Latest Review Date: June 2024

Category: Vision

DRAFT

POLICY:

Sustained-release intracameral glaucoma therapies (e.g. Durysta®, iDose ®TR) are considered investigational for all indications, including but not limited to, the treatment of open angle glaucoma or ocular hypertension.

DESCRIPTION OF PROCEDURE OR SERVICE:

Durysta® (bimatoprost intracameral implant) is an intracameral biodegradable, sustained-release implant designed to lower intraocular pressure (IOP) in individuals with conditions such as open angle glaucoma or ocular hypertension. The active ingredient involved is bimatoprost, which is a prostaglandin analog medication used to treat glaucoma and lower high eye pressure. Durysta is composed of biodegradable polymers designed to release bimatoprost in a non-pulsatile, steady-state manner over a 90-day period.

Durysta is delivered via a disposable single-use applicator that is inserted into the anterior chamber of the affected eye. Insertion is performed under magnification in an office or ambulatory surgery center. The presence of Durysta implants has been associated with corneal adverse reactions and increased risk of corneal endothelial cell loss. Per the FDA recommendation, administration of Durysta should be limited to a single implant per eye without retreatment. Caution should be used when prescribing Durysta in individuals with limited corneal endothelial cell reserve.

iDose®TR (travoprost intracameral implant) delivers continuous long-term prostaglandin analog therapy directly into the anterior chamber for the reduction of intraocular pressure in individuals with open-angle glaucoma or ocular hypertension.

Open-angle glaucoma is an optic neuropathy characterized by progressive peripheral visual loss. The peripheral vision loss is often followed by central field loss. Open-angle glaucoma is typically accompanied by intraocular pressure increases caused by increased aqueous production and/or decreased aqueous outflow. Elevated intraocular pressure presents a major risk factor for glaucomatous field loss. The higher the level of intraocular pressure, the greater the likelihood of optic nerve damage and visual field loss.

Ocular hypertension is distinguished from glaucoma in that there are no detectable changes in vision, no evidence of visual field loss, and no damage to the optic nerve. Individuals diagnosed with ocular hypertension are at an increased risk of developing glaucoma. Typical treatments for open-angle glaucoma and ocular hypertension include drug classes such as ophthalmic prostaglandins (e.g., latanoprost) and ophthalmic beta blockers (e.g., timolol), both of which have generic products available in their respective classes.

Lowering of IOP is the only proven method to decrease risk of development and/or worsening glaucomatous optic neuropathy. Topical medical therapy is an effective strategy, but many individuals are non-adherent to medications.  Barriers to adherence are multifold and include forgetfulness, difficulty with drop instillation, need for frequent administration.

KEY POINTS:

This policy was developed with medical literature review through June 15, 2024.

Summary of Evidence

The FDA approval of Durysta is based on results from two prospective, randomized, multicenter, double-masked, 20-month (including eight-month extended follow up) Phase 3 ARTEMIS studies evaluating the efficacy and safety of Durysta versus twice daily topical timolol drops, an FDA accepted comparator for registrational clinical trials, in individuals with OAG or OHT. In the two Phase 3 ARTEMIS studies, Durysta reduced IOP by approximately 30 percent from baseline over the 12-week primary efficacy period, meeting the predefined criteria for non-inferiority to the study comparator. Noted risks to using Durysta include, eye pain, eye irritation, lacrimation, and conjunctival hemorrhage. Studies have shown that Durysta is an effective treatment for glaucoma, but not superior to the standard of care. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

The FDA approval of Glaukos’ iDose TR in December 2023, was based on Phase 3 clinical program consisting of two pivotal studies that randomized 1,150 subjects across 89 clinical sites. Based on these outcomes, the FDA concluded in the prescribing information that iDose TR demonstrated non-inferiority to timolol ophthalmic solution in IOP reduction during the first 3 months. The FDA also noted that subsequently iDose TR did not demonstrate non-inferiority over the next 9 months. At 12 months, 81% of iDose TR subjects were completely free of IOP-lowering topical medications across both trials. Studies have shown that iDose TR is an effective treatment for glaucoma, but not superior to the standard of care. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Practice Guidelines and Position Statements

American Academy of Ophthalmology

The 2020 American Academy of Ophthalmology (AAO) preferred practice guidelines for the treatment of primary open-angle glaucoma note that the initial therapy choice may be influenced by cost, adverse event profile, and dosing schedules. The guidelines note prostaglandins as the most frequently used initial eye drops for lowering intraocular pressure in patients with glaucoma. The AAO does not prefer one prostaglandin over another.

In 2020, a bimatoprost intracameral implant (Allergan, Irvine, CA) received Food and Drug Administration (FDA) approval for use in patients with ocular hypertension and POAG. This biodegradable implant, which is injected with a 28-gauge delivery system, demonstrated noninferiority to twice daily timolol in phase III clinical trials. In phase I/II studies, a single bimatoprost sustained-release (SR) implant showed similar efficacy to topical bimatoprost 0.03% through 4 months of follow-up, and 68% of patients had a persistent effect at 6 months. At 24 months, central endothelial cell density was comparable between eyes that received the bimatoprost implant and those treated topically.

The practice guidelines do not mention the use of iDose TR in its recommendations.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Durysta®, bimatoprost, biodegradable implant, ocular implant, Allergan, OAG, open angle glaucoma, OHT, ocular hypertension, intracameral administration, iDose, iDose TR

APPROVED BY GOVERNING BODIES:

Durysta

On March 4, 2020, the FDA approved Allergan’s Durysta (bimatoprost implant) 10 mcg for intracameral administration to treat open-angle glaucoma (OAG) or ocular hypertension (OHT). Durysta (bimatoprost implant) is a biodegradable implant intended for a single administration and should not be re-administered to an eye that received a prior Durysta (bimatoprost implant).

iDose TR

December 14, 2023, Glaukos announces the FDA approval of iDose TR (travoprost intracameral implant). FDA approval was based on Phase 3 clinical program consisting of two pivotal studies that randomized 1,150 subjects across 89 clinical sites.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits. Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP contracts: Special benefit consideration may apply.  Refer to member’s benefit plan. 

