Summary
Interest in performance-based risk-sharing agreements (PBRSAs) in diagnostics have increased in recent years, following similar trends in pharmaceuticals.
Such deals allow patients to access innovative diagnostics earlier, whilst limiting payer risk, as continued coverage is subject to further evidence development, or linked to a measure of clinical outcomes.
A systematic review of publicly available performance-based risk-sharing agreements in the US, published in January 2022, identified 16 deals for non-imaging diagnostics, 88% of which were in oncology.
Due to confidential agreements in place, the number of diagnostics PBRSAs in the US may be well over these publicly available figures.
Harvard Pilgrim and Illumina struck a deal for non-invasive prenatal testing (NIPT) in 2018 and real-world evidence generated as a result showed demand for NIPT with minimal increase in costs for the Payer.
What are Performance-based Risk-Sharing Agreements and why do they matter in (early) access?
Performance-based risk-sharing agreements (PBRSAs), also known as managed entry arrangements or patient access schemes, are arrangements between a payer and a manufacturer, where the level or continuation of reimbursement is linked to the real-world performance of a product, such as health or economic outcomes, in a defined patient population over a specified period of time.
Well-designed PBRSAs allow patients to access innovative diagnostics earlier and facilitate market access for manufacturers. They can offer multiple benefits for payers in terms of cost containment, real-world evidence generation, and reductions in the uncertainty of long-term performance.
The first comprehensive systematic review of performance-based risk-sharing agreements in the United States for devices and diagnostics was published last month in the Journal of Managed Care & Specialty Pharmacy. We will focus on the data concerning diagnostics, and more specifically non-imaging diagnostics.
Learnings from the article
Following a strong trend for similar early-access pathways in pharmaceuticals, PBRSAs are increasingly more common for diagnostics.
There are 2 main types of PBRSAs:
1) Coverage with evidence development — where coverage is subject to generating additional evidence from a pre-defined study
2) performance-linked reimbursement (e.g. negotiating a lower price where the performance of a diagnostic does not meet a certain threshold).
Diagnostic manufacturers entered into PBRSAs with either US private health plans or public players (i.e., CMS, the Centers for Medicare & Medicaid Services).
A key player in the US diagnostics arena has been Palmetto GBA, a CMS contractor, with its data development program, which is a version of coverage with evidence development.
This typically involves an annual or biannual review of required manufacturer data submissions from prospective clinical studies on predefined patient outcomes by the contractor for continued coverage.
Multiple arrangements may exist for the same product under a different disease, but with different payers, and also for the same product in different disease areas.
Only 16 publicly available PBRSAs for non-imaging diagnostics in the US were identified for 2001-2020, with a noted increase in their frequency since 2014. This contrasts with devices where 30 deals were documented.
Amongst these 16 deals in non-imaging diagnostics, 14 covered oncology, namely precision medicine diagnostics, such as cancer classifier assays, genomic profiling or score, or epigenetic testing. One was a cardiology genetic test to predict warfarin responsiveness, and another was a genomic classifier test for interstitial lung disease. (Figure 1)
PBRSAs in non-imaging diagnostics by therapy area (%) N=16
A recent real-life example: Illumina and Harvard Pilgrim non-invasive prenatal test (NIPT)
In addition to this systematic review, a recent case of a risk-sharing deal between payer Harvard Pilgrim Health Care (HPHC) and NIPT manufacturer Illumina illustrates the potential benefits of PBRSAs.
Previously, NIPT, a more accurate test to screen for fetal gene anomalies, was only recommended for women above 35 or with other known risk factors. But in 2018, a deal struck between Harvard Pilgrim and Illumina made the test available to women under age 35, with average-risk pregnancies.
The partners anticipated that the cost of this test would be offset by reduced expenditures on other screening modalities. However, as part of risk-sharing, Illumina committed to cover any potential increased costs.
The arrangement also involved creating real-world data needed by payers and employers to demonstrate the clinical and economic value of the testing for the detection of fetal genetic anomalies.
In Sep 2021, study results of the real-world data were published, showing that thousands of women gained access to NIPT through the arrangement and suggesting that patients and physicians might have preferred this screening method.
Allowing women under 35 to access NIPT also resulted in minimal economic impact, increasing HPHC’s costs by less than 3 cents per member per month.
The publication of this real-world data comes after the American College of Obstetricians and Gynecologists (ACOG) updated their guideline to recommend NIPT to all pregnant women, not only those above 35. Other private Payers Aetna and United Healthcare had also updated their insurance policies to reflect this guideline.
However, real-world evidence generated via the HPHC and Illumina arrangement could provide assurance to more Payers to follow suit.
In the next article in this mini-series, we will look at the European diagnostic landscape, trends, and challenges as regards PBRSAs.
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