Pharmacy Prior Authorization Criteria

Everolimus products - PA, NF

Indications for Prior Authorization

Afinitor (everolimus tablet)

• For diagnosis of Neuroendocrine Tumors of Pancreatic Origin (PNET)
  Indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease. AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors.

  Afinitor is not indicated for the treatment of patients with functional carcinoid tumors.

• For diagnosis of Neuroendocrine Tumors of Gastrointestinal or Lung Origin
  Indicated for the treatment of adult patients with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors.

• For diagnosis of Renal Cell Carcinoma (RCC)
  Indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib.

• For diagnosis of Tuberous Sclerosis Complex (TSC) – Associated Renal Angiomyolipoma
  Indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.

• For diagnosis of Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA)
  Indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

• For diagnosis of Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR + BC)
  Indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole.

Torpenz (everolimus tablet)

• For diagnosis of Tuberous Sclerosis Complex (TSC)–Associated Renal Angiomyolipoma
  Indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.

• For diagnosis of Tuberous Sclerosis Complex (TSC)–Associated Subependymal Giant Cell Astrocytoma (SEGA)
  Indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

• For diagnosis of Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR + BC)
  Indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane, after failure of treatment with letrozole or anastrozole.

Afinitor Disperz (everolimus tablet for oral suspension)

• For diagnosis of Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA)
  Indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

• For diagnosis of Tuberous Sclerosis Complex (TSC)-Associated Partial-onset Seizures
  Indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures

Criteria

Brand Afinitor, Generic everolimus tablet*, Torpenz* (off-label), Yulithira*

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Neuroendocrine Tumors of Pancreatic Origin (PNET)

• Diagnosis of progressive neuroendocrine tumors of pancreatic origin
AND
• Disease is one of the following:
• Unresectable
• Locally advanced
• Metastatic
AND
• Trial or intolerance to generic everolimus tablet (applies to Brand Afinitor only)

Brand Afinitor, Generic everolimus tablet*, Torpenz* (off-label), Yulithira*

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Neuroendocrine Tumors of Pancreatic Origin (PNET)

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial and failure or intolerance to generic everolimus tablet (applies to Brand Afinitor only)

Brand Afinitor

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Neuroendocrine Tumors of Pancreatic Origin (PNET)

• Submission of medical records (e.g., chart notes) confirming diagnosis of progressive neuroendocrine tumors of pancreatic origin
AND
• Submission of medical records (e.g., chart notes) confirming disease is one of the following:
• Unresectable
• Locally advanced
• Metastatic
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of 3 month trial of generic everolimus tablet
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to generic everolimus tablet
OR
• Submission of medical records (e.g., chart notes) documenting one of the following:
• An adverse event (e.g., cellulitis) due to treatment with generic everolimus tablet
• Potential for an allergic reaction due to a non-active ingredient that is contained in generic everolimus tablet but not included in Afinitor

Brand Afinitor, Generic everolimus tablet*, Torpenz* (off-label), Yulithira*

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Neuroendocrine tumors of gastrointestinal or lung origin

• Diagnosis of progressive, well-differentiated, non-functional neuroendocrine tumors of gastrointestinal or lung origin
AND
• Disease is one of the following:
• Unresectable
• Locally advanced
• Metastatic disease
AND
• Trial or intolerance to generic everolimus tablet (applies to Brand Afinitor only)

Brand Afinitor, Generic everolimus tablet*, Torpenz* (off-label), Yulithira*

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Neuroendocrine tumors of gastrointestinal or lung origin

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial or intolerance to generic everolimus tablet (applies to Brand Afinitor only)

Brand Afinitor

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Neuroendocrine tumors of gastrointestinal or lung origin

• Submission of medical records (e.g., chart notes) confirming diagnosis of progressive, well-differentiated, non-functional neuroendocrine tumors of gastrointestinal or lung origin
AND
• Submission of medical records (e.g., chart notes) confirming disease is one of the following:
• Unresectable
• Locally advanced
• Metastatic disease
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of 3 months to generic everolimus tablet
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to generic everolimus tablet
OR
• Submission of medical records (e.g., chart notes) documenting one of the following:
• An adverse event (e.g., cellulitis) due to treatment with generic everolimus tablet
• Potential for an allergic reaction due to a non-active ingredient that is contained in generic everolimus tablet but not included in Afinitor

Brand Afinitor, Generic everolimus tablet*, Torpenz* (off-label), Yulithira*

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Renal Cell Carcinoma

• Diagnosis of advanced renal cell carcinoma
AND
• Trial and failure with one of the following*:
• Sutent (sunitinib)
• Nexavar (sorafenib)
AND
• Trial or intolerance to generic everolimus tablet (applies to Brand Afinitor only)

