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Early evidence development for new products - planning for reimbursement success

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Simon Shohet PhD, Senior Director, Global Market access and Pricing, Ipsen

Pharma Pricing & Market Access Congress 2017 22 February 2017 London

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Early evidence development for new products - planning for reimbursement success

  1. 1. Simon Shohet PhD, Senior Director, Global Market Access & Pricing, Ipsen. Early evidence development for new products – planning for reimbursement success World Evidence and Pharma Pricing & Market Access Congress - London - February 2017 Note: This presentation represents the author’s views and the content is not necessarily reflective of Ipsen’s company policy.
  2. 2. 2 European HTA and reimbursement processes are complex – can early planning help address uncertainty? “It is challenging even for those with considerable personal experience in European HTA processes to establish what is really happening in market access for new drugs. We recommend that efforts should be directed toward improving transparency in HTA, which should, in turn, lead to more effective processes” Akehurst R.L. et al. Variation in Health Technology Assessment and Reimbursement Processes in Europe Value in Health (2017) Simon Shohet, World Evidence and Pharma Pricing & Market Access Congress - London - February 21-23, 2017
  3. 3. Simon Shohet, World Evidence and Pharma Pricing & Market Access Congress - London - February 21-23, 2017 Pharma needs to adopt an agile business model that has “market access” at its core 3 Parameters Old model New model Organisation Silo’d and linear Cross-functional and payer and patient centric People Vertical technical skill sets Multi disciplinary and networked (T shaped). Medics understand health economics, marketeers understand trial design! Global v local governance Centrally driven/top down Delegated/decentralised/local empowerment with clear governance and accountabilities. Market access happens ‘on the ground’. R&D process Regulatory-approval driven Customer/payer driven – ‘agile’. Processes to integrate stakeholders into R&D. Evidence dev’mnt Late reaction to payer evidence needs Integrated approach (R&D, MA&P, MA,PA, Franchises), anticipating evidence needs of stakeholders early. Plan to capture RWE Pricing ‘always maximize’ mantra irrespective of volume opportunity ‘Always optimise’. Adaptive, ‘elastic’, value- based, willing to trade uncertainty Launch planning Linear, disconnected. Early engagement with multiple stakeholders. Cross-functional & integrated.
  4. 4. Why ‘Early’ Market Access? 4 Simon Shohet, World Evidence and Pharma Pricing & Market Access Congress - London - February 21-23, 2017 “The ultimate objective of market access must be to enable payment for a medicine at an optimal price for the manufacturer, at an acceptable cost to the payer and which ensures access to patients.“ Internally, it means working collaboratively in a fully integrated way across the development pathway, to generate a common evidence package that will enable regulatory approval and positive HTA appraisal. Phase I Phase II Phase III Filing Launch Early market access is about ‘design for reimbursement’ up to pivotal trial stage and ‘in-market’ collection of RWE. Includes in-house development and assets in-licensed from other companies. In the latter case robust early market access due diligence is critical. In-market
  5. 5. 5 Many reasons for HTA negative appraisals can be identified • Treatment switching/cross overs • Withdrawals • Use of ‘Surrogate outcomes’ e.g. PFS rather than ‘hard’ OS • Imbalance of sub-groups in trial • Results not generalisable to national clinical practice • Use of placebo rather than best supportive care • Comparator not standard of care • Lack of measurement/ impact on quality of life • Uncertainty over clinical benefit demonstrated Simon Shohet, World Evidence and Pharma Pricing & Market Access Congress - London - February 21-23, 2017 • Safety / toxicity issues • Lack of efficacy • Model assumptions challenged (e.g. time horizon, curve fitting) • Use of indirect comparison techniques (e.g. NMA) • Cost effectiveness calculations questioned (sources of costs, assumptions, ICER calc) • Budget impact unclear (e.g. market shares) • Lack of / inaccurate resource use data Sources: Author’s case study analysis of recent appraisals from NICE, IQWiG and HAS; Holmstrom et al. Payer/HTA requirements in metastatic breast cancer ISPOR 18th Annual European Congress | 7–11 November 2015 | Milan, Italy: See also Jonsson, B (2015), Molec Onc. (9), 1025 - 1033
  6. 6. 6 Several of these can be anticipated in trial design and model planning Reasons for HTA negative appraisals Clinical trial related Modeling and cost/pricing related Potentially within our control Surrogate outcomes Imbalance of sub-groups Results not generalisable Use of placebo arm Comparator not SoC Choice of end points QoL data collection Model assumptions Indirect comparison techniques Cost effectiveness calculations / ICER Budget impact Resource use/treatment cost data Largely outside our control Uncertain clinical benefit Withdrawals Safety / toxicity issues Lack of efficacy QALYs Simon Shohet, World Evidence and Pharma Pricing & Market Access Congress - London - February 21-23, 2017 Cross-over
  7. 7. 7 Early planning best practice means anticipating payer and regulatory questions concurrently …as part of an integrated evidence plan •Early advice from payers •Prototype econ. modelling •Define TPPs that incorporate payer value features (TVP) •Design Ph II/b and Ph III trials with agreed comparators, end-points and economic parameters •Build-in Real World evidence plans •Power trials for sub-population analysis •Plan to capture QoL to support utility and humanistic value •Timely preparation of HTA dossiers tailored to each HTA •Track / Capture RWE to sustain value argument Phase I Phase II Phase III Filing Launch TPP: Target Product Profile; TVP: Target Value Proposition Simon Shohet, World Evidence and Pharma Pricing & Market Access Congress - London - February 21-23, 2017
  8. 8. 8 There are several channels for seeking early advice to support evidence planning for reimbursement Three mechanisms to get early advice: all offer ‘non-binding’ guidance • National e.g. NICE + MHRA joint advice • National level advice • Face-to-face meeting with NICE and the Medicines and Healthcare products Regulatory Agency. • Regulatory and Health Technology Assessment advice in parallel, with reports from both agencies • Fees up to £50,000 • European Medicines Agency – Parallel Scientific Advice • Parallel regulatory and HTA advice procedure • Started in 2010: choose which HTA bodies to invite • Face-to-face meeting with participating bodies at the EMA offices • Simultaneous feedback from regulators and HTAs on a pharmaceutical company’s development plan • Fees are invoiced at the end and depend on time and complexity • EUNETHA – SEEDS: Shaping European Early Dialogues • Multi HTA Consortium (14 agencies) led by HAS • Project funded by European Commission • 10 Pilot projects AIFA, GBA, ZIN, TLV, HAS, CADTH and others also have similar mechanisms Simon Shohet, World Evidence and Pharma Pricing & Market Access Congress - London - February 21-23, 2017
  9. 9. Q & A

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