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The updated 2020 NTM Treatment Guidelines are now available
Get started with your Arikares Coordinator and take the fi rst step of your treatment journey. Enroll in the Arikares Support Program today.
Contact information for your Arikares Coordinator:
For more information, visitARIKAYCE.com/support
© 2020 Insmed Incorporated. All Rights Reserved. Insmed, ARIKAYCE, and Arikares are trademarks of Insmed Incorporated.All other trademarks are property of their respective owner. PP-ARIK-US-01141
25
Important questions to ask your doctor to help you prepare for a conversation about ARIKAYCE
How does ARIKAYCE work, and is it right for me?
How do I take ARIKAYCE, and how often?
How will I know if I’m getting better?
How long does treatment last, and how will we track my progress?
How is ARIKAYCE different from treatments I’ve taken in the past?
What side effects should I be aware of?
What should I do if I start experiencing side effects?
These are sample questions to help get the conversation started between you and your doctor. This is not, nor is it intended to be, a medical evaluation, examination, advice, consultation, diagnosis, or treatment. Always consult your doctor for all medical- and health-related matters.
4
An inhaled treatment delivered directly to your lungs
To watch how ARIKAYCE fi ghts MAC lung disease, visitARIKAYCE.com/action
ARIKAYCE is an inhaled antibiotic you take with a nebulizer. It is different from other inhaled antibiotics because the amikacin is contained inside tiny particles called liposomes. When you inhale ARIKAYCE, the liposomes containing the medicine travel into your lungs. Once inside the lungs, they release the medicine to fi ght the infection.
The inhaled, liposomal formulation of ARIKAYCE targets MAC bacteria within the lungs, giving you a different way to fi ght MAC lung disease
IMPORTANT SAFETY INFORMATION (cont’d)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.
3
ARIKAYCE was approved by FDA using the Limited Population pathway. This means FDA has approved this drug for a limited and specifi c patient population, and studies on the drug may have only answered focused questions about its safety and effectiveness.
ARIKAYCE was studied in adult patients. It is not known if ARIKAYCE is safe and effective in children younger than 18 years of age.
Find out about the fi rst and only FDA-approved treatment for MAC lung disease at ARIKAYCE.com
IMPORTANT SAFETY INFORMATION (cont’d)ARIKAYCE can cause serious side effects, including (cont'd):• worsening of chronic obstructive pulmonary disease (COPD). This is a serious and
common side effect of ARIKAYCE• serious allergic reactions. Serious allergic reactions that may lead to death have happened
to people who take ARIKAYCE. Stop taking ARIKAYCE right away and get emergency medical help if you have any of the following symptoms of a serious allergic reaction: hives, itching, redness or blushing of the skin (fl ushing), swollen lips, tongue or throat, trouble breathing or wheezing, shortness of breath, noisy high-pitched breathing (stridor), cough, nausea, vomiting, diarrhea, feel cramps in your stomach area, fast heart rate, feeling light headed, feeling faint, loss of control of the bowels or bladder (incontinence), and dizziness
If your MAC lung disease feels like it's getting in the way—
It's time to add ARIKAYCE
2
MAC=Mycobacterium avium complex.
Please see additional Important Safety Information throughout and enclosed full Prescribing Information, including Boxed Warning.
IMPORTANT SAFETY INFORMATIONARIKAYCE can cause serious side effects, including:• allergic infl ammation of the lungs. These respiratory problems may be symptoms of allergic infl ammation of the lungs
and often come with fever, wheezing, coughing, shortness of breath, and fast breathing• coughing up of blood (hemoptysis) 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, diffi cult or labored breathing, wheezing, and coughing or chest tightness
The fi rst and only FDA-approved treatment option designed specifi cally for MAC lung disease as part of a multidrug regimen in adults who continue to test positive after at least 6 months of a multidrug regimen alone.
In clinical studies, 3X more patients taking ARIKAYCE (amikacin liposome inhalation suspension) + multidrug regimen tested negative for MAC lung disease compared to those taking multidrug regimen alone (29.0% [65/224] vs 8.9% [10/112]).
ARIKAYCE is proven to help you attack the MAC bacteria.
