Care Continuum — Oral COVID-19 Antivirals and Pharmacy Policy Updates
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Summarizes Care Continuum's COVID-19 clinical guidance (comparison of oral antivirals Paxlovid and Molnupiravir) and pharmacy/formulary changes affecting prior authorization, step therapy, and quantity limits for Medicare and commercial members.
Scemblix (asciminib) and Fyarro (sirolimus protein-bound particles for injectable suspension) are new prior authorization requirements for Medicare.
Skytrofa was added to the self-administered drugs place-of-service prior authorization list for commercial plans.
Diabetic test strips policy updated to include strips related to continuous glucose monitors and for members with visual impairment.
COVID-19 Oral Antiviral Coverage
Oral antiviral (Paxlovid or Molnupiravir) coverage criteria
Covered when ALL of the following are met:
Source: document states testing requirement
Source: document lists CDC high-risk groups
Document specifies initiation within five days
Molnupiravir is not recommended in pregnancy or breastfeeding based on the product information and safety concerns documented in the source material. Paxlovid has limited human data on use in pregnancy or breastfeeding; clinicians should weigh potential benefits and risks when considering treatment in pregnant or lactating patients.
For both agents, apply the usual eligibility criteria (positive FDA‑approved COVID‑19 test, high‑risk for progression, and initiation within 5 days of symptom onset) when assessing treatment options for patients who are pregnant or breastfeeding, and involve obstetric or maternal–fetal medicine specialists as appropriate.
Paxlovid (nirmatrelvir/ritonavir) has multiple contraindicated drug interactions driven by CYP3A4 inhibition. The source lists examples of affected drugs including certain antiarrhythmics (e.g., amiodarone, dronedarone, flecainide, propafenone, quinidine), colchicine, some antipsychotics (e.g., lurasidone, pimozide, clozapine), ergot derivatives (dihydroergotamine, ergotamine), select statins (lovastatin, simvastatin), sildenafil, oral midazolam and triazolam, strong CYP3A4 inducers (carbamazepine, phenobarbital, phenytoin, rifampin), and herbal inducers such as St. John’s Wort.
Because ritonavir is a potent CYP3A4 inhibitor, concurrent use with these medications can lead to clinically significant increases or decreases in co‑medication concentrations and may be harmful. Review the patient’s current medication list for CYP3A4 substrates, inhibitors, and inducers, with pharmacy consultation as needed, and do not prescribe Paxlovid when a listed contraindicated medication cannot be safely stopped or substituted.
Initial Antiviral Therapy Details
Antiviral initial therapy
Initial dosing and administration notes
Document references renal dose adjustment and administration instructions
Document dosing and administration instructions
Key Definitions and Dosing
Prior Authorization, Documentation, and Operational Guidance
Prior authorization required for multiple drugs/indications
Multiple drugs and indications listed in the update now require prior authorization for commercial and/or Medicare members; examples called out include Kerendia, Saphnelo, Welireg, Skytrofa, Livmarli, Opzelura, Tavneos, Scemblix, and Fyarro. Submit PA requests per plan requirements before dispensing to avoid coverage delays.
- Examples of drugs now requiring PA: Kerendia, Saphnelo, Welireg, Skytrofa, Livmarli, Opzelura, Tavneos, Scemblix, Fyarro
- Applies to commercial and/or Medicare members as specified on the formulary/PDL
Medicare: new PA for Scemblix and Fyarro — update workflows
Medicare plans have new prior authorization requirements for Scemblix (asciminib) and Fyarro (sirolimus protein‑bound particles for injectable suspension). Update Medicare PA workflows and obtain authorization before providing these medications.
- Scemblix (asciminib) — new Medicare PA
- Fyarro (sirolimus protein‑bound particles for injectable suspension) — new Medicare PA
Commercial: Skytrofa added to self‑administered PA list
For commercial members, Skytrofa (lonapegsomatropin‑tcgd) has been added to the self‑administered drugs place‑of‑service prior authorization list; obtain PA when Skytrofa will be self‑administered in the outpatient/home setting.
