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Intended for US patients and caregivers
For Healthcare Professionals
Getting Your Prescription and
Starting Acthar

Because the way you get specialty medicines Specialty Medicines Specialty medicines treat a rare disease or a chronic condition. Specialty medicines may require special storage or handling, and may be part of a treatment plan that includes many other medicines. like Acthar® Gel (repository corticotropin injection) is different than going to your neighborhood drug store, we know you may have questions about how it works.

From the time your doctor writes your prescription for Acthar to the time the medicine is delivered to your doorstep, Acthar Patient Support is by your side every step of the way.

Number 1 Prescription

Your doctor prescribes Acthar for you. Your doctor’s office then submits your prescription to Acthar Patient Support. Once the prescription is submitted by your doctor, Acthar Patient Support will review your insurance coverage. Often, insurance companies require your doctor to complete an additional step known as a prior authorization Prior Authorization A prior authorization is a way insurance companies make sure that the medicine your doctor has prescribed is medically necessary for your condition. before approving the medicine.

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Number 2 Prior Authorization and Appeals

If you have insurance, Acthar Patient Support works with your insurance company. A prior authorization is a way insurance companies make sure that the medicine your doctor prescribed is needed for your condition. Acthar Patient Support will collect the required paperwork from your doctor and submit the information to your insurance company – you don’t have to manage the process. Your Case Manager will provide you with updates on the status of the approval process so you know what’s going on every step of the way.

Appeals process

While Acthar may be denied for insurance coverage for any number of reasons, it’s common to feel upset or frustrated. However, you can appeal Appeal You and your doctor work together (with the help of Acthar Patient Support) to request the insurance company reconsider its decision. this decision by the insurance company and there are many ways to approach an appeal. Acthar Patient Support can help you with the appeals process.

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Number 3 Assistance Options

Whether you have commercial insurance Commercial Insurance Health insurance that is provided by your employer, or bought by you. This includes any type of health insurance not provided by the government. or government insurance Government Insurance Insurance that is offered by the government, including Medicare, Medicare D, Medicare Advantage Plans, Medicaid plans (including Medicaid patients enrolled in a qualified health plan purchased through a health insurance exchange, TRICARE, Department of Defense (DOD), or Veterans Affairs (VA)). , we will guide you through the potential financial assistance options and programs that may be available to you and that you may qualify for. We want you to have access to your prescribed treatment.

If you have commercial insurance, assistance may be available through the Commercial Co-pay Program (Terms and Conditions below). You can work with your Case Manager to enroll in the program if you’re eligible.

If you have commercial insurance, assistance may be available through the Commercial Co-pay Program (Terms and Conditions below). You can work with your Case Manager to enroll in the program if you’re eligible.

Many commercial insurance plans cover Acthar, but if your insurance company won’t cover it or if you’ve had a change in your insurance coverage, you may be eligible for assistance. Your Case Manager can better help you understand your options and connect you with the appropriate resources.

If you have government insurance, Acthar Patient Support will help you understand your options for financial assistance.

Learn more about potential financial assistance options

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Number 4 Free, One-on-One Injection Training

Learning how to take or give Acthar is personal. That’s why Acthar Patient Support offers free, one-on-one injection training that’s based on your level of needs.

While your prescription is in the approval process, we’ll contact you to discuss your training needs and how best to accomplish them—in your home, online, or by phone. Then we will coordinate training with a nurse educator to help you get started.
See Step-by-Step Injection Training Guide in the Resources section.

Graphic representing injection training

At no additional cost to you, training will be provided by a licensed nurse educator in your area who will:

  • Review the materials needed—needles, syringes, alcohol wipes, etc
  • Show you or your care partner how and where to inject Acthar
  • Explain how to store Acthar and dispose of used needles and syringes
  • Answer any questions about how to inject Acthar
  • Come back to make sure your injections are going well. The nurse will come to visit you up to 3 times so that you have full confidence in taking Acthar.

Interested in injection training?

Your Nurse Navigator will be happy to assist. 1-888-435-2284

Monday through Friday, 8 AM to 9 PM ET

Number 5 Delivery

Acthar is delivered by your Specialty Pharmacy. Acthar Patient Support works with your Specialty Pharmacy Specialty Pharmacy A Specialty Pharmacy coordinates the delivery of specialty medicines that have specific shipping requirements, like the refrigeration that is required for Acthar. to begin the delivery process so you don't have to. After approval, someone from your Specialty Pharmacy will contact you to set up your delivery of Acthar.

