LAGEVRIO (molnupiravir)

LAGEVRIO (molnupiravir)

Self-Administration - oral

Indications for Prior Authorization:

The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for molnupiravir for the treatment of mild-to-moderate COVID-19 in adults:

• with positive results of direct SARS-CoV-2 viral testing, and
• who are at high risk for progression to severe COVID-19, including hospitalization or death. Refer to CDC website for additional details, and for
• whom alternative COVID-19 treatment options authorized by FDA are not accessible or clinically appropriate.

LIMITATIONS OF AUTHORIZED USE

• Molnupiravir is not authorized for use in patients who are less than 18 years of age.
• Molnupiravir is not authorized for initiation of treatment in patients hospitalized due to COVID-19. Benefit of treatment with molnupiravir has not been observed in subjects when treatment was initiated after hospitalization due to COVID-19.
• Molnupiravir is not authorized for use for longer than 5 consecutive days.
• Molnupiravir is not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.

Coverage Criteria:

For diagnosis of mild-to-moderate COVID-19:

• Dose does not exceed 800 mg (four 200 mg capsules) orally every 12 hours for 5 days, AND
• Patient is 18 years of age or older, AND
• Patient is not hospitalized due to COVID-19, AND
• Patient is considered high risk for progression to severe COVID-19 per the prescribing provider, AND
• Patient has tested positive for COVID-19 and it has been no more than 5 days since symptom onset

Coverage Duration:

• One 5-day treatment course

Authorization is not covered for the following:

The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

• For initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19
• For the use of pre-exposure or post-exposure prophylaxis for prevention of COVID-19

Additional Information:

• Examples of patients considered more likely to get severely ill from COVID-19 per the Centers for Disease Control and Prevention [CDC] include patients over age 65 years, patients that have cancer, chronic kidney disease, chronic liver disease, chronic lung disease, dementia or other neurological conditions, type 1 or type 2 diabetes, down syndrome, heart conditions, HIV infection, immunocompromised, mental health conditions, overweight and obesity, pregnancy, sickle cell disease or thalassemia, current/former smoking, solid organ or blood stem cell transplant, stroke or cerebrovascular disease, substance use disorders, tuberculosis.
• Molnupiravir may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which molnupiravir belongs (i.e., anti-infectives).
• Completion of the full 5-day treatment course and continued isolation in accordance with public health recommendations are important to maximize viral clearance and minimize transmission of SARS-CoV-2.
• If the patient misses a dose of molnupiravir within 10 hours of the time it is usually taken, the patient should take it as soon as possible and resume the normal dosing schedule. If the patient misses a dose by more than 10 hours, the patient should not take the missed dose and instead take the next dose at the regularly scheduled time. The patient should not double the dose to make up for a missed dose.
• Should a patient require hospitalization after starting treatment with molnupiravir, the patient may complete the full 5 day treatment course per the healthcare provider’s discretion.
• Molnupiravir is not recommended for use in pregnancy and has not been studied in pregnancy
• Molnupiravir is not authorized for use in patients less than 18 years of age because it may affect bone and cartilage growth

Policy Updates:

• 01/07/2022 – New policy approved by P&T.

References:

• Emergency Use Authorization 108 [Internet]. U.S. Food and Drug Administration. U.S. Food and Drug Administration; 2021 [cited 2022Jan5]. Available from: https://www.fda.gov/media/155053/download
• Molnupiravir prescribing information. Merck Sharp & Dohme Corp, December, 23 2021.
• People with certain medical conditions [Internet]. Centers for Disease Control and Prevention. Centers for Disease Control and Prevention; 2021 [cited 2022Jan4]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html