Oral Oncology

POLICY NUMBER

L.5.01.525

Afinitor (everolimus)

Nubeqa (darolutamide)

Afinitor DISPERZ (everolimus)                                                    Odomzo (sonidegib)

Akeega (niraparib/abiraterone)                                                    Ogsiveo (nirogacestat)

Alecensa (alectinib)                                                                     Ojemda (tovorafenib)

Alunbrig (brigatinib)

Ojjaara (momelotinib)

Augtyro (repotrectinib)                                                                 Onureg (azacitabine)

Avmapki Fakzynja Co-Pack (avutometinib/defactinib)                Orgovyx (relugolix)

Ayvakit (avapritinib)                                                                     Orserdu (elacestrant)

Balversa (erdafitinib)                                                                    Pemazyre (pemigatinib)

Bosulif (bosutinib)                                                                        Piqray (alpelisib)

Braftovi (encorafenib)                                                                  Pomalyst (pomalidomide)

Brukinsa (zanubrutinib)                                                               Qinlock (ripretinib)

Cabometyx (cabozantinib)                                                          Retevmo (selpercatinib)

Calquence (acalabrutinib)                                                           Revlimid (lenalidomide)

Caprelsa (vandetanib)                                                                 Revuforj (revumenib)

Cometriq (cabozantinib)                                                              Rezlidhia (olutasidenib)

Copiktra (duvelisib)                                                                     Romvimza (vimseltinib)

Cotellic (cobimetinib)                                                                   Rozlytrek (entrectinib)

Daurismo (glasdegib)                                                                  Rubraca (rucaparib)

Ensacove (ensartinib)                                                                 Rydapt (midostaurin)

Erivedge (vismodegib)                                                                Scemblix (asciminib)

Erleada (apalutamide)                                                                Sprycel (dasatinib)

Exkivity (mobocertinib)                                                                Stivarga (regorafenib)

Fareston (toremifene)                                                                 Sutent (sunitinib)

Fotivda (tivozanib)                                                                      Tabrecta (capmatinib)

Fruzaqla (fruquintinib)                                                                 Tafinlar (dabrafenib)

Gavreto (pralsetinib)                                                                    Tagrisso (osimertinib)

Gilotrif (afatinib)                                                                           Talzenna (talazoparib)

Gleevec (imatinib)

Tarceva (erlotinib)

Gomekli (mirdametinib)                                                               Targretin (bexarotene)

Hycamtin (topotecan)                                                                  Tasigna (nilotinib)

Ibrance (palbociclib)

Tazverik (tazemetostat)

Ibtrozi (taletrectinib)                                                                     Temodar (temozolomide)

Iclusig (ponatinib)

Thalomid (thalidomide)

Idhifa (enasidenib)                                                                      Tibsovo (ivosidenib)

Imbruvica (ibrutinib)                                                                    Tepmetko (tepotinib)

Inlyta (axitinib)

Truqap (capivasertib)

Inqovi (decitabine-cedazuridine)                                                 Tukysa (tucatinib)

Inrebic (fedratinib)

Turalio (pexidartinib)

Iressa (gefitinib)                                                                           Tykerb (lapatinib)

Itovebi (inavolisib)                                                                        Vanflyta (quizartinib)

Iwilfin (eflornithine)                                                                       Venclexta (venetoclax)

Jakafi (ruxolitinib)                                                                         Verzenio (abemaciclib)

Jaypirca (pirtobrutinib)

Vesanoid (tretinoin)

Kisqali (ribociclib)                                                                         Vitrakvi (larotrectinib)

Krazati (adagrasib)                                                                      Vizimpro (dacomitinib)

Lazcluze (lazertinib)                                                                     Voranigo (vorasidenib)

Lenvima (lenvatinib)                                                                     Votrient (pazopanib)

Lonsurf (trifluridine/tipiracil)                                                          Welireg (belzutifan)

Lorbrena (lorlatinib)                                                                      Xalkori (crizotinib)

Lumakras (sotorasib)                                                                   Xospata (gilteritinib)

Lynparza (olaparib)

Xpovio (selinexor)

Lysodren (mitotane)

Xtandi (enzalutamide)

