New Drugs Approval in Italy: Updated Analysis of the Applied Negotiation Conditions 2015-2017

Abstract

important). More than half (64%) perceived a gap between available and needed post-approval HCEI. A gap between available and needed PIE was noted by 45% of respondents. The majority of payers (80%) reported that they sometimes/rarely received HCEI communications; receipt of PIE was also uncommon (64% rarely or never). An increase in HCEI and PIE communication over the past year was noted by 43% and 39% of respondents, respectively. Regarding type of PIE, payers considered indication sought (82%), clinical trial results (84%), anticipated timeline for FDA approval (80%), and product pricing (86%) as very or extremely important. Almost all (95%) respondents would prefer to receive PIE within 1 year of the product's anticipated approval. Further, 47% of respondents would most prefer that a medical science liaison communicate PIE. ConCluSionS: New legislation and regulations pertaining to the proactive communication of HCEI and PIE may have prompted an increase in such communication by manufacturers in the past year. More frequent and relevant communications between manufacturers and population health decision makers may be helpful to improve formulary decision making and ultimately treatment decisions for patients in need of therapy.

Barriers and Opportunities for Implementation of Outcome-Based Spread Payments for High-Cost, One-Shot Curative Therapies

“…Multiple authors emphasized that multi-stakeholder agreement between payers and developers on financial terms of the MEA is crucial to enable the use of spread payments ( Brennan and Wilson, 2014 ; Edlin et al, 2014 ; Philipson, 2014 ; Basu, 2015 ; Drummond, 2015 ; Touchot and Flume, 2015 ; Jorgensen and Kefalas, 2015 ; Kleinke and McGee, 2015 ; Carr and Bradshaw, 2016 ; Montazerhodjat et al, 2016 ; Carlson et al, 2017 ; Marsden et al, 2017 ; Jorgensen and Kefalas, 2017 ; Yeung et al, 2017 ; Value in Health, 2017 ; Carr et al, 2018 ; Faulkner et al, 2018 ; Hanna et al, 2018 ; Hampson et al, 2018 ; Lidonnici et al, 2018 ; Sachs et al, 2018 ; Senior, 2018 ; Tuffaha and Scuffham, 2018 ; Salzman et al, 2018 ; Schaffer et al, 2018 ; AMCP, 2019 ; Drummond et al, 2019 ; Jönsson et al, 2019 ; FoCUS, 2019a ; FoCUS, 2019b ; Infante et al, 2019 ; Maes et al, 2019 ; Towse and Fenwick, 2019 ). However, many uncertainties on the ideal duration of spread payments, payment amount per installment and payment linkage to outcomes remain.…”