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The American Journal of Managed Care March 2018
False-Positive Mammography and Its Association With Health Service Use
Christine M. Gunn, PhD; Barbara Bokhour, PhD; Tracy A. Battaglia, MD, MPH; Rebecca A. Silliman, MD, PhD; and Amresh Hanchate, PhD
Incorporating Value Into Physician Payment and Patient Cost Sharing
Zirui Song, MD, PhD; Amol S. Navathe, MD, PhD; Ezekiel J. Emanuel, MD, PhD; and Kevin G. Volpp, MD, PhD
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Development and Implementation of an Academic Cancer Therapy Stewardship Program
Amir S. Steinberg, MD; Anish B. Parikh, MD; Sara Kim, PharmD; Damaris Peralta-Hernandez, RPh; Talaat Aggour, BPharm; and Luis Isola, MD
Patients Discharged From the Emergency Department After Referral for Hospitalist Admission
Christopher A. Caulfield, MD; John Stephens, MD; Zarina Sharalaya, MD; Jeffrey P. Laux, PhD; Carlton Moore, MD, MS; Daniel E. Jonas, MD, MPH; and Edmund A. Liles Jr, MD
Trends in Opioid and Nonsteroidal Anti-Inflammatory Use and Adverse Events
Veronica Fassio, PharmD; Sherrie L. Aspinall, PharmD, MSc; Xinhua Zhao, PhD; Donald R. Miller, ScD; Jasvinder A. Singh, MD, MPH; Chester B. Good, MD, MPH; and Francesca E. Cunningham, PharmD
Ambulatory Care–Sensitive Emergency Visits Among Patients With Medical Home Access
Dina Hafez, MD; Laurence F. McMahon Jr, MD, MPH; Linda Balogh, MD; Floyd John Brinley III, MD; John Crump, MD; Mark Ealovega, MD; Audrey Fan, MD; Yeong Kwok, MD; Kristen Krieger, MD; Thomas O'Connor, MD; Elisa Ostafin, MD; Heidi Reichert, MA; and Jennifer Meddings, MD, MSc
Improving Quality of Care in Oncology Through Healthcare Payment Reform
Lonnie Wen, RPh, PhD; Christine Divers, PhD; Melissa Lingohr-Smith, PhD; Jay Lin, PhD, MBA; and Scott Ramsey, MD, PhD
Assessing Medical Home Mechanisms: Certification, Asthma Education, and Outcomes
Nathan D. Shippee, PhD; Michael Finch, PhD; and Douglas R. Wholey, PhD
Patient-Reported Denials, Appeals, and Complaints: Associations With Overall Plan Ratings
Denise D. Quigley, PhD; Amelia M. Haviland, PhD; Jacob W. Dembosky, MPM; David J. Klein, MS; and Marc N. Elliott, PhD

Development and Implementation of an Academic Cancer Therapy Stewardship Program

Amir S. Steinberg, MD; Anish B. Parikh, MD; Sara Kim, PharmD; Damaris Peralta-Hernandez, RPh; Talaat Aggour, BPharm; and Luis Isola, MD
A cancer therapy stewardship program can be used to improve clinical quality and patient care by emphasizing the importance of value and evidence in oncology.

Objectives: Antibiotic stewardship is an integral aspect of hospital care, limiting the potential for resistance while working to minimize waste. A similar system is needed in oncology, given the rapid proliferation of new therapies and the challenges of navigating a complicated reimbursement environment. A “cancer therapy stewardship program” has never been described in the literature. Here, we detail our efforts to design and implement such a program and share lessons learned to inform future projects.

Study Design and Methods: For 1 year, a hematologist-oncologist (the “cancer therapy steward”) at Mount Sinai Hospital was in charge of addressing all requests for nonformulary or off-label chemotherapeutic and supportive medications and regimens. Requests consisted of the rationale for use and supporting data from medical journal articles. This pilot initiative was focused mainly on inpatient malignant hematology.

Results: Sixty-seven requests were made by 23 physicians, and all requests were ultimately approved. Requests tended to fall into 3 categories: 1) use of a single drug in a setting not approved by the FDA, 2) use of multiple drugs in novel combinations not approved by the FDA, and 3) adding novel drugs to existing FDA-approved regimens.

