INDEPENDENT REVIW PANEL ASSESSMENTS- AN ALTERNATIVE ROUTE TO MARKET ACCESS IN SCOTLAND?

Author(s)

Macaulay R
PAREXEL Access Consulting, London, UK

OBJECTIVES: Since 2002, the Scottish Medicines Consortium (SMC) has provided recommendations to NHS Scotland on whether any newly licensed medicine should be made available based on its net health benefit and cost-effectiveness. Following negative appraisal outcomes, companies may make resubmissions to the SMC following presentation of new analyses/evidence. However, in the absence of new data, the company can request that an Independent Review Panel (IRP) be convened to re-review existing data. Recently (October 2015) abiraterone was SMC-recommended in pre-chemotherapy prostate cancer following an IRP assessment. This research aims to evaluate how often IRP assessments have been convened and their impact on SMC decisions. METHODS: All SMC appraisals that involved an IRP assessment were identified from the SMC website (up to 30th November 2015). The appraisal history, dates, recommendation, and key rationale were extracted. RESULTS: Seven IRP assessments were identified: abiraterone, cetuximab, colestilan, pimecrolimus, pregabalin, ranlazine, and zoledronic acid. Only once did this result in the SMC changing the appraisal outcome from ‘not recommended’ to accepted/optimised. Each indication had been ‘not recommended’ by SMC an average of 2.0 times beforehand. The delay between publication of final advice following IRP and previous SMC decision was 9.7 months (range: 7-12 months). SMC detailed advice was available for 5/7 IRP assessments. In 4/5 instances, the key underlying rationale for ‘not recommended’ appraisal outcomes related to the clinical effectiveness, the one exception was abiraterone, where cost-effectiveness was inadequately justified. Additional data/analyses were presented by the manufacturer for consideration by the IRP in 3/5 instances. CONCLUSIONS: IRP assessments have only impacted SMC recommendations once; the only instance where the key SMC decision driver for the original negative appraisal related to its high cost/QALY ratio. Further utilisation of IRPs in such circumstances could potentially help optimise patent access to new medicines.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Value in Health, Vol. 19, No. 3 (May 2016)

Code

PHP32

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy

Disease

Multiple Diseases

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