Afinitor, Afinitor Disperz (everolimus) - PA, NF
Indications for Prior Authorization
Afinitor (everolimus tablet)
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For diagnosis of Advanced Neuroendocrine Tumors of Pancreatic Origin (PNET)
Indicated for the treatment of progressive PNET in adult patients with unresectable, locally advanced or metastatic disease.Afinitor is not indicated for the treatment of patients with functional carcinoid tumors.
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For diagnosis of Advanced 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 Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC)
Indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. -
For diagnosis of 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 Advanced 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. -
For diagnosis of Neuroendocrine Tumors of Gastrointestinal or Lung Origin
Indicated for the treatment of adults 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.
Torpenz (everolimus tablet)
-
For diagnosis of Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC)
Indicated for the treatment of adult patients with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. -
For diagnosis of 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 Advanced 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 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.The effectiveness of Afinitor Disperz is based on demonstration of durable objective response, as evidenced by reduction in SEGA tumor volume. Improvement in disease-related symptoms and overall survival in patients with SEGA and TSC has not been demonstrated.
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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)
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Advanced 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
- Trial and failure or intolerance to generic everolimus tablet (applies to Brand Afinitor only)
Brand Afinitor, Generic everolimus tablet, Torpenz (off-label)
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Advanced 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 Advanced Neuroendocrine Tumors of Pancreatic Origin (PNET)
- Submission of medical records (e.g., chart notes) confirming diagnosis of progressive neuroendocrine tumors of pancreatic origin AND
- Disease is one of the following:
- Unresectable, locally advanced
- Metastatic
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) to generic everolimus tablet AND
- Submission of medical records confirming the formulary alternative(s) has not been effective AND justification/rationale provided explaining how Brand Afinitor is expected to provide benefit when the formulary alternative has not been shown to be effective despite having the same active ingredient
Brand Afinitor, Generic everolimus tablet, Torpenz (off-label)
*Criterion is part of the FDA-approved label.
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Advanced Renal Cell Carcinoma
- Diagnosis of advanced renal cell carcinoma AND
- Trial and failure with one of the following*:
- Sutent (sunitinib)
- Nexavar (sorafenib)
- Trial and failure or intolerance to generic everolimus tablet (applies to Brand Afinitor only)
Brand Afinitor, Generic everolimus tablet, Torpenz (off-label)
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Advanced Renal Cell Carcinoma
- 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
*Criterion is part of the FDA-approved label.
Non Formulary
Length of Approval: 12 Month(s)
For diagnosis of Advanced 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)
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) to generic everolimus tablet AND
- Submission of medical records confirming the formulary alternative(s) has not been effective AND justification/rationale provided explaining how Brand Afinitor is expected to provide benefit when the formulary alternative has not been shown to be effective despite having the same active ingredient
Brand Afinitor, Generic everolimus tablet, Torpenz
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC)
- Diagnosis of renal angiomyolipoma and tuberous sclerosis complex (TSC) AND
- Trial and failure 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
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC)
- 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 Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC)
- Submission of medical records (e.g., chart notes) confirming diagnosis of renal angiomyolipoma and tuberous sclerosis complex (TSC) AND
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) to generic everolimus tablet AND
- Submission of medical records confirming the formulary alternative(s) has not been effective AND justification/rationale provided explaining how Brand Afinitor is expected to provide benefit when the formulary alternative has not been shown to be effective despite having the same active ingredient AND
- Prescribed by or in consultation with a nephrologist
Brand Afinitor, Generic everolimus tablet, Torpenz, Brand Afinitor Disperz, Generic everolimus tablet for oral suspension
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of 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 and failure or intolerance to generic everolimus tablet (applies to Brand Afinitor only) OR
- Trial and failure or intolerance to generic everolimus tablet for oral suspension (applies to Brand Afinitor Disperz only)
Brand Afinitor, Generic everolimus tablet, Torpenz, Brand Afinitor Disperz, Generic everolimus tablet for oral suspension
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Subependymal Giant Cell Astrocytoma
- Patient does not show evidence of progressive disease while on therapy AND
- One of the following:
- Trial and failure or intolerance to generic everolimus tablet (applies to Brand Afinitor only) OR
- Trial and failure 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 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:
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) to generic everolimus tablet (applies to Brand Afinitor only) OR
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) to generic everolimus tablet for oral suspension (applies to Brand Afinitor Disperz only)
- Submission of medical records confirming the formulary alternative(s) has not been effective AND justification/rationale provided explaining how Brand Afinitor or Brand Afinitor Disperz is expected to provide benefit when the formulary alternative has not been shown to be effective despite having the same active ingredient
Brand Afinitor, Generic everolimus tablet, Torpenz
*Criterion is part of the FDA-approved label.
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)
- Trial and failure or intolerance to generic everolimus tablet (applies to Brand Afinitor only)
Brand Afinitor, Generic everolimus tablet, Torpenz
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 and failure or intolerance to generic everolimus tablet (applies to Brand Afinitor only)
Brand Afinitor
*Criterion is part of the FDA-approved label.
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)
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) to generic everolimus tablet AND
- Submission of medical records confirming the formulary alternative(s) has not been effective AND justification/rationale provided explaining how Brand Afinitor is expected to provide benefit when the formulary alternative has not been shown to be effective despite having the same active ingredient
Brand Afinitor, Generic everolimus tablet, Torpenz (off-label)
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
- One of the following:
- Unresectable, locally advanced disease
- Metastatic disease
- Trial and failure or intolerance to generic everolimus tablet (applies to Brand Afinitor only)
Brand Afinitor, Generic everolimus tablet, Torpenz (off-label)
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 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 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
- One of the following:
- Unresectable, locally advanced disease
- Metastatic disease
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) to generic everolimus tablet AND
- Submission of medical records confirming the formulary alternative(s) has not been effective AND justification/rationale provided explaining how Brand Afinitor is expected to provide benefit when the formulary alternative has not been shown to be effective despite having the same active ingredient
Brand Afinitor Disperz, Generic everolimus tablet for oral suspension
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of TSC-associated Partial-onset Seizures
- Diagnosis of TSC-associated partial-onset seizures AND
- Patient is 2 years of age or older AND
- Trial and failure 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 TSC-associated Partial-onset Seizures
- Patient shows reduction in seizure frequency while on therapy AND
- Trial and failure 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 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
- Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) to generic everolimus tablet for oral suspension. AND
- Submission of medical records confirming the formulary alternative(s) has not been effective AND justification/rationale provided explaining how Brand Afinitor Disperz is expected to provide benefit when the formulary alternative has not been shown to be effective despite having the same active ingredient AND
- Prescribed by or in consultation with a neurologist
P & T Revisions
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
- Afinitor and Afinitor Disperz Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. February 2022.
- Torpenz Prescribing Information. Upsher-Smith Laboratories, LLC. Maple Grove, MN 55369. June 2024.
Revision History
- 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
HEALTHY LIVING