Cost planning for oncological therapies from the clinic's point of view regarding clinical care and studies [Kostenplanung onkologischer Therapien aus Sicht der Klinik im Rahmen klinischer Versorgung und Studien]

General conditions for performing medical and oncological care in Germany

Providing health care in any country reflects the country's legal system and financial resources. The entire medical system in Germany is in a constant change from a cost-unaware social affair institution to an economic market-based health care supplier. This is an extended and continuing process in which physicians have to weight economics, ethics, and demands of all stakeholders against each other and learn to prioritize use of resources. The goal of a comprehensive economy-oriented heath care is intended by the majority of politicians and parties in Germany and enforced by the implementation of flat rate ambulatory and Diagnosis-Related Groups (DRG) in-patient reimbursements. Multiple types of budget caps, insufficient flat rate reimbursements, payback of reimbursement as regress for pharmaceutical off-label use, federal-administered prices for heath care, self-coverage by hospitals for cost of patients' complications, non-reimbursement for expensive pharmaceuticals used for in-patients, etc. are just a few of the problems any physician has to face and solve daily. In contract to public believe the financial risk of diseases and medical care is not with any health insurance or sickness funds but with the heath care providing physician and/or his/her employer.

This results in a politically intended rationing of health care from optimal to minimal standards. According to the German Social Law Book V (SGB V) §12 medical care has to be acceptable, suitable and economically and should not exceed the necessary care. This is in contrast and in a remarkable contradiction to guideline standards which are demanded by patients and health insurances and continuously expanded by all health market stakeholders. But guideline-based treatment is not financially calculated and therefore not reflected in its reimbursement which can result in a financial loss and even bankruptcy for the providing physician or institution. A yearly over proportionally increase of costs above the inflation rate for innovative oncological pharmaceuticals and care has resulted in the need for active measures to comply with economic rules by hospital to financially survive and still provide oncology at state-of-the-art level without reducing standard of care. Current reimbursement rules for oncological therapies are complex and at least partially contradictive and do not provide a fair and adequate reimbursement. Pitfalls like off-label-use are likely the result. As a consequence a prospective and active steering and case management of oncological treatment in standard medical care as well as clinical studies is imperatively recommended. In the following a successful model is described how to adjust oncological care to its reimbursement without lowering standard of care below unacceptable limits.

Cost planning for clinical oncological care

Cost coverage for oncological therapies is mandatory for the above explained reasons for any oncological care provider. Therefore an active management has to accompany performance of any oncological therapy so costs and reimbursement for any given therapy in typical clinic setting has to be known in advance. All other factors influencing both have to be considered, too. In gyneco-oncology almost all current standard oncological therapies can be performed as ambulatory or outpatient therapies. Chemo therapy as in-patient care is often considered by German Medical Service of Health Insurances as primary unnecessary utilization of hospital beds and is not reimbursed at all unless there are detailed written and justified reasons for that exemption which in most cases is unlikely. This economic risk should be avoided if possible. Cost transparency can be initated through monthly medication price list reports for all physicians e.g. after the clinic's morning assembly [1].

Active individual oncological case management requires four steps as described in the following (modified after [2,3,4]):

The most important cost driver in most chemo therapies is primarily the pharmaceutical substance. Therefore a list of prices for a single cycle-day for a standardized patient (70kg BW, 1.8m² body surface, 90ml/min GFR) should be available to identify quickly between cost-covering and not cost-covering therapies before accepting a patient. For not cost-covering therapies individual solutions (e.g. private prescriptions, transfer to office-based physician) should be found to assure the quality of care. All cost of performance of a single chemo cycle-day can be estimated depending on necessary level of care at a flat rate of 100–150 € in an ambulatory university setting.

Further important factors to know and consider are

• Label or off-label use indication (for all oncological pharmaceuticals according to the package insert)

• insurance status (only private patients can get off-label-use on a routine base, because public sickness funds can reject payment for off-label use later)

• actual hospital budget spending caps and internal budgeting (=allowed number of patients to treat/year)

• applicable reimbursement options (ambulatory private of public health insurance prescription, day case, flat rate reimbursement, in-patient care, individual contracts, etc.)

A very important point is the last step: post-calculation and elimination of all potential errors along the way. Often bureaucratic errors occur or costs and reimbursement are unknown or neglected or invoices are not paid by local or foreign patients. By actively controlling and managing a chemo unit's financial risks can be minimized or even eliminated, costly reimbursement errors can be corrected and mainly avoided and so reimbursement optimized. The medication budget could be reduced with active cost management by over 80% within two years without reducing standard of care [4]. With active physician-based cost management all gyneco-oncological standard therapies can be performed cost-covering at present time in a university institution if increased efforts for cost-coverage and limited sacrifices regarding convenience are made. A few problems remain unsolved at present time for basic health insurance patients: costly off-label and innovative therapy pre-market certification [5], service accumulation, decrease of convenience and discontinuation of medical provider due to financial aspects.

Cost planning for clinical studies

Cost planning for clinical studies is analog to conventional oncological therapies as described above. According to Krankenhausentgeltgesetz (KhEntG) §7 and 8 performing oncological therapies within study concepts has to be reimbursed adequately and analog to standard therapies. This was in question a few years ago [6]. However, some aspects in the study stetting require particular attention e.g. cost of pharmaceuticals, off-label-use, clinic internal budgeting and spending caps as well as additional diagnostics and care and study-related costs.

