Clinical Pharmacy Prior Authorization and Coverage Criteria — Afinitor (everolimus)
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This document sets Colorado Rocky Mountain Health Plans' clinical pharmacy prior authorization and coverage criteria for Afinitor (everolimus), describing indications, initial and reauthorization requirements, and pediatric processing rules for members.
No material clinical or coverage changes in this revision.
Coverage criteria and indications
Covered indications and criteria
Covered when the specified indication-specific criteria below are met
Authorization will be issued for 12 months
Authorization will be issued for 12 months
Authorization will be issued for 12 months
Authorization will be issued for 12 months
Authorization will be issued for 12 months
Authorization will be issued for 12 months
Authorization will be issued for 12 months
Authorization will be issued for 12 months
Authorization will be issued for 12 months
Authorization will be issued for 12 months
Initial Therapy — Waldenström's / Lymphoplasmacytic lymphoma
Covered when ALL of the following are met for Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma:
Authorization will be issued for 12 months
Initial Therapy — Breast Cancer
Covered when ALL of the following are met for breast cancer:
Authorization will be issued for 12 months
Initial Therapy — Hodgkin Lymphoma
Covered when ALL of the following are met for classic Hodgkin lymphoma:
Authorization will be issued for 12 months
Initial Therapy — Soft Tissue Sarcoma / Related Conditions
Covered when ANY of the following soft tissue sarcoma subtypes are present:
Authorization will be issued for 12 months
Initial Therapy — Thymomas and Thymic Carcinomas
Covered when ALL of the following are met for thymomas or thymic carcinomas:
Authorization will be issued for 12 months
Reauthorization — general reauthorization criteria
Reauthorization covered when ALL of the following are met:
Authorization will be issued for 12 months
Thymic Carcinoma / Thymoma — Initial Authorization
Afinitor will be approved when BOTH of the following are met:
Thymic Carcinoma / Thymoma — Reauthorization
Approved on reauthorization when:
Reauthorization will be issued for 12 months if met
Thyroid Carcinoma — Initial Authorization
Afinitor will be approved based on ALL of the following:
Authorization will be issued for 12 months when all required conditions are met
Thyroid Carcinoma — Reauthorization
Approved on reauthorization when:
Authorization will be issued for 12 months
Uterine Neoplasms — Initial Authorization
Afinitor will be approved based on one of the following two pathways:
Uterine Neoplasms — Reauthorization
Approved on reauthorization when:
Authorization will be issued for 12 months
Tuberous Sclerosis Complex (TSC) associated Partial-onset Seizures — Initial Authorization
Approved when BOTH criteria are met:
TSC Partial-onset Seizures — Reauthorization
Approved on reauthorization when:
Authorization will be issued for 12 months
Bone Cancer - Osteosarcoma — Initial Authorization
Afinitor will be approved based on ALL of the following criteria:
Osteosarcoma — Reauthorization
Approved on reauthorization when:
Authorization will be issued for 12 months
Histiocytic Neoplasms — Initial Authorization
Afinitor will be approved when BOTH criteria are met:
Required
Initial Therapy — Histiocytic Neoplasms
Covered when ALL of the following are met
Authorization will be issued for 12 months while criteria met
Reauthorization — Histiocytic Neoplasms
Covered when the following is met
Authorization will be issued for 12 months
Initial Therapy — Gastrointestinal Stromal Tumor (GIST)
Covered when ALL of the following are met
Authorization will be issued for 12 months
Reauthorization — GIST
Covered when the following is met
Authorization will be issued for 12 months
NCCN Recommended Regimens
Used as basis for some covered regimens
Afinitor (everolimus) is not indicated for the treatment of patients with functional carcinoid tumors. This exclusion is stated in the policy background and applies when evaluating requests for coverage of Afinitor for carcinoid disease.
For classic Hodgkin lymphoma, one of the explicit initial-authorization requirements is that the patient has relapsed or refractory disease and the patient is not a candidate for autologous stem cell rescue/high-dose therapy (ASCR/HDT). Requests for patients who remain ASCR/HDT candidates therefore do not meet the Hodgkin initial-therapy criteria and are not covered under that indication.
This policy defines coverage by indication-specific inclusion criteria rather than by broad, across-the-board exclusions. Each covered use of Afinitor is set out as a distinct initial-authorization pathway (examples include thymic tumors, thyroid carcinoma, endometrial/uterine neoplasms, TSC-associated partial-onset seizures, osteosarcoma, and histiocytic neoplasms) and must meet the listed diagnostic and therapy-context requirements to be approved.
