NEW YORK – Diagnostics and pharmaceutical companies have formed coalitions to improve education and widen insurance coverage of comprehensive genomic profiling (CGP), recognizing that barriers to testing are limiting patients' access to precision oncology treatments.
One group, Access to Comprehensive Genomic Profiling Coalition (ACGP), is focusing its advocacy on payors, while another group, Precision Cancer Consortium (PCC), is working on educating doctors, patients, and health system stakeholders and creating streamlined workflows for efficiently using CGP for clinical trial matching. Both of these groups hope to improve access to CGP through their advocacy and increase the number of patients who receive precision cancer treatment or are eligible for targeted therapy clinical trials.
ACGP defines CGP as next-generation sequencing-based tests that detect, in various sample types, gene substitutions, insertions and deletions, copy number alterations, and rearrangements or fusions. While there is national Medicare coverage in the US for NGS panels to inform treatment for advanced cancer patients, there is uneven coverage for patients covered by commercial insurance plans, said Maude Champagne, treasurer of ACGP.
"The access problem [for CGP] was the reverse [of] what we typically see: where the Medicare population has access, but commercially insured population does not have wide access to it," she said, explaining that once diagnostics companies in this space realized this was a problem that impacted them all, they decided to band together under the banner of ACGP to try to "solve [it] together in a much more efficient way."
ACGP was founded in late 2020 by a group of diagnostics firms, and this year, ACGP began adding pharma companies to its membership to help boost its message. The group's mission is to improve access to CGP by educating insurers about the clinical utility and economic value of these assays in cancer care.
The founding members of the coalition are Exact Sciences, Foundation Medicine, Illumina, Labcorp, Qiagen, Roche Diagnostics, and Thermo Fisher Scientific. Champagne, who is also director of market access, strategy, and operations at Illumina, said the idea for the coalition sparked during a hallway conversation among folks from different diagnostics firms at a conference where they realized how pervasive coverage issues really were.
"Our engagement is with the payors directly," Champagne said. "We've aligned on a single narrative of what is the role of CGP, what is the benefit that it brings into the healthcare system. We have these discussions with payors to tell them what the clinical and economic utility is [for CGP] and what it brings to the healthcare system."
These conversations are particularly necessary, the group has found, since the 2015 publication of the randomized SHIVA study from France, which failed to show that genomically matched treatments improved patients' outcomes. Those findings, Champagne noted, has left their mark on coverage decisions in the US. "We do find American payors that are referring back to SHIVA saying that one prospective trial showed there was no benefit [to CGP]," she said.
While SHIVA wasn't the ringing endorsement of the utility of precision oncology the diagnostics industry would have liked to have seen, some experts have argued that the study shouldn't be a black mark against genomic profiling since the lack of benefit for some patients was due to deficiencies of the study framework and broader access barriers, such as the lack of targeted therapies and incorrect therapy matching.
Added to this is the fact that it can be difficult to capture CGP's true value to the healthcare system. A 2022 review that explored health technology value assessments of genomic profiling in England, Canada, Australia, and New Zealand found that the assessment processes do not consider the systemic benefits of wider CGP use such as impacts on clinical trial participation.
One of the benefits of forming the coalition is it increases the diagnostic industry's collective power to generate the evidence payors want for CGP, as compared to what they could do individually. Toward that end, ACGP recently launched a working group focused on evidence generation to support the clinical utility of CGP, but the group is still in the early stages, Champagne noted.
"Evidence generation is something that's costly and time consuming," she said. "Now that we've heard some of the objections from payors, we're looking into creating evidence that can be in the public domain that would help better inform payors when they're making decisions about CGP."
If more pharma companies eventually join the group, it could further bolster the group's power to advocate for CGP coverage because the drugmakers "effectively created the need for CGP," Champagne said. So far, ACGP's pharma members include Blueprint Medicines, AstraZeneca, and Loxo Oncology.
The group will round out its advocacy for CGP by including perspectives from provider and patient communities. ACGP wants to partner with patient advocacy groups, oncology medical associations, and individual oncologists and discuss their experiences using CGP in conversations with payors.
Drugmakers raising awareness of tests
PCC, which was founded more recently in April, has focused its initial efforts on educating diverse stakeholders in the healthcare community. The group has six pharma and biotech members, including Roche, Bayer, GlaxoSmithKline, and Novartis, which founded the group, and recent additions Eli Lilly and Janssen.
