Reddy-Everolimus

Everolimus

• Brand(s): Afinitor and generics (see formulary for a funded list of generics)
• Dosage Form/Strength: 2.5 mg, 5 mg, 10 mg tablet

For the treatment of metastatic renal cell carcinoma (mRCC) as second or third line¹ therapy in patients previously treated for mRCC with a funded tyrosine kinase inhibitor (TKI).

Exclusion criteria: Use in the 4^th line setting or later in the treatment course of their disease

Dosage: 10 mg daily

Renewal will be considered for those who have demonstrated benefit from Afinitor therapy (i.e., no disease progression) and is expected to continue to do so.

¹Funded TKIs include sunitinib (Sutent), sorafenib (Nexavar), and pazopanib (Votrient). The criteria are derived from the review of everolimus for provincial funding for the treatment of MRCC at the time of the original review. Drugs that may have been used as standard treatment in first line may have included interferon and temserolimus.
Everolimus is currently not funded after progression on axitinib (Inlyta) or nivolumab.

For the treatment of patients who have progressive, unresectable, well or moderately differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors (pNET).

Patient must have an ECOG* ≤ 2 (prior to the start of Afinitor therapy).

*ECOG = Eastern Cooperative Oncology Group Status

Exclusion criteria: the patient’s disease progressed while taking sunitinib (Sutent) to treat pNET.

Dosage: 10 mg daily

Duration of Approval: 1 year

Renewal will be considered for those who have benefited from Afinitor therapy (i.e. no disease progression) and is expected to continue to do so.
Reimbursement of Afinitor will be considered until disease progression occurs on Afinitor.

Duration of Approval: 1 year

For the treatment of unresectable, locally advanced or metastatic, well-differentiated non-functional neuroendocrine tumours (NETs) of gastrointestinal or lung origin (GIL) in adult patients meeting the following criteria:

1. Documented radiological disease progression within six months; AND

2. Good performance status (ECOG 0-2).

Treatment should continue until confirmed disease progression or unacceptable toxicity.

Renewals will be considered where the patient’s physician has confirmed that the Patient has benefited or continues to benefit from therapy with Afinitor as evidenced by no disease progression, and that they are expected to continue to do so.

For the treatment of postmenopausal women with hormone-receptor positive, HER2 negative advanced breast cancer meeting the following criteria:

1. Afinitor is to be used in combination with exemestane; AND

2. Patient must have an ECOG* ≤ 2 after recurrence or progression following a non-steroidal aromatase inhibitor (NSAI).

*ECOG = Eastern Cooperative Oncology Group Status

Dosage: 10 mg daily (dose titration is allowed).

Duration of Approval: 1 year

Renewals will be considered for patients who have benefited or continues to benefit from therapy with Afinitor and is expected to continue to do so.

Duration of Approval: 1 year

For the treatment of renal angiomyolipoma (AML) associated with tuberous sclerosis complex (TSC) in patients who meet all the following conditions:

1. Presence of coalescent or multifocal AMLs in either one or both kidneys; AND

2. AML progression despite previous embolization and/or surgery; AND

3. Further embolization and/or surgery is not recommended due to a documented clinical reason

   (Note: The physician must submit a clinical note with the request outlining/detailing why invasive therapy cannot be considered).

The approved dosage: 10 mg orally once daily.

Duration of Approval: 1 year

Case-by-Case consideration will be considered in patients who have never been treated with invasive procedures such as embolization and/or surgery. The physician must provide detailed clinical rationale (e.g., from clinical consultation notes) as to why embolization and/or nephrectomy would be medically contraindicated for the patient.

Renewals will be considered in patients with the following documented benefits from therapy:

• No AML progression (i.e., no significant new lesions and increase in kidney volume, as well as no significant AML related bleeding); AND
• There is a reduction in volume of AMLs identified prior to treatment with the everolimus.

Duration of Approval: 2 years

For the treatment of Subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC) for whom surgical resection cannot be considered* for reasons such as:

1. Location, size, and/or distribution of tumour(s); OR

2. SEGA progression despite previous surgical interventions; OR

3. Neurocognitive problems/ other complications secondary to previous surgical interventions.

*Requests must provide details/ consultation notes outlining why the patient cannot be considered for surgical treatment.

Duration of Approval: 1 year

Renewals will be considered in patients with the following documented benefits from therapy:

• Stabilization of SEGA progression (based on assessment of SEGA volume and/or appearance of new lesions); AND
• Improvement of symptoms (e.g., reduced seizure frequency and decreased need for neurosurgical intervention).

Duration of Approval: 2 years

EAP Drug Request Form:

Standard Form for EAP Drug Requests