— Ongoing shifts in COVID-19 variants and vaccination rates complicate attempts to compare the effectiveness of available and emerging outpatient treatment options –

— Current evidence suggests all four drugs under review have prices reasonably aligned with patient benefits

— At the April 12 virtual meeting, ICER’s independent appraisal committee will review the evidence, hear further testimony from stakeholders, and deliberate over comparative clinical effectiveness, potential benefits beyond the health care system, and the long-term value for money of these treatments —

BOSTON, March 28, 2022 – The Institute for Clinical and Economic Review (ICER) today posted its revised Evidence Report assessing the comparative clinical effectiveness and value of the following treatments for COVID-19:

  • sotrovimab (GlaxoSmithKline and Vir Biotechnology)
  • molnupiravir (Merck)
  • PF-07321332/ritonavir (Paxlovid™, Pfizer)
  • fluvoxamine (Investigator initiated)

“The evidence on outpatient treatments for COVID-19 must be viewed as highly sensitive to the evolving landscape of COVID-19 variants and vaccination status in the US,” said ICER President Steven Pearson, MD, MSc. “What we have today, however, does suggest that the drugs of interest are all – to different degrees –  able to reduce hospitalizations among patients with mild-to moderate COVID-19 who are at high risk of progression to severe disease. At their current negotiated price (sotrovimab, molnupiravir, and Paxlovid) or their generic market price (fluvoxamine), these drugs appear to have prices reasonably aligned with patient benefits.  Of course, as hospitalization rates due to COVID-19 rise or fall in the future due to variant effects, the clinical value of these treatments will change accordingly, but they all have potential benefits beyond the health system as well that are addressed in our report and that we look forward to discussing further at our public meeting.”

This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC (Midwest England CEPAC) on April 12, 2022. The Midwest England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.

A draft version of this report was previously open for a four-week public comment period. The updated Evidence Report and voting questions  reflect changes made based on comments received from patient groups, drug manufacturers, and other stakeholders. Detailed responses to public comments can be found here.

Key Clinical Findings

ICER’s evidence ratings for the treatments reviewed include:

1.  Sotrovimab delivers at least a small net health benefit when compared to no active treatment, with the possibility of a substantial net health benefit (“B+”).

2.  Molnupiravir is at least comparable to no active treatment, with the potential of a small net health benefit (“C+”).

3. Paxlovid delivers at least a small net health benefit when compared to no active treatment, with the possibility of a substantial net health benefit (“B+”).

4. Fluvoxamine is at least comparable to no active treatment, with the potential of a small net health benefit (“C+”).

Key Cost-Effectiveness Findings

At their current negotiated price (sotrovimab, molnupiravir, and Paxlovid) or their generic market price (fluvoxamine), these drugs appear—at this time—to have prices reasonably aligned with patient benefits.  Should background risks of hospitalization from mild-moderate COVID-19 be reduced with the Omicron (or future) variant, or should these treatments be used in lower-risk populations, including patients with full vaccination, their cost effectiveness would be significantly reduced. 

TreatmentTreatment Course Price*ICER’s Health Benefit Price Benchmark
Sotrovimab$2,100$3,000 – $5,200
Molnupiravir$707$1,200- $2,000
Paxlovid$529$3,600- $5,800
Fluvoxamine$12$1,300- $2,100
*Excludes administration, monitoring, or markup-related costs.

ICER’s HBPB is a price range suggesting the highest US price a manufacturer should charge for a treatment, based on the amount of improvement in overall health patients receive from that treatment, when a higher price would cause disproportionately greater losses in health among other patients in the health system due to rising overall costs of health care and health insurance. In short, it is the top price range at which a health system can reward innovation and better health for patients without doing more harm than good.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.