Starting patients on Acthar Gel

When prescribing Acthar Gel, there is an entire support team available through Mallinckrodt

The Acthar Gel support team includes the Acthar Sales Specialist, the Acthar Reimbursement Manager (ARM), and the Case Manager at the Acthar Hub, a no-cost resource for patients and healthcare professionals.

Request a rep Sales specialist

Acthar Sales Specialists provide clinical and promotional information, including tools and resources to support Acthar Gel treatment. They may provide contact information for other members of the Acthar Gel support team.

Checklist

ARMs provide dedicated access and reimbursement support to help healthcare professionals work through the reimbursement process. ARMs can provide tools, resources, and patient status updates in person.

Case manager icon

Case Managers support patients and healthcare professionals from a central location, the Acthar Hub. Patient support includes helping patients through the reimbursement process, providing information about financial assistance options, scheduling injection training, and coordinating home delivery of Acthar Gel with the Specialty Pharmacy. Support for healthcare professionals includes working with office staff to facilitate the insurance company approval process as well as providing ongoing assistance for patients.

 

Steps to follow after prescribing Acthar Gel

Clipboard

Step 1

Complete the Acthar Gel Start Form and fax it to the Acthar Hub at 1-877-937-2284.

Checkbox with the number 4

Step 2

The Acthar Hub faxes back a confirmation and contacts the office within 4 business hours to explain next steps, including prior authorization requirements.

Telephone

Step 3

The Acthar Hub may contact the office staff with questions. Responding in a timely manner helps ensure patients get Acthar Gel as soon as possible.

 

Help your eligible patients get 5 free vials* of Acthar Gel with the Commercial Starter Program

The Acthar Gel Ophthalmology Commercial Starter Program* is available for Acthar Gel–naive, commercially or privately insured patients who are prescribed Acthar Gel for an on-label ophthalmic indication. The program is free of charge and allows eligible patients quick access to therapy while you and the Acthar Gel support team work through the reimbursement process. Please see full Terms and Conditions below.

Eligibility

  • Therapy-naive commercially or privately insured patients
  • Valid on-label prescription for Acthar Gel

Steps

  • Submit both a Start Form and Commercial Starter Program Form to the Acthar Hub
  • Acthar Hub verifies commercial or private insurance
  • Commercial Starter Program Form is triaged to Specialty Pharmacy for fulfillment
  • Specialty Pharmacy contacts patient to schedule delivery
    • Upon receipt of the Start Form and the Commercial Starter Program Form, 1 vial will be shipped to the patient
    • Patient will continue to receive 1 vial at a time while the Acthar Hub is working through the benefits verification and approval process

Vial limitations

  • Provides a maximum of 5 vials per Acthar Gel referral
  • Patients may receive up to 3 additional vials if documentation is provided

*Acthar Gel Commercial Starter Program Terms and Conditions

To be eligible, patients need to be Acthar-naive, have a valid Acthar Gel prescription for an FDA-approved, on-label ophthalmic indication, and have verified commercial or private insurance. A patient who is participating in Medicare, Medicaid, or any government-funded healthcare plan is not eligible to participate in the Program. The Program is valid for one vial of Acthar Gel at a time as needed, up to five vials, prior to coverage approval by the patient’s insurance. The patient will no longer receive vials under the Program when the patient receives insurance approval, a final denial of coverage, or the fifth vial. The patient may receive up to an additional three vials if the prescriber provides documentation of need and the patient has not received a final determination from the insurance company. The patient agrees not to seek reimbursement from any third-party payor for all or any part of Acthar Gel dispensed pursuant to the Program. The Program is void where prohibited by law. Mallinckrodt reserves the right to rescind, revoke, or amend the Program at any time without notice. By participating in the Program, the patient agrees to these eligibility terms and conditions.

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INDICATION

Acthar® Gel (repository corticotropin injection) is indicated for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

Important Safety information

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

INDICATION

Acthar® Gel (repository corticotropin injection) is indicated for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

Important Safety information

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.