Renal Cell Cancer Pricing, Reimbursement, and Access
Renal Cell Cancer Pricing, Reimbursement, and Access
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There is moderate concern among payers regarding spend on renal cell cancer (RCC) drugs, but access restrictions remain mild.
Publisher: Datamonitor Healthcare
- Highlights
- Description
- Contents
Highlights
- Spend on RCC medicines is a moderate level concern for payers, but few utilization management mechanisms are in place due to the smaller spend in the indication compared to more prevalent cancers.
- Combination therapies pose challenges for payers as many markets do not have a clear path for HTA assessment and price negotiation for these products.
- Contracting in RCC may occur in the future, but for now the practice is limited to a small fragment of the market within the TKI class. Payers express more enthusiasm regarding contracting for immuno-oncology compounds due to the absence of differentiation and headto- head trials, along with a higher budget impact.
- Manufacturers are exploring the use of TKI inhibitors and immuno-oncology compounds in adjuvant settings. Clinical trials for these settings are required to produce more stringent evidence to support their use. Accepted endpoints such as DFS or OS require lengthy trial durations (five years on average).
- Preferred use of Cabometyx versus Opdivo in the first and second line will likely be up to physician choice, due to the absence of headto- head trials. Physicians may look to safety and method of administration in determining preferred choice on an individual patient-bypatient basis.
Key Questions Answered
- What access controls are currently in place for RCC medicines?
- How likely is it that contracting practices will occur in this indication?
- What is the likely pricing strategy for combination therapies, which have the potential to double payers’ expenditures?
- What are payers’ perceptions regarding the use of RCC medicines in the adjuvant setting?
- What factors will likely contribute to payers’ preference for Opdivo or Cabometyx in second-line use?
Overview
There is moderate concern among payers regarding spend on renal cell cancer (RCC) drugs, but access restrictions remain mild. Spend in RCC is among the top five oncology indications. Although payers could receive some reprieve with patent expirations for key drugs such as Sutent and Avastin, these savings are likely to be offset by the abundance of pipeline therapies in development. A significant portion of these involve using combination therapies, which could potentially double the cost of treatment. Despite concerns regarding growing spend, most payers do not have strict management utilization strategies. European payers have narrowed patient populations eligible for reimbursement, but most are in line with clinical trial inclusion and exclusion criteria. US payers report an especially challenging environment to control access to RCC medicines.
CONTENTS
6 OVERVIEW
7 REGULATORY LABELS
7 Marketed renal cell cancer products in the US, Japan, and five major EU markets
11 Bibliography
13 GLOBAL ACCESS LEVERS
14 Expenditure on RCC medicines poses a moderate concern for payers
15 Pipeline compounds, and particularly combinations, have some payers concerned
16 Access to RCC medicines is subject to mild restrictions
22 Contracting is expected to be used more widely in the future
23 Combination treatments may present a particular challenge in the future, especially if developed by different manufacturers
29 EVIDENCE AND VALUE
29 Importance of RCC clinical trial endpoints in the US and five major EU markets
33 Median overall survival remains the gold standard endpoint for RCC
37 Complete response rate is valued by physicians, but not by payers
38 Quality of life is mostly tied to safety, but can support added benefit assessments in some markets
39 Safety differences among products could impact HTA evaluations, and differences in hospitalizations are most relevant for payers
40 UK payers prefer clinical trials with strict stopping criteria, while others continue to focus on pricing to manage costs
43 Presenting evidence of value along the entire treatment pathway through sequencing studies would be valued, especially for combinations
46 Biomarker stratification will be critical for optimizing placement in the future treatment agorithm
47 Bibliography
48 ACCESS TO RECENTLY APPROVED AND PIPELINE DRUGS
49 Combination therapies Tecentriq + Avastin and Opdivo + Yervoy are likely to be reimbursed in first-line RCC
56 Cabometyx’s Phase II data lack power to convince payers of the added benefit over Sutent
58 National bodies leave the choice between second-line options Cabometyx and Opdivo to physicians
61 Treatments targeting the adjuvant setting continue to face a number of challenges
62 Price benchmarks for PD-1 inhibitors in RCC are reliant upon other approved indications
65 PRICING
68 US
68 Insights and strategic recommendations
69 Bibliography
70 CANADA
71 JAPAN
71 Insights and strategic recommendations
71 Japan’s pricing strategy is reliant on pricing premiums for innovative medicines
75 Bibliography
76 FRANCE
76 Insights and strategic recommendations
77 ASMR rating has an impact on pricing
78 Bibliography
79 GERMANY
79 Insights and strategic recommendations
79 Positive assessment from the G-BA will impact price negotiations
80 Bibliography
81 ITALY
81 Insights and strategic recommendations
82 Bibliography
84 SPAIN
84 Insights and strategic recommendations
84 National reimbursement decisions are not a major access barrier in Spain
84 Regional access to RCC treatments varies in Spain
85 Bibliography
86 UK
86 Insights and strategic recommendations
87 NICE approval is a key market access barrier
87 Bibliography
88 METHODOLOGY
88 Primary research
88 Price assumptions
89 Exchange rates
90 Bibliography
LIST OF FIGURES
89 Figure 1: Price sources and calculations for the US and five major EU markets, by country
LIST OF TABLES
8 Table 1: Marketed products and their approved indications for RCC in the US, Japan, and five major EU markets
18 Table 2: Levers impacting access to RCC drugs in the US and five major EU markets, by country
25 Table 3: Pricing, market access, and reimbursement strategies for combination therapies
30 Table 4: Importance of key endpoints in RCC clinical trial design, by country
50 Table 5: Likely reimbursement of first-line combination therapies in RCC, by country
57 Table 6: Pricing and reimbursement prospects for Cabometyx in the first line, by country
59 Table 7: Preference for second-line treatment: Opdivo versus Cabometyx, by country
63 Table 8: Pricing strategies for the PD-1 inhibitors, by country
66 Table 9: Pricing of key RCC drugs in the US, Japan, and five major EU markets, by country
69 Table 10: NCCN guidelines for RCC medicines
72 Table 11: Japan – pricing premiums given to medicines that can demonstrate benefit over comparators
73 Table 12: Price calculation methodologies for RCC drugs in Japan launched after 2008
77 Table 13: Transparency Committee’s ASMR ratings and pricing implications
78 Table 14: Transparency Committee’s SMR ratings and pricing implications
82 Table 15: AIFA web registry and managed entry agreements for RCC drugs
85 Table 16: Spanish Society of Hospital Pharmacy ratings
90 Table 17: Exchange rates used for calculating drug prices
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