Oscar Varubi (rolapitant) (PG178) Form

Chemotherapy-Induced Nausea and Vomiting (CINV)

Chemotherapy-Induced Nausea and Vomiting (CINV) is a common and distressing side effect of cancer treatments. It can occur immediately after treatment (acute CINV), or it can be delayed, occurring more than 24 hours after treatment (delayed CINV). The severity and risk of CINV depend on the specific chemotherapy agents used, with some agents being highly emetogenic, meaning they have a high risk of causing nausea and vomiting.

Varubi (rolapitant)

Varubi (rolapitant) is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for use in adults in combination with dexamethasone and a 5-HT3 receptor antagonist for the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately or highly emetogenic cancer chemotherapy.

• Varubi (rolapitant) inhibits the CYP2D6 enzyme and is contraindicated with concomitant use of CYP2D6 substrates with a narrow therapeutic index, such as thioridazine and pimozide, due to an increased risk of QT prolongation.¹
• The American Society of Clinical Oncology (ASCO) guidelines recommend a 3- or 4-drug combination regimen including a neurokinin 1 (NK1) receptor antagonist for prevention of nausea and vomiting associated with moderate and highly emetogenic chemotherapy.

Definitions

• "5-HT3 Receptor Antagonist" is a class of antiemetic agents (e.g. ondansetron, granisetron) that block serotonin binding to 5-HT3 receptors in the gut and central nervous system.
• "Chemotherapy-Induced Nausea and Vomiting (CINV)" is nausea and/or vomiting that occurs as a side effect of chemotherapy treatment. It can be acute (within 24 hours of treatment) or delayed (more than 24 hours after treatment).
• "Emetogenic Chemotherapy" is chemotherapy that has a high risk of causing nausea and vomiting.
• "Highly Emetogenic Chemotherapy" is chemotherapy agents that cause vomiting in >90% of patients receiving them. Examples include cisplatin, carboplatin, cyclophosphamide, and doxorubicin.
• "Moderately Emetogenic Chemotherapy" is chemotherapy agents that cause vomiting in 30-90% of patients receiving them. Examples include oxaliplatin, irinotecan, and azacitidine.
• "Neurokinin-1 (NK1) Receptor Antagonist" is a class of antiemetic agents (e.g. rolapitant) that block NK1 receptors in the brain and gut to prevent nausea and vomiting signals.

Medical Necessity Criteria for Initial Authorization

The Plan considers Varubi (rolapitant) medically necessary when ALL of the following criteria are met:

1. Prescribed by or in consultation with an oncologist or hematologist; AND
2. The member is 18 years of age or older; AND
3. The member has been diagnosed with cancer and is undergoing moderately or highly emetogenic chemotherapy; AND
4. Varubi (rolapitant) is being prescribed in combination with other antiemetic agents as part of a comprehensive treatment plan to prevent nausea and vomiting; AND
5. The member is unable to use, or has tried and failed aprepitant (Emend) for prevention of chemotherapy-induced nausea and vomiting; AND
6. The member is not taking CYP2D6 substrates with a narrow therapeutic index such as thioridazine and pimozide; AND
7. Varubi (rolapitant) is being prescribed at a dose and frequency that is within FDA approved labeling OR is supported by compendia or evidence-based published dosing guidelines.

If the above prior authorization criteria are met, Varubi (rolapitant) will be approved for the duration of chemotherapy treatment.

Medical Necessity Criteria for Reauthorization

Reauthorization for up to 6 months will be granted if the member has recent (within the last 3 months) clinical chart documentation demonstrating ALL of the following criteria:

1. The member still meets the applicable Initial Authorization criteria; AND
2. The member continues to receive moderately or highly emetogenic chemotherapy; AND
3. The member has demonstrated a positive response to Varubi (rolapitant), as evidenced by ANY of the following:
   • A decrease in the frequency or severity of nausea/vomiting episodes; or
   • A reduced need for rescue antiemetic medications; or
   • Ability to complete planned chemotherapy cycles without dose reduction or delays due to nausea/vomiting; or
   • Absence of emetic episodes; or
   • No episodes of emesis and absence of nausea that interferes with daily activities; or
   • No use of rescue medication.

Experimental or Investigational / Not Medically Necessary

Varubi (rolapitant) for any other indication or use is considered not medically necessary by the Plan, as it is deemed to be experimental, investigational, or unproven. Non-covered indications include, but are not limited to, the following:

• Chemo-radiation Induced Nausea and Vomiting
  In patients receiving antineoplastic regimens with a low or minimal emetogenic risk
• Post Operative Nausea and Vomiting (PONV)³