2018 Study on Renal Cell Cancer Pricing, Reimbursement, and Access – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Renal Cell Cancer Pricing, Reimbursement, and Access” report has been added to ResearchAndMarkets.com’s offering.

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.

Key Topics Covered

OVERVIEW

REGULATORY LABELS

Marketed renal cell cancer products in the US, Japan, and five major EU markets

Bibliography

GLOBAL ACCESS LEVERS

Expenditure on RCC medicines poses a moderate concern for payers

Pipeline compounds, and particularly combinations, have some payers concerned

Access to RCC medicines is subject to mild restrictions

Contracting is expected to be used more widely in the future

Combination treatments may present a particular challenge in the future, especially if developed by different manufacturers

EVIDENCE AND VALUE

Importance of RCC clinical trial endpoints in the US and five major EU markets

Median overall survival remains the gold standard endpoint for RCC

Complete response rate is valued by physicians, but not by payers

Quality of life is mostly tied to safety, but can support added benefit assessments in some markets

Safety differences among products could impact HTA evaluations, and differences in hospitalizations are most relevant for payers

UK payers prefer clinical trials with strict stopping criteria, while others continue to focus on pricing to manage costs

Presenting evidence of value along the entire treatment pathway through sequencing studies would be valued, especially for combinations

Biomarker stratification will be critical for optimizing placement in the future treatment agorithm

Bibliography

ACCESS TO RECENTLY APPROVED AND PIPELINE DRUGS

Combination therapies Tecentriq + Avastin and Opdivo + Yervoy are likely to be reimbursed in first-line RCC

Cabometyx’s Phase II data lack power to convince payers of the added benefit over Sutent

National bodies leave the choice between second-line options Cabometyx and Opdivo to physicians

Treatments targeting the adjuvant setting continue to face a number of challenges

Price benchmarks for PD-1 inhibitors in RCC are reliant upon other approved indications

PRICING

US

Insights and strategic recommendations

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CANADA

JAPAN

Insights and strategic recommendations

Japan’s pricing strategy is reliant on pricing premiums for innovative medicines

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

Bibliography

SPAIN

Insights and strategic recommendations

National reimbursement decisions are not a major access barrier in Spain

Regional access to RCC treatments varies in Spain

Bibliography

UK

Insights and strategic recommendations

NICE approval is a key market access barrier

Bibliography

METHODOLOGY

Primary research

Price assumptions

Exchange rates

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LIST OF FIGURES

Figure 1: Price sources and calculations for the US and five major EU markets, by country

LIST OF TABLES

Table 1: Marketed products and their approved indications for RCC in the US, Japan, and five major EU markets

Table 2: Levers impacting access to RCC drugs in the US and five major EU markets, by country

Table 3: Pricing, market access, and reimbursement strategies for combination therapies

Table 4: Importance of key endpoints in RCC clinical trial design, by country

Table 5: Likely reimbursement of first-line combination therapies in RCC, by country

Table 6: Pricing and reimbursement prospects for Cabometyx in the first line, by country

Table 7: Preference for second-line treatment: Opdivo versus Cabometyx, by country

Table 8: Pricing strategies for the PD-1 inhibitors, by country

Table 9: Pricing of key RCC drugs in the US, Japan, and five major EU markets, by country

Table 10: NCCN guidelines for RCC medicines

Table 11: Japan – pricing premiums given to medicines that can demonstrate benefit over comparators

Table 12: Price calculation methodologies for RCC drugs in Japan launched after 2008

Table 13: Transparency Committee’s ASMR ratings and pricing implications

Table 14: Transparency Committee’s SMR ratings and pricing implications

Table 15: AIFA web registry and managed entry agreements for RCC drugs

Table 16: Spanish Society of Hospital Pharmacy ratings

Table 17: Exchange rates used for calculating drug prices

For more information about this report visit https://www.researchandmarkets.com/r/kk70e8

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Related Topics: Kidney Cancer Drugs