Common Strategies for Cancer Drug Management

J Clin Pathways. 2024;10(5)12-14.

Clinical pathways currently represent the most prescriptive ap­proach to cancer drug management. They can help standardize treatment selection, reduce variation in care, and improve pa­tient outcomes. However, oncologists’ awareness and adoption of pathways are largely concentrated in highly sophisticated provider organizations, including the most highly integrated integrated delivery networks (IDNs) and centralized commu­nity oncology networks and groups. Formularies and order sets are two more traditional approaches to guiding treatment. They have been widely adopted over the past several decades by both hospitals and community providers. These basic manage­ment strategies address treatments used in nearly all therapeutic areas, but they may have a more immediate impact in oncology, given the rapid evolution of precision medicine and the grow­ing availability of new products and new classes.

• Since 2016, HMP Market Access Insights (MAI) has studied the prevalence of cancer drug management programs, including pathways (added in 2019), in IDNs and community oncology groups.
  • Four hundred and fifty-seven participants in our 2024 provider research program included oncology pharmacists and oncologists representing 147 IDNs and medical oncologists and practice managers representing 124 community oncology practices.
• We also examined pathways’ influence and impact on oncologists’ treatment decisions by conducting a unique two-arm study with 130 oncologists using advanced conjoint analysis in Q4 2023; we have previously shared results in the Journal of Clinical Pathways from that study.^1-4
• This column discusses formularies and order sets, two internal structures and processes that guide oncology treatment selection. They are widely implemented in provider organizations treating patients with cancer but are less prescriptive than pathways.

HMP MAI’s research into the structures and processes for providers’ and payers’ cancer drug management will continue for its ninth year in 2025.

Formularies

Formularies identify all the treatments a provider organiza­tion considers appropriate for treating diseases, including cancers. Formularies are required for IDNs accredited by the Joint Commission and many state regulators; most but not all IDN formularies now include inpatient and outpatient drugs. IDNs will frequently include nearly all US Food and Drug Administration (FDA)-approved cancer drugs for their approved indications and may additionally include off-label indications with National Comprehensive Cancer Network (NCCN) evidence scores of 1, 2A, or, sometimes, 2B. On­cologists seeking to prescribe off-formulary treatments are usually required to provide a rationale and sometimes sup­porting data to pharmacy or medical managers.

Formularies are less prevalent in community settings. Major accrediting organizations including the Commission on Cancer (CoC) and the American Society of Clinical Oncology (ASCO) require that a group have systems in place to ensure that effec­tive therapies are selected, and to monitor appropriate use. For­mularies are typically the first step toward accomplishing these goals and are common among groups affiliated with networks and in many sophisticated but independent groups. Commu­nity group formularies vary in their restrictiveness; prescribing off-formulary may be highly restricted in network-affiliated groups and high control groups but may also be regularly al­lowed subject to payers’ approval in many smaller or less-rigor­ously managed groups.

Order Sets (or Treatment Plans)

Order sets are now deployed via EHRs and replace earlier paper-based tools called “flow charts.” An order set is a tem­plate developed by a small team that may include oncologists, pharmacists, and nurses. The order set identifies key parts of the selected course of treatment, including cycle definitions, therapeutic and supportive care medications used, dosing and scheduling, diagnostic tests, patient monitoring, and some­times patient education requirements.

Order sets are meant to reduce variation in the use of a specific cancer drug or regimen and to save time for providers by offering a readily available reference to treatment planning. They relieve the prescriber and team from having to develop a plan for each patient. While order sets do not explicitly guide treatment selection, many oncologists and oncology pharma­cists see them as useful in reducing variation in selection. Or­der sets may be useful in “nudging” an oncologist toward a preferred treatment in IDNs and groups where order sets are available only for preferred treatments. IDNs increasingly de­velop order sets for all cancer drugs on formulary (Figure 1). In fact, a majority report having order sets for more than two-thirds of their on-formulary drugs in 2024.

Order sets are increasingly comprehensive in IDNs, as 70% of participating IDNs with order sets report having policies to de­velop order sets for all cancer drugs on their formularies. In community groups, order sets are common only in the most sophisticated groups and networks; many groups lack the time or expertise to develop and update order sets, and consequently either rely on either EHR vendors, on third-party sources, or do not consistently develop order sets. Only 25% of our par­ticipating groups reported having an order set in their EHR for more than 2/3 of their on-formulary cancer drugs. This il­luminates a trend in which community reliance upon order sets appears to be declining from 2022, as only 30% of the groups with any order sets reported that oncologists selected a treat­ment with an associated order set in more than 75% of cases. Compared to IDNs, where at 82% of IDNs, oncologists and pharmacists state that they select a treatment with order sets > 75% of cases (Figure 2).

Nearly all IDNs and close to half of community organizations employ formal assessment processes for new cancer drugs. IDNs’ processes tend to be formal and multidisciplinary with several committees engaged in a process that can require two to six months before a new treatment is routinely available in an oncologists’ EHR. Community oncology practices’ approach­es are variable, ranging from formal processes resembling IDNs’ in large networks (eg, The US Oncology Network) to “ad hoc” processes during which oncologists in a group review journal articles and manufacturer-provided data prior to including a new agent in their group’s formulary. Regardless of approach, the importance of assessment criteria is highly similar across settings (Figure 3).

HMP MAI’s oncology provider studies have illuminated key cancer drug management strategies, including pathways and more traditional methods including formularies and order sets. This work compared the prevalence, adoption and assessment criteria between community oncology groups and IDN oncol­ogy service lines.