Table 60: Hereditary Angioedema Agents
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
Drug Category: Complement Inhibitors
Medication Class/Individual Agents: Hereditary Angioedema Agents
I. Prior-Authorization Requirements
Hereditary Angioedema Agents – Acute Agents |
Clinical Notes |
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Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
1 Zuraw B, Farkas H. Hereditary angioedema (due to C1 inhibitor deficiency): General care and long-term prophylaxis. In Saini S (Ed). UpToDate [database on the internet]. Waltham (MA): UpToDate; 2026 [cited 2026 Mar]. Available from: http://www.utdol.com/utd/index.do. 2 Busse PJ, Christiansen SC, Riedl MA, Banerji A, Bernstein JA, Castaldo AJ, et al. US HAEA Medical Advisory Board 2020 Guidelines for the Management of Hereditary Angioedema. J Allergy Clin Immunol Pract. 2021;9(1):132-150.e3. 3 Maurer M, Magerl M, Betschel S, Aberer W, Ansotegui IJ, Aygören-Pürsün E, et al. The international WAO/EAACI guideline for the management of hereditary angioedema-The 2021 revision and update. Allergy. 2022;77(7):1961-1990.
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Hereditary Angioedema Agents – Prophylactic Agents |
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| # | This designates a brand-name drug with FDA “A”-rated generic equivalents. PA is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent. |
| MB | This drug is available through the health care professional who administers the drug or in an outpatient or inpatient hospital setting. MassHealth does not pay for this drug to be dispensed through the retail pharmacy. If listed, PA does not apply through the acute hospital inpatient setting, unless on the APAD/APEC carve-out drug list, or in the emergency, trauma, or urgent acute hospital outpatient settings. Please refer to 130 CMR 433.408 for PA requirements for other health care professionals. Notwithstanding the above, this drug may be an exception to the unified pharmacy policy; please refer to respective MassHealth Accountable Care Partnership Plans (ACPPs) and Managed Care Organizations (MCOs) for PA status and criteria, if applicable. |
II. Therapeutic Uses
FDA-approved, for example:
- Treatment of acute attacks of hereditary angioedema (HAE) (Berinert, Ekterly, icatibant, Kalbitor, Ruconest)
- Prophylaxis against angioedema attacks in patients with HAE (Andembry, Cinryze, Dawnzera, Haegarda, Orladeyo, Takhzyro)
Note: The above list may not include all FDA-approved indications.
III. Evaluation Criteria for Approval
Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.
- All PA requests must include clinical diagnosis, drug name, dose, and frequency.
- Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply.
- A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
- For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
- Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.
Andembry, Cinryze, Dawnzera, Haegarda, Orladeyo, Takhzyro
- Documentation of all the following is required:
- appropriate diagnosis; and
- prescriber is an allergist or immunologist or consult notes from an allergist or immunologist are provided; and
- one of the following:
- member has > one HAE attack/30 days; or
- member has a history of recurrent laryngeal attacks; and
- appropriate dosing.
- For recertification of Dawnzera, documentation of one of the following is required:
- requested dosing is every eight weeks; or
- requested dosing is every four weeks and one of the following:
- member has had ≥ one HAE attack in the last six months; or
- both of the following:
- member has been HAE attack free for ≥ six months; and
- clinical rationale for every four-week dosing instead of every eight-week dosing.
- For recertification of Takhzyro, documentation of one of the following is required:
- requested dosing is every four weeks; or
- requested dosing is every two weeks and one of the following:
- member has had ≥ one HAE attack in the last six months; or
- both of the following:
- member has been HAE attack free for ≥ six months; and
- clinical rationale for every two-week dosing instead of every four-week dosing.
Berinert > 14 injections/30 days, icatibant > six injections/30 days, Kalbitor > 12 injections/30 days, Ruconest > eight injections/30 days
- Documentation of all the following is required:
- appropriate diagnosis; and
- prescriber is an allergist or immunologist or consult notes from an allergist or immunologist are provided; and
- appropriate dosing; and
- member has > two HAE attacks/30 days.
- For recertification for exceeding quantity limits, documentation of both of the following is required:
- appropriate dosing; and
- member has > two HAE attacks/30 days.
Ekterly
- Documentation of all the following is required:
- appropriate diagnosis; and
- prescriber is an allergist or immunologist or consult notes from an allergist or immunologist are provided; and
- one of the following:
- medical necessity for use of the requested agent instead of alternative agents available without prior authorization (e.g., needle phobia); or
- inadequate response or adverse reaction to two or contraindication to all of the following: Berinert, icatibant, Kalbitor, Ruconest; and
- one of the following:
- requested quantity is ≤ eight tablets/30 days; or
- member has > two HAE attacks/30 days; and
- appropriate dosing.
- For recertification, documentation of both of the following is required:
- appropriate dosing; and
- one of the following:
- requested quantity is ≤ eight tablets/30 days; or
- member has > two HAE attacks/30 days.
Original Effective Date: 03/2012
Last Revised Date: 04/2026
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Last updated 04/02/26