Tuesday, June 20, 2023

UCSF: Papers on Liquid Biopsy: (1) Payor Policy for LBX & MRD Today; (2) MCED and Payor Views and Forecasts

Two papers currently from the UCSF TRANSPERS team.

The first, Douglas et al., in JNCCN, looks at payor policies for liquid biopsy (both for oncogenes, like EGFR, and for relapse, e.g. minimal residual disease).  Find the paper here.  See also the op ed by Socal here.   (Douglas et al. had surveyed ctDNA policies up to 2019 in 2020 here.)

The second, Trosman et al, is in Health Affairs Scholar and reports a study of the views of private payers today, as they look towards coverage of MCED in the future (multi cancer early detection.)  Find Trosman et al. here.   

(This paper is distinguished by being a formal structured survey about MCED.  Some prior policy papers have been consensus documents or the organized best-thinking of a few author-experts e.g. Kisiel.)


Here are some takeaways from the abstract of Douglas et al.

  •  A total of 71 of 1,066 total policies met study inclusion criteria, of which 57 were private policies and 14 were Medicare LCDs.
    • 70% of private policies and 100% of Medicare LCDs covered at least one indication. 
  • Among 57 private policies, 89% specified a policy for at least 1 clinical indication, with coverage for ctDNA for initial treatment selection most common (69%). 
  • Of 40 policies addressing progression, coverage was provided 28% of the time, and of 20 policies addressing MRD, coverage was provided 65% of the time. 
    • Non-small cell lung cancer (NSCLC) was the cancer type most frequently covered for initial treatment (47%) and progression (60%).
  • Among policies with ctDNA coverage, coverage was restricted to patients without available tissue or in whom biopsy was contraindicated in 91% of policies. MRD was commonly covered for hematologic malignancies (30%) and NSCLC (25%). 
  • Of the 14 Medicare LCD policies, 64% provided coverage for initial treatment selection and progression, and 36% for MRD.  
  • Concluding: Some private payers and Medicare LCDs provide coverage for ctDNA testing. Private payers frequently cover testing for initial treatment, especially for NSCLC, when tissue is insufficient or biopsy is contraindicated. Coverage remains variable across payers, clinical indications, and cancer types despite inclusion in clinical guidelines, which could impact delivery of effective cancer care.


Here are some takeaways from the discussion section of Trosman on MCED:

  • Our study provides the first empirical evidence on payer coverage considerations and evidence needs for MCED with a cohort of U.S. private payers. 
  • We found that 84% of payers saw potential merit in using MCED tests for cancers that lack screening, but only 37% agreed with using it as a gateway to existing screening. The most frequent barriers to coverage were the inclusion of cancers without a proven benefit from early diagnosis (74%), perceived high false-negative rates (53%), and the lack of evaluative protocols for unconfirmed cancers (53%). 
  • For evidence, 58% would accept surrogate endpoints versus mortality data and 64% would accept rigorous real-world evidence versus an RCT. The majority (74%) did not expect MCED tests to reduce disparities unless access barriers to downstream care are reduced and MCED testing is covered by Medicaid.

An unedited GPT4 AI view of Trosman/MCED is here.