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The Selection Process for Oral Chemotherapeutic Agents for a Formulary

Khilna Patel, PharmD BCOP
Clinical Pharmacy Manager, Hematology/Oncology
NewYork-Presbyterian Hospital/Columbia University Medical Center
New York, NY

Sapna Parmar, PharmD BCOP
Clinical Pharmacy Manager, Stem Cell Transplantation
NewYork-Presbyterian Hospital/Columbia University Medical Center
New York, NY

Since its development in the 1950s, the formulary has advanced beyond being a simple list of medications. Today the formulary may be more accurately described as a frequently updated list of medications and related information representing the clinical expertise of a multidisciplinary team. The formulary system, which is intended to guide the safe, appropriate, and cost-effective use of pharmaceuticals in patient care, is an essential tool for institutions.

With the increasing number of cancer diagnoses, an area of particular interest is the accelerating expansion of oral chemotherapeutic agents. In recent years the treatment paradigm has shifted from parenteral to oral cytotoxic or targeted agents for several malignancies. Because of the rising cost of oral antineoplastic agents, healthcare organizations must carefully evaluate the cost-benefit profile of new agents that come on the market. After an oral chemotherapy agent is approved for an institution’s formulary, that hospital or system is responsible for obtaining the agent and keeping it in stock. Fulfilling this responsibility is often cost prohibitive and also impractical—depending on the number of patients on each drug.

It is ultimately the responsibility of the hospital’s Formulary and Therapeutics (F&T) Committee (which may be composed of several subcommittees) to shape the continuously evolving formulary system. Given the complex and multifaceted nature of the decision process, as well as the practical aspects of keeping oral antineoplastic agents on the formulary, a multistep qualitative approach is often required.

At NewYork–Presbyterian Hospital and other institutions, a detailed screening process has been developed to help determine the true need for, or benefit of, adding an agent to the formulary. This process is used for all agents but is particularly important for oral chemotherapy medications.

In our process, a requestor initially completes a questionnaire indicating the purpose of the formulary addition and whether alternatives are available. Methods of use or a treatment protocol must be outlined to determine whether off-label use will occur. Supporting literature should also be included to ensure that safety and efficacy data are evaluated objectively. In addition, the prescriber is encouraged to summarize his or her clinical experience with the requested drug. In order for pharmacoeconomic analyses to be conducted, a projected number of patients anticipated to be treated in a 12-month period and the average duration of therapy should be included. Finally, any conflicts of interest must be noted. The completed form is then submitted to the drug information center to be distributed to the appropriate subcommittee. For example, our institution has a hematology/oncology subcommittee composed of oncologists, clinical pharmacists, and oncology nurses. Typically, the clinical pharmacist is responsible for creating a drug monograph that is presented to the subcommittee. The subcommittee’s decision may influence the final verdict of the F&T Committee.

When a request is submitted, a multitude of factors must be considered in the decision-making process. First and foremost, are similar alternative agents available on the formulary? Is there a novel mechanism of action? Would the agent be additive therapy or a replacement therapy for current regimens? Next, the design of the registrational trial must be carefully evaluated; the potential weaknesses of the study design must be assessed, with attention to whether it included an appropriate comparator arm. How do data on the new medication compare with the historical efficacy and safety data of treatment alternatives, if any? The presenter should be aware of any other potential indications the new medication is being studied for.

Given the rising cost of pharmaceuticals, a pharmacoeconomic analysis should also be incorporated into the decision-making process. However, cost-management initiatives must never compromise the pharmacy department’s ability to provide the best possible care to patients. In addition, a thorough literature search should be conducted, including expert opinion from national guidelines, issue statements, review articles, and any new abstracts; this information may affect the final decision of the F&T Committee.

After a consensus has been reached and the drug has been added to the formulary, a postdecision course must be considered. We recommend making a checklist of tasks covering the logistical aspects. For example, one task would be to ensure that the medication is available from the manufacturer or wholesaler. Subsequently, paper or electronic order sets must be created and vetted through information technology. Existing guidelines or policies may need to be updated as a result of the formulary addition (e.g., the antiemetic policy, the extravasation and infiltration guideline, the chemotherapy spillage policy, the chemotherapy order-writing or order-processing policies). Depending on the complexity of the agent, the creation of a new guideline may be necessary to delineate appropriate prescribing, dispensing, and administration. The appropriate managers, staff members, and healthcare personnel must be notified about the new agent so that a supply can be ordered. Finally, ongoing formulary maintenance such as class reviews and routine drug evaluations is a key element in this process. The F&T Committee needs to regularly review its criteria for use of individual drugs in light of changes made to clinical guidelines and newly approved indications.

Although our model will continue to evolve, the aforementioned steps are now our central consideration when selecting oral cytotoxic or targeted medications to be added to the formulary. It is critical to incorporate the perspectives of all concerned parties (pharmacy staff, nursing staff, and prescribers) to ensure effective and efficient delivery of the medications. Our process is intended to rationalize, standardize, and expedite the assessment of new drugs, and institutions should consider adapting this method.