For U.S. Healthcare Professionals

Reimbursement & Billing Resources

Let us help you take the guesswork out of patient access, reimbursement, and coverage.

Click or scroll to review and download reimbursement resources.

For more information about AKYNZEO®, please see the full US Prescribing Information.

Insurance verification Request Form

Billing and Coding Guides Sample Claim Forms Sample Letters of Medical Necessity

Insurance Verification Request Form

Specialists are available to assist you with supporting patient access to AKYNZEO®. Submit a verification request form to determine:

Insurance Verification Request Form

Coverage benefits
Prior Authorization assistance
Claim denial and appeal support

AKYNZEO® Capsules and AKYNZEO® Injection Billing and Coding Guides

Capsules Coding Guide

AKYNZEO® Capsules Coding Guide

Injection Coding Guide

AKYNZEO® Injection Coding Guide

For all AKYNZEO® formulations, learn about billing and coding including:
- International Classification of Disease, Tenth Revision, Clinical Modification (ICD-10-CM) Codes
- Healthcare Common Procedure Coding System (HCPCS) Codes
- J code for AKYNZEO Injection, J1454
- J code for AKYNZEO Capsules, J8655
- National Drug Codes (NDCs)
Remember to verify a payer's coding and coverage policies before administering AKYNZEO®

Sample Claim Forms for AKYNZEO® Injection

Sample Form 1450

Sample Form 1500

Review these annotated sample forms to understand important details you should include about AKYNZEO® when submitting CMS-1450 (UB-04) and CMS-1500 forms
Remember, actual coverage and reimbursement decisions are made by individual payers. Providers have sole responsibility in selecting proper codes and ensuring accuracy of submissions

Sample Letter of Medical Necessity and Appeal

Letter of Medical Necessity

Letter of Medical Necessity

Letter of Appeal

Letter of Appeal

Use and adapt these sample letters when submitting information to payers to explain AKYNZEO® medical necessity, or help patients navigate an insurance appeal process

Have a question?

Helsinn Cares is here to help. Call 1-84HELSINN-U (1-844-357-4668), and select prompt 2 to speak with a Helsinn Cares representative.

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Indication

AKYNZEO (netupitant/palonosetron) capsules is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

AKYNZEO (fosnetupitant/palonosetron) injection is indicated in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy.

Limitations of Use

AKYNZEO injection has not been studied for the prevention of nausea and vomiting associated with anthracycline plus cyclophosphamide chemotherapy.

AKYNZEO is a combination of palonosetron, a serotonin-3 (5-HT₃) receptor antagonist, and netupitant or fosnetupitant, substance P/neurokinin-1 (NK-1) receptor antagonists: palonosetron prevents nausea and vomiting during the acute phase and netupitant/fosnetupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.

Important Safety Information

Warnings and Precautions

Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving palonosetron, one of the components of AKYNZEO, with or without known hypersensitivity to other 5-HT₃ receptor antagonists
Serotonin syndrome has been reported with 5-HT₃ receptor antagonists alone but particularly with concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, seizures, and gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue AKYNZEO and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if AKYNZEO is used concomitantly with other serotonergic drugs

Adverse Reactions

Most common adverse reactions (≥3%) for AKYNZEO capsules are headache, asthenia, dyspepsia, fatigue, constipation and erythema. The safety profile of AKYNZEO injection was generally similar to AKYNZEO capsules

Drug Interactions

Use with caution in patients receiving concomitant medications primarily metabolized by CYP3A4. The plasma concentrations of CYP3A4 substrates can increase when co-administered with AKYNZEO. The inhibitory effect on CYP3A4 can last for multiple days
- Dexamethasone doses should be reduced when given with AKYNZEO. A more than two-fold increase in the systemic exposure of dexamethasone was observed 4 days after a single dose of netupitant or a single infusion of fosnetupitant
- Consider the potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolized via CYP3A4 (alprazolam, triazolam) when administering with AKYNZEO. When administered with netupitant, the systemic exposure to midazolam was significantly increased
Avoid concomitant use of AKYNZEO in patients on chronic use of a strong CYP3A4 inducer such as rifampin as this may decrease the efficacy of AKYNZEO

Use in Specific Populations

Avoid use of AKYNZEO in patients with severe hepatic impairment, severe renal impairment, or end-stage renal disease
Advise women of potential risk to fetus; limited data are available; may cause fetal harm

For more information about AKYNZEO, please see the full US Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, or Helsinn Safety or Medical Information at 1-84HELSINN-U (1-844-357-4668), select prompt 1.

Reference: 1. AKYNZEO® [package insert]. Iselin, NJ: Helsinn Therapeutics (U.S.), Inc; February 2023.