XOLAIR Distribution

Specialty Pharmacies

XOLAIR Access Solutions works with specialty pharmacies (SPs) to help patients receive their medicines.

An SP may provide the following services:

  • Reimbursement resources
  • Clinical services to support patients throughout their treatment
  • The ability to manage the specialty handling and shipping needs linked with many specialty therapies

You can work with your preferred SP or contact XOLAIR Access Solutions to learn which SP the patient’s health insurance plan requires.

The SPs listed below are part of the XOLAIR Specialty Pharmacy Network chosen to dispense XOLAIR to your office.

Distributor Telephone Fax Web Orders
Absolute Pharmacy Care (Puerto Rico)* 787-892-8700 787-841-1149 www.absolutepharmacypr.com
AcariaHealth 800-511-5144 877-541-1503 www.acariahealth.com
Accredo Health Group 866-839-2162, Option 2 866-531-1025 www.accredo.com
Acro Pharmaceutical Services 800-906-7798 877-381-3806 www.acropharmacy.com
Aetna Specialty Pharmacy* 866-782-2779 866-329-2779 www.aetna.com/individuals-families/pharmacy/specialty-pharmacy.html
Amber Pharmacy 888-370-1724 877-645-7514 www.amberpharmacy.com
Aureus Health Services
(including Meijer SP)
844-428-7387 844-228-7387 www.aureushealthservices.com
Avella Specialty Pharmacy 877-546-5779 877-546-5780 www.avella.com
BannerHealth* 480-684-7070 N/A www.bannerhealth.com
BioScript* 902-422-8528 902-422-2619 www.bioscript.ca
BriovaRx Specialty Pharmacy 855-577-6313 866-876-8966 www.BriovaRx.com
Cardinal Health Specialty Pharmacy (Oncosource)* 888-662-6779 877-800-4790 https://chsprx.com/CHSPRx/Home/Index.aspx
Cigna Specialty Pharmacy* 800-835-3784 800-351-3616 www.cigna.com/specialty-pharmacy-services
Commcare Specialty Pharmacy* 877-203-7973 888-203-7980 www.commcarepharmacy.com
CVS Caremark Specialty Pharmacy 800-237-2767 800-323-2445 www.cvscaremarkspecialtyrx.com
Diplomat Pharmacy* 877-977-9118 800-550-6272 www.diplomatpharmacy.com
Exactus Specialty Pharmacy* 866-458-9246 866-458-9245 www.exactusrx.com
Heritage Biologics 1-855-937-7273   http://www.heritagebiologics.com/
Humana Pharmacy (aka Rightsource)* 800-486-2668 877-405-7940 www.humanapharmacy.com
Kroger Health SP (Formerly ModernHealth)
855.802.3230 888.315.3270 http://www.krogerspecialtypharmacy.com
MagellanRx (aka ICORE)* 866-554-2673 866-364-2673 www.magellanhealth.com
Maxor Specialty Pharmacy* 866-629-6779 866-217-8034 www.maxor.com
PerformRx* 800-555-5690 800-684-5504 www.performrx.com
Pharmacy Advantage* 800-456-2112 888-400-0109 www.pharmacyadvantagerx.com
Prime Therapeutics 855-457-0007 877-828-3939 www.primetherapeutics.com
Reliance Rx* 716-929-1000 716-532-7360 www.reliancerxsp.com
Special Care Pharmacy Services (Puerto Rico only) 877-899-8997 888-341-1586 www.scpspr.com
US Bioservices 888-518-7246 888-418-7246 www.usbioservices.com/payers/pharmacy-services
Walgreens Specialty Pharmacy 888-782-8443 866-677-6685 www.walgreens.com/pharmacy/specialtypharmacy.jsp

*These pharmacies are owned by specific payers and are available to dispense for their own plan members only.

We work with these specialty pharmacies to make patient and clinical support available to XOLAIR patients and their prescribers. Additional specialty pharmacies are available as well.

Genentech and Novartis Pharmaceuticals Corporation do not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item.

Buy and Bill

With buy and bill, the practice purchases the medication in advance, then bills the patient’s health insurance plan for reimbursement. The practice is responsible for storing and handling the drug as well as collecting the patient’s co-pay for both the drug and its administration. With buy and bill, practices can maintain a stock of the drug, giving them the flexibility to treat patients when clinically appropriate.

Genentech and Novartis AG have contracted with a network of authorized specialty distributors to service practices choosing to purchase XOLAIR through the buy and bill model. Customers can purchase XOLAIR through authorized specialty distributors and wholesalers that have made a commitment to product integrity. These partners have agreed to distribute only products purchased directly from Genentech and Novartis AG and not to distribute XOLAIR through secondary channels.

