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Phenotype Submission - new users of 3 monthly intravitreal anti-VEGF (aflibercept, bevacizumab, ranibizumab)

Atlas Cohort Definition:

1782483 Aflibercept

1782482 Bevacizumab

1782481 Ranibizumab

Cohort Definition Names:

-Long-names: Adults ≥18 years who are new users of 3 monthly intravitreal anti-VEGF medications for blinding diseases, no prior history of cancer, and 365 day observation prior to cohort entry. FYI: there are separate cohorts for new users of aflibercept, bevacizumab, and ranibizumab. Patients are right censored if they switch therapies.

-Short names: new users of 3 monthly aflibercept, new users of 3 monthly bevacizumab, and new users of 3 monthly ranibizumab

Contributor Names:

-Cindy Cai

-Asieh Golozar

-And many others who were involved with the anti-VEGF/kidney failure 2023 SOS Challenge

Clinical Description:

-Intravitreal anti-VEGF medications are common treatments for multiple binding conditions including but not limited to diabetic retinopathy/diabetic macular edema, retinal vein occlusion, and neovascular age-related macular degeneration. Patients are typically given a loading dose of 3 monthly injections before switching to other treatment algorithms (for example, as needed or treat-and-extend). Some patients are started on one medication, for example bevacizumab, and can be switched to another one, for example aflibercept, due to a variety of reasons (e.g., treatment failure, patient request, insurance mandates).

Logic Description:

-See above

Recommended Study Applications:

-NA

Assertion Statement:

-Used in the anti-VEGF/kidney failure 2023 SOS Challenge project and successfully deployed on multiple administrative claims and electronic health record databases

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1782483 Aflibercept
[SOS Phenotype Devt] aflibercept exposures after new use with 3 exposures in 21-70d windows
Cohort Entry Events
People may enter the cohort when observing any of the following:

drug exposures of ‘[SOS] aflibercept’.
Inclusion Criteria

  1. has at least 1 prior exposure with 2 or more prior exposures in 21-70d with blinding disease and no other cancer and 365d before first

Entry events having at least 1 drug exposure of ‘[SOS] aflibercept’, starting anytime on or before cohort entry start date; having at least 1 drug exposure of ‘[SOS] aflibercept’, starting between 70 days before and 21 days before ‘[SOS] aflibercept’ start date; having at least 1 drug exposure of ‘[SOS] aflibercept’ for the first time in the person’s history, starting between 70 days before and 21 days before ‘[SOS] aflibercept’ start date; with all of the following criteria:

having at least 1 observation period, starting anytime up to 365 days before ‘[SOS] aflibercept’ start date and ending between 0 days after and all days after ‘[SOS] aflibercept’ start date.

having no drug exposures of ‘[SOS] aflibercept ranibizumab and bevacizumab’, starting anytime prior to ‘[SOS] aflibercept’ start date; allow events outside observation period.

having no condition occurrences of ‘[SOS] Malignant neoplasms excluding non-melanoma skin cancer’, starting anytime on or before ‘[SOS] aflibercept’ start date; allow events outside observation period.

with any of the following criteria:

having at least 1 condition occurrence of ‘[SOS] Retinal Vein Occlusion’, starting anytime on or before ‘[SOS] aflibercept’ start date.
having at least 1 condition occurrence of ‘[SOS] Age related Macular Degeneration’, starting anytime on or before ‘[SOS] aflibercept’ start date.
having at least 1 condition occurrence of ‘[SOS] Diabetic retinopathy’, starting anytime on or before ‘[SOS] aflibercept’ start date.
having at least 1 condition occurrence of ‘[SOS] Macular edema’, starting anytime on or before ‘[SOS] aflibercept’ start date.
Cohort Exit
The cohort end date will be based on a continuous exposure to ‘[SOS] aflibercept’: allowing 180 days between exposures, adding 0 days after exposure ends, and using days supply and exposure end date for exposure duration. The person exits the cohort when encountering any of the following events:

drug exposures of ‘[SOS] bevacizumab’.
drug exposures of ‘[SOS] ranibizumab’.
Cohort Eras
Entry events will be combined into cohort eras if they are within 0 days of each other.

Appendix 1: Concept Set Definitions

[SOS] aflibercept
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
40244266 aflibercept Drug RxNorm NO YES NO

[SOS] aflibercept ranibizumab and bevacizumab
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
40244266 aflibercept Drug RxNorm NO YES NO
1397141 bevacizumab Drug RxNorm NO YES NO
19080982 ranibizumab Drug RxNorm NO YES NO

[SOS] Age related Macular Degeneration
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
374028 Age related macular degeneration Condition SNOMED NO YES NO
4224741 Degenerative disorder of macula Condition SNOMED NO NO NO

[SOS] bevacizumab
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
1397141 bevacizumab Drug RxNorm NO YES NO

[SOS] Diabetic retinopathy
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
4174977 Retinopathy due to diabetes mellitus Condition SNOMED NO YES NO

