Any company marketing a drug in the United States knows the drill: good access depends on preferred formulary placement and avoiding onerous prior authorization and step therapy rules. Now, there’s a new force to contend with- one that can become friend or foe in the pathway to access and reimbursement, particularly for oncology drugs- clinical pathways. U.S. healthcare payers who struggle with balancing access to innovative, lifesaving cancer therapies against the need to control the rising costs of oncology treatment are increasingly turning to clinical pathways as an extra lever of control over drug costs and utilization. Clinical pathways are evidence-based, detailed protocols of treatment that specify acceptable drugs, dosing levels, and the schedule of administration based on the stage and state of the patient’s disease.

Managed care organizations (MCOs) with clinical pathways often provide incentives to encourage physicians to follow their desired protocols. Oncology practices have adopted these protocols, frequently tying compliance to oncologists’ performance reviews. The American Society of Clinical Oncology’s (ASCO’s) State of Cancer in America report in 2017 noted a 42% increase in practices reporting compliance with a pathways program from 2014 to 2016. This approach has become particularly prevalent in breast cancer with an anticipated 260,000 newly-diagnosed incident cases in the U.S. in 2019 and a rising number of treatment options. Of 93 pharmacy and medical directors initially surveyed in January 2019 by Decision Resources Group (DRG), 97% reported that their MCOs had a clinical pathway program for breast cancer (65%) or would have one in 2020 (32%). Additionally, out of 101 oncologists surveyed by DRG, 69% reported participating in a clinical pathways program for breast cancer- 47% follow one or more MCO pathways and 83% reported that their oncology practices have implemented a breast cancer pathway.

Clinical Pathways Go Beyond the Clinical

Clinical pathway programs build upon clinical guidelines developed by professional organizations but go a step further by seeking to standardize care and cut unnecessary costs. In short, when two therapies have similar efficacy and safety, payers’ pathways will favor the lower-cost option.

DRG’s primary market research suggests the strategy is paying off for payers. Sixty-seven percent of twenty-seven MCOs with breast cancer pathways represented in the final survey reported that these programs improved patient outcomes, while 52% indicated that pathways reduced their spending on breast cancer drugs and increased the use of preferred agents.

A majority surveyed MCOs and oncologists using clinical pathways reported having such pathways for all three breast cancer subtypes with 70% or more pathways applying to endocrine-based HR-positive/HER2-positive and HR-positive/HER2-negative cancers, but pathways are also common for triple-negative disease, for which new targeted therapies are now available. While treatment of HER2-positive disease is largely established, with Herceptin-based therapy accepted as a standard of care, treatment of HR-positive/HER2-negative disease is more fragmented, particularly with the introduction of three CDK4/6 inhibitors. Ibrance, Kisqali, and Verzenio, alongside the traditional hormonal agents and chemotherapy. By using pathways, MCOs can further promote preferred, lower-cost options when therapies have similar efficacy.

The Pathway to Access Isn’t Always Clear

Despite their significant effect on treatment, particularly for oncology, pathways vary greatly by the organizations that promote them and pathway details are rarely shared with the public. However, Anthem, one of the nation’s largest insurers, has been upfront and public about its Anthem Cancer Care Quality Program ( Other prominent developers of clinical pathways include Cardinal Health P4 Pathways, Eviti, eviCore, New Century Health, NCCN (Value Pathways), and Via Oncology. DRG research suggests that rather than rely on third parties, many MCOs and oncology practices develop their own programs separately, but also sometimes in collaboration with each other.

Pharmaceutical companies may find there is little they can do to directly influence pathways. However, they can increase their chances that their products will be supported in pathways by following many of the same principles that drive formulary placement and prescribing. First and foremost, a drug must meet the efficacy and safety test. Factors such as progression-free survival, overall survival, and objective response rate are highly rated determinants of pathway placement, particularly for oncology practice-sponsored programs. Not surprisingly, the National Comprehensive Cancer Network (NCCN) and ASCO are key stakeholders of influence in oncology practice pathways, outside of the practice’s own internal panel of oncologists.

In addition to their own practices’ pathways, many oncologists must consider multiple pathways by the various MCOs that insure their patients. When a conflict exists between their practices’ pathway and their patients’ insurance company, many oncologists will defer to the MCO pathway, thus making it critical that drug companies be attuned to payers’ needs. Not surprisingly, payers are cost-conscious in their clinical pathway creation. Surveyed MCO directors suggest that the cost-effectiveness of a therapy has more of an influence on pathway inclusion and position than the actual price itself. Among the most common sources of data influencing therapies’ inclusion in pathways is real-world outcomes, suggesting payers are looking beyond clinical trials to see actual positive outcomes in their own membership.

As the pipeline brings new therapies to the competitive breast cancer market, the clinical pathway will take on a heightened role in a therapy’s ultimate market success. The products best positioned to thrive in this new world will offer superior efficacy to existing alternatives at a competitive price or at least a showing that the price is justified by the long-term positive outcomes.

Learn more about the market access environment in the U.S. from our Access & Reimbursement detailed, expanded analysis solution.

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