Now Approved ARIKAYCE

The first and only FDA-approved medication for the treatment of refractory (difficult to treat) Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug treatment plan

This product was approved by FDA using the Limited Population pathway. This means FDA has approved this drug for a limited and specific patient population, and studies on the drug may have only answered focused questions about its safety and effectiveness.

It is not known if ARIKAYCE is safe and effective in children younger than 18 years of age.

Taking each step with the Arikares Support Program

Living with this condition is not easy; neither is starting on a new treatment. The Arikares™ Support Program is here to provide you with important information and ongoing support throughout your treatment journey.

How can the Arikares Support Program help?

The Arikares Support Program is designed to help you get started on ARIKAYCE and become familiar with how to use your device. Additionally, the program provides assistance with insurance coverage and information on financial support options for eligible patients.

Who is your Arikares Support Program team?

If you sign up, you will be assigned an Arikares Coordinator. He or she will be dedicated to answering your questions and providing one-on-one support during your treatment journey.

If you sign up, you can request device training, and will be assigned an Arikares Trainer. The Arikares Trainer is a nurse or respiratory therapist who will provide in-person training to help you become familiar with how to take your treatment.

A step-by-step look at how the Arikares Support Program works

Step 1
Step 1

Prescription & program enrollment

After being prescribed ARIKAYCE, you can enroll in the Arikares Support Program in one of the following ways:

Step 2
Step 2

Welcome

After enrolling in the Arikares Support Program, you will receive:

  • A welcome pack in the mail
  • A call from your Arikares Coordinator to answer questions you may have and explain your next steps
Step 3
Step 3

First shipment of ARIKAYCE arrives to your home

You will receive your medicine

  • Your first 28-day supply of medicine arrives, along with your Lamira™ Nebulizer System
Step 4
Step 4

Device training

You can schedule an in-home training session

  • About 2 days after receiving your medicine, you are eligible to receive an in-home training session with an Arikares Trainer
Step 5
Step 5

Ongoing support

Your Arikares Coordinator will be in touch throughout your treatment journey to provide important information and support along the way.

1-833-ARIKARE (1-833-274-5273)
Arikares Support Program
Monday through Friday from 8 AM to 8 PM Eastern Time

The role of your Arikares Coordinator

You
Arikares Coordinator
Schedule an optional device training with your Arikares Trainer
Coordinate medication shipments with your specialty pharmacy
Speak with your
insurance company
Remember, your Arikares Coordinator is here to help, so reach out if you have questions about how the program works

Arikares in-home training session

The Arikares Trainer is a nurse or respiratory therapist. When you first start treatment, he or she can conduct an in-home training session to show you how to take your first dose of medicine and make it a part of your daily routine.

The Arikares Trainer will also:

  • Make sure you or your caregiver knows how to administer your treatment moving forward
  • Answer questions about how to take your treatment
  • Provide tips on handling your device
Be sure to enroll in the Arikares Support Program—here for you throughout your MAC treatment journey

Savings and financial support

Insmed is committed to providing access to ARIKAYCE

To learn more about potential savings and financial support options, Arikares Coordinators are available to answer your questions at
1-833-ARIKARE (1-833-274-5273).

For patients with commercial or private insurance

ARIKAYCE Co-pay Savings Program*

  • Eligible patients using private or commercial insurance can save on out-of-pocket costs for ARIKAYCE
  • Not valid for prescriptions covered by or submitted for reimbursement under Medicaid, Medicare, Veterans Affairs (VA), Department of Defense (DoD), TRICARE or similar federal or state programs, including any state pharmaceutical assistance program
  • Eligibility can be determined by calling the Arikares Support Program 1-833-ARIKARE (1-833-274-5273)
*See full terms and conditions.
For patients with government insurance

Medicare Part D extra help—Low-Income Subsidy (LIS) program

Medicare patients who have limited income and resources may qualify for extra help to pay for medication. The LIS, or "Extra Help," program from Medicare provides financial assistance for patients who may not be able to afford the costs associated with their Medicare Part D plan.

Those who are eligible for LIS may:

  • Receive assistance paying their monthly minimum
  • Have a reduced or no deductible
  • Have a reduced or no prescription coinsurance and co-payments
  • Have no gap in coverage
State-sponsored programs

Some states sponsor prescription financial assistance programs, each with its own eligibility requirements.

These programs are not offered by Insmed.
For any questions about cost or insurance coverage, call 1-833-ARIKARE (1-833-274-5273) Monday through Friday from 8 AM to 8 PM Eastern Time

Healthcare professional resources

ARIKAYCE Co-pay Savings Program Terms and Conditions

Most patients who are eligible pay $0 co-pay every month up to a $32,000 maximum program benefit per calendar year, and subject to a monthly program benefit limit of $8,000 per month. Patient will be responsible for any co-pay once limit is reached. Depending on the private or commercial health insurance plan, savings may apply toward co-pay, coinsurance, or deductible.

Who is eligible?

Patients who have been prescribed ARIKAYCE, are at least 18 years of age, a resident of the 50 United States, the District of Columbia, or Puerto Rico, and have commercial or private health insurance may be eligible for the ARIKAYCE Co-pay Savings Program. ARIKAYCE must be covered by your commercial or private insurance. This program is not valid for cash-paying customers. This offer is not valid for prescriptions covered by or submitted for reimbursement under Medicaid, Medicare, VA, DoD, TRICARE or similar federal or state programs, including any state pharmaceutical assistance program.