Optimal is the identification of all costs in advance according to a study protocol in the initial phase of a study before ethic commission submission. If physicians are unable to perform this, support through Study centers e.g. Münchner Studien Zentrum (MSZ) is helpful [7]. All study-related costs as well as the experimental arm or arms – if off-label-use – should be identified and fully reimbursed by the study sponsor. A modern patient administration system can differentiate between medical necessary costs and study related costs – e.g. weekly tumor markers or two-weekly imaging is not clinical standard of care – and admit patients simultaneously in these both different categories during one hospital visit.

Decent and adequate study contracts require

• honest contracts

• honest cost calculations

• honest distribution of financial sponsor support between study centers and periphery

During calculation the principal investigator evaluation the study costs should avoid shifting costs for clinical studies into clinic budget for the benefit of the sponsor as well as identify insufficient study concepts which are just for marketing and increase of medication turnover especially in off-label use setting. Any participation in clinical studies should not result in a loss for the clinic or in subsidizing pharmaceutical studies from the clinic budget. A renegotiation of study contracts is often possible to reach cost coverage. A rejection of not-cost covering study contracts should be considered in case of insufficient study funding.

Discussion

Prospective and active planning of costs of oncological therapies in a university and/or hospital setting can avoid spending over reimbursement and consecutive loss for the provider of care. Therefore economic problems have to be identified in advance and creative solutions to be found to maintain quality of care without reduction of essential medical care. Such cost planning can't be done by health insurances or hospital administration because their interest is not focused on the patient. Physicians are the only professional group involved to adjust care to costs regarding medical necessity and should take over this responsibility supported by all other groups involved. Increased and profound economic knowledge and further education within the physicians' professional group supports this concept. Physicians have to realize that in times of limited resources in a heath care system they can't change it and it is finally any state's responsibility to provide the absolute amount of financial resources for health care. Physicians have to accept that they can't cover and fill out the gap between optimal medical care and limited reimbursements but within the given financial frame they can optimize as far as possible. To reach this goal economic information and all related numbers should be available and transparent to all involved especially to oncological case-managing physicians. Horizontal communication in clinics needs to be adjusted and improved between physician, pharmacy, reimbursement, and administration among others. Economic evaluations for studies need to be identical as for clinical care. Support for physicians for analysis of study protocols can come through clinical study centers. This concept allows exceptions from the rule which are necessary but should be reasonably limited to not potentially expand financial losses.

Active and prospective evaluation of all cost aspects for oncological therapies in clinic and studies allows performance of state-of-the-art therapies with minimal identified and quantified risks and financial losses and might even allow to identify gain potential with can be reinvested into patient care. A reduction of pharmaceutical budget over 80% through active physicians' cost management within two years [4] at a German University clinic proved the successful implementation of this concept [2].

References:

[1] Jacobs VR, Kiechle M: Erfahrungen und Konsequenzen von Kostentransparenz durch monatlichen Medikamenten- und Chemoreport an einer Universitätsfrauenklinik im ersten Jahr. [Experience and consequences from cost transparency due to monthly medication and chemo report at a university OB/GYN clinic within its first year.] 26. Jahrestagung der Deutschen Gesellschaft für Senologie (DGS), Dresden 2006. Senologie 2006:3(3):167.

[2] Jacobs VR, Thoedtmann J, Brunner B, Kiechle M: An economic model to reduce the cost of chemotherapy for gynecologic cancer. Int J Fertil Womens Med. 2004 Nov-Dec;49(6):274–7.

[3] Jacobs VR, Thödtmann J, Brunner B, Kiechle M: Modell eines aktiven Kostenmanagements gynäko-onkologischer Therapien zur Reduktion der Medikamentenkosten um 58.7% innerhalb eines Jahres. [Model of an active cost management of gyneco-oncological therapies for reduction of medication costs by 58.7% within one year.] Geburtshilfe Frauenheilkd 2005;65(1):46–55.

[4] Jacobs VR, Thoedtmann J, Euler U, Paepke S, Fischer T, Harbeck N, Kiechle M: Physician-based active cost management of oncological therapies reducing pharmaceutical costs by 83.4% in two years without leaving standard of care. Onkologie. 2005 Aug;28(8–9):441–5.

[5] Jacobs VR: Current Status of Financing and Reimbursement of Herceptin (Trastuzumab) for Adjuvant and Advanced Therapy of Breast Cancer in Germany. Breast Care 2006;1(2):86–94.

[6] Jacobs VR: Das aktuelle Bundessozialgerichtsurteil zur Studienfinanzierung: Onkologische Studien in Deutschland vor dem finanziellen Ende? [The recent decision of the German Federal Social Court regarding funding of studies: will oncological studies in Germany be terminated for financial reasons?] Onkologie 2004;27(6):589–590.

[7] Bredenkamp R, Egert S, Jacobs VR: Modernes Studienmanagement und Wirtschaftliche Durchführung von klinischen Studien aus Sicht der Universitäts-/Frauenklinik. [Modern Study Management and economic performance of clinical studies from the university & OB/GYN clinic perspective.] In: Harbeck N (Edit.): Das frühe Mammakarzinom. [Early Breast Cancer.] Uni-Med Verlag, Bremen 2008 (in print).