It’s time to add ARIKAYCE
More patients tested and stayed negative for MAC lung disease after
taking ARIKAYCE
MACNEGATIVE
3
ARIKAYCE was approved by FDA using the Limited Population pathway. This means FDA has approved this drug for a limited and specifi c patient population, and studies on the drug may have only answered focused questions about its safety and effectiveness.
ARIKAYCE was studied in adult patients. It is not known if ARIKAYCE is safe and effective in children younger than 18 years of age.
Find out about the fi rst and only FDA-approved treatment for MAC lung disease at ARIKAYCE.com
IMPORTANT SAFETY INFORMATION (cont’d)ARIKAYCE can cause serious side effects, including (cont'd):• worsening of chronic obstructive pulmonary disease (COPD). This is a serious and
common side effect of ARIKAYCE• serious allergic reactions. Serious allergic reactions that may lead to death have happened
to people who take ARIKAYCE. Stop taking ARIKAYCE right away and get emergency medical help if you have any of the following symptoms of a serious allergic reaction: hives, itching, redness or blushing of the skin (fl ushing), swollen lips, tongue or throat, trouble breathing or wheezing, shortness of breath, noisy high-pitched breathing (stridor), cough, nausea, vomiting, diarrhea, feel cramps in your stomach area, fast heart rate, feeling light headed, feeling faint, loss of control of the bowels or bladder (incontinence), and dizziness
If your MAC lung disease feels like it's getting in the way—
It's time to add ARIKAYCE
2
MAC=Mycobacterium avium complex.
Please see additional Important Safety Information throughout and enclosed full Prescribing Information, including Boxed Warning.
IMPORTANT SAFETY INFORMATIONARIKAYCE can cause serious side effects, including:• allergic infl ammation of the lungs. These respiratory problems may be symptoms of allergic infl ammation of the lungs
and often come with fever, wheezing, coughing, shortness of breath, and fast breathing• coughing up of blood (hemoptysis) 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, diffi cult or labored breathing, wheezing, and coughing or chest tightness
The fi rst and only FDA-approved treatment option designed specifi cally for MAC lung disease as part of a multidrug regimen in adults who continue to test positive after at least 6 months of a multidrug regimen alone.
In clinical studies, 3X more patients taking ARIKAYCE (amikacin liposome inhalation suspension) + multidrug regimen tested negative for MAC lung disease compared to those taking multidrug regimen alone (29.0% [65/224] vs 8.9% [10/112]).
ARIKAYCE is proven to help you attack the MAC bacteria.
It’s time to add ARIKAYCE
More patients tested and stayed negative for MAC lung disease after
taking ARIKAYCE
MACNEGATIVE
The updated 2020 NTM Treatment Guidelines are now available
Get started with your Arikares Coordinator and take the fi rst step of your treatment journey. Enroll in the Arikares Support Program today.
Contact information for your Arikares Coordinator:
For more information, visitARIKAYCE.com/support
© 2020 Insmed Incorporated. All Rights Reserved. Insmed, ARIKAYCE, and Arikares are trademarks of Insmed Incorporated.All other trademarks are property of their respective owner. PP-ARIK-US-01141
25
Important questions to ask your doctor to help you prepare for a conversation about ARIKAYCE
How does ARIKAYCE work, and is it right for me?
How do I take ARIKAYCE, and how often?
How will I know if I’m getting better?
How long does treatment last, and how will we track my progress?
How is ARIKAYCE different from treatments I’ve taken in the past?
What side effects should I be aware of?
What should I do if I start experiencing side effects?
These are sample questions to help get the conversation started between you and your doctor. This is not, nor is it intended to be, a medical evaluation, examination, advice, consultation, diagnosis, or treatment. Always consult your doctor for all medical- and health-related matters.
4
An inhaled treatment delivered directly to your lungs
To watch how ARIKAYCE fi ghts MAC lung disease, visitARIKAYCE.com/action
ARIKAYCE is an inhaled antibiotic you take with a nebulizer. It is different from other inhaled antibiotics because the amikacin is contained inside tiny particles called liposomes. When you inhale ARIKAYCE, the liposomes containing the medicine travel into your lungs. Once inside the lungs, they release the medicine to fi ght the infection.
