Xyntha Solofuse — Blue Cross Blue Shield of Montana

Initial criteria

• Requested agent is eligible for continuation of therapy AND the prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed OR criteria below apply
• Patient has diagnosis of hemophilia A AND ONE of the following: (a) currently experiencing a bleed AND (i) patient is out of medication AND (ii) patient needs a one-time emergency supply; OR (b) agent is FDA labeled or compendia supported for hemophilia A AND used for ONE of the following: prophylaxis AND not combined with Hemlibra (emicizumab-kxwh); OR immune tolerance therapy (ITT)/immune tolerance induction (ITI) AND not combined with Hemlibra AND (i) ITT/ITI duration ≤ 33 months OR (ii) ≥ 20% decrease in inhibitor level over last 6 months and further treatment needed; OR on-demand use for bleeds; OR peri-operative management of bleeding
• Patient has diagnosis of von Willebrand disease AND agent is FDA labeled or compendia supported for VWD AND ONE of the following: (a) experiencing a bleed AND (i) out of medication AND (ii) needs one-time emergency supply; OR (b) type 1, 2A, 2M, or 2N VWD AND ONE of the following: inadequate response to desmopressin (DDAVP, Stimate), no response on DDAVP trial with 1- and 4-hour post infusion labs, intolerance/hypersensitivity to DDAVP, labeled contraindication to DDAVP, or documented reason cannot use DDAVP; OR (c) type 2B or 3 VWD AND used for ONE of the following: prophylaxis AND (i) agent is Vonvendi AND severe Type 3 VWD OR another subtype labeled for prophylaxis; OR (ii) agent is not Vonvendi; OR on-demand use for bleeds; OR peri-operative management of bleeding
• For any FDA-labeled indication, patient’s age within labeling OR support present for use at that age
• Prescriber is a hemophilia specialist or has consulted with such specialist
• Patient does not have any FDA-labeled contraindications to requested agent
• Prescriber provides actual prescribed dose including patient weight, intended use/regimen (prophylaxis, ITT/ITI, on-demand, peri-operative), and for hemophilia A also severity of factor deficiency and inhibitor status
• Patient will not use the requested agent in combination with another agent of the same category unless medical records support the need for >1 unique agent in same category

Reauthorization criteria

• Patient previously approved for requested agent through plan’s PA process
• If using for prophylaxis: (a) diagnosis of hemophilia A AND not used in combination with Hemlibra OR (b) patient has another diagnosis
• Prescriber is a hemophilia specialist or has consulted with such specialist
• Patient has no FDA-labeled contraindications to requested agent
• Prescriber provides actual prescribed dose, including patient weight, intended use/regimen, and if hemophilia A, severity of factor deficiency and inhibitor status
• Prescriber has verified patient does not have >5 on-demand doses on hand OR there is support for having more
• Patient will not use requested agent with another in same category unless supported by medical records
• If on ITT/ITI therapy: not used in combination with Hemlibra AND ITT/ITI duration ≤ 33 months OR ≥20% decrease in inhibitor level over last 6 months and further treatment needed

Approval duration

initial: emergency 3 months; peri-operative 3 months; on-demand 3 months; prophylaxis up to 12 months (≥3 months); ITT/ITI up to 6 months or ≤33 months total; renewal: peri-operative 3 months; on-demand 3 months; prophylaxis up to 12 months (≥3 months); ITT/ITI up to 6 months (≤33 months total)