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Bladder Cancer Pricing, Reimbursement, and Access

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    Report

  • 79 Pages
  • September 2018
  • Region: Global
  • Citeline
  • ID: 4775347

Overview


  • Payers are concerned about the budget impact of immunotherapies in oncology as a whole, rather than bladder cancer as an indication
  • Payers are likely to enter preferential contracts/tenders with immunotherapies in the future
  • Roche’s pricing strategy is securing Tecentriq access in the second line
  • Opdivo is not reimbursed across Europe in the second line
  • Payers may be more lenient with erdafitinib due to its targeted nature

Highlights


  • The cost of bladder cancer treatment is not a huge concern for payers due to the relatively small patient numbers, however, they are worried about the overall budget impact of immunotherapies across all indications.
  • Checkpoint inhibitors present an attractive target for future contracting due to the high budget impact of the class. However, products must be deemed therapeutically equivalent across a wide breadth of indications before these practices can take place.
  • Payers highlight the growing value of time to subsequent therapy as a supportive endpoint for immunotherapies. With many clinical trials now designed to treat until “loss of clinical benefit” rather than progression, payers frequently cite the relevance of this endpoint versus PFS.
  • Roche’s competitive pricing strategy is securing Tecentriq access in the second-line setting. Merck & Co is likely to be less willing to reduce the price of Keytruda to account for the uncertainty surrounding the drug’s efficacy in bladder cancer, in order to avoid losing revenue in other, more established indications.
  • Opdivo is not recommended for reimbursement in the second-line setting across Europe due to a lack of Phase III data. With no Phase III trial in development, payers indicate that the manufacturers are focusing their efforts on the combination with Yervoy for first-line patients.

Key Questions Answered


  • What access controls are currently in place for bladder cancer medicines?
  • What new cost-control measures are likely to be implemented in the future?
  • What clinical trial evidence do payers desire for immune checkpoint inhibitors?
  • How will increased competition among the immunotherapy drug class impact cost?
  • How is Roche’s competitive pricing strategy impacting Tecentriq’s access?

Table of Contents

OVERVIEW
REGULATORY LABELS
Bibliography
GLOBAL ACCESS LEVERS
Payers are concerned about the budget impact of immunotherapies in oncology, not bladder cancer as an indication
Moderate cost-control techniques are implemented for bladder cancer therapies, but these tend not to be specific for IOs
Payers are concerned about potential approvals of immunotherapy combinations in bladder cancer, but there are currently no specific controls
The prices of PD-1/PD-L1 inhibitors are decreasing as competition heats up
Immunotherapy drugs present an opportunity for contracting, but payers await more competition
EVIDENCE AND VALUE
Importance of bladder cancer clinical trial endpoints in the US and five major EU markets
Median overall survival remains the gold-standard endpoint for bladder cancer
Time to subsequent therapy and PFS2 are becoming increasingly valued by payers
QoL is mostly tied to safety, but can support added benefit assessment in some markets
Duration of response is a key point of differentiation for physicians, but payers prefer alternative endpoints
Payers in the UK prefer clinical trials with time-based stopping criteria; others are more focused on cost control through price negotiations
AEs could be a distinguishing feature if price and efficacy are equivalent
Payers consider sequencing trials to be valuable in early treatment lines, and for combination therapies
Complete response rates are accepted by some payers in the neoadjuvant setting
Bibliography
ACCESS TO RECENTLY APPROVED AND PIPELINE DRUGS
Lower administration frequencies are preferred for immunotherapies, but overall cost is the most important factor
Second-line advanced bladder cancer
First-line advanced bladder cancer
Payers are likely to be lenient with erdafitinib due to its targeted nature and the high unmet need within the advanced bladder cancer population
PRICING
US
Insights and strategic recommendations
CANADA
Insights and strategic recommendations
JAPAN
Insights and strategic recommendations
Bibliography
FRANCE
Insights and strategic recommendations
ASMR rating has an impact on pricing
Bibliography
GERMANY
Insights and strategic recommendations
Positive assessment from the G-BA will impact price negotiations
Bibliography
ITALY
Insights and strategic recommendations
SPAIN
Insights and strategic recommendations
National reimbursement decisions are not a major access barrier in Spain
UK
Insights and strategic recommendations
NICE and SMC assessments drive reimbursement decisions
METHODOLOGY
Primary research
Price assumptions
Exchange rates
Bibliography
LIST OF FIGURES
Figure 1: Price sources and calculations, by country
LIST OF TABLES
Table 1: Marketed bladder cancer products and approved indications in the US, Japan, and five major EU market
Table 2: Key access levers for bladder cancer therapies across the US and five major EU markets
Table 3: Future use of contracts/tenders for immunotherapies across the US and five major EU markets
Table 4: Importance of bladder cancer clinical trial endpoints in the US and five major EU markets, by country
Table 5: Payer views on time-based stopping rules for immunotherapies in the US and five surveyed EU markets
Table 6: Importance of immunotherapy administration frequency for payers in the US and five surveyed EU markets
Table 7: Reimbursement of Tecentriq, Keytruda, and Opdivo in second-line advanced bladder cancer across the US and five major EU markets, by country
Table 8: Pricing of key bladder cancer drugs in the US, Japan, and five major EU markets, by country
Table 9: Pricing premiums given to medicines in Japan that can demonstrate benefit over comparators
Table 10: Transparency Committee's ASMR ratings and pricing implications
Table 11: Transparency Committee's SMR ratings and pricing implications
Table 12: Exchange rates used for calculating branded drug prices