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Evidence-Based Oncology February 2016

Evolving Practices in Managing Costly Immunotherapy

Carina Verdier Dolan, PharmD, BCOP
To address the nationwide concern of costly immunotherapy agents, this article features health system inpatient and outpatient strategies that can help mitigate their costs.
Inpatient Practices for Mitigating the Cost of Immunotherapy

It is not unusual for physicians to request a continuation of medication that the patient is receiving, on an outpatient basis, while that patient is admitted to the hospital. Moreover, when a cancer patient is admitted to the hospital for emergency care, new treatment options can be prescribed and administered as a matter of convenience. However, some medications require administration inside a hospital to ensure close monitoring by healthcare professionals. Without a proactive and comprehensive approach to medication management via P&T formulary policies, pharmacists will be hard-pressed to balance true patient considerations with the economic consequences of medication administration outside of the most cost-effective setting.
Expert Committees to Oversee Approval of Drug Use

To assist in the system-wide organization and coordination of policies and procedures, designated committees, involving key stakeholders and experts within the institution, must be created to facilitate the approval of processes surrounding these expensive items.
1. High Drug Cost Committee
This multidisciplinary committee is formed in alliance with the P&T committee to evaluate medications that cost the healthcare system a large amount of money. The committee should include physicians, pharmacists, finance or reimbursement specialists, and administrator champions to set policies and procedures documenting which marketed drugs will be evaluated using a scoring system to grade each medication, including available clinical data and pricing information. Additional factors, such as limited distribution channels and specialty pharmacy should also be considered. Each evaluation will determine the medications that will be allowed to be administered in-house as compared with those restricted to outpatient use only. It is important to remember that there remains no universal definition of a “high cost” drug. Rather, each organization must define the threshold above which this additional level of scrutiny will be applied.
2. Off-label Use Committee
Frequently, medications are studied in supplemental disease states beyond the conditions for which they were initially approved. The Off-label Use Committee is designed to approve the use of medications for an off-label indication. The team can be comprised of prominent chief medical officers and high-ranking pharmacy administrators, including a drug information officer. Physicians who submit an application for off-label administration should also be required to provide evidence-based proof of therapeutic validity. A decision on the submission-for-use should be reported to the applicant within 48 hours to provide real-time support and feedback.
3. Oncology Subcommittee
As a division of the formal P&T Committee, the oncology subcommittee includes lead oncology physicians and pharmacists throughout the healthcare system. This group convenes to discuss the clinical and operational aspects of oncolytics and supportive care medications used to treat cancer. They can make recommendations on agents to be added to the formulary or non-formulary, as well as participate in quality assurance, informatics, and therapeutic equivalence activity. Given the anticipated product pipeline, this group could help lead an organization’s initial level of understanding and familiarity with the biosimilar pipeline.  
Outpatient Practices for Mitigating the Cost of Immunotherapy

In contrast to the inpatient diagnosis-related group codes for the purposes of hospital payment, the primary mechanism in ambulatory settings for authorization of drug regimens is the approval by a patient’s insurance company. Multiple services can be used to ensure accurate payment for drugs and to improve the overall fiscal responsibility of an infusion clinic (Figure 2).

1. Insurance Approval
Receiving prior authorization on a patient’s medications and services, prior to delivery, is an excellent method of verifying reimbursement for the patient. Employment of a billing specialist, with support provided by a pharmacist or pharmacy technician, can capture drug payments and prevent loss of significant revenue to the infusion clinic. While this service may incorporate additional steps, it can provide a preventive measure to ensure maximum allowable compensation.
2. Patient Assistance Programs
Patient assistance programs originated to provide a means to supply medications to patients with low income, a lack of health insurance, or a gap in prescription plan coverage. These programs are often funded by drug manufacturers and require the patient to meet an eligibility criterion to be accepted in the program. This avenue can provide auxiliary medications to the pharmacy that would have otherwise been a cost to the pharmacy budget. Participating in medication replacement programs are a cost-effective measure for the infusion clinic, and the patients they serve.
3. Medication Billing
Depending on the services and infusions the clinic provides, it may be necessary to adopt a multi-billing system approach to maximize reimbursement. Outpatient account billing is an intricate process of submitting national drug codes with correct billing units and physician services in correlation with documentation. One step during the submission process is accounting for the amount of drug used for treatment. During the compounding process of intravenous medications, it may be necessary to dispose of a portion of unused drug. Insurance providers may allow for compensation of this remaining portion. It is important to have regular discussions with the finance department with regards to multi-billing approaches, including but not limited to, appropriateness of billing for waste, previously rejected claims, and updated code and billing unit information.

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