SPONSORED FEATURE: JOHNS HOPKINS MEDICINE
ISSUES IN ACCESS TO CANCER MEDICATIONS IN LOW- AND MIDDLE-INCOME COUNTRIES GILBERTO DE LIMA LOPES, JR, MD, MBA, FAMS, THE JOHNS HOPKINS SINGAPORE INTERNATIONAL MEDICAL CENTRE,
SINGAPORE AND THE JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE, BALTIMORE, MD, USA
In the last five decades major breakthroughs have been realized in the treatment of cancerbut, mainly due to the high cost of new drugs, for those of us who practice in low- and middle-income countries (LMIC) many of these advances are but an aspiration and hope for thefuture. LMIC account for about 60% of new cancer cases and nearly two thirds of relateddeaths, demonstrating the lower ability these nations have to address the disease; yetemerging economies incur a paltry 6.2% of the global cancer cost and are responsible for awhopping 89% of the global cancer expenditure gap.
Cost of cancer in low- and middle-income countries
expressing breast cancer. This contrasted to 55% of patients in
We have calculated the economic burden of cancer per patient, Singapore, a high-income country in south-east Asia. Moreover,including direct medical costs, non-medical costs and we validated these results using sales data from IMS Health andproductivity losses, in South America, China and India to be calculated the expenditure per capita on the same index of drugsUS$7.92, US$4.32 and US$0.54, respectively, which is little to be US$0.49 in Thailand, US$0.48 in Malaysia, US$0.12 in thewhen compared to US$183, US$244 and US$460 in the United Philippines, US$0.11 in Vietnam and US$0.04 in Indonesia asKingdom, Japan and the United States, in that order. Adjusting compared to US$6 in Singapore and US$20 in the Unitedby income at current exchange rates, the cost of cancer care States. Not surprisingly, access correlated strongly with GNI perrepresents 0.12% of gross national income per capita (GNI) in capita (R2=0.99) and, interestingly, with cost-effectivenessSouth America, 0.05% in India and 0.11% in China. In the United (R2=0.7), even though only Thailand routinely uses healthKingdom, Japan and United States the corresponding cost was economics evaluations when deciding on therapeutic coverage0.51%, 0.6% and 1.02% of GNI per capita, respectively.
This paper is a summary version of a more comprehensive and
Access to cancer medications in low- and middle- detailed manuscript which wil be published in an upcoming
issue of Nature Reviews Clinical Oncology.
Little data has been presented or published on the prevalence ofuse of cancer medications in emerging markets. In a survey and Universal coverage for health care in emergingfocus group of medical oncologists and health care policy economiesexperts from six South-east Asian nations at the first Southeast With the goal of improving access to health care, universalAsian Cancer Care Access Network (SEACCAN) meeting in insurance coverage, the fundamental element of functional2011, we estimated that approximately 15% of patients in low- health care systems as it pools resources and providesand middle-income countries in the region had access to an financial protection from the costs of il ness, is increasinglyindex of medications which included oxaliplatin in the adjuvant common in emerging Asian and Latin American countries. treatment of colon cancer, bevacizumab and cetuximab in the However, the majority of countries, many of which are inpal iative treatment of colorectal cancer; gefitinib or erlotinib in Africa, stil lack universal coverage. Encouragingly, largethe treatment of patients with metastatic lung cancer who middle-income countries which stil lack universal coverageharbour epidermal growth factor receptor mutations; sorafenib are working towards it. Indonesia recently passed legislationin the management of advanced hepatocel ular carcinoma; and establishing the first steps towards comprehensive coveragetrastuzumab in the adjuvant therapy of early HER2/neu over- and China’s efforts are wel under way and on target to cover
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most of its population in coming years.
