NAVIGATING INSURANCE AND SUPPORT PROGRAMS FOR … · 55 SMA360° can provide support throughout the...

A GUIDE FOR PATIENTS WITH SPINAL MUSCULAR ATROPHY AND THEIR CAREGIVERS

NAVIGATING INSURANCE AND SUPPORT PROGRAMS FOR SPINRAZA® (nusinersen)

INDICATIONSPINRAZA® (nusinersen) 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 additional Important Safety Information on page 69 and accompanying full Prescribing Information.

age 48Later-onset

SMA (Type 3) treated with

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age 19Later-onset

SMA (Type 2)treated with

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age 2.5Infantile-onset

SMA (Type 1)treated with

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Individual results may vary based on several factors, including severity of disease, initiation of treatment, and duration of therapy.

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

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Definitions for words that are blue and bold in this brochure can be found on pages 65 to 68.

WELCOME TO THE SPINRAZA® (nusinersen) PATIENT AND CAREGIVER INSURANCE GUIDEFacing a diagnosis of spinal muscular atrophy (SMA) for you or your child can feel overwhelming. No matter where you are on your journey, there are decisions to make about medical care, health plans, and the services and support you may need. Biogen is here to help you learn about your choice so you can decide which options best fit your needs.

This guide gives you information about health plan coverage for SPINRAZA, which is a prescription medicine approved by the US Food and Drug Administration (FDA) to treat SMA in children and adults. This guide also tells you about programs that are available to support you or your child’s care.

age 7Later-onset

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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 additional Important Safety Information on page 69 and accompanying full Prescribing Information.


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SELECTED IMPORTANT SAFETY INFORMATIONThe most common side effects of SPINRAZA include lower respiratory infection, fever, constipation, headache, vomiting, 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. Before taking SPINRAZA, tell your healthcare provider if you are pregnant or plan to become pregnant.This information is not intended to replace discussions with your healthcare provider.Please see additional Important Safety Information on page 69 and accompanying full Prescribing Information.

THIS GUIDE EQUIPS YOU WITH TOOLS TO ADVOCATE FOR INSURANCE COVERAGE OF SPINRAZA TREATMENT FOR YOURSELF OR YOUR LOVED ONE

Understand your options for financial assistance and connect with support services from SMA360°

Learn about types of health plans

Understand your health plan’s coverage for SPINRAZA

Navigate your plan’s approval process with your doctor and learn what to do if coverage for SPINRAZA is denied

One program that can help you with your SPINRAZA treatment is SMA360°. Biogen created this support service especially for patients with SMA who are prescribed SPINRAZA. Your SMA360° team will guide you step by step through the process of starting SPINRAZA. They will also help you with your health plan benefits and find sources to help cover the cost of SPINRAZA treatment.

SMA360° 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 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 additional Important Safety Information on page 69 and accompanying full Prescribing Information.

A BIOGEN SMA360° TEAM WILL BE THERE FOR YOU THROUGHOUT THE SPINRAZA TREATMENT JOURNEY

Once the Biogen Start Form has been sent in by your doctor, your Family Access Manager (FAM) will reach out to begin helping you with the logistics of your treatment.* Your FAM will be your go-to person whenever you have a question or concern related to your treatment journey while on SPINRAZA.† Your FAM can provide information on SMA360° support services and how you may be eligible for programs tailored to your needs. Your FAM can• Coordinate the logistics of starting your treatment• Prepare you for the treatment journey by educating you on what to expect• Connect with you at the treatment center, if you choose, to help with logistics as necessaryThe relationship you have with your FAM should be comfortable for you and your family.

