ModifiedWellcare HawaiiPolicy CP.PHAR.215

Factor VIII (Human, Recombinant)

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This policy governs prior authorization and medical-necessity criteria for human and recombinant factor VIII products used primarily to treat hemophilia A for Commercial, HIM, and Medicaid members.

Policy Summary

PayerWellcare Hawaii

PolicyFactor VIII (Human, Recombinant)

Policy CodePolicy N/A

Change TypeModified

Effective Date06.01.16

Next Review DateN/A

Key ActionSubmit clinical documentation showing that the member meets all applicable approval criteria, including diagnosis, hematologist involvement, indication, relevant laboratory or bleeding history, and requested dose.

SourceLink

POLICY UPDATE CHANGES

Kovaltry, Afstyla, and Koate-DVI were added or incorporated into the policy's product coverage information.

Documentation requests and preference requirements for Helixate before Kogenate and ReFacto were removed.

Initial prophylaxis criteria no longer require severe hemophilia or a history of two or more joint bleeds.

Non-prophylactic approval was changed to three months initially with one three-month reauthorization.

Denial based on an inhibitor titer of at least 5 Bethesda units was removed.

Routine prophylaxis criteria were revised to permit coverage for severe hemophilia or non-severe hemophilia with at least one life-threatening or serious spontaneous bleed.

A one-month approval duration was added for factor VIII use after valoctocogene gene therapy administration in hemophilia A.

The requirement for prescriber attestation that the member does not participate in contact sports was removed.

The FDA-approved Xyntha indication for routine prophylaxis of bleeding episodes was added.

Monoclate-P was removed because it was no longer available on the market.

3 monthsSurgical or acute bleeding approval

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