Vabysmo™ (faricimab-svoa) - CAM 362

Description
Faricimab is a humanized bispecific antibody that acts through inhibition of two pathways by binding to vascular endothelial growth factor A (VEGF-A) and angiopoietin 2 (Ang-2). By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization and vascular permeability. By inhibiting Ang-2, faricimab is thought to promote vascular stability and desensitize blood vessels to the effects of VEGF-A. Ang-2 levels are increased in some patients with nAMD and DME. The contribution of Ang-2 inhibition to the treatment effect and clinical response for nAMD and DME has yet to be established.

Policy
Initial Criteria

  1. Member has one of the following diagnoses:
    1. Neovascular (wet) age-related macular degeneration (nAMD)
    2. Diabetic macular edema (DME)
  2. Prescribed by or in consultation with an ophthalmologist
  3. Member does not have ocular or periocular infection
  4. Member does not have active intraocular inflammation
  5. Trial and failure, contraindication, or intolerance to ONE of the following:
    1. Compounded Avastin* prepared by a 503(B) Outsourcing Facility
    2. Lucentis (ranibizumab)

Auth duration: 6 months

Reauthorization Criteria

  1. Documentation of positive clinical response to therapy (such as: Improvement in Best Corrected Visual Acuity (BCVA) compared to baseline, stable vision)

Auth duration: 12 months

Rationale
This medical policy was developed in June 2022 and is based on the clinical studies provided to the U.S. Food and Drug Administration for approval.

Neovascular (wet) Age-Related Macular Degeneration (nAMD) (1)
The safety and efficacy of Vabysmo were assessed in two randomized, multi-center, double-masked, active comparator-controlled, 2-year studies (TENAYA - NCT03823287 and LUCERNE — NCT03823300) in patients with nAMD.

A total of 1,329 newly diagnosed, treatment-naive patients were enrolled in these studies, and 664 patients received at least 1 dose of Vabysmo. Patient ages ranged from 50 to 99 with a mean of 75.9 years. The studies were identically designed two-year studies. Patients were randomized in a 1:1 ratio to one of two treatment arms: 1) aflibercept 2 mg administered fixed every 8 weeks (Q8W) after 3 initial monthly doses; and 2) Vabysmo 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first 4 doses, followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to determine whether to give a 6 mg (0.05 mL of 120 mg/mL solution) dose via intravitreal injection on one of the following three regimens: 1) Weeks 28 and 44; (also referred to as Q16W dosing); 2) Weeks 24, 36 and 48 (also referred to as Q12W dosing); or 3) Weeks 20, 28, 36 and 44 (also referred to as Q8W dosing). However, the utility of these criteria to guide dosing intervals has not been established.

At week 48, after 4 initial monthly doses in the Vabysmo arm, 45% of patients received the Weeks 28 and 44 dosing, 33% of patients received the Weeks 24, 36 and 48 dosing, and the remaining 22% of patients received dosing every 8 weeks. These percentages are reflective of what happened within the conduct of these trials and indicate that some patients did well on two doses spaced 16 weeks apart, or three doses spaced 12 weeks apart, but the percentages may not be generalizable to a broader nAMD population for a variety of reasons. The inclusion/exclusion criteria limited enrollment to a select subset of treatment naive, newly diagnosed nAMD patients and there is no empirical data that a similar magnitude would be observed if eligibility criteria allowed for broader enrollment. The disease activity criteria, which was instrumental in determining dose frequency, is unvalidated. Stricter criteria would have changed how patients were treated resulting in different percentages of subjects in each dose interval cohort. There was not a similarly dosed aflibercept arm for comparison, which makes the percentages difficult to interpret.

Both studies demonstrated non-inferiority to the comparator control (aflibercept) at the primary endpoint, defined as the mean change from baseline in Best Corrected Visual Acuity (BCVA) when averaged over the week 40, 44, and 48 visits and measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter chart. The primary endpoint analysis was a noninferiority comparison for the mean change in BCVA between the aflibercept and the Vabysmo arm. The lower bound of the 95% confidence interval for the mean change in BCVA could not be lower than minus 4 letters to declare non-inferiority. In both studies, Vabysmo treated patients had a non-inferior mean change from baseline in BCVA compared to patients treated with aflibercept. Detailed results of both studies are shown in Table 1, Figure 1, and Figure 2 below. The clinical efficacy for the second year of the study has not been reviewed.

