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INDEX:
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Effective Date: 07/01/2021 Title: Viltepso (viltolarsen)
Revision Date: Document: BI687:00
CPT Code(s): J1427
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Viltepso (viltolarsen) requires prior authorization.

2)    Viltepso is used to treat Duchenne Muscular Dystrophy.

3)    Viltepso is a specialty medication covered under the medical benefit.


Medical Statement

Duchenne Muscular Dystrophy

1)    Diagnosis of DMD with mutation amenable to exon 53 skipping confirmed by genetic testing;

2)    Prescribed by or in consultation with a neurologist;

3)    Age ≤ 9 years at therapy initiation;

4)    4. Member has all of the following assessed within the last 30 days (a, b, and c):

a.    Ambulatory function (e.g., ability to walk with or without assistive devices, not wheelchair dependent) with one of the following (i or ii):

                                          i.    6-minute walk test (6MWT) distance ≥ 201 m;

                                        ii.    Time-to-stand (TTSTAND) < 10 seconds;

b.    Stable cardiac function with left ventricular ejection fraction (LVEF) ≥ 40%;

c.    Stable pulmonary function with predicted forced vital capacity (FVC) ≥ 50%;

5)    Inadequate response (as evidenced by a significant decline in 6MWT, TTSTAND, LVEF, or FVC) despite adherent use of an oral corticosteroid (e.g., prednisone, Emflaza™) for ≥ 6 months, unless contraindicated or clinically significant adverse effects are experienced; *Prior authorization is required for Emflaza

6)    Viltepso is prescribed concurrently with an oral corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;

7)    Viltepso is not prescribed concurrently with other exon-skipping therapies (e.g., Exondys 51®, Vyondys 53™);

8)    Dose does not exceed 80 mg/kg per week.

 

Approval duration: 6 months

 

Reauthorization Criteria

 

1)    Currently receiving medication for DMD with mutation amenable to exon 53 skipping or member has previously met initial approval criteria;

2)    Member is responding positively to therapy as evidenced by one of the following (a or b):

a.    All of the following assessed within the last 6 months (i, ii, and iii):

                                          i.    Ambulatory function (e.g., ability to walk with or without assistive devices, not wheelchair dependent) with one of the following (1 or 2): 1) 6MWT distance ≥ 201 m; 2) TTSTAND < 10 seconds;

                                        ii.    Stable cardiac function with LVEF ≥ 40%;

                                       iii.    Stable pulmonary function with predicted FVC ≥ 50%;

b.    Member has received this medication via a healthcare insurer without meeting the requirements above (see criterion 2a), and medical record shows improved or stable LVEF and FVC, assessed within the last 6 months;

3)    Member has been assessed by a neurologist within the last 6 months;

4)    Viltepso is prescribed concurrently with an oral corticosteroid, unless contraindicated or clinically significant adverse effects are experienced;

5)    Viltepso is not prescribed concurrently with other exon-skipping therapies (e.g., Exondys 51, Vyondys 53);

6)    If request is for a dose increase, new dose does not exceed 80 mg/kg per week.

 

Approval duration: 6 months


Reference

1)    Viltepso Prescribing Information. Paramus, NJ: NS Pharma, Inc.; August 2020. Available at: www.viltepso.com. Accessed October 9, 2020.

2)    Clemens PR, Rao VK, Connolly AM, et al. Safety, tolerability, and efficacy of viltolarsen in boys with Duchenne muscular dystrophy amenable to exon 53 skipping: A phase 2 randomized clinical trial. JAMA Neurol. 2020; 77(8) 982-991.

3)    ClinicalTrials.gov. Study to assess the efficacy and safety of viltolarsen in ambulant boys with DMD (RACER53). Available at: https://clinicaltrials.gov/ct2/show/NCT04060199. Accessed October 9, 2020.

4)    Birnkrant DJ, Bushby K, Bann CM, et al. Diagnosis and management of Duchenne muscular dystrophy, part 1: diagnosis, and neuromuscular, rehabilitation, endocrine, and gastrointestinal and nutritional management. Lancet Neurol. 2018; 17: 251-267.

5)    Gloss D, Moxley RT, Ashwal S, Oskoui M. Practice guideline update summary: corticosteroid treatment of Duchenne muscular dystrophy. Neurology. 2016; 86: 465-472. Reaffirmed on January 26, 2019.

6)    Institute for Clinical and Economic Review. Deflazacort, eteplirsen, and golodirsen for Duchenne muscular dystrophy: Effectiveness and value. Published August 15, 2019. Available at: https://icer-review.org/material/dmd-final-evidence-report. Accessed October 9, 2020.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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