Coverage decisions remain subject to state mandates, federal requirements, member-specific benefit plan coverage, other applicable policies, and utilization management programs. Automated approvals or limits based on prior claims/medication history and supply limits may be applied per the program.
Continued coverage (reauthorization) is contingent on clinical benefit: reauthorization will be denied if there is evidence of disease progression while the patient is on Afinitor. For all listed indications the policy requires that the patient not show evidence of progressive disease at the time of reauthorization.
What providers must submit and watch for
Prior authorization required; pediatric auto-process
Prior authorization is required for Afinitor per the Clinical Pharmacy Programs. Prescriptions for members under 19 years of age will automatically process without a coverage review.
Waldenström's / lymphoplasmacytic lymphoma — document diagnosis and disease status
For initial authorization for Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, document a diagnosis of one of these conditions and that the disease is non-responsive to primary treatment, progressive, or relapsed.
Breast cancer — document diagnosis, receptor/HER2 status, menopausal status, and combination therapy
For breast cancer initial authorization, document a diagnosis of recurrent or metastatic breast cancer that is HR‑positive or inflammatory and HER2‑negative, confirm menopausal status (postmenopausal OR premenopausal with ovarian suppression OR male), and specify the endocrine agent to be used in combination (exemestane, fulvestrant, or tamoxifen).
Hodgkin lymphoma — document relapsed/refractory status and ASCR/HDT ineligibility
For classic Hodgkin lymphoma initial authorization, document diagnosis of relapsed or refractory disease and that the patient is not a candidate for autologous stem cell rescue/high‑dose therapy (ASCR/HDT).
Soft tissue sarcoma — document subtype and disease extent
For eligible soft tissue sarcoma subtypes, document the specific qualifying subtype (malignant PEComa, recurrent angiomyolipoma, or lymphangioleiomyomatosis) and that disease is locally advanced unresectable or metastatic where applicable.
Thymoma/thymic carcinoma — document diagnosis and specified therapy-line context
For thymic carcinoma or thymoma initial authorization, document the diagnosis and the therapy context: pre‑ or postoperative systemic therapy for those who cannot tolerate first‑line combination regimens, first‑line therapy for those who cannot tolerate first‑line combination regimens, or second‑line therapy.
Demonstrate diagnosis and meet indication‑specific criteria
Prior authorization requests must demonstrate the specific diagnosis and that the patient meets the indication‑specific criteria (examples in policy include thymic carcinoma/thymoma with intolerance to first‑line regimens; thyroid carcinoma with unresectable/persistent/metastatic and symptomatic or progressive disease; uterine endometrial carcinoma when used with letrozole; PEComa as second‑line; TSC seizures as adjunctive therapy; osteosarcoma as second‑line with sorafenib; histiocytic neoplasms with PIK3CA mutation).
Initial approval requires meeting diagnosis and molecular/prior‑therapy criteria
Initial approval is granted when the listed diagnosis and the required molecular or prior‑therapy criteria are met — examples include histiocytic neoplasms requiring a PIK3CA mutation and GIST requiring documented progression after listed prior agents.
Document prior aromatase inhibitor failure for breast cancer when applicable
Background and criteria reference prior lines of therapy for breast cancer (use with exemestane after failure of letrozole or anastrozole) — providers should document prior aromatase inhibitor failure where applicable.
Breast cancer — combination with specified endocrine therapy required
Breast cancer must be prescribed in combination with one of the listed endocrine therapies; document which agent will be used (exemestane, fulvestrant, or tamoxifen) and the combination context required by the criteria.
- Exemestane when progressed within 12 months or on a non‑steroidal aromatase inhibitor
- Fulvestrant
- Tamoxifen
Document line‑of‑therapy and intolerance to first‑line regimens when required
When the policy specifies therapy‑line or combination restrictions, document inability to tolerate first‑line combination regimens or prior‑line status as required (e.g., intolerance to first‑line combinations or use as second‑line where specified).
GIST — document prior progression on listed agents and planned combination agent
For GIST initial authorization, document progression after single‑agent therapy with imatinib, ripretinib (Qinlock), regorafenib (Stivarga), and sunitinib (Sutent), and indicate the allowed combination agent to be used with Afinitor.
