Global Novel Oral Anticoagulants (NOACs) Pricing, Reimbursement, and Access Markets 2017 - Focus on the US and Europe

Dublin, July 20, 2017 -- The "NOACs Pricing, Reimbursement, and Access" report has been added to Research and Markets' offering.

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.

Key Topics Covered:

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

For more information about this report visit https://www.researchandmarkets.com/research/85lxzr/noacs_pricing

CONTACT: Research and Markets
         Laura Wood, Senior Manager
         [email protected]
         For E.S.T Office Hours Call 1-917-300-0470
         For U.S./CAN Toll Free Call 1-800-526-8630
         For GMT Office Hours Call +353-1-416-8900
         U.S. Fax: 646-607-1907
         Fax (outside U.S.): +353-1-481-1716
         Related Topics: Cardiovascular Drugs