A GUIDE FOR CAREGIVERS AND INDIVIDUALS WITH … · a guide for caregivers and individuals with sma...

A GUIDE FOR CAREGIVERS AND INDIVIDUALS WITH SMAUNDERSTANDING HEALTH INSURANCE OPTIONS AND SUPPORT PROGRAMS FOR SPINRAZA

INDICATIONSPINRAZA is a prescription medicine used to treat spinal muscular atrophy (SMA) in pediatric and adult patients.

SELECTED IMPORTANT SAFETY INFORMATIONIncreased risk of bleeding complications has been observed after administration of similar medicines. Your healthcare provider should perform blood tests before you start treatment with SPINRAZA and before each dose to monitor for signs of these risks. Seek medical attention if unexpected bleeding occurs.

Please see full Prescribing Information for additional Important Safety Information.Confidential and proprietary to Biogen.

https://www.spinraza.com/content/dam/commercial/specialty/spinraza/caregiver/en_us/pdf/spinraza-prescribing-information.pdf

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SELECTED IMPORTANT SAFETY INFORMATIONIncreased risk of kidney damage, including potentially fatal acute inflammation of the kidney, has been observed after administration of similar medicines. Your healthcare provider should perform urine testing before you start treatment with SPINRAZA and before each dose to monitor for signs of this risk.

Please see following pages for additional Important Safety Information and full Prescribing Information.Confidential and proprietary to Biogen.

USING THIS GUIDEFacing a diagnosis of spinal muscular atrophy (SMA) for you or your child can feel overwhelming. No matter where you are on your journey, living with SMA means there is a lot of information to think about. In addition to medical care, the insurance choices you face may be daunting.

Biogen is here to help. Learning about the available choices and determining which options best fit your needs is important for your path toward care.

This brochure provides background information about SPINRAZA® (nusinersen), a treatment option your doctor may have prescribed. The brochure also gives you information about the different health insurance options and programs that are available to support your/your child’s care.

In addition, we would like to introduce you to SMA360°™, support services from Biogen, designed to help you navigate the treatment process with SPINRAZA.a Your SMA360° team can help you with treatment logistics and provide insurance and financial assistance.

This guide will help you learn more about

Definitions for words in bold in this brochure can be found on pages 16 and 17.a SMA360° services from Biogen are available only to those who have been prescribed SPINRAZA. SMA360° is intended for US residents only.

SPINRAZA: What it is and how it works

Different types of health insurance (also called health plans in this guide)

Other financial assistance services

Insurance and financial assistance for SPINRAZA

SMA360°: Your circle of support

Questions about health insurance coverage for SPINRAZA

Insurance terms you should know

Ask your healthcare provider (HCP) for more information about SPINRAZA, or visit SPINRAZA.com. You can also call us with any questions at

1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 am to 8:00 pm ET.

Biogen does not exercise control over or endorse any third party websites referenced in this document.


http://SPINRAZA.com

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SELECTED IMPORTANT SAFETY INFORMATIONThe most common side effects of SPINRAZA include lower and upper respiratory infections, constipation, headache, back pain, and post-lumbar puncture syndrome.

These are not all of the possible side effects of SPINRAZA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This information is not intended to replace discussions with your healthcare provider.


TABLE OF CONTENTS

HOW TO TALK WITH YOUR DOCTOR ABOUT TREATMENT FOR SMA ................................................... 4

ABOUT SPINRAZA ............................................................................................................................................ 5• What is SPINRAZA?• How does SPINRAZA work?

NAVIGATING YOUR HEALTH INSURANCE OPTIONS ................................................................................. 6• Commercial (private) health insurance• What are the different types of commercial health insurance plans?• Other types of health plans• Enrolling in Medicaid• Additional government assistance services

SMA360°TM: YOUR CIRCLE OF SUPPORT ................................................................................................... 13• Enrolling in SMA360°

INSURANCE AND FINANCIAL ASSISTANCE FOR SPINRAZA .................................................................. 14• Getting affordable access to treatment

FREQUENTLY ASKED QUESTIONS ABOUT SPINRAZA ............................................................................ 15

IMPORTANT HEALTH INSURANCE TERMS YOU NEED TO KNOW ........................................................ 16

YOUR SPINRAZA TREATMENT INCLUDES SUPPORT FROM BIOGEN ................................................... 18


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Increased risk of kidney damage, including potentially fatal acute inflammation of the kidney, has been observed after administration of similar medicines. Your healthcare provider should perform urine testing before you start treatment with SPINRAZA and before each dose to monitor for signs of this risk.