Lytgobi (futibatinib)

Yonsa (abiraterone)

Matulane (procarbazine)

Zejula (niraparib)

Mekinist (trametinib)                                                                     Zelboraf (vemurafenib)

Mektovi (binimetinib)                                                                    Zolinza (vorinostat)

Nerlynx (neratinib)                                                                        Zydelig (idelalisib)

Nexavar (sorafenib)                                                                      Zykadia (ceritinib)

Nilandron (nilutamide)

Zytiga (abiraterone)

Ninlaro (ixazomib)

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

 Related policies - 

• Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment in Non-Small-Cell Lung Cancer (EGFR, ALK, BRAF, ROS1, RET, MET, KRAS)

• Genetic Testing for FLT3, NPM1, CEBPA, IDH1 and IDH2 Variants in Cytogenetically Normal Acute Myeloid Leukemia

• Germline and Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment in Breast Cancer (BRCA1, BRCA2, PIK3CA, Ki-67, RET, BRAF, ESR1)

• Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment in Metastatic Colorectal Cancer (KRAS, NRAS, BRAF, and HER2)

• Comprehensive Genomic Profiling for Selecting Targeted Cancer Therapies

• Somatic Genetic Testing To Select Individuals with Melanoma or Glioma for Targeted Therapy (BRAF)

POLICY

Prior authorization is required.

The requested agent may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following:

   1. There is documentation that the individual is currently receiving the requested agent;

   2. The prescriber states the individual is using the requested agent AND is at risk if therapy is changed;

   3. ALL of the following:

      1. ONE of the following:

         1. The individual has an FDA approved diagnosis for the requested agent; OR

         2. The use of the requested agent is for an indication that is supported by compendia. (NCCN Compendium™ level of evidence 1 or 2A, AHFS, DrugDex level of evidence 1 or 2A);

      2. Genetic testing has been completed (if applicable) using an FDA approved genetic test if required for therapy with the requested agent and results indicate therapy with requested agent is appropriate;

      3. ONE of the following:

         1. The individual has tried and failed the first line agent for the intended indication (if applicable); OR

         2. The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to the first line agent; AND

      4. ONE of the following:

         1. The requested agent is a preferred agent*; OR

         2. The requested agent is a non-preferred agent, and the patient meets ONE of the following:

            1. The individual's medication history indicates use of a preferred agent for the requested indication;

            2. The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to the preferred agent; OR

            3. The prescriber has provided documentation in support of use of the non-preferred agent over the preferred agent which has been reviewed and approved by a Clinical Reviewer;

2. If requested medication is not being used as monotherapy, drug must be used in combination with other chemotherapeutic or adjuvant agent(s) as approved by the FDA prescribing information or regimen is supported by compendia (NCCN Compendium™ level of evidence 1 or 2A, AHFS, DrugDex level of evidence 1 or 2A) and/or medical literature;

3. The individual does not have an FDA labeled contraindication to the requested agent;

4. The individual does not have an FDA labeled limitation of use for the requested agent that is otherwise not supported in National Comprehensive Cancer Network (NCCN); AND

5. ONE of the following:

   1. The dose is within FDA labeling; OR

   2. The dose is not within FDA approved labeling and the prescriber has submitted documentation in support of therapy with a higher dose for the intended diagnosis which has been reviewed and approved by the Clinical Reviewer.

 Length of Approval:  Up to 3 months for dose titration requests                                  Up to 12 months for all other requests

Avmapki Fakzynja Co-Pack (avutometinib/defactinib), Ensacove (ensartinib), Fotivda (tivozanib), Fruzaqla (fruquintinib), Gomekli (mirdametinib), Ibtrozi (taletrectinib), Inqovi (decitabine-cedazuridine), Iwilfin (elfornithine), Lytgobi (futibatinib), Ojemda (tovorafenib), Ojjaara (momelotinib), Onureg (azacitadine), Orgovyx (relugolix), and Vanflyta (quizartinib) are considered not medically necessary as there are other formulary options covered by the Plan which share the same place in therapy.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

POLICY HISTORY

02/05/2019: New policy added. Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee. Effective 01/01/2019.

