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Real-Time Rationing of Scarce Resources: The Northeast Proton Therapy Center Experience

From the Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA

Address reprint requests to Reshma Jagsi, MD, DPhil, Massachusetts General Hospital, Department of Radiation Oncology, Cox 3, 100 Blossom St, Boston, MA 02114; e-mail: rjagsi{at}partners.org

The telephone line is silent. I have just delivered the news to an anxious mother whom I will never meet. We will not be able to offer her 3- year-old son, who recently underwent resection of a posterior fossa ependymoma, a treatment slot at the Northeast Proton Therapy Center in Boston, MA. Postoperative radiation is the standard of care for her son's disease, and radiating with protons might reduce the late effects of treatment to her young son's brain. Yet in light of the other patients competing for the scarce proton treatment slots, we must recommend that she pursue treatment for her son elsewhere, as we will not have an open slot in time. Because proton therapy is only available at our center and one in California, her son will most likely end up receiving conformal photon therapy, with a higher integral dose to the normal brain. "How can this be?" she asks. "Why can't my son get the treatment we feel would be best? We're in America."

Introduction
Since the Massachusetts General Hospital (MGH) opened the Northeast Proton Therapy Center (NPTC), long-distance consultations—and often such heartbreaking calls to turn away patients—are becoming increasingly common. Proton beams differ from the photon beams more commonly used by having a limited and controllable range, beyond which they do not deposit radiation dose.¹ This allows for more precisely targeted, conformal treatment plans than those possible with other techniques. As a result, protons may allow two potential benefits. First, protons may permit radiation dose escalation, thereby potentially improving tumor control and cure. Second, protons allow decreased radiation doses to selected normal tissues, thereby potentially decreasing the side effects of treatment. Because of the potential for an improved therapeutic ratio with protons, considerable interest has developed in this technique. Two proton centers are operational in the United States, and several others are in the process of planning and construction.

MGH physicians have used proton beams to treat cancer patients since 1974. Initially, patients were treated at the Harvard Cyclotron Laboratory (Cambridge, MA), originally constructed for research in physics and adapted only later for therapeutic use. The Harvard Cyclotron Laboratory was supplanted in 2001 by the specially designed NPTC, where over 500 patients have been treated to date.

With the construction of the NPTC, interest has spread throughout the oncology community regarding proton therapy. Patients from around the world have sought consultation for possible proton treatment. Yet only a limited number of treatment slots have been available. For the first year of operation, only one rotational and one fixed beam were functioning, and the center could accommodate only 25 patients per day. With the opening of a second gantry, this is expected to increase to over 50 patients per day. Nevertheless, demand for these limited slots is high, and the department has been forced to confront the difficult issues of resource allocation directly.

In this article, the system of priority-setting used at the NPTC will be placed in the context of the ethical literature on resource allocation, in order to provide a deeper understanding of the complex issues involved not only in this case, but also in the myriad of other circumstances in which clinicians are increasingly being called on to make difficult allocation decisions.

Rationing in America
In the face of limited resources and unlimited demand, every society must eventually confront the ethical dilemmas of health care rationing. Rationing often occurs implicitly, via mechanisms such as price, delay, physician discretion, or social barriers to access. Alternatively, it may be guided by explicit policies governing the allocation of scarce resources.^2,3

Implicit rationing has dominated in the United States, and Americans have thus largely been protected from the debates over prioritization that have plagued state-funded systems of health care.^4,5 Aside from the famous Oregon plan,⁶ and situations of extreme scarcity such as organ transplantation, Americans have largely been spared the discomfort that accompanies the realization that sometimes, even those who would benefit from a certain form of health care may not receive it.⁷ Indeed, American physicians⁸ and the American public⁹ have high expectations of the health care system and are likely to be frustrated when faced with situations of scarcity. This raises significant challenges for those who must allocate scarce health care resources.

Proton Slot Allocation
Like those organizations that distribute transplantable organs and allocate Medicaid services in Oregon, the NPTC has devised a formal system by which to allocate its scarce resources. A committee of physicians, nurses, physicists, and administrators within the Department of Radiation Oncology developed a broad system by which the total number of treatment slots were distributed according to disease category. The committee was guided by the hospital and departmental missions of patient care, research, and teaching, as well as by the research mission of the National Cancer Institute, which has provided substantial funding for the NPTC's construction and operations. As such, slots were allocated for sites in which proton therapy had already been shown to be clinically beneficial, such as skull base and cervical spine sarcomas,¹⁰ but were also allocated for other sites in which clinical trials had been designed to assess the potential benefits of proton therapy. The rationale for this approach was the idea that the NPTC, as one of the first such centers in operation in the United States, has an obligation to treat a wide variety of patients so that it may research the role of protons in different malignancies. Only once the relative benefits achieved with protons are more firmly documented in various disease sites can accurate assessments be made regarding which patients would benefit the most from protons.

