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Impact of the healthcare payment system on patient access to oral anticancer drugs: an illustration from the French and United States contexts
© Benjamin et al.; licensee BioMed Central Ltd. 2014
Received: 24 July 2013
Accepted: 11 June 2014
Published: 20 June 2014
Oral anticancer drugs (OADs) allow treating a growing range of cancers. Despite their convenience, their acceptance by healthcare professionals and patients may be affected by medical, economical and organizational factors. The way the healthcare payment system (HPS) reimburses OADs or finances hospital activities may impact patients’ access to such drugs. We discuss how the HPS in France and USA may generate disincentives to the use of OADs in certain circumstances.
French public and private hospitals are financed by National Health Insurance (NHI) according to the nature and volume of medical services provided annually. Patients receiving intravenous anticancer drugs (IADs) in a hospital setting generate services, while those receiving OADs shift a part of service provision from the hospital to the community. In 2013, two million outpatient IADs sessions were performed, representing a cost of €815 million to the NHI, but positive contribution margin of €86 million to hospitals. Substitution of IADs by OADs mechanically induces a shortfall in hospital income related to hospitalizations. Such economic constraints may partially contribute to making physicians reluctant to prescribe OADs. In the US healthcare system, coverage for OADs is less favorable than coverage for injectable anticancer drugs. In 2006, a Cancer Drug Coverage Parity Act was adopted by several states in order to provide patients with better coverage for OADs. Nonetheless, the complexity of reimbursement systems and multiple reimbursement channels from private insurance represent real economic barriers which may prevent patients with low income being treated with OADs. From an organizational perspective, in both countries the use of OADs generates additional activities related to physician consultations, therapeutic education and healthcare coordination between hospitals and community settings, which are not considered in the funding of hospitals activities so far.
Funding of healthcare services is a critical factor influencing in part the choice of cancer treatments and this is expected to become increasingly important as economic constraints grow. Drug reimbursement systems and hospital financing changes, coupled with other accompanying measures, should contribute to improve equal and safe patient access to appropriate anticancer drugs and improve the management and care pathway of cancer patients.
Most anticancer drugs are usually administered by intravenous (IV) route during hospitalizations including inpatient (overnight hospital stay) and outpatient hospitalizations (one-day hospital stay). IV treatments are mainly administered during outpatient hospitalizations while inpatient hospitalizations are usually used for the first administration if there is a need to manage potential immediate adverse effects such as allergic reactions, or for disabled patients requiring additional care. As a result, medical oncology activities have been structured for many years within hospital settings and many anticancer drugs are still only delivered during inpatient and outpatient hospitalizations. Nonetheless, since the end of 1990s, an increasing number of anticancer drugs have been developed for oral use, especially for the treatment of breast cancer, non-small lung cancer, colorectal cancer and prostate cancer. In a task force report on oral chemotherapy, a National Comprehensive Cancer Network (NCCN) working group has estimated that this trend would continue, since 25% of anticancer drugs currently under development are planned to be available as an oral formulation . Others have estimated that 10% of current anticancer drugs are available in an oral form . It has been postulated that oral anticancer drugs (OADs) may contribute to improving patients’ quality of life [3, 4], since administration of OADs avoids the inconvenience of infusions, the risk of infections or extravasations, pain at the site of infusion, stress related to infusion, and visits to hospital. This route of administration allows patients to take their medication at home. The follow-up of patients receiving OADs may be still performed in hospital setting. The increasing incidence of cancer, development of more therapeutic alternatives, increasing patient involvement in disease management and treatment decisions, claimed improvements of quality of life, limitations on hospital resources, and healthcare policies have all contributed to the move towards OADs. It has been demonstrated that, assuming equivalent efficacy, patients prefer OADs to IV medication [5, 6]. However, the use of OADs is still controversial in the medical community [7, 8]. The main criticisms towards OADs relate to potential difficulties in the management of drug therapy, such as drug interactions, controlling treatment adherence, and managing adverse effects [1–3, 7–10]. Economic considerations relating to the use of OADs may also have an impact on their prescription and usage and thus may influence patient access to these drugs [11, 12]. So far, most published studies on OADs have focused on treatment adherence and safety [2–4, 7, 8]. Few studies have specifically investigated the economic implications related to the use of OADs [7, 13, 14]. Nonetheless, it seems critical to develop a global approach to this issue, since medical, organizational, financial and regulatory issues are closely interdependent. With respect to publicly available information and data, France and the United States of America (U.S.) were the two countries for which relevant published information on the oral and IV drug payment system was available. These two healthcare systems provided an opportunity to illustrate the issue of patient access to OADs which can be explained by different mechanisms. In France the economic implications of OADs were raised during roundtable discussions in 2008 . In the U.S., the adoption in 2006 of the oral and IV chemotherapy parity legislation provides an opportunity to illustrate economic issues around the patient access to these drugs. The aim of this article is to discuss how the healthcare payment system (HPS) may create disincentives to the use of OADs within the French and U.S. healthcare systems. These two different healthcare systems provide an interesting basis to illustrate the common issues related to the patient access to OADS.
