Local Coverage Article Response to Comments

Response to Comments: Nusinersen (Spinraza)

A56058

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Article ID
A56058
Article Title
Response to Comments: Nusinersen (Spinraza)
Article Type
Response to Comments
Original Effective Date
07/26/2018
Retirement Date
N/A
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Article Guidance

Article Text

The following are the comment summaries and contractor responses for Novitas Solutions Draft Local Coverage Determination (LCD) DL37682 Nusinersen (Spinraza) which was posted for comment on January 18, 2018 and presented at the February 2018 Contractor Advisory Committee (CAC) Meeting. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments

NumberCommentResponse
1

One commenter asked that in addition to the board certified neurologist, a board-certified Physical Medicine and Rehabilitation physician with subspecialty certificate in Neuromuscular Medicine also be able to prescribe or administer Spinraza. Additionally, one commenter asked for pediatricians, pulmonologists and any physician with expertise in spinal muscular atrophy (SMA) to be able to prescribe and administer Spinraza.

Thank you for your comments. After review, the policy will be updated to allow a board-certified Physical Medicine and Rehabilitation physician with a subspecialty certificate in Neuromuscular Medicine to also prescribe Spinraza. Other provider specialties with “expertise” in spinal muscular atrophy (SMA) are not considered to have met the specific certification requirements to prescribe/order Spinraza as outlined in the LCD. It is important to note, that this policy does not limit which physician specialties can administer Spinraza to the patient, only which physician specialty can prescribe/order the treatment for the patient.

2

Many commenters would like to see Spinraza covered in those who develop signs and symptoms after 21 months of age. One commenter mentioned a study that included 6 individuals (phase Ib/IIa) who had onset of symptoms after 21 months of age. Commenters mentioned the difficulty of historians recalling the onset of symptoms in older patients and also difficulty in obtaining medical records in some cases. They also expressed an opinion that some patients may not exhibit any signs and symptoms until later in life yet still have a need for Spinraza.

Thank you for your comments. After careful consideration, the requirement to have documentation of developed signs and symptoms by 21 months of age will be removed from the final policy.

3

A few commenters would like clarification on what measurement scales are approved. One commenter asked for manual muscle testing (MMT) to be an approved measurement scale.

Thank you for your comments. The policy does not specify which measurement scale to use. It is recognized that there are many measurement scales available and that different patients may best be monitored by different measurement scales. This policy allows the treating physician to utilize the best objective measurement scale to document both the patient’s baseline and response to treatment. It is expected that the same objective measurement scale will be used for both baseline and response to treatment.

4

A few commenters mentioned that the continuation criteria for coverage in the draft is confusing and needs clarification. They are particularly concerned about the words “sustained beneficial clinical response to treatment." Commenters would like to see that stability of motor function is considered a beneficial response as is a reduction in the rate of motor function decline.

Thank you for your comments. The intent of the policy is that a sustained beneficial clinical response includes those that improve motor function, those that have stable motor function and those that have a slower rate of decline in motor function while on Spinraza. If a patient is able to demonstrate one of these three, then that is considered a beneficial, clinical response to treatment. After review, agree to revise the statement for clarification purposes in the final policy.

5

A couple of commenters wanted Place of Service (POS) 11 – Office added. One commenter wanted POS 49 – Independent Clinic added.

Thank you for your comments. After review, POS 11 will be added for coverage. We will not be adding POS 49 at this time as it can be used by a variety of settings most of which do not seem appropriate for administering Spinraza. If there is a specific provider need for POS 49, the contractor can consider this on a case-by-case basis through the redetermination (appeals) process.

6

Multiple commenters mentioned obtaining coverage for Medicaid (emphasis added).

As a Medicare Administrative Contractor, Novitas is not involved in setting any coverage policies or rules for Medicaid.

7

Many commenters requested coverage for all types (I – IV) of SMA. One commenter supported the coverage of Spinraza for SMA types I – III based on published available literature and clinical trials data.

Thank you for your comments. No change will be made to the LCD. If additional evidence becomes available for review to expand coverage, please submit to the contractor for consideration once this LCD is final through the JL LCD Reconsideration Process or JH LCD Reconsideration Process.

8

One commenter mentioned that the full effect of Spinraza may not be known after only 10 months of treatment (first year of treatment statement in the draft LCD).

Thank you for your comment. We will revise the policy to include the loading doses and 3 maintenance doses in the initial treatment phase prior to the evaluation for continuation of Spinraza, thus allowing for a longer time frame for the patient to show any response to treatment.

9

One commenter wanted genetic confirmation of SMA regardless of phenotype as the only basis for Spinraza coverage.

Thank you for your comment. Genetic confirmation remains one of the criteria needed to be met for coverage. Criteria listed are based on published, clinical trial data. If additional studies become available for review, please submit them to the contractor for consideration once this LCD is final through the JL LCD Reconsideration Process or JH LCD Reconsideration Process.

10

One commenter felt that the history and background section of the LCD is misleading.

Thank you for your comment. The history and background section provides an overview of SMA and potential treatment options. There were no specific sentences or paragraphs identified by the commenter as being misleading. This section has no bearing on coverage. No changes will be made to the final policy.

Associated Documents

Related Local Coverage Documents
LCDs
L37682 - (MCD Archive Site)
Related National Coverage Documents
N/A
Public Versions
Updated On Effective Dates Status
07/20/2018 07/26/2018 - N/A Currently in Effect You are here

Keywords

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