Getting Patients Started on SOLIRIS

Prescribing SOLIRIS

Healthcare providers must be REMS certified to prescribe SOLIRIS.

Access Support

Help your patients take advantage of Alexion’s optional patient support offerings through OneSource™, including the CoPay Program.

Ordering SOLIRIS

Alexion offers multiple options for ordering SOLIRIS.

Reimbursement

Helpful resources to support coding and billing for SOLIRIS for anti-AChR antibody-positive gMG.

Prescribing SOLIRIS

Get REMS Certified to Prescribe SOLIRIS

Because of the risk of meningococcal infections, SOLIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the SOLIRIS REMS, prescribers must enroll in the program.

HCPs who prescribe SOLIRIS must be specifically certified. Certification consists of reviewing REMS educational materials and enrolling in the SOLIRIS REMS. Click below to get certified or to learn more.

Additional resources to get started:

Healthcare Provider Starter Kit

A collection of helpful forms and guides to answer your questions, get your patients started, and provide them with education and support.

Patient-Doctor Discussion Guide

This guide helps to facilitate patient-doctor discussions regarding their anti-AChR antibody-positive gMG.

Download
SELECT IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Serious Meningococcal Infections
REMS

Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

Please see additional Important Safety Information for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections, below.

Access Support

OneSource™—A free, personalized patient support program offered by Alexion

Whether a patient has been newly diagnosed or has had their condition for years, our specialists will be by your side. We can help make sense of health insurance coverage, answer questions about treatment with SOLIRIS® (eculizumab), and foster connections to community resources.

With our experience and resources, we’re here to help you and your patients feel supported every step of the way. Here’s an overview of the services we offer.

Education

When your patients have questions about their condition or treatment with SOLIRIS, we’ll work to help find them answers.

Health insurance navigation

Health insurance can be complicated for your patients to navigate, so we’re here to help them make sense of it all.

Community connections

With OneSource™ by their side, your patients will never have to go it alone. We can help connect them with others in the rare disease community who understand their experience.

Ongoing support

Living with anti-AChR antibody-positive gMG can be overwhelming. OneSource™ can help your patients and provide the support they need.

The Alexion OneSource™ CoPay Program may help patients pay for eligible out-of-pocket medication and infusion costs.

The Alexion OneSource™ CoPay Program ("Program") pays for eligible out-of-pocket medication and infusion costs, where applicable, associated with qualifying Alexion products ("Qualifying Products") up to $15,000 US dollars per calendar year. This program is valid ONLY for patients with commercial insurance who have a valid prescription for a US Food and Drug Administration-approved indication for a qualifying Alexion product. By participating in the Program, participants acknowledge that they understand and agree to comply with the complete terms and conditions, available at AlexionOneSource.com/CoPay.

There are two ways for your patients to fill out the START Form:
PDF Download

Completed forms should be emailed to onesource@alexion.com or faxed to 1-800-420-5150

 

Additional resources to get started:

Common Prior Authorization Criteria

A summary of common prior authorization criteria for the anti-AChR antibody-positive gMG indication.

Sample Letters and Tips

A sample letter that may be used as a guide when drafting an appeal to a patient’s health insurance plan as well as a sample letter that explains why the drug is medically necessary.

Clinical Reference Library

A repository overview inclusive of high-quality references and other evidence available in the public domain.

Download

Ordering

Call to Place an Order

Your Alexion customer operations representative can help streamline the ordering process.

888-SOLIRIS (888-765-4747).

The representative will be able to identify an authorized distributor to coordinate delivery.

RECEIPT & STORAGE OF SOLIRIS1

All SOLIRIS orders are shipped overnight by a cold chain shipper.

  • Store SOLIRIS vials refrigerated at 2°-8° C (36°-46° F) in the original carton to protect from light until time of use
  • SOLIRIS vials may be stored in the original carton at controlled room temperature (not more than 25° C/77° F) for only a single period up to 3 days
  • Do not use beyond the expiration date stamped on the carton
  • Refer to section 2: Dosage and Administration of the SOLIRIS Prescribing Information for more information for stability and storage of diluted solutions of SOLIRIS
  • DO NOT FREEZE
  • DO NOT SHAKE
  • Please see section 16: How Supplied/Storage and Handling in the SOLIRIS Prescribing Information for more information

Reimbursement

Download our Coding & Billing Guide

SOLIRIS Coding and Billing Guide provides helpful information about patient access processes, coding, and billing for SOLIRIS to support reimbursement of claims related to the treatment of adult patients with anti-AChR antibody-positive gMG.

Claims Support

Please contact your field reimbursement manager or call Alexion OneSource™ for support with claims issues.

888-765-4747

See Other Resources

Discover additional tools to help you and your patients.

View all resources
Warning: Serious Meningococcal Infections
Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early.
  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection).
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.
Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.

Contraindications

  • Patients with unresolved serious Neisseria meningitidis infection
  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection

Warnings and Precautions

Serious Meningococcal Infections

Risk and Prevention

The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis).

Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

REMS

Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

Other Infections

Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Use caution when administering Soliris to patients with any systemic infection.

Infusion-Related Reactions

Administration of Soliris may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥10%) is: musculoskeletal pain.

Indication

Generalized Myasthenia Gravis (gMG)

Soliris is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see full Prescribing Information for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections.

Warning: Serious Meningococcal Infections
Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris and may become rapidly life-threatening or fatal if not recognized and treated early.
  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection. (See Serious Meningococcal Infections for additional guidance on the management of the risk of meningococcal infection).
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.
Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.

Contraindications

  • Patients with unresolved serious Neisseria meningitidis infection
  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection

Warnings and Precautions

Serious Meningococcal Infections

Risk and Prevention

The use of Soliris increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis).

Vaccinate or revaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If Soliris must be initiated immediately in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide 2 weeks of antibacterial drug prophylaxis. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

REMS

Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

Other Infections

Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported.

Patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Use caution when administering Soliris to patients with any systemic infection.

Infusion-Related Reactions

Administration of Soliris may result in infusion-related reactions, including anaphylaxis or other hypersensitivity reactions. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥10%) is: musculoskeletal pain.

Indication

Generalized Myasthenia Gravis (gMG)

Soliris is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Please see full Prescribing Information for SOLIRIS, including Boxed WARNING regarding serious meningococcal infections.

Reference:

  1. SOLIRIS. Prescribing information. Alexion Pharmaceuticals, Inc.