Table 1. Primary Endpoint Resultsa in the TENAYA and LUCERNE Studies

 

TENAYA

LUCERNE

 

Vabysmo (N = 334)

Aflibercept (N = 337)

Vabysmo (N = 331)

Aflibercept (N = 327)

Mean change in BCVA as measured by ETDRS letter score from baseline (95% CI)

5.8

(4.6, 7.1)

5.1

(3.9, 6.4)

6.6

(5.3, 7.8)

6.6

(5.3, 7.8)

Differences in LS mean (95% CI)

0.7

(-1.1, 2.5)

 

0.0

(-1.7, 1.8)

 

Average of weeks 40, 44 and 48.

BCVA: best corrected visual acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; CI: confidence interval; LS: least square.

Figure 1. Mean Change in Visual Acuity from Baseline to Week 48 in TENAYA

Figure 2. Mean Change in Visual Acuity from Baseline to Week 48 in LUCERNE

Treatment effects in evaluable subgroups (e.g., age, gender, race, baseline visual acuity) in each study were consistent with the results in the overall population.

Diabetic Macular Edema (1)
The safety and efficacy of Vabysmo were assessed in 2 randomized, multi-center, double-masked, active comparator-controlled 2-year studies (YOSEMITE - NCT03622580 and RHINE — NCT03622593) in patients with DME.

A total of 1,891 diabetic patients were enrolled in the two studies with a total of 1,262 patients treated with at least 1 dose of Vabysmo. Patient ages ranged from 24 to 91 with a mean of 62.2 years. The overall population included both anti-VEGF naive patients (78%) and patients who had been previously treated with a VEGF inhibitor prior to study participation (22%).

The studies were identically designed 2-year studies. Patients were randomized in a 1:1:1 ratio to 1 of 3 treatment regimens: 1) aflibercept Q8W, patients received fixed aflibercept 2 mg administered every 8 weeks (Q8W) after the first 5 monthly doses; 2) Vabysmo Q8W, patients received fixed Vabysmo 6 mg administered Q8W after the first 6 monthly doses; and 3) Vabysmo Variable, patients received Vabysmo 6 mg administered every 4 weeks for at least 4 doses and until the central subfield thickness (CST) of the macula measured by optical coherence tomography was less than approximately 325 microns, then the interval of dosing was modified by up to 4-week interval extensions or reductions in up to 8 week interval increments based on CST and visual acuity disease activity criteria at study drug dosing visits. However, the utility of these disease activity criteria to guide dosing intervals has not been established.

After 4 initial monthly doses, the patients in the Vabysmo variable arm could have received between the minimum of three and the maximum of 11 total injections through Week 56 inclusive. At Week 56, 32% of patients had completed at least one Q12W interval followed by one full Q16W interval. Seventeen percent (17%) of patients were treated on Q8W and/or Q4W dosing intervals through Week 56 (7% only on Q4W). Sustainability of the Q16W dosing interval cannot be determined based on year 1 data alone. These percentages are reflective of what happened within the conduct of these trials, but the percentages are not generalizable to a broader DME population for a variety of reasons. The inclusion/exclusion criteria limited enrollment to a select subset of DME patients and there is no empirical data that a similar magnitude would be observed if eligibility criteria allowed for broader enrollment. The disease activity criteria, which was instrumental in determining dose frequency, is unvalidated. Stricter criteria would have changed how patients were treated resulting in different percentages of subjects in each dose interval cohort. There was not a similarly dosed aflibercept arm for comparison which makes the percentages difficult to interpret.

Both studies demonstrated non-inferiority to the comparator control (aflibercept) at the primary endpoint, defined as the primary endpoint, defined as the mean change from baseline in BCVA at year 1 (average of the week 48, 52 and 56 visits), measured by the ETDRS Letter Score. The primary endpoint analysis was a non-inferiority comparison for the mean change in BCVA between the aflibercept and Vabysmo groups. The lower bound of the 97.5% confidence interval for the mean change in BCVA could not be lower than minus 4 letters to declare noninferiority. In both studies, Vabysmo Q8W and Vabysmo Variable treated patients had a mean change from baseline in BCVA that was non-inferior to the patients treated with aflibercept Q8W. Detailed results of both studies are shown in Table 2, Figure 3 and Figure 4 below. The clinical efficacy for the second year of the study has not been reviewed.

