Download access and reimbursement support resources to help your patients with access to STRENSIQ.
STRENSIQ is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).
Field Reimbursement Managers
Resource that explains how Alexion Field Reimbursement Managers (FRMs) provide education and support to healthcare providers and their offices to help facilitate patient access to prescribed Alexion therapies.
STRENSIQ Prescription Form
A prescription form for healthcare providers to complete and submit to PANTHERx Rare Pharmacy, the exclusive preferred specialty pharmacy for STRENSIQ.
How to Access STRENSIQ
Resource that provides education to healthcare providers and their offices on the administrative aspects of the STRENSIQ access process, including benefit investigations, prior authorizations, reauthorizations, and Alexion support resources.
STRENSIQ Common Prior Authorization Criteria
Resource that outlines common payer criteria for prior authorization of STRENSIQ in HPP and explains the prior authorization process for healthcare providers and their offices.
STRENSIQ Letter of Medical Necessity
A template letter healthcare providers can use when responding to insurance requests for a letter of medical necessity for STRENSIQ in HPP.
HPP Substrate Testing Resource Guide
An interactive, educational guide that provides an overview of substrate testing and substrate testing labs commonly required for STRENSIQ prior authorizations and reauthorizations.
HPP Genetic Testing Resource Guide
An interactive, educational guide that provides an overview of genetic testing and genetic testing labs commonly required for STRENSIQ prior authorizations and reauthorizations.
Adult Radiographic Evidence for STRENSIQ Prior Authorizations and Reauthorizations
An interactive, educational guide with detailed information and explanations for radiographic tests commonly required for STRENSIQ prior authorizations and reauthorizations.
Renal and Ophthalmologic Assessments for STRENSIQ Prior Authorizations and Reauthorizations
An interactive, educational guide with information on prior authorization and reauthorization criteria relevant to renal and ocular specialists for STRENSIQ.
Metabolic Bone Specialist Self-Credentialing Letter
A template letter healthcare providers can use to establish their qualifications as a metabolic bone specialist to a health plan.
Peer-to-Peer Medical Review
Resource that provides education and guidance for healthcare providers and their offices on peer-to-peer reviews as a step before submitting a formal appeal.
STRENSIQ Sample Appeal Letter
A template letter healthcare providers can use to assist with the appeals process if coverage for STRENSIQ in HPP is denied.
Compendium of HPP References for STRENSIQ
Resource that compiles key references for STRENSIQ in HPP, including Prescribing Information, FDA approval letter, and publicly available evidence for healthcare providers.
Common Assessments for STRENSIQ Prior Authorizations and Reauthorizations
An interactive, educational guide with in-depth descriptions and information on multiple functional assessments commonly required for STRENSIQ prior authorizations and reauthorizations.
Reauthorization Guide
Resource that provides education and support for healthcare providers, their offices, and infusion centers about the reauthorization process, including health plan requirements and timing implications for reauthorizations.
Get your patients started with OneSource
OneSource, a personalized patient support program offered by Alexion, is available Monday through Friday, 8:30 AM - 8 PM ET.
Initiate STRENSIQ under the supervision of a healthcare provider with appropriate medical monitoring and support measures. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue STRENSIQ and immediately initiate appropriate medical treatment, including use of epinephrine. Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur [see Warnings and Precautions (5.1)].
- Life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in STRENSIQ-treated patients. Signs and symptoms consistent with anaphylaxis included difficulty breathing, choking sensation, nausea, periorbital edema, and dizziness. These reactions have occurred within minutes after subcutaneous administration of STRENSIQ and have been observed more than 1 year after treatment initiation. Other hypersensitivity reactions have also been reported in STRENSIQ-treated patients, including vomiting, fever, headache, flushing, irritability, chills, erythema, rash, pruritus, and oral hypoesthesia. Consider the risks and benefits of re-administering STRENSIQ following a severe reaction. If the decision is made to re-administer, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction.
- Lipodystrophy: Localized lipodystrophy, including lipoatrophy and lipohypertrophy has been reported at injection sites after several months in patients treated with STRENSIQ in clinical trials. Advise patients to follow proper injection technique and to rotate injection sites.
- Ectopic Calcifications: Patients with HPP are at increased risk for developing ectopic calcifications. Events of ectopic calcification, including ophthalmic (conjunctival and corneal) and renal (nephrocalcinosis, nephrolithiasis), have been reported in the clinical trial experience with STRENSIQ. There was insufficient information to determine whether the reported events were consistent with the disease or due to STRENSIQ. No visual changes or changes in renal function were reported resulting from the occurrence of ectopic calcifications.
Ophthalmology examinations and renal ultrasounds are recommended at baseline and periodically during treatment with STRENSIQ to monitor for signs and symptoms of ophthalmic and renal ectopic calcifications and for changes in vision or renal function. - Possible Immune-Mediated Clinical Effects: In clinical trials, most STRENSIQ-treated patients developed anti-asfotase alfa antibodies and neutralizing antibodies which resulted in reduced systemic exposure of asfotase alfa. In postmarketing reports, some STRENSIQ-treated patients with initial therapeutic response subsequently developed recurrence and worsening in disease-associated laboratory and radiographic biomarkers (some in association with neutralizing antibodies) suggesting possible immune-mediated effects on STRENSIQ’s pharmacologic action resulting in disease progression. The effect of anti-asfotase alfa antibody formation on the long-term efficacy of STRENSIQ is unknown. There are no marketed anti-asfotase alfa antibody tests. If patients experience progression of HPP symptoms or worsening of disease-associated laboratory and imaging biomarkers after a period of initial therapeutic response to STRENSIQ, consider obtaining anti-asfotase alfa antibody testing by contacting STRENSIQ Medical Information at Alexion at 1-888-765-4747 or by email at medinfo@alexion.com. Close clinical follow up is recommended.
In clinical trials, the most common adverse reactions (≥ 10%) reported were injection site reactions (63%), lipodystrophy (28%), ectopic calcifications (14%), and hypersensitivity reactions (12%). Possible immune-mediated clinical effects have been identified during post-approval use of STRENSIQ.
DRUG INTERACTIONS
Drug Interference with Laboratory Tests:
- Laboratory tests utilizing alkaline phosphatase (ALP) as a detection reagent could result in erroneous test results for patients receiving treatment due to the presence of asfotase alfa in clinical laboratory samples. Inform laboratory personnel that the patient is being treated with STRENSIQ and discuss use of an alternative testing platform which does not utilize an ALP-conjugated test system.
- Elevated serum ALP measurements detected through clinical laboratory testing are expected in patients receiving STRENSIQ due to circulating concentrations of asfotase alfa. Do not rely on serum ALP measurements for clinical decision making in patients treated with STRENSIQ.
- Pregnancy & Lactation: There are no available data on STRENSIQ use in pregnant women, the presence of STRENSIQ in human milk, or the effects on the breastfed infant or on milk production, to inform a drug associated risk.
INDICATION
STRENSIQ® (asfotase alfa) is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).
Please see full Prescribing Information for STRENSIQ (asfotase alfa), including Boxed WARNING regarding hypersensitivity reactions including anaphylaxis.