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Are Clinical Pathways Expanding Beyond Oncology?

By Barbara Kowalski and Edlaine Riodin

In oncology, clinical pathways—recommendations of specific treatments for a specified group of patients—have long been used to help control costs and treatment variation while improving outcomes. Clinical pathways may be payer-driven or provider-driven based on the organization that develops and controls the pathways, and financial incentives and policing mechanisms encourage provider buy-in and adherence.

While clinical pathways are used mainly in oncology, we’re starting to see them in non-oncology treatment settings. Children’s Hospital of Philadelphia (CHOP) has adopted clinical pathways for the treatment of dozens of non-oncology indications such as asthma, atopic dermatitis and sepsis. CHOP’s goal is to incorporate an evidence-based approach to treatment to standardize high-quality care. Clinical pathways have also been adopted in immunology including Crohn’s disease, psoriasis and gastroenterology for which several high-cost therapies are FDA-approved, according to recent data from MMIT and The Dedham Group.

Moreover, we’re seeing that decision-makers at integrated delivery networks (IDNs) are increasingly looking at other therapeutic areas that may benefit from management through a pathway. While these decision-makers account for multiple factors when considering adoption of a clinical pathway, the main driver is financial. Organizations routinely monitor pharmaceutical areas of highest cost and evaluate data from contracted health plans to identify areas that may benefit from a pathway. By implementing a pathway for a specific therapeutic area, hospitals can streamline utilization across the health system and leverage bargaining power for better pricing. Pathways can also help streamline inventory management and allow for electronic medical record standardization. When developing a pathway, IDN decision-makers also consider treatment guidelines established by professional organizations and staff comfort and competency with the pathway agents of choice.

MMIT recently posed a series of questions on pathway utilization to a group of IDN directors of pharmacy through our market access community message board. Eighty percent of respondents reported having adopted or being in the process of developing clinical pathways for various non-oncology indications including rheumatology, venous thromboembolism prophylaxis, blood borne pathogen exposure, asthma, COVID, pulmonary embolism, diabetes and heart failure. This trend in clinical pathway adoption for non-oncology indications was also validated by the provider participants who reported adoption of clinical pathways in rheumatoid arthritis, Crohn’s disease and psoriasis.

Pathways 101

Products are managed differently on a clinical pathway versus a drug formulary. For instance, a clinical pathway recommends a specific sequence of products within a treatment protocol while a formulary lists covered products that providers can choose from. Moreover, pathways differ from guidelines in that the latter offers providers a set of treatment options (without sequencing) based on the current medical knowledge, including the benefits vs. risks.

Products managed by clinical pathways are designated as either “on pathway” or “off pathway.” Products designated as “on pathway” are included in the recommended options available to providers. Furthermore, pathway positioning of products that are “on pathway” may be:

  • Advantaged whereby its utilization may be broader than its FDA-approved label, and the product may be considered a preferred option vs. competing products
  • Positioned per its FDA-approved label
  • Positioned as more restrictive than its FDA-approved indication​ such as a step through a biosimilar or other competing product(s)

Products designated as “off pathway” are not listed as an option on the pathway and its selection is considered as going “off pathway.” However, physicians still have the ability to prescribe an “off pathway” product on a case-by-case basis with supportive rationale. A pathway adherence rate of 80%​ or greater is typically targeted and may vary by indication. Policing mechanisms such as committee approval​, peer benchmarking,​ and financial incentives and/or penalties​ encourage adherence to pathways. 

Pathways and Payers 

What happens when an IDN pathway isn’t aligned with a patient’s health plan coverage? Our IDN panelists explained that the majority of their pathways do align with the major insurers in their area and deviations are tracked to assure providers use the drug required by the payer. Providers submit a prior authorization before use of the medication and, if denied, the provider is alerted to change the order to an alternate choice on the pathway. In some cases, the health center will try for an exemption, but as one IDN stated, “Unfortunately, the third-party payer drives therapeutic options for a patient.”

Specialty manufacturers should be paying attention to pathways in non-oncology indications as there is a trend toward increasing adoption, particularly in areas where biosimilars and biologics are emerging. Manufacturers will want to ensure their brand is included on leading pathways and positioned favorably for optimal market access. Pre- and post-launch engagement planning should include monitoring of pathways for non-oncology indications. With the increased cost of medications and competition of new medications, we expect that the adoption of non-oncology pathways will continue increase.

To see how MMIT can help you gain insight into clinical pathways in immunology, learn more about our PULSE Analytics solution.

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Barbara Kowalski

Barbara Kowalski

Barbara Kowalski is MMIT’s Senior Director of Market Research.

Edlaine Riodin

Edlaine Riodin is the Market Research Manager at MMIT.

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