innovative cancer therapies : putting costs into context

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  • Innovative Cancer TherapiesPutting Costs Into Context

    David Khayat, MD, PhD

    The costs of cancer care are rising, and spending on expensive innovative anticancer agents is likely to come under

    scrutiny as health care payers are confronted by the challenge of resource limits in the face of infinite demand. Indi-

    rect costs account for the major part of total attributable costs of cancer and are dominated by the cost of mortality

    in individuals of working age (who therefore do not contribute to economic productivity). Although cancer is a lead-

    ing cause of morbidity and premature mortality, in 2007, it was estimated that cancer accounted for only around 6%

    of the total health care costs in Europe. It is estimated that cancer drug costs constitute around 12% of total direct

    cancer costs and 5% of the costs of all drugs. Countries vary in their uptake of novel anticancer agents. However,

    even in Francea leading nation for the use of these agentsthe costs of innovative anticancer drugs accounted for

  • approximately 10 million disease-adjusted life years lostacross the European Union in 2002. This makes cancerthird only to mental illness and cardiovascular disease interms of disease burden.12

    Cancer Cost

    As President of the French National Cancer Institute,10 Iasked leading French health economists to determine can-cer costs in France. Their report indicated that these costscan be divided into direct costs (including inpatient/out-patient care, prevention, screening, and research) andindirect costs (including loss of production and produc-tivity). Direct costs evaluate the cost of curative careadministered by health care professionals and institutions,eg, costs associated with inpatient care, prescription medi-cines, and radiotherapy. They do not cover all adminis-tered care, and palliative care in particular may not becovered.10 Indirect cancer costs are evaluated using 2 dif-ferent methods: the human capital method, whichattempts to estimate the loss of individual income causedby premature death (or economic costs of the lost years oflife) and the of the friction costs method, which measuresthe loss of income related to the absence of an individualfrom the workplace.10

    Total cancer costs in France were approximately 29billion in 2004 (Table 2)10; direct costs represented

  • 2). This figure far exceeds the direct costs of cancer care(11.9 billion). Similarly, in Sweden, indirect costsaccounted for 70% of total breast cancer costs in 2002.Lost production caused by premature death accounted for52% of the indirect costs.14 Therefore, dying from cancercosts significantly more than treating this disease.

    Across Europe, cancer drugs account for 5% of alldrug costs.13 Drug costs averaged 12% of total direct can-cer costs, although this varied between 5% and 9% inNorway, the United Kingdom, Switzerland, and Den-mark and >20% in the Czech Republic, Hungary, andPoland. Although cancer care often is viewed as costly, thedirect per-patient costs (Fig. 1), and the proportion ofcosts attributed to drug therapy (Fig. 2) are lower thanthose for other chronic diseases.15

    Do Innovative Cancer Therapies Offer Valuefor Money?

    It is estimated that the total sales of oncology drugs in 25countries (including 19 European countries) haveincreased 5-fold from 1995 to 2005.13 In France, the costof innovative cancer therapies rose from 335 million in2003 to 714 million in 2006. According to the FrenchPharmaceutical Companies Association, in 2006, drugcosts in France accounted for approximately 20% of thesocial security health budget (approximately 28 billion).However, innovative anticancer drugs were responsiblefor just 0.75 billion, or

  • Researchers at Swedens Karolinska Institute ana-lyzed the relation between the availability of new anti-cancer drugs and the associated effect on survival in 3different ways.13 First, according to 1 analysis, 44% of theimprovement in cancer survival rates from 1992 to 2000at 50 US cancer centers could be attributed to newer anti-cancer drugs. Second, 14% to 19% of the intercountrydifferences in 5-year cancer survival rates across 5 majorEuropean Union countries were because of the uptake ofnewer drugs (after 1985). Finally, these researchers mod-eled the effect of newer drug vintages on cancer mortal-ity (adjusted for age and gross domestic product) in 20countries from 1995 to 2003; adjusted mortalitydecreased by approximately 16% during this period, andthe use of newer drugs accounted for 30% of this trend(ie, an absolute reduction of approximately 5%).13

    The Karolinska study was criticized for flawed dataand methodology,38,39 with more rapid access to innova-tive drug therapy suggested as a surrogate marker of otherfactors that prolong survival, including improved diagno-sis.38,39 However, although the Karolinska data have limi-tations, they are worth considering.