TREATMENT FOR SMA

ABOUT SPINRAZA

HEALTH INSURANCE OPTIONS SMA360° FINANCIAL

ASSISTANCEFREQUENTLY ASKED

QUESTIONSIMPORTANT

TERMS

HOW TO TALK WITH YOUR DOCTOR ABOUT TREATMENT FOR SMAPatients with SMA have a treatment option. In December 2016, the United States Food and Drug Administration (FDA) approved SPINRAZA as the first prescription medicine to treat SMA in pediatric and adult patients.

If you have questions about SPINRAZA as a treatment choice for yourself or your loved one, talk with your doctor. He or she is the one you should speak with first about a potential treatment option for SMA. Here is a list of questions you may want to ask your doctor:

For more information about SPINRAZA, read this brochure or go to SPINRAZA.com. Your doctor can also find information about SPINRAZA and how to get patients started on treatments at SPINRAZA-HCP.com.

Is SPINRAZA the right treatment choice for me/my loved one?

What might we expect from treatment with SPINRAZA?

What do we have to do to get started on the treatments?

When would the treatments begin?

How often are the treatments?


http://SPINRAZA.com

http://SPINRAZA-HCP.com

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ABOUT SPINRAZA



QUESTIONSIMPORTANT

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ABOUT SPINRAZA

WHAT IS SPINRAZA?

SPINRAZA is the first and only FDA-approved treatment for SMA, a genetic disease in which a lack of survival motor neuron (SMN) protein affects the part of the nervous system that controls motor function.

In a controlled study, individuals with infantile-onset SMA treated with SPINRAZA achieved and sustained a clinically meaningful improvement in motor function compared to untreated individuals.

The efficacy of SPINRAZA was also supported by open-label uncontrolled studies in symptomatic individuals who ranged in age from approximately 1 month to 15 years at the time of first dose, as well as presymptomatic individuals who ranged in age from 8 to 42 days at the time of first dose. In these studies of individuals who had or were likely to develop Type 1, 2, or 3 SMA, some individuals treated with SPINRAZA showed improvements, including

• The achievement of milestones such as the ability to sit independently, stand, or walk when they would otherwise be unable to do so

• Maintaining milestones at ages when they would be expected to lose them• Surviving longer than expected considering the typical course of their disease (number of SMN2 copies)

The safety of SPINRAZA has been evaluated in multiple studies of individuals with SMA.

HOW DOES SPINRAZA WORK?

In laboratory tests and animal studies, SPINRAZA was shown to increase full-length SMN protein by targeting the process through which it is produced by a gene called SMN2.

SPINRAZA.COM | SMA360°TM 1-844-4SPINRAZA (1-844-477-4672)


http://SPINRAZA.COM

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TREATMENT FOR SMA

ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS

NAVIGATING YOUR HEALTH INSURANCE OPTIONS There are many different types of health insurance options that may help cover some or most of the cost of care for individuals with SMA who receive SPINRAZA treatment. They may provide different levels of coverage and operate in different ways. This section gives you an overview of the different types of health insurance.

COMMERCIAL (PRIVATE) HEALTH INSURANCE There are many different types of commercial health insurance plans (also called private health plans). Each type of plan provides varying levels of coverage and operates in a unique way. You may get commercial health insurance from your employer or union, but you can also purchase it from a private insurance firm or an insurance exchange. Commercial health plans are all different and may have their own specific premiums, out-of-pocket costs, out-of-network providers, and much more. Call your health insurance plan to learn more about the services your plan covers. Also, some health plans have rules for coverage and reimbursement when care is outside of their approved network of providers.

WHAT ARE THE DIFFERENT TYPES OF COMMERCIAL HEALTH INSURANCE PLANS? The table below can help you generally understand how each type of commercial health insurance plan works.