Once you are enrolled in SMA360°, a Lead Case Manager (LCM) will call to follow up with you. The LCM will tell you about financial assistance programs and help you find the most affordable way to start and stay on treatment with SPINRAZA. To help you make informed decisions, an LCM can• Help you research your health plan benefits and understand your current coverage• Educate you on the eligibility details of the $0 Copay Program from Biogen,‡ which can

potentially cover both the cost of your SPINRAZA prescription and the treatment procedure

FAMILY ACCESS MANAGER

LEAD CASE MANAGER

*SMA360° services from Biogen are available only to those who have been prescribed SPINRAZA. SMA360° is intended for US residents only.† Please remember that your or your child’s doctor should be the primary resource for any questions related to SMA and SPINRAZA.‡ Depending on your income or, in some cases, if your medication is obtained from an out-of-network provider, there may be an annual cap that limits the amount of assistance that you can receive over 1 year. Federal and state laws and other factors may prevent or otherwise restrict eligibility. Individuals receiving coverage from Medicare, Medicaid, the VA/DoD, TRICARE®, or any other governmental or pharmaceutical assistance may not be eligible. The $0 Copay Program is only available once your claim has been submitted to and paid for by your insurance company. Individuals may remain enrolled in the $0 Copay Program for as long as eligibility criteria are met. Contact an LCM for full eligibility requirements.TRICARE is a registered trademark of the Department of Defense (DoD), DHA. All rights reserved.


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SMA360° can provide support throughout the approval process for SPINRAZA. Contact your FAM directly or call SMA360° at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 AM to 8:00 PM ET

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age 2.5Infantile-onset(Type 1) SMAtreated withSPINRAZA

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TABLE OF CONTENTS

1. UNDERSTANDING HOW SPINRAZA IS COVERED BY YOUR PLAN .............................. 8

2. NAVIGATING YOUR HEALTH PLAN’S APPROVAL PROCESS FOR SPINRAZA ............ 15

3. WHAT TO DO IF YOUR COVERAGE IS DENIED .......................................................... 25

4. SUGGESTIONS FOR WRITING YOUR LETTER OF APPEAL ......................................... 32

5. QUESTIONS TO ASK YOUR HEALTH PLAN ................................................................ 36

6. WHAT TO CONSIDER WHEN CHOOSING A HEALTH PLAN ....................................... 39

7. YOUR HEALTH PLAN OPTIONS ................................................................................. 42

8. FINANCIAL ASSISTANCE AND BIOGEN RESOURCES ................................................ 59

9. GLOSSARY OF KEY TERMS ........................................................................................ 65


UNDERSTANDING HOW SPINRAZA® (nusinersen)

IS COVERED BY YOUR PLAN

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Please see additional Important Safety Information on page 69 and accompanying full Prescribing Information.


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What you can do

Review and understand your health plan’s medical policy before starting treatment with SPINRAZA • Call the customer service phone number on your insurance ID card to

request that your health plan send you its medical policy for SPINRAZA. Many health plans’ medical policies are also available online; check your health plan’s website

• If you are insured through an employer, contact your employer’s human resources department. The employer’s benefits manager may be able to provide you with the medical policy

If you have a government health plan, such as Medicaid or Medicare, ask your FAM for more information about SPINRAZA coverage

Connect with a case manager or patient advocate at your health plan who can become your contact person

UNDERSTANDING HOW SPINRAZA IS COVERED BY YOUR HEALTH PLAN

SECTION 1.

YOUR HEALTH PLAN’S MEDICAL POLICY

A medical policy is a set of guidelines. A health plan uses these guidelines to assess if a medical service or drug is medically necessary and eligible for coverage. A plan may set certain limits on coverage based on its medical policy.

Health plans have a medical policy for treatments and services. This can include a drug that is provided by your doctor or in a treatment center, a medical procedure, or special equipment. Health plans can review and update their policies. This is to ensure that policies meet the latest medical support.


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HOW YOUR HEALTH PLAN’S MEDICAL POLICY AFFECTS COVERAGE FOR SPINRAZA

The medical policy for SPINRAZA can vary from plan to plan. For instance, the FDA has approved SPINRAZA for use in both children and adults. However, some health plans may not cover patients of all ages.

Health plans may have age and type of SMA criteria that must be met in order for SPINRAZA to be prescribed

Some patients who receive SPINRAZA may also face coverage restrictions because of location. Their provider and/or the treatment center may be out of network or out of state

For many drugs that treat rare diseases, such as SPINRAZA, health plans may require a prior authorization (PA) renewal after a certain period. This is also called a reauthorization requirement (see page 22)

age 48Later-onset

(Type 3) SMA treated with

SPINRAZA

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What happens if my ME for SPINRAZA is denied? There are several reasons an insurer may deny your request, but there are things you can do to reverse that decision. If your insurer denies coverage of care, you can request an appeal. You may also have the option to request an independent external review. See more information about both on page 26.