Distributor Telephone Fax Web Orders
ASD Healthcare (ABSG) 800-746-6273 800-547-9413 www.asdhealthcare.com/
Besse Medical (ABSG) 800-543-2111 800-543-8695 www.besse.com/
BioSolutions Direct (ABSG) 866-860-3565 888-899-0063 www.biosolutionsdirect.com/
Cardinal Specialty Distribution 855-855-0708 888-345-4916 specialtyonline.cardinalhealth.com
CuraScript Specialty Distribution (aka Priority Healthcare Distribution, Inc.) 877-599-7748 866-277-4024 www.curascriptsd.com
CVS Caremark 888-217-4240 800-323-2445 www.cvscaremarkspecialtyrx.com
McKesson Specialty Health 855-477-9800 800-289-9285 mscs.mckesson.com
Metro Medical (A Cardinal Health Specialty Solutions company; For community physicians only)
800-768-2002
615-256-2194
www.metromedicalorder.com
Morris & Dickson Specialty Distribution​ (MDSD) 800-710-6100 318-524-3096 mdspecialtydist.com
Oncology Supply (ABSG)
800-633-7555
800-248-8205
www.oncologysupply.com

 

We work with these authorized distributors to provide XOLAIR patients and their prescribers.

Genentech and Novartis Pharmaceuticals Corporation do not influence or advocate the use of any one specialty distributor or specialty pharmacy. We make no representation or guarantee of service or coverage of any item.

Spoilage Replacement Program

The Genentech Spoilage Replacement Program provides for replacement of infused, injected and self-administered products, which are prescribed and prepared for a labeled indication, yet not administered due to unforeseen patient clinical circumstances, subject to certain limitations and conditions set forth by Genentech. The purpose of the program is to support our commitment to protecting patient safety by preventing the use of spoiled, damaged or contaminated products.

Please contact Genentech Customer Service at (800) 551-2231 to submit a request for replacement of spoiled product or to obtain additional information about the Program.

To request replacement product:

  • Contact Genentech Customer Service at (800) 551-2231 to obtain the Genentech Spoilage Replacement Program Form
  • Complete the Genentech Spoilage Replacement Program Form and fax it back to Genentech Customer Service at (877) 329-6737 within 30 days of the spoilage event
  • The request may take up to 3 business days to review. If approved by Genentech, further instructions for returning product or completing a Certificate of Destruction will be provided
  • The spoiled product or completed Certificate of Destruction must be received by Genentech within 60 days of approval of the spoilage request  
    • Replacement product generally ships within 11 business days following receipt of the spoiled product or completed Certificate of Destruction

Important guidelines:

  • Each instance of spoilage replacement requires completion of the Spoilage Replacement Program Form. Replacement is on a case-by-case basis at the sole discretion of Genentech; please retain all original product packaging for returns processing
  • Genentech does not ship replacement product if the spoiled product has been used for an off-label indication
  • Genentech does not ship replacement product if ANY portion of the product has been administered
  • Genentech will only ship replacement product to licensed facilities
  • All spoilage replacement requests are subject to review by Genentech; returned product is subject to analysis
  • Replacement is not available if any amount has been billed to a patient or an insurance claim has been remitted to a payer
  • Requests are subject to certain limitations and conditions. Genentech has the right to modify or discontinue the Spoilage Replacement Program at any time without notice
     

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

XOLAIR® (omalizumab) IS INDICATED FOR:

  • Moderate to severe persistent asthma in patients 6 years of age and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients
  • Chronic idiopathic urticaria in patients 12 years of age and older who remain symptomatic despite H1 antihistamine treatment

Limitations of Use:

  • XOLAIR is not indicated for treatment of other allergic conditions or other forms of urticaria
  • XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus

Important Safety Information

Boxed WARNING: Anaphylaxis

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, observe patients closely for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur.

CONTRAINDICATIONS

The use of XOLAIR is contraindicated in patients with a severe hypersensitivity reaction to XOLAIR or to any ingredient of XOLAIR.

WARNINGS AND PRECAUTIONS

Anaphylaxis

Anaphylaxis has been reported to occur after administration of XOLAIR in asthma premarketing clinical trials and in postmarketing spontaneous reports. The frequency of anaphylaxis attributed to XOLAIR use was estimated to be 0.1% and at least 0.2% (based on an estimated exposure of about 57,300 patients from June 2003 through December 2006), respectively.

A case-control study showed that among XOLAIR users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with XOLAIR, compared to those with no prior history of anaphylaxis.

Observe patients closely for an appropriate period of time after administration of XOLAIR, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports. Anaphylaxis occurred with the first dose of XOLAIR in 2 patients and with the fourth dose in 1 patient; the time to onset of anaphylaxis was 90 minutes after administration in 2 patients and 2 hours after administration in 1 patient. Discontinue XOLAIR in patients who experience a severe hypersensitivity reaction.

Malignancy

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 adults and adolescents (≥12 years of age) with asthma and other allergic disorders. The observed malignancies in XOLAIR-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to XOLAIR or use in patients at higher risk for malignancy (eg, elderly, current smokers) is not known.

A subsequent 5-year observational study of 5007 XOLAIR-treated and 2829 non- XOLAIR -treated adolescent and adult patients with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen found that the incidence rates of primary malignancies (per 1000 patient years) were similar in both groups (12.3 vs 13.0, respectively). Study limitations which include the observational study design, the bias introduced by allowing enrollment of patients previously exposed to XOLAIR (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%) preclude definitively ruling out a malignancy risk with XOLAIR.

