Helsinn Akynzeo

Helsinn Cares Patient and Caregiver Access Resources for AKYNZEO®

Affordability and Access Options for Patients

Helsinn Cares offers valuable patient programs to help support the affordability of and access to AKYNZEO®. Depending on the patient’s eligibility, resources may be available to reduce patient costs for AKYNZEO®.

Three programs available for patients are described below. One or more may be right for your patients:

1. Pay $0 Savings Program

2. Quick Start Voucher Program

3. Patient Assistance Program


Pay $0 for AKYNZEO® With the Pay $0 Savings Program*

Helsinn cares savings program

With the AKYNZEO® Pay $0 Savings Program:

  • Eligible patients with commercial insurance can pay $0 co-pay on each prescription, with an $1,800 annual limit
  • For patients who pay cash, the program will pay up to $150 per prescription for a maximum of $1,800 per year
  • No activation or enrollment is required
  • To receive an AKYNZEO® Pay $0 Savings Card, download a pre-activated card online at www.AKYNZEOsavingsprogram.com

*Restrictions apply. Not available to patients enrolled in state or federal healthcare programs, including Medicare, Medicaid, Medigap, VA, DoD or TRICARE.

Eligibility Criteria: Good toward the purchase of AKYNZEO® prescriptions. No substitutions permitted. Save this card to reuse with each prescription. Not available to patients enrolled in state or federal healthcare programs, including Medicare, Medicaid, Medigap, VA, DoD or TRICARE. Offer available to MA residents through June 30, 2017. For all other patients, this offer will expire October 3, 2019. May not be combined with any other coupon, discount, prescription savings card, free trial or other offer. Federal law prohibits the selling, purchasing, trading, or counterfeiting of this card. Such activities may result in imprisonment of 10 years, fines up to $25,000, or both. Void outside the USA and where prohibited by law. Helsinn Therapeutics (U.S.), Inc. reserves the right to rescind, revoke, or amend this offer at any time without notice. Patients and pharmacies are responsible for disclosing to insurance carriers the redemption and value of the card and complying with any other conditions imposed by insurance carriers on third party payers. The value of this card is not contingent on any prior or future purchases. The card is solely intended to provide savings on any purchase of AKYNZEO®. Use of the card for any one purchase does not obligate the patient to make future purchases of AKYNZEO® or any other product.

AKYNZEO® Quick Start Voucher Program

The Helsinn Cares Quick Start Voucher Program is for patients whose insurance company requires prior authorization for coverage of their AKYNZEO® prescription. The program will provide the first dose of AKYNZEO® (one [1] tablet) for free so that the patient can start therapy while waiting for approval of their prior authorization request by the insurance company.

Enrollment in Helsinn Cares is required to assess eligibility for the AKYNZEO® Quick Start Voucher. The program is open to all patients with insurance—commercial and government plans—as long as they meet eligibility criteria.

Enroll a Patient in Helsinn Cares. Download the Enrollment Form. Or call 1-84HELSINN-U (1-844-357-4668, select prompt 2).

Helsinn Cares Patient Assistance Program

Enrollment in Helsinn Cares is required to assess the eligibility for the Patient Assistance Program.

Helsinn Cares Patient Assistance Program has been specifically designed for patients who need assistance paying for AKYNZEO®.

  • AKYNZEO® is available at no cost to uninsured and underinsured patients, including Medicare Part D beneficiaries, if they meet eligibility requirements
  • Patients, caregivers, physicians, or case managers can call 1-84HELSINN-U (1-844-357-4668, select prompt 2), or fax a program enrollment form to 1-844-357-4669, to see if the patient is eligible for this special program
  • Eligibility criteria include:
    • Patient is prescribed AKYNZEO®
    • Patient is a US resident; this includes Puerto Rico, Guam, and the US Virgin Islands. For the purpose of this program, the patient must have a valid mailing address that is not a P.O. box
    • Patient is uninsured or underinsured, with no covered AKYNZEO benefit
    • Patient has insurance, but prior authorization and 1 appeal were denied (if applicable)
    • Patient must meet income criteria, and income documentation is required
  • Helsinn reserves the right, at its sole discretion, to discontinue the Patient Assistance Program or change the qualifications at any time
  • Product supply for the program depends upon availability
  • The enrollment form, insurance information, financial documentation, signature of the prescribing healthcare professional, and patient's signature are required for the form to be considered complete

Patient Assistance Enrollment Form

Remember: Helsinn Cares resources help ensure access to Helsinn medications

Helsinn is committed to helping every patient obtain the Helsinn medication
he or she needs. For answers to specific questions on Helsinn Cares,
please call 1-84HELSINN-U (1-844-357-4668, select prompt 2) or fax: 1-844-357-4669.
For medical information, please call: 1-855-541-3495.

Indication

AKYNZEO is indicated 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 is an oral fixed combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.1

Important Safety Information
Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, have been reported 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: headache, asthenia, dyspepsia, fatigue, constipation and erythema

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 two-fold increase in the systemic exposure of dexamethasone was observed 4 days after single dose of netupitant
    • 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

For more information about AKYNZEO, please see Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Helsinn at 1-855-541-3498 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reference:
1. AKYNZEO® (netupitant/palonosetron) capsules. Full Prescribing Information.


AKYNZEO® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license.

Indication

AKYNZEO is indicated 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 is an oral fixed combination of palonosetron and netupitant: palonosetron prevents nausea and vomiting during the acute phase and netupitant prevents nausea and vomiting during both the acute and delayed phase after cancer chemotherapy.1

Important Safety Information
Warnings and Precautions

  • Hypersensitivity reactions, including anaphylaxis, have been reported 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: headache, asthenia, dyspepsia, fatigue, constipation and erythema

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 two-fold increase in the systemic exposure of dexamethasone was observed 4 days after single dose of netupitant
    • 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

For more information about AKYNZEO, please see Full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Helsinn at 1-855-541-3498 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reference:
1. AKYNZEO® (netupitant/palonosetron) capsules. Full Prescribing Information.


AKYNZEO® is a registered trademark of Helsinn Healthcare SA, Switzerland, used under license.

AKYNZEO® is a registered trademark of Helsinn Healthcare SA, Switzerland, distributed and marketed by Helsinn Therapeutics (U.S.), Inc. under license.
©2017 Helsinn Therapeutics (U.S.), Inc. All rights reserved. HELS-US0041a(1) 03/2017