NOACs Pricing, Reimbursement, and Access
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.
Publisher: 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 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.
CONTENTS
6 OVERVIEW
7 EXECUTIVE SUMMARY
8 REGULATORY LABELS
8 Approved labels for marketed NOACs in the US, Japan, and five major EU markets
13 Bibliography
14 GLOBAL ACCESS LEVERS
14 The high cost of NOACs is a much greater concern in Europe than in the US
23 Bibliography
24 EVIDENCE AND VALUE
24 An ability to show a reduction in the rate of major bleeds using real-world clinical data should help uptake of NOACs
25 Concerns remain about the transferability of trial results into clinical practice
32 ACCESS TO RECENTLY APPROVED AND PIPELINE PRODUCTS
32 Payers generally view NOACs as highly similar from a clinical perspective
35 Betrixaban will be competing with enoxaparin for hospital budgets
39 Approval of companion antidotes will not affect reimbursement decisions
41 Bibliography
43 PRICING
44 US
44 Insights and strategic recommendations
56 Bibliography
58 JAPAN
58 Price premiums are awarded for added benefit or innovation
60 Bibliography
62 FRANCE
62 Insights and strategic recommendations
88 Bibliography
90 GERMANY
90 Insights and strategic recommendations
103 Bibliography
105 ITALY
105 Insights and strategic recommendations
109 Bibliography
111 SPAIN
111 Insights and strategic recommendations
111 National reimbursement decisions are not a barrier to access
111 Regional formularies or assessments
115 Bibliography
117 UK
117 Insights and strategic recommendations
117 NICE approval is a key market access barrier
132 Regional formulary decisions
137 The SMC recommends the use of NOACs in SPAF and VTE
149 Bibliography
151 METHODOLOGY
151 Primary research
151 Price assumptions
153 Bibliography
LIST OF TABLES
9 Table 1: Marketed NOAC products and approved indications in the US, Japan, and five major EU markets
18 Table 2: Levers impacting access to anticoagulants in the five major EU markets
21 Table 3: Levers impacting access to NOACs in the US and five major EU markets
34 Table 4: French and German HTA decisions
43 Table 5: Pricing of the NOACs in the seven major markets
46 Table 6: Prior authorization criteria for NOACs in six major health plans
48 Table 7: Formulary placement of NOACs in selected 2016 commercial formularies
50 Table 8: Formulary placement of NOACs in top 10 2016 Medicare Part D formularies
55 Table 9: Formulary placement of NOACs in selected large Medicaid states’ preferred drug lists
58 Table 10: Pricing premiums given to medicines that can demonstrate benefit over comparators in Japan
60 Table 11: Price calculation methodologies for NOACs in Japan
63 Table 12: Transparency Commission’s ASMR ratings and pricing implications
64 Table 13: Transparency Committee’s SMR ratings and pricing implications
65 Table 14: Transparency Commission’s assessment of SPAF treatments in France
77 Table 15: Transparency Commission’s assessment of VTE treatments in France
83 Table 16: Transparency Commission’s assessment of Praxbind (reversal agent for Pradaxa) in France
91 Table 17: G-BA assessment of key SPAF therapies in Germany
97 Table 18: G-BA assessment of key VTE therapies in Germany
106 Table 19: AIFA’s reimbursement decisions for NOACs in Italy
108 Table 20: Reimbursement conditions for antidotes in Italy
109 Table 21: Local formulary decisions for NOACs in Italy
113 Table 22: Spain regional assessments of anticoagulants
119 Table 23: NICE assessments of key SPAF therapies in the UK
127 Table 24: NICE assessments of key VTE therapies in the UK
134 Table 25: Regional formulary decisions for SPAF therapies in the UK
136 Table 26: Regional formulary decisions for VTE therapies in the UK
138 Table 27: SMC decisions on key SPAF therapies
143 Table 28: SMC decisions on key VTE therapies
149 Table 29: SMC decisions on key antidotes
152 Table 30: Price sources and calculations, by country
153 Table 31: Exchange rates used for calculating prices
Table 5: US pricing of key marketed drugs
Table 7: Formulary placement of NOACs in selected 2016 commercial formularies
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