The disincentive effect of the hospital per-case payment system: illustration from the French situation
Estimation of the costs induced by outpatient chemotherapy sessions in France
National Health Insurance perspective
Number of outpatient chemotherapy sessions performed in 2013
Official unit tariff applied in 2014#
Cost for the National Health Insurance
1 511 364
599 059 349 €
216 503 560 €
2 221 864
815 562 909 €*
Estimation of the contribution margin accrued by the outpatient chemotherapy sessions in France
National Health Insurance perspective
Total hospital costs associated with outpatient chemotherapy sessions (DRG 28Z07Z)
Costs associated with expensive drugs**
Costs associated with physician fees**
Costs attributable to the administration of chemotherapy***
Amount/fee paid by the National Health Insurance
Net contribution margin for public and private hospitals+
Number of sessions performed in 2013#
Unit hospital cost per DRG†
Cost associated with expensive drugs
Cost associated with physician fees
Total cost associated with physician fees
(A x B)
(A x C)
(A x D)
(A x B) - ((A x C)+ (A x D)) = (E)
(F) – (E)
1 511 364
1 393 477 068 €
825 355 880 €
568 121 728 €
599 059 349 €
30 937 621€
584 741 500 €
401 787 750 €
22 025 500 €
160 928 250 €
216 503 560 €
55 575 310 €
2 221 864
1 978 219 108€
1 227 143 630 €
22 025 500 €
729 049 978 €
86 512 931 €
The impact of the gap in health insurance coverage on the patient access to oral anticancer drugs: illustration from the Medicare health insurance
Reimbursement may also be a concern for certain diseases for which no therapeutic option in IV form is available, such as myeloma, or for drugs which are only available in oral formulations. Therefore the price of OADs, which may be higher than that of IV chemotherapy, may be a barrier to patient access to these drugs [28, 29]. The higher the price of the medication, the higher the co-pay will be. The price of anticancer drugs is such that the annual threshold set by Medicare can quickly be reached due to the number of treatment administrations needed, especially for cancers that require long therapeutic protocols. This cost is expected to increase over time as more targeted therapies, whose price is higher compared to cytotoxic chemotherapies, become available. It is therefore important that patients be clearly informed about their insurance coverage to help them evaluate if such treatments are compatible with their economic situation to ensure continuity of care throughout the treatment trajectory. Inadequate assessment of these conditions can lead patients to interrupt treatment or to delay refilling prescriptions, when faced with high out-of-pocket costs for these medicines. These situations increase the risk of treatment failure and may lead to increasing use of emergency services and hospitalizations for advanced cancer, which ultimately transfers cost from the patient to the hospital system.
In addition to the economic barrier related to co-payment, the reimbursement rule applied by the Medicare insurance program plays a role in regulating eligibility for reimbursement of OADs. The reimbursement of OADs by Medicare Part B is limited to the treatment of certain serious diseases or certain clinical emergencies, such as advanced kidney disease requiring transplantation. Four criteria determine whether OADs are reimbursed or not and are subject to prior validation by the Medicare insurance scheme on a case-by-case basis. The OADs must have been approved by the Food And Drug Administration (FDA), it must be bio-equivalent to a molecule administered intravenously, it should have the same therapeutic indications to those covered by the IV treatment and should be limited to a list of diseases that can be treated by a restrictive list of oral chemotherapy (busulfan, capecitabine, cyclophosphamide, etoposide, fludarabine, melphalan, methotrexate, temozolomide, topecan) . Finally the prescription of OADs should be performed by a physician or other health care practitioner licensed to prescribe chemotherapy. This complex reimbursement scheme may require actions to assist the patient with financial issues in order to identify a co-payment program or a free drug program in certain cases. This should be initiated before treatment initiation in order to avoid drug cost being incurred by the patient.
