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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: 07/01/2022 Title: Vabysmo
Revision Date: 09/01/2023 Document: BI706:00
CPT Code(s): C9097, J2777
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)    Vabysmo (faricimab-svoa) requires prior authorization.

2)    Vabysmo is indicated for the treatment of patients with:

• Neovascular (wet) age-related macular degeneration (nAMD)

• Diabetic macular edema (DME)


Medical Statement

Initial Approval Criteria

 

A. Ophthalmic Disease (must meet all):

 

1. Diagnosis of one of the following (a or b):

a. nAMD;

b. DME;

2. Prescribed by or in consultation with an ophthalmologist;

3. Age ≥ 18 years;

4. Failure of bevacizumab intravitreal solution, unless contraindicated or clinically significant adverse effects are experienced;

*Prior authorization may be required for bevacizumab intravitreal solution. Requests for IV formulations of Avastin, Mvasi, and Zirabev will not be approved

5. Dose does not exceed (a or b):

a. nAMD: 6 mg (1 vial) every 4 weeks for the first 4 doses;

b. DME: one of the following (i or ii):

i. Fixed dosing regimen: 6 mg (1 vial) every 4 weeks for the first 6 doses, then 6 mg every 8 weeks thereafter;

ii. Variable dosing regimen: 6 mg (1 vial) every 4 weeks for at least 4 doses and until a central subfield thickness (CST) of < 325 μM is achieved, then one of the following (a or b):

a) 6 mg (1 vial) every 8 to 16 weeks;

b) 6 mg (1 vial) every 4 weeks, and one of the following (a or b):

6. Member has had an inadequate response to every 8-week dosing, defined as one of the following (a or b):

a) CST has increased between > 10% and ≤ 20% with an associated ≥ 5- to < 10-letter best-corrected visual acuity (BCVA) decrease from the reference values;

b) CST has increased by > 20% without an associated ≥ 10-letter BCVA decrease from the reference values;

7. Member has had an inadequate response to every 12-week dosing, defined as > 10% increase in CST and ≥ 10-letter BCVA decrease from the reference value.

 

Approval duration:

nAMD – 4 months (first 4 doses)

DME – 6 months (up to 6 doses)

 

 

Continued Therapy

A. Ophthalmic Disease (must meet all):

1. Currently receiving medication via QualChoice benefit or member has previously met initial approval criteria;

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

a. Regressed neovascularization;

b. Improvement in visual acuity;

c. Maintenance of corrected visual acuity from prior treatment;

d. Supportive findings from optical coherence tomography or fluorescein angiography;

 

3. If request is for a dose increase, new dose does not exceed (a or b):

a. nAMD: one of the following (i, ii, or iii):

i. 6 mg (1 vial) every 16 weeks;

ii. 6 mg (1 vial) every 12 weeks if member has documented active disease at week 24;

iii. 6 mg (1 vial) every 8 weeks if member has documented active disease at week 20;

 

b. DME: one of the following (i or ii):

 i. Fixed dosing regimen: 6 mg (1 vial) every 8 weeks;

ii. Variable dosing regimen: 6 mg (1 vial) every 4 weeks until a CST of < 325 μM is achieved, then one of the following (1 or 2):

1) 6 mg (1 vial) every 8 to 16 weeks;

2) 6 mg (1 vial) every 4 weeks, and one of the following (a or b):

a) Member has had an inadequate response to every 8-week dosing, defined as one of the following (i or ii):

i) CST has increased between > 10% and ≤ 20% with an associated ≥ 5- to < 10-letter BCVA decrease from the reference values);

ii) CST has increased by > 20% without an associated ≥ 10-letter BCVA decrease from the reference values;

 

b) Member has had an inadequate response to every 12-week dosing, defined as > 10% increase in CST and ≥ 10-letter BCVA decrease from the reference value.

 

 

Approval duration: 6 months

 

 

Codes Used In This BI:

 

1)    C9097  Inj, faricimab-svoa, 0.1mg (Code deleted and replaced by J2777 eff 10-1-22)

2)    J2777       Injection, faricimab-svoa, 0.1 mg


Reference

1. Vabysmo Prescribing Information. South San Francisco, CA: Genentech, Inc.; January 2022. Available at: www.vabysmo.com. Accessed February 17, 2022.

2. American Academy of Ophthalmology Retina/Vitreous Panel. Preferred Practice Pattern® Guidelines. Age-Related Macular Degeneration. San Francisco, CA: American Academy of Ophthalmology; October 2019. Available at www.aao.org/ppp. Accessed February 18, 2022.

3. Faricimab Drug Monograph. Clinical Pharmacology. Available at http://www.clinicalpharmacology-ip.com/. Accessed February 18, 2022.

4. Heier J, Khanani A, Quezada RC, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet 2022; 399(10326):729-740. doi: https://doi.org/10.1016/S0140-6736(22)00010-1

5. Heier J, Basu K, Ives J, et al. Faricimab in neovascular age related macular degeneration TENAYA and LUCERNE study results. Presented at the Angiogenesis in February 12-13, 2021. Oral presentation. Available at: https://medically.gene.com/global/en/unrestricted/ophthalmology/ANGIOGENESIS-2021/angiogenesis-2021-presentation-heier-phase-3-namd-tenay.html. Accessed February 18, 2022.

 

Addendum:

1)    Effective 10-01-2022: C9097 deleted and replaced by J2777.

2)    Effective 09/01/2023: Updated verbiage.


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.
This policy has recently been updated. Please use the index above or enter policy title in search bar for the latest version.