Table 2. Primary Endpoint Resultsa in the YOSEMITE and RHINE Studies

 

YOSEMITE

RHINO

 

Vabysmo Q8W N = 315

Vabysmo Variable N = 313

Aflibercept Q8W N = 312

Vabysmo Q8W N = 317

Vabysmo Variable N = 319

Aflilbercept Q8W N = 315

Mean change in BCVA as measured by ETDRS letter score from baseline (97.5% CI)

10.7

(9.4, 12.0)

11.6

(10.3, 12.9)

10.9

(9.6, 12.2)

11.8

(10.6, 13.0)

10.8

(9.6, 11.9)

10.3

(9.1, 11.4)

Differences in LS mean (97.5% CI)

-0.2

(-2.0, 1.6)

0.7

(-1.1, 2.5)

 

1.5

(-0.1, 3.2)

0.5

(-1.1, 2.1)

 

Average of weeks 48, 52, 56.

Q8W: Every 8 weeks; BCVA: best corrected visual acuity; ETDRS: Early Treatment Diabetic Retinopathy Study; CI: confidence interval; LS: least square.

Figure 3. Mean Change in Visual Acuity from Baseline to Year 1 (Week 56) in YOSEMITE

Figure 4. Mean Change in Visual Acuity from Baseline to Year 1 (Week 56) in RHINE

Treatment effects in the subgroup of patients who were anti-VEGF naive prior to study participation were similar to those observed in the overall population. Treatment effects in evaluable subgroups (e.g., by age, gender, race, baseline HbA1c, baseline visual acuity) in each study were generally consistent with the results in the overall population.

Summary of Evidence
Based on the clinical studies provided to the U.S. Food and Drug Administration for approval, faricimab-svoa (Vabysmo™) may be medically necessary for the treatment of patients with neovascular (wet) age-related macular degeneration (nARMD) or diabetic macular edema (DME). All other indications are considered experimental, investigational and/or unproven due to lack of clinical evidence.

References

  1. U.S. Food and Drug Administration. Highlights of Prescribing Information. Vabysmo™ (faricimab-svoa). January 2022. Available at: <www.accessdata.fda.gov>. Accessed June 10, 2022.
  2. Vabysmo [package insert]. South San Francisco, CA; Genentech, Inc.; January 2022. Accessed January 2022.
  3. Solomon SD, Chew E, Duh EJ, et al. Diabetic Retinopathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Mar;40(3):412-418.
  4. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Diabetic Retinopathy PPP – Update 2017. Nov 2017.
  5. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retinal Vein Occlusions PPP – Update 2017. Nov 2017.
  6. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Age-Related Macular Degeneration PPP – Update 2017. Nov 2017.
  7. Royal College of Ophthalmologists. Clinical Guidelines – Retinal Vein Occlusion (RVO) Guidelines – July 2015. Accessed at https://www.rcophth.ac.uk/standards-publications-research/clinical-guidelines.
  8. Heier JS, Khanani AM, Quezada et al; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Jan 21. pii: S0140-6736(22)00010-1. doi: 10.1016/S0140-6736(22)00010-1.
  9. Wykoff CC, Abreu F, Adamis AP, et al; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Jan 21. pii: S0140-6736(22)00018-6. doi: 10.1016/S0140-6736(22)00018-6.
  10. Vabysmo [package insert]. South San Francisco, CA; Genentech, Inc.; January 2022. Accessed January 2022.
  11. Solomon SD, Chew E, Duh EJ, et al. Diabetic Retinopathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Mar;40(3):412-418.
  12. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Diabetic Retinopathy PPP – Update 2017. Nov 2017.
  13. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Retinal Vein Occlusions PPP – Update 2017. Nov 2017.
  14. American Academy of Ophthalmology-Preferred Practice Patterns (AAO-PPP) Retina/Vitreous Panel, Hoskins Center for Quality Eye Care. Age-Related Macular Degeneration PPP – Update 2017. Nov 2017.
  15. Royal College of Ophthalmologists. Clinical Guidelines – Retinal Vein Occlusion (RVO) Guidelines –July 2015. Accessed at https://www.rcophth.ac.uk/standards-publicationsresearch/clinical-guidelines.
  16. Heier JS, Khanani AM, Quezada et al; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular agerelated macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Jan 21. pii: S0140-6736(22)00010-1. doi:10.1016/S0140-6736(22)00010-1.

