01REQUIREMENTS: Initial Berinert claims need documentation of all of the following: an HAE diagnosis due to C1INH deficiency (Type 1 or Type 2) confirmed by the listed C4, C1-INH protein and C1-INH function levels or by a C1-INH gene mutation, or HAE with normal C1INH with normal levels plus a mutation in one of the listed genes, or HAE-unknown confirmed by an HAE specialist with medical records; documentation that medications known to cause angioedema (ACE inhibitors, estrogens, angiotensin II receptor blockers, NSAIDs) were evaluated and discontinued when appropriate; for acute attack treatment, the patient is under 18, or is over 18 and has tried icatibant with an inadequate response, intolerance or FDA-labeled contraindication; the dose is within the program quantity limit of 2 acute attacks per month, or a higher quantity is supported (for example, more than 2 attacks per month in the past 3 months); the agent is not used with another acute HAE agent; the prescriber is an allergist or immunologist or has consulted one; and there is no FDA-labeled contraindication.
02Initial approval length is 12 months.
03Renewal requires prior approval through the BCBSMS review process, prescriber communication with the patient about attack frequency and severity, verification that the patient does not have more than a 1-month supply (enough for 2 acute attacks) on hand, the same quantity and specialist requirements, and no FDA-labeled contraindication.
04Renewal approval length is 12 months.
05Berinert is quantity limited to 20 units/kg per infusion, up to 2 doses per 30 days.
06Services related to delivery or administration of a medication determined not medically necessary will also be considered not medically necessary.
07Self-administered drugs may be covered under the State Health Plan pharmacy benefit, with prior authorization requests submitted to the plan's Pharmacy Benefit Manager, and services for delivery or administration of a self-administered drug are not covered under the medical benefit.
08The use of samples by an individual will not be considered current or stable therapy.