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OBTAINING ACCESS FOR SPINRAZA 

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 Benefit Investigation to determine if an authorization and/or medical exception is needed prior to treatment approval. Biogen has developed multiple resources to assist your practice or facility in navigating the approval process for SPINRAZA once treatment has been prescribed.

Access Resources

PROCESS OVERVIEW

Includes a step-by-step process for the management of the reimbursement process for SPINRAZA, and a list of available access resources for SPINRAZA to support your patients

FACT SHEET FOR SPINRAZA

Contains information about SPINRAZA, including product and procedure codes that may be required

FAQS ABOUT SMA AND SPINRAZA

Includes the answers to questions that your office may have about SMA and SPINRAZA

SPINRAZA CLINICAL OVERVIEW

Provides information about the multiple clinical studies of SPINRAZA, including the trial designs and efficacy and safety results

TIPS TO SUCCESSFULLY COMPLETING A SPINRAZA START FORM

Explains the SPINRAZA Start Form and provides tips on how to complete each section so that your patients can enroll in Biogen support services

Helpful Guides

GUIDE TO PRIOR AUTHORIZATION (PA) SUBMISSIONS

Provides steps and tips when submitting a PA

GUIDE TO REQUESTING A MEDICAL EXCEPTION (ME)

Contains tips for submitting an ME

Sample Letters

SAMPLE LETTER OF MEDICAL NECESSITY

Provides a Word template of a sample letter to use when requesting an ME for a patient

Practice/Facility Resources

INSURANCE CARRIER CONTACT SHEET

Provides a template to help your office record contact information for the insurance carriers that are contacted the most

UNDERSTANDING MEDICAL VS PHARMACY BENEFIT

Includes overview information about distinguishing between medical and pharmacy benefit cards

OBTAINING ACCESS FOR SPINRAZA 

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 Benefit Investigation to determine if an authorization and/or medical exception is needed prior to treatment approval. Biogen has developed multiple resources to assist your practice or facility in navigating the approval process for SPINRAZA once treatment has been prescribed.

Access Resources

PROCESS OVERVIEW

Includes a step-by-step process for the management of the reimbursement process for SPINRAZA, and a list of available access resources for SPINRAZA to support your patients

FACT SHEET FOR SPINRAZA

Contains information about SPINRAZA, including product and procedure codes that may be required

FAQs ABOUT SMA AND SPINRAZA

Includes the answers to questions that your office may have about SMA and SPINRAZA

SPINRAZA CLINICAL OVERVIEW

Provides information about the multiple clinical studies of SPINRAZA, including the trial designs and efficacy and safety results

TIPS TO SUCCESSFULLY COMPLETING A SPINRAZA START FORM

Explains the SPINRAZA Start Form and provides tips on how to complete each section so that your patients can enroll in Biogen support services

Helpful Guides

GUIDE TO PRIOR AUTHORIZATION (PA) SUBMISSIONS

Provides steps and tips when submitting a PA

GUIDE TO REQUESTING A MEDICAL EXCEPTION (ME)

Contains tips for submitting an ME

Sample Letters

SAMPLE LETTER OF MEDICAL NECESSITY

Provides a Word template of a sample letter to use when requesting an ME for a patient

Practice/Facility Resources

INSURANCE CARRIER CONTACT SHEET

Provides a template to help your office record contact information for the insurance carriers that are contacted the most

UNDERSTANDING MEDICAL VS PHARMACY BENEFIT

Includes overview information about distinguishing between medical and pharmacy benefit cards

Key Icon

For any access, reimbursement, or distribution questions about SPINRAZA, contact your Biogen representative or call a Lead Case Manager (LCM) at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 AM-8:00 PM ET, to get more information about SMA360o™ support services.

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. Perform a platelet count and coagulation laboratory testing at baseline and prior to each administration of SPINRAZA and as clinically needed.

In a clinical study, 11% of SPINRAZA-treated patients with normal or above normal platelet levels at baseline developed a platelet level below the lower limit of normal compared to zero sham-procedure control patients. No patient had a platelet count <50,000 cells per mcL and no patient developed a sustained low platelet count despite continued drug exposure.

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 a clinical study (mean treatment exposure 7 months), 33% of SPINRAZA-treated patients had elevated urine protein, compared to 20% of sham-control patients. In a group of later-onset SMA patients (mean treatment exposure 34 months), 69% had elevated urine protein.

No elevations in serum creatinine or cystatin C were observed in studies with SPINRAZA. Conduct quantitative spot urine protein testing (preferably using a first morning urine specimen) at baseline and prior to each dose of SPINRAZA. For urinary protein concentration >0.2 g/L, consider repeat testing and further evaluation.

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 that occurred in the controlled study in at least 20% of SPINRAZA-treated patients and occurred at least 5% more frequently than in control patients were upper respiratory infection (39% vs 34%), lower respiratory infection (43% vs 29%), and constipation (30% vs 22%). Serious adverse reactions of atelectasis were more frequent in SPINRAZA-treated patients (14%) than in control patients (5%). Because patients in the controlled study were infants, adverse reactions that are verbally reported could not be assessed in this study. In the open-label studies, the most common adverse events in later onset patients were headache (50%), back pain (41%) and post lumbar puncture syndrome (41%).

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.