Dear Medical Staff—

The Omicron variant of SARS-CoV-2 is taking its toll on all of us, but we are pleased to be able to share information about some new treatment options that while limited at first will hopefully help us reduce the number of patients who progress to severe disease.

If you are a referring patients for treatment, please read the entire email.

Key Points:

  • There are new outpatient treatment options available for patients with mild to moderate COVID-19

  • In addition, there is one therapeutic for COVID prevention for highest risk patients

  • All of these therapies are in limited supply, so a referral is required, and all referrals will be prioritized for the highest risk individuals to receive treatment

  • Allocation is done at the federal and state level, supply on hand is subject to change

  • Some logistics are still being worked out, where that is the case, this will be denoted below

Treatment options: (more details about the dosing, mechanism of action and inclusions/exclusions are in the Denver Health COVID-19 Treatment Guideline)

  1. Monoclonal antibodies (treatment)

    • Sotrovimab*

  2. Oral antivirals (treatment)

    • Nirmatrelvir/ritonavir (Paxlovid)*

  3. Intravenous antivirals (treatment)

    • Remdesivir (Veklury)*

  4. Pre-exposure prophylaxis (prevention)

    • Tixagevimab/cilgavimab (Evusheld)**

* The above treatments reduce hospitalization due to COVID-19 or death by ≈80-90% and should be considered equally efficacious.

** relative risk reduction of symptomatic, PCR+ COVID-19 infection of 77%

Patient Selection:

  • For the 3 treatment options, the eligibility criteria are the same, with some differences in exclusions and timing of treatment.

  • Mild to moderate COVID-19 (symptomatic with + test), AND

  • Age >12 years and >40 kg, AND

  • At least 1 risk factor for progression to severe disease

Exclusions:

o hospitalized due to COVID-19

o new or worse O2 requirement due to COVID-19

o Beyond the therapeutic window for the therapy

§ Must initiate treatment within

· 10 days of symptom onset for Sotrovimab,

· within 7 days for Remdesivir and

· within 5 days for Paxlovid

· Contraindications

o Severe liver disease or eGFR <30 for Remdesivir and Paxlovid

o Many medication contraindications with Paxlovid (see list in the Denver Health COVID-19 Treatment Guideline and the EUA below)

For Pre-exposure prophylaxis Tixagevimab/cilgavimab (Evusheld)

· Moderate to severe immunocompromising conditions (see list of immunocompromising conditions in attachments)

· It is not authorized for use in unvaccinated individuals unless full vaccination is not possible due to a history of severe allergic reaction to the COVID-19 vaccine.

· Can be dosed again in 6 months if prevalence of COVID remains high and immunocompromising condition still present

Referral process:

For treatment options:

· Assess your patient for meeting treatment criteria

· Talk to your patient about their willingness to receive treatment including ability to go to the Peña Urgent Care Clinic to receive intravenous treatment

· Inform your patient that patients will be prioritized for treatment and so depending on the number of referrals, the current therapy allocation and their personal risk, they may or may not be prioritized for treatment

· Place referral for “AMB Referral to COVID-19 Outpatient Therapies”

· Complete the referral completely

· Remdesivir billing being finalized, so will not be an immediate option

For pre-exposure prophylaxis:

· Referral will be made by entering a Therapy Plan within Beacon

· We are still working on completing the build in Epic, determining our prioritization process, and building capacity to provide these infusions—more information will be disseminated about this soon

Do’s/Don’ts

· Please DO NOT place a referral before you have confirmed an infection. Placing a referral with “COVID test result pending” just pushes the work to our central team to follow up test results—with up to 800 referrals per week to prioritize, we do not have the capacity to do this

· Please DO follow up test results on your high risk patients promptly so that they are in the treatment window timeframe when you place the referral

· Please DO NOT refer your patient without talking to the patient about these therapy options (about 50% of patients decline treatment when we call them)

For more information:

Thank you to Becky Hanratty, Tim Jenkins, Katie Shiadeh and their teams for their this guidance and the email message. I am so grateful for their expertise.

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