[SOS] Macular edema
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
4290333 Macular retinal edema Condition SNOMED NO YES NO
4208200 Postoperative cystoid macular edema Condition SNOMED YES YES NO

[SOS] Malignant neoplasms excluding non-melanoma skin cancer
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
4112752 Basal cell carcinoma of skin Condition SNOMED YES YES NO
4111921 Squamous cell carcinoma of skin Condition SNOMED YES YES NO
443392 Malignant neoplastic disease Condition SNOMED NO YES NO

[SOS] ranibizumab
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
19080982 ranibizumab Drug RxNorm NO YES NO

[SOS] Retinal Vein Occlusion
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
440392 Retinal vascular occlusion Condition SNOMED NO YES NO
4334245 Retinal artery occlusion Condition SNOMED YES YES NO
437544 Arterial retinal branch occlusion Condition SNOMED YES YES NO
4338905 Cilioretinal artery occlusion Condition SNOMED YES YES NO

==============================

1782482 Bevacizumab

[SOS Phenotype Devt] bevacizumab exposures after new use with 3 exposures in 21-70d windows
Cohort Entry Events
People may enter the cohort when observing any of the following:

drug exposures of ‘[SOS] bevacizumab’.
Inclusion Criteria

  1. has at least 1 prior exposure with 2 or more prior exposures in 21-70d with blinding disease and no other cancer and 365d before first

Entry events having at least 1 drug exposure of ‘[SOS] bevacizumab’, starting anytime on or before cohort entry start date; having at least 1 drug exposure of ‘[SOS] bevacizumab’, starting between 70 days before and 21 days before ‘[SOS] bevacizumab’ start date; having at least 1 drug exposure of ‘[SOS] bevacizumab’ for the first time in the person’s history, starting between 70 days before and 21 days before ‘[SOS] bevacizumab’ start date; with all of the following criteria:

having at least 1 observation period, starting anytime up to 365 days before ‘[SOS] bevacizumab’ start date and ending between 0 days after and all days after ‘[SOS] bevacizumab’ start date.

having no drug exposures of ‘[SOS] aflibercept ranibizumab and bevacizumab’, starting anytime prior to ‘[SOS] bevacizumab’ start date; allow events outside observation period.

having no condition occurrences of ‘[SOS] Malignant neoplasms excluding non-melanoma skin cancer’, starting anytime on or before ‘[SOS] bevacizumab’ start date; allow events outside observation period.

with any of the following criteria:

having at least 1 condition occurrence of ‘[SOS] Retinal Vein Occlusion’, starting anytime on or before ‘[SOS] bevacizumab’ start date.
having at least 1 condition occurrence of ‘[SOS] Age related Macular Degeneration’, starting anytime on or before ‘[SOS] bevacizumab’ start date.
having at least 1 condition occurrence of ‘[SOS] Diabetic retinopathy’, starting anytime on or before ‘[SOS] bevacizumab’ start date.
having at least 1 condition occurrence of ‘[SOS] Macular edema’, starting anytime on or before ‘[SOS] bevacizumab’ start date.
Cohort Exit
The cohort end date will be based on a continuous exposure to ‘[SOS] bevacizumab’: allowing 180 days between exposures, adding 0 days after exposure ends, and using days supply and exposure end date for exposure duration. The person exits the cohort when encountering any of the following events:

drug exposures of ‘[SOS] aflibercept’.
drug exposures of ‘[SOS] ranibizumab’.
Cohort Eras
Entry events will be combined into cohort eras if they are within 0 days of each other.

Appendix 1: Concept Set Definitions

[SOS] aflibercept
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
40244266 aflibercept Drug RxNorm NO YES NO

[SOS] aflibercept ranibizumab and bevacizumab
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
40244266 aflibercept Drug RxNorm NO YES NO
1397141 bevacizumab Drug RxNorm NO YES NO
19080982 ranibizumab Drug RxNorm NO YES NO

[SOS] Age related Macular Degeneration
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
374028 Age related macular degeneration Condition SNOMED NO YES NO
4224741 Degenerative disorder of macula Condition SNOMED NO NO NO

[SOS] bevacizumab
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
1397141 bevacizumab Drug RxNorm NO YES NO

[SOS] Diabetic retinopathy
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
4174977 Retinopathy due to diabetes mellitus Condition SNOMED NO YES NO

[SOS] Macular edema
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
4290333 Macular retinal edema Condition SNOMED NO YES NO
4208200 Postoperative cystoid macular edema Condition SNOMED YES YES NO

[SOS] Malignant neoplasms excluding non-melanoma skin cancer
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
4112752 Basal cell carcinoma of skin Condition SNOMED YES YES NO
4111921 Squamous cell carcinoma of skin Condition SNOMED YES YES NO
443392 Malignant neoplastic disease Condition SNOMED NO YES NO

