Reimbursement and Support

Overview of A.S.A.P. Support Options

The Acthar Support & Access Program helps patients get started with Acthar

Created and sponsored by Mallinckrodt at no cost to your patients, the Acthar Support & Access Program (A.S.A.P.) is a resource staffed with reimbursement experts who provide help with getting Acthar to your patients quickly and at the lowest possible cost based on their insurance coverage. A.S.A.P. can also coordinate home injection training services at your request. Review the below information to learn more about what A.S.A.P. offers. For any additional questions, please contact A.S.A.P.

Insurance Coverage

Co-pay Assistance

Delivery

Home Injection Training

Insurance Coverage

  • Most insurance plans cover Acthar
  • If a plan does not cover Acthar, or if your patients are uninsured or underinsured, they may be eligible for Mallinckrodt’s patient assistance program at no cost to them*

Co-pay Assistance

  • A.S.A.P. can help identify financial assistance for patients who have been prescribed Acthar. Full co-pay coverage may be available for qualified patients

Delivery

  • The Acthar prescription and all necessary injection supplies are shipped directly to your patient's home from the Specialty Pharmacy
  • Real-time tracking is available

Home Injection Training

*Program administered via a third-party organization.

Programs administered via an independent charitable organization.

Getting started is easy

Step 1

Your office downloads, completes, and faxes the Referral/Prescription Form to A.S.A.P. at 1-877-937-2284.

Download the Referral/Prescription Form or ask your Acthar Specialty Sales Consultant.

Step 2

A.S.A.P. faxes back a confirmation and contacts your office within 2 hours.

Step 3

A.S.A.P. may contact you with questions. Responding in a timely manner helps ensure your patients get Acthar as soon as possible.

If you have any questions, contact Acthar Support & Access Program (A.S.A.P.):

PHONE: 1-888-435-2284

FAX: 1-877-937-2284

A.S.A.P. will keep you and your patients informed about the delivery status of their Acthar prescription.

Commercial Co-pay Program

$0 co-pays for eligible patients with commercial or private insurance

Eligible patients with commercial or private insurance may receive the following benefits:

  • $0 co-pay per dispense of Acthar
  • Streamlined enrollment during the Acthar Welcome Call
  • Automatic processing by the Specialty Pharmacy

Talk to your patients about the Acthar Co-pay Assistance Program. Let them know to expect a call from the Acthar Support & Access Program (A.S.A.P.) team to discuss program eligibility.

Patients who do not qualify can call A.S.A.P. toll-free at 1-888-435-2284 for help identifying financial assistance through third-party programs and resources.

Terms and Conditions:

  • The Acthar Commercial Co-pay Assistance Program provides drug co-pay assistance of up to $25,000 per calendar year for eligible patients
  • This program is valid for eligible, privately and commercially insured patients. For more details about the eligibility criteria, see below
  • This program is not valid for prescriptions for which payment may be made in whole or in part under federal or state health programs, including but not limited to Medicare or Medicaid
  • This program is not valid for uninsured patients
  • Program offer is limited to one membership per person and is not transferrable
  • Patients should consult their insurance provider concerning any limitations that may apply to this program under their insurance policy
  • The program does not represent prescription drug coverage or insurance and is not intended to substitute for such coverage
  • Patients are responsible for any co-payment or coinsurance costs above and beyond the program’s annual maximum benefit
  • Void where prohibited by law
  • Not valid outside the United States
  • Mallinckrodt ARD, Inc. reserves the right to terminate or modify this program at any time without notice

Eligibility Criteria:

  • Approved indication
  • US permanent resident
  • Patient (or patient’s legal representative) must be 18 years of age or older to opt in to program
  • Commercially or privately insured
  • Not insured by a federal or state healthcare plan or where prohibited by law

How to Get Acthar for Your Patients

Physician referrals

When filling out the Referral/Prescription Form, following these guidelines may help maximize success with the payer:

  • Be sure to include phone numbers for your direct office contact and backup office contact
  • Provide clinical documentation and copies of detailed patient charts/notes
  • Since Prior Authorizations are common, a Letter of Medical Necessity may be needed

If the referral is denied, you have the option to appeal through A.S.A.P.

  • If you receive a denial letter, or any correspondence directly from the payer, fax it to A.S.A.P. immediately
  • If the appeal process is unsuccessful, qualified patients will be referred to the Patient Assistance Program to receive Acthar at no cost*

If you have any questions about the Acthar referral process or the status of an existing referral, please call A.S.A.P. at 1-888-435-2284, Monday–Friday, 8 am–8 pm ET, or Saturday, 9 AM–2 PM ET.

*Program administered via a third-party organization.

For more information, please call the Acthar Support & Access Program (A.S.A.P.) at 1-888-435-2284, Monday–Friday, 8 am–8 pm ET, or Saturday, 9 AM–2 PM ET.

Home Injection Training Services (HITS)

Licensed nurses are available throughout the country to teach patients and caregivers how to self-inject Acthar in the privacy of their own home. Healthcare providers who think their patients can benefit from an in-home training session can request one through A.S.A.P.

Home Injection Training Services will be provided at no cost and are made available through support from Mallinckrodt.

Requesting Home Injection Training Services for your patient is easy

Step 1

Initial and date the Home Injection Training Services (HITS) section on the Referral/Prescription Form.

