NOACs Pricing, Reimbursement, and Access

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A combination of the high cost of novel oral anticoagulants (NOACs) (relative to highly genericized vitamin K antagonists) and the large patient populations these drugs address, has resulted in this class of compounds being a top priority for European payers. The impact of NOACs on European budgets is so great that a UK payer stated that this represented their single largest budgetary concern over the past year. However, in the US, payers were not as concerned with the budgetary impact of the NOACs, citing that this falls outside of their top 20 budgetary concerns. Additionally, most interviewed US payer view NOACs as the new standard of care due to their reduction of serious bleeding events and hence cost saving as compared to vitamin K antagonists.

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Payers interviewed by Datamonitor Healthcare generally view the marketed NOAC compounds as highly similar, acknowledging that while there are some minor differences in the clinical data of these compounds, the rate of events in their trials is so low that it is hard to attribute these differences to the medications. Moving forward, payers view patients with poor renal function as an area of high unmet need.

Payers interviewed discussed how they would welcome a simple dosing regimen that would not need to be modified for patients with poor renal function; this “one size fits all” dosing regimen would simplify the prescribing of physicians and ensure that all of the patients received the correct dose regardless of their renal function.

However, payers cautioned that it is unlikely that improvements in treatment with respect to efficacy and safety can be achieved given the opposing coagulation and anticoagulation processes in the body. They also stress the importance of delivering game-changing improvements and emphasize that a new agent with the same mechanism of action would be unlikely to capture market share or even be reimbursed unless it targeted specific subpopulations that are currently underserved.

Opinions around the clinical attractiveness of betrixaban (pipeline medication in development for prophylaxis of venous thromboembolism) were split, with some viewing the results from the APEX trial as clinically relevant while others did not feel the medication provided benefit.

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