| Coverage Policy Manual | |
| Policy #: | 2020023 |
| Category: | Pharmacy |
| Initiated: | January 2021 |
| Last Review: | April 2024 |
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| Bimatoprost (e.g., Durysta™) | |
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| Description: |
Blimatoprost is an intracameral implant, sustained-release drug delivery system that is a prostaglandin analogue with ocular hypotensive activity. It involves the use of a biodegradable, solid polymer drug delivery system for slow, sustained drug release designed to lower intraocular pressure (IOP) over a 4-6 month period. It is administered via a single-use applicator that is inserted into the anterior chamber of the affected eye. Prior to this approval, pharmacologic therapy consisted of topical eye drops with varying mechanisms of action. Due to an increased risk of corneal endothelial cell loss, individuals should only receive one implant per eye and no retreatment.
Regulatory Status
On March 4, 2020, the FDA approved Bimatoprost (e.g., Durysta) 10 mcg for the intracameral administration for open-angle glaucoma (OAG) or ocular hypertension (OHT).
Coding:
See CPT/HCPCS Code section below.
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Policy/ Coverage: |
Effective October 1, 2020, Prior Approval is required for Bimatoprost (e.g., Durysta™)
The initial use of this drug requires documentation of direct physician involvement and signature in the ordering and evaluation as documented in the medical records submitted for prior approval. Concurrent review will require continued evidence of appropriate physician involvement.
The Step Therapy Medication Act is applicable to fully insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.
Effective July 2024
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of bimatoprost intracameral implant (e.g., Durysta), for the treatment of open-angle glaucoma or ocular hypertension or any indication or circumstance does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, the use of bimatoprost for the treatment of any indication, condition or circumstance is considered investigational.
Investigational services are specific contract exclusions in most member benefit certificate of coverage.
Effective September 2023 - June 2023
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
INITIAL APPROVAL STANDARD REVIEW for up to 12 months
The use of bimatoprost meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for the treatment of open angle glaucoma or ocular hypertension when ALL the following are met:
Dosage and Administration
Dosing per FDA Guidelines
For ophthalmic intracameral administration.
Intracameral implant containing bimatoprost 10 mcg, in the drug delivery system.
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of bimatoprost, for any indication or circumstance not described above, does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness above, including:
For members with contracts without primary coverage criteria, the use of bimatoprost for the treatment of any indication, condition or circumstance not described above is considered investigational including but not limited to:
Investigational services are specific contract exclusions in most member benefit certificate of coverage.
Effective October 1, 2020, Prior Approval is required for Bimatoprost (e.g., Durysta™)
The initial use of this drug requires documentation of direct physician involvement and signature in the ordering and evaluation as documented in the medical records submitted for prior approval. Concurrent review will require continued evidence of appropriate physician involvement.
The Step Therapy Medication Act is applicable to fully-insured (Arkansas Blue Cross, Health Advantage, and Exchange) and specified governmental (ASE/PSE and ASP) health plans. The law is not applicable to FEP or self-insured ERISA groups (including but not limited to Walmart, Tyson or other Blue Advantage groups). Initial approval for exigent request is 28 days. Otherwise, initial approval for standard review is up to 1 year.
Effective January 2022
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of bimatoprost for the treatment of open angle glaucoma or ocular hypertension meets primary coverage criteria when ALL the following are met:
INITIAL APPROVAL STANDARD REVIEW for up to 12 months
Dosage and Administration
Intracameral implant containing bimatoprost 10 mcg, in the drug delivery system.
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The use of bimatoprost does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness for any indication, circumstance or other condition not outlined above, including:
For members with contracts without primary coverage criteria, the use of bimatoprost for the treatment of any indication, circumstance, or other condition not outlined above is considered investigational including:
Investigational services are specific contract exclusions in most member benefit certificate of coverage.
Effective Prior to January 2022
Effective January 1,2021, Prior Approval is required for Bimatoprost (Durysta™)
The initial use of this drug requires documentation of direct physician involvement and signature in the ordering and evaluation as documented in the medical records submitted for prior approval. Concurrent review will require continued evidence of appropriate physician involvement.
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
The use of bimatoprost (Durysta™) for the treatment of open angle glaucoma or ocular hypertension meets primary coverage criteria when ALL the following are met
Dosage and Administration
Intracameral implant containing bimatoprost 10 mcg, in the drug delivery system.
Please refer to a separate policy on Site of Care or Site of Service Review policy #2018030 for pharmacologic/biologic medications.
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
For members with contracts without primary coverage criteria, the use of bimatoprost (Durysta™) for the treatment of any indication or circumstance other condition those outlined above is considered investigational including:
Investigational services are specific contract exclusions in most member benefit certificate of coverage
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| Rationale: |
There are several studies for bimatoprost that are ongoing currently. One phase 3 study has been completed and results reported.
