Insurance and Billing

Malbec / MK-8748-002 / EyeBio

A randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)

Inclusion Criteria

Participants must meet all of the following criteria:

• Be willing and able to understand the study procedures and risks involved and provide written informed consent before the first study-related activity
• Be male or female ≥50 years of age
• If female, have a negative serum pregnancy test at Screening and further negative urine tests immediately before each dose of study medication if the participant is a female of childbearing potential (defined as any female who has begun menstruation and who is not permanently sterile, and is not postmenopausal [defined as a female who has not had a menstrual period for at least 12 months without an alternative medical cause]); such participants must agree to use an acceptable method of contraception such as a condom and a second highly effective method of contraception as described in Appendix C from Screening up to and including 100 days after the last dose of study medication. If the participant is initiating hormonal contraception at the time of Screening or within 1 cycle of Day 1, participant agrees to use a double-barrier method of contraception until completing 1 full cycle of hormonal contraception. An acceptable double-barrier combination method is a condom with either diaphragm or sponge with spermicide
• If male, be surgically sterile for at least 6 weeks, or agree to use an acceptable method of contraception, such as a condom, and a second highly effective method of contraception as described in Appendix C from Screening up to and including 100 days after the last dose of study medication
• Have treatment-naive CNV secondary to AMD including subfoveal, juxtafoveal and extrafoveal lesions (evidenced by fluid, subretinal hyperreflective material, or leakage) or retinal angiomatous proliferations (RAP) and polypoidal choroidal vascularization (PCV)lesions, with a total lesion size (including blood, scar/atrophy & neovascularization) of≤9 disc areas (DA) (22.53 mm2), of which at least 50% must be active CNV in the study eye
• The diagnosis must have been made within 21 days prior to Day 1 of the study treatment (the maximum Screening Period for these participants is, therefore, 21 days)
• Have a decrease in vision in the study eye that has been determined by the Investigator to be primarily the result of NVAMD
• Have an ETDRS BCVA letter score between 78 and 24 (20/32 to 20/320 Snellen equivalent), inclusive, in the study eye. In the event both eyes are eligible, the worse-seeing eye should be enrolled in the trial
• Have a presence of IRF and/or SRF affecting the central subfield of the study eye on SD-OCT as determined by the IRC at Screening

Exclusion Criteria

Participants must not meet any of the following exclusion criteria:

General Exclusion Criteria:

• Have uncontrolled blood pressure at Screening, defined as systolic ≥ 180 mmHg and/or diastolic ≥100 mmHg while a participant is at rest
  • If a participant’s initial reading exceeds these values, a second reading may be obtained later the same day or on another day during the Screening period. If the participant’s blood pressure is controlled by antihypertensive medication, the participant should be taking the same medication continuously for at least 30 days prior to Day 1
• Have history of stroke (cerebral vascular accident) or myocardial infarction within 180 days prior to Day 1
• Have any active malignancy
• Currently have evidence of, or a history of, any clinically significant autoimmune, cardiovascular, hematologic, hepatic, metabolic, peripheral vascular, renal, or respiratory disease that would preclude trial participation in the opinion of the Investigator

Ocular Exclusion Criteria:

• Have a history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
• Have had Yttrium-Aluminium Garnet laser capsulotomy in the study eye within 90 days of Screening
• Have had any prior macular laser photocoagulation in the study eye
• Have uncontrolled glaucoma (defined as IOP ≥30 mmHg despite treatment with antiglaucoma medication) in the study eye
• Have had glaucoma-filtering surgery (trabeculectomy or tube shunt) in the study eye
• Have any history of retinal detachment or treatment or surgery for retinal detachment in the study eye
• Have any history of uveitis in either eye
• Have significant media opacities, including cataract, in the study eye that might interfere with VA, assessment of safety, optical coherence tomography (OCT), or fundus photography as determined by the IRC
• Have a cataract in the study eye that in the judgment of the Investigator is expected to require surgical extraction within 12 months of Screening
• Have aphakia in the study eye
• Have allergy to fluorescein dye
• Have had vitrectomy in the study eye
• Have known or former (if participant has undergone refractive and/or cataract surgery) refractive error with a spherical equivalent of ≥ −8 diopters in the study eye
• Have active retinal disease other than the condition under investigation in the study eye
• Have any history or evidence of a concurrent ocular condition present in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention or affect macular edema or alter VA during the study (e.g., vitreomacular traction; epiretinal membrane; other causes of CNV, such as pathological myopia, angioid streaks, presumed ocular histoplasmosis syndrome, and multifocal choroiditis)
• Have structural damage to the center of the macula in the study eye that, in the opinion of the Investigator or Sponsor, is likely to preclude improvement in BCVA, including atrophy of the RPE, subretinal fibrosis or scar, significant macular ischemia, organized hard exudates in the foveal center, or other evidence of chronic disruption of the macular architecture
• Have active or suspected ocular or periocular infection or inflammation in either eye at Day 1
• Have a known hypersensitivity to any of the components of EYE201/MK-8748 or aflibercept formulation or prior hypersensitivity to monoclonal antibodies
• Have history of prior treatment with ocriplasmin (JETREA®), ILUVIEN®, OZURDEX® IVT implants, or other intraocular or periocular corticosteroids in the study eye at any time
• Have previously received anti-VEGF therapy or other IVT therapy in the study eye
• Be currently using drugs with known retinal toxicity (eg, hydroxychloroquine, pentosan sulfate)
• Presence of amblyopia, amaurosis, or ocular disorders with BCVA < 38 letters (ETDRS testing charts) in the fellow eye at Screening
• Have any subfoveal atrophy or scarring, complete RPE and outer retinal atrophy involving the fovea, blood over the fovea, or subfoveal fibrosis in the study eye. Additionally, no more than 25% of the total lesion size may be made up of scarring or atrophy, as determined by the reading center
• Have had previous photodynamic therapy with verteporfin in the study eye
• Have the presence of significant and large serous PEDs such as those with a vertical height of ≥ 400 μm
• Have the presence of a tear of the RPE
• Have any subretinal hemorrhage that comprises more than 50% of total lesion size in the study eye
• Have previously received anti-complement IVT therapy (pegcetacoplan or avacincaptad pegol) in the study eye
• Previous therapeutic radiation in the region of the study eye
• History of macular pathology unrelated to AMD affecting vision or contributing to the presence of fluid including central serous chorioretinopathy

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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