Help from prescription to treatment

From the moment your doctor prescribes Acthar, you’ll be supported every step of the way. To begin the process, an Acthar Case Manager will call to get you started and provide an overview of the process for obtaining Acthar.

Here’s how it works:

Your doctor sends your Acthar prescription to the Acthar Hub and a personal Case Manager is assigned to support you throughout the approval process.

Your Case Manager works with your doctor and insurance company to determine your eligibility for coverage and work through any plan requirements and/or approvals.

You may receive calls from your Case Manager to request additional information and to provide you with status updates about your prescription for Acthar.

The Specialty Pharmacy calls you to schedule delivery of your medication and track the shipment.

Acthar is delivered right to your door.

The Acthar Hub is a resource provided by Mallinckrodt Pharmaceuticals that:

  • Works with your doctor and insurance company to determine your eligibility for coverage, and works through any plan requirements and/or approvals for Acthar
  • Provides information on financial assistance options
  • Can provide you with injection training in your home, online, or over the phone
  • Is available at 1-888-435-2284 Monday through Friday from 8 am to 9 pm ET, and Saturday from 9 am to 2 pm ET 

After you have been prescribed Acthar:

  • You receive a welcome call from your Case Manager at the Hub
  • Your Case Manager discusses the process for obtaining insurance coverage, your co-pay or coinsurance, and injection training
  • An Acthar Welcome Letter and the Rheumatology Treatment Guide arrive at your home
  • Your Case Manager works with your doctor and insurance company to determine coverage. If you hear from your insurance company, please let your Case Manager know
    • Responding to the plan requirements may take some time, but your Case Manager will help you through this process

After you have been approved to start Acthar treatment:

  • Your Specialty Pharmacy calls to schedule delivery
    • You must confirm delivery timing with the Specialty Pharmacy to receive Acthar
  • An Acthar Starter Kit arrives at your home
  • Acthar is shipped to your home in a refrigerated container
    • A signature is required for delivery because someone must be available to place the Acthar vials in the refrigerator when they are received
  • A registered nurse can provide injection training in your home, online, or by phone to help you or your caregiver learn to inject Acthar. If you are interested in this service, which is offered at no cost to you, let your Case Manager know. He or she will work with your doctor on the request

Please note: If your doctor prescribes Acthar directly through a Specialty Pharmacy, the Acthar Hub will not receive your information. Please contact your doctor’s office to let them know that you would like to receive the services and support of the Acthar Hub. Alternatively, call 1-888-435-2284 Monday through Friday from 8 am to 9 pm ET, and Saturday from 9 am to 2 pm ET, to speak to a Case Manager about receiving Acthar Hub services.

Financial Assistance Options

If you have private insurance

If you have private or commercial insurance, you may be eligible for the Acthar Commercial Co-pay Program. It provides:

  • $0 co-pay for eligible patients*
  • Enrollment over the phone during the Acthar welcome call or anytime you are speaking with your Case Manager
  • Automatic processing by the Acthar Specialty Pharmacy with no attempt to collect a co-pay

 

  • The Acthar Commercial Co-pay Program provides drug co-pay assistance of up to $25,000 per calendar year for each eligible patient. This program is not for patients receiving prescription reimbursement under any federal-, state-, or government-funded insurance programs or where prohibited by law. Additional Terms and Conditions and eligibility criteria apply. Mallinckrodt ARD, Inc. reserves the right to terminate or modify this program at any time without notice.

If you have government insurance

If you have government insurance, you may be eligible to receive financial support through Independent Charitable Foundations:

  • Your Case Manager will provide information on Independent Charitable Foundations, fund availability, and contact information, and will let you know about documentation you may have to provide
  • Please note that you will be responsible for working with the Independent Charitable Foundations and applying for funding
  • Mallinckrodt does not determine Independent Charitable Foundations’ fund eligibility criteria, or have any influence over the patients chosen or types of assistance provided

If you do not have insurance

If you do not have insurance coverage, you may be able to receive financial support through the Acthar Patient Assistance Program:

  • Mallinckrodt provides Acthar at no cost to eligible patients with a valid, on-label prescription for Acthar who have no insurance, are underinsured, or are rendered uninsured
  • Your Case Manager will transfer you to the Acthar Patient Assistance Program to determine eligibility
  • This program is administered via a third-party organization

 

† Acthar Patient Assistance Program eligibility criteria:

  • Valid Acthar prescription for an FDA-approved indication
  • Permanent US resident
  • Household income at or below 700% of the Federal Poverty Level
  • Patients may be subject to random income verification to determine eligibility

 

Important safety information
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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 H.P. Acthar® Gel?
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Acthar is a prescription medicine for flares or on a regular basis (maintenance) in people with dermatomyositis or polymyositis (DM-PM).

Acthar is a prescription medicine for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus).

Acthar is a prescription add-on medicine for the 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 H.P. Acthar® Gel?

Acthar is a prescription medicine for flares or on a regular basis (maintenance) in people with dermatomyositis or polymyositis (DM-PM).

Acthar is a prescription medicine for flares or on a regular basis (maintenance) in people with systemic lupus erythematosus (lupus).

Acthar is a prescription add-on medicine for the 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 1-800-778-7898.

Please see full Prescribing Information