ASC: A comfortable environment

By Inder Paul Singh, MD

Since the commercial launch of Durysta (bimatoprost intracameral implant, Allergan) in June 2020, I have had the opportunity to insert this 10-µg biodegradable intracameral implant in a wide variety of open-angle glaucoma patients. For patients with mild, moderate or advanced glaucoma, those on one to even four classes of medications, young or old, pre- or post-SLT or even MIGS, it can make an incredible impact on compliance and patient satisfaction.

PATIENT

ACCEPTANCE

Although approved for a single administration, the safety, efficiency of implantation and positive patient experience have allowed for high patient acceptance. A medication that is released 24 hours a day close to the area of pathology may have unique benefits of controlling the pressure and even modifying the disease going forward. This could be why the Phase 2 trials demonstrated 2 years of efficacy with a single implant in 25% of subjects. With its long-term IOP control, Durysta may help tackle adherence issues and improve the quality of IOP control with fewer IOP peaks and fluctuations. This could also help explain why Phase 3 studies have also shown that eyes randomized to Durysta had a slower rate of change in standard perimetry mean deviation than eyes that were randomized to timolol over the course of 1 year.

INSERTION AND LOCATION

The insertion should be performed with good head stabilization, under aseptic conditions and using proper magnification. This can be achieved while the patient is in the supine position using a microscope/loops or with the patient sitting upright at the slit lamp depending on the provider’s comfort level and infrastructure.

The insertion can be placed in the office setting, minor procedure room or at an ASC/hospital. In-office insertion allows for more control of scheduling, potentially less total time, more familiarity/acceptance for the patient. I transitioned to inserting at the slit lamp soon after commercialization. Having experience implanting Durysta in the supine position during the Phase 2 and 3 trials allowed me to develop a comfort level and confidence in transitioning to the slit lamp technique.

Although the slit lamp insertion has its advantages, many surgeons still feel more comfortable implanting the product in the supine position. Since not all surgeons have access to a microscope or have the infrastructure necessary for supine implantation, use of an ASC can be a good solution. Surgeons are already comfortable performing procedures at an ASC, the environment and the flow allow for a smooth transition. Prepping for a procedure is commonplace at a facility and allows surgeons the confidence of sterility and access to a microscope and other instruments if need be.

BILLING CONSIDERATIONS

When using Durysta in the office, the provider bills both the J-code and the CPT code (66030). When using it in the facility, you only bill your professional fees. The facility takes care of billing for the drug. When using it in the office, there is a little more work for the office to do, as the facility isn’t involved.

When performing Durysta at an ASC, along with the surgeon payment, there is payment to the ASC for the drug itself and a separate facility fee. Patients may end up paying slightly more if they have a copay due to the added facility charge.

Depending on whether the implantation is performed as a standalone or in combination with other surgeries, the reimbursement to the facility may vary or may not be reimbursed at all. For instance, if performing Durysta implantation at the time of cataract extraction, the facility and the surgeon are not paid a separate fee because the procedure is bundled with cataract surgery. The facility is still reimbursed for the cost of the drug.

This also can be true for implanting Durysta at the same time of a standalone MIGS procedure. If there is an NCCI edit or separate procedure rule, reimbursement is reduced. For instance, implanting Durysta at the same time as a standalone goniotomy still results in zero ASC and surgeon payment, but the drug cost is still paid to the ASC. However, when implanting Durysta at the same time as a glaucoma tube surgery, one would still receive a separate surgeon and ASC reimbursement. It is important for the surgeon to check with insurance carriers to know which procedures are bundled with surgery or will be paid independently of the primary procedure.

CONCLUSION

We are lucky to have this new product in our glaucoma toolbox. The versatility of patient selection, technique and location allow more surgeons to feel comfortable incorporating this treatment into their regimen.

About the Author

Inder Paul Singh, MD, is a glaucoma specialist at the Eye Centers of Racine and Kenosha in Wisconsin. Email him at ipsingh@amazingeye.com.

Disclosures: Dr. Singh reports financial relationships with Aerie, Alcon, Allergan, Bausch + Lomb, Ellex, New World Medical, Shire and Sun Ophthalmics.

