大的被補償的處方或者藥物的數量)、固定的共同支付(fixed copayments，每一次處方或藥物，病人付固定的費用)、共同保險(coinsurance，病患支付百分比的價格)、最高限額(ceilings，病患支付全部費用或部分的費用，支付上限為一最高限額，之後，藥物是免費或者可以降低費用)、及階梯式的共同支付(tier copayments)依照一般非商標藥物或商標藥物而給予不同的共同支付)。

目標

確定最高限度和共同支付(費用分享)政策，對藥物使用、健康照護使用、健康結果及成本(支出)的影響。

搜尋策略

搜尋以下資料庫及網站：登錄有效實務和照護團體機構(最後搜尋的日期：2007年9月6日)、登錄於Cochrane中心的控制性試驗(2007年8月27日)、MEDLINE (2007年8月29日)、EMBASE (2007年8月29日)、NHS EED(2007年8月27日)、ISI Web of Science(2007年1月9日)、CSA Worldwide Political Science Abstracts(2003年10月21日)、EconLit(2003年10月23日)、SIGLE(2003年11月12日)、INRUD(2003年11月21日)、PAIS International(2004年3月23日)、 International Political Science Abstracts(2004年1月9日)、PubMed(2004年2月25日)、 NTIS(2004年3月3日)、IPA(2004年4月22日)、OECD Publications & Documents(2005年8月30日)、SourceOECD(2005年8月30日)、World Bank Documents & Reports (2005年8月30日)、World Bank eLibrary(2005年5月4日)、JOLIS(2006年2月22日)、Global Jolis(2006年2月22日)、WHOLIS(2006年2月22日)、WHO網站瀏覽(2005年8月25日)。

選擇標準

在這篇評論中所定義的政策，是由政府、非政府間的組織或者私人保險公司形成的法律、規章、或者金融的或行政的命令。我們包括大量司法或照護系統的最高限度和共同支付政策的隨機控制試驗、非隨機控制試驗、打斷時間序列分析、重複測量研究、及前後控制的研究。所被納入的研究，包括至少以下一項客觀的結果測量指標：藥物的使用、健康照護的使用、健康結果或成本(支出)。

資料收集與分析

兩位作者獨立的摘取資料及評估研究限制。我們進行時間序列研究，用足夠的資料做量性分析。

主要結論

我們包括30項評估(在21篇研究)。所有這些，11項評估固定共同支付，6項評估共同保險和最高限額，4項評估最高限度，3項評估固定共同支付和最高限額，3項評估階梯式共同支付，1項評估最高限額，及1項評估固定共同支付和共同保險和最高限度，及1項評估固定共同支付和最高限度。多數納入的評估是觀察性的研究，且發現其證據品質通常是低到中等級。 經由研究，採用或增加直接共同支付可降低藥物使用及節省計畫用藥支出。病患透過藥物終止或者分享費用來承擔責任。調查者發現維持生命或是治療慢性情況重要的藥物及其他類似藥物的使用減少。少數研究報告在健康及使用健康照護的效果。一項研究發現當採用最高限度在一群脆弱的人群，會增加健康照護的使用，而在健康上有負向的效果。其他研究發現，當在一群脆弱的人群對一項被認為處方過多的藥物採用最高限度，或者增加一般人口的第一層藥物的共同支付追蹤，並從兩層到三層系統的轉移，其在使用健康照護服務上都沒有統計顯著性的改變。

作者結論

我們發現最高限度和共同支付政策差異。介入措施的強度報告不良，和不同的環境、人群和介入措施，使研究很困難去比較。最高限度和共同支付政策可以降低藥物使用及節省計畫用藥的支出。無論如何，雖然在健康成果沒有足夠可用的資料，但是大量降低使用維持生命的藥物，或是治療慢性情況重要的藥物，可能對健康有負向的影響，且會造成使用健康照護服務及全部的支出增加的結果。如果只有納入不重要的藥物，或者建立免除支付不重要的藥物以保證病患得到需要的醫療護理，直接支付很少會引起危害。

翻譯人

本摘要由高雄榮民總醫院林麗英翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

病人用藥支付政策，以確保較合理的藥物使用。 大量的健康照護費用是花費在藥物上，且數量仍在增加中。在藥物上花費較多，會造成意味著較少的錢可供醫院、醫師或甚至其他非健康照護服務方面的使用。濫用、過度使用和未充分適當的使用藥物，這些會導致浪費資源及健康傷害。因此有壓力要去確保較合理的使用藥物及控制藥物成本，但是又不會降低健康的利益。 這篇評論發現21篇研究是評估政府、非政府機構及健康保險公司的政策執行，以改善藥物使用或節省(第三者)藥物花費或兩者。五項政策評估當人們的處方已滿時，他們直接支付其使用的藥物費用： ＊最高限度(caps，處方藥物給付到一個最高的量，之後人們必須對他們的用藥付款)； ＊固定的共同支付(fixed copayments，每一次處方或藥物，人們付固定的費用) ＊階梯式的共同支付(tier copayments，人們支付每張處方或者藥物固定的款項，可以依靠，例如，藥物是一個商標名稱還是一個一般非商標的名稱)； ＊共同保險(coinsurance，人們支付部分比例的藥物價格)； ＊最高限額(ceilings，人們支付部分或全部的藥物費用，支付上限到一最高的量，例如，一年，到達此最高量之後，人們不需要付費或者付較低的藥物費用)。 一般認為，假如人們必須直接支付他們的用藥，他們可能降低他們的藥物的使用(不管是全面或是被認為是過度處方的藥物或是相較其他可得到的治療有較低的成本效益的藥物)；他們可能買便宜的藥物；或者他們可能為他們自己的藥付錢，或者兩者皆是。 這些評論發現最高限度和共同支付政策可以降低整體藥物的使用及降低第三者藥物花費。但是發現減少使用的藥物是維持生命的藥物及治療慢性情況的重要藥物兩者，以及其他的藥物。雖然在健康成果方面沒有足夠可用的資料，大量降低對人們健康是重要的藥物的使用可能有負向的影響。這可能導致健康照護服務的使用增加，而造成整體花費增加。人們直接支付他們的藥物的政策，如果只有納入不重要的藥物到此政策中，是很少會引起危害的，或者建立免除支付的政策，以保證人們得到需要的醫療護理。