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OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

 

ACCESS

A CLEAR PATH TO ACCESS FOR 80% OF YOUR PATIENTS WITH COMMERCIAL INSURANCE*

Covered at any tier, PA and other restrictions may apply. Coverage is plan specific and subject to change.

OPZELURA has broad coverage for commercially insured patients. Most health plans require a prior authorization (PA) before approving coverage for OPZELURA.

Key information to include in a prior authorization for OPZELURA1,2
Patient AgeThe patient must be 12 years of age or older
IndicationOPZELURA is indicated for nonsegmental vitiligo
Diagnosis CodeICD-10 diagnosis code L802
Step Through 
Medications

This may include a topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI).

Be sure to include your patient’s most recent chart notes!

Body Surface Area (BSA)Indicate the BSA that will be treated:
Nonsegmental vitiligo is up to 10%
Not Approved for Combination Use

Confirm OPZELURA will not be used with:

  • Therapeutic biologics
  • Other JAK inhibitors
  • Potent immunosuppressants
  • Other brand products

OPZELURA was studied as a monotherapy treatment. Many plans do not approve combination use.

ICD, international classification of diseases; JAK, Janus kinase.

*VANTAGE Fingertip Formulary, October 2023.

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ADDITIONAL DOCUMENTS AND FORMS

Here are some documents that may be helpful, including downloadable forms, letters of appeal, and even more resources for prior authorizations.

Template Letter of Appeal for Nonsegmental Vitiligo

Sample Letter of Appeal - Additional Tube of OPZELURA

Sample Letter of Medical Necessity

IncyteCARES for OPZELURA Prescription and Enrollment Form

LOOKING FOR A PLAN-SPECIFIC PA FORM?

Go to CoverMyMeds.com and enter the patient’s Rx BIN, PCN, and Group #.

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DID YOU INCLUDE…

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A diagnosis from the Prescribing Information?

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The ICD-10 code and diagnosis that aligns to the patient’s condition?

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Other products tried and the reasons for ineffectiveness? (If applicable, address intolerance or experienced side effects.)

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The BSA % intended to be treated?

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The patient’s most recent chart notes?

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An explanation for discontinued therapies like potent immunosuppressants, other JAK inhibitors, or therapeutic biologics?

Need help?

Visit CoverMyMeds online or call 1-866-452-5017 for assistance with:

  • Finding a specific PA form
  • Understanding a PA denial
  • Obtaining the PA status
  • Navigating the appeals process

BIN, bank identification number; BSA, body surface area; JAK, Janus kinase; PA, prior authorization; PCN, processor control number; Rx, prescription.

Coverage Determination: What Comes Next?

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PA APPROVED

Your patients may be eligible for the copay savings program. Terms and conditions apply.

COPAY SAVINGS

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PA DENIED

For eligible patients whose PAs are denied, the Commercial Access Program (CAP) may provide a limited quantity of OPZELURA while an appeal is being pursued.

COMMERCIAL ACCESS PROGRAM

PA, prior authorization.

 
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IncyteCARES

IncyteCARES is here to support your eligible patients during their treatment with OPZELURA.

Visit IncyteCares for more resources

SETTING PATIENT EXPECTATIONS

View our checklist for setting patient expectations.

VIEW THE CHECKLIST
VISIBLE RESULTS

See facial and body repigmentation photos of OPZELURA clinical trial participants.

VIEW PATIENT PHOTOS

Important Safety Information and indication

 

INDICATION

OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.

Limitations of Use: Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.

IMPORTANT SAFETY INFORMATION

SERIOUS INFECTIONS
Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include:
  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease.
  • Invasive fungal infections, including cryptococcosis and pneumocystosis.
  • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. Carefully consider the benefits and risks of treatment prior to initiating OPZELURA in patients with chronic or recurrent infection. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with OPZELURA.

Serious lower respiratory tract infections were reported in the clinical development program with topical ruxolitinib.

No cases of active tuberculosis (TB) were reported in clinical trials with OPZELURA. Cases of active TB were reported in clinical trials of oral Janus kinase inhibitors used to treat inflammatory conditions. Consider evaluating patients for latent and active TB infection prior to administration of OPZELURA. During OPZELURA use, monitor patients for the development of signs and symptoms of TB.

Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), were reported in clinical trials with Janus kinase inhibitors used to treat inflammatory conditions including OPZELURA. If a patient develops herpes zoster, consider interrupting OPZELURA treatment until the episode resolves.

Hepatitis B viral load (HBV-DNA titer) increases, with or without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking oral ruxolitinib. OPZELURA initiation is not recommended in patients with active hepatitis B or hepatitis C.

MORTALITY

In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA.

MALIGNANCIES

Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients with a known malignancy (other than successfully treated non-melanoma skin cancers), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

Non-melanoma skin cancers, including basal cell and squamous cell carcinoma, have occurred in patients treated with OPZELURA. Perform periodic skin examinations during OPZELURA treatment and following treatment as appropriate. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. Patients who are current or past smokers are at additional increased risk. Discontinue OPZELURA in patients who have experienced a myocardial infarction or stroke.

Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with OPZELURA, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue OPZELURA in patients that have experienced a myocardial infarction or stroke.

THROMBOSIS
Thromboembolic events were observed in trials with OPZELURA. Thrombosis, including pulmonary embolism (PE), deep venous thrombosis (DVT), and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with an oral JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers. Avoid OPZELURA in patients at risk. If symptoms of thrombosis occur, discontinue OPZELURA and treat appropriately.
Thrombocytopenia, Anemia, and Neutropenia

Thrombocytopenia, anemia, and neutropenia were reported in the clinical trials with OPZELURA. Consider the benefits and risks for individual patients who have a known history of these events prior to initiating therapy with OPZELURA. Perform CBC monitoring as clinically indicated. If signs and/or symptoms of clinically significant thrombocytopenia, anemia, and neutropenia occur, patients should discontinue OPZELURA.

Lipid Elevations

Treatment with oral ruxolitinib has been associated with increases in lipid parameters including total cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.

Adverse Reactions

In nonsegmental vitiligo, the most common adverse reactions (incidence ≥1%) are application site acne (6%), application site pruritus (5%), nasopharyngitis (4%), headache (4%), urinary tract infection (2%), application site erythema (2%), and pyrexia (1%).

Pregnancy

There is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.

Lactation

Advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).

Please see Full Prescribing Information, including Boxed Warning, and Medication Guide for OPZELURA.

Indication

OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients

Important Safety Information

Important Safety Information and indication

Serious Infections

Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include:

Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death. Reported infections include:

References: 1. OPZELURA [Prescribing information]. Wilmington, DE: Incyte Corporation. 2. AAPC. Diseases of the skin and subcutaneous tissue (L00-L99). In: 2022 ICD-10-CM Expert: Diagnosis Codes for Providers & Facilities. 2021;1220-1240. Accessed July 28, 2022. https://aapc.vitalsource.com/#/