Many oncology manufacturers assume that a therapy’s inclusion on clinical pathways is more important than its coverage profile, but this isn’t always true. According to MMIT Pulse Analytics data, roughly 64% of U.S. oncologists are exposed to third-party clinical pathways developed either by an oncology group or a payer. However, a payer or PBM’s medical policies and formulary placement can also have a huge impact on a drug’s utilization.
Patient access can easily be blocked by a misalignment between pathway placement and coverage requirements, without manufacturers realizing the disconnect. Unless these access barriers are identified and resolved, affected patients will be forced to pay out of pocket or appeal to either the payer or the manufacturer for financial assistance. The burden of coordinating treatment should never fall on patients at their most vulnerable point.
Across every oncology class, manufacturers need to know which organizations—IDNs, provider organizations, payers or PBMs—have the biggest positive and/or negative influence on their products’ utilization. Simply tracking clinical pathways and coverage restrictions in isolation is not sufficient. Real-world data (RWD), especially claims data, can reveal a more nuanced picture of how access works in reality. How does the intersection of clinical pathways and coverage policies affect provider prescribing behavior? What about reimbursement after treatment?
Why pathway placement matters
Oncology drugs in the most competitive classes, such as NSCLC and multiple myeloma, are likely to be subject to clinical pathways, which may be either provider- or payer-driven, depending on the developing organization. While pathways are usually based on outcomes data from the National Comprehensive Cancer Network and other respected organizations, they also incorporate cost, biomarkers, and comorbidities.
A drug’s inclusion or omission from clinical pathways is often a key factor in its utilization rates. Typically, an IDN’s clinical pathway is integrated into the electronic medical record (EMR) system physicians use throughout the day. If a manufacturer’s drug is not on the pathway, physicians may be unable to select it as an option for therapy.
While prescribing an off-pathway drug is not prohibited, most pathways use financial incentives and penalties to encourage provider adherence. According to MMIT data, approximately 86% of oncologists who are subject to treatment pathways adhere to them. Off-pathway requests are typically routed through a lengthy committee approval process, which can cause delays for patients in urgent need of treatment.
When pathway/policy misalignment impacts access
Notably, a drug’s inclusion on a clinical pathway does not necessarily mean that payers already cover it, or that medical exceptions will be automatically granted to providers. In some cases, payers and institutions vehemently disagree about what treatment is appropriate. Even if a policy and a pathway are developed by the same payer, they don’t always align, as they’re created by different departments with different intentions.
Many manufacturers presume that physicians conduct a coverage review before prescribing, but this isn’t always the case. The treating physician may not know what the coverage policy dictates, which can create problems when the patient suddenly becomes responsible for the entire cost of treatment. Patients who have been prescribed a non-covered drug as part of their treatment regimen will receive a denial of coverage from their health plan, which in turn creates a patient assistance challenge for manufacturers.
Even when a drug is covered, a payer’s policy might be more restrictive than the drug’s label. As policy terms are rarely reflected in the EMR pathway selection process, physicians must know in advance when to alter the treatment plan to meet a payer’s requirements, such as a step-through therapy or a certain test progression.
What integrated pathway, coverage, lab and claims data reveals
To develop a strong market access strategy, manufacturers need to see the full picture of how access works in practice. By integrating real-world data sets—including lab tests and results, pharmacy and medical claims, and even EMR data—with payer policy and clinical pathway data, manufacturers can conduct their own checks-and-balances review of patients’ treatment journeys.
Oncology manufacturers are accustomed to tracking how specific drugs and combination regimens are listed on IDN and hospital pathways, which are often biomarker-specific. They are also used to closely following payer policy data, which indicates how a drug is covered and reveals all of the utilization management restrictions at play that affect reimbursement.
With the addition of lab data, especially biomarker data, manufacturers can locate and stratify qualifying patients before they are diagnosed and begin treatment. Perhaps most importantly, the integration of medical and pharmacy claims data with these other data sets can reveal the impact that the testing journey, pathway positioning and policy restrictions have on patient access in reality. How and where is access failing, and why?
How to leverage RWD with payers and IDNs
Manufacturers can use their new insights to proactively target the payers and institutions impeding patient access to their therapies. RWD can help manufacturers make a strong case for coverage directly to the payer. If a manufacturer discovers that 40% of qualifying patients with a certain type of cancer are being treated at specialty organizations where their drug is on pathway, they have a better chance of persuading the payer to develop a policy for this sizable patient population.
In some cases, RWD might reveal that a manufacturer’s payer contracting hasn’t resulted in the expected level of access, as a competitor is receiving preference on the pathway at the most common treatment facilities. For example, as the result of a single conversation with a payer, one MMIT client was able to gain .5% overall market share by encouraging tighter pathway/policy alignment—a seemingly insignificant increase that led to a big bump in revenue.
Also, for drugs that are left off of a clinical pathway, integrated RWD can help manufacturers persuade pathway influencers to reconsider their stance. If payers are covering a drug for a significant percentage of the patient population treated by an IDN, it’s only logical to add that drug to the pathway. Depending on the organization’s protocol, manufacturers can either meet with key opinion leaders or submit a formal value proposition with real-world evidence to explain the benefits of their therapy.
In an increasingly complex marketplace, oncology manufacturers need a well-rounded understanding of how pathways and policies function during the treatment journey. Knowing which organizations hold the most power over their critical patient populations is the first step in an effective targeting plan. Real-world data is essential for this task—a key tool in oncology manufacturers’ quest to ensure greater access to life-saving therapies.
To see how IDN-level pathways data can inform your market access strategy, learn more about PULSE Analytics. Hear more about MMIT’s real-world data capabilities on this BioPharma Dive webinar, RWD: Overcoming the Chasm Between Payer Policy and Real-Life Practice.