CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Susvimo (ranibizumab) for intravitreal use via ocular implant

Defines medical benefit coverage, prior authorization, and clinical criteria for Susvimo (ranibizumab) intravitreal implant for neovascular (wet) age-related macular degeneration and diabetic macular edema for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySusvimo (ranibizumab) for intravitreal use via ocular implant

Policy CodePolicy N/A

Change TypeNo material change

Effective Date06/01/2022

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing age ≥18, diagnosis (nAMD or DME), prior response to at least two intravitreal VEGF injections, baseline and periodic BCVA, and retina specialist involvement.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 mg/24 wksapproved implant dose/maintenance interval

6 moinitial authorization duration

12 morenewal authorization duration

3xendophthalmitis rate vs monthly

J2779applicable HCPCS/CPT code

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met for initial therapy:

Initial Criteria: Patient is at least 18 years of age; prescribed by or in consultation with a retina specialist; diagnosis of neovascular (wet) age-related macular degeneration (AMD) or diabetic macular edema (DME); patient has previously responded to at least two intravitreal injections of a VEGF inhibitor medication (e.g., aflibercept, bevacizumab, brolucizumab, ranibizumab); best corrected visual acuity (BCVA) measured at baseline and periodically during treatment; for AMD: inadequate response, intolerance, or contraindication to bevacizumab, Lucentis (ranibizumab) or Byooviz (ranibizumab) and Eylea (aflibercept); for DME: inadequate response, intolerance, or contraindication to bevacizumab, Lucentis (ranibizumab), and Eylea (aflibercept); patient is free of ocular and periocular infection; no active intraocular inflammation; therapy will not be used concurrently with other ophthalmic VEGF inhibitors unless supplemental treatment is clinically necessary after 16 weeks of Susvimo monotherapy with documentation of treatment outcome; patient has not required removal of a Susvimo implant in the past; no hypersensitivity to other ranibizumab products; current Susvimo-treated patients or MMP members who received Susvimo within the prior 365 days are exempt from step therapy requirements.

All bullets from Initial Criteria must be satisfied

Continuation Therapy

Covered when ALL of the following are met for continuation therapy:

Continuation Criteria: Patient continues to meet all initial criteria; patient is tolerating treatment without unacceptable toxicity (examples include endophthalmitis, retinal detachment, implant dislocation, vitreous hemorrhage, conjunctival erosion, conjunctival retraction); patient has had a beneficial response to therapy (e.g., improvement in baseline BCVA) and continued administration is necessary for maintenance; for supplemental treatment only: documented insufficient response during Susvimo every-24-week regimen and requires supplemental intravitreal ranibizumab.

Continuation requires demonstration of benefit and tolerability

Investigational/Off-Label Use

Not covered when used outside recognized indications or doses:

Investigational/Unrecognized Use: Therapies used at doses or for conditions other than those recognized as medically accepted indications per standard reference compendia (e.g., AHFS-DI, Micromedex DrugDex, Clinical Pharmacology, Lexi-Drugs) or peer-reviewed published literature are considered investigational and are not covered by Neighborhood Health Plan of Rhode Island.

Neighborhood does not provide coverage for investigational uses

Uses at doses or for conditions that are not recognized as medically accepted indications in standard reference compendia are considered investigational and are not covered. Accepted compendia include AHFS-DI, Thomson Micromedex DrugDex, Clinical Pharmacology, Wolters Kluwer Lexi-Drugs, or peer-reviewed medical literature that provides sufficient evidence to support the use.

Susvimo (ranibizumab) via intravitreal implant is covered under the Medical Benefit only when used within the policy’s stated guidelines. Use outside these guidelines or for investigational purposes may result in non-payment unless an exception is approved.

Coding and Quantity Limits

Applicable HCPCS/CPT CodesHCPCSCovered

J2779

Injection, ranibizumab, via intravitreal implant (susvimo), 0.1 mg

Dose and billable unit

Approved implant dose2 mg delivered continuously via Susvimo ocular implant (0.02 mL of 100 mg/mL)

Billable unit1 billable unit = 0.1 mg

Quantity limit / maximum dose4 mg (40 units) every 168 days (approximately 6 months)

Supplemental intravitreal injectionIf clinically necessary, supplemental 0.5 mg intravitreal ranibizumab may be administered while implant is in place

Surgical handling noteInitial fill, implant insertion and implant removal are surgical procedures performed under aseptic conditions in an operating room

Prior Authorization & Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Coverage of Susvimo (ranibizumab) via intravitreal implant will be reviewed prospectively via the prior authorization process and must meet the clinical criteria outlined in the policy. Use outside of these guidelines may result in non-payment unless an exception is approved.