Type of health plan

Has a network of providers?

Need a referral to see a specialist?

What happens if I need out-of-network care?

Health Maintenance Organization (HMO)

Yes Yes

HMOs cover out-of-network care if• The HMO’s network of doctors do not have the

experience to treat a certain health problem• A network doctor refers you to an out-of-network doctor• You have an emergency

Exclusive Provider Organization (EPO)

Yes No

EPOs do not include out-of-network care, even when the plan’s doctors do not have the experience to treat a certain health problem. EPOs must pay for out-of-network care if you have an emergency.

Preferred Provider Organization (PPO)

Yes No

PPOs provide out-of-network care but may not pay for the full cost of treatment. If you choose to see an out-of-network doctor, you may have to pay for some of your treatment, even if you have an emergency.

Point-of-Service (POS) Plan Yes No POS plans provide out-of-network care but you may

have higher costs for out-of-network providers.

Indemnity or Fee-for-Service (FFS)

No No Not applicable.


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TREATMENT FOR SMA

ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS

OTHER TYPES OF HEALTH PLANS

High deductible health planThis type of plan has a higher deductible than other types of plans; however, its monthly premium is usually lower. A higher deductible means that you will have to pay more money out-of-pocket before the insurance plan will pay for any healthcare expenses. There are ways to help pay for the expenses in a high deductible health plan, such as health savings accounts or a health reimbursement arrangement, which puts aside pretax money to pay for some medical expenses.

Tiered provider networkThis type of plan separates HCPs based on quality and costs. For example, a patient may pay less when they are treated by an HCP that has a higher quality and lower cost.

Government-funded health insuranceMany people get health insurance through a program that is funded by the state or federal government. These programs include

If you have a child with SMA, Medicaid or CHIP are the programs that will most likely help you pay for the cost of your child’s care. Medicare may be an insurance option for adults with SMA who receive disability benefits from Social Security. TRICARE is the health program for United States military personnel and their families; it may provide insurance coverage for a child with SMA if a parent has TRICARE coverage for the family.

Call your health insurance provider to learn more about the services your plan covers. The number to call is generally on the back of your insurance card.

Medicaid

Children’s Health Insurance Program (CHIP)

Medicare

US Department of Defense (DoD)/TRICARE®

US Department of Veterans Affairs (VA)

TRICARE is a registered trademark of the Department of Defense, Defense Health Agency. All rights reserved.


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ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS

MedicareMedicare health insurance covers people 65 years and older as well as people younger than 65 years who have certain disabilities. There are 4 parts to Medicare that cover different parts of health insurance:

• Part A is the hospital insurance that covers hospital stays, skilled nursing facilities, hospice, and home healthcare• Part B is the medical insurance that covers doctor services, outpatient and home healthcare, durable medical

equipment, and preventive services• Part C is called Medicare Advantage and includes the services covered in Part A and Part B and, usually, also includes

prescription drug coverage• Part D is prescription drug coverage that typically includes medicine that is not administered in a doctor’s office or

hospital and is not covered under Part A or Part B

Medicare may be an insurance option for adults with SMA who have a work history but can no longer work because of disability due to SMA. After 2 years of receiving disability benefits from Social Security, enrollment in Medicare is automatic. To learn about disability benefits through Social Security, contact 1-800-772-1213 or visit ssa.gov.

Medicare does not cover all healthcare expenses. If you have original Medicare Parts A and B, there is additional insurance coverage called a Medigap policy or Medicare supplemental insurance that can cover what Medicare does not. The best time to buy a Medigap policy is during an Open Enrollment Period after you enroll in Part B. If you do not enroll in a Medigap policy during this time, it may not be available later or may cost more. In addition, some states may not have Medigap policies available to Medicare recipients who are younger than 65 years. If you have original Medicare and would like to learn if your state offers a Medigap policy, contact Medicare directly or call your state’s insurance department.

Medicaid can help you afford medical costs for SMA and other conditions by offering

People with low income People with disabilities Pregnant women

• Hospital visits• Home healthcare

• Doctor or nurse visits• Medical tests

• X-rays• Transportation to medical care

To learn more about Medicare contact 1-800-MEDICARE or visit Medicare.gov.