Conclusions: Our cancer therapy stewardship program yielded many useful insights into how our physicians face challenging clinical situations. It also helped to improve overall clinical quality and patient care by emphasizing the importance of value-based care and evidence-based medicine. Expanding this program will likely lead to many interesting experiments aimed at improving medical education and research, patient safety outcomes, and clinical quality.

Am J Manag Care. 2018;24(3):147-151
Takeaway Points

A cancer therapy stewardship program can be used to improve clinical quality and patient care by emphasizing the importance of value and evidence in oncology.
  • This is the first known description of applying the idea of drug stewardship to oncology.
  • We share several important insights gained and lessons learned, which have real-world implications for healthcare institutions, especially in terms of quality improvement.
  • This research builds a foundation upon which further work in this area may begin, including studies focusing on cost-effectiveness and clinical quality innovation.
  • Benefits realized from this type of work may have broader implications, including at the healthcare policy level.
Antibiotic stewardship programs are an integral part of infectious disease management. Such programs have been shown to reduce resource overutilization, costs, drug resistance, and prescribing errors, thereby improving overall quality and value in healthcare.1-4 A similar program designed to help guide cancer treatment has never been described in the medical literature to date.

Cancer care makes up a sizable portion of US healthcare expenditures, which continue to increase despite recent reforms. According to CMS, total US healthcare spending in 2014 increased 5.3% from the previous year to $3 trillion.5 The cost of cancer care alone, estimated at $125 billion in 2010 and projected to reach $158 billion by 2020, is a significant contributor to this total.6 This issue is garnering more attention from both the healthcare sector and the public, especially as it relates to the soaring costs of cancer drugs.7 Indeed, Kantarjian et al showed that the average price of new antineoplastic agents doubled from 2003 to 2013, rising from $4500/month to more than $10,000/month.8 These price increases have become difficult to justify because a correlation between the cost of a given cancer drug and its relative benefit, as measured by a number of validated parameters, is often lacking.8 Regrettably, a majority of the cost of cancer treatment often eventually falls on patients and their families, resulting in substantial financial burdens.

In response to this situation, discussions about value-based cancer care have become increasingly common. Many leaders in oncology, including the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network, have been very active in these discussions, releasing consensus statements, drafting policy, and leading lobbying efforts. For example, in 2015, ASCO developed its “Conceptual Value Framework,” a tool meant to help physicians and patients assess the value of novel antineoplastic agents based on clinical benefits and potential toxicities, all within the context of cost.9

The concepts of value-based care and cost-consciousness have also become essential to hospitals and health systems as they grapple with the challenges of an evolving reimbursement environment. The importance of these ideas in oncology is illustrated by the rise of the bundled payment and diagnosis-related group systems, which outline reimbursement policies within the context of value and cost. As an example, the setting in which a patient receives cancer treatment usually determines the reimbursement for the institution, with outpatient treatment generally being reimbursed at higher rates. Such policies provide additional incentive for healthcare systems to emphasize outpatient, as opposed to inpatient, cancer care.

Despite the many reasons for preferentially giving cancer therapy in the outpatient setting, circumstances do occasionally arise that require inpatient treatment. Perhaps the most common scenario is when a patient experiences a complication or crisis secondary to cancer progression. We hypothesize that, as with antibiotic stewardship programs, there are significant potential benefits to developing an institutional system to monitor and regulate the use of cancer treatments in all clinical settings. Here, we aim to describe our efforts to design and implement a “cancer therapy stewardship program” at our institution and to share lessons learned in order to inform future work in this new and evolving area.


Mount Sinai Hospital is a major tertiary care teaching facility and regional referral center with 1171 inpatient beds and National Cancer Institute designation. There are 2 committees in place to work with physicians who treat cancer. The Oncology Pharmacy/Therapeutics Subcommittee reviews requests from providers for the hospital to add certain oncology-related medications to the hospital formulary. The Chemotherapy Council evaluates various cancer treatment regimens and decides whether or not they should be built into our computer-based chemotherapy ordering system to facilitate their use. Both groups are composed of physicians, nurses, and pharmacists.

We developed this stewardship program after hypothesizing that adding a layer of oversight specifically for the use of nonformulary or off-label cancer therapies and regimens at our institution may help optimize clinical efficiency and value. Although both of the committees described above peripherally address this issue, their main concerns have to do with the system-wide availability of these therapies, both in the formulary and in the electronic ordering system. Due to myriad anecdotal accounts of unofficial nonformulary requests, we decided it was important to also have a way to review the indications for and evidence behind specific requests on a case-by-case basis to ensure appropriateness. The ultimate goal of this initiative was to promote evidence-based practice and to minimize waste and resource overutilization while improving patient outcomes.