The inhaled, liposomal formulation of ARIKAYCE targets MAC bacteria within the lungs, giving you a different way to fi ght MAC lung disease
IMPORTANT SAFETY INFORMATION (cont’d)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.
5
Please see additional Important Safety Information throughout and enclosed full Prescribing Information, including Boxed Warning.
Living with MAC lung disease can be challenging. You may have tried treatments in the past and not seen results. ARIKAYCE is the only FDA-approved treatment designed for people like you.
ARIKAYCE + multidrug regimen was studied in 224 patients with MAC lung disease who had either stopped responding or never responded to their previous treatment.
Studied in patients who did not respond to other treatments
IMPORTANT SAFETY INFORMATION (cont’d)Before using ARIKAYCE, tell your healthcare provider about all medical conditions, including if you:• have asthma, COPD, shortness of breath, or wheezing
(bronchospasm)
6
Culture conversion: Testing negative for MACOne of the key goals of treating MAC lung disease is culture conversion. Culture conversion means you no longer test positive for MAC bacteria in your lungs.
Additional measuresAdditional measures evaluated in the ARIKAYCE study included:• Improvement in the distance walked over a 6-minute period
(6-minute walk test)• Improvement in responses to the St George's Respiratory
Questionnaire, designed to measure impact on overall health, daily life, and perceived well-being in patients with lung disease
After testing negativeIn the clinical study, patients continued ARIKAYCE treatment for 12 months after testing MAC-negative.
Please see additional Important Safety Information throughout and enclosed full Prescribing Information, including Boxed Warning.
IMPORTANT SAFETY INFORMATION (cont’d)Before using ARIKAYCE, tell your healthcare provider about all medical conditions, including if you (cont'd):• have been told you have poor lung function
Information about the study
Updated 2020 NTM Treatment Guidelines now recommend ARIKAYCEfor MAC lung disease patients who continue to test positive after
at least 6 months of multidrug regimen alone.Read more on pages 18-19
7
8
PROVEN RESULTS: In the clinical study, more ARIKAYCE patients tested negative for 12 months—and beyond
IMPORTANT SAFETY INFORMATION (cont’d)Before using ARIKAYCE, tell your healthcare provider about all medical conditions, including if you (cont’d):• have hearing problems, such as ringing in your ears or hearing loss• have dizziness or a sense of the room spinning • have kidney problems
Please see additional Important Safety Information throughout and enclosed full Prescribing Information, including Boxed Warning.
End of treatment
AS MANYPATIENTSTESTEDNEGATIVE
with ARIKAYCE +multidrug regimen
29% (65/224)
VS
multidrugregimen alone8.9% (10/112)
PRIMARYSTUDY RESULTS
ADDITIONALSTUDY RESULTS
with ARIKAYCE +multidrug regimen
18.3% (41/224)
VS
multidrugregimen alone
2.7% (3/112)
with ARIKAYCE +multidrug regimen
16.1% (36/224)
VS
multidrugregimen alone
0% (0/112)
3X AS MANYPATIENTSTESTEDNEGATIVE7X AS MANY
PATIENTSTESTEDNEGATIVE16X
3 monthsafter stoppingtreatment
9
Those who tested negative with ARIKAYCE remained negative, even after stopping treatment
End of treatment
3 monthsafter stoppingtreatment
65 patientstested negative
36 patientsremained negative
10 patientstested negative
0 patientsremained negative
10 0
65/224 vs 10/112 36/41 vs 0/3
6536
ARIKAYCE +multidrugregimen
224patients
Multidrugregimen
alone
112patients
41 patientsstayed negative
3 patientsstayed negative
3
41/65 vs 3/10
41VS VS VS
PRIMARY STUDY RESULTS
ADDITIONAL STUDY RESULTS
Additional study resultsIn the ARIKAYCE clinical study, there was no improvement in the 6-minute walk test and St George's Respiratory Questionnaire measurements at the end of 6 months.
