RESOURCE LIBRARY / ACCESS & REIMBURSEMENT

Access and reimbursement resources for SPINRAZA

Resources to help your practice
navigate the SPINRAZA
treatment journey

Obtaining approval for your patient’s SPINRAZA treatment for SMA may involve several steps, which is why we have developed a robust set of resources to assist your practice. Explore the sections below to find relevant, downloadable resources for gaining access to SPINRAZA, navigating reimbursement claims, and working with a specialty pharmacy.

Find the resources you need

ACCESS

Information to help you navigate the steps to product access, including prior authorizations, medical exceptions, appeals, and reauthorizations.
Sample Letter of Medical Necessity
template
Sample Letter of Medical Necessity
for Continuation of Care Resource Guide for Practices &
Facilities

FINANCIAL ASSISTANCE

Resources for copay and coinsurance programs and information on how SMA360°™* patient support can help with SPINRAZA costs.
Copay reimbursement form
Reimbursement tracking log

*SMA360° services from Biogen are available only to those who have been prescribed SPINRAZA. SMA360° is intended for US residents only.

 

SPECIALTY PHARMACY

SPINRAZA can be ordered only directly through a specialty distributor, CuraScript SD®, for buy-and-bill, or from a specialty pharmacy, Accredo®. Ordering SPINRAZA follows a similar process as other products administered at your site of care. For assistance with the procurement process, please contact your Biogen Representative.
Resource Guide for Practices &
Facilities
 

Billing Code for SPINRAZA

The NDC for SPINRAZA is 64406-058-01

Did you know the SMA360° support program provides services for patients who have been prescribed SPINRAZA?

EXPLORE SMA360° PATIENT SUPPORT
START YOUR PATIENT ON SPINRAZA

INDICATION

SPINRAZA® (nusinersen) 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.

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

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ABOUT SMA
What Is SMA? Multidisciplinary Care
Why SPINRAZA?
About SPINRAZA How SPINRAZA Works Presymptomatic Efficacy Early-Onset Efficacy Later-Onset Efficacy Real-World Evidence Safety
Starting SPINRAZA
How to Start Dosing & Administration
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