icotinib, an epidermal growth factor receptor inhibitor, whichwas approved by the Chinese Food and Drug Administration
Use of generics and biosimilars for off-patent (SFDA) in June 2011; and NanoxelTM, a nano-particle based
paclitaxel formulation, developed by Darbur Pharma, an Indian
Once generic competition sets in, the price of medications can company that has since been acquired by Fresenius Kabi, adrop significantly, often by 80% or more. Several, mostly older, German health care company. Several caveats have to be raisedchemotherapy drugs are included in the WHO’s Essential Drugs however. First, scrutiny of new medications in low- and middle-List. These are selected based on disease prevalence, efficacy, income countries may be less rigorous than in the United Statessafety and comparative cost-effectiveness. Major chal enges for and Europe, raising the possibility of safety and efficacy issuesthe greater penetration of generics include public and health and second, it is unlikely that a significant number of importantcare worker perception and quality issues.
new drugs wil be developed solely for emerging markets.
WHO defines Biosimilars as biotherapeutic products that are
similar in quality, safety and efficacy to licensed reference Clinical research and participation in clinical trialsbiotherapeutic products. While there are currently approved Physicians and patients in low- and middle-income countriesversions of supportive medications such as granulocyte and often choose to participate in clinical trials as a means oferythrocyte colony stimulating factors, prospective randomized accessing medications that would otherwise not be covered inclinical trials wil be needed before biosimilars of monoclonal health systems with limited resources. While there are clearlyantibodies such as bevacizumab, cetuximab, rituximab and positive effects of increasing clinical trial participation intrastuzumab become more extensively available, likely making emerging markets, it is important to note that there are alsothese substitutes more expensive and therefore less accessible chal enges. Authors often cite difficulties with ethical mattersthan regular generics.
such as the adequacy of informed consent, financialcompensation and potential conflicts of interest, as wel as
potential lack of adequate oversight from regulatory authorities,
The World Trade Organization’s (WTO) Trade-Related Aspects and potential ethnic differences in treatment results. of Intel ectual Property Rights agreement (TRIPS) went intoeffect in January 1995, al owing countries to issue compulsory Newer payment systems: Tiered pricing, accesslicenses on grounds of public interest, without the consent of a programmes, risk-sharing agreementspatent holder, and permitting the production of generic Price discrimination, which despite its inequitable soundingmedications while intel ectual property rights are stil in effect. name is an important concept in economics and business,The Doha Declaration in November 2001 introduced consists of charging different prices for the same product inprovisions for least developed countries and for those that do different markets or segments of a market, usual y based on thenot have drug production capacity, al owing the export of consumer’s ability to pay and on elasticity of demand. Also cal edmedications produced under compulsory licensing in specific differential, tiered or equity pricing, it is a common practice insituations. The patent owner, in the case of medications most industries outside health care, where discounts andusual y a pharmaceutical company, stil holds rights to its rebates are common place, al owing companies to expand theinvention and is entitled to compensation under TRIPS; number of customers who are able to afford its products. Pricegovernments wil usual y request a voluntary license before discrimination policies have al owed for successful distributionissuing a compulsory one. Many countries, including Brazil and of lower-cost vaccines and AIDS medications in the developingSouth Africa for instance, issued compulsory licenses to world. The main problems with price discrimination include theincrease access to HIV medications in the last couple of risk of paral el importing from low to high cost countries,decades and the United States considered using it to create political backlash in nations where prices are higher and the factstockpiles of ciprofloxacin during the Anthrax scares which that even cheaper medications may not be cheap enough in low-fol owed the 11 September, 2001 attacks.
Drug development geared exclusively towards Health technology assessment, cost-effectiveness
and value-based insurance design and pricing
A number of pharmaceutical companies in emerging markets Just as in Canada and Western Europe, low- and middle-incomehave started to develop drugs that are not intended, at least countries that enabled universal coverage have struggled withinitial y, to be sold in high-income economies. Examples include rising health care and medication costs, often leading to the
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creation of agencies or groups that provide formal and informal since its foundation in 2000. In cancer care, GAVI has been ablehealth technology assessment, one dimension of which is cost- to lead negotiations in decreasing the cost of cancer preventingeffectiveness. While the main reasons for establishing these vaccines in low-income countries, bringing the price per dose ofagencies or groups are similar around the world, namely the hepatitis B and HPV vaccines down to US$0.18 and US$5,creation of an objective and transparent way of assessing respectively. alternative interventions in the setting of limited resources,
Most importantly, the Al iance provides a model that those of
aiming to improve health care quality, low- and middle-income us interested in increasing access to cancer medications in low-countries struggle even more with lack of resources, human and middle-income countries can draw inspiration from andcapital and knowledge of the subject.
