ACTEMRA Coverage

Benefits Investigations

Genentech Rheumatology Access Solutions can conduct a benefits investigation (BI) to help you determine if a Genentech medicine is covered, if prior authorizations (PAs) are required, which specialty pharmacy (SP) the health insurance plan prefers and if patient assistance might be needed.

Potential outcomes of a BI:

  • Treatment is covered
  • PA is required
  • Treatment is denied

A BI may be initiated once the SMN and PAN are submitted to Genentech Rheumatology Access Solutions.

These can be downloaded from Forms and Documents or submitted online via My Patient Solutions. Be sure to specify on the SMN whether the BI should be done for ACTEMRA intravenous (IV), subcutaneous (SC) or both formulations.

The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and health care provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.

Prior Authorization

Genentech Rheumatology Access Solutions can help you identify if a prior authorization (PA) is necessary and offer resources as you obtain it for your patient. PA support may be provided once the SMN and PAN are submitted to Genentech Rheumatology Access Solutions.

If your patient’s request for a PA is not granted, your Immunology Field Reimbursement Manager (IFRM) or Genentech Rheumatology Access Solutions Specialist can work with you to determine your next steps. You can find more tips like this in Forms and Documents.

The completion and submission of coverage- or reimbursement-related documentation are the responsibility of the patient and health care provider. Genentech makes no representation or guarantee concerning coverage or reimbursement for any service or item.

RSVP for ACTEMRA for Intravenous (IV) Infusion

When a medical treatment is authorized for a limited period of time, it will generally require reverification for coverage of continued treatment. Genentech Rheumatology Access Solutions can help you obtain reverification for your patients.

Each year, you will receive a list of the ACTEMRA patients you have referred to Genentech Rheumatology Access Solutions. You must review and select the patients for whom you wish to have a BI completed and send the list back to us. If you do not wish to use this service, you may opt out by checking the box on the enrollment form or by calling us directly.

You can download the enrollment form from Forms and Documents.

ACT Fast Program

With the ACT Fast Program, eligible patients taking ACTEMRA may receive free medicine while awaiting an insurance coverage determination.

If you think your patient qualifies for the ACT Fast Program, submit the completed SMN and PAN to Genentech Rheumatology Access Solutions.

Eligible patients can receive a 14-day supply of ACTEMRA every two weeks for up to 6 months. Once coverage has been determined, the patient no longer qualifies for the ACT Fast Program.

PAN=Patient Authorization and Notice of Request for Transmission of Health Information to Genentech Access Solutions and Genentech® Access to Care Foundation.

SMN=Statement of Medical Necessity.

Important Safety Information & Indication

Indication

ACTEMRA is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).

ACTEMRA is indicated for the treatment of giant cell arteritis (GCA) in adult patients.

ACTEMRA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.

Important Safety Information

BOXED WARNING and Additional Important Safety Information

RISK OF SERIOUS INFECTIONS:

Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt ACTEMRA until the infection is controlled.

Reported infections include:

  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA use.
  • Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral and other infections due to opportunistic pathogens.

The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ACTEMRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

ACTEMRA is contraindicated in patients with known hypersensitivity to ACTEMRA.

Other serious or potentially life-threatening adverse reactions that have been reported in clinical trials with ACTEMRA include gastrointestinal perforations. Use ACTEMRA with caution in patients who may be at risk for GI perforations.

Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests. 

Hypersensitivity reactions, including anaphylaxis and death, have occurred.

  • If anaphylaxis or other hypersensitivity reaction occurs, stop administration of ACTEMRA immediately and discontinue ACTEMRA permanently.

Avoid use of live vaccines concurrently with ACTEMRA, as clinical safety has not been established.

Other potential risks of ACTEMRA include demyelinating disorders and malignancies. Treatment with ACTEMRA is not recommended in patients with active hepatic disease or hepatic impairment.

Most common adverse reactions (≥ 5%) include upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions (SC only). 

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see accompanying full Prescribing Information, including BOXED WARNING, for additional important safety information.