Brand Afinitor, Generic everolimus tablet*, Torpenz* (off-label), Yulithira*

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Renal Cell Carcinoma

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial or intolerance to generic everolimus tablet (applies to Brand Afinitor only)

Brand Afinitor

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Renal Cell Carcinoma

• Submission of medical records (e.g., chart notes) confirming diagnosis of advanced renal cell carcinoma
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure with one of the following*:
• Sutent (sunitinib)
• Nexavar (sorafenib)
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of a 3 month trial of generic everolimus tablet
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to generic everolimus tablet
OR
• Submission of medical records (e.g., chart notes) documenting one of the following:
• An adverse event (e.g., cellulitis) due to treatment with generic everolimus tablet
• Potential for an allergic reaction due to a non-active ingredient that is contained in generic everolimus tablet but not included in Afinitor

Brand Afinitor, Generic everolimus tablet*, Torpenz*, Yulithira*

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Tuberous Sclerosis Complex (TSC) – Associated Renal Angiomyolipoma

• Diagnosis of renal angiomyolipoma and tuberous sclerosis complex (TSC)
AND
• Trial or intolerance to generic everolimus tablet (applies to Brand Afinitor only)
AND
• Prescribed by or in consultation with a nephrologist

Brand Afinitor, Generic everolimus tablet*, Torpenz*, Yulithira*

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Tuberous Sclerosis Complex (TSC) – Associated Renal Angiomyolipoma

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial or intolerance to generic everolimus tablet (applies to Brand Afinitor only)

Brand Afinitor

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Tuberous Sclerosis Complex (TSC) – Associated Renal Angiomyolipoma

• Submission of medical records (e.g., chart notes) confirming diagnosis of renal angiomyolipoma and tuberous sclerosis complex (TSC)
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of 3 month trial of generic everolimus tablet
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to generic everolimus tablet
OR
• Submission of medical records (e.g., chart notes) documenting one of the following:
• An adverse event (e.g., cellulitis) due to treatment with generic everolimus tablet
• Potential for an allergic reaction due to a non-active ingredient that is contained in generic everolimus tablet but not included in Afinitor
AND
• Prescribed by or in consultation with a nephrologist

Brand Afinitor, Generic everolimus tablet*, Torpenz*, Yulithira*, Brand Afinitor Disperz, Generic everolimus tablet for oral suspension*

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma

• Diagnosis of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS)
AND
• Patient is 1 year of age or older
AND
• One of the following:
• Trial or intolerance to generic everolimus tablet (applies to Brand Afinitor only)
OR
• Trial or intolerance to generic everolimus tablet for oral suspension (applies to Brand Afinitor Disperz only)

Brand Afinitor, Generic everolimus tablet*, Torpenz*, Yulithira*, Brand Afinitor Disperz, Generic everolimus tablet for oral suspension*

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma

• Patient does not show evidence of progressive disease while on therapy
AND
• One of the following:
• Trial or intolerance to generic everolimus tablet (applies to Brand Afinitor only)
OR
• Trial or intolerance to generic everolimus tablet for oral suspension (applies to Brand Afinitor Disperz only)

Brand Afinitor, Brand Afinitor Disperz

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma

• Submission of medical records (e.g., chart notes) confirming diagnosis of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS)
AND
• Patient is 1 year of age or older
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of 3 month trial with generic everolimus tablet or generic everolimus tablet for oral suspension
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to generic everolimus tablet or generic everolimus tablet for oral suspension
OR
• Submission of medical records (e.g., chart notes) documenting one of the following:
• An adverse event (e.g., cellulitis) due to treatment with generic everolimus product
• Potential for an allergic reaction due to a non-active ingredient that is contained in generic of everolimus product but not included in Afinitor or Afinitor Disperz

Brand Afinitor, Generic everolimus tablet*, Torpenz*, Yulithira*

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Breast cancer

• Diagnosis of hormone receptor positive, HER-2 negative advanced breast cancer
AND
• Trial and failure, contraindication, or intolerance to one of the following*:
• Femara (letrozole)
• Arimidex (anastrozole)
AND
• Trial or intolerance to generic everolimus tablet (applies to Brand Afinitor only)

Brand Afinitor, Generic everolimus tablet*, Torpenz*, Yulithira*

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Breast cancer

• Patient does not show evidence of progressive disease while on therapy
AND
• Trial or intolerance to generic everolimus tablet (applies to Brand Afinitor only)