10
• coughing up of blood (hemoptysis). Coughing up bloodis a serious and common side effect of ARIKAYCE
• severe breathing problems. Severe breathing problemscan be symptoms of bronchospasm. Bronchospasmis a serious and common side effect of ARIKAYCE.Bronchospasm symptoms include:
– shortness of breath
– wheezing
– diffi cult or laboredbreathing
– 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.
ARIKAYCE can cause serious side effects, such as:• allergic infl ammation of the lungs. These respiratory
problems may be symptoms of allergic infl ammation ofthe lungs and often come with:
Knowing the possible side effects of ARIKAYCE
Everyone responds to treatment differently. If you have questions
about the possible side effects associated with
ARIKAYCE, be sure to speak with your doctor
Please see additional Important Safety Information throughout and enclosed full Prescribing Information, including Boxed Warning.
– fever– coughing
– fast breathing
– wheezing
– shortness of breath
11
19.7% of patients taking ARIKAYCE + multidrug regimen experienced serious side effects compared to 16.1%
of patients taking a multidrug regimen alone
ARIKAYCE may cause serious side effects, including:• serious allergic reactions. Serious allergic reactions that may lead to death have
happened to people who take ARIKAYCE. Stop taking ARIKAYCE right away and getemergency medical help if you have any of the following symptoms of a seriousallergic reaction: hives, itching, redness or blushing of the skin (fl ushing), swollen lips,tongue or throat, trouble breathing or wheezing, shortness of breath, noisy high-pitched breathing (stridor), cough, nausea, vomiting, diarrhea, feel cramps in yourstomach area, fast heart rate, feeling light headed, feeling faint, loss of control of thebowels or bladder (incontinence), and dizziness
• hearing loss or ringing in the ears (ototoxicity). Ototoxicity is a serious and commonside effect of ARIKAYCE. Tell your healthcare provider right away if you have hearingloss or you hear noises in your ears such as ringing or hissing. Tell your healthcareprovider if you start having problems with balance or dizziness (vertigo)
• worsening kidney problems (nephrotoxicity). ARIKAYCE is in a class of medicines whichmay cause worsening kidney problems. Your healthcare provider may do a blood testto check how well your kidneys are working during your treatment with ARIKAYCE
• worsening muscle weakness (neuromuscular blockade). ARIKAYCE is in a classof medicines which can cause muscle weakness to get worse in people whoalready have problems with muscle weakness (myasthenia gravis)
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.
Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements.
12
The most common side effects of ARIKAYCE are:• changes in voice and hoarseness (dysphonia)
• cough during or after a dose of ARIKAYCE
• muscle pain
• sore throat
• tiredness (fatigue)
• diarrhea
• nausea
• headache
• fever
• decreased weight
• vomiting
• rash
• increased sputum
• chest discomfort
These are not all of the possible side effects of ARIKAYCE.
Cough during or after a dose of ARIKAYCE was reported most by patients during
the fi rst monthof treatment
Most common side effects of ARIKAYCE
Please see additional Important Safety Information throughout and enclosed full Prescribing Information, including Boxed Warning.
13
Talk to your doctor about side effects
If you experience any side effects while taking ARIKAYCE, be sure to
talk to your doctor about them
Most patients who experienced side effects did not stop treatment
81% (182/224) of patients taking ARIKAYCE + multidrug
regimen did not stop treatment even though they had at least one side effect
Ready for a proven MAC treatment, designed
specifi cally for patients like you?
Consider ARIKAYCE
14
A recent survey reported potential techniques and strategies to help manage certain respiratory-related side effects when taking ARIKAYCE.
The survey was conducted via telephone with 26 patients prescribed ARIKAYCE during a 2-month period at 2 academic medical centers in the United States.
Survey disclosures• This information is not included in the ARIKAYCE full Prescribing Information• Writing assistance was provided to the authors through funding from
Insmed Incorporated• Insmed was not involved with the conceptualization, development, conduct, or analyses
of the study
Side effect management survey
Please see additional Important Safety Information throughout and enclosed full Prescribing Information, including Boxed Warning.
