HIV Regulatory Practices and Their Influence Over Reimbursement Decisions


      This analysis compares the studies that four regulatory agencies used to make their decisions and compares the relationship between the reasons for regulatory decisions and reasons for reimbursement decisions.


      The scientific discussions and the studies used to make regulatory decisions for 15 different HIV drugs approved over the last 12 years (2000-2012) were compared for the FDA, EMA, Health Canada and Australia the Australian Therapeutic Goods Administration. The studies used to make regulatory decisions were then compared to the studies used in the reimbursement decisions of France, Scotland, Canada and Australia.


      In all 15 cases reviewed the FDA, EMA and Health Canada used at least one of the same studies to come to their decision and in 13 of the cases Australia also used that same study. In 14 cases the FDA approved the drug before the other regulatory authorities; the longest time before another regulatory agency approved a drug was 15 months for rilpivirine. In six cases the FDA commissioned studies that other regulatory bodies and reimbursement agencies used later. All of the studies were interventional studies. Reimbursement agencies always used studies that were previously cited in regulatory documents. These agencies would also use studies intended for the regulatory approval of another drug as a source for information in a review.


      Reimbursement agencies and other regulatory agencies are influenced by the FDA in the studies they consider, as illustrated by at least six cases in which other agencies used studies commissioned by the FDA after approval. This influence is easier to see in the last five years, but may be older than that due to improvements in published reports.