Brand Afinitor

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Breast cancer

• Submission of medical records (e.g., chart notes) confirming diagnosis of hormone receptor positive, HER-2 negative advanced breast cancer
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to one of the following*:
• Femara (letrozole)
• Arimidex (anastrozole)
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of 3 months to generic everolimus tablet.
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to generic everolimus tablet
OR
• Submission of medical records (e.g., chart notes) documenting one of the following:
• An adverse event (e.g., cellulitis) due to treatment with generic everolimus tablet
• Potential for an allergic reaction due to a non-active ingredient that is contained in generic of everolimus tablet but not included in Afinitor

Brand Afinitor Disperz, Generic everolimus tablet for oral suspension*

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Tuberous Sclerosis Complex (TSC)-associated Partial-onset Seizures

• Diagnosis of TSC-associated partial-onset seizures
AND
• Patient is 2 years of age or older
AND
• Trial or intolerance to generic everolimus tablet for oral suspension (applies to Brand Afinitor Disperz only)
AND
• Prescribed by or in consultation with a neurologist

Brand Afinitor Disperz, Generic everolimus tablet for oral suspension*

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Tuberous Sclerosis Complex (TSC)-associated Partial-onset Seizures

• Patient shows reduction in seizure frequency while on therapy
AND
• Trial or intolerance to generic everolimus tablet for oral suspension (applies to Brand Afinitor Disperz only)

Brand Afinitor Disperz

Non Formulary

Length of Approval: 12 Month(s)
For diagnosis of Tuberous Sclerosis Complex (TSC)-associated Partial-onset Seizures

• Submission of medical records (e.g., chart notes) confirming diagnosis of TSC-associated partial-onset seizures
AND
• Patient is 2 years of age or older
AND
• One of the following:
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming a minimum duration of 3 months to generic everolimus tablet for oral suspension.
AND
• Submission of medical records (e.g., chart notes) documenting objective information indicating a lack of adequate clinical response to generic everolimus tablet for oral suspension
OR
• Submission of medical records (e.g., chart notes) documenting one of the following:
• An adverse event (e.g., cellulitis) due to treatment with generic everolimus tablet for oral suspension
• Potential for an allergic reaction due to a non-active ingredient that is contained in generic everolimus tablet for oral suspension but not included in Afinitor Dizperz
AND
• Prescribed by or in consultation with a neurologist

P & T Revisions

2026-06-10, 2025-12-18, 2025-12-18, 2025-07-03, 2024-08-02, 2024-06-21, 2023-06-15, 2023-05-11, 2022-05-19, 2022-01-20, 2021-11-03, 2021-09-27, 2021-05-11, 2020-04-01, 2020-01-28

References

1. Afinitor and Afinitor Disperz Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. May 2026.
2. Torpenz Prescribing Information. Upsher-Smith Laboratories, LLC. Maple Grove, MN 55369. May 2026.
3. NCCN Drugs & Biologics Compendium. Accessed May 2026.

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Revision History

• 2026-06-10: 2026 Annual Review. No clinical criteria changes, operational and reference updates only. Updating verbiage to standard for embedded step through generics for PA and non-formulary. Also, adding new generic, Yulithira, as target to guideline.
• 2025-12-18: No criteria change, bulk copy oRX-EHB
• 2025-12-18: no criteria changes, added IL statute operational note
• 2025-07-03: 2025 Annual Review. Updated guideline name to Everolimus Products. Updated language in non formulary criteria with no change to clinical intent. Background updates.
• 2024-08-02: Added Torpenz as target to guideline.
• 2024-06-21: 2024 Annual Review. Added trial and failure or intolerance of generic everolimus to formulary reauthorization criteria. Updated non-formulary criteria. Background updates.
• 2023-06-15: Removed Oncologist specialist requirement
• 2023-05-11: Program update to remove requirement that patient is not a candidate for curative surgical resection, patient does not require immediate surgery, patient is post menopausal, and used in combination with Aromasin (exemestane) for their respective indications
• 2022-05-19: 2022 Annual Review - added criterion confirming patient is a post-menopausal for breast cancer indication and age criterion where applicable
• 2022-01-20: Added embedded step for brand Afinitor and Brand Afinitor Disperz to try respective generic products first. No COT required for brand-generic step. Brand Afinitor and Brand Afinitor Disperz will also be excluded on Premium. Added NF sections for brand Afinitor and Brand Afinitor Disperz that mirrors the initial PA criteria.
• 2021-11-03: Added new Afinitor generic formulation (generic everolimus 10 mg tablet) to mirror brand Afinitor. Added new generics for Afinitor Disperz (generic everolimus tablet for oral suspension) to mirror Brand Afinitor Disperz. Updated background and references.
• 2021-09-27: 2021 Annual Review
• 2021-05-11: 2021 Annual Review
• 2020-04-01: Reference update only
• 2020-01-28: added new generic formulation

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