Novel ophthalmic pharmaceuticals drive innovation, improve outcomes

Special to Ophthalmology Times®

Innovative drug delivery methods are reshaping modern medicine and will inevitably define the future of ophthalmology.

Strategies that minimize the burden on patients and provide excellent outcomes and safety are increasingly available via novel drug delivery methods.

In ophthalmology, these novel technologies offer sustained drug delivery to targeted tissues, often bypassing the ocular surface and obviating concerns about preservatives found in topical formulations.

Related: Real-world outcomes validate intraocular drug delivery method

Notable examples of these approaches to ophthalmic drug delivery include dexamethasone intraocular suspension 9% (Dexycu; EyePoint Pharmaceuticals, Inc), dexamethasone ophthalmic insert 0.4 mg (Dextenza; Ocular Therapeutix), and bimatoprost implant 10 μgµ(Durysta; Allergan).

Drug delivery innovations
Implementing ways to take treatment out of the hands of patients became even more imperative over the past year as the pandemic and government mandates influenced social behaviors.

For example, elderly patients who might normally have had assistance from family or friends had to obtain and administer ophthalmic drugs on their own.

Regarding the cataract portion of my practice, both Dexycu and Dextenza play an integral role. They are similar in that they make it possible, in most cases, for patients to avoid conventional steroid drops after surgery.

Both deliver dexamethasone (in different concentrations) in a sustained-release manner through the first postoperative month. Their distinction, however, primarily lies in the delivery method.

Dexycu, which is formulated using proprietary Verisome sustained-release technology, is a hydrophobic, bioerodible liquid steroid depot that is injected into the posterior chamber at the end of surgery.

Related: Study: Dexamethasone intraocular suspension 9% offering high surgeon, patient satisfaction after cataract surgery

Once injected, it forms a 2-mm sphere that delivers a bolus of dexamethasone and tapers over the first few weeks after surgery.

In the controlled clinical studies that supported Dexycu’s FDA approval, the drug provided a significant anti-inflammatory efficacy that began early and was sustained throughout the postoperative period.^1,2

These findings reflect what I’ve found in my patients as well. Following the positive experiences reported by other surgeons, I’ve been administering Dexycu directly into the capsular bag, which has been helpful in keeping the drug depot reliably in place.³

Although the pivotal trials for Dexycu were conducted in cataract surgery, it is approved for any ocular surgery and has been used for postoperative inflammation control in minimally invasive glaucoma surgeries and even vitreoretinal surgeries.^4,5

Dextenza is inserted into the lower lid tear canaliculus at the end of cataract surgery, where it elutes dexamethasone onto the ocular surface, providing an ancillary benefit of punctal occlusion, and gradually resorbs after approximately 30 days.⁶

Related: New options continue to fill drug delivery pipeline

Regarding its potential benefit to the ocular surface, I am also currently conducting a clinical trial evaluating Dextenza in conjunction with the Systane iLux (Alcon) meibomian gland dysfunction treatment device.

Durysta, the most recent entrant into the market, is the first intracameral biodegradable sustained-release implant designed to lower IOP in patients with open-angle glaucoma or ocular hypertension.

This drug’s FDA approval was based on the results of 2 phase 3 studies in a substantial cohort of patients that compared Durysta with twice-daily topical timolol drops.

In both studies, Durysta reduced IOP by approximately 30% from baseline over the 12-week primary efficacy period.⁷

I find Durysta’s capabilities very interesting, especially as a cornea specialist who has done considerable research into the interplay between dry eye and glaucoma.⁸

Related: Single administration of intracameral bimatoprost implant: IOP lowering, safety


Reimbursement redux
As positive data accumulate on these drugs, I’ve incorporated them into my practice—as I do with all new technologies that I deem worthwhile—by identifying patients I think will benefit from them. Then I use the products to provide the highest quality of care.

However, as is often the case with novel drugs and devices, some providers are interested in pursuing their use but are held back by concerns about reimbursement.

It’s important to understand that because these products have been granted transitional pass-through payment status by Centers for Medicare and Medicaid Services (CMS), it is possible to use them to your patients’ advantage without negatively affecting your practice or ambulatory surgical center’s bottom line. In fact, reimbursement is typically average sales price plus 6%.

Although transitional pass-through status has been a part of the CMS reimbursement landscape for more than 20 years, many ophthalmologists are either unfamiliar with it or deterred by its complexity.

Educating yourself and your administrative staff about the nuances of this process is key to unlocking its rewards.

Related: CMS 2022 Physician Fee Schedule includes payment cut

Pass through is termed “transitional” because it is meant to be a temporary designation afforded newly approved products for a few years as they transition to widespread use.

When pass-through status is bestowed on a product by CMS, a Healthcare Common Procedure Coding System code is promulgated—first a C-code and then a J-code.

These codes must be used during billing for the practice to receive reimbursement.

Pass-through status is conferred for at least 2 years but is typically not longer than 3 years. This gives physicians time to learn about these products and their real-world performance.

Additionally, CMS collects utilization data during this period and employs this information when determining how to adjust the payment rate after transitional pass-through status expires.

Product utilization during this time is crucial to provide sufficient claims data for CMS to make an accurate determination regarding future reimbursement.

