A new study examining medical policy determinations for pharmacogenetic (PGx) testing among major US health plans has revealed substantial inconsistencies in coverage policies, potentially limiting patient access to precision medicine approaches.
The analysis, published in The American Journal of Managed Care, evaluated coverage policies for 65 clinically relevant drug-gene pairs across eight major health insurers, three laboratory benefit managers (LBMs), and Medicare's Molecular Diagnostic Services (MolDX) program.
Key Coverage Findings
The research found striking disparities in coverage policies. MolDX demonstrated the most comprehensive coverage, including all 65 drug-gene pairs evaluated. This was followed by Avalon Healthcare Solutions (50 pairs) and UnitedHealthcare (45 pairs). However, eight of the twelve policies reviewed covered 10 or fewer drug-gene pairs, highlighting significant coverage limitations among many insurers.
Only three policies - from MolDX, Avalon, and UnitedHealthcare - indicated coverage for multi-gene panel testing, despite recent evidence showing these panels can reduce adverse drug reactions by 30%.
Evidence Evaluation Patterns
The study revealed interesting patterns in how insurers evaluate evidence for coverage decisions. Society guidelines were the most frequently cited evidence source, with 413 total citations across all policies. The Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines were particularly influential, being cited 271 times.
Other commonly referenced sources included:
- Randomized controlled trials and prospective studies
- Retrospective association studies
- Systematic reviews and meta-analyses
- Guidelines from organizations like the National Comprehensive Cancer Network (NCCN)
Notably, cost-effectiveness studies were infrequently cited, appearing only 43 times across all medical policies, despite evidence suggesting many PGx tests are cost-effective or cost-saving.
Impact on Healthcare Access
The variability in coverage policies has significant implications for healthcare access and equity. Without insurance coverage, patients may face substantial out-of-pocket costs for PGx testing, which can range from $200 to over $500 per test. The actual cost billed to insurers may be even higher depending on vendor or hospital laboratory policies.
"It is imperative that third-party payers take steps to increase transparency regarding their evidence thresholds for determining clinical utility and coverage of PGx tests," the study authors noted. They emphasized that clear and standardized evidence thresholds could facilitate more consistent coverage decisions and enhance patient access to evidence-based PGx testing.
Future Directions
The researchers called for several key improvements:
- Development of uniform health technology assessment guidelines
- Greater transparency in evidence evaluation processes
- Increased consideration of cost-effectiveness data
- Standardization of coverage determination processes
These changes could help ensure more equitable access to PGx testing while maintaining evidence-based standards for coverage decisions.
The study highlights the urgent need for collaboration between payers and the PGx community to standardize evidence evaluation processes, which could lead to more consistent coverage policies and improved patient access to beneficial genetic testing.