What can I do if my health plan does not cover SPINRAZA?If you or a loved one with SMA does not meet your health plan’s coverage, or there is no policy for SPINRAZA, there are steps you can take to get coverage.

Step 1: Contact your health plan and encourage it to cover the treatment. It is important for your family and for other patients who are being prescribed SPINRAZA but are not getting approval. By advocating, it shows the health plan that there are patients trying to get treatment.

Step 2: Encourage your doctor to call your health plan and request a medical exception (ME) for you or your child (see page 20)

Step 3: If you are insured through an employer, ask your employer’s human resources department to advocate on your behalf. Your employer may have contacts at the insurance company

Step 4: Call your FAM for assistance. Your FAM can answer questions and provide guidance for finding support services and patient advocacy groups

QA

QA

FREQUENTLY ASKED QUESTIONS


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age 36Later-onset(Type 3) SMA treated with SPINRAZA

Ian

SMA360° can provide support throughout the approval insurance process. Contact your FAM for additional information about your coverage for SPINRAZA.



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 additional Important Safety Information on page 69 and accompanying full Prescribing Information. 11


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KEEP NOTES WHEN SPEAKING WITH YOUR HEALTH PLAN

Use the health plan call log to help you keep records of phone calls with your health plan.

MY HEALTH PLAN CALL LOG

Date of call

Name of person I spoke with

Best phone number or email of person I spoke with

What we spoke about

My next steps

Date of call



What we spoke about

My next steps


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MY HEALTH PLAN CALL LOG

Date of call



What we spoke about

My next steps

Date of call



What we spoke about

My next steps

https://www.spinraza.com/content/dam/commercial/specialty/spinraza/caregiver/en_us/pdf/spinraza-prescribing-information.pdfKeeley.GuillermeSticky NoteMarked set by Keeley.Guillerme

NAVIGATING YOUR HEALTH PLAN’S APPROVAL

PROCESS FOR SPINRAZA® (nusinersen)

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NAVIGATING YOUR HEALTH PLAN’S APPROVAL PROCESS FOR SPINRAZA

SECTION 2.

WHAT TO EXPECT

Benefits InvestigationOnce you are prescribed SPINRAZA, your doctor’s office will research your plan’s coverage. This called a Benefits Investigation. The Benefits Investigation helps you and your doctor’s office understand

Your current coverage for SPINRAZA

The steps and documents your insurer requires for approval such as a PA and a Letter of Medical Necessity

Coverage restrictions, such as the need for a referral (referral restriction) or out-of-state/out-of-network restrictions

If you need to file a request for an ME

Your out-of-pocket costs, including deductibles, copayments, and coinsurance

If your health plan does not cover SPINRAZA, you may be able to request an ME (see page 20).

Make sure your doctor’s office has your health plan information.Remember to provide your doctor’s office with the insurance cards from your health plans.


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What you can do

Stay informed.

Ask your doctor’s office and FAM what your insurer requires for a coverage decision.

Be sure to be available during the insurance approval process. You may need to provide additional information.

Prior authorizationMost plans require a PA for SPINRAZA. Following the Benefits Investigation, your doctor’s office will file a PA. This is the request for coverage approval from your health plan (primary payer or primary insurer) before you start treatment (see page 19).

Medical exceptionIf SPINRAZA is not covered for your or your loved one’s treatment, your doctor can request an ME. This is a special request for treatment that requires additional paperwork from your doctor’s office. See page 20 for more information about an ME and what you may need to do.

Health plan’s coverage decisionYour health plan will review this information to make sure that it meets its coverage requirements. Someone from your plan will contact you and/or your doctor’s office with a decision. If your request for coverage is denied, you and your doctor’s office can appeal the decision (see page 26).

If you have more than 1 health plan, work with your doctor’s office to learn if that plan will cover SPINRAZA.

Your doctor’s office, and possibly you, will need to submit information to receive authorization for SPINRAZA treatment. Ask your doctor’s office if it has all the information it needs to submit the PA or ME. If not, provide the information as soon as possible.