Despite reforms to provide equal access to OADs, co-payments still exist, which means that patients’ economic conditions remains one of the several barriers to a wider use of OADs . The gap in healthcare coverage results in a persistent out-of-pocket expense for every patient, potentially leading to decreased medication adherence that may reduce treatment effectiveness, as has been demonstrated by Fung et al. in patients with diabetes . Suboptimal treatment effectiveness may lead to complications, diminished quality-of-life and general health status, and premature death. In this context, a cross-sectional cohort study using administrative claims data showed that 10% of cancer patients with Medicare and commercial insurance abandoned their treatment by OADs . This study also showed that the rate of treatment discontinuation increased with the amount of co-payment. Another study showed that funding considerations influenced patients’ choice of treatment modalities . The Medicare health insurance system is a good illustration of the potential impact of the economic environment on the use of OADs and indicates that the issue of OADs should not be considered only in medical terms but also with respect to economic aspects [25, 32].
These issues need to be considered since higher drug costs increases co-payment to the patient. Out-of pocket expenditures are expected to rise as the cost of anticancer drugs increases and as the proportion of population who are underinsured rises. This issue is particularly important for cancers where there is no choice between IV and oral anticancer drugs. Restriction of availability of OADs due to economic constraints may not be the best way of controlling health care expenditures, since treatment non-adherence may induce unexpected additional costs related to complications and suboptimal treatment effectiveness.
The impact of oral anticancer drugs on healthcare organization
In France, all costs related to cancer care are covered in full by the National Health Insurance (NHI) in a specific program for patients with chronic disease (ALD, Affection de Longue Durée). In principle, there is no substantial out-of-pocket cost that may prevent patients from accessing cancer care. Nonetheless, the use of OADs deprives hospitals of sources of potential revenue because they are transferred in part to the community sectors. This transfer could influence the prescription of cancer treatment in hospitals (via indirect incentives) and thus could influence patient access to such medications. Even though OADs are covered in full by the NHI, shifts of resources from hospital to the community sector are likely to create a barrier to more widespread use of these drugs . In the U.S., the patient access to OADs may be influenced in part by additional copayments and out of pocket payments incurred by the patients and the complexity of the reimbursement systems, which can discourage patients from receiving treatment with OADs. Nevertheless we should underline that the example of the Medicare program that we used in this study is not representative of all healthcare reimbursement systems in the U.S. for which there is variability especially in the private sector and for which published information remains limited. In addition, the American healthcare system is changing quickly and current reforms (e.g. Affordable Care Act, 2010) may contribute to improving patient access to healthcare in the near future. However it remains that in both systems, the absence of revenue to compensate for additional activities to manage patients treated with OADs may be a disincentive to the use of OADs.
Patient access to oral and IV anticancer drugs is an international issue whose determinants may vary from one country to another, but which raises the common issue of safe and appropriate patient access to cancer drugs . As a result, the safe use of OADs seems to be determined by both the patients’ socio-economic conditions and their ability to handle insurance copayments and the healthcare system-related factors including the availability of hospital resources for providing adequate counseling, therapeutic education, and follow-up care for patients treated with OADs. Insurance payment system may have a negative impact on patient access to OADs through economic factors, in addition to patients’ care related factors such as ability to manage oral treatment, age, geographical origin, disease, stage of disease, patient’s preference.
The issue of patient access to OADs underlines the necessity to adapt healthcare services, hospital budget financing and insurance coverage to the introduction and widespread use of innovative drugs. This issue is expected to grow in importance as more and more OADs become available in the near future. Drug reimbursement systems and hospital payment are key factors contributing to increased quality and safety of cancer care by providing cancer patients with the most appropriate care. Further studies on OADs to understand the impact of non-adherence on treatment effectiveness in real life settings and to quantify healthcare resource utilization are needed. Such studies could help guide the appropriate development of new OADs. The use of OADs also highlights a major need to further develop a more complete or encompassing Health Technology Assessment (HTA) in order to anticipate the real impact of such treatments on healthcare systems. Due to the increasing number of OADs available, the economic and organizational impact of their prescription should be considered in the future in order to insure adequate access to these drugs for eligible patients when considered as a relevant treatment option for the patient. In addition, given potential interactions between factors influencing access to OADs, further research and analysis to determine the relative impact of such factors would be useful.
The authors thank Adam Doble (Foxymed, Paris, France) for critical and linguistic review of the manuscript and Marcia K. Horn (International Cancer Advocacy Network (ICAN), USA) for assistance in actualizing information on the status of state legislation in the United States regarding access to oral therapeutics.
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