Assay Management & Reporting

Hemophilia Toolkit

Adherence & Assay Management: Assay Management & Reporting


Assay management, an important element of cost containment, requires rigorous oversight and reporting, which should be expected from any dispensing specialty pharmacy. Assay management is the process of filling a prescription as close to the prescribed target dose as possible using one or more available factor replacement vials. Vials come in a range of unit or assay sizes. Factor pricing can vary significantly among dispensing pharmacies for the same medication. Providers write prescriptions based on units per kilogram (U/kg) of patient weight. Tightly monitoring how much factor medication is dispensed through the specialty pharmacy helps an employer reduce waste and better manage costs.

The National Hemophilia Foundation’s Medical Scientific Advisory Council recommends that factor be dispensed within +/- 5% to +/- 10% of the prescribed target dose. Payers and employers can and should require tighter assay management; in most cases, +/- 1% to +/- 2% of the target dose can be achieved.

Prescription Data = Transparency + Cost Control

Prescription data is the actual written prescription that sets the targeted dose to be dispensed. Employers typically do not have access to this data — but they can and should require vendors to collect it.

Why it matters:

  • Confirms the correct number of units dispensed
  • Verifies per unit cost
  • Ensures accurate assay management
  • Reduces over dispensing and waste
  • Provides true transparency into specialty pharmacy performance

Bottom line:
Requiring prescription level data is one of the most effective ways employers can control hemophilia drug spend.

Monitor Dispensing Closely to Reduce Waste

Per‑unit prices vary widely across specialty pharmacies. HTCs, as federally recognized centers, have access to 340B pricing — often resulting in lower average cost per unit.

Tight oversight of dispensing practices helps employers:

  • Prevent unnecessary shipments
  • Reduce waste from incorrect dosing
  • Ensure accurate assay management
  • Avoid avoidable high‑cost claims

The National Bleeding Disorders Foundation can support employers with retrospective analyses to identify waste and improve dosing accuracy.

While substitution therapy is not subject to the waste that can occur from assay management, waste can still occur due to weight-based dosing and a limited number of vial sizes.

Substitution therapy utilizes the same amount of the medication every 28 days regardless of the dosing schedule. This provides consistency in budget planning for payers and employers.

For substitution therapy, because a second medication is needed to treat a bleed (with a separate prescription for on-demand factor replacement therapy), payers are able to track the use of each medication, allowing for transparency and visibility in the claims data.

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