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THE HEALTH PLAN APPROVAL PROCESS FOR SPINRAZA

This diagram can help you understand the steps to getting SPINRAZA approved and receiving treatment.

BENEFITSINVESTIGATION

After you receive a prescription for SPINRAZA, your doctor’s office will conduct a Benefits Investigation (page 15) to determine your health plan’s coverage for SPINRAZA.Your out-of-pocket costs, including deductibles, copayments and coinsurance, will also be determined.

IF PA OR ME DENIED,APPEAL

DECISION

Sometimes, even if your treatment with SPINRAZA is medically necessary, your coverage may be denied. If your health plan denies your PA or ME request, you can appeal (page 26). Contact your FAM and doctor’s office right away for assistance.

REQUEST PA OR ME

Most insurers require a PA (page 19) for SPINRAZA. Your doctor’s office will file the necessary paperwork. If SPINRAZA is not covered by your health plan, your doctor’s office can request an ME (page 20) and submit additional paperwork so that you may receive coverage.

RECEIVE TREATMENT

SPINRAZA is administered at a treatment center.In order to keep receiving treatments, your doctor’s office will submit requests for reauthorization (page 22) on an ongoing basis.


SMA360° IS HERE TO SUPPORT YOU Enroll in SMA360° and a FAM will contact you to help with this process. SMA360° will also help determine if you are eligible for the $0 Copay Programs from Biogen. Contact your FAM directly or SMA360° at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 AM to 8:00 PM ET.


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HOW LONG IS THE APPROVAL PROCESS?

There is no set timeline for the insurance approval process. There are several factors that can affect how long it takes for approval, such as

• The Benefits Investigation

• Completing and submitting a PA

• The internal review process at your health plan

If you have more than 1 plan, a Benefits Investigation must be conducted with each, and required paperwork must be submitted. The time it takes to receive approval can vary from plan to plan. If your doctor feels that treatment is urgent, he or she may request an expedited review of the approval request.

The approval process can be as short as a few days for expedited reviews, but the length of time can vary from plan to plan. If you have any questions, contact your FAM.

What you can doLearn what steps need to be taken for approval and what you can do to help. Be sure your doctor’s office and FAM have all of your health plan and treatment information. Missing or incomplete information can slow down the process.


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WHAT IS A PRIOR AUTHORIZATION?

What you can doYour doctor’s office will need to submit information to receive authorization for SPINRAZA treatment. Ask your doctor’s office if it has all the information it needs to submit the PA. If not, provide the information as soon as possible.

Your health plan may grant coverage for some services and drugs only after a PA is approved. Another name for a PA is a precertification.

PAs are very common for drugs that treat rare diseases, such as SPINRAZA. Health plans may require a PA on a treatment for many reasons. A PA lets a health plan decide if the treatment is medically necessary. It also allows health plans to make sure that drugs are being used appropriately.

PA requirements vary among health plans. Some plans have their own PA form. Your doctor’s office must complete and submit the form to the health plan along with any additional information requested. Documents and information commonly submitted with a PA for SPINRAZA include

Health plan ID numbers for you or your loved one

Test results confirming SMA diagnosis, such as genetic testing

Baseline functional exam results and baseline labs

Patient notes and medical history

Medical articles about the disease and drug

Letter of Medical Necessity, if needed

Treatment center

Your FAM can help your doctor’s office with the PA process.


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REQUESTING A MEDICAL EXCEPTIONSometimes a treatment is not covered by a health plan. However, it may still be prescribed if you and your doctor’s office request an ME.

ME requests are usually more complex than PAs. They require more specific documentation, such as a Letter of Medical Necessity from your doctor’s office. Your FAM can assist with the ME process.

Some states have laws that require health plans to respond to an ME request within a certain period of time. Contact your FAM to learn whether this applies in your state.

What you can doAsk your doctor’s office and FAM what steps need to be taken for approval of the ME. See what you can do to help. You may want to contact your health plan directly and advocate for yourself or for your loved one with SMA.


If you have questions about the ME process for a SPINRAZA, contact your FAM directly or SMA360° at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, 8:30 AM to 8 PM ET.