Remember, management strategies should be discussed with your doctor, as they may vary patient by patient
IMPORTANT SAFETY INFORMATION (cont’d)Before using ARIKAYCE, tell your healthcare provider about all medical conditions, including if you (cont’d):• have neuromuscular disease, such as myasthenia gravis
15
Below are potential management strategies used in the survey for certain side effects. Always talk to your doctor before starting any management techniques.
Changes in voice and hoarseness (dysphonia)Management strategies included:
• changing ARIKAYCE administration to the evening• brief interruptions of ARIKAYCE• antitussive agents• lozenges• warm water or glycerin gargle post-dosing• soothing fl uid intake
• bronchodilator use• brief interruptions of ARIKAYCE• limiting physical activity• increasing supplemental oxygen,
if already administering
Shortness of breath (dyspnea)Management strategies included:
• bronchodilator use• changing ARIKAYCE administration to the evening• brief interruptions of ARIKAYCE• antitussive agents• lozenges• warm water or glycerin gargle post-dosing• soothing fl uid intake
Increased coughingManagement strategies included:
Increased sputum productionManagement strategies included:
* Increased sputum production may be a form of airway clearance in itself.
• airway clearance* (eg, specifi c breathingtechniques, chest percussion, and positiveexpiratory pressure therapy)
16
Receiving your ARIKAYCE treatment
At the start of your treatment, you will receive 2 shipments froma specialty pharmacy.
They will include:• A 28-day supply of ARIKAYCE• A one-time shipment of the Lamira® Nebulizer System
Going forward, you will receive monthly shipments of a 28-day supply of ARIKAYCE.
Please see additional Important Safety Information throughout and enclosed full Prescribing Information, including Boxed Warning.
IMPORTANT SAFETY INFORMATION (cont’d)Before using ARIKAYCE, tell your healthcare provider about all medical conditions, including if you (cont’d):• 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 withcomplete deafness in babies at birth. The deafness affects both ears and cannotbe changed
For more details about what you will receive, visitARIKAYCE.com/instructions
17
Taking your ARIKAYCE treatment
• ARIKAYCE is designed to be taken with the Lamira Nebulizer System,and should be taken once daily
• You can administer ARIKAYCE in your own home or anywhere with aclean, fl at surface
– Administering ARIKAYCE takes about 14 minutes, but could take upto 20 minutes
To watch step-by-step instructions on taking ARIKAYCE, visitARIKAYCE.com/instructions
Treating MAC lung disease involves taking more than 1 medication. These medications work together to fi ght the MAC bacteria
18
Adding ARIKAYCE to a multidrug regimen is now strongly recommended for MAC lung disease patients who continue to test positive after at least 6 months of a multidrug regimen alone. The guidelines were created by leading scientifi c communities to provide recommendations and standards for NTM treatment.
The updated 2020 NTM Treatment Guidelines* now recommend ARIKAYCE
The guidelines recommend a multidrug regimen of at least 3 antibiotics.The guidelines suggest starting treatment rather than waiting for certain diagnosed patients.
Start treatmentafter MAC lung disease is diagnosed
1-5 monthsafter treatment initiation
6 monthsafter starting treatment
Start on a multidrug regimen
Get sputum testedevery 1-2 months
The guidelines recommend regular doctor visits and monthly sputum cultures in order to assess whether or not a patient is responding to therapy.
The guidelines recommend that your doctor evaluates if your multidrug regimen is working after 6 months of treatment.
Test MAC-negative after 6 months?
* ATS/ERS/ESCMID/IDSA NTM guidelines. ATS=American Thoracic Society; ERS=European Respiratory Society; ESCMID=European Society of Clinical Microbiology and Infectious Diseases; IDSA=Infectious Diseases Society of America.
Please see additional Important Safety Information throughout and enclosed full Prescribing Information, including Boxed Warning.
19
Add ARIKAYCE at 6 monthsGuidelines recommend adding ARIKAYCE for patients who
continue to test positive after 6 months of treatment
ARIKAYCE was approved by FDA using the Limited Population pathway for a limited and specifi c patient population.
