A Comparison of Coverage Restrictions for Biopharmaceuticals and Medical Procedures.

BACKGROUND

Differences in payer evaluation and coverage of pharmaceuticals and medical procedures suggest that coverage may differ for medications and procedures independent of their clinical benefit. We hypothesized that coverage for medications is more restricted than corresponding coverage for nonmedication interventions.

METHODS

We included top-selling medications and highly utilized procedures. For each intervention-indication pair, we classified value in terms of cost-effectiveness (incremental cost per quality-adjusted life-year), as reported by the Tufts Medical Center Cost-Effectiveness Analysis Registry. For each intervention-indication pair and for each of 10 large payers, we classified coverage, when available, as either "more restrictive" or as "not more restrictive," compared with a benchmark. The benchmark reflected the US Food and Drug Administration label information, when available, or pertinent clinical guidelines. We compared coverage policies and the benchmark in terms of step edits and clinical restrictions. Finally, we regressed coverage restrictiveness against intervention type (medication or nonmedication), controlling for value (cost-effectiveness more or less favorable than a designated threshold).

RESULTS

We identified 392 medication and 185 procedure coverage decisions. A total of 26.3% of the medication coverage and 38.4% of the procedure coverage decisions were more restrictive than their corresponding benchmarks. After controlling for value, the odds of being more restrictive were 42% lower for medications than for procedures. Including unfavorable tier placement in the definition of "more restrictive" greatly increased the proportion of medication coverage decisions classified as "more restrictive" and reversed our findings.

CONCLUSIONS

Therapy access depends on factors other than cost and clinical benefit, suggesting potential health care system inefficiency.