This site is intended for US health care professionals.
01. Foundational / Icons / 32x32px/Menu @1x Open Menu 01. Foundational / Icons / 32x32px/Close @1x Close Menu

How to prescribe OHTUVAYRE® (ensifentrine)

Receive coverage and access support for your patient taking OHTUVAYRE through Verona Pathway Plus and direct delivery of prescriptions to your patients through our Durable Medical Equipment (DME) accredited Specialty Pharmacy (SP) network.

Step 1

Complete the OHTUVAYRE Prescription and Patient Enrollment & Consent Form

  • The Prescription Form includes the OHTUVAYRE and DME prescriptions
  • Ensure your patient completes the Patient Consent Form during the office visit to expedite Verona Pathway Plus enrollment for additional support
Prescription and Patient Enrollment & Consent Form

Step 2

Submit via fax

Fax the OHTUVAYRE Prescription and Patient Enrollment & Consent Form to Verona Pathway Plus at 1-833-392-8999 or 1-877-830-4555.

Accessa and coverageb

  • Medicare patients have access to OHTUVAYRE through the durable medical equipment benefitc
  • Prior authorizations or step edits are not required per Centers for Medicare & Medicaid Services Policyd
    • Secondary insurance providers may have additional requirements
  • The Specialty Pharmacy will reach out if additional information is needed
  • Field Access Managers are available to provide education and access support
  • Original Medicare and Advantage plans will cover 80% of the cost for OHTUVAYRE; the patient is responsible for the remaining 20%
  • With additional insurance, the patient cost may be as little as $0 per month

(Medicare Advantage only)

  • Once the annual maximum out-of-pocket spend for medical expenses has been met, patients generally pay as little as $0 per month

aCoverage is not guaranteed; patients should check with their insurance provider for coverage rules and restrictions.

bThese descriptions of typical patient out-of-pocket costs are for informational purposes only. Merck does not make any warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for any particular use. Patients should contact their insurance provider for their out-of-pocket costs.

cPatients residing in a long-term care facility may be covered under Part D benefits, and may have additional requirements.

dPrivately purchased secondary plans may require prior authorization.

Accessa and coverageb

  • Most Medicaid plans will require a prior authorization
  • The Specialty Pharmacy will reach out if additional information is needed
  • Field Access Managers are available to provide education and access support
  • Patients with Medicaid generally pay less than $15 per monthc

aCoverage is not guaranteed; patients should check with their insurance provider for coverage rules and restrictions.

bThese descriptions of typical patient out-of-pocket costs are for informational purposes only. Merck does not make any warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for any particular use. Patients should contact their insurance provider for their out-of-pocket costs.

cMedicaid out-of-pocket expenses vary by state. Please confirm with your local rules.

Accessa

  • Most commercial plans will require a prior authorization
  • The Specialty Pharmacy will reach out if additional information is needed
  • Field Access Managers are available to provide education and access support

Affordabilityb

  • Your eligible, privately insured patients may save on their out-of-pocket costs for their prescription for OHTUVAYRE.
  • Not valid for patients who are uninsured or patients with Medicare or other Government Program insurance. Not all patients are eligible. Certain restrictions apply. Please see Terms and Conditions.

Tell your eligible, privately insured patients to visit OHTUVAYRE.com to review the Terms and Conditions.

aCoverage is not guaranteed; patients should check with their insurance provider for coverage rules and restrictions.

bThese descriptions of typical patient out-of-pocket costs are for informational purposes only. Merck does not make any warranties or guarantees, expressed or implied, concerning the accuracy or appropriateness of this information for any particular use. Patients should contact their insurance provider for their out-of-pocket costs.

INDICATION

OHTUVAYRE® (ensifentrine) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

SELECT SAFETY INFORMATION

CONTRAINDICATIONS

OHTUVAYRE is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.

WARNINGS AND PRECAUTIONS

Acute Episodes of Bronchospasm
OHTUVAYRE should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. OHTUVAYRE has not been studied in the relief of acute symptoms and extra doses of OHTUVAYRE should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting bronchodilator.

 

Paradoxical Bronchospasm
As with other inhaled medicines, OHTUVAYRE may produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with OHTUVAYRE, it should be treated immediately with an inhaled, short-acting bronchodilator. OHTUVAYRE should be discontinued immediately and alternative therapy should be instituted.

 

Psychiatric Events Including Suicidality
Treatment with OHTUVAYRE is associated with an increase in psychiatric adverse reactions. Psychiatric events including suicide-related adverse reactions were reported in clinical studies in patients who received OHTUVAYRE (1 suicide attempt and 1 suicide). Additionally, the most commonly reported psychiatric adverse reactions in the pooled 24-week safety population were insomnia (6 patients [0.6%] OHTUVAYRE 3 mg; 2 patients [0.3%] placebo), and anxiety (2 patients [0.2%] OHTUVAYRE 3 mg; 1 patient [0.2%] placebo). Depression-related reactions including depression, major depression, and adjustment disorder with depressed mood occurred in 4 patients (0.4%) receiving OHTUVAYRE and no patients receiving placebo.

 

Before initiating treatment with OHTUVAYRE, healthcare providers should carefully weigh the risk and benefits of treatment with OHTUVAYRE in patients with a history of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes, and if such changes occur to contact their healthcare provider. Healthcare providers should carefully evaluate the risks and benefits of continuing treatment with OHTUVAYRE if such events occur.

