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DURYSTA (bimatoprost implant)

Policy Number: MP-735

Latest Review Date: July 2020

Category: Pharmacy

Policy Grade: C

POLICY STATEMENT

Durysta (bimatoprost implant) is considered investigational and not medically necessary for all indications, including when used for the treatment of open angle glaucoma or ocular hypertension.

DESCRIPTION OF PROCEDURE OR SERVICE

Durysta (bimatoprost implant) is described as the first intracameral biodegradable sustained release implant designed to lower intraocular pressure in patients 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.

The standard of care treatment for open angle glaucoma or ocular hypertension is eye drops that are self-administered using the following technique:

  • Wash your hands before use
  • Take out contact lenses before using this medicine
  • Do not touch the container tip to the eye, lid, or other skin
  • Tilt your head back and drop drug into the eye.
  • After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for one to two minutes. This keeps the drug in your eye.

A large number of patients report non-compliance with self-administering eye drops due to either forgetfulness or side effects. Durysta, ocular implant device, has been developed to combat this non-compliance rate.

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 patients with limited corneal endothelial cell reserve.

KEY POINTS

This policy was developed with medical literature review through July 17, 2020.

Table 1. Clinical Outcomes of Durysta (Bimatoprost Implant) Use

ClinicalTrials.gov Identifier, study name

Author, year, country

Study Design

Population  Characteristics

Interventions

Comparators

Clinical Outcomes, Length of Follow up

NCT01157364:

“Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension”

Allergan (sponsor)

Craven et al, 2020, US

Interventional Randomized

Allocation: Randomized;

Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment

109 participants (56 female, 53 male) with diagnosis of OAG or OCH

SR bimatoprost treatment

topical bimatoprost treatment

A single administration of bimatoprost sustained-release implant (Bimatoprost SR) lowered intraocular pressure for up to 1 year in 40% of patients and up to 2 years in 28%, with no additional treatment.

Efficacy of re-administration with a second implant of Bimatoprost SR was similar to that with the first implant.

The safety profile of Bimatoprost SR was favorable during the 24-month study.

NCT02247804:

“Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension”

Allergan (sponsor), 2020, US

Interventional Randomized

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

594 participants (288 female, 306 male) with diagnosis of either OAG or OCH in each eye and both eye require IOP lowering treatment

Bimatoprost SR administered on Day 1, Day 16, Week 32 with timolol vehicle (placebo) administered once in the morning and once in the evening for up to 20 months

Timolol 0.5% administered once in morning and once in the evening for up to 20 months with sham (applicator without needle) administered on Day 1, Day 16, and Week 32

This study was designed to evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.

Noninferiority is deduced with relative safety.

No publication association with this study is reported.

NCT02250651:

“Safety and Efficacy of Bimatoprost Sustained-Release (SR) in Patients With Open-Angle Glaucoma or Ocular Hypertension”

Allergan (sponsor), 2020, US

Interventional Randomized

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

527 participants

Bimatoprost SR administered on Day 1, Day 16, Week 32 with timolol vehicle (placebo) administered once in the morning and once in the evening for up to 20 months

Timolol 0.5% administered once in morning and once in the evening for up to 20 months with sham (applicator without needle) administered on Day 1, Day 16, and Week 32

NR.

No publication association with this study is reported.

OAG: open angle glaucoma; OHT: ocular hypertension; IOP: intraocular pressure; SR: sustained release; US: United States; NR: not reported

Summary of Evidence

The FDA approval of Durysta is based on results from two 20-month (including 8-month extended follow up) Phase 3 ARTEMIS studies evaluating 1,122 subjects on the efficacy and safety of Durysta versus twice daily topical timolol drops, an FDA accepted comparator for registrational clinical trials, in patients 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. There are several ongoing studies that have not yet been completed.

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 patients are non-adherent to medications.  Barriers to adherence are multifold and include forgetfulness, difficulty with drop instillation, need for frequent administration. Durysta could make an impact on non-compliance glaucoma management issue. There are risks to using Durysta, such as, 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 FDA clearance is for single use per each eye. In the studies reviewed, Durysta was implanted every four months for one year. At this time the existing evidence is insufficient to prove the medical necessity of this technology.

Practice Guidelines and Position Statements

American Academy of Ophthalmology

The 2015 Primary Open-Angle Glaucoma practice guidance from the American Academy of Ophthalmology recommends switching eye-drop agents or adding on for combination therapy when target IOP is not achieved with one drug alone. The practice guidance has not been updated to include the use of Durysta in its recommendations at the time of this review.

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

APPROVED BY GOVERNING BODIES

On March 4, 2020, the U.S. Food and Drug Administration (FDA) approved Allergan’s Durysta (bimatoprost implant) 10 mcg for intracameral administration to treat open-angle glaucoma (OAG) or ocular hypertension (OHT). As per the FDA labeled package insert, 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).

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: Special benefit consideration may apply. Refer to member’s benefit plan. FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

CURRENT CODING

HCPCS Codes

For dates of service 10/1/20 and after:

J7351

Injection, bimatoprost, intracameral implant, 1 microgram (Effective 10/1/2020)

PREVIOUS CODING

Prior to 10/1/20, there was not a specific code for Durysta.

J3490

Unclassified drugs

REFERENCES

  1. American Academy of Ophthalmology Preferred Practice Pattern Glaucoma Panel, Hospkins Center for Quality Eye Care. Primary Open-Angle Glaucoma 2015. Available at https://www.aao.org/preferred-practice-pattern/primary-open-angle-glaucoma-suspect-ppp-2015. Accessed on July 16, 2020.
  2. Aref, Ahmad A. Bimatoprost Implant (Durysta). https://eyewiki.org/Bimatoprost_Implant_ (Durysta) #cite_note-:0-4. Accessed July 16, 2020.
  3. 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.
  4. Delfaro, A. Week in review: Eye tick, acid attack, AMD style. Available at https://www.aao.org/headline/week-in-review-eye-tick-acid-attack-amd-style. Accessed July 16, 2020.
  5. Kolomeyer, Natasha N. Top 7 Things to Know About First Sustained-Release Glaucoma Medication. https://www.aao.org/young-ophthalmologists/yo-info/article/top-7-things-to-know-about-first-sustained-release. Accessed July 16, 2020.
  6. Lewis RA, Christie WC, Day DG, et al. Bimatoprost Sustained-Release Implants for Glaucoma Therapy: 6-Month Results From a Phase I/II Clinical Trial. Am J Ophthalmol 2017; 175:137–147.
  7. Rajan, K. Biodegradable bimatoprost implant gains FDA approval. Available at https://www.aao.org/headline/biodegradable-bimatoprost-implant-gains-fda-approv. Accessed July 16, 2020.

POLICY HISTORY

Medical Policy Panel, July 2020 (9): New policy created. No coverage change over previously allowed internal processing guidelines. Remains non-covered.

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.


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.