About XOLAIR® Access Solutions™: Roles and Responsibilities

The chart below shows how health care providers, patients, specialty pharmacies and the experts at XOLAIR Access Solutions can work together to help patients obtain coverage for XOLAIR® (Omalizumab) for Subcutaneous Use:

The health care provider Patient The specialty pharmacy XOLAIR Access Solutions
  • Assesses patient and determines treatment
  • In most cases, enrolls patient with XOLAIR Access Solutions
  • May work directly with specialty pharmacies and distributors that dispense XOLAIR
  • Can enroll with XOLAIR Access Solutions directly but is usually referred by a health care provider
  • Can contact XOLAIR Access Solutions to find out the status of their case
  • Will work with the specialty pharmacy or distributor once monthly shipments have been approved by their health insurance plan
  • Should continue to contact their health care provider for questions regarding their XOLAIR therapy and diagnosis
  • Can contact XOLAIR Access Solutions about co-pay assistance if necessary
  • May be eligible for referral to the Genentech® Access to Care Foundation if uninsured or underinsured
  • Confirms in-network status and patient benefits. If the specialty pharmacy or distributor is out of network (i.e., has no contract with the health insurance plan), the patient will be referred to an appropriate specialty pharmacy or to XOLAIR Access Solutions
  • Stocks XOLAIR to provide quick access to the prescription
  • May also contact patients to ensure that the medication is being dosed properly and to answer injection questions
  • May assist with insurance changes or recertification in many cases
  • Works with patients, doctors and specialty pharmacies or distributors to provide reimbursement information
  • Assesses the patient's benefits and prior authorization requirements
  • Provides information regarding which specialty pharmacies and distributors are contracted with the payer
  • Refers the case to an appropriate specialty pharmacy or distributor
  • May make referrals of patients to independent, non-profit organizations that provide co-pay assistance
  • May make referrals of uninsured and underinsured patients to the Genentech Access to Care Foundation

XOLAIR (Omalizumab) for Subcutaneous Use Indication

XOLAIR is indicated for adults and adolescents (12 years of age and older) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with ICS. XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions.

WARNING

Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, patients should be closely observed for an appropriate period of time after XOLAIR administration, and health care providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Patients should also be informed of the signs and symptoms of anaphylaxis and instructed to seek immediate medical care should symptoms occur (see WARNINGS, and PRECAUTIONS, Information for Patients).

XOLAIR Safety Information

  • XOLAIR should only be administered in a health care setting by health care providers prepared to manage anaphylaxis that can be life- threatening.
  • XOLAIR should not be administered to patients who have experienced a severe hypersensitivity reaction to XOLAIR (see Boxed WARNING). XOLAIR should be discontinued in patients who experience a severe hypersensitivity reaction.
  • Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR- treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of asthma and other allergic disorders.
  • Patients should be given and instructed to read the Medication Guide before starting treatment and before each subsequent treatment.
  • Patients receiving XOLAIR should be told not to decrease the dose of, or stop taking any other asthma medications unless otherwise instructed by their physician.
  • The adverse reactions most commonly observed among patients treated with XOLAIR in clinical studies included injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in XOLAIR-treated patients and control patients.

Please see full Prescribing Information, including Boxed WARNING and Medication Guide, for additional Important Safety Information.

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