Requests reviewed prospectively via prior authorization
Coverage determined based on policy clinical criteria

Step Therapy

Step Therapy Requirements & Exceptions

Step therapy requirements apply for most members. Members who have previously received Susvimo within the past 365 days or patients currently on treatment with Susvimo may remain on treatment and are not subject to step therapy. For new starts, the patient must have previously responded to at least two intravitreal injections of a VEGF inhibitor (e.g., aflibercept, bevacizumab, brolucizumab, ranibizumab) and, depending on indication, have an inadequate response, intolerance, or contraindication to other specified agents (see policy).

Background

Susvimo is an ocular implant that continuously delivers ranibizumab 2 mg (0.02 mL of 100 mg/mL solution) with refill-exchange procedures approximately every 24 weeks (about 6 months). The initial fill, implant insertion, and implant removal are surgical procedures performed under aseptic conditions by a physician experienced in vitreoretinal surgery. Supplemental intravitreal ranibizumab (0.5 mg) may be given while the implant is in place if clinically necessary.

Definitions

Susvimo ocular implant — definition and refill details

DefinitionSusvimo ocular implant: an ocular implant that continuously delivers ranibizumab 2 mg (0.02 mL of 100 mg/mL) for treatment of nAMD and DME in patients who previously responded to ≥2 intravitreal VEGF injections

Refill-exchange intervalRefill-exchange procedures are administered every 24 weeks (approximately every 6 months)

Refill-exchange procedure requirementsRefill-exchange and implant procedures must be performed under aseptic conditions by a physician experienced in ophthalmic or vitreoretinal surgery

Timing constraint for initial fill/insertionNo more than 30 minutes should pass between the initial fill of the ocular implant and insertion into the patient's eye

Safety profile noteClinical trials showed equivalent visual outcomes vs monthly ranibizumab but a higher rate of certain ocular adverse events, including a 3-fold higher rate of endophthalmitis

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicySusvimo (ranibizumab) for intravitreal use via ocular implant

Policy CodePolicy N/A

Change TypeNo material change

Effective Date06/01/2022

Next Review DateN/A

SourceLink

On This Page

Patients previously treated with Susvimo within 365 days: step therapy exempt
Initial therapy requires prior response to ≥2 intravitreal VEGF inhibitor injections
For nAMD: inadequate response/intolerance/contraindication to bevacizumab, Lucentis, Byooviz, and Eylea required
For DME: inadequate response/intolerance/contraindication to bevacizumab, Lucentis, and Eylea required

Documentation Required

Required Documentation for Prior Authorization

The following documentation must be submitted with prior authorization requests to support medical necessity and facilitate review: age, treating provider specialty, diagnosis, prior treatment history, baseline and periodic ocular metrics, and safety/tolerability information.

Patient age (≥18 years)
Prescribing or consulting provider is a Retina Specialist
Diagnosis: neovascular (wet) AMD or Diabetic Macular Edema (DME)
Documentation of prior response to ≥2 intravitreal VEGF inhibitor injections (agent names and dates)
For nAMD/DME: documentation of inadequate response, intolerance, or contraindication to specified agents as described in policy
Baseline best corrected visual acuity (BCVA) and periodic BCVA measurements during treatment
Documentation of absence of ocular/periocular infection and absence of active intraocular inflammation
If supplemental intravitreal ranibizumab is used, include documentation of insufficient response to Susvimo monotherapy at 24 weeks and clinical rationale
History of any prior Susvimo implant removal or hypersensitivity to ranibizumab products

Denial Risk

Prior Authorization and Guideline Adherence

Use of Susvimo outside the policy criteria (for example, without required prior treatments, without specialist involvement, or without required documentation) may result in denial of coverage or non-payment. Coverage decisions are made via the prior authorization process and continuation will be reviewed against continuation criteria including treatment benefit and absence of unacceptable toxicity.

Non-adherence to published guideline criteria may result in non-payment
Continuation requires documented benefit and tolerability (no unacceptable toxicities such as endophthalmitis, retinal detachment, implant complications)
Initial coverage duration: 6 months; continuation coverage: 12 months (subject to meeting continuation criteria)