Letter of Medical Necessity - Neuromyelitis Optica Spectrum Disorder ( anti- AQP4 antibody positive )
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drug label
Soliris prescribing information
Have more Soliris questions?
Submit MSL Request
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Your request will be referred to the appropriate Alexion Pharmaceuticals Inc. medical professional, such as a Soliris pharmaceutical rep; Medical Science Liaison (MSL) or medical affairs.
Need to report a Soliris issue?
ONLINE FORMReport adverse event
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You can report a Soliris adverse event on MedWatch, the FDA's medical product safety reporting program for health professionals, patients and consumers.
prior authorization
Soliris Prior authorization resources
NOT PROVIDED BY BRANDComplete Letter of Medical Necessity
NOT PROVIDED BY BRANDCoverage Authorization Request
NOT PROVIDED BY BRANDComplete Coverage Authorization appeals
Alexion Access Navigator ( All indications)
Letter of Medical Necessity - generalized Myasthenia Gravis ( Anti- AchR+)
Letter of Medical Necessity - atypical Hemolytic Uremic Syndrome
NOT PROVIDED BY BRANDCoverage Authorization Appeal - atypical Hemolytic Uremic Syndrome
NOT PROVIDED BY BRANDCoverage Authorization Appeal - Paroxysmal Nocturnal Hemoglobinuria
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If available, these templates are provided by the brand to help you navigate insurance, especially with newer drugs.
Benefits investigation
NOT PROVIDED BY BRANDBenefits investigation resources
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Benefits investigations are conducted to determine whether a therapy is covered under a patient's insurance, if a prior authorization is required, and which specialty pharmacies are preferred.
Reimbursement help (FRM)
Receive Assistance from an FRM Regarding Reimbursement Information
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Some brands offer a field reimbursement manager who will work with your clinical staff and preferred pharmacy to help make sure patients don't fall through the cracks.
financial assistance
Soliris Financial assistance options
Co-pay savings program
commercial only
Enroll in patient savings program
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Overview
Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)
Patient benefit
A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max
Patient eligibility
Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance
How to sign up
Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form
Bridge program
commercial only
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Overview
Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)
Patient benefit
100% free (outside of insurance)
Patient eligibility
HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries
How to sign up
Typically HCP assisted enrollment (via form)
Foundation programs
under insured
no insurance
goverment insurance
65+
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Overview
Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned
Patient benefit
Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and co-pays) until the grant is exhausted
Patient eligibility
Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.
How to sign up
Patients submit proof of out-of-pocket drug costs to charities for reimbursement
patient education
Soliris Patient education
Getting started on Soliris
NOT PROVIDED BY BRANDInstructions For Use - generalized Myasthenia Gravis ( Anti- AchR+)
NOT PROVIDED BY BRANDInstructions For Use - Neuromyelitis Optica Spectrum Disorder ( anti- AQP4 antibody positive )
NOT PROVIDED BY BRANDInstructions For Use - atypical Hemolytic Uremic Syndrome
NOT PROVIDED BY BRANDInstructions For Use - Paroxysmal Nocturnal Hemoglobinuria
Patient toolkit
About Soliris - generalized Myasthenia Gravis ( Anti- AchR+)
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
ASK PATIENT TO: Open Camera on Phone Scan QR Code & Tap Link
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Other resources brands publish to help support patients and caregivers.
people also ask
Soliris FAQs
What is the risk of using Soliris during pregnancy?Limited data on outcomes of pregnancies that have occurred following Soliris use in pregnant women have not identified a concern for specific adverse developmental outcomes. However, there are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in pregnancy. Animal studies using a mouse analogue of the Soliris molecule (murine anti-C5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 2-8 times the human dose. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
What are the risks associated with PNH and aHUS in pregnancy?PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, and adverse fetal outcomes, including fetal death and premature delivery. aHUS in pregnancy is associated with adverse maternal outcomes, including pre-eclampsia and preterm delivery, and adverse fetal/neonatal outcomes, including intrauterine growth restriction (IUGR), fetal death and low birth weight.
What data is available on the use of Soliris during pregnancy?A pooled analysis of prospectively (50.3%) and retrospectively (49.7%) collected data in more than 300 pregnant women with live births following exposure to Soliris have not suggested safety concerns. However, these data cannot definitively exclude any drug-associated risk during pregnancy because of the limited sample size.
What is the risk of using Soliris during lactation?Although limited published data does not report detectable levels of eculizumab (active ingredient in Soliris) in human milk, maternal IgG is known to be present in human milk. Available information is insufficient to inform the effect of eculizumab on the breastfed infant. There are no data on the effects of eculizumab on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Soliris and any potential adverse effects on the breastfed child from eculizumab or from the underlying maternal condition.
Is Soliris safe and effective for pediatric patients?Soliris has not been established as safe and effective for the treatment of PNH, gMG, or NMOSD in pediatric patients. However, Soliris has been established as safe and effective for the treatment of aHUS in pediatric patients based on four adequate and well-controlled clinical studies, which included 47 pediatric patients between the ages of 2 months and 17 years. The safety and effectiveness of Soliris for the treatment of aHUS appears similar in pediatric and adult patients.
What vaccines should be administered to pediatric patients receiving Soliris?Pediatric patients receiving Soliris should be administered vaccinations for the prevention of infection due to Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae type b (Hib) according to ACIP guidelines.
What is the experience with Soliris in geriatric patients?Fifty-one patients aged 65 years or older were treated with Soliris in clinical trials in the approved indications, including PNH, aHUS, gMG, and NMOSD. Although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.
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