PAXLOVID (nirmatrelvir and ritonavir)

PAXLOVID (nirmatrelvir and ritonavir)

Self Administration - Oral

Indications for Prior Authorization:

The U.S. Food and Drug Administration has issued an Emergency Use Authorization (EUA) for Paxlovid

• Treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death
• Limitations of Use:
  • Paxlovid is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19
  • Paxlovid is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19
  • Paxlovid is not authorized for use for longer than 5 consecutive days

Coverage Criteria:

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

• Dose does not exceed 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) twice daily for 5 days, AND
• Patient is 12 years of age or older, AND
• Patient weighs at least 40 kg, 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:

• Recommended dose: 300 mg nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) with all three tablets taken together orally twice daily for 5 days
  • Nirmatrelvir must be co-administered with ritonavir
• Moderate renal impairment (eGFR ≥30 to <60 mL/min): 150 mg nirmatrelvir and 100 mg ritonavir twice daily for 5 days
• Severe renal impairment (eGFR <30 mL/min based on CKD-EPI formula): not recommended
• Severe hepatic impairment (Child-Pugh Class C): not recommended
• The 5-day treatment course of Paxlovid should be initiated as soon as possible after a diagnosis of COVID-19 has been made, and within 5 days of symptom onset
• 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
• Paxlovid 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 Paxlovid belongs (i.e., anti-infectives)
• Contraindications:
  • Patients with a history of clinically significant hypersensitivity reactions [e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome] to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product
  • Contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions (e.g., alfuzosin, pethidine, piroxicam, propoxyphene, ranolazine, amiodarone, dronedarone, flecainide, propafenone, quinidine, colchicine, lurasidone, pimozide, clozapine, dihydroergotamine, ergotamine, methylergonovine, lovastatin, simvastatin, sildenafil [Revatio®] when used for pulmonary arterial hypertension, triazolam, oral midazolam)
  • Contraindicated with drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. Paxlovid cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer (e.g., apalutamide, carbamazepine, phenobarbital, phenytoin, rifampin, St. John's Wort)
• Warnings: risk of serious adverse reactions due to drug interactions, hepatotoxicity, risk of HIV-1 resistance development

Policy Updates:

• 1/7/2022 – New policy approved by P&T.

References:

• Emergency Use Authorization 105 [Internet]. U.S. Food and Drug Administration. U.S. Food and Drug Administration; 2021 [cited 2022Jan4]. Available from: https://www.fda.gov/media/155049/download
• Paxlovid Prescribing Information. Pfizer Labs. New York, NY. December 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