Convenience of in-office administration

By Oluwatosin Smith, MD

Since approval by the FDA in March 2020, Durysta (bimatoprost intracameral implant, Allergan) has become an option available for use in patients with ocular hypertension and open-angle glaucoma. Use of the implant is unusual for most physicians because of its novel intraocular sustained release mechanism.

In-office administration can be common due to both patient and physician convenience. The office location easily meets criteria for implanting under magnification, using sterile technique with the patient’s head stabilized. Here, I discuss the multi-pronged in-office process.

PATIENT SELECTION

Patient selection and recruitment for Durysta requires keeping the option foremost in one’s mind during patient care. Durysta is ideal for patients with ocular hypertension or glaucoma that require IOP lowering. Issues surrounding poor medication adherence and ocular surface disease are indications, but other clinical scenarios include:

• Before/after selective laser trabeculoplasty
• As an augmentation of MIGS procedures
• Preservative intolerance
• When a stopgap in care is required because of other health issues or future planned ocular surgery.

It is important to keep contraindications for implantation in view during the selection process. In discussions with patients, my focus remains on the benefits of an implant that slowly releases medication exactly where needed.

I also provide efficacy statistics in patients who may be on multiple medications. We discuss the efficacy duration of 4-6 months found in clinical trials and the approved one-time implantation (up to 20 months in 25% of people) and that we would restart medication or explore other treatment options when the effect wears off. Patients are given educational material to review as the prior authorization process begins.

In discussing the actual implantation process, words like “placing” vs “injecting” are helpful reassurances about the process. Many patients are excited about the benefits even before knowing what the implantation entails.

PRIOR AUTHORIZATION (PA)

Once a decision is made to proceed, the PA process is initiated. Allergan provides reimbursement authorization support through an online portal called EyeCue. Some offices obtain their own PA because of convenience and billing office staff that is already familiar with PA processes. Always ensure that authorizations are done prior to implantation. There are a growing number of insurance plans that authorize Durysta use, with traditional Medicare being the biggest plan.

PATIENT SCHEDULING AND BILLING

Once approved, the patient and office location staff are notified. This allows the patient to know their copay and helps office staff confirm the pre-scheduled implantation appointment and Durysta implant availability. A previously made appointment, scheduled 2-4 weeks after patient selection, is kept. The Durysta implantation is interspersed with other patient visits and does not interfere with clinic flow.

For most ophthalmology offices, “buy and bill” is an unfamiliar process, but once accounts are set up it is really easy. It involves direct procurement of the implant from the pharmaceutical company. The medication is then shipped directly to the doctor’s office and, after use, billed out to the patient’s insurance.

DAY OF IMPLANTATION

Upon arrival for implantation, offices must obtain appropriate consent and address any patient questions.

Implantation can be done in one or both eyes at a particular visit. Betadine is instilled in the operative eye and allowed to sit for a few minutes after a topical anesthetic has been instilled.

In-office implantation can occur in a minor-procedure room or at the slit lamp as long as the patient’s head is stabilized. Surgeons should determine the most comfortable location for them based on experience and handedness for their initial administrations. My preference is slit lamp implantation.

Prior to placement, a repeat drop of tetracaine is given and an optional eyelid speculum can be used to keep lids open. A sterile field is created and the Durysta injector is opened, making sure that the packaging is intact and undamaged. The implant is then injected through the clear cornea into the anterior chamber where it’s released. Antibiotic drops are instilled, and the patient stays upright for 20 minutes before leaving.

The implantation is usually well tolerated, and patients are pleasantly surprised that it was different from what they had anticipated.

FOLLOW-UP

A subsequent follow-up visit in 1 month off topical glaucoma medications is scheduled. Patients are given an opportunity to report any symptoms. The visit also includes an IOP check and gonioscopy to determine the implant position in the inferior angle and its relation to the iris and cornea.

There may be a need to add a glaucoma medication. Otherwise, a subsequent follow-up visit in 4-6 months is then scheduled after the 1-month follow up is concluded. OM

About the Author