For an individual patient to obtain one of the slots within his particular disease category, his physician must present his case at "proton rounds." During these meetings, the proton center staff determines whether proton treatment is likely to be beneficial for a presented case and which individual patients should be allocated the next available slots for their particular disease sites. This process was developed with and approved by the hospital ethics committee.

Prioritization: Theoretical Approaches
The extensive literature on rationing includes a number of philosophical approaches. Utilitarian approaches, favored by philosophers Bentham¹¹ and Mill,¹² and applied to the case of rationing by scholars such as Kaplan,¹³ seek to maximize welfare and may rely on cost-effectiveness analyses to determine priorities. Yet utilitarianism is often criticized for focusing on society rather than the individual, and thereby demeaning the dignity of human life.

In contrast, liberal arguments are grounded in Kant's categoric imperative that "one must act to treat every person as an end and never as a means only."¹⁴ At the root of these arguments is a belief that human beings possess an inherent dignity that stems from their capacity for rational thought and freely willed action. This dignity merits respect for its own sake. Such an approach, based on the work of philosophers such as Kant and Rawls,¹⁵ has been applied to resource allocation by a number of ethicists. For example, Hadorn criticizes the way in which utilitarian schemes tend to equate procedures that produce a large benefit to small numbers of individuals with those that produce a small benefit to large numbers of individuals. Instead, he notes the importance of "the rule of rescue," or the perceived duty to save endangered life whenever possible.¹⁶

More recently, scholars have suggested what might be characterized as a communitarian approach, emphasizing the importance of shared values within a culture in determining the moral worth of choices. As Ubel notes, "Many allocation dilemmas have no simple solutions, and highly trained, intellectually rigorous philosophers would completely disagree with each other about the best solution, for example about the extent to which severely ill patients deserve treatment priority. In such situations, the public deserves a role."¹⁷ Indeed, understanding public values may be particularly important when a health care provider is faced with the difficult situation of explaining allocation decisions to a patient.

Prioritization: Public Values
Empirical studies of public preferences regarding prioritization have identified a number of potentially relevant factors.^18–24 Of note, most of these studies were conducted in societies with state-financed health care systems, in which allocation decisions have been more visible than in the United States (with the notable exception of Oregon). There is a great need for further data regarding the values of American society, to inform deliberation such as that which occurs weekly in the NPTC proton rounds, and studies are underway to gather this sort of information.²⁵

The current system of prioritization at the NPTC takes into account several of the factors that have been identified in the international literature as possibly relevant for guiding such decision processes. It is important to note that those who propose consideration of public values in rationing decisions caution that the factors identified in this fashion should be weighed carefully to ensure that they are not "irrational" or "ethically objectionable, as when they reflect discriminatory attitudes."²⁶ Thus, the NPTC currently considers some, but not all, of the factors identified thus far in the literature, as discussed below. Such an approach, based on principles derived from public deliberation, but embracing the flexibility that professional discretion allows, attempts to strike a reasonable balance on the spectrum from fully explicit allocation schemes decided by the public and fully implicit schemes decided by professionals.^27–31

Benefit
The extent to which an individual patient would benefit from proton treatment, as compared to the next best treatment (usually conformal photon treatments such as intensity modulated photon therapy), is a primary consideration in the proton allocation decisions for the slots for any given site. Health economists have proposed sophisticated tools for measuring the benefit of interventions in terms of both duration and quality of life.^32–34 Decisions at the NPTC do not currently utilize a formal QALY (quality adjusted life year)-gained analysis of each case, but investigation is ongoing regarding the feasibility of employing a more rigorous mechanism of assessing potential benefit. The evidence regarding the benefit from proton treatment in many diseases is still being gathered, however, so that quantitating the magnitude of the expected benefit is difficult.

Equity
Health equity is a broad, multifactorial concept that is a central aspect of social justice in the general sense, insofar as health is an essential precondition for the exercise of an individual's autonomy.³⁵ Scholars have offered complex interpretations of health equity, and while concerns about distribution of health care resources are but one aspect of health equity, the equitable distribution of benefit from health care is nevertheless an important consideration.³⁶

Concerns about equity appear to resonate with those making the allocation decisions at the NPTC, and equity concerns are the basis on which other potential considerations (discussed in the following sections), such as personal responsibility and contribution to society, are rejected. Equity is also the general basis on which consideration is given, not only to the marginal benefit afforded by protons over the next best available treatment, but also to the absolute outcome that results from the next best available treatment—which may be a separate indication of need—analogous to the "no-treatment profile" that has been found important in several empirical studies.^37,38

Age
The literature on health care rationing is replete with debates over considering age as an independent criterion in resource allocation.^39–42 Philosophical arguments include utilitarian arguments based on productivity, Daniels' "life-time perspective" interpretation of Rawls' original position,⁴³ Callahan's concept of a "natural life span,"^44,45 and Williams' concept of "fair innings."⁴⁶ Yet each of these arguments has been criticized.^47–49

A complicating factor is the fact that age often correlates with expected benefit, and this is particularly true in the case of proton therapy. One of the main benefits of protons is the ability to spare normal tissues from radiation dose, thereby decreasing the long-term side effects and risks of radiation-induced malignancy. These side effects are greatest in pediatric patients, whose organs are still growing. Furthermore, these effects are deemed "late effects" because they take years to develop. Thus, elderly patients who may expire of comorbid conditions before they develop late effects are less likely to benefit from protons.