The group held its first virtual education session in September, focused on precision oncology and community care in five countries. The group is hoping to draw in patients, healthcare providers, and health authorities with these education sessions and increase their awareness of the value of genomic testing.
"The PCC aims to make precision oncology and genomic testing the new normal, by supporting efforts to improve patient access to CGP in routine care and in clinical trials," a spokesperson for the group said in an email statement.
When drugmakers' therapies, and associated revenues, rely on genomic testing to identify eligible patients, it's not unusual for sponsors to spearhead education campaigns to raise awareness of the need to test. For example, Boehringer Ingelheim in 2012 launched the Let's Test campaign to raise awareness of the need to test non-small cell lung cancer patients for EGFR mutations and ALK rearrangements to determine their eligibility for targeted therapies. The company was setting the stage for an EGFR inhibitor it was developing at the time, which is now known as Gilotrif (afatinib).
A decade later, the field has increasingly moved away from single-gene testing to large NGS panels to inform cancer treatment. And the formation of PCC suggests that drugmakers collectively recognize that this diagnostic technology is a critical bridge linking their products to the patients who have the best chance of benefiting from them.
PCC's first goal is to disseminate criteria for assessing the benefit of comprehensive genomic testing to guide decision-making in cancer care. A second goal is to develop an ambassador program to engage providers and health systems and support the implementation of precision medicine in healthcare systems.
Separately, the PCC member companies also hope to develop "analytical capabilities" that more efficiently leverage genomic testing to identify clinical trials options for patients. The Clinical Matching Program is still in the early stages, but PCC intends to collaborate with existing matching platforms and develop tools to improve them, rather than create its own.
Toward this end, the PCC's Clinical Matching Program, "aims to improve trial matching by reducing inefficiencies and avoiding multiple screenings while using molecular information in a more economic way," a PCC spokesperson said.
Addressing cost misconceptions
Insurers often have perceptions of how much CGP and the downstream targeted therapies may cost, but ACGP is helping payors better understand how the tests are billed and how clinical trial costs are handled.
One area of education is the role insurers play in clinical trials, which are often the only avenues for accessing investigational precision oncology therapies for many patients. Most commercial insurers are required under the Patient Protection and Affordable Care Act to cover routine patient care costs in clinical trials, such as office visits and lab tests, if a patient is eligible for the study. The cost of the investigational drug and any additional tests done purely for research purposes are often covered by the trial sponsor.
"There's a bit of a misconception that patients may get a lot of fancy ancillary tests that go with a clinical trial that would be the responsibility of the payor and would incur more costs," Champagne said.
For example, a 2021 retrospective study of insurance costs for patients enrolled in a lung cancer trial showed savings of more than $5,500 per month for commercial insurers for patients on the trial versus patients receiving standard-of-care systemic therapy.
ACGP also helps insurers understand how CGP can be used economically and how hospitals bill for genomic profiling. Champagne said many health systems' billing codes group genomic profiling into two categories: tests interrogating less than 50 genes and tests for 51 or more genes. A large CGP assay that interrogates 300 genes, for example, may be billed the same way as a test that is much smaller, Champagne said.
"We have to address the perception of cost; there's this idea that 500 genes might be very expensive compared to 50, but the reality isn't necessarily so," Champagne said. "If you consider the number of single-gene biomarker tests that are necessary across the patient cancer journey, it's much more cost efficient to actually go with CGP upfront than to go through all of the single-gene assays."
As more biomarker-informed therapies are approved, Champagne is optimistic that insurers will also become more open to covering larger CGP panels upfront. One tipping point may come as diagnostics companies garner more approvals for biomarker tests that can guide tissue-agnostic treatment, she said. There are currently five biomarker tests that have such approvals, including tumor mutation burden at 10 mutations per megabase and above, microsatellite instability, as well as NTRK, BRAF, and RET mutations.
"Now that we have five biomarkers across all tumor types that have a therapeutic associated with it, and if you add on top of those the specific biomarkers that are relevant in each tumor type, there's a moment where it's going to tip the scale, where you know it's going to make more sense to order a CGP panel upfront to make sure that what's on guideline is covered," Champagne said. "A number of payors have been saying that the tipping number was five [pan-tumor] biomarkers."