Grand Rounds January 12, 2024: Design and Implementation of a Weighted Lottery to Equitably Allocate Scarce Covid-19 Resources (Erin K. McCreary, PharmD, BCIDP)

Posted on by Elizabeth Mccamic

Speaker

Erin K. McCreary, PharmD, BCIDP
Director of Infectious Diseases Improvement and Clinical Research Innovation, UPMC
Clinical Assistant Professor of Medicine, University of Pittsburgh
President-Elect, Society of Infectious Diseases Pharmacists (SIDP)

Keywords

COVID-19, therapeutics, health equity, pragmatic clinical trial

Key Points

  • In April 2020, UPMC established a COVID Therapeutics Committee to determine a process for allocating experimental COVID-19 therapies. UPMC did not allow patients to receive experimental COVID-19 therapies outside of the context of a clinical trial and used the REMAP-CAP platform, a global pragmatic adaptive trial platform, in all clinic sites.  Any patient admitted to the hospital with COVID-19 completed a COVID intake form in their admission record, and if they opted to learn about experimental therapies, a FaceTime call was set up with a research coordinator.
  • The COVID Therapeutics Committee worked with the state health department to develop a policy for fair allocation of scarce medications to treat COVID-19. The guiding principles of the policy were developed to safeguard the public’s health by allocating scarce treatments to maximize community benefit; to lessen the impact of social inequities, to ensure that no patient is refused access to treatment based on age, disability, religion, race, ethnicity, national origin, immigration status, gender, perceived quality of life, sexual orientation, or gender identify; and to ensure that all patients receive individualized assessments by clinicians based on the best available medical evidence.
  • The first drug that used the new process was Remdesivir in May 2020. UPMC set clear criteria based on the published data at the time for who could and could not receive Remdesivir. Setting clear inclusion/exclusion criteria based on highest level clinical evidence is crucial.
  • UPMC established weighted factors for the Remdesivir lottery that were established by the ethics and clinical committee. Criteria included essential workers (25% increased odds of drug allocation), patients with an area of deprivation index score 80-100 (25% increased odds), end-of-life prognosis, defined as greater than 50% chance of death within one year from underlying conditions (50% decreased odds). The criteria were updated in June 2020 when it was determined that Remdesivir was safe for pregnant people, increasing odds because 2 lives could be saved.
  • The COVID Therapeutics Committee created communication materials to be transparent and to get buy-in. The committee worked with communications specialists who partnered with palliative care providers and others to draft FAQs and other communication guidance for clinician teams who were having conversations about drug allocations with patients and families.
  • There was a daily process for the Remdesivir lottery. Every patient with COVID-19 was automatically considered. Patients were screened by local teams at each site. If a patient was part of the daily allocation, the committee informed the local team by email and the drug was shipped from a central location to the local site.
  • The first monoclonal antibody (mABs) treatment for treatment of COVID-19 was approved in November 2020. UPMC built upon the success of the Remdesivir lottery and in December 2020, UPMC began infusing monoclonal antibodies across 45 UPMC locations. Clinicians wrote a consult for mABs and the pharmacy delivered whichever mAB that was available.
  • When Evusheld was approved in December 2021 a similar weighted lottery process was put into place. All eligible patients were gathered from data warehouse and manual EHR entry. The therapeutics and ethics committees grouped immunocompromised patients into 3 risk categories, with a lottery for those patients in group 1 (highest risk). Patients from disadvantaged communities had increased odds of receiving treatment. The lottery was repeated weekly with notification of allocation.
  • Through this work, UPMC learned that allocation does not actually mean receiving the drug. The lottery structurally improved allocation. Association of lottery with underrepresented racial and ethnic groups other than Black was not evaluated due to small numbers. Factors associated with not receiving drug need further explored

 

Learn More

Read more in JAMA Network.

Discussion Themes

-The allocation didn’t match the likelihood that an individual would receive the drug. Any hypothesis for why this occurred? We have a few hypotheses. We went through every iteration of how do you contact patients. Only about 40% of our patients are enrolled in My UPMC. We know there is a digital gap in disadvantaged patients and elderly patients. Many patients did not answer the phone. There were also patients who wanted to talk to their doctor, and they needed time to pull in their provider.

 

Tags

#pctGR, @Collaboratory1