Managing Rx With Expanded Indications

As prescription drugs gain new FDA-approved uses, pharmacy costs can rise along with that progress. At Excellus BlueCross BlueShield (BCBS), we’re here to help employers navigate these changes with a focus on access, affordability and thoughtful utilization management.

What Are Expanded Indications?

An expanded indication is a medication that was approved for one condition and is later approved to treat additional conditions, age groups, or stages of disease. These approvals can be good news for patients—but they also mean more people may use the drug, which can increase overall costs associated with that specific agent.

That’s why Excellus BCBS closely monitors expanded indications and adjusts utilization management policies when needed. Our goal is to support access while helping manage the impact on premiums and plan costs.

How Excellus BCBS Helps Manage Pharmacy Costs

Excellus takes a proactive, end-to-end approach to managing pharmacy trends. This work begins long before a drug reaches the market and continues as new uses and formulations emerge.

Our approach includes:

1. Monitoring drugs in development and upcoming FDA approvals
2. Reviewing clinical evidence and treatment guidelines
3. Making formulary decisions that balance value and access
4. Using prior authorization to support appropriate use[EM1] 
5. Tracking utilization and costs across all lines of business

This ongoing process helps ensure medications are used safely, effectively, and responsibly.

Where Expanded Indications are Having the Biggest Impact

Inflammatory Conditions: Supporting Care While Managing Growth

Inflammatory conditions include chronic diseases such as rheumatoid arthritis, psoriasis, asthma, and inflammatory bowel disease. These conditions are often treated with specialty medications, many of which continue to gain new FDA-approved uses.

As indications expand, more members may qualify for treatment. This can increase utilization and costs, which is why utilization management plays an important role.

For drugs like Dupixent®, Excellus BCBS regularly reviews approval data, clinical guidance, and market changes. Over time, coverage criteria may be adjusted to reflect real-world use while still managing spend. Without our utilization management measures, expanded indications for Dupixent® could have added an estimated $7.7M in costs, but our strategies delivered $23.6M in savings in 2024 alone.*

This careful balancing act has helped Excellus BCBS support access for members while also generating meaningful savings, demonstrating that affordability and access can go hand in hand.

GLP-1 Medications: Managing Demand with Care

GLP-1 medications were originally used to treat diabetes but have expanded to support weight management. Demand for these drugs has grown quickly as shortages have resolved and new indications are explored.

Several factors are driving increased utilization, including:

• More new starts and ongoing therapy
• Expanded indications under review or in development
• A strong pipeline of new medications

To manage this growth, Excellus BCBS uses utilization management strategies that align with clinical guidelines. These may include prior authorization, formulary placement, and claims safeguards to help prevent duplicate or inappropriate use.

These steps are designed to make sure GLP-1 medications are available for members who need them most—while helping employers manage rising costs.

Oncology: New Uses and New Formulations

Cancer treatments often begin with a small number of approved uses and expand over time. One example is Keytruda®, which was first approved in 2014 for advanced melanoma not removable by surgery and is now used to treat many different types of cancer.

Each new indication means more patients may benefit, but it also increases overall pharmacy and medical costs.

In addition to expanded indications, some cancer drugs are now available in new forms. Certain medications that were once given only through intravenous (IV) infusion are becoming available as subcutaneous (SC) injections.

For example, Keytruda® now has an SC formulation that is still given by a health care professional but takes less time to administer. This can offer added convenience and operational benefits for health systems.

Another example is Itvisma®, a newly approved formulation for spinal muscular atrophy. It expands treatment options to patients age 2 and older, increasing access for families who previously had limited options.

While there are limits on how oncology drugs can be managed due to regulatory requirements, Excellus BCBS continues to look for responsible ways to support access and affordability.

Here to Help—Today and Tomorrow

Expanded indications and new drug formulations are an important part of medical progress. At the same time, they create real cost pressures for health plans and employers.

Excellus BlueCross BlueShield is here to help navigate these changes with care, compassion, and responsibility. Through thoughtful utilization management and ongoing collaboration, we work to support access to needed medications while helping keep coverage affordable for everyone.

Because when care is managed thoughtfully, everybody benefits.

Disclaimer

*2024 Health Plan Data

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