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Compassionate Use Programme: Projection of uptake across England & Wales.
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Proposal. Rationale 1. A FOC programme will provide consultants, pharmacists and nurses with experience enabling a fast up take following NICE. D&T will be completed ahead of reimbursement Pharmacy will have added Lurbinectedin to the Chemo care prescribing system HCP training completed Familiarity in dealing with side effect profile. 2. Patients on FOC lurbinectedin transition smoothly to paying customers following NICE reimbursement. 3. Raise awareness of lurbinectedin in 1L maintenance therapy across the oncology community. KOL’s work at key centres and can influence other hospitals in Alliance Small sales team will struggle to cover all hospitals in first months – word of mouth.
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What Immedica can do Pre-NICE. Promotional Activity Permitted. As long as within the licensed indications. ABPI Code Clause 3 allows promotional activity only if the product is licensed for that use in the UK. 2. NHS Free-of-Charge (FOC) Schemes Company may choose to offer medicine FOC until NICE decision Must follow NHS England or Wales governance processes: Local trust / ICS approval Pharmacy review Documented agreement for duration of FOC period.
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Considerations for Pre MHRA / Post MHRA approval FOC schemes.
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Likely hospitals to take up CUP. It is predicted that the leading KOLs who make up the BTOG steering committee will lead with a CUP..
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Estimate of uptake of CUP by leading KOL’s in England & Wales.
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Enables key oncologists to gain hands-on experience with lurbinectedin. Builds authentic KOL support and advocacy ahead of formal launch. Facilitates data generation (real-world insights, case studies, compassionate use outcomes). Data for HTA & Future Access Supports collection of UK-based RWE useful for NICE and other HTA bodies. May uncover additional value arguments (QoL, PROs, etc.)..