WHAT TO DO IF YOUR ME REQUEST IS DENIED

There are many reasons why an ME may be denied. Fortunately there are several steps you and your doctor’s office can take to try to reverse your health plan’s decision, such as an appeal (see page 26).


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WHAT HAPPENS WHEN YOUR HEALTH PLAN APPROVES COVERAGE FOR SPINRAZA

1ST

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Your health plan will notify you, your doctor’s office, and/or SMA360°™.* Be sure to communicate any information you receive from your health plan with your doctor’s office and FAM.

Confirm your appointment for treatment with your FAM. Frequent communication is important through this process.

Once coverage is approved, follow up with your doctor’s office to ensure an appointment is scheduled for your or your loved one’s first treatment.

You may also want to follow up with your health plan to understand your coverage. Clarify your benefits for the drug and procedure and ask about any out-of-pocket costs.

SPINRAZA is shipped to your treatment location.

Because SPINRAZA is specialty drug, you may get a call from the specialty pharmacy to confirm the order. It is very important to answer this call and speak to the specialty pharmacy. If you don’t, there may be a delay in scheduling your treatment.

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


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WHAT IS REAUTHORIZATION AND HOW OFTEN WILL IT HAPPEN?

Health plans typically approve SPINRAZA for a certain length of time or number of doses. But patients receiving SPINRAZA require ongoing therapy. This typically continues beyond the initial period approved by your health plan.

For many drugs that treat rare diseases, such as SPINRAZA, health plans may require a PA renewal after a certain period. Reauthorization periods for SPINRAZA may vary among health plans, but

• They are usually 6 months to 1 year

• They typically cover 1 to 3 maintenance doses, depending on the timing of your treatment and how it lines up with the reauthorization period

Health plans typically will reauthorize the use of SPINRAZA for patients who have a clinical response. Your health plan’s medical policy will define what it means to have a clinical response to treatment and it is important that you document your SPINRAZA treatment response as well. A response may include

• Improvement in a motor function

• No change in maintaining certain abilities

• Slowed disease progression

WHAT TO DO IF YOUR REAUTHORIZATION REQUEST IS DENIED

There are many reasons that a reauthorization may be denied. Fortunately, there are several steps you and your doctor’s office can take to try to reverse your health plan’s decision, such as an appeal (see page 26).

What you can do

Use a symptom log to record your or your loved one’s response to treatment.

• Responses can include maintaining self-care activities or gaining a new motor milestone function. Photos and videos may also help when sharing with your doctor

• This step is critical because your doctor’s office may want to submit the symptom log to support your reauthorization request


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The most common side effects of SPINRAZA include lower respiratory infection, fever, constipation, headache, vomiting, 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. Before taking SPINRAZA, tell your healthcare provider if you are pregnant or plan to become pregnant.This information is not intended to replace discussions with your healthcare provider.Please see additional Important Safety Information on page 69 and accompanying full Prescribing Information.

age 20Later-onset(Type 3) SMA treated withSPINRAZA

Lauren

23


WHAT TO DO IF YOUR COVERAGE IS DENIED

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WHAT TO DO IF YOUR COVERAGE IS DENIED

SECTION 3.

UNDERSTANDING WHY YOUR COVERAGE WAS DENIED

Sometimes, even if your treatment with SPINRAZA is medically necessary, your coverage may still be denied. If your health plan denies your PA or ME request, you can appeal. This may mean that you and your doctor’s office need to fill out paperwork and provide detailed documentation. You also need to communicate with your health plan(s).

age 2.5Infantile-onset(Type 1) SMAtreated withSPINRAZA

Sofia

Speak with your health plan. You have the right to know why your request was denied. Your plan will most likely tell you in writing why your coverage was denied and how you can appeal.

• Your coverage may be denied due to a billing, coding, or administrative error. If so, your doctor’s office may be able to resolve the issue without the necessity of a formal appeal. If this is the case, alert your FAM, who can follow up with your doctor’s office

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REQUESTING AN APPEAL

Depending on the state where you live and your health plan, there are typically 3 levels for appeal. You can choose to have the doctor’s office write an appeal letter to the health plan or write an appeal letter of your own. For more information, see the next section of this guide.