CURRENT CODING:

CPT Codes:

HCPCS Codes:

REFERENCES:

1. American Academy of Ophthalmology Preferred Practice Pattern Glaucoma Panel, Hospkins Center for Quality Eye Care. Primary Open-Angle Glaucoma 2022. Available online at: www.aao.org/preferred-practice-pattern/primary-open-angle-glaucoma-suspect-ppp.
2. American Academy of Ophthalmology Preferred Practice Pattern Glaucoma Panel, Hospkins. Center for Quality Eye Care(2020) Primary Open-Angle Glaucoma 2020. https://www.aao.org/preferred-practice-pattern/primary-open-angle-glaucoma-ppp.
3. Aref, Ahmad A. Durysta (Bimatoprost Implant) Available online at: eyewiki.aao.org/Durysta_(Bimatoprost_Implant).
4. Craven ER, Walters T, Christie WC, Day DG, Lewis RA, Goodkin ML, Chen M, Wangsadipura V, Robinson MR, Bejanian M; Bimatoprost SR Study Group. 24-Month Phase I/II Clinical Trial of Bimatoprost Sustained-Release Implant (Bimatoprost SR) in Glaucoma Patients. Drugs. 2020 Feb; 80(2):167-179. doi: 10.1007/s40265-019-01248-0. 
5. Gedden SJ, Vinod K, Wright MM, et al. Primary Open-Angle Glaucoma PPP 2020. AAO PPP Glaucoma Committee, Hoskins Center for Quality Eye Care. Nov 2020. Available online at: www.aao.org/education/preferred-practice-pattern/primary-open-angle-glaucoma-ppp.
6. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
7. Huang AS, Meyer JJ. Bimatoprost Ophthalmic Solution. 2022 Nov 14. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan–.
8. Kolomeyer, Natasha N. Top 7 Things to Know About First Sustained-Release Glaucoma Medication. aao.org/young-ophthalmologists/yo-info/article/top-7-things-to-know-about-first-sustained-release.
9. Lewis RA, Christie WC, Day DG, Craven ER, Walters T, Bejanian M, Lee SS, Goodkin ML, Zhang J, Whitcup SM, Robinson MR; Bimatoprost SR Study Group. Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results From a Phase I/II Clinical Trial. Am J Ophthalmol. 2017 Mar;175:137-147. doi: 10.1016/j.ajo.2016.11.020. Epub 2016 Dec 22.
10. Medeiros FA, Walters TR, Kolko M, et al.(2020) Phase 3, Randomized, 20-Month Study of Bimatoprost Implant in Open-Angle Glaucoma and Ocular Hypertension (ARTEMIS 1). Ophthalmology. 2020 Jun 13:S0161-6420(20)30555-8. doi: 10.1016/j.ophtha.2020.06.018. Epub ahead of print.
11. Rajan, K. Biodegradable bimatoprost implant gains FDA approval. Available online at: www.aao.org/headline/biodegradable-bimatoprost-implant-gains-fad-approv.
12. Sarkisian SR, Ang RE, Lee AM, et al. Travoprost Intracameral Implant for Open-Angle Glaucoma or Ocular Hypertension: 12-Month Results of a Randomized, Double-Masked Trial. Ophthalmol Ther. 2024;13(4):995-1014. doi:10.1007/s40123-024-00898-y
13. Sarkisian SR Jr, Ang RE, Lee AM, et al. Phase 3 Randomized Clinical Trial of the Safety and Efficacy of Travoprost Intraocular Implant in Patients with Open-Angle Glaucoma or Ocular Hypertension. Ophthalmology. Published online February 27, 2024. doi:10.1016/j.ophtha.2024.02.022
14. U.S. Food and Drug Administration (FDA).(2020) Durysta. Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211911s000lbl.pdf
15. U.S. Food and Drug Administration (FDA).(2023) iDose®TR. Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218010s000lbl.pdf

POLICY HISTORY:

Medical Policy Group, July 2020 (9): This technology was previously investigational for dates of service prior to July 2020 per MP#495: Investigational Criteria. No change to coverage stance.

Medical Policy Administration Committee, August 2020.

Medical Policy Group, September 2020: Quarterly coding update.  Added code J7351 to Current Coding and moved J3490 to Previous Coding.

Medical Policy Group, April 2021 (9): Updated references. No change to policy statement.

Medical Policy Group, June 2021 (9): 2021 Updates to Key Points, References. Policy statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Group, December 2021 (9): Added CPT code 66030 to Current Coding.

Medical Policy Group, June 2022 (9): 2022 Updates to Key Points, References. No change to policy statement.

Medical Policy Group, June 2023 (9): Updates to Key Points, Benefits Application and References. Reviewed by consensus. No new published peer-reviewed literature identified that would alter coverage statement at this time.

Medical Policy Group, June 2024 (6): Updates to Policy title “Sustained-Release Intracameral Glaucoma Therapy”, Policy statement updated to include iDose TR, Description, Key Points, Key Words, Governing Bodies, Practice Guidelines, Current Coding (+0660T-0661T, J3490, J7355) and References. Travoprost intracameral implant (i.e., iDose TR) previously non-covered per MP 495 Investigational Criteria. On draft 7/1/24- 8/15/24.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.