Dublin, Aug. 09, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Prostate Cancer Pricing, Reimbursement, and Access" report to their offering. Novel antiandrogens will need to present risk-sharing agreements in EU markets, while discussing contracting with US payers to ensure a competitive advantage. Vaccines suffer from inconclusive response measures and unattractive dosing. This report addresses the following questions: - How do access restrictions for prostate cancer drugs differ across markets and why? - Which clinical trial comparators and outcomes are necessary for approval and uptake in each market? - What impact, if any, will value assessment tools have on US reimbursement patterns? - When and where are risk-sharing agreements useful in gaining market access? - What are US and EU payers' and physicians' opinions on drugs targeting non-metastatic CRPC or metastatic HSPC? - Which vaccines have a chance for uptake and reimbursement in US and EU markets? - What does the future hold for radiotherapy Xofigo? Key Topics Covered: EXECUTIVE SUMMARY MARKET CONTEXT - Marketed prostate cancer products in the US, Japan, and five major EU markets - Pipeline prostate cancer treatments in late-stage development - Bibliography. GLOBAL PAYER AND KEY OPINION LEADER INSIGHTS - Insights and strategic recommendations - Payer archetypes and trends in access - Non-metastatic castration-resistant prostate cancer - Metastatic hormone-sensitive prostate cancer - Evidence for the impact of earlier or combination treatment on overall resource use could gain traction with payers - Patient-reported outcomes will become increasingly important, particularly for Xofigo - Similar novel antiandrogens look to differentiate themselves from one another - Providers grapple with whether or not combinations provide better long-term outcomes than sequential use of the drugs - Advent of bundled payments will drive the need for data on optimal care pathways - Novel immunotherapies and vaccines are welcomed alternatives, but will face similar challenges to Provenge - Bibliography US PRICING - Pricing trends in the US look toward greater cost control - Bibliography US PAYER AND KEY OPINION LEADER INSIGHTS - Insights and strategic recommendations - Insurers commonly reimburse NCCN-backed indications; obtaining a category 1 recommendation will become increasingly important - If efficacy and safety data are not differentiated from other drugs, twice-daily dosing may hinder BAY-1841788's potential - Jevtana will be restricted to use after docetaxel, unless a substantial benefit is shown in FIRSTANA trial - Prescribing patterns differ between medical oncologists and urologists; payers consider management of CRPC by oncologists as ideal - Cancer Drug Coverage Parity Act of 2 - could close gap in out-of-pocket costs between oral and inpatient drugs - New drugs mean new opportunities for contracting - Bibliography US REIMBURSEMENT - Insights and strategic recommendations - NCCN guidelines reflect FDA labels - NCCN Evidence Blocks - Drug value frameworks will guide the formation of clinical pathways and reimbursement criteria in the future - Payers have limited utilization management options despite rising costs, but oncology pathways are making inroads - Branded prostate cancer therapies are generally found on top tiers as specialty drugs - Prior authorization and step therapy criteria from numerous payers restrict the use of Xtandi - Bibliography JAPAN - Price premiums are awarded for added benefit or innovation - Pricing of launched prostate cancer treatments - Bibliography PRICING IN THE FIVE MAJOR EU MARKETS FIVE MAJOR EU MARKETS PAYER AND KEY OPINION LEADER INSIGHTS - Insights and strategic recommendations - ESMO drug ratings praise Xofigo, but are uncertain about Xtandi's and Zytiga's role before Docetaxel - Jevtana restricted in many European countries due to poor benefit-to-risk ratio - Xofigo is restricted to use after docetaxel therapy in most European countries - Real-world data are a priority for assessment bodies FRANCE - Insights and strategic recommendations - ASMR rating has an impact on pricing - The majority of new market entrants will be compared to Zytiga, - While price is a concern, effective and tolerable vaccines will be a welcomed alternative GERMANY - Insights and strategic recommendations - Positive assessment from the G-BA will impact price negotiations - Cell therapies will find entry into the German market at the hospital level through supplemental funding mechanisms ITALY - Insights and strategic recommendations - All established prostate cancer treatments are reimbursed by AIFA - Regional health authorities perform thorough health technology assessments on new drugs - Oral drugs subject to monitoring SPAIN - Insights and strategic recommendations - National reimbursement decisions are not a major access barrier in Spain - Regional restrictions tend to align with adverse event profiles and clinical trial exclusion Criteria - Spanish Oncology Genitourinary Group recommendations UK - Insights and strategic recommendations - NICE and SMC assessments drive reimbursement decisions - Cancer Drugs Fund For more information visit http://www.researchandmarkets.com/research/b3...ate_cancer
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