[SOS] ranibizumab
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
19080982 ranibizumab Drug RxNorm NO YES NO

[SOS] Retinal Vein Occlusion
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
440392 Retinal vascular occlusion Condition SNOMED NO YES NO
4334245 Retinal artery occlusion Condition SNOMED YES YES NO
437544 Arterial retinal branch occlusion Condition SNOMED YES YES NO
4338905 Cilioretinal artery occlusion Condition SNOMED YES YES NO

==============================

1782481 Ranibizumab

[SOS Phenotype Devt] ranibizumab exposures after new use with 3 exposures in 21-70d windows
Cohort Entry Events
People may enter the cohort when observing any of the following:

drug exposures of ‘[SOS] ranibizumab’.
Inclusion Criteria

  1. has at least 1 prior exposure with 2 or more prior exposures in 21-70d with blinding disease and no other cancer and 365d before first

Entry events having at least 1 drug exposure of ‘[SOS] ranibizumab’, starting anytime on or before cohort entry start date; having at least 1 drug exposure of ‘[SOS] ranibizumab’, starting between 70 days before and 21 days before ‘[SOS] ranibizumab’ start date; having at least 1 drug exposure of ‘[SOS] ranibizumab’ for the first time in the person’s history, starting between 70 days before and 21 days before ‘[SOS] ranibizumab’ start date; with all of the following criteria:

having at least 1 observation period, starting anytime up to 365 days before ‘[SOS] ranibizumab’ start date and ending between 0 days after and all days after ‘[SOS] ranibizumab’ start date.

having no drug exposures of ‘[SOS] aflibercept ranibizumab and bevacizumab’, starting anytime prior to ‘[SOS] ranibizumab’ start date; allow events outside observation period.

having no condition occurrences of ‘[SOS] Malignant neoplasms excluding non-melanoma skin cancer’, starting anytime on or before ‘[SOS] ranibizumab’ start date; allow events outside observation period.

with any of the following criteria:

having at least 1 condition occurrence of ‘[SOS] Retinal Vein Occlusion’, starting anytime on or before ‘[SOS] ranibizumab’ start date.
having at least 1 condition occurrence of ‘[SOS] Age related Macular Degeneration’, starting anytime on or before ‘[SOS] ranibizumab’ start date.
having at least 1 condition occurrence of ‘[SOS] Diabetic retinopathy’, starting anytime on or before ‘[SOS] ranibizumab’ start date.
having at least 1 condition occurrence of ‘[SOS] Macular edema’, starting anytime on or before ‘[SOS] ranibizumab’ start date.
Cohort Exit
The cohort end date will be based on a continuous exposure to ‘[SOS] ranibizumab’: allowing 180 days between exposures, adding 0 days after exposure ends, and using days supply and exposure end date for exposure duration. The person exits the cohort when encountering any of the following events:

drug exposures of ‘[SOS] aflibercept’.
drug exposures of ‘[SOS] bevacizumab’.
Cohort Eras
Entry events will be combined into cohort eras if they are within 0 days of each other.

Appendix 1: Concept Set Definitions

[SOS] aflibercept
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
40244266 aflibercept Drug RxNorm NO YES NO

[SOS] aflibercept ranibizumab and bevacizumab
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
40244266 aflibercept Drug RxNorm NO YES NO
1397141 bevacizumab Drug RxNorm NO YES NO
19080982 ranibizumab Drug RxNorm NO YES NO

[SOS] Age related Macular Degeneration
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
374028 Age related macular degeneration Condition SNOMED NO YES NO
4224741 Degenerative disorder of macula Condition SNOMED NO NO NO

[SOS] bevacizumab
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
1397141 bevacizumab Drug RxNorm NO YES NO

[SOS] Diabetic retinopathy
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
4174977 Retinopathy due to diabetes mellitus Condition SNOMED NO YES NO

[SOS] Macular edema
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
4290333 Macular retinal edema Condition SNOMED NO YES NO
4208200 Postoperative cystoid macular edema Condition SNOMED YES YES NO

[SOS] Malignant neoplasms excluding non-melanoma skin cancer
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
4112752 Basal cell carcinoma of skin Condition SNOMED YES YES NO
4111921 Squamous cell carcinoma of skin Condition SNOMED YES YES NO
443392 Malignant neoplastic disease Condition SNOMED NO YES NO

[SOS] ranibizumab
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
19080982 ranibizumab Drug RxNorm NO YES NO

[SOS] Retinal Vein Occlusion
Concept Id Concept Name Domain Vocabulary Excluded Descendants Mapped
440392 Retinal vascular occlusion Condition SNOMED NO YES NO
4334245 Retinal artery occlusion Condition SNOMED YES YES NO
437544 Arterial retinal branch occlusion Condition SNOMED YES YES NO
4338905 Cilioretinal artery occlusion Condition SNOMED YES YES NO

@cindyxcai could you please attach the json of the definition as a.txt file to this thread. I can then grab that into the library

t