LEVELS IN THE APPEALS PROCESS

Level 1: Internal Appeal/Request for Reconsideration You or your doctor’s office may contact your health plan and request that it reconsider its decision. Your doctor may request to speak with the medical reviewer to resolve the issue.

External Independent ReviewIf you cannot resolve the denial with your health plan, you may have the right to request an independent third-party review. This means your health plan will no longer have the final say regarding your benefits and coverage. See below for information on the external appeals process.

Level 3:

Level 2: Internal Appeal/Medical DirectorYou or your doctor can request a second-level appeal. A medical director at your health plan who was not involved in the original decision usually reviews the second-level appeal.

In general, an internal appeal for a PA must be completed by a health plan within 30 days of a request. However, health plans vary; be sure to confirm the time frame with your health plan.

If you receive a denial for SPINRAZA, time is critical for an appeal to be submitted. Contact your FAM and doctor’s office right away for assistance.

If you or your loved one with SMA is facing an urgent health situation, you may request an expedited appeal and external review. Each state has different rules for this process. See page 29 in this section for more information on expedited appeals.


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HOW THE EXTERNAL REVIEW PROCESS WORKS

If your health plan denies your internal appeal, you can request an external review. An independent medical professional will review your case. The reviewer does not get any financial incentives to perform the review. Your health plan is required by law to accept the external reviewer’s decision.

To request an external review, you must file a written request within 60 days after your internal appeal is rejected. Some plans may allow you more time to file your request.

STANDARD EXTERNAL REVIEWS ARE DECIDED WITHIN 60 DAYS AFTER YOUR REQUEST IS RECEIVED BY YOUR HEALTH PLAN.

Know your rights for an external reviewHealth plans in all states must participate in an external review process.

STATE

Some states have an external review process that meets or exceeds the standards of the healthcare law. The health plans in these states will follow the state’s external review process. You will get all of the protections outlined in that process

Some states do not have an external review process that meets the minimum standards of the healthcare law. In these states, the federal government’s Department of Health and Human Services (HHS) will oversee the external review process

FEDERAL

Refer to the final denial letter sent to you by your health plan. This letter should tell you when you must make your request.


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What you can doProvide to your doctor’s office the EOB from your primary health plan about the SPINRAZA denial

• Your doctor’s office will need to provide the secondary plan with paperwork that shows that your primary plan denied coverage

Support your doctor’s office by calling your secondary plan and explaining your situation. Be sure to write down any information you get during this call, as well as who you spoke with. See the health plan call log on page 12 to help you take notes Remember to tell your doctor’s office or Biogen FAM about any information that may help with the coverage request for the secondary plan

IF COVERAGE WAS DENIED BY YOUR PRIMARY HEALTH PLAN AND YOU HAVE A SECONDARY HEALTH PLAN

Your secondary health plan may be an option if your primary health plan denied coverage for SPINRAZA. You and your doctor’s office can work together to advocate for coverage with the secondary plan.

You can choose to have the doctor’s office write an appeal letter to the health plan or you can write an appeal letter of your own. For more information, see the next section of this guide.

Claireage 19Later-onsetSMA (Type 2)treated with SPINRAZA


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 additional Important Safety Information on page 69 and accompanying full Prescribing Information. 28


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REQUESTING AN APPEAL WHEN YOUR HEALTH SITUATION IS URGENT

In urgent situations, you may ask for an external review at the same time as an internal review. This may help speed up the process. You can file an expedited appeal if you are currently receiving treatment and your doctor believes a delay would risk your life, affect your ability to regain maximum function, or subject you to severe pain. Your health plan must make a decision within 4 business days after your request is received.

WHERE TO FIND HELP WITH YOUR APPEAL

While you are working with your doctor’s office, you have several additional places to get help with filing a request for an appeal:

Patient advocateYou may request the help of a patient advocate to act on your behalf for a range of healthcare-related issues, including PAs and appeals. The Patient Advocate Foundation is a national nonprofit organization that helps patients settle issues with their insurers regarding access to care. Visit the Patient Advocate Foundation at www.patientadvocate.org.

State consumer assistance programSome states have consumer assistance programs to help with appeals or requests for external review. Your health plan’s letter denying your request for coverage should have the contact information for your state’s consumer assistance program. You can also call the insurance department in your state for this information.