MedicaidMedicaid provides low-cost or free health coverage to millions of Americans, including


http://ssa.gov

http://Medicare.gov

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SELECTED IMPORTANT SAFETY INFORMATIONThese are not all of the possible side effects of SPINRAZA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.



TREATMENT FOR SMA

ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS

Understanding commercial insurance and Medicaid togetherPeople with SMA may have commercial health insurance at the time of diagnosis. Many individuals who have been diagnosed with SMA may also get Medicaid to help pay for costs that commercial health insurance does not cover. If your commercial insurance plan does not cover certain medical costs or equipment, you may consider applying for Medicaid to help address those coverage limitations and exclusions. The first step in becoming eligible for Medicaid is an official verification of your/your child’s disability by Social Security (see page 11). In most states, if a person with SMA is eligible for SSI benefits, he or she is automatically enrolled in Medicaid. If your state does not automatically enroll your child in Medicaid, you will need to apply with another agency. Social Security will direct you to the appropriate office.

Medicaid waiver programsPeople living with SMA may qualify for other Medicaid assistance not based soley on income. This can be done through Medicaid waivers, which is when a state Medicaid service waives the rules so that someone can be eligible for Medicaid. Medicaid waivers may help provide additional services and wraparound Medicaid coverage so you or your loved one can receive long-term care in your own community.The federal government allows states to apply for waivers from the traditional Medicaid rules, so they can offer additional assistance options. To learn more about waivers available in your state, visit medicaid.gov/medicaid and select “State Waivers List.” Kidswaivers.org is another helpful resource to learn more about available Medicaid waivers for children.

Medicaid (cont’d)Medicaid is administered by your state. This means that each state has different requirements for income, the number of people in your household, family status, and other factors. Your state may also help pay for other care, such as

• Medicines• Breathing care• Physical therapy

• Occupational therapy• Chiropractic services

• Prosthetics• Case management

Medicaid provides coverage for many people with severe disabilities, including children who live in families with low income.


http://medicaid.gov/medicaid

http://Kidswaivers.org

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TREATMENT FOR SMA

ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS

ENROLLING IN MEDICAID

How to applyContact your state Medicaid office to determine how to apply for Medicaid. You can find your state Medicaid office by visiting Medicaid.gov or by calling 1-877-267-2323 and following the prompts to get the phone number for your state’s office.

What you need to have availableEach state has different Medicaid application requirements, so you should check with your state office. There is general information that will be required:

Your or your child’s name and date

of birth

Information about incomes from work

and any other source

Information about your current commercial

health insurance

Documentation of disability status

from Social Security

The Social Security numbers for the patient and both parents (if the

patient is a child)

Once approved, Medicaid can help pay for some costs that may not be covered by commercial insurance.


http://Medicaid.gov

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TREATMENT FOR SMA

ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS

ADDITIONAL GOVERNMENT ASSISTANCE SERVICES

Supplemental Security Income

Supplemental Security Income (SSI) is a federal income supplement program that helps adults and children with disabilities who have limited income.

SMA is a condition that fits the criteria for disability to qualify for SSI, which includes children younger than 18 years who have a physical or mental condition that has the following characteristics:

1Causes serious

functional limitations

Characteristics of a condition that qualifies for SSI

2Has lasted, or can

be expected to last, for 12 months

or more

3Can lead to death

SSI also considers income and resources. If you are the parents of a child under the age of 18 with SMA, SSI will look at a part of the incomes and resources of you and your spouse to see if your child can qualify.

What SSI assesses to see if you qualify Description

Income• Includes your salary, Social Security benefits, pensions, food stamps, and help from someone

with food or shelter• Amount is set by each state

Resources

• Includes bank accounts, cash, investments such as stocks and bonds, and real estate (except your current home)

• Does not include your current home and the land it is on, your primary vehicle, household goods, personal property (such as wedding rings), and any educational funds (such as grants or scholarships)

• Resource limits are $2,000 or less for an individual/child and $3,000 or less for a couple


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TREATMENT FOR SMA

ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS

Children’s Health Insurance Program

For children in families that do not qualify for Medicaid, the Children’s Health Insurance Program (CHIP) provides low cost coverage for those who cannot afford other health insurance plans. Children who qualify for CHIP will not need to buy an insurance plan. If your child is younger than 19 years and has SMA, he or she may be eligible for CHIP.

