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Obtaining approval for your patient’s treatment for spinal muscular atrophy (SMA) often requires your practice or facility to complete several steps, including conducting a thorough Benefits Investigation to determine if an authorization and/or medical exception is needed prior to treatment approval. We have developed multiple resources to assist your practice or facility in navigating the approval process for SPINRAZA once treatment has been prescribed.

SPINRAZA OVERVIEW

Basic product information and clinical study overview.

SPINRAZA PRODUCT FACT SHEET

Offers a high-level overview of SPINRAZA, including the relevant product codes.

SPINRAZA CLINICAL OVERVIEW

Provides high-level information about the controlled and open-label studies with SPINRAZA.

SPINRAZA ACCESS

Information to help you navigate the steps to product access, including prior authorizations, medical exceptions, appeals, and reauthorizations.

SPINRAZA ACCESS OVERVIEW

Includes a step-by-step summary of the reimbursement process for SPINRAZA.

GUIDE TO BENEFITS INVESTIGATION

Reviews the process of conducting a Benefits Investigation for a prospective patient and the ways SMA360° may be able to help.

GUIDE TO REAUTHORIZATION

Explains the process and requirements for reauthorization (renewal of authorization per health plans) for patients who have previously received SPINRAZA.

GUIDE TO PRIOR AUTHORIZATION SUBMISSIONS AND CHECKLIST

Details the prior authorization process and the submission of documentation to health plans to gain approval for SPINRAZA.

GUIDE TO REQUESTING MEDICAL EXCEPTIONS (ME) AND APPEALING DENIALS AND CHECKLISTS

Provides guidance for submitting an ME—which may be necessary for certain patients—and for appealing a denial of coverage.

FINANCIAL ASSISTANCE

Resources for copay and coinsurance programs and information on how SMA360°™ can help SPINRAZA patients and their caregivers.

FINANCIAL ASSISTANCE OPTIONS FOR SPINRAZA

Offers guidance to help patients receiving SPINRAZA and their families navigate the cost of treatment. Includes information about copays, coinsurance, and the assistance provided by SMA360°.

SAMPLE LETTERS OF MEDICAL NECESSITY

Templates that can be customized and sent to health plans to request SPINRAZA approval for certain patients with spinal muscular atrophy (SMA).

TREATMENT NAÏVE

For use when requesting coverage for new patients starting on SPINRAZA.

SECONDARY HEALTH PLAN

For use when requesting coverage for SPINRAZA from a secondary health plan when attempts for primary insurance coverage have been exhausted.

APPEAL

For use when appealing a denial of initial coverage or reauthorization for SPINRAZA.

REAUTHORIZATION

For use when helping to achieve reauthorization (if needed) for patients who have previously received SPINRAZA.

OFFICE RESOURCES

Educational and practical resources to support your office in determining patient coverage and tracking communications with health plans.

HEALTH PLAN REFERENCE SHEET

A template your staff can use to record information from health plans that are used most frequently.

BENEFITS INVESTIGATION WORKSHEET

An editable form that can be used for an actual patient, as well as instructions for gathering information to determine a patient’s level of health plan coverage.

REIMBURSEMENT TRACKING LOG

A log that your staff can use to help keep track of the reimbursement process for your patients receiving SPINRAZA.

COPAY REIMBURSEMENT FORM

A form for your staff to complete to help eligible patients receive reimbursement through the $0 Drug and $0 Procedure Copay Programs.

SPINRAZA OVERVIEW

Basic product information and clinical study overview.

SPINRAZA PRODUCT FACT SHEET

Offers a high-level overview of SPINRAZA, including the relevant product codes.

SPINRAZA CLINICAL OVERVIEW

Provides high-level information about the controlled and open-label studies with SPINRAZA.

SPINRAZA ACCESS

Information to help you navigate the steps to product access, including prior authorizations, medical exceptions, appeals, and reauthorizations.

SPINRAZA ACCESS OVERVIEW

Includes a step-by-step summary of the reimbursement process for SPINRAZA.

GUIDE TO BENEFITS INVESTIGATION

Reviews the process of conducting a Benefits Investigation for a prospective patient and the ways SMA360° may be able to help.

GUIDE TO REAUTHORIZATION

Explains the process and requirements for reauthorization (renewal of authorization per health plans) for patients who have previously received SPINRAZA.

GUIDE TO PRIOR AUTHORIZATION SUBMISSIONS AND CHECKLIST

Details the prior authorization process and the submission of documentation to health plans to gain approval for SPINRAZA.

