Assay Management & Reporting

Hemophilia and Bleeding Disorders 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 closely to the prescribed target dose as possible using one or more available clotting factor 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 should 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 is the actual prescription that sets the targeted dose to be dispensed. Employers do not traditionally have access to prescription data. However, they can and should require vendors to collect this information. Having actual prescription data provides the payer with transparency to verify the number of units dispensed, per unit cost and assay management.

Per unit prices differ among specialty/dispensing pharmacies. Hemophilia Treatment Centers are recognized by the federal government and have access to discounted medications under the 340B Drug Pricing Program, which may offer competitive and/or lower average pricing per unit.


Tightly monitoring how much factor medication is dispensed through the specialty pharmacy helps employers reduce waste and better manage costs. The National Hemophilia Foundation is available to help employers with a retrospective analysis to help minimize waste related to assay management.

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 clotting factor), payers are able to track the use of each medication, allowing for transparency and visibility in the claims data.