Working to Keep the Lights On in the Era of High-Cost Antineoplastic Treatment: Strategies for Managing Inpatient Drug Administration

Zahra Mahmoudjafari, PharmD BCOP DPLA
Clinical Pharmacy Manager—Hematology, Bone Marrow Transplant, Cellular Therapeutics
University of Kansas Health System
Kansas City, KS

The cost of cancer care has never been higher, and as the U.S. Food and Drug Administration (FDA) continues to approve new drugs, those costs climb higher still. Between August 2018 and July 2019, the FDA approved 17 new antineoplastic therapies.¹ The costs associated with adult cancer treatment in the United States continue to be significant, totaling approximately $87.2 billion in 2012.² New targeted antineoplastic agents are priced at $6,000–$12,000 per month, or approximately $70,000–$140,000 annually, with immunotherapy costs even higher.³ Drug acquisition costs are the biggest source of spending in the pharmacy department and can account for approximately 80% of the total budget.⁴ Under a diagnosis-related group payment structure and with these new approvals, total inpatient drug spending is increasing and contributing to rising total hospital expenditures. Independent of the increasing cost of treatment, institutions are working with higher operating costs and changing reimbursement models while also being challenged to provide high-quality, consistent patient care at the lowest possible expense.⁵

Given these staggering statistics, it is imperative to implement cost-saving strategies, maximize reimbursement through use of drug discounts (i.e., federal 340B outpatient drug discount pricing) and avoid diagnosis-related group inpatient reimbursement.⁶ The American Society of Health-System Pharmacists has recommended guidelines for medication management strategies that cover three areas:⁷ pharmacy-directed activities, such as purchasing, inventory management, and waste reduction interdisciplinary activities reimbursement and charging strategies.

A survey of 281 cancer institutions confirmed that one strategy includes administering antineoplastic treatment in the outpatient clinic setting. A growing number of published articles on the implementation of such changes by single institutions document the achievement of remarkable cost savings. One study described the implementation of a policy limiting inpatient administration of antineoplastic medication that resulted in decreased numbers of inpatient admissions and associated drug cost savings of approximately $160,000 annually.⁸ Another report demonstrated drug cost savings of nearly $2 million and a cumulative cost savings for a health system of approximately $3.3 million in a 2-year period.⁹ Shifting the administration of these agents to the outpatient setting benefits both the treating institution and the patient because of pricing structures.

Another cost-saving strategy includes the use of Pharmacy and Therapeutics (P&T) committees to restrict medication usage to specific areas of administration, specialties, or patient populations. One report described the development of a standardized review process with a request form for the use of outpatient-restricted medications.¹⁰ Another institution developed a High-Cost Medication Review Committee, describing a standard process for inpatient high-cost medication approval. This committee was composed of a multidisciplinary team that reviewed inpatient requests based on clinical efficacy and appropriateness, with an expectation that a decision is made within 48 hours. Through the establishment of the review committee, the institution reported a cost savings of approximately $490,000 annually.¹¹

At our institution, we have implemented a number of these strategies. For example, we routinely transition our chemotherapy regimens to the outpatient setting. Complex hematologic regimens such as R-ICE, R-EPOCH, HyperCVAD, and HIDAC are routinely administered in the outpatient setting. We consistently administer both autologous and allogeneic preparative regimens in the outpatient setting. Our approach has been successful because we have clear guidelines for patients who are receiving outpatient administration, including adequate patient caregiver support, requirements for proximity to the outpatient infusion center, and a triage line that is available for questions and support. Our outpatient infusion clinic is open 7 days a week and is open until 7 pm on weekdays and 2 pm on weekends. We also use tools such as ambulatory infusion pumps and have in place policies regarding approved line access for outpatient administration of chemotherapy via an ambulatory pump.

Formulary management is a key element to our cost-containing strategy. Our Hematology/Oncology/Bone Marrow Transplant (H/O/BMT) P&T Subcommittee, a multidisciplinary team with hematologists and oncologists serving as voting members, reviews all new drug approvals for clinical efficacy while also evaluating them for cost. Our formulary categorizations include addition to formulary without restriction addition to formulary with restrictions nonformulary not stocked nonformulary not allowed.