    Access

    Substantial disparities exist between European countries inper capita spending on novel anticancer agents. Accordingto 2005 data, France, Switzerland, and Austria were theleading European nations.13 By 2005, the use of trastuzu-mab in France was approximately 50% higher than theEuropean average. Data from 2007 to 2008 suggest thatuptake of new agents remains high in France, moderate inGermany and Italy, and low in the United Kingdom.1

    Access to new anticancer drugs in France has beenimproved by several measures. More than 75% of healthcare funding in France is provided by the National SocialSecurity system.40 Cancer care is covered under the Affec-tions de Longue Duree and French patients receive fullreimbursement of their health care costs. In 2004, I per-suaded the French government to set up a new locus bywhich hospitals receive full, unrestricted state reimburse-ment for costly innovative anticancer drugs. This freedclinicians to prescribe novel agents according to clinicalneed, although it was contingent on meeting specific crite-ria with full reimbursement only realized when drugs areprescribed according to the good use contract. Duringthe 5 years after the introduction of this legislation, ex-penditure on cancer drugs increased from 230 million to1 billion, suggesting substantial under use of innovativetherapies before 2004.

    Access to an effective drug can be delayed by regula-tory approval even when data support its use. In 2005, Ilobbied the French government to establish the Tempo-rary Treatment Protocol (PTT) to help prevent delays.The PTT convenes a panel of experts to assess data con-cerning new indications for drugs that are alreadyapproved (eg, in 2005, it was demonstrated that trastuzu-mab provides significant benefits as adjuvant treatmentfor breast cancer,41,42 but it approved only for metastaticdisease; therefore, patients could not benefit from thesefindings pending regulatory review). The PTT panelreviews new data, and, if it expects that a drug will begranted a new indication by the European MedicinesAgency, patients are given immediate access in that indi-cation. If the drug gains this indication, then patients con-tinue to be treated. If not, then access is stopped.

    In conclusion, the adoption of novel anticancertherapies into clinical practice is vital to reduce cancermortality rates. The potential reduction in indirect cancercosts could exceed the direct costs of therapy as well asproviding patient benefits. In France, where innovativedrugs are fully reimbursed subject to a good use con-tract, such benefits were achieved in 2006 using a rela-tively small proportion of the health care budget. TheFrench health care system differs from that of many othercountries, but the key issue is the cost in proportion to thetotal health care budget, rather than who pays. Crucially,well designed, noninterventional, postapproval studies arerequired to properly assess the costs and benefits of inno-vative anticancer drugs.

    FUNDING SOURCESMedical writing assistance from Prism Ideas Ltd. wasfunded by Association pour la Vie, Espoir Contre leCancer.

    CONFLICT OF INTEREST DISCLOSURESDavid Khayat has received consultancy fees from Roche, AstraZenecaand Sanofi-Aventis.

    REFERENCES1. Wilking N, Jonsson B, Hogberg D. Comparator Report on Patient

    Access to Cancer Drugs in Europe. Stockholm, Sweden: The Karo-linska Institute; 2009. Available at: http://vocuspr.com/vocuseu/Newsroom/ViewAttachment.aspx?SiteNameESMO&EntityPRAsset&AttachmentTypeF&EntityID103275&AttachmentIDf60eb64a-e480-48ec-a5ca-b5c9163d3b70. Accessed October 24, 2010.

    2. Stuckler D, Basu S, Suhrcke M, et al. The public health effect ofeconomic crises and alternative policy responses in Europe: an em-pirical analysis. Lancet. 2009;374:315-323.

    Commentary

    2370 Cancer May 1, 2012

  • 3. DAddario G, Fruh M, Reck M, et al. Metastatic non-small-celllung cancer: ESMO Clinical Practice Guidelines for diagnosis, treat-ment and follow-up. Ann Oncol. 2010;21(suppl 5):v116-v119.

    4. Cardoso F, Senkus-Konefka E, Fallowfield L, et al. Locally recurrentor metastatic breast cancer: ESMO Clinical Practice Guidelines fordiagnosis, treatment and follow-up. Ann Oncol. 2010;21(suppl5):v15-v19.

    5. Dreyling M. Newly diagnosed and relapsed follicular lymphoma:ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010;21(suppl 5):v181-v183.

    6. Van CE, Nordlinger B, Cervantes A. Advanced colorectal cancer:ESMO Clinical Practice Guidelines for treatment. Ann Oncol.2010;21(suppl 5):v93-v97.

    7. Ferlay J, Autier P, Boniol M, et al. Estimates of the cancer incidenceand mortality in Europe in 2006. Ann Oncol. 2007;18:581-592.

    8. Verdecchia A, Francisci S, Brenner H, et al. Recent cancer survivalin Europe: a 2000-02 period analysis of EUROCARE-4 data. Lan-cet Oncol. 2007;8:784-796.

    9. Guerin S, Doyon

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