GUIDE TO REQUESTING MEDICAL EXCEPTIONS (ME) AND APPEALING DENIALS AND CHECKLISTS

Provides guidance for submitting an ME—which may be necessary for certain patients—and for appealing a denial of coverage.

FINANCIAL ASSISTANCE

Resources for copay and coinsurance programs and information on how SMA360°™ can help SPINRAZA patients and their caregivers.

FINANCIAL ASSISTANCE OPTIONS FOR SPINRAZA

Offers guidance to help patients receiving SPINRAZA and their families navigate the cost of treatment. Includes information about copays, coinsurance, and the assistance provided by SMA360°.

SAMPLE LETTERS OF MEDICAL NECESSITY

Templates that can be customized and sent to health plans to request SPINRAZA approval for certain patients with spinal muscular atrophy (SMA).

TREATMENT NAÏVE

For use when requesting coverage for new patients starting on SPINRAZA.

SECONDARY HEALTH PLAN

For use when requesting coverage for SPINRAZA from a secondary health plan when attempts for primary insurance coverage have been exhausted.

APPEAL

For use when appealing a denial of initial coverage or reauthorization for SPINRAZA.

REAUTHORIZATION

For use when helping to achieve reauthorization (if needed) for patients who have previously received SPINRAZA.

OFFICE RESOURCES

Educational and practical resources to support your office in determining patient coverage and tracking communications with health plans.

HEALTH PLAN REFERENCE SHEET

A template your staff can use to record information from health plans that are used most frequently.

BENEFITS INVESTIGATION WORKSHEET

An editable form that can be used for an actual patient, as well as instructions for gathering information to determine a patient’s level of health plan coverage.

REIMBURSEMENT TRACKING LOG

A log that your staff can use to help keep track of the reimbursement process for your patients receiving SPINRAZA.

COPAY REIMBURSEMENT FORM

A form for your staff to complete to help eligible patients receive reimbursement through the $0 Drug and $0 Procedure Copay Programs.

Key Icon

Please contact your Biogen representative to request printed copies of the above resources.

Photo of Ruby aged 4 years old with Type 2 SMA
Ruby
age 4

Later-onset (Type 2) SMA
treated with SPINRAZA

Individual results may vary based on several factors, including severity of disease and duration of therapy.

INDICATION

SPINRAZA is indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.

IMPORTANT SAFETY INFORMATION

Coagulation abnormalities and thrombocytopenia, including acute severe thrombocytopenia, have been observed after administration of some antisense oligonucleotides. Patients may be at increased risk of bleeding complications.

In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 24 of 146 SPINRAZA-treated patients (16%) with high, normal, or unknown platelet count at baseline developed a platelet level below the lower limit of normal, compared to 10 of 72 sham-controlled patients (14%). Two SPINRAZA-treated patients developed platelet counts <50,000 cells per microliter, with the lowest level of 10,000 cells per microliter recorded on study day 28.

Renal toxicity, including potentially fatal glomerulonephritis, has been observed after administration of some antisense oligonucleotides. SPINRAZA is present in and excreted by the kidney. In the sham-controlled studies for patients with infantile-onset and later-onset SMA, 71 of 123 SPINRAZA-treated patients (58%) had elevated urine protein, compared to 22 of 65 sham-controlled patients (34%).

Laboratory testing and monitoring to assess safety should be conducted. Perform a platelet count, coagulation laboratory testing, and quantitative spot urine protein testing at baseline and prior to each dose of SPINRAZA and as clinically needed.

Severe hyponatremia was reported in an infant treated with SPINRAZA requiring salt supplementation for 14 months.

Cases of rash were reported in patients treated with SPINRAZA.

SPINRAZA may cause a reduction in growth as measured by height when administered to infants, as suggested by observations from the controlled study. It is unknown whether any effect of SPINRAZA on growth would be reversible with cessation of treatment.

The most common adverse reactions (≥20% of SPINRAZA-treated patients and ≥5% more frequently than in control patients) that occurred in the infantile-onset controlled study were lower respiratory infection and constipation. Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients (18%) than in control patients (10%). Because patients in this controlled study were infants, adverse reactions that are verbally reported could not be assessed. The most common adverse reactions that occurred in the later-onset controlled study were pyrexia, headache, vomiting, and back pain. Post-lumbar puncture syndrome has also been observed after the administration of SPINRAZA.

Please see full Prescribing Information for additional Important Safety Information.

As a courtesy, our full Prescribing Information is also available en Español. For prescribing decisions, please refer to official approved labeling.