NOACs Pricing, Reimbursement, and Access

DESCRIPTION

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 Research Company 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 EXECUTIVE SUMMARY

7 REGULATORY LABELS
7 Approved labels for marketed NOACs in the US, Japan, and five major EU markets
12 Bibliography

13 GLOBAL PAYER AND KEY OPINION LEADER INSIGHTS
13 Insights and strategic recommendations
13 The high cost of NOACs is a much greater concern in Europe than in the US
22 An ability to show a reduction in the rate of major bleeds using real-world clinical data should help uptake of NOACs
25 Payers generally view NOACs as highly similar from a clinical perspective
28 Pipeline insights
35 Bibliography

37 US PRICING

38 US REIMBURSEMENT
38 Insights and strategic recommendations
50 Bibliography

52 JAPAN
52 Price premiums are awarded for added benefit or innovation
53 Pricing of launched SPAF and VTE treatments
56 Bibliography

57 PRICING IN THE FIVE MAJOR EU MARKETS

58 FRANCE
58 Insights and strategic recommendations
86 Bibliography

88 GERMANY
88 Insights and strategic recommendations
101 Bibliography

103 ITALY
103 Insights and strategic recommendations
107 Bibliography

109 SPAIN
109 Insights and strategic recommendations
109 National reimbursement decisions are not a barrier to access
110 Regional formularies or assessments
113 Bibliography

115 UK
115 Insights and strategic recommendations
115 NICE approval is a key market access barrier
130 Regional formulary decisions
135 The SMC recommends the use of NOACs in SPAF and VTE
146 Bibliography

149 METHODOLOGY
149 Primary research
149 Price assumptions
151 Bibliography

LIST OF TABLES
8 Table 1: Marketed NOAC products and approved indications in the US, Japan, and five major EU markets
17 Table 2: Levers impacting access to anticoagulants in the five major EU markets
20 Table 3: Levers impacting access to NOACs in the US and five major EU markets
26 Table 4: French and German HTA decisions
37 Table 5: US pricing of key marketed drugs
40 Table 6: Prior authorization criteria for NOACs in six major health plans
42 Table 7: Formulary placement of NOACs in selected 2016 commercial formularies
44 Table 8: Formulary placement of NOACs in top 10 2016 Medicare Part D formularies
49 Table 9: Formulary placement of NOACs in selected large Medicaid states’ preferred drug lists
53 Table 10: Pricing premiums given to medicines that can demonstrate benefit over comparators in Japan
53 Table 11: Pricing of NOACs in Japan
55 Table 12: Price calculation methodologies for NOACs in Japan
57 Table 13: Pricing of key NOACs in the five major EU markets
59 Table 14: Transparency Commission’s ASMR ratings and pricing implications
60 Table 15: Transparency Committee’s SMR ratings and pricing implications
61 Table 16: Transparency Commission’s assessment of SPAF treatments in France
73 Table 17: Transparency Commission’s assessment of VTE treatments in France
80 Table 18: Transparency Commission’s assessment of Praxbind (reversal agent for Pradaxa) in France
89 Table 19: G-BA assessment of key SPAF therapies in Germany
95 Table 20: G-BA assessment of key VTE therapies in Germany
104 Table 21: AIFA’s reimbursement decisions for NOACs in Italy
106 Table 22: Reimbursement conditions for antidotes in Italy
107 Table 23: Local formulary decisions for NOACs in Italy
111 Table 24: Spain regional assessments of anticoagulants
117 Table 25: NICE assessments of key SPAF therapies in the UK
125 Table 26: NICE assessments of key VTE therapies in the UK
132 Table 27: Regional formulary decisions for SPAF therapies in the UK
134 Table 28: Regional formulary decisions for VTE therapies in the UK
136 Table 29: SMC decisions on key SPAF therapies
141 Table 30: SMC decisions on key VTE therapies
146 Table 31: SMC decisions on key antidotes
150 Table 32: Price sources and calculations, by country
151 Table 33: Exchange rates used for calculating prices

Samples

Table 5 – US pricing of key marketed drugs

Table 5 - US pricing of key marketed drugs

Table 7 – Formulary placement of NOACs in selected 2016 commercial formularies

Table 7 - Formulary placement of NOACs in selected 2016 commercial formularies

Author: Jack Allen
Published: 12 May 2017
Number of pages: 153
Price: $7,500
Formats: PDF, XLSX
Report code: DMKC0172764

To Procure or for More Info, Please Write us at: info@omensol.com

 

 

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