Let's talk access! Moving towards fair prices and transparent markets - Ward Rommel
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Let’s talk access! Moving towards fair prices and transparent markets Ward Rommel Chair, Access to Medicines Task Force Association of European Cancer Leagues (ECL) 6th Hearing of the Special Committee on Beating Cancer 28 January 2021
30 Cancer societies 25 Countries Make safe and effective medicines available to all cancer patients in Europe
CHALLENGE 1: SOME PROGRESS, BUT WE ARE NOT THERE YET Relative survival for lung cancer in Belgium Males Females Source: Belgian Cancer Registry
CHALLENGE 2: DISPARITIES IN ACCESS Based on sample of 31 product/indication pairs approved by the US FDA since 2014 Source: OECD (2020) Addressing Challenges in Access to Oncology Medicines - Analytical Report
CHALLENGE 3: PRICE LEVEL & PRICE INCREASES Monthly and median costs of cancer drugs at the time of FDA approval 1965-2019 Price of cell & gene therapy: new order of magnitude: €80.000- €700.000 e.g. CAR-T (Kymriah, Yescarta) Source: Dr Peter B Bach, Memorial Sloan Kettering Cancer Centre
CHALLENGE 4: LACK OF TRANSPARENCY ABOUT PRICE VALUE Value? Cost of R&D? 9 6 •2,56*10 (Tufts, 2016) - 648-757*10 (Prasad, 2017) •CAR-T Government grants for R&D: $200m •Total R&D: $304m Prasad, V. (2018) Tisagenlecleucel: the first approved CAR-T cell therapy Source: Vokinger et al. (2020) Prices and clinical benefit of cancer drugs in the USA and Europe
CHALLENGE 5: MEDICINE SHORTAGES Increase in oncology drug shortages Drop in 5-year survival rate Are oncology medicines shortages a Do shortages negatively impact current problem? on patients’ chances of survival? 47% (2019) vs 39% (2018)* 68% (oncologists) vs 45% (HCP)** * EAHP (2019) Medicines shortages report: Medicines shortages in the hospital sector - prevalence, nature and impact on patient care ** LNCC/IPSOS (2019) Online survey for the French League Against Cancer conducted by IPSOS between October- December
FAIR PRICE & FAIR PRICING What's a fair price ? = justifiable, predictable and cost-effective within the aims and priorities of the A ‘fair price’ is key to healthcare systems and the available budget. affordability! ‘justifiable’ ‘predictable’ ‘cost-effective(ness)’ Prerequisite for obtaining price that reflects the need for policy common criterion fairer prices = higher level documented and makers, health payers and for evaluating of transparency clinically relevant benefit systems to be able to whether the price of a medicine & predict the total cost of seems ‘justifiable’ reasonable relationship investing in the treatment between cost of bringing the product to market and the price
FAIR PRICE, FAIR PRICING & AFFORDABILITY Policy asks 1.xMake fair pricing, affordability and 3. Expand existing structures (e.g. sustainability of health systems a core EURIPID database) to share info on net element of EU pharmaceutical and prices of medicines and strive towards cancer policy the full implementation of the 2019 WHA Resolution on price transparency 2.xEstablish a High-Level Working Group on fair pricing facilitated by 4. Support and promote international the European Commission, collaboration (i.e. HTA, Horizon connecting relevant stakeholders to (i) Scanning, joint procurement and define a fair price (ii) identify negotiations initiatives) opportunities and challenges connected to different pricing models
SYSTEM OF INCENTIVES & OBLIGATIONS Policy asks 1.xDefine unmet need with 3.xRevise the current system of incentives stakeholders based on added a. attach conditionalities to national and EU public patient/societal benefit funding b. ensure that public investment in R&D is accounted for and that the resulting meds are 2.xStimulate and steer public fairly priced and private R&D towards areas with limited treatment options, 4. Involve academia & NGOs in drug development low survival and/or low support and train academia & civil society in commercial interest regulatory science for better translation of focus on kids and rare diseases research into product development
MEDICINE SHORTAGES Policy asks 1.xMore transparency on the causes & 2.xMore cooperation consequences of shortages a. foster joint action between MS allowing a. reinforce the legislative framework to medicine agencies to exchange best practices improve notifications and obligations of b. harmonize the working framework (i.e. the MAHs to supply the market definition of shortages, catalogue of b. boost the EMA's capacity shortages) in all MS 3. A new approach a. switch from crisis management to an upstream approach b. require legally binding EU shortage management and prevention plans for all meds marketed in >1 MS c. develop early warning shortage systems, building on the SPOC system experience
GET IN TOUCH WITH US! CONTACT ECL A2M TF TWITTER Ward.Rommel@komoptegenkanker.be @CancerLeagues Chair of the A2M TF #LetsTalkAccess WEBSITE FACEBOOK www.cancer.eu @CancerLeagues Access to Medicines
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