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ENIEDSMA360° services from Biogen are available only to those who have been prescribed SPINRAZA. SMA360° is intended for US residents only.


Lauren

WHERE TO FIND HELP WITH YOUR APPEAL (cont’d)

Your employerIf your health plan is administered by your employer, your employer may be able to help you with requesting an appeal. Contact your human resources department for more information.

FAMs and SMA360° do not file appeals with health plans, but your FAM may be able to help you get started with your appeal. Call your FAM directly or SMA360° at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 AM to 8:00 PM.

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The most common side effects of SPINRAZA include lower respiratory infection, fever, constipation, headache, vomiting, 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. Before taking SPINRAZA, tell your healthcare provider if you are pregnant or plan to become pregnant.This information is not intended to replace discussions with your healthcare provider.Please see additional Important Safety Information on page 69 and accompanying full Prescribing Information.



SUGGESTIONS FOR WRITING YOUR LETTER

OF APPEAL

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

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age 19Later-onset(Type 2) SMA treated with SPINRAZA

Claire

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SUGGESTIONS FOR WRITING YOUR LETTER OF APPEAL

SECTION 4.

As mentioned earlier, you may also choose to write and submit your own letter of appeal to your health plan as a way to potentially reverse the denial of coverage. A letter from the patient or caregiver can have a meaningful impact with a health plan.

The outline on the next page can help you write and submit a letter to show your health plan why you or your loved one should be covered for treatment with SPINRAZA.

WHEN AND HOW SHOULD I SUBMIT MY LETTER OF APPEAL?

You can submit the letter to your health plan at any time during the appeals process, but it is suggested that you submit it before an external review is done. This is a review by a third party (see page 27).

Once your letter is written, it should be sent to your health plan. Check your denial letter to find out to whom you should send the letter and for any relevant deadlines.

A copy of your letter should also be provided to your prescriber so that he or she is aware of your communication with the plan. Your prescriber may also choose to make your letter a part of his or her appeal on your behalf.


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SAMPLE OUTLINE: SUGGESTIONS FOR WRITING YOUR LETTER OF APPEAL

Let the plan know that you are writing this letter to appeal the denial of coverage for SPINRAZA and ask the plan to reconsider this decision.

Begin with an explanation

If you are not the patient, explain your relationship to the patient (eg, caregiver, father, mother, etc). You may also wish to include the following:• A description of yourself or your loved one, including age, gender, and other details• A description of your family. If there is a family history of SMA, include that here• An overview of your or your loved one’s education and employment (if applicable)• A photo of you or your loved one (optional)

Provide a brief background of the patient

Let the health plan know• Age at which symptoms first appeared• Your genetic confirmation of the diagnosis• What symptoms were later found to be related to SMA but were not recorded.

These may include falling, walking too late, or trouble feeding• How your or your loved one’s SMA has worsened over time (give specific

examples and time frames)

Describe your or your loved one’s SMA

Here are some examples, but you may have others. • Bathing • Walking • Doing housework• Dressing • Shopping • Attendance in school or school activities• Grooming • Cooking • Ability to work or hold a job• Using the restroom • Eating and • Driving or using independently drinking public transportation

Describe how SMA has affected your or your loved one’s activities and daily tasks


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Give examples of how SMA has required you or your loved one to adapt

Include relevant information about• How caregivers and/or support people may be necessary for you or your loved one• Your or your loved one’s use of mobility devices, such as walkers or wheelchairs

Describe what you believe SPINRAZA has done, or could do, for you or your loved one

Give as much detail as possible. Describe• How SPINRAZA has helped, or could help, you or your loved one• Why SPINRAZA has been, or would be, important to you or your loved one• Specific examples of the impact the drug has made (if applicable)

Your FAM can provide assistance to you and your doctor’s office when filing an appeal. SMA360° does not file appeals with health plans. Call your FAM directly or SMA360° at 1-844-4SPINRAZA (1-844-477-4672), Monday through Friday, from 8:30 AM to 8:00 PM.


Conclude your letter

End your letter by• Summarizing your main points• Restating your request for the plan to reconsider its decision to deny coverage• Including your contact information


QUESTIONS TO ASK YOUR HEALTH PLAN

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QUESTIONS TO ASK YOUR HEALTH PLAN

SECTION 5.