Age, per se, has generally not been considered when making allocation decisions within a particular disease site at the NPTC, except insofar as it might correlate with benefit. Pediatric patients are accorded some degree of preference, and the proportion of slots allocated to pediatric patients is greater than the proportion that pediatric patients constitute among all cancer patients, as well as greater than the proportion they constitute of patients seen at the MGH. This is generally justified by reference to the greater benefit expected in this population, however.

Virtue or Contribution to Society
It has been suggested that individuals who contribute to society or lead virtuous lives, such as renowned researchers, might be given preference.⁵⁰ In contrast, individuals such as prisoners,⁵¹ might be accorded lesser preference. This may be justified as maximizing the overall societal gain from treatment, or as a reward for virtue. This sort of argument has also been made to justify prioritizing parents of young children or those caring for elderly relatives.^52–54

Yet the idea that one should judge the relative worth of individuals is one of the most criticized aspects of pure utilitarian theory. Furthermore, other studies have shown that many members of the public value equity as an independent criterion, as discussed above. The dangers of considering the relative worth of individuals are clear, and those making allocation decisions at the NPTC generally do not utilize this criterion. It appears to be exactly the sort of ethically objectionable criterion that proponents of incorporating societal value preferences warn about.

Still, there is one aspect of the allocation decisions that does reflect this sort of thinking: the priority that is accorded to patients eligible and willing to participate in research protocols. By contributing to research, it is felt that the benefit from treating the patient extends beyond the individual, to all of society. In this case only, the potential contribution to society is considered.

Personal Responsibility
Certain studies have also indicated that the public prefers to allocate resources to individuals who are not deemed morally responsible for having caused their disease.⁵⁵ Thus, smokers and heavy alcohol users might be denied priority because their lifestyle choices may have contributed to their acquisition of the disease for which they are being treated.^56,57 Yet the literature on health behaviors and addictions indicates that smoking and drinking are far from pure acts of free will. Indeed, by preferring those who do not smoke or drink, we may unwittingly punish those who have lived their lives on the least advantaged side of an uneven playing field. Thus, lifestyle is generally not considered in the NPTC allocation decisions, except when ongoing behavior is expected to compromise the benefit afforded by treatment.

Ability to Pay
One of the most difficult dilemmas that those making allocation decisions face is the fact that the NPTC functions within the broader American health care system, in which a large number of individuals are uninsured. In order for the NPTC to remain financially viable, it must cover its operating expenses. Therefore, at least a majority of the patients treated must have some ability to pay, either personally or through insurance. The MGH does participate in a free care pool, and free care has been provided to some patients for proton treatment. In situations in which protons are felt to offer significant advantages in patients without the means to pay for treatment, the decision to offer free care is made in conjunction with the Department Chief and hospital's Chief Medical Officer. Hence, ability to pay does play some role in influencing which patients are offered proton treatment, just as it influences access to many other forms of medical treatment in this country. As ethically troubling as this may be, without a broader change in the US health care system, it is impossible for the NPTC to operate in any other fashion.

Other Factors
Occasional patients with low-grade malignancies or who require chemotherapy before radiation may be placed on a waiting list, and for these patients, time spent waiting is considered. The NPTC also accords some degree of preference to individuals from the Boston area, out of a sense of obligation to serve the community within which the MGH operates, although considerations of benefit and equity are the primary factors influencing allocation decisions.

Significance
In conclusion, the NPTC experience provides a concrete case in which the theoretical arguments regarding health care resource allocation are actively being applied. The ethical dilemmas and issues of patient communication raised by the case of the NPTC are relevant to all caregivers who must allocate scarce resources, whether they are novel technologies, such as proton treatment, or other treatments for which demand exceeds supply, such as investigational chemotherapeutic agents.

The issue of health care rationing has recently received increased attention from the media, the pharmaceutical industry, and scholars alike.^58,59 As new technologies continue to proliferate, and as the elderly—particularly the oldest members of this group—increase in number, health care costs will continue to increase, and the issue of health care rationing will inevitably rise to the political agenda. Rationing will be necessary not because of intrinsic scarcity, as in the case of the NPTC, but because of the extrinsic scarcity that results from society's desire to allocate resources to sectors of the economy other than health care. The time to debate the ethical merits of various rationing approaches is now, before a crisis atmosphere prevents careful reflection and moral deliberation. Health care professionals, ethicists, economists, and the public must work together to create morally acceptable and practically applicable systems within which these difficult choices are made. Concrete cases such as the NPTC are important in their own right, as well as to help focus thinking about such issues.

Authors' Disclosures of Potential Conflicts of Interest

The authors indicated no potential conflicts of interest.

NOTES

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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Submitted October 10, 2003; accepted November 17, 2003.

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