07/11/2019: Added drug names to the top of the policy. Policy description updated regarding brand/generic drugs and quantity limits. Policy statements unchanged. Sources updated.

08/01/2019: Added drug names to the top of the policy. Policy description updated to add brand/generic drugs and quantity limits. Policy statements unchanged. Sources updated.

11/01/2019: Added drug names to the top of the policy. Policy updated to state that Ibrance and Verzenio are preferred agents and trial and failure of 1 preferred agent must be documented before consideration of Kisqali or Kisqali/Femara pack.

04/24/2020: Policy updated to add brand/generic drugs and quantity limits. Sources updated.

05/20/2020: Policy description updated to revise quantity limits for Sutent (sunitinib).

06/30/2020: Added Fareston (toremifine), Nilandron (nilutamide), and Tukysa (tucatinib) to the top of the policy. Policy description updated to add the brand/generic drugs and the applicable quantity limits. Policy section updated to change "patient" to "member." Sources updated.

10/23/2020: Policy updated to add Pemazyre (pemigatinib), Qinlock (ripretinib), Retevmo (selpercatinib), Tabrecta (capmatinib), and the applicable quantity limits.

01/20/2021: Policy updated regarding quantity limits for Iclusig (ponatinib), Mekinist (trametinib), and Xpovio (selinexor).

05/01/2021: Added Gavreto (pralsetinib), Inqovi (decitabine-cedazuridine), Onureg (azacitabine), and Orgovyx (relugolix) to the top of the policy. Removed Xeloda (capecitabine) from the policy. Policy description updated to add quantity limits for Gavreto (pralsetinib). Policy section updated to state that Orgovyx (relugolix), Onureg (azacitadine), and Inqovi (decitabine-cedazuridine) are considered not medically necessary as there are other formulary options covered by the Plan which share the same place in therapy. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Sources updated.

08/18/2021: Added the following drug names to the top of the policy: Fotivda (tivozanib), Tepmetko (tepotinib), and Ukoniq (umbralisib). Policy description revised to update quantity limits for Ayvakit (avapritinib) and Xtandi (enzalutamide). Added quantity limits for Fotivda (tivozanib), Tepmetko (tepotinib), and Ukoniq (umbralisib). Sources updated.

03/11/2022: Policy description updated to add quantity limit for Lumakras (sotorasib). Sources updated.

04/18/2022: Policy description updated to add quantity limits for Exkivity (mobocertinib) and to update the quantity limit for Nexavar (sorafenib). Sources updated.

11/07/2022: Policy description updated for Calquence (acalabrutinib) to change "capsules" to "tablets." Sources updated.

11/21/2022: Policy updated to remove Ukoniq (umbralisib). Sources updated.

01/23/2023: Policy description updated to add a new dosage form of Imbruvica (ibrutinib). Sources updated.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

05/15/2023: Policy description updated to add quantity limits for Krazati (adagrasib) and Rezlidhia (olutasidenib). Added list of related medical policies. Policy statement updated to add Fotivda (tivozanib) and Lytgobi (futibatinib) as not medically necessary as there are other formulary options covered by the Plan which share the same place in therapy. Sources updated.

06/01/2023: Policy description updated to add a new dosage form of Lumakras (sotorasib). Sources updated.

08/21/2023: Policy updated to add new dosage forms of Zejula (niraparib). Sources updated.

09/18/2023: Policy updated to add new dosage forms of Mekinist (trametinib) and Tafinlar (dabrafenib). Sources updated.

01/10/2024: Policy updated to add new dosage forms of Bosulif (bosutinib), Rozlytrek (entrectinib), Talzenna (talazoparib), and Xalkori (crizotinib). Sources updated.

03/25/2024: Policy description updated to add quantity limits for Akeega (niraparib/abiraterone), Augtyro (repotrectinib), Orserdu (elacestrant), and Truqap (capivasertib). Revised dosage forms for Thalomid (thalidomide). Policy section updated to add Fruzaqla (fruquintinib), Ogsiveo (nirogacestat), and Ojjaara (momelotinib) as not medically necessary as there are other formulary options covered by the Plan which share the same place in therapy. Sources updated.

