Insurance and Billing

ARTEMIS / Adverum / ADVM-022-12

A Multi-Center, Randomized, Double-Masked, Active-Comparator-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Ixoberogene soroparvovec (Ixo-vec) in Participants with Neovascular Age-Related Macular Degeneration

Inclusion Criteria

• Able and willing to provide informed consent (or have a legally authorized representative who is able and willing to provide informed consent) prior to any study assessments and procedures and comply with the study requirements and visits
• Male or female with a diagnosis of CNV secondary to nAMD in the study eye, with nAMD disease activity (i.e., any fluid [IRF or SRF] present on SD-OCT) at Screening Visit 1 (Day -56 to -49)
• At least 50 years old at Screening Visit 1 (Day -56 to -49)
• ETDRS BCVA letter score ≥ 35 and ≤ 78 (approximate Snellen equivalent of 20/200 to 20/32) in the study eye at Screening Visit 1 (Day -56 to -49) with no loss of vision ≥ 5 ETDRS letters from Screening Visit 1 (Day -56 to -49) to Day 1
• ETDRS BCVA letter score ≥ 35 (approximate Snellen equivalent of 20/200 or better) in the non-study eye at Screening Visit 1 (Day -56 to -49)

• Demonstrated a meaningful anatomic response to anti-VEGF therapy, as determined by the CRC based on SD-OCT images of the study eye collected at Screening Visit 1 (Day - 56 to Day -49) and at Day 1. A meaningful anatomic response is defined as either:

  • Complete resolution of fluid (SRF/IRF) at Day 1, OR

  • Reduction in CST at Day 1 from Screening Visit 1 (Day -56 to Day -49) of:  

    • 10% for participants with CST > 300 μm at Screening Visit 1

    • 5% for participants with CST ≤ 300 μm at Screening Visit 1

• Able to reliably use eye drops per protocol, according to the Investigator’s judgment

• Women of childbearing potential (i.e., postmenarcheal, has not reached a postmenopausal state [> 12 continuous months of amenorrhea with no identified cause other than menopause], or has not undergone surgical sterilization [removal of both ovaries and/or uterus]) must have a negative pregnancy test during screening and agree to use an acceptable form of contraception that results in a failure rate < 1% per year (e.g., bilateral tubal ligation; surgical sterilization of the participant’s sole male partner; oral, implantable, or injectable hormonal contraceptives that inhibit ovulation; hormone-releasing intrauterine devices; copper intrauterine devices) or agree to remain abstinent (refrain from heterosexual intercourse). Of note, contraception methods that do not result in a failure rate of < 1% per year (e.g., male or female condom with or without spermicide; cap, diaphragm, or sponge with spermicide) are not acceptable. The reliability of sexual abstinence should be evaluated in relation to the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception

• Sexually active male participants must agree to use an acceptable form of contraception that results in a failure rate < 1% per year during the study, if their female partners are of childbearing potential

General Exclusion Criteria

• History of a medical condition (systemic disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) giving reasonable suspicion of a condition that contraindicates the use of Ixo-vec, compromises the participant’s ability to comply with the planned study activities, or that might affect the interpretation of the results of the study or render the participant at high risk for treatment complications in the opinion of the Investigator. History of severe COVID-19 infection may meet this exclusion criteria if, in the opinion of the Investigator, it is likely to lead to any of the complications listed above.

• Received any prior gene therapy
• Received any non-gene therapy IMP or medical device in the study eye within 3 months of Screening Visit 1 (Day -56 to Day -49) or 5 half-lives of the IMP prior to dosing with Ixo-vec, whichever is longer
• History of allergy, hypersensitivity, or contraindications to the use of any product or its excipients administrated within this protocol including aflibercept, corticosteroids (i.e., difluprednate), or fluorescein dye or sodium fluorescein used in angiography (mild allergy amenable to treatment is allowable)
• Evidence of poorly controlled diabetes or glycated hemoglobin (HbA1c) ≥ 8.0% from Screening Visit 1 (Day -56 to Day -49) to Week 1
• Female participants who are pregnant or breastfeeding or who intend to become pregnant or breastfeed in the future

• History or evidence of any of the following cardiovascular diseases:

  • Myocardial infarction in the 6-month period prior to Day 1

  • Uncontrolled hypertension defined as systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg, despite using blood pressure-lowering medication within the screening period. If blood pressure-lowering medications are required, participant should be on a stable dose of the same medication continuously for 30 days prior to Day 1