We began by performing an exhaustive review of the US National Library of Medicine online database for descriptions of similar projects. We used the keywords chemotherapy, antineoplastic, hematology, and oncology along with the secondary keywords stewardship and control, in all potential combinations. This literature search yielded no results focusing on a stewardship program to help guide and encourage the rational use of evidence-based regimens to treat cancer.

The stewardship pilot program took place at Mount Sinai Hospital from June 30, 2014, to June 30, 2015. Although outpatient requests were included as the need arose, the program focused on the inpatient setting because requests were easier to centralize and track and it was felt that such a program would have a larger and more measurable impact in the hospital, where cancer treatment is more expensive. All physicians who requested medications through this program were on faculty at the attached medical school; no private-practice providers were involved. Inclusion criteria were any requests made for nonformulary and/or off-label cancer therapies that were submitted along with supporting evidence. Exclusion criteria included any drugs that were on formulary and being used for approved indications, as well as those that could only be obtained through restricted specialty pharmacies. Our preliminary findings were presented as an abstract at the 2015 Annual Meeting of the Society of Hematologic Oncology in Houston, Texas.10

A board-certified hematologist-oncologist specializing in hematologic malignancies was designated by the division chair to act as the “steward” and address all requests for use of nonformulary or off-label antineoplastic agents and regimens. All medical staff in the division, including faculty, fellows, and ancillary providers, were directed by the oncology pharmacy to contact the steward by email whenever they attempted to order such medications. The medical team would have to officially submit at least 1 peer-reviewed journal article and their rationale for use to the steward. The steward would then have an academic discussion with the team, as well as with other physicians and pharmacists who made up an informal “stewardship committee,” and then either approve or deny the request. The decision was then communicated via email to supervising oncology pharmacists who would release the drug(s) in question if the request was approved. All requests were collected by the steward over the course of the year in an email folder and then reviewed retrospectively to prepare this report.


Over the course of 1 year, 67 requests for nonformulary or off-label antineoplastic agents/regimens were made and reviewed by the Cancer Therapy Stewardship Program, as detailed in the Table. These requests came from 23 physicians and pertained to 66 patients. Ninety-seven percent of the requests (n = 65) were for inpatients, whereas the remaining 2 requests were for 1 outpatient. The most common context for these requests was progression of disease, which necessitated inpatient stabilization and management. Upon review, these requests tended to fall into 1 of the following categories: 1) use of a drug in a setting not approved by the FDA (eg, using bendamustine for multiple myeloma), 2) use of multiple drugs in novel combinations not approved by the FDA (eg, combining romidepsin and brentuximab for non-Hodgkin lymphoma), and 3) adding novel drugs to existing FDA-approved regimens (eg, adding daratumumab to a carfilzomib-based regimen for multiple myeloma).

The most commonly approved medication was bendamustine (n = 15), either alone or in combination with brentuximab (n = 6), which was the third most commonly requested medication for inpatients. Plerixafor was approved 8 times for inpatients, primarily for stem cell mobilization in patients with amyloidosis. One patient with T-cell lymphoma had multiple requests; he had received bendamustine during an admission for disease progression, then received brentuximab and romidepsin during a second admission for continued progression of disease. The only outpatient requests were nivolumab and granisetron for a patient with progressive Hodgkin lymphoma and uncontrolled nausea who was intolerant of ondansetron. All requests eventually were approved after going through stewardship review.


Our experience with piloting this stewardship program yielded many useful insights. For instance, collecting data on prescribing practices gave our department the ability to systematically review and analyze how our physicians dealt with challenging clinical situations in hematologic oncology. The fact that every request was approved helped demonstrate to department leadership that our physicians are attuned to providing optimal evidence-based care. Furthermore, by focusing on nonformulary or off-label agents and regimens, the program also served to highlight novel and experimental approaches to managing complicated diseases for which standard therapies have failed. The stewardship process facilitated discussions among the treatment teams so that everyone involved could work together to pursue better patient outcomes. By encouraging discussion and collaboration, the program also served to promote evidence-based practice and academic exploration at our institution.

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