ADVERSE REACTIONS

The most common adverse reactions ≥1% in OHTUVAYRE and greater than placebo in the pooled population in the ENHANCE-1 and ENHANCE-2 clinical trials were back pain (1.8% vs 1.0%), hypertension (1.7% vs 0.9%), urinary tract infection (1.3% vs 1.0%), and diarrhea (1.0% vs 0.7%).

 

These are not all of the possible risks associated with OHTUVAYRE.

DOSAGE AND ADMINISTRATION

The recommended dosage of OHTUVAYRE is 3 mg (one unit-dose ampule) twice daily, once in the morning and once in the evening, administered by oral inhalation using a standard jet nebulizer with a mouthpiece.

SPECIAL POPULATIONS

Pediatric Use
The safety and effectiveness of OHTUVAYRE have not been established in pediatric patients.

 

Lactation
There are no data on the presence of ensifentrine in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OHTUVAYRE and any potential adverse effects on the breastfed child from OHTUVAYRE or from the underlying maternal condition.

 

Geriatric Use
In clinical trials, patients aged 65 and older showed no overall differences in the safety or effectiveness of OHTUVAYRE compared with younger adults, but greater sensitivity in some older individuals cannot be ruled out.

 

Hepatic Impairment
Ensifentrine systemic exposure increased by 2.3-fold in subjects with moderate or severe hepatic impairment compared with healthy subjects. Use OHTUVAYRE with caution in patients with hepatic impairment.

 

Before prescribing OHTUVAYRE® (ensifentrine), please read the accompanying Prescribing Information. The Patient Information and Instructions for Use also are available.

 

INDICATION
SELECT SAFETY INFORMATION

OHTUVAYRE® (ensifentrine) is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.

SELECT SAFETY INFORMATION

CONTRAINDICATIONS

OHTUVAYRE is contraindicated in patients with hypersensitivity to ensifentrine or any component of this product.

WARNINGS AND PRECAUTIONS

Acute Episodes of Bronchospasm
OHTUVAYRE should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. OHTUVAYRE has not been studied in the relief of acute symptoms and extra doses of OHTUVAYRE should not be used for that purpose. Acute symptoms should be treated with an inhaled, short-acting bronchodilator.

 

Paradoxical Bronchospasm
As with other inhaled medicines, OHTUVAYRE may produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with OHTUVAYRE, it should be treated immediately with an inhaled, short-acting bronchodilator. OHTUVAYRE should be discontinued immediately and alternative therapy should be instituted.

 

Psychiatric Events Including Suicidality
Treatment with OHTUVAYRE is associated with an increase in psychiatric adverse reactions. Psychiatric events including suicide-related adverse reactions were reported in clinical studies in patients who received OHTUVAYRE (1 suicide attempt and 1 suicide). Additionally, the most commonly reported psychiatric adverse reactions in the pooled 24-week safety population were insomnia (6 patients [0.6%] OHTUVAYRE 3 mg; 2 patients [0.3%] placebo), and anxiety (2 patients [0.2%] OHTUVAYRE 3 mg; 1 patient [0.2%] placebo). Depression-related reactions including depression, major depression, and adjustment disorder with depressed mood occurred in 4 patients (0.4%) receiving OHTUVAYRE and no patients receiving placebo.

 

Before initiating treatment with OHTUVAYRE, healthcare providers should carefully weigh the risk and benefits of treatment with OHTUVAYRE in patients with a history of depression and/or suicidal thoughts or behavior. Patients, their caregivers, and families should be advised of the need to be alert for the emergence or worsening of insomnia, anxiety, depression, suicidal thoughts, or other mood changes, and if such changes occur to contact their healthcare provider. Healthcare providers should carefully evaluate the risks and benefits of continuing treatment with OHTUVAYRE if such events occur.

ADVERSE REACTIONS

The most common adverse reactions ≥1% in OHTUVAYRE and greater than placebo in the pooled population in the ENHANCE-1 and ENHANCE-2 clinical trials were back pain (1.8% vs 1.0%), hypertension (1.7% vs 0.9%), urinary tract infection (1.3% vs 1.0%), and diarrhea (1.0% vs 0.7%).

 

These are not all of the possible risks associated with OHTUVAYRE.

DOSAGE AND ADMINISTRATION

The recommended dosage of OHTUVAYRE is 3 mg (one unit-dose ampule) twice daily, once in the morning and once in the evening, administered by oral inhalation using a standard jet nebulizer with a mouthpiece.

SPECIAL POPULATIONS

Pediatric Use
The safety and effectiveness of OHTUVAYRE have not been established in pediatric patients.

 

Lactation
There are no data on the presence of ensifentrine in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for OHTUVAYRE and any potential adverse effects on the breastfed child from OHTUVAYRE or from the underlying maternal condition.

 

Geriatric Use
In clinical trials, patients aged 65 and older showed no overall differences in the safety or effectiveness of OHTUVAYRE compared with younger adults, but greater sensitivity in some older individuals cannot be ruled out.

 

Hepatic Impairment
Ensifentrine systemic exposure increased by 2.3-fold in subjects with moderate or severe hepatic impairment compared with healthy subjects. Use OHTUVAYRE with caution in patients with hepatic impairment.

 

Before prescribing OHTUVAYRE® (ensifentrine), please read the accompanying Prescribing Information. The Patient Information and Instructions for Use also are available.