Related: Tear tests in eye care: Use, reimbursement outlined

In essence, transitional pass-through status is intended to encourage the use of newly FDA-approved medical devices, drugs, and biologics across all fields of medicine and to boost Medicare patients’ access to these innovative therapies by temporarily paying more than established facility fees.

During a product’s pass-through status phase, CMS evaluates utilization and claims data to decide whether it is an effective innovation that should have its own reimbursement code once pass through is over.

If utilization shows that it doesn’t justify its own code, it will end up getting bundled into the facility fee, which will increase slightly but not enough to cover the cost of the product.

As I see it, the onus is on us as physicians to make use of innovative products that benefit our patients during the pass-through period to help ensure our patients can continue to have access to these products once this phase is complete.

Programs such as EyePoint Assist can help practices navigate coding, obtain samples, and even provide direct reimbursement in the event of claims denial (see Reimbursement Assistance Programs for more details).

Related: Practical tips, pearls to help ease patients' financial burdens

All patients benefit from drug delivery advances, and most are eager not to self-administer eye drops. But the ones who benefit the most tend to be those who have challenges with memory, vision, or dexterity that make it difficult to use eye drops.

Once again, this confluence of issues has been compounded by the ongoing challenges associated with COVID-19, which in some instances has made it more difficult than usual for patients to access assistance.

Using pass-through products such as Dexycu or Dextenza may involve a few more administrative steps at the moment, but taking postoperative inflammation management out of the hands of the patients is invariably worth the effort.

In addition to discussing this with the patient and perhaps their caregiver or family member, our surgical coordinators contact the patient’s insurer, if applicable.

Together, we determine if the pass-through drug is covered and how to get precertification approval—a process made easier with resources from the manufacturers of each product.

In many practices, a substantial proportion of patients will be covered with Medicare Part B, to which pass-through status directly applies; for those under Medicare Advantage or commercial insurance, coverage depends on local or regional contracts, and the support provided by manufacturers can help manage this complexity.

As with many new processes, increasing familiarity results in streamlining and greater ease within a practice.

Understanding pass-through status

• Dexycu and Dextenza have been granted pass-through status.
• Pass-through payments have no direct effect on physicians’ fees.
• CMS, not the drug manufacturers, determines the price of pass-through products.
• The budget for pass-through payments is set aside by CMS a year in advance.
• Congress created pass-through payments to ensure that new drugs, devices, and biologics are available for patients and are paid for separately from a physician’s bundled payment.
• While a product has pass-through status, CMS evaluates utilization and claims data in an effort to decide whether it is an innovation that should eventually have its own reimbursement code.
• If you have questions about whether a pass-through product is covered for a particular patient or any other concern regarding reimbursement or usage of these products, contact the manufacturer.
• Generally, the companies that have a transitional pass-through product are eager to help practices affordably access these innovative treatments so that patients will get top-tier treatment and utilization rates will support a permanent reimbursement code.

Ensuring pass-through payments are properly processed strengthens our ability to offer patients the latest innovations in drugs and devices.

Although it may mean navigating an unfamiliar billing process at the start, this effort is critical because it can make a world of difference to our most vulnerable patients who will benefit from advanced drug delivery methods.

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About the author
Lisa M. Nijm, MD, JD
E: lmnijm@uic.edu
Nijm is the founder and medical director of Warrenville EyeCare and LASIK in Warrenville, Illinois; assistant clinical professor of ophthalmology at the University of Illinois Eye and Ear Infirmary in Chicago; and the founder of MDNegotiation.com. She is a consultant for Allergan, EyePoint, and Ocular Therapeutix.

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References

1. Donnenfeld E, Holland E. Dexamethasone intracameral drug-delivery suspension for inflammation associated with cataract surgery: a randomized, placebo-controlled, phase III trial. Ophthalmology. 2018;125(6):799-806. doi:10.1016/j.ophtha.2017.12.029

2. Donnenfeld ED, Solomon KD, Matossian C. Safety of IBI-10090 for inflammation associated with cataract surgery: phase 3 multicenter study. J Cataract Refract Surg. 2018;44(10):1236-1246. doi:10.1016/j.jcrs.2018.07.015

3. Osher RH, Weinstock RJ. Dexamethasone intraocular suspension 9% in the capsular bag. J Cataract Refract Surg.

4. Tan NE, Radcliffe N. Outcomes of dexamethasone intraocular suspension during cataract surgery and concomitant cataract-micro-invasive glaucoma surgery (MIGS). Invest Ophthalmol Vis Sci. 2020;61(7):4253

5. Kiernan DF. Dexamethasone intracameral drug-delivery suspension for inflammation associated with vitreoretinal surgery. BMJ Open Ophthalmol. 2020;5(1):e000491. doi:10.1136/bmjophth-2020-000491

6. Tyson SL, Bafna S, Gira JP, et al. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019;45(2):204-212. doi:10.1016/j.jcrs.2018.09.023

7. Shirley M. Bimatoprost implant: first approval. Drugs & Aging. 2020 2020;37(6):457-462. doi:10.1007/s40266-020-00769

8. Nijm LM, De Benito-Llopis L, Rossi GC, Vajaranant TS, Coroneo MT. Understanding the dual dilemma of dry eye and glaucoma: an international review. Asia Pac J Ophthalmol (Phila). 2020;9(6):481-490. doi:10.1097/APO.0000000000000327