NOACs Pricing, Reimbursement, and Access

  • ID: 4331629
  • Report
  • 153 pages
  • Datamonitor Healthcare
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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.

Payers interviewed 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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Executive Summary

Regulatory Labels
  • Approved labels for marketed NOACs in the US, Japan, and five major EU markets
  • Bibliography
Global Payer and Key Opinion Leader Insights
  • Insights and strategic recommendations
  • The high cost of NOACs is a much greater concern in Europe than in the US
  • An ability to show a reduction in the rate of major bleeds using real-world clinical data should help uptake of NOACs
  • Payers generally view NOACs as highly similar from a clinical perspective
  • Pipeline insights
  • Bibliography
US Pricing

US Reimbursement
  • Insights and strategic recommendations
  • Bibliography
Japan
  • Price premiums are awarded for added benefit or innovation
  • Pricing of launched SPAF and VTE treatments
  • Bibliography
Pricing in the Five Major EU Markets

France
  • Insights and strategic recommendations
  • Bibliography
Germany
  • Insights and strategic recommendations
  • Bibliography
Italy
  • Insights and strategic recommendations
  • Bibliography
Spain
  • Insights and strategic recommendations
  • National reimbursement decisions are not a barrier to access
  • Regional formularies or assessments
  • Bibliography
UK
  • Insights and strategic recommendations
  • NICE approval is a key market access barrier
  • Regional formulary decisions
  • The SMC recommends the use of NOACs in SPAF and VTE
  • Bibliography
Methodology
  • Primary research
  • Price assumptions
  • Bibliography
List of Tables:
Table 1: Marketed NOAC products and approved indications in the US, Japan, and five major EU markets
Table 2: Levers impacting access to anticoagulants in the five major EU markets
Table 3: Levers impacting access to NOACs in the US and five major EU markets
Table 4: French and German HTA decisions
Table 5: US pricing of key marketed drugs
Table 6: Prior authorization criteria for NOACs in six major health plans
Table 7: Formulary placement of NOACs in selected 2016 commercial formularies
Table 8: Formulary placement of NOACs in top 10 2016 Medicare Part D formularies
Table 9: Formulary placement of NOACs in selected large Medicaid states’ preferred drug lists
Table 10: Pricing premiums given to medicines that can demonstrate benefit over comparators in Japan
Table 11: Pricing of NOACs in Japan
Table 12: Price calculation methodologies for NOACs in Japan
Table 13: Pricing of key NOACs in the five major EU markets
Table 14: Transparency Commission's ASMR ratings and pricing implications
Table 15: Transparency Committee's SMR ratings and pricing implications
Table 16: Transparency Commission's assessment of SPAF treatments in France
Table 17: Transparency Commission's assessment of VTE treatments in France
Table 18: Transparency Commission's assessment of Praxbind (reversal agent for Pradaxa) in France
Table 19: G-BA assessment of key SPAF therapies in Germany
Table 20: G-BA assessment of key VTE therapies in Germany
Table 21: AIFA’s reimbursement decisions for NOACs in Italy
Table 22: Reimbursement conditions for antidotes in Italy
Table 23: Local formulary decisions for NOACs in Italy
Table 24: Spain regional assessments of anticoagulants
Table 25: NICE assessments of key SPAF therapies in the UK
Table 26: NICE assessments of key VTE therapies in the UK
Table 27: Regional formulary decisions for SPAF therapies in the UK
Table 28: Regional formulary decisions for VTE therapies in the UK
Table 29: SMC decisions on key SPAF therapies
Table 30: SMC decisions on key VTE therapies
Table 31: SMC decisions on key antidotes
Table 32: Price sources and calculations, by country
Table 33: Exchange rates used for calculating prices
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