A NEW PACE FOR THE SMC?

Author(s)

Macaulay R
PAREXEL Access Consulting, London, UK

OBJECTIVES: Access for oncology drugs can be severely constrained under obligate cost-utility HTA bodies, such as the SMC, NICE, pCODR and PBAC. Indeed the rejection rate for NICE oncology single technology appraisals is over three-times that of non-oncology ones (40% vs. 13%). In April 2014, the SMC announced it would adopt a more flexible approach in its review of end-of-life and orphan therapies. Going forwards, if the initial SMC advice is not to recommend, a Patient and Clinician Engagement Group (PACE) meeting can be convened. This meeting aims to capture the benefits of the medicine outside of the considerations of the conventional process and was anticipated to constitute a “major factor” in the SMC decision. This research aims to evaluate what effect PACE groups have had on SMC appraisal outcomes METHODS: All SMC approvals from April 2014 were identified and the recommendation, indication and whether a PACE meeting was convened was extracted. RESULTS: CONCLUSIONS: This new SMC PACE process is being well utilized, particularly in the appraisals of oncologics, and has resulted in many appraisals that would have been rejected being recommended instead. This has produced more timely market access for patients, without the need for multiple rounds of resubmissions, as was often the case pre-PACE. Nevertheless, rejection rates of oncology drugs still remain substantially higher than for non-oncology drugs.

Conference/Value in Health Info

2015-11, ISPOR Europe 2015, Milan, Italy

Value in Health, Vol. 18, No. 7 (November 2015)

Code

PCN276

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Pricing Policy & Schemes, Reimbursement & Access Policy, Risk-sharing Approaches

Disease

Oncology

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