Continue multidrug regimen
NO
YES
IMPORTANT SAFETY INFORMATION (cont’d)Before using ARIKAYCE, tell your healthcare provider about all medical conditions, including if you (cont’d):• 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 thebest way to feed your baby during treatment with ARIKAYCE
The guidelines recommend staying on treatment for a minimum of 12 months after testing negative for MAC. This is to make sure the MAC bacteria is cleared from your lungs.
Additional guidelines recommendation
20
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.
An Arikares Coordinator and Arikares Trainer are available to help you If you sign up, your Arikares Coordinator will be your point person to help answer your questions during your treatment journey. He or she will also provide information about your device, insurance coverage for your medication, and how the Arikares Support Program works.
You can also request a voluntary device training session by an assigned Arikares Trainer. He or she is a trained nurse or respiratory therapist who is available to come to your home to show you how to use your nebulizer to administer your medicine.
Arikares provides ongoing support throughout your treatment journey.
The Arikares Support Program
For more on how the Arikares Support Program can help you, visitARIKAYCE.com/support
There, you can download the Arikares Enrollment Form and bring it to your doctor’s offi ce.
Arikares Support Program
1-833-ARIKARE(1-833-274-5273)
or1-973-437-2376
Monday through Friday from 8 AM to 8 PM
Eastern Time
WelcomeStep 2
Step 4
Step 5
Step 1
Step 3First shipment of ARIKAYCE
Prescription & program enrollment
Voluntary device training
Ongoing support
WelcomeStep 2
Step 4
Step 5
Step 1
Step 3First shipment of ARIKAYCE
Prescription & program enrollment
Voluntary device training
Ongoing support
WelcomeStep 2
Step 4
Step 5
Step 1
Step 3First shipment of ARIKAYCE
Prescription & program enrollment
Voluntary device training
Ongoing support
WelcomeStep 2
Step 4
Step 5
Step 1
Step 3First shipment of ARIKAYCE
Prescription & program enrollment
Voluntary device training
Ongoing support
WelcomeStep 2
Step 4
Step 5
Step 1
Step 3First shipment of ARIKAYCE
Prescription & program enrollment
Voluntary device training
Ongoing support
A step-by-step look at how the Arikares Support Program works
Step 1: After receiving your prescription, you can enroll in the Arikares Support Program in one of the following ways:• Download the Arikares Enrollment Form at ARIKAYCE.com/support
and bring it to your doctor’s offi ce• Call 1-833-ARIKARE (1-833-274-5273) or 1-973-437-2376 and
someone will help you enroll over the phone
Step 2: After enrolling in the Arikares Support Program, you will receive:• A Welcome Pack in the mail• A call from your Arikares Coordinator to welcome you to
the program
Step 3: Your medicine is delivered directly to your home• Your medicine arrives at your home, along with a device to
help you take it
Step 4: You can schedule an in-home or virtual training session• About 2 days after receiving your medicine, you are eligible to
receive an in-home or virtual training session with an Arikares Trainer
Step 5: Ongoing support• Your Arikares Coordinator will be in touch throughout your
treatment journey to provide important information and supportalong the way
21
22
Savings and fi nancial support
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 fi nancial 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 programsSome states sponsor prescription fi nancial assistance programs, each with its own eligibility requirements.
*These programs are not offered by Insmed.
Find more details on savings and fi nancial support atARIKAYCE.com/savings
Insurance coversARIKAYCE for most patients
For patients with commercial or private insurance
ARIKAYCE Co-pay Savings Program†
• Eligible patients using private or commercial insurance may pay as little as a $0 co-pay for ARIKAYCE® (amikacin liposome inhalation suspension)
• 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
• Eligibility can be determined by calling the Arikares Support Program at 1-833-ARIKARE (1-833-274-5273) or at 1-973-437-2376
†ARIKAYCE Co-pay Savings Program Terms and ConditionsMost patients who are eligible pay as little as a $0 co-pay every month up to a $32,000 maximum program benefi t per calendar year, and subject to a monthly program benefi t 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 benefi t, and does not cover or provide support for supplies, procedures, or any physician-related services associated with ARIKAYCE. General, non-product specifi c 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 benefi t received by the patient through this offer. This offer is not conditioned on any past, present, or future purchase, including refi lls. 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 benefi ciary of any government-funded program as noted above; (2) should you begin receiving prescription benefi ts 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 benefi ts or if you wish to discontinue your participation, please call 1-833-ARIKARE (1-833-274-5273) or 1-973-437-2376.