04/16/2024: Policy updated to add Vanflyta (quizartinib) as not medically necessary as there are other formulary options covered by the Plan which share the same place in therapy. Sources updated.

09/30/2024: Policy updated to add Iwilfin (elfornithine) and Ojemda (tovorafenib) as not medically necessary as there are other formulary options covered by the Plan which share the same place in therapy. Sources updated.

10/01/2024: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Added new dose and quantity limits for Retevmo (selpercatinib). Policy language updated to change "member" to "individual." Medically necessary criteria updated to add the following statement: If requested medication is not being used as monotherapy, drug must be used in combination with other chemotherapeutic or adjuvant agent(s) as approved by the FDA prescribing information or regimen is supported by compendia (NCCN Compendium™ level of evidence 1 or 2A, AHFS, DrugDex level of evidence 1 or 2A) and/or medical literature. Sources updated. Effective 12/01/2024.

11/20/2024: Policy updated to add Voranigo (vorasidenib) and new dosage forms of Augtyro (repotrectinib). Policy statements unchanged. Sources updated.

12/01/2024: Medically necessary criteria update noted on 10/01/2024 effective after 60-day notice.

03/20/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy updated to add Welireg (belzutifan) and the applicable quantity limits. Sources updated.

05/15/2025: Policy updated to add Lazcluze (lazertinib) and the applicable quantity limits. Policy description updated to remove the following statement: *Ibrance and Verzenio are preferred agents and trial and failure of 1 preferred agent must be documented before consideration of Kisqali or Kisqali/Femara Pack. Sources updated.

05/31/2025: Policy updated to add Scemblix (asciminib) and the applicable quantity limits. Sources updated.

09/15/2025: Policy updated to add Gomekli (mirdametinib), Itovebi (inavolisib), Revuforj (revumenib), and Romvimza (vimseltinib). Removed Farydak (panobinostat) as it is no longer on the market. Policy description updated to add quantity limits for Brukinsa (zanubrutinib), Itovebi (inavolisib), Revuforj (revumenib), and Romvimza (vimseltinib). Medically necessary policy statement revised to change "ONE of the following criteria" to "ALL of the following criteria" and to add Gomekli (mirdametinib) as not medically necessary as there are other formulary options covered by the Plan which share the same place in therapy. Sources updated.

11/01/2025: Policy updated to add Avmapki Fakzynja Co-Pack (avutometinib/defactinib), Ensacove (ensartinib), Ibtrozi (taletrectinib), and Zykadia (ceritinib) to the list of drugs. Policy description updated to add quantity limits for Ogsiveo (nirogacestat) and Zykadia (ceritinib). Policy section updated to add Avmapki Fakzynja Co-Pack (avutometinib/defactinib), Ensacove (ensartinib), and Ibtrozi (taletrectinib) as not medically necessary as there are other formulary options covered by the Plan which share the same place in therapy. Removed Ogsiveo (nirogacestat) from the not medically necessary policy statement. Sources updated.

01/20/2026: Policy updated to add Jaypirca (pirtobrutinib) to the list of drugs. Policy description updated to add quantity limits for Jaypirca (pirtobrutinib) and Votrient (pazopanib). Sources updated.

SOURCE(S)

1. Afinitor/Afinitor Disperz prescribing information. Novartis Pharmaceuticals Corporation. August 2025. Last accessed August 2025.