- Skytrofa added to commercial self‑administered PA list (place of service guidance updated)
- Obtain PA for home/self‑administered use per commercial plan policy
Step therapy updates — Lybalvi and Eprontia added
Step therapy programs were updated to add Lybalvi and Eprontia where specified: Lybalvi is added as a step 2 therapy for atypical antipsychotics (commercial and Medicare as noted) and Eprontia is added as a second‑line agent for anticonvulsant therapy on Medicare open formulary.
- Lybalvi — added as step 2 therapy for atypical antipsychotics (commercial and Medicare as specified)
- Eprontia — added as second‑line anticonvulsant on Medicare open formulary
Maintenance of self‑administered PA list — ongoing updates
The self‑administered prior authorization document will be actively maintained to add or delete medications as relevant; monitor the policy document for future place‑of‑service PA changes.
- Policy maintenance committed to add/delete medications relevant to self‑administered PA
- Check formulary/PDL updates for changes to the self‑administered list
Antiviral eligibility documentation — positive test, high‑risk status, timing
For Paxlovid or Molnupiravir, documentation must show a positive FDA‑approved COVID‑19 test and that the patient is high‑risk for progression to severe COVID‑19; treatment must be initiated within five days of symptom onset.
- Positive FDA‑approved COVID‑19 test required
- Patient meets CDC high‑risk criteria (e.g., age >65, cancer, pregnancy, BMI ≥25, chronic disease, diabetes, immunocompromised)
- Initiation of treatment within 5 days of symptom onset
Reference materials and contacts — PDL and provider communications
Reference the Network Health Preferred Drug List (select the member's plan from the dropdown) for up‑to‑date formulary and PA requirements; subscribe to provider communications (The Script, The Pulse, The Consult) or contact the pharmacy department for assistance.
- Network Health PDL: networkhealth.com/look‑up‑medications (select plan)
- Subscribe to provider communications or contact pharmacy for questions
Quantity limit denial — exceeding plan limits will be denied
Requests that exceed the plan's established quantity level limits will be denied; the denial message will state: 'The quantity requested exceeds the plan's limitation. Coverage cannot be authorized at this time.'
- Plan‑specific quantity limits apply (e.g., Paxlovid 30 tablets/course; Molnupiravir 40 capsules/course)
- Denial message: The quantity requested exceeds the plan's limitation. Coverage cannot be authorized at this time.
Prior authorization required for newly listed drugs — obtain PA to avoid denial
Coverage may be denied if prior authorization is not obtained for newly listed drugs that require PA (for Medicare: Scemblix and Fyarro; for commercial: Skytrofa where specified). Obtain the required PA before dispensing to avoid denial.
- Medicare: Scemblix and Fyarro are new PA requirements — obtain PA prior to treatment
- Commercial: Skytrofa added to self‑administered PA list — obtain PA when applicable
Step Therapy Program Updates
| Drug class / program | Step change | Notes |
|---|---|---|
| Atypical antipsychotics | ||
| Atypical antipsychotics | ||
| Anticonvulsant therapy | ||
| Added Lybalvi as step 2 therapy | ||
| Added Lybalvi as second-line agent | ||
| Added Lybalvi as second-line agent | ||
| Added Eprontia as second-line therapy (open formulary only; excluded on closed) |
Pharmacy Quantity Limits
Place-of-Service and Self‑Administration Guidance
Skytrofa added to self‑administered PA list; update place‑of‑service handling
Skytrofa has been added to the self‑administered prior authorization list and the place‑of‑service guidance for self‑administered drugs has been updated — treat Skytrofa as a home/self‑administered medication when checking PA and billing.
- Update site‑of‑care and billing workflows to reflect Skytrofa’s self‑administered PA requirement.
Clinical Background
Early outpatient treatment with oral antivirals reduces the risk of progression to hospitalization or death in high‑risk patients. The EPIC‑HR trial showed that when Paxlovid was given within 5 days of symptom onset it reduced the risk of hospitalization or death by approximately 80% compared with placebo; the MOVe‑OUT trial showed Molnupiravir given within the same window reduced the risk by approximately 30% compared with placebo.
Both agents were authorized by the FDA under emergency pathways for treatment of non‑hospitalized patients with laboratory‑confirmed COVID‑19 who are at increased risk for severe disease, and both are intended to be initiated within 5 days of symptom onset in eligible patients.
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