Tofersen (Qalsody™)
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the medical policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Qalsody is indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
This indication is approved under accelerated approval based on reduction in plasma neurofilament light chain
observed in patients treated with Qalsody. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review:
Chart notes or medical record documentation supporting use as applicable in section IV and V.
A. Initial Requests:
1. Member has weakness attributable to ALS confirmed by diagnostic tests including imaging, nerve conduction studies, laboratory values.
2. Genetic testing confirming SOD1 mutation
3. Forced Vital Capacity (FVC) > 45% of predicted value for gender, height and age
B. Continuation Requests:
1. Documentation of clinical benefit from Qalsody therapy
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a neurologist, neuromuscular specialist or physician specializing in the treatment of amyotrophic lateral sclerosis (ALS).
IV. CRITERIA FOR INITIAL APPROVAL
Authorization of 12 months may be granted for treatment of ALS when all of the following criteria are met:
A. Member is 18 year of age or older
B. Member has weakness attributable to ALS confirmed by diagnostics testing (e.g., medical history and diagnostic testing including, nerve conduction studies, imaging and laboratory values to support the diagnosis)
C. Genetic testing confirming a SOD1 mutation
D. Forced Vital Capacity (FVC) > 45% of predicted value for gender, height and age
E. Member does not have a tracheostomy
V. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for members continuing with Qalsody therapy for the treatment of ALS when the following criteria are met:
A. There is a clinical benefit from Qalsody therapy
B. Invasive ventilation or tracheostomy is not required
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
REFERENCES
1. Qalsody [package insert]. Cambridge, MA: Biogen MA, Inc.; April 2023.
2. Miller TM, Cudkowicz ME, Genge A, et al. VALOR and OLE Working Group. Trial of Antisense Oligonucleotide Tofersen for SOD1 ALS. N Engl J Med. 2022 Sep 22;387(12):1099-1110
3. EFNS Task Force on Diagnosis and Management of Amyotrophic Lateral Sclerosis; Andersen PM, et al. EFNS guidelines on the Clinical Management of Amyotrophic Lateral Sclerosis (MALS) – revised report of an EFNS task force. Eur J Neurol. 2012;19(3):360-75.
ORIGINAL EFFECTIVE DATE: 8/30/2023
MOST RECENT REVIEW DATE: 1/1/2024
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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