A phase 3 study reported in AAO, included a total of 594 subjects. They were randomized to the 10 mcg bimatoprost implant (n=198), 15 mcg bimatoprost implant (n=198) and BID timolol (n=198) treatment groups. The mean age of the study population was 62.5 years. Most of the study eyes, (78.1%) were diagnosed with primary OAG. Mean IOP in the study eyes was similar among the treatment groups. Completion rates were 90.4% (10 mcg), 79.3% (15 mcg) and 86.9% (timolol groups). There were 3 administration cycles, week 1, week 16 and week 32. Participants were to be followed through month 20 or for at least 12 months after their last bimatoprost implant or sham administration. Treatment-emergent adverse events (TEAE) most leading to early exit from the bimatoprost implant treatment groups included corneal endothelial cell loss and corneal edema. Implants were removed in 7 subjects (3.6%) in the 10mcg bimatoprost implant group and 16 subjects (8.3%) in the 15 mcg bimatoprost group because of TEAEs, primarily corneal endothelial cell loss and edema.
Results showed that both strengths of bimatoprost implants were noninferior to timolol in IOP lowering through week 12. One year after 3 administration, IOP was controlled in most subjects without further treatment. Risk-benefit assessment favored the 10 mcg implant over the 15 mcg implant.
The 2015 Primary Open-Angle Glaucoma practice guidance from the American Academy of Ophthalmology (AAO), 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 bimatoprost (DurystaTM) in its recommendations at this time.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through August 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2022. No new literature was identified that would prompt a change in the coverage statement.
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2023. No new literature was identified that would prompt a change in the coverage statement.
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2024. The following literature prompted the change in coverage policy to non-coverage.
The FDA approval of bimatoprost intracameral implant 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 bimatoprost intracameral implant versus twice daily topical timolol o.5% drops in patients with OAG or OHT. Bimatoprost intracameral implant demonstrated an intraocular pressure (IOP) reduction of approximately 5-8 mmHg in patients with a mean baseline IOP of 24.5 mmHg. In the two Phase 3 ARTEMIS studies, bimatoprost intracameral implant 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. The most common ocular adverse reaction observed in two randomized, active-controlled clinical trials with bimatoprost intracameral implant in patients with OAG or OHT was conjunctival hyperemia, which was reported in 27% of patients. Other common ocular adverse reactions reported in 5-10% of patients were foreign body sensation, eye pain, photophobia, conjunctival hemorrhage, dry eye, eye irritation, intraocular pressure increased, corneal endothelial cell loss, vision blurred, and iritis. Ocular adverse reactions occurring in 1 5% of patients were anterior chamber cell, lacrimation increased, corneal edema, aqueous humor leakage, iris adhesions, ocular discomfort, corneal touch, iris hyperpigmentation, anterior chamber flare, anterior chamber inflammation, and macular edema. The following additional adverse drug reactions occurred in less than 1% of patients: hyphema, iridocyclitis, uveitis, corneal opacity, product administered at inappropriate site, corneal decompensation, cystoid macular edema, and drug hypersensitivity.
Lowering of IOP is the only proven method to decrease risk of development and worsening of 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 or need for frequent administration. Intracameral implant technology could make an impact on glaucoma management in individuals who may be at risk for non-compliance, however the current regulatory approval only allows for a single use per eye. Bimatoprost intracameral implant has not been compared to bimatoprost topical solution yet, which would allow for a head-to-head evaluation of a novel drug delivery system. Published clinical trials do not show that bimatoprost intracameral implant is superior to the standard of care, and with the limited duration of use permitted by the FDA clearance the bimatoprost intracameral implant has a limited utility. Bimatoprost implant biodegradation is also not uniform: according to Weinreb at al, phase 3 studies showed some degree of variability among patients, further complicating possible implant re-administration timeline. At this time the existing evidence is insufficient to prove the medical necessity of this technology.
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| CPT/HCPCS: | |
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| References: |
American Academy of Ophthalmology Preferred Practice Pattern Glaucoma Panel, Hospkins Center for Quality Eye Care.(2015) Primary Open-Angle Glaucoma 2015. Accessed on September 21,2020.
Available at https://www.aao.org/preferred-practice-pattern/primary-open-angle-glaucoma-suspect-ppp-2015. 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. Craven ER, Walters T, Christie WC, et al.(2020) 24-month phase i/ii clinical trial of bimatoprost sustained-release implant (bimatoprost sr) in glaucoma patients. Drugs. 2020;80:167-179. 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. PMID: 32544560. U.S. Food and Drug Administration (FDA).(2020) Durysta. Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211911s000lbl.pdf Accessed on September 2, 2021 |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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