The delivery process:

  • Your Case Manager will let you know when your prescription is approved
  • Your Specialty Pharmacy will call you to arrange a shipment for a delivery time when someone will be able to sign for, receive, and immediately refrigerate the medicine
  • It is important that you answer any calls from 1-800, 1-888, 1-877, 1-844, 1-855, or blocked callers because your Specialty Pharmacy may call from those types of numbers If you miss the call, call back as soon as possible to ensure your medicine will be sent to you
  • Acthar is shipped to your home in a refrigerated container A signature is required for delivery because someone must be available to put the medicine in the refrigerator as soon as it is received
  • The package arriving from your Specialty Pharmacy will contain prescribing information for Acthar, Acthar vial(s), syringes and needles, disposal instructions, and contact information for the Specialty Pharmacy
It is important to answer 1-800 calls because they may be from the Specialty Pharmacy
It’s important to answer 1-800 calls because they may be from the Specialty Pharmacy.

Acthar Commercial Co-pay Program Terms and Conditions:

  • Patient must have a valid Acthar® Gel prescription for an FDA-approved, on-label indication.
  • Patient must be a permanent US resident. Offer is good only in the United States and US Territories.
  • Patient (or patient’s legal representative) must be 18 years of age or older to opt into program.
  • This program is valid for eligible privately and commercially insured patients.
  • This program is not valid for patients covered by Medicare, Medicare D, Medicare Advantage Plans, Medicaid plans (including Medicaid patients enrolled in a qualified health plan purchased through a health insurance exchange [marketplace], TRICARE, Department of Defense (DOD), Veterans Affairs (VA)), or any other state or federal medical or pharmacy benefit program.
  • The Acthar Commercial Co-pay Program provides drug co-pay assistance of up to $25,000 per calendar year for each eligible patient.
  • The program covers out-of-pocket costs for Acthar® Gel only. The program will not and shall not be applied toward the cost of any other product, healthcare provider service, supply charges or other treatment costs.
  • This program does not constitute prescription drug coverage or insurance and is not intended to substitute for such coverage. This program is not valid for uninsured patients and cannot be used as primary insurance.
  • The offer is not valid for drug costs that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs, which reimburse you for the entire cost of your prescription drugs.
  • Enrollment in the co–pay assistance program does not guarantee assistance. Whether an expense is eligible for the copay benefit will be determined at the time the benefit is paid. Eligible co-pay expenses must be in connection with a separately paid claim for Acthar® Gel which is otherwise covered by a private/commercial insurance plan.
  • If your insurance status changes, you must notify us prior to fulfilling your next prescription of Acthar® Gel.
  • This program offer is limited to 1 membership per person and is not transferable and cannot be combined with any other co-pay assistance program, free trial, discount, prescription savings card, or other offer.
  • Patients should consult their insurance provider concerning any limitations that may apply to this program under their insurance policy. Patients are responsible for any co-payment or coinsurance costs above and beyond the program’s annual maximum benefit.
  • The program is not available where prohibited by law.
  • Mallinckrodt reserves the right to rescind, revoke, or amend the co-pay assistance program at any time without notice.
  • Patient will be subject to ineligibility from the Program for violation of these Terms & Conditions.
You Are Your Own Best Advocate

We’re here to help guide you if your insurance company denies your prescription.

Let Your Voice Be Heard
Resources for you

Resources for You

Videos and materials to support you as you learn how to take Acthar.

View Resources

Need support now?

Acthar Patient Support is available at
1-888-435-2284

Monday through Friday, 8 AM to 9 PM ET

Saturday, 9 AM to 2 PM ET

 
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What is Acthar Gel?

Acthar® Gel (repository corticotropin injection) is used for:

  • The reduction of proteinuria in people with nephrotic syndrome of the idiopathic type (unknown origin) without uremia (accumulation of urea in the blood due to malfunctioning kidneys) or that due to lupus erythematosus (lupus)
  • Treatment of infantile spasms in infants and children under 2 years of age
  • Treatment for adults with acute relapses or flares of multiple sclerosis (MS). Studies have shown Acthar Gel to be effective in speeding recovery from an MS relapse. However, there is no evidence that Acthar affects the ultimate outcome or natural history of the disease
  • Treatment of severe acute and chronic allergic and inflammatory conditions affecting different parts of the eye. This can include the front part of the eye such as the cornea and iris, or the back part of the eye such as the optic nerve and retina
  • Treatment for people with symptoms of sarcoidosis
  • Treatment for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus)
  • Treatment for flares or on a regular basis (maintenance) in people with systemic dermatomyositis or polymyositis (DM-PM)
  • Adjunctive therapy for short-term administration (to tide patients over an acute episode or exacerbation) in: psoriatic arthritis (PsA); rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis

Acthar is injected beneath the skin or into the muscle.

IMPORTANT SAFETY INFORMATION

DO NOT take Acthar until you have talked to your doctor if you have any of the following conditions:

  • A skin condition called scleroderma
  • Bone density loss or osteoporosis
  • Any infections, including fungal, bacterial, or viral
  • Eye infections, such as ocular herpes simplex
  • Had recent surgery
  • Stomach ulcers or a history of stomach ulcers
  • Heart failure
  • Uncontrolled high blood pressure
  • Allergies to pig-derived proteins
  • Have been given or are about to receive a live or live attenuated vaccine
  • Suspected congenital infections (in children under 2 years of age)
  • If you have been told that you have Cushing’s syndrome or Addison’s disease

Tell your doctor about any other health problems that you have. Give your doctor a complete list of medicines you are taking. Include all nonprescription medicines, vitamins, and herbal supplements that you are taking.