CHIP can help you afford medicines and treatments for medical conditions by covering doctor visits, checkups, immunizations, medicines, dental and vision care, hospital visits, medical tests, X-rays, and emergency services.

Not all doctors accept patients who have Medicaid or CHIP. You may want to ask the office staff if they accept Medicaid or CHIP when you make an appointment. If you have trouble finding a doctor, your CHIP plan can help you.

Insurance Terms

Signing up for SSI will help you or your child become enrolled in Medicaid and other programs. To learn more about SSI, visit socialsecurity.gov

or call 1-800-772-1213.

To apply for SSI benefits

For Your Child

If your child has SMA, review the Social Security Child Disability Starter Kit at ssa.gov/disability/disability_starter_kits_child_eng.htm. This kit provides answers for frequently asked questions about applying for SSI benefits for children with rare diseases like SMA and includes a worksheet that will help you gather the information you need.

1. To start the SSI application process, contact Social Security to determine if your income and resources are within the appropriate eligibility limits. You can call toll-free at 1-800-772-1213.

2. Fill out the online Child Disability Report at ssa.gov/childdisabilityreport. At the end of the report, you will be asked to sign a form that gives your child’s primary HCP permission to provide information about your child’s diagnosis. This will allow Social Security to make a decision on your claim.

For You

If you have SMA and want to apply for Social Security disability insurance benefits, you can do so online at socialsecurity.gov or by calling 1-800-772-1213. If you call, a Social Security representative will make an appointment for you to apply with a separate telephone call or at a local Social Security office.

Once you are/your child is accepted for SSI, you may also be eligible for other government programs such as Medicaid, food stamps, and more social services.


http://www.socialsecurity.gov

http://ssa.gov/disability/disability_starter_kits_child_eng.htm

http://ssa.gov/childdisabilityreport

http://www.socialsecurity.gov

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TREATMENT FOR SMA

ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS

SMA360°: YOUR CIRCLE OF SUPPORTWe understand that life can be challenging for a caregiver or an individual living with SMA. SMA360° is a support service from Biogen created to help families navigate the following areas of the treatment process with SPINRAZA:a

• Treatment logistics• Insurance and financial assistance

Your SMA360° team includes your Family Access Manager (FAM) and your SMA Support Coordinator.

A complete list of the SMA360° offerings can be found at SPINRAZA.com/support. Talk to your HCP if you have questions regarding SMA or SPINRAZA.

ENROLLING IN SMA360°

Enrolling in SMA360° is done with your HCP when a treatment decision to start SPINRAZA is made. You will complete the patient information on a Start Form, and your physician will complete the medical section of the form. The form is then sent to enroll you or your child in the program.

You can contact an SMA Support Coordinator at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 am to 8:00 pm ET, to get more information about these services.

a SMA360° services from Biogen are available only to those who have been prescribed SPINRAZA. SMA360° is intended for US residents only.

Ask your HCP for more information about SPINRAZA, or visit SPINRAZA.com. You can also call us with any questions at 1-844-4SPINRAZA (1-844-477-4672),

Monday through Friday, from 8:30 am to 8:00 pm ET.


http://SPINRAZA.com/support

http://SPINRAZA.com

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TREATMENT FOR SMA

ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS

INSURANCE AND FINANCIAL ASSISTANCE FOR SPINRAZATo help you make informed decisions, SMA Support Coordinators can:• Investigate your insurance benefits to help you understand your current coverage• Collaborate with HCPs so they can obtain prior authorizations for treatment• Provide support in the event of denied insurance claims• Educate you on the eligibility details of the $0 Copay Program from Biogen, which can potentially cover both

your SPINRAZA prescription and the treatment procedure• Supply background and resources to refer you to third-party charity organizations• Counsel you and your family on the possibility of adding or changing insurance coverage

GETTING AFFORDABLE ACCESS TO TREATMENT

$0 Drug Copay Program Generally, all individuals on nongovernment insurance are eligible, regardless of income, and there is no annual maximum on the amount Biogen will cover as part of the program. Insurance will be billed first and must pay before copay assistance will be applicable. Individuals receiving coverage from Medicare, Medicaid, the VA/DoD, TRICARE®, or any other governmental or pharmaceutical assistance may not be eligible. Contact an SMA Support Coordinator for more information.