2. Akeega prescribing information. Janssen Biotech, Inc. August 2024. Last accessed August 2025.

3. Alecensa prescribing information. Genentech, Inc. April 2024. Last accessed August 2025.

4. Alunbrig prescribing information. Takeda Pharmaceuticals America, Inc. August 2025. Last accessed August 2025.

5. Augtyro prescribing information. E.R. Squibb & Sons, LLC. June 2024. Last accessed August 2025.

6. Avmapki Fakzynja Co-Pack prescribing information. Verastem Inc. May 2025. Last accessed October 2025.

7. Ayvakit prescribing information. Blueprint Medicines Corporation. July 2025. Last accessed August 2025.

8. Balversa prescribing information. Janssen Products LP. November 2024. Last accessed August 2025.

9. Bosulif prescribing information. Pfizer Laboratories Div Pfizer Inc. December 2024. Last accessed August 2025.

10. Braftovi prescribing information. Array BioPharma Inc. July 2025. Last accessed August 2025.

11. Brukinsa prescribing information. BeOne Medicines USA, Inc. July 2025. Last accessed August 2025.

12. Cabometyx prescribing information. Exelixis Inc. March 2025. Last accessed August 2025.

13. Calquence prescribing information. AstraZeneca Pharmaceuticals LP. January 2025. Last accessed August 2025.

14. Caprelsa prescribing information. Genzyme Corporation. May 2025. Last accessed August 2025.

15. Cometriq prescribing information. Exelixis, Inc. February 2025. Last accessed August 2025.

16. Copiktra prescribing information. Secura Bio, Inc. July 2024. Last accessed August 2025.

17. Cotellic prescribing information. Genentech, Inc. November 2024. Last accessed August 2025.

18. Daurismo prescribing information. Pfizer Laboratories Div Pfizer Inc. January 2025. Last accessed August 2025.

19. Ensacove prescribing information. Xcovery Holdings, Inc. December 2024. Last accessed October 2025.

20. Erivedge prescribing information. Genentech, Inc. December 2024. Last accessed August 2025.

21. Erleada prescribing information. Janssen Products, LP. April 2025. Last accessed August 2025.

22. Exkivity prescribing information. Takeda Pharmaceuticals America, Inc. September 2023. Last accessed August 2024.

23. Fareston prescribing information. Kyowo Kirin, Inc. November 2024. Last accessed August 2025.

24. Fotivda prescribing information. AVEO Pharmaceuticals, Inc. August 2025. Last accessed August 2025.

25. Fruzagla prescribing information. Takeda Pharmaceuticals America, Inc. March 2025. Last accessed August 2025.

26. Gavreto prescribing information. Genentech, Inc. November 2024. Last accessed August 2025.

27. Gilotrif prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. September 2024. Last accessed August 2025.

28. Gleevec prescribing information. Novartis Pharmaceuticals Corporation. June 2025. Last accessed August 2025.

29. Gomekli prescribing information. SpringWorks Therapeutics, Inc. February 2025. Last accessed July 2025.

30. Hycamtin prescribing Information. Novartis Pharmaceuticals Corporation. July 2022. Last accessed August 2025.

31. Ibrance prescribing information. Pfizer Laboratories Div Pfizer Inc. May 2025. Last accessed August 2025.

32. Ibtrozi prescribing information. Nuvation Bio Inc. June 2025. Last accessed October 2025.

33. Iclusig prescribing information. Takeda Pharmaceuticals America, Inc. December 2024. Last accessed August 2025.

34. Idhifa prescribing information. Celgene Corporation. January 2025. Last accessed August 2025.

35. Imbruvica prescribing information. Pharmacyclics LLC. December 2024. Last accessed August 2025.

36. Inlyta prescribing information. Pfizer Laboratories Div Pzifer Inc. February 2025. Last accessed August 2025.

37. Inqovi prescribing information. Taiho Pharmaceutical Co., Ltd. November 2024. Last accessed August 2025.

38. Inrebic prescribing information. Celgene Corporation. May 2025. Last accessed August 2025.

39. Iressa prescribing information. AstraZeneca Pharmaceuticals, LP. February 2023. Last accessed August 2025.

40. Itovebi prescribing information. Genentech, Inc. January 2025. Last accessed August 2025. 

41. Iwilfin prescribing information. USWM, LLC. December 2024. Last accessed August 2025.

42. Jakafi prescribing information. Incyte Corporation. June 2025. Last accessed August 2025.

43. Jaypirca prescribing information. Eli Lilly and Company. December 2025. Last accessed January 2026.

44. Kisqali prescribing information. Novartis Pharmaceuticals Corporation. July 2025. Last accessed August 2025.

45. Krazati prescribing information. Mirati Therapeutics, Inc. July 2024. Last accessed August 2025.

46. Lazcluze prescribing information. Janssen Biotech, Inc. August 2025. Last accessed August 2025.

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CODE REFERENCE

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