Coding Section

Code Number Description
HCPCS J2777 Injection, faricimab-svoa, 0.1 mg
  J3590 Unclassified biologics
  C9097 Injection, faricimab-svoa, 0.1 mg; 1 billable unit = 0.1 mg (Effective 07/01/2022)
  C9399 Unclassified drugs or biologicals (Discontinue use on 07/01/2022)
ICD-10

E08.311

Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

 

E08.3211

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, right eye

 

E08.3212

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, left eye

 

E08.3213

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, bilateral

 

E08.3219

Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E08.3311

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, right eye

 

E08.3312

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, left eye

 

E08.3313

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

 

E08.3319

Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E08.3411

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye

 

E08.3412

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, left eye

 

E08.3413

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, bilateral

 

E08.3419

Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E08.3511

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, right eye

 

E08.3512

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, left eye

 

E08.3513

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, bilateral

 

E08.3519

Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, unspecified eye

 

E09.311

Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema

 

E09.3211

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

 

E09.3212

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

 

E09.3213

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

 

E09.3219

Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E09.3311

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

 

E09.3312

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

 

E09.3313

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

 

E09.3319

Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E09.3411

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

 

E09.3412

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

 

E09.3413

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

 

E09.3419

Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E09.3511

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

 

E09.3512

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

 

E09.3513

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

 

E09.3519

Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

 

E10.311

Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

 

E10.3211

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

 

E10.3212

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

 

E10.3213

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

 

E10.3219

Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E10.3311

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

 

E10.3312

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

 

E10.3313

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

 

E10.3319

Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E10.3411

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

 

E10.3412

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

 

E10.3413

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

 

E10.3419

Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E10.3511

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

 

E10.3512

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

 

E10.3513

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

 

E10.3519

Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

 

E11.311

Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema

 

E11.3211

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

 

E11.3212

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

 

E11.3213

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

 

E11.3219

Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E11.3311

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

 

E11.3312

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

 

E11.3313

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

 

E11.3319

Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E11.3411

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

 

E11.3412

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

 

E11.3413

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

 

E11.3419

Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E11.3511

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

 

E11.3512

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

 

E11.3513

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

 

E11.3519

Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

 

E13.311

Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema

 

E13.3211

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

 

E13.3212

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

 

E13.3213

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

 

E13.3219

Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E13.3311

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

 

E13.3312

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

 

E13.3313

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

 

E13.3319

Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E13.3411

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

 

E13.3412

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

 

E13.3413

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

 

E13.3419

Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye

 

E13.3511

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

 

E13.3512

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

 

E13.3513

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

 

E13.3519

Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye

 

H35.3210

Exudative age-related macular degeneration, right eye, stage unspecified

 

H35.3211

Exudative age-related macular degeneration, right eye, with active choroidal neovascularization

 

H35.3212

Exudative age-related macular degeneration, right eye, with inactive choroidal neovascularization

 

H35.3213

Exudative age-related macular degeneration, right eye, with inactive scar

 

H35.3220

Exudative age-related macular degeneration, left eye, stage unspecified

 

H35.3221

Exudative age-related macular degeneration, left eye, with active choroidal neovascularization

 

H35.3222

Exudative age-related macular degeneration, left eye, with inactive choroidal neovascularization

 

H35.3223

Exudative age-related macular degeneration, left eye, with inactive scar

 

H35.3230

Exudative age-related macular degeneration, bilateral, stage unspecified

 

H35.3231

Exudative age-related macular degeneration, bilateral, with active choroidal neovascularization

 

H35.3232

Exudative age-related macular degeneration, bilateral, with inactive choroidal neovascularization

 

H35.3233

Exudative age-related macular degeneration, bilateral, with inactive scar

 

H35.3290

Exudative age-related macular degeneration, unspecified eye, stage unspecified

 

H35.3291

Exudative age-related macular degeneration, unspecified eye, with active choroidal neovascularization

 

H35.3292

Exudative age-related macular degeneration, unspecified eye, with inactive choroidal neovascularization

 

H35.3293

Exudative age-related macular degeneration, unspecified eye, with inactive scar

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2022 Forward     

08/15/2023 Annual review, no change to policy intent.

12/01/2022

New Policy

 

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