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: http://www.nice.org.uk/nicemedia/pdf/FAD.pdf. 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) |