Access and support for your patients on NUCALA

After prescribing NUCALA, the following information will guide you through the steps in helping appropriate patients access NUCALA. Additional resources and links can also be found below.

How to access NUCALA

Support icon — 1 Verify patient benefits

Red list icon — 2Review NUCALA financial assistance options

Truck icon — 3Arrange for patient to receive NUCALA

Savings icon — 4 Billing and reimbursement

Stopwatch icon — 5Help patients start successfully

1. Verify patient benefits

Gateway to NUCALA can help you navigate the insurance process for covering NUCALA. You may also contact the specialty pharmacy or patient’s payer directly.

Gateway to NUCALA English enrollment form

Gateway to NUCALA Spanish enrollment form

Initiate a benefits investigation

Verify benefits by working with Gateway to NUCALA or contacting the payer directly. Benefits investigations do not guarantee coverage. If your patient is not enrolled in Gateway to NUCALA, please complete the enrollment form above.

If the patient will receive treatment at an alternative site of care (ASOC):

Consult the patient’s insurance or contact Gateway to NUCALA to identify an appropriate ASOC. Work with the ASOC to determine responsibility for benefits investigation and prior authorization.

Prior authorization (PA)

Determine any PA requirements. Gateway to NUCALA can provide PA support for enrolled patients. Gateway to NUCALA cannot complete PA forms or submit related information to plans.

Obtain needed forms from the patient’s plan

Follow up with the patient’s plan to determine PA submission status if requested

CoverMyMeds^® offers electronic PA forms for NUCALA and is free to use. Call 1-866-452-5017 or visit covermymeds.com

CoverMyMeds developed and maintains the website and is responsible for its content. Neither GSK nor CoverMyMeds can guarantee success in obtaining third-party coverage or reimbursement. It is always the healthcare provider's responsibility to provide and submit accurate and complete information. Providers should contact prescription health plans for specific information on their coding, coverage, and payment policies.

All trademarks, trade names, or logos mentioned or used are the property of their respective owners. CoverMyMeds and GSK are not affiliated entities.

Important Notice: Information regarding CoverMyMeds is brought to you as a courtesy of GSK.

Appeals support

If PA is denied, and you feel that NUCALA is appropriate for your patient, you can consider an appeal
Gateway to NUCALA can help you and your patient understand the appeals process

See below for sample letters of appeal and medical necessity

Sample letter of appeal

Sample letter of medical necessity

2. Patient access support

The following assistance programs may be available for your patients:

Gateway to NUCALA will evaluate the patient’s eligibility for GSK’s sponsored assistance programs. Call 844-4-NUCALA (844-468-2252) Monday through Friday, 8 AM to 8 PM ET
The NUCALA Co-pay Program can help eligible patients covered by commercial insurance pay as little as $0 for NUCALA (maximum of $15,000 for 12 months). See full terms and conditions
Bridge to NUCALA Program offers free product to eligible commercially insured patients when their initial prior authorization process exceeds 5 days
The NUCALA Patient Assistance Program may help your uninsured patients who meet eligibility criteria to obtain access to NUCALA free of charge

3. Arrange for patient to receive NUCALA

NUCALA is available through a variety of distribution options based on the site of care. Gateway to NUCALA can help identify the options that may be available for your patient.

At-home administration

Send the prescription to an in-network specialty pharmacy

Inform patient to expect a call from the specialty pharmacy to approve shipment and provide co-pay

View at-home administration

In-office administration

Specialty pharmacy

Order NUCALA from an in-network specialty pharmacy

Inform patient to expect a call from the specialty pharmacy to approve shipment and provide co-pay

Verify the correct shipping address and shipping date with the specialty pharmacy, and follow up as needed

Buy and bill

Order NUCALA from specialty distributor once prior authorization is approved

Alternative site of care

Confirm appointment for administration has been scheduled at alternative site of care

Ordering guide

Find specialty pharmacies and distributors currently participating in the distribution network for NUCALA.

View in-office administration

4. Billing and reimbursement

Gateway to NUCALA can help provide information about relevant codes and identify coding requirements for NUCALA.

Permanent J-code for NUCALA

J2182

Click for more codes

Your practice or hospital outpatient department may need more information on Centers for Medicare and Medicaid Services (CMS) claims forms 1500 and 1450. Details and examples of each are provided below.

Example of CMS-1500 claim form

For products and services provided in the physician office setting

Example of CMS-1450 claim form

For products and services provided in hospital outpatient department

5. Help patients start successfully

After ordering NUCALA for patients, there are steps you can take to help patients start:

Instruct patients to accept and return calls from the specialty pharmacy to prevent delays in starting treatment. Specialty pharmacies may not mention NUCALA in messages, as brand names may be omitted to protect privacy

Encourage patients to take advantage of the MyNUCALA patient support program

Patient Support Program

MyNUCALA offers tools and services to help patients along their NUCALA journey including:

Autoinjector patient starter kit

Progress trackers

Doctor conversation starters

Nurse Support Line to help answer patient questions about NUCALA

Learn more about MyNUCALA

Next: Dosing and administration

Request a Rep

Gateway to NUCALA

Prescribing Information

Indication & Important Safety Info

Indication

NUCALA is indicated for the add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Important Safety Information

CONTRAINDICATIONS
NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

CONTRAINDICATIONS
NUCALA should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions (eg, anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred with NUCALA. These reactions generally occur within hours of administration but can have a delayed onset (ie, days). If a hypersensitivity reaction occurs, discontinue NUCALA.

Acute Asthma Symptoms or Deteriorating Disease
NUCALA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.

Opportunistic Infections: Herpes Zoster
Herpes zoster infections have occurred in patients receiving NUCALA. Consider vaccination if medically appropriate.

Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with NUCALA. Decreases in corticosteroid doses, if appropriate, should be gradual and under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

Parasitic (Helminth) Infection
Treat patients with pre-existing helminth infections before initiating therapy with NUCALA. If patients become infected while receiving NUCALA and do not respond to anti-helminth treatment, discontinue NUCALA until infection resolves.

ADVERSE REACTIONS
In a clinical trial in patients with CRSwNP receiving NUCALA, the most common adverse reactions (≥5%) were oropharyngeal pain and arthralgia.

Systemic reactions, including hypersensitivity, also occurred. Manifestations included urticaria, erythema, and rash; 1 of the 3 reactions occurred on the day of dosing.

Injection site reactions occurred at a rate of 2% in patients receiving NUCALA vs <1% in patients receiving placebo.

USE IN SPECIFIC POPULATIONS
The data on pregnancy exposures are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as mepolizumab, are transported across the placenta in a linear fashion as the pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimesters.

Please see full Prescribing Information and Patient Information for NUCALA.

MPLWCNT210134 August 2021

To report SUSPECTED ADVERSE REACTIONS, contact GSK at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Trademarks are owned by or licensed to the GSK group of companies.

This is my caption

Access and support for your patients on NUCALA

The following assistance programs may be available for your patients:

J2182

Patient Support Program