Performance Based Risk Sharing Database

The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute

Case Database

Case Record Field Descriptions

Category Field Description Example
Product Info Case Product name Velcade
Product Info Year Year of start of scheme or year of publication if not available 2007
Product Info Country Country in which scheme applies UK
Product Info Therapeutic area Therapeutic area for the intervention(s) covered in the scheme Oncology
Product Info Disease area Disease area for the intervention(s) covered in the scheme Multiple Myeloma
Product Info Product(s) Product name (generic) bortezomib
Product Info Product type Pharmaceutical, Diagnostic or Device Pharmaceutical
Product Info Manufacturer Manufacturer(s) involved in the scheme Johnson and Johnson
Product Info Agency Agency involved in the scheme UK National Health Service
Product Info Comments Free text box  
Product Scheme Description Short Version Short summary of scheme J & J agreed to reimburse the NHS in either cash or product for patients who do not respond (Response measure: 50% decrease in serum M protein) after 4 cycles of treatment with Velcade. Responding patients receive additional 4 cycles.
Product Scheme Description Length of scheme (years) Length of the Scheme in years and/or whether scheme is time restricted (i.e. the period of time for the scheme is fixed) and/or current status Not time restricted. Still approved.
Product Scheme Description Long Version Long summary of scheme  
Product Scheme Description Current Status Active, Not Active, Presumed Active, Presumed Not Active  
Product Scheme Description Link to other cases link  
Evidence / Results Type 1: (according to taxonomy) Type of scheme according to taxonomy Performance-linked reimbursement, conditional treatment continuation
Evidence / Results Results Summary of results of the scheme Manufacturer received unlimted access.
Evidence / Results Source (Primary) Public source for information about the scheme (additional sources containing in references section) NICE. Final appraisal determination: Bortezomab therapy for relapsed multiple myeloma. Accessed at: Accessed on: 3/31/09
Product Factors Efficacy/Effectiveness evidence Evidence regarding the efficacy/effectiveness of the product (e.g. amount of evidence, trial endpoints, and comparators) Single phase III trial: Strong efficacy (surrogate endpoints: TTP and response). Trial stopped early.
Limited data on overall survival: Secondary endpoint, trial stopped early.
Product Factors Saftey evidence Evidence regarding the safety of product Bortezomib is associated with peripheral neuropathy in 30% of patients
Product Factors Budget impact/usage Evidence about the budget impact of the product (e.g., target population, treatment duration, and off-label use) High cost: Cost per cycle, £3,000. Variable treatment duration—treat until tumor progression.
Product Factors Cost-effectiveness Evidence about the cost-effectivenss of the product Not cost-effective at 1st submission (£35,000/QALY, substantial uncertainty). ICER with rebate, stopping rule: £20,700/QALY
Product Factors Treatment characteristics Characteristics of treatment with the product (e.g. duration of treatment by days or cycles, dosing, adminstration) 1.3mg/m2 IV two times a week for 6 weeks for cycles 1 - 4, then cycles 5-9 velcade is given weekly.
Product Factors List price List price in reference country (if available/accesible). Otherwise list price in the U.S. using the average wholesale price $1468.20 per dose (United States price)
Market Factors Payer reimbursement focus Cost-effectiveness vs. Clinical effectiveness Cost-effectiveness
Market Factors Public versus private payer Is the payer a public (e.g CMS or NHS) payer or a private payer Public
Market Factors Disease/treatment landscape E.g. competitor products, unmet need First-in-class, no good alternatives at 1st relapse
Market Factors Size of patient population Approximate size of the patient population in the reference country There are approximately 45,000 people in the United States living with multiple myeloma, and the American Cancer Society estimates that approximately 14,600 new cases of myeloma are diagnosed each year in the United States.
Market Factors Alternative Payment Model Framework Fee for Service with No Link to Quality & Value  
Additional Info Response measure SUMMARY METRIC(S) USED IN SCHEME Response defined as a patient, at first relapse, with a 50% or greater reduction in serum M-protein, within 4 cycles of treatment, compared to baseline level immediately prior to VELCADE treatment
Additional Info Additional References: Additional references beyond the primary scheme reference (above)