Patients who are currently ineligible for the ARIKAYCE Co-pay Savings Program may reapply if their circumstances change.

This is not an insurance benefit, and does not cover or provide support for supplies, procedures, or any physician-related services associated with ARIKAYCE. General, non-product specific insurance deductibles above the amount set forth above are also not covered. Insmed reserves the right to rescind, revoke, terminate, or amend this offer, eligibility, and terms and conditions at any time without notice. Patients, pharmacists, and prescribers cannot seek reimbursement from health insurance or any third party for any part of the benefit received by the patient through this offer. This offer is not conditioned on any past, present, or future purchase, including refills. The co-pay card is non-transferable, limited to one per person, and cannot be combined with any other offer or discount. This program is not valid where prohibited by law, taxed, or restricted. Offer has no cash value.

For Patients: If your prescription is covered by insurance, you may need to notify the insurance carrier of redemption of this co-pay card. By redeeming this co-pay card, you are certifying that (1) you are not a beneficiary of any government-funded program as noted above; (2) should you begin receiving prescription benefits from any government-funded program, you will withdraw from this program; and (3) you acknowledge and understand that adherence to the terms and conditions of this offer is necessary to ensure compliance with laws pertaining to any government-funded program. For questions regarding your eligibility or benefits or if you wish to discontinue your participation, please call 1-833-ARIKARE (1-833-274-5273).

BY PARTICIPATING IN THE ARIKAYCE CO-PAY SAVINGS PROGRAM, YOU AND YOUR PHARMACIST UNDERSTAND AND AGREE TO COMPLY WITH THESE ELIGIBILITY REQUIREMENTS AND TERMS OF USE.

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IMPORTANT SAFETY INFORMATION AND INDICATION Expand + Collapse
IMPORTANT SAFETY INFORMATION AND INDICATION

ARIKAYCE can cause serious side effects, including:

  • allergic inflammation of the lungs. These respiratory problems may be symptoms of allergic inflammation of the lungs and often come with fever, wheezing, coughing, shortness of breath, and fast breathing
  • coughing up of blood (hemoptysis). Coughing up blood is a serious and common side effect of ARIKAYCE
  • severe breathing problems. Severe breathing problems can be symptoms of bronchospasm. Bronchospasm is a serious and common side effect of ARIKAYCE. Bronchospasm symptoms include shortness of breath, difficult or labored breathing, wheezing, and coughing or chest tightness
  • worsening of chronic obstructive pulmonary disease (COPD). This is a serious and common side effect of ARIKAYCE

While using ARIKAYCE, these side effects may become serious enough that treatment in a hospital is needed. Call your healthcare provider or get medical help right away if you have any of these serious side effects while taking ARIKAYCE. Your healthcare provider may ask you to stop using ARIKAYCE for a short period of time or completely stop using ARIKAYCE.

Do not use ARIKAYCE if you are allergic to any aminoglycoside, or any of the ingredients in ARIKAYCE.

Before using ARIKAYCE, tell your healthcare provider about all medical conditions, including if you:

  • have asthma, COPD, shortness of breath, or wheezing (bronchospasm)
  • have been told you have poor lung function
  • have hearing problems, such as ringing in your ears or hearing loss
  • have dizziness or a sense of the room spinning
  • have kidney problems
  • have neuromuscular disease, such as myasthenia gravis
  • are pregnant or plan to become pregnant. It is not known if ARIKAYCE can harm your unborn baby. ARIKAYCE is in a class of medicines that may be connected with complete deafness in babies at birth. The deafness affects both ears and cannot be changed
  • are breastfeeding or plan to breastfeed. It is not known if the medicine in ARIKAYCE passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with ARIKAYCE

Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements.

ARIKAYCE may cause serious side effects, including:

  • hearing loss or ringing in the ears (ototoxicity). Ototoxicity is a serious and common side effect of ARIKAYCE. Tell your healthcare provider right away if you have hearing loss or you hear noises in your ears, such as ringing or hissing. Tell your healthcare provider if you start having problems with balance or dizziness (vertigo)
  • worsening kidney problems (nephrotoxicity). ARIKAYCE is in a class of medicines which may cause worsening kidney problems. Your healthcare provider may do a blood test to check how well your kidneys are working during your treatment with ARIKAYCE
  • worsening muscle weakness (neuromuscular blockade). ARIKAYCE is in a class of medicines which can cause muscle weakness to get worse in people who already have problems with muscle weakness (myasthenia gravis)

The most common side effects of ARIKAYCE include: changes in voice and hoarseness (dysphonia), sore throat, diarrhea, muscle pain, nausea, tiredness (fatigue), fever, vomiting, headache, decreased weight, increased sputum, rash, chest discomfort, or cough during or after a dose of ARIKAYCE, especially in the first month after starting treatment.

These are not all of the possible side effects of ARIKAYCE. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is ARIKAYCE?

ARIKAYCE is a prescription medicine used to treat adults with refractory (difficult to treat) Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug treatment plan (regimen).

It is not known if ARIKAYCE is safe and effective in children younger than 18 years of age.

This product was approved by FDA using the Limited Population pathway. This means FDA has approved this drug for a limited and specific patient population, and studies on the drug may have only answered focused questions about its safety and effectiveness.