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.DoD=Department of Defense; VA=Veterans Affairs.
23
ARIKAYCE is the fi rst and only FDA-approved treatment for MAC lung disease as part of a multidrug regimen in adults who did not respond to a multidrug regimen alone.
To learn about MAC lung disease, go to ARIKAYCE.com/what-is-mac
24
The updated 2020 NTM Treatment Guidelines are now available
Get started with your Arikares Coordinator and take the fi rst step of your treatment journey. Enroll in the Arikares Support Program today.
Contact information for your Arikares Coordinator:
For more information, visitARIKAYCE.com/support
© 2020 Insmed Incorporated. All Rights Reserved. Insmed, ARIKAYCE, and Arikares are trademarks of Insmed Incorporated.All other trademarks are property of their respective owner. PP-ARIK-US-01141
25
Important questions to ask your doctor to help you prepare for a conversation about ARIKAYCE
How does ARIKAYCE work, and is it right for me?
How do I take ARIKAYCE, and how often?
How will I know if I’m getting better?
How long does treatment last, and how will we track my progress?
How is ARIKAYCE different from treatments I’ve taken in the past?
What side effects should I be aware of?
What should I do if I start experiencing side effects?
These are sample questions to help get the conversation started between you and your doctor. This is not, nor is it intended to be, a medical evaluation, examination, advice, consultation, diagnosis, or treatment. Always consult your doctor for all medical- and health-related matters.
4
An inhaled treatment delivered directly to your lungs
To watch how ARIKAYCE fi ghts MAC lung disease, visitARIKAYCE.com/action
ARIKAYCE is an inhaled antibiotic you take with a nebulizer. It is different from other inhaled antibiotics because the amikacin is contained inside tiny particles called liposomes. When you inhale ARIKAYCE, the liposomes containing the medicine travel into your lungs. Once inside the lungs, they release the medicine to fi ght the infection.
The inhaled, liposomal formulation of ARIKAYCE targets MAC bacteria within the lungs, giving you a different way to fi ght MAC lung disease
IMPORTANT SAFETY INFORMATION (cont’d)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.
The updated 2020 NTM Treatment Guidelines are now available
Get started with your Arikares Coordinator and take the fi rst step of your treatment journey. Enroll in the Arikares Support Program today.
Contact information for your Arikares Coordinator:
For more information, visitARIKAYCE.com/support
© 2020 Insmed Incorporated. All Rights Reserved. Insmed, ARIKAYCE, and Arikares are trademarks of Insmed Incorporated.All other trademarks are property of their respective owner. PP-ARIK-US-01141
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Important questions to ask your doctor to help you prepare for a conversation about ARIKAYCE
How does ARIKAYCE work, and is it right for me?
How do I take ARIKAYCE, and how often?
How will I know if I’m getting better?
How long does treatment last, and how will we track my progress?
How is ARIKAYCE different from treatments I’ve taken in the past?
What side effects should I be aware of?
What should I do if I start experiencing side effects?
These are sample questions to help get the conversation started between you and your doctor. This is not, nor is it intended to be, a medical evaluation, examination, advice, consultation, diagnosis, or treatment. Always consult your doctor for all medical- and health-related matters.
4
An inhaled treatment delivered directly to your lungs
To watch how ARIKAYCE fi ghts MAC lung disease, visitARIKAYCE.com/action
ARIKAYCE is an inhaled antibiotic you take with a nebulizer. It is different from other inhaled antibiotics because the amikacin is contained inside tiny particles called liposomes. When you inhale ARIKAYCE, the liposomes containing the medicine travel into your lungs. Once inside the lungs, they release the medicine to fi ght the infection.
The inhaled, liposomal formulation of ARIKAYCE targets MAC bacteria within the lungs, giving you a different way to fi ght MAC lung disease
IMPORTANT SAFETY INFORMATION (cont’d)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.