CurrentCareSourcePolicy N/A

Strensiq (asfotase alfa) pharmacy coverage

Defines pharmacy benefit coverage, prior authorization requirements, dosing, and medical necessity criteria for Strensiq (asfotase alfa) for members with hypophosphatasia in the CareSource Arkansas PASSE program.

Policy Summary

PayerCareSource

PolicyStrensiq (asfotase alfa) pharmacy coverage

Policy CodePolicy N/A

Change TypeRemoved age & prescriber specialty requirements (most recent)

Effective Date01/01/2022

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes and supporting clinical evidence for initial and reauthorization requests.

SourceLink

POLICY UPDATE CHANGES

New policy for Strensiq created.

Removed age requirement and prescriber specialty requirement.

6 monthsinitial approval duration

12 monthsreauthorization approval duration

Homesite of service

Pharmacybenefit type

Coverage Criteria for Strensiq (asfotase alfa)

inv-01: Initial Therapy

Covered when ALL of the following are met

Initial authorization for Strensiq in pediatric-onset HPP: Member has diagnosis of hypophosphatasia (HPP) with perinatal/infantile- OR juvenile-onset; chart notes documenting clinical evidence of HPP with onset prior to 18 years (biochemical, medical history, radiographic evidence); radiographic features consistent with rickets (e.g., metaphyseal widening/fraying, bowing, generalized hypomineralization) OR poor growth impairing function not due to another etiology, OR pain refractory to initial conservative therapy (physical therapy, rest, NSAIDs, acetaminophen); documented reduced activity of unfractionated serum alkaline phosphatase (ALP) and presence of one or two pathogenic variants in the ALPL gene; dosing consistent with policy (see dosing threshold).

If all requirements met, approve for 6 months.

inv-02: Continuation/Reauthorization

Covered for continuation when ALL of the following are met

Reauthorization for Strensiq: Chart notes have been provided showing the member has shown improvement of signs and symptoms of disease.

Policy Summary

PayerCareSource

PolicyStrensiq (asfotase alfa) pharmacy coverage

Policy CodePolicy N/A

Change TypeRemoved age & prescriber specialty requirements (most recent)

Effective Date01/01/2022

Next Review DateN/A

Key ActionSubmit prior authorization with chart notes and supporting clinical evidence for initial and reauthorization requests.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Therapy Requirements

inv-13: Initial therapy

Initial authorization dosing and requirements

Initial therapy: Diagnosis of pediatric-onset HPP with onset <18 years and supportive chart notes (biochemical, radiographic, history); documented reduced serum ALP activity and one or two pathogenic ALPL variants; dosing per policy: perinatal/infantile-onset HPP — 2 mg/kg subcutaneously three times weekly or 1 mg/kg six times weekly (may increase to 3 mg/kg three times weekly for insufficient efficacy); juvenile-onset dosing similar (2 mg/kg three times weekly or 1 mg/kg six times weekly).

Initial approval duration: 6 months.

Billing and Dosing Information

Billing code requirementNDC

NDC required

Must use valid NDC

Initial approval dosing — Strensiq (asfotase alfa)

Perinatal/infantile-onset dosing2 mg/kg subcutaneously (SQ) three times per week OR 1 mg/kg SQ six times per week; may increase to 3 mg/kg SQ three times per week for insufficient efficacy

Juvenile-onset dosing2 mg/kg SQ three times per week OR 1 mg/kg SQ six times per week; six-times-weekly regimen may be limited by injection site reactions

Dose adjustment for inadequate responseIncrease to 3 mg/kg SQ three times per week if insufficient efficacy (e.g., no improvement in respiratory status, growth, or radiographic findings)

Tolerability considerationInjection site reactions may limit tolerability of the six-times-per-week regimen

Provider Actions, Documentation, and Billing Rules

Prior Authorization

Prior Authorization Required

Prior authorization required for non-preferred product. Providers must submit chart notes and supporting clinical evidence for both initial requests and reauthorizations. Use a valid NDC on claims.

Prior authorization required for non-preferred product
Submit chart notes and clinical evidence for initial and reauthorization
Must use valid NDC on pharmacy claims

Note

Provider Action

Provider/Billing action: ensure prior authorization is obtained before dispensing non-preferred product and include supporting documentation with the PA request to avoid claim denial.

Obtain prior authorization before dispensing non-preferred product
Include clinical documentation with PA submission

Documentation Required

Required Clinical Documentation

Document and submit chart notes demonstrating clinical evidence of hypophosphatasia (HPP) with onset prior to 18 years. Include biochemical evidence (reduced unfractionated serum alkaline phosphatase), genetic testing results showing one or two pathogenic ALPL variants, radiographic findings (eg, metaphyseal widening, fraying, bowing, hypomineralization), and clinical course (eg, poor growth impairing function, pain refractory to conservative therapy). For reauthorization, provide notes showing clinical improvement in signs and symptoms.

Chart notes showing HPP onset < 18 years
Biochemical evidence: reduced unfractionated serum ALP
Genetic testing: one or two pathogenic ALPL variants
Radiographic evidence: rickets-like changes (metaphyseal widening/fraying, bowing, hypomineralization)
Clinical history: poor growth impairing function, pain not responsive to conservative care
Reauthorization: documentation of clinical improvement

Denial Risk

Billing / Denial Risk

Billing/denial risk: claims for non-preferred products without prior authorization will be denied. Invalid or missing NDC may cause billing rejection. Ensure dosing matches allowed regimen in clinical policy when submitting claims.

Lack of prior authorization for non-preferred product → denial
Invalid or missing NDC may trigger billing rejection
Align submitted dosing with policy-authorized regimens

OpenPayer

Strensiq (asfotase alfa) pharmacy coverage

Coverage Criteria for Strensiq (asfotase alfa)

Initial Therapy Requirements

Reauthorization / Continuation Requirements

Billing and Dosing Information

Provider Actions, Documentation, and Billing Rules

Background

Definitions

Step Therapy

Site of Care