Drug Coverage Policies And Clinical Guidelines Alignment: Most Coverage Decisions Include Additional Restrictions

Area of Science:

• Health Services Research
• Pharmaceutical Policy
• Clinical Practice Guidelines

Background:

• Utilization management (UM) criteria significantly impact patient access to specialty drugs.
• The methods health plans use to create UM criteria are not fully understood.
• Understanding the alignment between clinical guidelines and UM criteria is crucial for patient access.

Purpose of the Study:

• To examine the alignment between clinical practice guidelines and utilization management criteria set by health plans for specialty drugs.
• To assess how consistently health plans adhere to guideline recommendations when establishing coverage policies.

Main Methods:

• Reviewed 389 drug-indication pairs from US-based clinical practice guidelines (excluding oncology and biosimilars) using the Tufts Medicine Specialty Drug Evidence and Coverage Database (December 2023).
• Categorized guidelines based on whether they recommended UM, considering alignment with FDA label information (line of therapy, clinical requirements).
• Analyzed 5,699 coverage policies from 18 large commercial health plans.

Main Results:

• Most health plans (61%) imposed UM criteria on drug coverage decisions.
• When guidelines recommended UM, 67% of plans' coverage decisions aligned.
• When guidelines did not recommend UM, only 37% of plans' decisions were consistent, indicating weak overall alignment.

Conclusions:

• There is a notable inconsistency between health plan UM criteria and clinical practice guideline recommendations.
• Health plans are more likely to align with guidelines when UM is recommended, but overall alignment remains weak.
• This misalignment may create barriers for patients accessing appropriate specialty drug therapies.