  • Stroke in the 6-month period prior to Day 1

• Any history of ongoing bleeding disorders. The use of aspirin or other anticoagulants (e.g., Factor Xa inhibitors) is permitted
• Use of systemic immunosuppressive drugs (e.g., intravenous steroids, methotrexate, azathioprine, cyclosporin, secukinumab, denosumab, and anti-tumor necrosis factors [TNFs], such as adalimumab, infliximab, etanercept) within the 90 days prior to Screening Visit 1 (Day -56 to Day -49). Low stable doses of corticosteroids (defined as ≤ 10 mg prednisolone / prednisolone or equivalent dose) are permitted, as well as any inhaled, nasal or dermal steroid use
• Received anti-VEGF IVT injection in the study eye within 28 days prior to Screening Visit 1 (Day -56 to -49) or systemic anti-VEGF therapy during the 3-month period prior to Screening Visit 1 (Day -56 to Day -49).

• History of malignancy within the 5 years prior to Screening Visit 1 (Day -56 to Day -49), except for the following adequately treated:

  • Local basal cell or squamous cell carcinoma of the skin

  • Carcinoma in situ of the cervix or breast

  • Papillary, non-invasive bladder cancer

  • Prostate cancer Stage 1 and 2 for which observation is clinically indicated with stable prostate-specific antigen for 6 months

  • Any other cancer that has been in complete remission for at least 2 years or considered surgically cured

• Positive for human immunodeficiency virus (HIV) infection or hepatitis B or C virus at Screening Visit 1 (Day -56 to Day -49) unless having received a documented cure for hepatitis C virus.
• History of COVID-19 or syphilis within 6 weeks prior to Week 1
• Any febrile illness within 1 week prior to Day 1

Ocular Exclusion Criteria

• Any active ocular or periocular infection (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in the study eye from Screening Visit 1 (Day -56 to Day -49) to Week 1
• Evidence of the total area of scar or macular fibrosis making up ≥ 50% of the total lesion area, atrophy, or other structural damage in the center of the fovea in the study eye as confirmed by the CRC at Screening Visit 1 (Day -56 to Day -49)
• Central subfield of the study eye affected by fibrosis or geographic atrophy, assessed by color fundus photography (CFP) at Screening Visit 1 (Day -56 to Day -49) and confirmed by the CRC
• Evidence of subretinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is ≥ 1 disc area in size in the study eye, as confirmed by the CRC at Screening Visit 1 (Day -56 to Day -49) (if blood is under the fovea, fovea must be surrounded 270 degrees by visible CNV)
• Any history or evidence of a concurrent intraocular condition in the study eye, including retinal diseases other than nAMD, that, in the judgment of the Investigator, could reduce the potential for visual improvement, confound assessment of the macula or require medical or surgical intervention during the study

• History or evidence of the following in the study eye:

  • Intraocular or refractive surgery within 90 days prior to Screening Visit 1 (Day -56 to Day -49)

  • Any previous penetrating keratoplasty or vitrectomy

  • Any previous panretinal photocoagulation

  • Any previous submacular surgery, other surgical intervention (including port delivery system) or laser treatment for age-related macular degeneration

• Any history or evidence of retinal detachment (with or without repair) or retinal pigment epithelium rip/tear in the study eye, as determined by the Investigator during screening or at Day 1
• Aphakia and/or complete or partial absence of posterior capsule at Screening Visit 1 (Day -56 to Day -49) or cataract extraction or yttrium aluminum garnet (YAG) laser capsulotomy in the study eye within 3 months prior to Screening Visit 1 (partial absence of the posterior capsule due to YAG laser capsulotomy performed > 3 months prior to Screening Visit 1 is acceptable)
• Uncontrolled ocular hypertension or glaucoma in the study eye from Screening Visit 1 (Day -56 to Day -49) to Week 1 (defined as IOP > 22 mmHg despite treatment with antiglaucoma medication, or according to Investigator’s judgment) or current use of ≥ 2 IOP lowering medications or normal tension glaucoma/suspect in the study eye
• Any history of IOP elevation related to topical steroid administration in either eye
• Any history of uveitis or inflammation (grade trace or above) except mild anticipated post-operative inflammation that resolved in either eye
• Any history of intraocular or periocular steroid treatment for any ocular condition (e.g., IVT Triesence®, Iluvien®, or Ozurdex®) within 6 months prior to Screening Visit 1 (Day -56 to Day -49)

