CurrentHawaii Medical Service Association (HMSA)Policy N/A

Cinryze (C1 esterase inhibitor [human])

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This policy governs HMSA Medicare Advantage coverage and prior authorization for Cinryze to prevent hereditary angioedema attacks in adults, adolescents, and children age 6 years and older who meet the policy’s diagnostic and clinical criteria.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyCinryze (C1 esterase inhibitor [human])

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateJan 19, 2026

Last ReviewSep 1, 2025

Next Review DateN/A

Key ActionObtain precertification for Cinryze using the HMSA medical specialty drug policy website fax form.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial and reauthorization approval period

Age 6+FDA-approved age range for routine prophylaxis

>50%Example significant reduction in attack frequency for continuation therapy

40 mg/dayHigh-dose antihistamine trial threshold

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CurrentHawaii Medical Service Association (HMSA)Policy N/A

Cinryze (C1 esterase inhibitor [human])

Customize your policy alerts

Sign up for all Hawaii Medical Service Association (HMSA) policy alerts

Know when Hawaii Medical Service Association (HMSA) releases new policies or updates existing guidance.

Monitor payer policy activity

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Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyCinryze (C1 esterase inhibitor [human])

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateJan 19, 2026

Last ReviewSep 1, 2025

Next Review DateN/A

Key ActionObtain precertification for Cinryze using the HMSA medical specialty drug policy website fax form.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsInitial and reauthorization approval period

Age 6+FDA-approved age range for routine prophylaxis

>50%Example significant reduction in attack frequency for continuation therapy

40 mg/dayHigh-dose antihistamine trial threshold

Coverage Criteria

Initial therapy for hereditary angioedema

Authorization of 12 months may be granted for prevention of hereditary angioedema attacks when either qualifying diagnostic pathway is met at the time of diagnosis.

Qualifying HAE diagnostic pathway

C1 inhibitor deficiency or dysfunction pathway: Member has C1 inhibitor deficiency or dysfunction confirmed by laboratory testing and meets a qualifying C1-INH antigenic or functional level criterion.
Normal C1 inhibitor pathway: Member has normal C1 inhibitor confirmed by laboratory testing and meets a qualifying genetic-mutation or clinical family-history pathway.

Continuation and reauthorization therapy

Authorization of 12 months may be granted for continuation of therapy when all of the following criteria are met.

Continuation therapy

Previously authorized therapy: Member was previously authorized by HMSA/CVS for prevention of hereditary angioedema attacks.
Current treatment: Member is currently receiving therapy with the requested medication.
Benefit from therapy: Member is receiving benefit from therapy, including a significant reduction in attack frequency since starting treatment and reduced use of medications for acute attacks.Example: greater than 50% reduction in attack frequency

Clinical Thresholds

C1-INH antigenic level

CriterionC1-INH antigenic level is below the lower limit of normal.

Testing requirementThe result must be confirmed by laboratory testing.

Reference standardThe lower limit of normal is defined by the laboratory performing the test.

C1-INH functional level

Functional thresholdFunctional C1-INH is less than 50%.

Alternative thresholdFunctional C1-INH is below the lower limit of normal.

Related antigenic result

Authorization and Documentation

Prior Authorization

Submit precertification for Cinryze

Precertification is required for Cinryze. Please refer to the HMSA medical specialty drug policy website for the fax form.

Documentation Required

Provide clinical documentation for initial authorization

For initial authorization, documentation must be available upon request to support the request. Include the following, as applicable:

C1 inhibitor functional and antigenic protein levels
F12, angiopoietin-1, plasminogen, kininogen-1 (KNG1), heparan sulfate-glucosamine 3O-sulfotransferase 6 (HS3ST6), or myoferlin (MYOF) gene mutation testing
Chart notes confirming family history of angioedema and that the angioedema was refractory to a trial of high-dose antihistamine therapy

Clinical Background

Cinryze (C1 esterase inhibitor [human]) is indicated for routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients 6 years of age and older with hereditary angioedema (HAE). The policy recognizes HAE associated with C1 inhibitor deficiency or dysfunction, as well as HAE with normal C1 inhibitor associated with specified gene mutations or a documented family history and failure of high-dose antihistamine therapy.

Response to Therapy

Benefit from therapy

Attack frequencyA significant reduction in attack frequency since starting treatment.

Example magnitudeA reduction of greater than 50% in attack frequency.

Acute-attack medication useA reduction in the use of medications to treat acute attacks since starting treatment is also required.

Initial Therapy

Initial therapy — prevention of HAE attacks

Authorization of 12 months may be granted for prevention of HAE attacks when either of the following diagnostic pathways is met at the time of diagnosis.

Qualifying HAE diagnostic pathway

C1 inhibitor deficiency or dysfunction
- Qualifying C1-INH laboratory result
  - Low C1-INH antigenic level: C1-INH antigenic level is below the lower limit of normal as defined by the laboratory performing the test.Below laboratory lower limit of normal
  - Low C1-INH functional level with normal antigenic level: C1-INH antigenic level is normal and functional C1-INH is less than 50% or below the lower limit of normal as defined by the laboratory performing the test.

Continuation and Reauthorization

Reauthorization

Authorization of 12 months may be granted to members requesting continuation of therapy for prevention of HAE attacks who were previously authorized by HMSA/CVS when all of the following criteria are met.

Reauthorization criteria

Previous HMSA/CVS authorization: Member was previously authorized by HMSA/CVS for continuation of therapy.
Currently receiving requested medication: Member is currently receiving therapy with the requested medication.
Benefit from therapy
- Reduced attack frequency: Member has a significant reduction in the frequency of attacks since starting treatment.