- Prior progression after imatinib (Gleevec)
- Prior progression after ripretinib (Qinlock)
- Prior progression after regorafenib (Stivarga)
- Prior progression after sunitinib (Sutent)
- Document intended combination agent (imatinib, regorafenib, or sunitinib)
Neuroendocrine tumor documentation — site, disease status, and SSTR/Ki‑67 where applicable
For neuroendocrine tumor requests, provide documentation supporting the site of origin (GI, lung, thymic, or pancreatic), disease extent (unresectable, locally advanced, or metastatic), and tumor characteristics for well‑differentiated grade 3 NETs (including Ki‑67 and SSTR‑based PET imaging where applicable).
Document diagnosis and supporting disease status (HR/HER2 where relevant)
Providers must include the specific diagnosis and supporting disease status (e.g., relapsed, refractory, metastatic), and receptor/HER2 status where applicable, to meet initial authorization criteria for each indication.
Clinical documentation must demonstrate diagnosis and treatment context
Clinical documentation must show the treatment context required by the indication: line of therapy, specified combination agent, or presence of required mutation as listed in the criteria.
Provide molecular evidence for histiocytic neoplasms and prior‑therapy history for GIST
For histiocytic neoplasms and GIST, include molecular and prior‑therapy evidence: for histiocytic neoplasms document presence of a PIK3CA mutation; for GIST document prior treatment history showing progression after imatinib, ripretinib, regorafenib, and sunitinib and the intended combination agent.
Denial risk if criteria not met
Coverage may be denied if the member does not meet the specific clinical criteria listed for the requested indication; ensure submitted documentation directly maps to the indication‑specific requirements.
Reauthorization denied for progressive disease
Reauthorization will be denied if there is evidence of progressive disease while the patient is on Afinitor therapy.
Reauthorization denied on evidence of progression
Requests for reauthorization are specifically denied when documentation shows objective evidence of disease progression while on Afinitor; monitor and document disease status before renewal requests.
Denial triggers: missing diagnosis, molecular evidence, or prior‑therapy history
Requests lacking the specified diagnosis (for example, GIST or a listed histiocytic neoplasm) or missing required molecular evidence (PIK3CA mutation for histiocytic neoplasms) or documentation of prior therapies for GIST may be denied.
Initial authorization requirements by disease group
Neuroendocrine tumor initial therapy
Covered when the following is met
Reauthorization and continuation requirements
Step therapy and combination requirements
| Requirement | Details | Coverage |
|---|---|---|
| Combination therapy required for breast cancer initial authorization | ||
| Afinitor must be used in combination with one of the following endocrine therapies: (a) Exemestane (when patient progressed within 12 months or while on a non-steroidal aromatase inhibitor such as anastrozole or letrozole), (b) Fulvestrant, or (c) Tamoxifen. | ||
| Covered when all breast cancer initial authorization criteria are met including combination use as specified |
| Requirement | Examples / Where applied | Coverage |
|---|---|---|
| Prior therapy intolerance or specified line-of-therapy requirement | ||
| Some indications limit Afinitor to patients who cannot tolerate first-line combination regimens (e.g., thymic carcinoma/thymoma pre-/postoperative or first-line when unable to tolerate combos) or specify use as second-line/subsequent therapy and require combination with a named agent (e.g., osteosarcoma used as second-line in combination with sorafenib). | ||
| Covered when indication-specific criteria are met, including documented intolerance to first-line combination regimens or required second-line context as listed |
| Requirement | Specific prior agents failed | Coverage |
|---|---|---|
| Prior-agent failures required before Afinitor for GIST initial authorization | ||
| Disease must have progressed after single-agent therapy with: (a) Imatinib (Gleevec), (b) Ripretinib (Qinlock), (c) Regorafenib (Stivarga), and (d) Sunitinib (Sutent). Additionally, Afinitor must be used in combination with one of: imatinib, regorafenib, or sunitinib. | ||
| Covered when GIST diagnosis, specified disease state, documented progression after the listed agents, and required combination use are met |
Background and scope
Everolimus (Afinitor) is an mTOR kinase inhibitor with multiple oncology and tuberous sclerosis complex (TSC) indications listed in the policy. Indications noted include HR-positive, HER2-negative advanced breast cancer in combination with exemestane after aromatase inhibitor failure; progressive pancreatic neuroendocrine tumors and well-differentiated non-functional GI/lung neuroendocrine tumors that are unresectable, locally advanced, or metastatic; advanced renal cell carcinoma after prior VEGF TKI therapy; renal angiomyolipoma in TSC; SEGA in TSC; and adjunctive treatment of TSC-associated partial-onset seizures in patients aged ≥2 years. The policy also references NCCN recognition and additional tumor types where everolimus may be used.
Key definitions
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