AN INNOVATIVE SOLUTION TO ACHIEVE COST-EFFECTIVENESS AND A POSITIVE NICE APPRAISAL? – THE CABAZITAXEL CASE STUDY

Author(s)

Macaulay R1, Dave K1, Walsh SC2
1PAREXEL International, London, UK, 2PAREXEL, London, UK

Oncology therapies have historically struggled to receive positive appraisals by cost-effectiveness health technology assessment (HTA) bodies, such as the National Institute of Health and Care Excellence (NICE). Indeed, between March 2000 and March 2017, 30% of NICE single technology appraisals (STAs) within oncology received a negative appraisal versus 11% of appraisals outside oncology. Many high-cost innovative oncology treatments are dosed via an intravenous route based on a patient’s weight or body surface area. The patient-specific nature of this dosing means that within opened drug vials there is leftover drug that is typically discarded (both the European Medicines Agency [EMA] and Medicines and Healthcare Products Regulatory Agency [MHRA] advise that vial-sharing should not be practiced). Such vial wastage may substantially increase the cost of treatment and may significantly impact cost-effectiveness estimates. In May 2016, NICE published a positive recommendation for cabazitaxel for metastatic prostate cancer that was contingent upon, among other things, the company making cabizitaxel available in pre-prepared intravenous-infusion bags containing the precise dosing needed per patient to minimize wastage. Subsequently, in August 2016 the manufacturer agreed to be able to supply the drug in vials with an additional discount to apply that reflects wastage costs. The rationale for seeking this additional vial-supply was not publically stated. However, this may have been driven by the associated costs in implementing quality and audit systems alongside infusion preparation procedures to ensure the safety/quality of resultant ready-infusions. Further, the shelf-life from point of infusion preparation is typically 24 hours, which will have associated wastage. In conclusion, HTA bodies may be receptive to company-sponsored innovative delivery mechanisms to minimise wastage associated with weight-based dosed intravenous-infusion products. This can support zero-wastage assumptions in cost-effectiveness modelling and public reimbursement. As this case-study shows, the associated costs should be carefully considered with potential preference to simple-discount/rebate schemes.

Conference/Value in Health Info

2017-11, ISPOR Europe 2017, Glasgow, Scotland

Value in Health, Vol. 20, No. 9 (October 2017)

Code

PHP298

Topic

Health Policy & Regulatory

Disease

Oncology

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