TRICARE is a registered trademark of the Department of Defense, Defense Health Agency. All rights reserved.

$0 Procedure Copay ProgramIn addition to the above criteria, you are eligible for this program if you meet the following requirements:• You are not a resident of Massachusetts, Michigan, Minnesota, or Rhode Island• Your HCP submits a request for treatment using an approved procedure code for anesthesia, imaging

procedures, and/or surgical procedure/drug administration. Only codes approved by Biogen shall be eligible under the program

Third-party funding assistanceIf it is determined that you are not eligible for the $0 Copay Program, an SMA Support Coordinator can help you find charitable organizations that may provide third-party assistance.

A complete list of the SMA360°TM offerings can be found at SPINRAZA.com/support. To inquire about specific program details, and to find out if you are eligible,

contact an SMA Support Coordinator at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 am to 8:00 pm ET.

Talk to your HCP if you have questions regarding SMA or SPINRAZA.


http://SPINRAZA.com/support

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TREATMENT FOR SMA

ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS

FREQUENTLY ASKED QUESTIONS ABOUT SPINRAZAThe following is a list of questions that you may have about SPINRAZA, as it relates to access to treatment for you or your loved one.

1. How do I order SPINRAZA? SPINRAZA is available by prescription only. Only your doctor can order SPINRAZA.

2. How long will it take to get SPINRAZA? If you are enrolled in SMA360°TM, you will be contacted by your FAM or SMA Support Coordinator to discuss

the logistics surrounding treatment with SPINRAZA. He or she will help you navigate the scheduling process with your doctor.

3. Where is SPINRAZA available and how can I/my loved one get treated at that location? SPINRAZA is administered in a healthcare setting, such as a center or hospital that specializes in treating SMA.

Talk with your doctor about where he or she would have your SPINRAZA treatment take place.

4. My doctor has never heard of SPINRAZA. Can you send him or her information? If your doctor does not know about SPINRAZA, ask him or her to contact a representative from Biogen for

more information.

5. How can I purchase SPINRAZA and send it to my relative/friend in another country? You cannot purchase SPINRAZA directly. Only a doctor can order SPINRAZA in a country in which the product

has been approved.

6. What happens if SPINRAZA is not covered by my insurance? Biogen recognizes that insurance coverage for SPINRAZA is a key consideration for families. As part of

our ongoing commitment to the SMA community, Biogen has created a support services program in the United States called SMA360°.a SMA360° support provides certain services that address nonmedical barriers to access. These include logistical assistance, product education, insurance benefit investigations, and financial assistance. For more information about SMA360°, please see page 13 of this brochure.

7. Who will be eligible for financial assistance programs for SPINRAZA? Each individual’s eligibility for Biogen’s financial assistance will be dependent on a number of factors. For this

reason, we suggest you contact an SMA Support Coordinator at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 am to 8:00 pm ET, for information about these services.

aSMA360° services from Biogen are available only to those who have been prescribed SPINRAZA. SMA360° is intended for US residents only.


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SELECTED IMPORTANT SAFETY INFORMATIONThese are not all of the possible side effects of SPINRAZA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.



TREATMENT FOR SMA

ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS

IMPORTANT HEALTH INSURANCE TERMS YOU NEED TO KNOWCommercial insurance: A broad category of health insurance coverage, under which benefits are privately purchased directly from a health plan or through an employer, a broker, or a public health insurance marketplace (also known as an insurance exchange). Individuals with private commercial insurance may have a range of benefits, including • HMO, where coverage is typically granted only if patients use in-network providers • PPO, where patients may use out-of-network providers but at a higher out-of-pocket cost

Copayment (copay): A set amount a patient will pay for a health service covered by insurance.