What is Acthar Gel?

Acthar® Gel (repository corticotropin injection) is used for:

  • The reduction of proteinuria in people with nephrotic syndrome of the idiopathic type (unknown origin) without uremia (accumulation of urea in the blood due to malfunctioning kidneys) or that due to lupus erythematosus (lupus)
  • Treatment of infantile spasms in infants and children under 2 years of age
  • Treatment for adults with acute relapses or flares of multiple sclerosis (MS). Studies have shown Acthar Gel to be effective in speeding recovery from an MS relapse. However, there is no evidence that Acthar affects the ultimate outcome or natural history of the disease
  • Treatment of severe acute and chronic allergic and inflammatory conditions affecting different parts of the eye. This can include the front part of the eye such as the cornea and iris, or the back part of the eye such as the optic nerve and retina
  • Treatment for people with symptoms of sarcoidosis
  • Treatment for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus)
  • Treatment for flares or on a regular basis (maintenance) in people with systemic dermatomyositis or polymyositis (DM-PM)
  • Adjunctive therapy for short-term administration (to tide patients over an acute episode or exacerbation) in: psoriatic arthritis (PsA); rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis

Acthar is injected beneath the skin or into the muscle.

What is the most important information I should know about Acthar?

  • Never inject Acthar directly into a vein
  • Always inject Acthar beneath the skin or into the muscle
  • Follow your doctor’s instructions for injecting Acthar
  • Never stop treatment suddenly unless your doctor tells you to do so
  • Try not to miss any scheduled doctor’s appointments. It is important for the doctor to monitor you while taking Acthar

Acthar and corticosteroids have similar side effects.

  • You may be more likely to get new infections. Also, old infections may become active. Tell your doctor if you see any signs of an infection. Contact your doctor at the first sign of an infection or fever. Signs of infection are fever, cough, vomiting, or diarrhea. Other signs may be flu or any open cuts or sores
  • When taking Acthar long term, your adrenal gland may produce too much of a hormone called cortisol. This can result in symptoms of Cushing’s syndrome. This may cause increased upper body fat, a rounded “moon” face, bruising easily, or muscle weakness
  • Sometimes when you stop taking Acthar long term, your body may not produce enough natural cortisol. This is called “adrenal insufficiency.” Your doctor may prescribe a steroid medicine to protect you until the adrenal gland recovers
  • You might develop high blood pressure, or retain too much fluid. As a result of this, your doctor may recommend some changes to your diet, such as eating less salt and taking certain supplements
  • Vaccines may not work well when you are on Acthar. Talk to your doctor about which vaccines are safe to use when you are taking Acthar
  • Acthar may hide symptoms of other diseases. This can make it more difficult for your doctor to make a diagnosis if something else is going on
  • Stomach or intestinal problems. Acthar may increase the risk of bleeding stomach ulcers. Tell your doctor if you have stomach pains, bloody vomit, bloody or black stools, excessive tiredness, increased thirst, difficulty breathing, or increased heart rate
  • Taking Acthar can make you feel irritable or depressed. You may also have mood swings or trouble sleeping
  • If you have other conditions, such as diabetes or muscle weakness, you may find they get worse
  • You might develop certain eye conditions, such as cataracts, glaucoma, or optic nerve damage
  • Your body may develop allergies to Acthar. Signs of allergic reaction are:
    • Skin rash and itching
    • Swelling of the face, tongue, lips, or throat
    • Trouble breathing
  • Long-term Acthar use can affect growth and physical development in children. This can be reversed when Acthar is no longer needed
  • Acthar may cause osteoporosis (weak bones)
  • Acthar might harm an unborn baby. Therefore, tell your doctor if you are pregnant or plan on becoming pregnant

What are the most common side effects of Acthar?

The most common side effects of Acthar are similar to those of steroids. They include:

  • Fluid retention
  • High blood sugar
  • High blood pressure
  • Behavior and mood changes
  • Changes in appetite and weight

Specific side effects in children under 2 years of age include:

  • Increased risk of infections
  • High blood pressure
  • Irritability
  • Symptoms of Cushing’s syndrome
  • Thickening of the heart muscle (cardiac hypertrophy)
  • Weight gain

The above side effects may also be seen in adults and children over 2 years of age.

These are not all of the possible side effects of Acthar.

Tell your doctor about any side effect that bothers you, or that does not go away. Call your doctor or pharmacist for medical advice about side effects. You may report side effects to the FDA. Call 1-800-FDA-1088 or visit www.fda.gov/medwatch. You may also report side effects by calling 1-800-844-2830.

Please see full Prescribing Information for additional Important Safety Information.

For parents and caregivers of IS patients, please also see Medication Guide.