• Any history of treatment with complement inhibitors (e.g., pegcetacoplan and avacincaptad pegol) for geographic atrophy in the study eye

• Known history of ocular herpes simplex virus, varicella-zoster virus, or cytomegalovirus, including viral uveitis, retinitis, or keratitis in either eye
• Previous therapeutic radiation near the region of the study eye

SEC is contracted as a participating provider or preferred provider with a multitude of health insurance plans. Many of these plans offer more than one insurance product, often with specific limitations. The best way to know if we take your insurance plan is to call your insurance provider directly and ask about the services you plan on receiving from our physicians. 

It is your responsibility as a patient to know your insurance coverage and familiarize yourself with your insurance benefits and cost-sharing agreement.

As a patient you are specifically responsible for:

·         Verifying that SEC is a contracted provider with your insurance plan.

·         Obtaining a referral prior to seeing our providers if required by your plan.

·         Knowing if an authorization is needed in advance of services being rendered.

·         Determining that you are eligible at the time of service.

·         Knowing what services are covered or not covered by your insurance plan.

·         Your co-payment, co-insurance, and deductible.

Current In-Network Carrier Relationships

Please note that we are continually updating our list of in-network carriers. If you would like to check an insurance not on this list or have additional questions, please contact our business office directly at (509) 623-9765 between 8:00 am and 4:30 pm, Monday - Friday.

• AARP Medicare Complete
• Aetna
• All Savers
• Allegiance
• Allied Benefit Systems
• Ameriben
• Asuris Northwest Health
• Benefit Administrative Systems
• Blue Cross of Idaho
• Champ VA
• Cigna
• Community Health Plan of Washington
• Corporate Benefit Services Vision Plan
• Cypress Benefit Administrators
• Department of Labor and Industries WA
• First Choice Health Network
• First Health Network
• GEHA
• Health Comp
• Health Net Commercial
• HMA
• Humana
• Indian Health Services
• Kaiser Permanente
• LifeWise
• Medica
• Medicaid of WA and ID
• Medicare
• Moda Commercial Plans
• Molina Healthcare of WA and ID
• Mountain Health Co-Op            
• Multiplan and PHCS
• Northwest Benefits Network
• Pacific Source Health Plans
• Premera Blue Cross
• Providence Health Plan
• Railroad Medicare
• Regence Blue Shield
• Tricare West Region
• TriWest Choice
• Trusteed Plan
• United Healthcare
• Vision Service Plan (VSP)
• Web TPA

Contact your insurance company directly to verify if a referral is needed.

It is the policy of SEC that payment is due at the time of service unless other financial arrangements are made in advance. We require all patients to pay their co-payment, co-insurance, and deductible at the beginning of each visit.  At the conclusion of your visit, you will be billed for any outstanding balances.

We will be happy to bill your medical or vision insurance as a courtesy, please provide your insurance information to the front office staff upon check-in. Billing your insurance does not place all financial responsibilities onto this practice and you will be held accountable for any unpaid balances by your plan.

SEC is contracted with many insurance carriers; however, our services may not be covered by your particular insurance plan. Being referred to our clinic by another physician does not guarantee that your insurance will cover our services.

It is recommended that you verify your insurance benefits and coverages prior to your visit. Do not assume that you will not owe anything if you have more than one insurance policy, a referral, or an authorization.

SEC is required to collect all co-payment, co-insurance, and deductible amounts at the time of service, per our contracts. Please do not ask us to write off these amounts from your account or apply additional discounts.

Payments can be made by:

• Calling our business office
• Mailing in a check
• Accessing Patient Portal
• Coming into the clinic in person

Accepted payment methods:

• Cash
• Check
• Credit/Debit
• Care Credit (Restrictions apply)

If you do not have insurance or SEC is not contracted with your specific insurance plan full payment is expected at the time of service. A 10% discount is applied for payments at time of service for patients that do not have insurance (certain exclusions may apply for elective services).

The No Surprises Act protects people covered under group and individual health plans from receiving surprise medical bills when they receive most emergency services, non-emergency services from out-of-network providers at in-network facilities, and services from out-of-network air ambulance service providers.

More info HERE. 

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