This formulary status is reflected in our electronic medical record for medications that are restricted to use in the outpatient setting; a best-practice advisory alert appears upon the entry of outpatient restricted medications. When a medication has been categorized as high cost or restricted to outpatients, we note this on the maintained list that is readily accessible to our team.

If a medication that is restricted to outpatient administration is requested in the inpatient setting, our clinical pharmacist enters the request through an electronic High-Cost Log. Information required in the request includes indication, literature supporting use, potential alternative therapies, and the reason for inpatient administration. This log electronically notifies the cancer care leadership team of the request. The administrator then sends a request, including information about the patient’s case and supporting literature, to the H/O/BMT P&T Subcommittee for a vote within 48 hours. If the request is approved by the subcommittee, the administrator approves the electronic log request, thereby notifying our supply chain team to order the medication. After the medication has been ordered, the supply chain team updates the electronic request, and this is communicated to the clinical team pharmacist. This log must be used each time a dose is requested. If the request is denied, the requesting provider is notified, and the patient does not receive the requested medication as an inpatient. This log was initiated in January 2019 and has been used to process 228 requests in the first 11 months following its initiation. The log has also been instrumental in tracking trends and has resulted in the creation of an approved utilization policy for rituximab. In addition, this approach allows our purchasing team to maintain the minimum amount of stock of these high-cost therapies, making us good stewards of the pharmacy budget.

Engagement of our physician colleagues through our H/O/BMT P&T Subcommittee has been essential to our success. By using evidence-based studies and drug assessment data to review each new medication, we define our utilization up front. We routinely report back and discuss methods for cost reduction, supported by evidence-based research, to propose changes. We also identify physician champions for specific initiatives. Despite these electronic standardizations, the success of our high-cost management program is owed in large part to the activities of our clinical pharmacy team. Their active daily involvement and enforcement of the guidelines has been crucial to the success of these efforts.

By using the outpatient administration process outlined above, formulary management, technological tools, and partnership with the multidisciplinary team, we minimize cost to the institution while continuing to deliver consistent and high-quality patient care. Each of these strategies, if implemented, can be helpful to other institutions seeking to minimize their overall inpatient drug costs.

References

1. American Association for Cancer Research. AACR Cancer Progress Report 2019. Available at https://www.cancerprogressreport.org/Documents/AACR_CPR_2019.pdf. Accessed November 27, 2019.
2. Soni A. Top five most costly conditions among adults age 18 and older, 2012: estimates for the U.S. civilian non-institutionalized population. Statistical Brief #471. Agency for Healthcare Research and Quality. April 2015. Available at www.meps.ahrq.gov/mepsweb/data_files/publications/st471/stat471.pdf. Accessed November 27, 2019.
3. Kantarjian HM, Fojo T, Mathisen M, Zwelling LA. Cancer drugs in the United States: justum pretium—the just price. J Clin Oncol. 2013;31:3600-3604.
4. NORC at the University of Chicago. Trends in hospital inpatient drug costs: issues and challenges. Final report. October 11, 2016. Available at www.aha.org/content/16/aha-fah-rx-report.pdf. Accessed November 27, 2019.
5. Barr TR, Towle EL. Oncology practice trends from the National Practice Benchmark. J Oncol Pract. 2014;10:407-410.
6. Warren A, Shankar A. Oncology transactions and the 340B drug pricing program. J Oncol Pract. 2013;9:89–91.
7. ASHP Expert Panel on Medication Cost Management. ASHP guidelines on medication cost management strategies for hospitals and health systems. Am J Health-Syst Pharm. 2008;65:1368-1384.
8. Foster AE, Reeves DJ. Inpatient antineoplastic medication administration and associated drug costs: Institution of a hospital policy limiting inpatient administration. P T. 2017;42:388-393.
9. McBride A, Campen CJ, Camamo J, et al. Implementation of a pharmacy-managed program for the transition of chemotherapy to the outpatient setting. Am J Health Syst Pharm. 2018;75:e246-e258.
10. Lau KM, Derry K, Dalton A, Martino J. Outcomes of inpatient administration of restricted antineoplastic medications at a large academic medical institution. P T. 2019;44:481-485.
11. Durvasula R, Kelly J, Schleyer A, Anawalt BD, Somani S, Dellit TH. Standardized review and approval process for high-cost medication use promotes value-based care in a large academic medical system. Am Health Drug Benefits. 2018;11:65-73.