CANCER MEDICINES THE TRANSFORMATION The dose

CANCER MEDICINES – THE TRANSFORMATION • The dose banding and standardisation story • The impact upon the commercial management of cancer medicines • What are the Cancer Vanguards • Background to project work on Biosimilars?

DOSE STANDARDISATION AND VANGUARD • Easier to do nothing • ‘It’s been tried before’ • Definition of a Vanguard: ‘A group of people / person leading the way in new developments or ideas’

Dose Banding and Standardisation of Cancer Medicines Richard Nuttall Electronic Prescribing Pharmacist, Royal Marsden Hospital, London

Objectives • National Dose Banding Project • How has the use of dose banding changed the way patients are treated? • Does dose banding impact upon the commercial management of cancer medicines?

THE NATIONAL DOSE BANDING PROJECT

Carter Report Reduce variation in the NHS Hospital Pharmacy Transformation Programme – • e-prescribing and administration • accurate (high cost) medicine coding • consolidating stock-holding (less stock / fewer deliveries) • by Apr 2020

www. england. nhs. uk • How to Guide • Banding tables • CQUIN information

Published Tables

Dose Banding Methods • Single Container • Bands as far apart as possible / fewer doses • Designed for batch production / waste minimised • Multi-container (Pick and Mix) • Each dose made from multiple smaller syringes • Only 4 -5 sizes of syringe need to be stocked • High Cost Drugs • Vial sizes taken into account • Usually more dose bands required

Pick and Mix • • Only 4 -5 syringe sizes needed to be stocked Optional 50 m. L syringe (local practice) Use tables to calculate how to make up doses Uses a different dose banding table! No substitution with single-container bags. • New Hospira Plum 330 pump can take anthracyclines in a bag – don’t need Pick & Mix

Pick and Mix – Cyclophos

Pick and Mix vs Single Bag • Pick and mix doses are different from single container doses • Pick and mix doses have more bands but the doses are easier to make up from combining syringes • 5 FU, cyclophosphamide, doxorubicin, epirubicin Pick & Mix Single Bag

HOW HAS DOSE BANDING CHANGED THE WAY PATIENTS ARE TREATED?

Patient Benefits • Studies have shown no clinical difference between banded products and calculated doses • Most doses will not need to be ordered in advance as they will be stocked batches • Last-minute changes or cancellations can be placed back into pharmacy stock and used for another patient • Dose reductions will mostly also be stocked – no delay to patient treatment • New urgent patient treatment will be ‘off the shelf’ and faster to supply • Higher quality batch products subject to QA and QC

Other Benefits • Combining dose bands with coordinated clinic appointments can promote vial sharing in high cost drugs – pembrolizumab? ?

Re-use Example (Carboplatin) At RMH monthly average for carboplatin wastage before banding was approx. 30% of all doses • Too many unused doses filled wastage fridge – too difficult to maintain any kind of stock control and re-use • After banding, wastage has dropped to zero! • Now looking at buying in even more banded doses – takes some time to find baseline levels of stock • May need to alter with patient variation over time

IV Pumps • Anthracyclines traditionally couldn’t go through an IV pump • Pick and mix created for syringe pumps • New pumps (e. g. Plum 360) can take anthracyclines – switch banding method and doses

IMPACT ON THE COMMERCIAL MANAGEMENT OF CANCER MEDICINES

NICE & New Drugs • • New drugs to be banded from the start Banding to become part of the NICE approval process Formal process being devised Tables will be produced once the commissioning paper has been approved

Carter Review and Batches “Batch preparation of chemotherapy will have some advantages, and may enable Trusts to procure these drugs at lower cost. Over 1 -2 years cost savings should be realised through product standardisation, the potential for commercial suppliers to enter the UK market for dosebanded products” “Overall, the standardisation of doses should reduce costs for providers, while releasing capacity within local units to support other activities and in particular clinical trial and research. ”

What needs standardisation? • Drug doses (banding) • Drug presentation (fluid type and volume) • Drug administration (e. g. HD mtx, cisplatin, filters etc. ) • Drug stability • Drug labelling (font, layout, barcodes)

Standard Product Definitions • Library of monographs produced by David Lovett (NHS Pharmaceutical Aseptic Services) • Phase 1 drugs complete • Phase 2 drugs to be released in smaller groups

Expiry & Vial Sharing • Batch products need long expiries – at least 1 month, preferably 3 months for practical aseptic stock control • Shorter expiry drugs can still be banded – make in-house if necessary – banding can assist with vial sharing

Purchasing Banded Items • Banded products purchased from either industry or NHS manufacturing units • Batches of banded products • Economies of scale • Collaboration (no need for multiple units to make the same product) • Contract framework for pricing per molecule • Customer service / manufacturing times / complaints formalised • Patient-specific banded products • For lower use or short expiry items

Aseptic Demand • High volume waste (of unbanded products) • Outsourcing – 50%-60% of workload – large variation • Future • Banded products can replace pt-specific outsourced (? 50 -60%) – can achieve 70%? • In house for pt-specifc doses 25% • Balance of non-banded products 25% - outsourced • What needs standardising? • Easier pre-empting for workload / manufacturing schedule

Fewer Stock Items Carboplatin – >40 doses vs. 16 doses

Azacitidine (vol issue) • • • Max vol 4 m. L (SPC) Usual max 2 m. L (RMH Nursing Guide) Wide variance of max between centres Split into syringes of equal volume Safety needle vs viscous solution Entering into an electronic prescribing system / worksheets • 8 h expiry – can be outsourced? Yes?

5 -Fluorouracil (conc issue) • 25 mg/m. L vs 50 mg/m. L • Pick and mix requires 25 mg/m. L • Single container uses 50 mg/m. L – but either strength can be used… 25 mg/m. L vials will just use double the volume which will always be measurable… Bands 25 mg/m. L 50 mg/m. L 1000 mg 40 m. L 20 m. L 1100 mg 44 m. L 22 m. L 1200 mg 48 m. L 24 m. L 1350 mg 54 m. L 27 m. L

E-Prescribing Systems • Entering and maintenance of dose banding tables (master tables vs protocol tables) • Variable volume drugs: volume based on • Drug dose (e. g. conc-dependent) • Patient size (e. g. vinca alkaloids in paeds) • Capped volumes & split syringes (e. g. SC bolus) • Switching brands → Switching presentation? → New setup in prescribing system