build upon. Through engagement and goal setting, recipient
At the same time, low- and middle-income countries may countries have incentives to create and develop their health and
leverage from health systems that promote value in oncology. human capital infrastructure with adequate technical supportValue-based insurance design and pricing may eventual y fol ow from the Al iance’s technical partners; second, through thein the wake of health technology assessment and cost- provision of funding, the Al iance creates a functioning market ineffectiveness evaluations. Many new drugs in oncology improve vaccines for low-income countries, generating interest andmedian overal survival by just a few months at a cost of solutions from private players. Final y, GAVI has been the testthousands or tens of thousands of US dol ars. Value-based case for a new approach in innovative funding models, throughinsurance design and pricing, with a basic premise that an the creation in 2006 of the International Finance Facility forintervention’s cost should be linked to the benefit it provides, Immunization, which issues bonds in capital markets, leveragedcould potential y bring the cost of new medications closer to by guarantees of future donations. The Facility, which is fundedthresholds in which these would be considered cost-effective. by many donor countries such as Australia, France, Italy, theThis would also avoid the rationing of more effective and life- Netherlands, Norway, South Africa, Spain, Sweden, and thesaving medications due to high costs. These can also help United Kingdom and has the World Bank as its treasurer, hasindustry and payers establish price discrimination policies as raised in excess of US$3.5 bil ion in capital markets, effectivelycost-effectiveness thresholds vary according to national per more than doubling the amount of funds available to GAVI. capita income.
Public-private partnerships and philanthropy: The It wil take the whole world to control cancer in low- and middle-
GAVI Al iance and the international financing facility income countries. Only through multiple stakeholder
involvement, including governments, industry and civil society,
The chal enge of access to cancer medications in low- and and through the creation of a global entity to fight cancer,middle income countries can only be effectively addressed supported by a global fund in the mould of the GAVI Al iance andthrough a combination of public and private efforts. Throughout the International Finance Facility for Immunization wil we trulythe world there are a growing number of such entities aiming to be able to win the fight against the disease. Final y, it is ofimprove health care financing and delivery in low- and middle- paramount importance to note that, while in this perspective theincome countries. The most relevant example to this author has focused on access to medications, effective cancercommentary is that of the GAVI Al iance and the International control plans have to be cultural y appropriate, comprehensiveFinancing Facility for Immunization.
and holistic, involving data gathering, health education,
The GAVI Al iance, formerly the Global Al iance for Vaccines prevention, screening, early detection, surgical and
and Immunization, is a public-private partnership that has made radiotherapeutic treatments in addition to access to anti-cancersignificant strides in increasing access to vaccines, including drugs. lthose that prevent cancer, such as human papil omavirus [HPV]and Hepatitis B, in low-income countries. Bringing together al
(The author welcomes comments and would like to invite readers
significant stakeholders, including industry, donor and recipient to contribute with stories and their experience by emailing governments, UNICEF, WHO, The World Bank, The Bil and us or posting them at “Access to Cancer Care in Low and Melinda Gates Foundation and other philanthropists, research Middle Income Countries”, a webpage which is available atand technical agencies and representatives from civil society http:/ www.facebook.com/CancerControlInLowAndMiddleIncomeCgroups, the Al iance has helped immunize an additional 325 ountries?ref=hl)mil ion children and likely helped avert 5.5 mil ion future deaths
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Prof. Dr. Gabriele Linke, Universität Rostock _________________________________________________________________________________________ Verzeichnis der wissenschaftlichen Veröffentlichungen Monographien 2003: Populärliteratur als kulturelles Gedächtnis. Reihe American Studies: A Monograph Series, vol. 104. Heidelberg: Winter. 382 S. 1987: Untersuchungen zur Wirkung von T