Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the
www.fepblue.org
website.
Nusinersen (Spinraza) may be considered medically necessary when the following criteria are met:
-
The individual has a diagnosis of Spinal Muscular Atrophy (SMA) type 1,2, or 3;
and
-
The individual's diagnosis was confirmed by genetic testing confirming the mutation or deletion of genes in chromosome 5q (medical records required);
and
-
Information has been provided that indicates the individual has two (2) or more copies of SMN2 gene as determined by genetic testing;
and
-
If the individual has ONE of the following:
-
Type 1 or 2 and information has been provided that indicates the individual had onset of SMA symptoms at or before 21 months of age;
or
-
Type 3 and information has been provided that indicates the individual's onset of SMA symptoms occurred after 18 months of age;
and
-
The individual has had at least one of the following baseline (prior to starting therapy with the requested agent) functional assessments based on individual age and motor ability:
- Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND)
- Hammersmith Infant Neurological Examination (HINE-2)
- Hammersmith Functional Motor Scale - Expanded (HFMSE)
- Six-minute walk test (6MWT)
- Bayley Scales of Infant and Toddler Development (BSID)
- Motor Function Measurement score (MFM32)
-
Revised Upper Limb Module (RULM) test;
and
-
The individual does NOT require invasive ventilation or tracheostomy;
and
-
The individual has not received gene therapy for the requested indication (e.g., Zolgensma [onasemnogene abeparvovec-xioi]);
and
-
The individual will NOT be using the requested agent in combination with Evrysdi (risdiplam) for the requested indication;
and
-
The prescriber is a specialist in the area of the individual's diagnosis (e.g., neurologist, geneticist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis;
and
- The requested quantity (dose) is within FDA labeled dosing for the requested indication.
Initial Authorization:
6 months
Reauthorization Criteria
Continuation of treatment with nusinersen (Spinraza) beyond six (6) months after initiation of therapy may be considered medically necessary when
ALL
of the following are met:
-
The individual was previously approved for the requested agent through Blue Cross Blue Shield of North Dakota's precertification process;
and
-
The individual has had improvements or stabilization from baseline (prior to starting therapy with the requested agent) with the requested agent as indicated by one of the following functional assessments based on individual age and motor ability:
- Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND)
- Hammersmith Infant Neurological Examination (HINE-2)
- Hammersmith Functional Motor Scale - Expanded (HFMSE)
- Six-minute walk test (6MWT)
- Bayley Scales of Infant and Toddler Development (BSID)
- Motor Function Measurement score (MFM32)
-
Revised Upper Limb Module (RULM) test;
and
-
The individual does NOT require invasive ventilation or tracheostomy;
and
-
The individual has not received gene therapy for the requested indication (e.g., Zolgensma [onasemnogene abeparvovec-xioi]);
and
-
The individual will NOT be using the requested agent in combination with Evrysdi (risdiplam) for the requested indication;
and
-
The prescriber is a specialist in the area of the individual's diagnosis (e.g., neurologist, geneticist) or the prescriber has consulted with a specialist in the area of the individual's diagnosis;
and
- The requested quantity (dose) is within FDA labeled dosing for the requested indication.
The use of nusinersen (Spinraza) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