Deductible: The amount you have to pay for the healthcare services covered by your insurance plan before your insurance plan will pay for the services.

Government-funded health insurance: A broad category of health insurance coverage, under which insurance benefits are provided through a government program, such as Medicare or Medicaid.

Preferred provider (or in-network provider): A provider who has been contracted by an insurer to provide healthcare services to its members.

Medicaid: A health insurance program that is administered by the state government to provide coverage for individuals with low incomes or for children with disabilities and special needs. In most states, Medicaid beneficiaries are typically covered by one of the following programs: • Fee-for-service state Medicaid, which is operated by the state government as a single statewide program • Medicaid Managed Care, which is operated by private health plans contracted by the state

Medicare: A government health insurance program that provides coverage for individuals older than 65 years and for those younger than 65 who have certain disabilities.


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TREATMENT FOR SMA

ABOUT SPINRAZA



QUESTIONSIMPORTANT

TERMS



IMPORTANT HEALTH INSURANCE TERMS YOU NEED TO KNOW (cont’d)Network: The institutions (eg, hospitals, laboratories), providers (eg, doctors), and suppliers your plan works with to provide healthcare services.

Out-of-network provider (or nonpreferred provider): A provider who is not in your plan’s network.

Out-of-pocket cost (sometimes called OOP): The amount of money an individual may have to pay for the cost of covered healthcare services. OOP costs vary depending on the type of cost-sharing structure of the health plan benefit.

Premium: The amount that must be paid by a family or an individual to obtain coverage. For some people with private commercial coverage, their employer may pay for at least a portion of the health insurance premium.

Prior authorization (or preauthorization): The requirement by a plan that, before coverage is allowed, it must be determined that a treatment or medication is medically necessary.

Provider network: A group of HCPs (such as physicians), facilities (such as hospitals), and suppliers (such as pharmacies) that are contracted with an insurer to provide services and products to its members.

Referral: An order or permission granted by the primary care provider for a patient to receive specialty care. For example, some individuals with SMA may need a referral to see a specialist, such as a pulmonologist or an orthopedist.


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Please see full Prescribing Information for additional Important Safety Information.Confidential and proprietary to Biogen.

YOUR SPINRAZA TREATMENT INCLUDES SUPPORT FROM BIOGENSPINRAZA is the first and only FDA-approved treatment indicated for pediatric and adult patients with SMA. In clinical studies, SPINRAZA therapy produced meaningful improvements in motor function. Work with your SMA Support Coordinator and your FAM to explore your insurance options for obtaining SPINRAZA. SMA360°TM can provide additional financial assistance and support services.

INDICATIONSPINRAZA is a prescription medicine used to treat spinal muscular atrophy (SMA) in pediatric and adult patients.

IMPORTANT SAFETY INFORMATIONIncreased risk of bleeding complications has been observed after administration of similar medicines. Your healthcare provider should perform blood tests before you start treatment with SPINRAZA and before each dose to monitor for signs of these risks. Seek medical attention if unexpected bleeding occurs.

Increased risk of kidney damage, including potentially fatal acute inflammation of the kidney, has been observed after administration of similar medicines. Your healthcare provider should perform urine testing before you start treatment with SPINRAZA and before each dose to monitor for signs of this risk.

The most common side effects of SPINRAZA include lower and upper respiratory infections, constipation, headache, back pain, and post-lumbar puncture syndrome.

These are not all the possible side effects of SPINRAZA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


SPINRAZA.COM | SMA360°TM 1-844-4SPINRAZA (1-844-477-4672)

Ask your HCP for more information about SPINRAZA, or visit SPINRAZA.com. You can also call us with any questions at 1-844-4SPINRAZA (1-844-477-4672),

Monday through Friday, from 8:30 am to 8:00 pm ET.

http://www.spinraza-hcp.com/content/dam/commercial/specialty/spinraza/hcp/en_us/pdf/spinraza-prescribing-information.pdf

http://SPINRAZA.COM

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A GUIDE FOR CAREGIVERS AND INDIVIDUALS WITH … · a guide for caregivers and individuals with sma...

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