This section may help you start a conversation with your health plan about your benefits for SPINRAZA. Use the lines below to fill in specific information that your health plan shares with you. You can refer to this section in follow-up discussions.

Representative name and ID number:

What does my plan cover for treatment with SPINRAZA? What does it not cover?

Will my plan cover a hospital stay or ancillary service, such as anesthesia, if needed?

Do I need a referral or prior authorization for treatment with SPINRAZA?

What will my doctor need to provide in order to receive approval for SPINRAZA?

Do I need to have SPINRAZA reauthorized after initial approval? When? How often?

What benefit exclusions apply to treatment with SPINRAZA?


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What restrictions are in place before I can get SPINRAZA?

What documentation needs to be provided?

What will be my out-of-pocket costs to pay for SPINRAZA? Deductibles? Copays? Out-of-pocket maximum?

What will be my out-of-pocket costs to pay for SPINRAZA administration? Deductibles? Copays? Out-of-pocket maximum?

I plan on receiving treatment with SPINRAZA at [name of SMA treatment center/name of facility]. Is this treatment center covered by my plan?

Treatment with SPINRAZA needs to be provided out of network and/or out of state. Will I be covered? What is the exception process?

If SPINRAZA is not covered for me, what is considered medically necessary for treatment with SPINRAZA? What supporting documents are required?

If coverage is denied, what is your appeals process?


WHAT TO CONSIDER WHEN CHOOSING A

HEALTH PLAN

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WHAT TO CONSIDER WHEN CHOOSING A HEALTH PLAN

SECTION 6.

WHAT YOUR HEALTH PLAN COVERS

Typically, health plans cover general categories of healthcare services. These include doctor visits, medical tests, and treatments. Each plan may have different rules about how SMA care is covered. Talk to your health plan about specifics.

WHAT DOCTORS, TREATMENT CENTERS, AND PHARMACIES ARE IN YOUR PLAN

Your health plan is likely to have a network of providers who have agreed to provide services to its members. The out-of-pocket cost for seeing an in-network provider is typically lower than out-of-network providers. In some cases, if you choose to see an out-of-network provider, you may be responsible for 100% of the provider’s bill. This depends on the type of coverage and the specifics of your plan.

People with Medicaid are often limited to seeing participating providers in their state. People who have Medicaid Managed Care plans might also be limited to seeing in-network providers within their state. Contact your state Medicaid office for more information.

People with SMA may have to travel long distances and/or out of state to access treatment centers that specialize in SMA. This means that these people will receive care from out-of-state or out-of-network providers. Generally, states must pay for the out-of-state services to the same extent that an in-state service would be paid if

You have an emergency

Your health would be endangered if you needed to travel back to your home state

Your state decides that the needed services are more easily available in another state

People in your area often use an out-of-state provider—for example, in areas that border another state


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WHAT YOU MAY PAY

Health plans take on a portion of the cost of medical care and medicines, but they don’t take on all of the costs. Often the patient must pay some of the cost. This is called cost sharing. The health plan pays a portion of the cost and shares the remaining cost with the patient.

There are several examples of cost sharing, including deductibles, coinsurance, and copayments. Some preventive services that you get with in-network providers do not require cost sharing. In addition, people who have Medicaid often pay a lower cost-sharing amount.

Where you can receive insurance counseling• Your FAM and LCM can counsel you and your family on changing or adding

insurance coverage

• In addition to support from SMA360°™,* there may be a patient relations point of contact at your doctor’s office who can provide insurance counseling

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


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YOUR HEALTH PLAN OPTIONS

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YOUR HEALTH PLAN OPTIONS

SECTION 7.

There are many different types of health plan options that may help cover some or most of the cost of SPINRAZA treatment. They may provide different levels of coverage and operate in different ways.

There are 2 main types of health insurance available in the United States:

This section gives you an overview of the different types of health insurance.

Commercial health insurance includes private insurance plans provided by employers and unions. You may also

purchase commercial health plan coverage through firms or the

NAVIGATING INSURANCE AND SUPPORT PROGRAMS FOR … · 55 SMA360° can provide support throughout the...

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