Step 2

Fax the Referral/Prescription Form as you normally would to the Acthar Support & Access Program (A.S.A.P.) at 1-877-937-2284.

Step 3

As soon as Acthar is ready for shipment from the Specialty Pharmacy to your patient’s home, the selected home health agency in your patient’s area will contact him or her to set up the injection training visit. During the training visit the nurse will:

  • Review the injection materials and supplies with your patient and his or her care partner
  • Prepare the medication and supplies for the Acthar injection
  • Demonstrate the injection process. (The nurse will show the patient how to extract the medication from the vial, and where to inject, but your patient or care partner will actually perform the injection—the nurse will not inject the patient)
  • Review proper disposal and storage procedures
  • Answer any questions about the injection

Frequently Asked Questions about Home Injection Training Services (HITS)

What qualifications must the nurse meet?
All of the nurses are carefully screened with background checks and investigations of credentials. They must maintain their professional licensing or certification, pass a thorough skills competency program, and participate in ongoing education programs. Additionally, the Acthar Support & Access Program (A.S.A.P.) will send Acthar-specific injection training guides and product information to the patient's home prior to the injection training visit as additional support for the nurse.
Are all injection supplies and equipment provided by the visiting nurse?
No. Your patient will receive Acthar and the necessary injection supplies from the Specialty Pharmacy as he or she normally would.
Does insurance pay for Home Injection Training Services?
Home Injection Training Services will be provided at no cost and are made available through support from Mallinckrodt.
How quickly will the injection services be scheduled?
Once your patient's Acthar prescription is ready to ship from the Specialty Pharmacy, the selected home health agency will work to schedule the visit at a time that is most convenient for your patient. Typically, injection training visits are scheduled within 48 hours from the time your patient receives his or her Acthar shipment from the Specialty Pharmacy. Staff from A.S.A.P. will help to guide and expedite this process.
Will the nurse give my patient an actual injection?
No. The visiting nurse will provide direction on how to self-inject Acthar and answer any questions your patient may have about the injection process, but will not actually perform the injection.
Who can my patient call if he or she has questions?
Acthar patients or their care partners can call the Acthar Support & Access Program at 1-888-435-2284, Monday–Friday, 8 AM–8 PM ET or Saturday, 9 AM–2 PM ET and ask for assistance with Acthar Home Injection Training Services.Acthar patients can also call ActharPACT (Patient & Acthar Coaching Team) at 1-877-546-PACT (1-877-546-7228).

ActharPACT (Patient & Acthar Coaching Team)

ActharPACT program information

Long-term support for your patients

As soon as you decide Acthar is right for your patient, use ActharPACT (Patient & Acthar Coaching Team) to help your patient manage symptomatic sarcoidosis. This service comes at no cost to your patient. Have them call the 24/7 hotline now at 1-877-546-PACT or direct them to sign up online.

ActharPACT connects your patient with a personal nurse coach who can:

  • Help them answer questions about Acthar
  • Talk with them about any concerns they may have
  • Help them problem-solve and stay motivated
  • Connect them with other useful resources

Your patient’s nurse coach will keep in touch with them throughout treatment. Calls can be as frequent or infrequent as they like. Your patient may also cancel this service at any time.

ActharPACT also provides other helpful resources:

  • Personalized follow-up materials with useful information about Acthar
  • Reminders
  • A 24/7 hotline to answer your questions

Important Safety Information

SEE More

Contraindications

  • Acthar should never be administered intravenously
  • Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar

Important Safety Information

CLOSE

Contraindications

  • Acthar should never be administered intravenously
  • Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of Acthar
  • Acthar is contraindicated where congenital infections are suspected in infants
  • Acthar is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origins

Warnings and Precautions

  • The adverse effects of Acthar are related primarily to its steroidogenic effects
  • Acthar may increase susceptibility to new infection or reactivation of latent infections
  • Suppression of the hypothalamic-pituitary-axis (HPA) may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g. trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA suppression after stopping treatment
  • Cushing’s syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms
  • Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Blood pressure, sodium and potassium levels may need to be monitored
  • Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy
  • Acthar can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Monitor for signs of bleeding
  • Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression, and psychosis. Existing conditions may be aggravated
  • Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis
  • Prolonged use of Acthar may produce cataracts, glaucoma and secondary ocular infections. Monitor for signs and symptoms
  • Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH activity
  • There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver
  • Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients
  • Decrease in bone density may occur. Bone density should be monitored for patients on long-term therapy
  • Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Adverse Reactions

  • Common adverse reactions for Acthar are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain
  • Specific adverse reactions reported in IS clinical trials in infants and children under 2 years of age included: infection, hypertension, irritability, Cushingoid symptoms, constipation, diarrhea, vomiting, pyrexia, weight gain, increased appetite, decreased appetite, nasal congestion, acne, rash, and cardiac hypertrophy. Convulsions were also reported, but these may actually be occurring because some IS patients progress to other forms of seizures and IS sometimes mask other seizures, which become visible once the clinical spasms from IS resolve

Other adverse events reported are included in the full Prescribing Information.

Please see full Prescribing Information.

Indication

H.P. Acthar® Gel (repository corticotropin injection) is indicated for symptomatic sarcoidosis.

References