Acute Asthma Symptoms

XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus.

Corticosteroid Reduction

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of XOLAIR therapy for asthma. Decrease corticosteroids gradually under the direct supervision of a physician. In CIU patients, the use of XOLAIR in combination with corticosteroids has not been evaluated.

Eosinophilic Conditions

In rare cases, patients with asthma on therapy with XOLAIR may present with serious systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome. These events usually, but not always, have been associated with the reduction of oral corticosteroid therapy. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between XOLAIR and these underlying conditions has not been established.

Fever, Arthralgia, and Rash

In postapproval use, some patients have experienced a constellation of signs and symptoms, including arthritis/arthralgia, rash, fever, and lymphadenopathy with an onset 1 to 5 days after the first or subsequent injections of XOLAIR. These signs and symptoms have recurred after additional doses in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.

Parasitic (Helminth) Infection

Monitor patients at high risk of geohelminth infection while on XOLAIR therapy. Insufficient data are available to determine the length of monitoring required for geohelminth infections after stopping XOLAIR treatment.

Laboratory Tests

Due to formation of XOLAIR:IgE complexes, serum total IgE levels increase following administration of XOLAIR and may remain elevated for up to 1 year following discontinuation of XOLAIR. Do not use serum total IgE levels obtained less than 1 year following discontinuation to reassess the dosing regimen for asthma patients, because these levels may not reflect steady state free IgE levels.

ADVERSE REACTIONS
Indication-Specific Adverse Reactions

Asthma:

In patients ≥12 years of age, the most commonly observed adverse reactions (≥1% more frequent in XOLAIR-treated patients) from 4 placebo-controlled asthma studies were: arthralgia (8%), pain (general) (7%), leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%), pruritus (2%), dermatitis (2%), and earache (2%).

In pediatric patients 6 to 12 years of age, the most commonly observed adverse reactions (≥3% more frequent in XOLAIR-treated pediatric patients) were: nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bite, and epistaxis.

Injection Site Reactions

Injection site reactions of any severity occurred at a rate of 45% in XOLAIR-treated patients compared with 43% in placebo-treated patients. The types of injection site reactions included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation. Severe injection site reactions occurred more frequently in XOLAIR treated patients compared with patients in the placebo group (12% vs 9%, respectively).

Chronic Idiopathic Urticaria:

In patients ≥12 years of age, the most commonly observed adverse reactions: (≥2% XOLAIR-treated patients and more frequent than in placebo) from 3 placebo-controlled CIU studies (Day 1 to Week 12) for XOLAIR 150 mg and 300 mg, respectively, were: headache (12%, 6%), nasopharyngitis (9%, 7%), arthralgia (3%, 3%), viral upper respiratory infection (2%, 1%), nausea (1%, 3%), sinusitis (1%, 5%), upper respiratory tract infection (1%, 3%), and cough (1%, 2%).

Injection Site Reactions

Injection site reactions of any severity occurred during the trials in more XOLAIR-treated patients (11 patients [2.7%] at 300 mg, 1 patient [0.6%] at 150 mg) compared with 2 placebo-treated patients (0.8%). The types of injection site reactions included: swelling, erythema, pain, bruising, itching, bleeding, and urticaria. None of the events resulted in study discontinuation or treatment interruption.

Cardiovascular and Cerebrovascular Events from Clinical Studies in Patients with Asthma

A 5-year observational study was conducted in 5007 XOLAIR-treated and 2829 non- XOLAIR -treated patients ≥ 12 years of age with moderate to severe persistent asthma and a positive skin test reaction to a perennial aeroallergen to evaluate the long term safety of XOLAIR, including the risk of malignancy. Similar percentages of patients in both cohorts were current (5%) or former smokers (29%). Patients had a mean age of 45 years and were followed for a mean of 3.7 years. More XOLAIR -treated patients were diagnosed with severe asthma (50%) compared to the non- XOLAIR -treated patients (23%). A higher incidence rate (per 1000 patient-years) of overall cardiovascular and cerebrovascular serious adverse events (SAEs) was observed in XOLAIR -treated patients (13.4) compared to non- XOLAIR -treated patients (8.1). Increases in rates were observed for transient ischemic attack (0.7 vs 0.1), myocardial infarction (2.1 vs 0.8), pulmonary hypertension (0.5 vs 0), pulmonary embolism/venous thrombosis (3.2 vs 1.5), and unstable angina (2.2 vs 1.4), while the rates observed for ischemic stroke and cardiovascular death were similar among both study cohorts. The results suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with XOLAIR, however the observational study design, the inclusion of patients previously exposed to XOLAIR (88% for a mean of 8 months), baseline imbalances in cardiovascular risk factors between the treatment groups, an inability to adjust for unmeasured risk factors, and the high study discontinuation rate (44%) limit the ability to quantify the magnitude of the risk.

Pregnancy

The data with XOLAIR use in pregnant women are insufficient to inform on drug associated risk

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 or Novartis Pharmaceuticals Corporation at 888-669-6682.

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