scholarly journals Shifting the Risk in Pricing and Reimbursement Schemes? A Model of Risk-Sharing Agreements for Innovative Drugs

2011 ◽  
Author(s):  
Stefano Capri ◽  
Rosella Levaggi
Keyword(s):  
Risk Sharing ◽  
Pricing And Reimbursement ◽  
Innovative Drugs

scholarly journals Il governo dell’innovazione farmaceutica in Italia: quali strumenti di governance regionale proporre?

2016 ◽  
Vol 3 (Suppl. 1) ◽  
pp. S7-S12
Author(s):  
Sabina Nuti
Keyword(s):  
Risk Sharing ◽  
Decisive Role ◽  
Regional Governance ◽  
New Drugs ◽  
Adoption Process ◽  
Value For Money ◽  
Expensive Drug ◽  
Italian Regions ◽  
Governance Tools ◽  
Innovative Drugs

Managing pharmaceutical innovation in Italy: which regional governance tools can be adopted? Within the Italian federalist framework, national and regional governance tools for pharmaceutical care have been developed in recent years. From a financial perspective, the pharmaceutical outpatient expenditure has already been put under control and this has markedly contributed to reducing the overall costs. The hospital pharmaceutical expenses instead have grown. On this last element bears how innovative and expensive drugs are introduced and managed; among these drugs, cancer drugs have a decisive role. In the last years the AIFA (Agenzia Italiana del Farmaco – Italian Drugs Agency) policies regarding the adoption process of new drugs have stressed the concept of value for money: any innovative and expensive drug is linked to a webbased control register in order to monitor outcomes. The aim is to relate the drug price to the obtained results (payment by result and risk-sharing) or at least to institute simple financial agreements (cost-sharing) that can be defined as managed entry agreements (MEA). The critical point that can cause equity problems is the way these national governance tools are applied in different regional contexts. There are in fact marked differences among Italian regions. Most regions are aware that the only way to rule the system, and in particular the use of innovative drugs, is to have stronger evidence-based management tools able to connect different systems of oncological prescriptions. The aim is to follow patients in different care settings in order to measure the pathway phases in terms of consumption, costs and quality outcomes and therefore evaluate in actual practice the value for money of innovative drugs.

Should health authorities offer risk-sharing contracts to pharmaceutical firms? A theoretical approach

2011 ◽  
Vol 6 (3) ◽  
pp. 391-403 ◽  
Author(s):  
Fernando Antonanzas ◽  
Carmelo Juarez-Castello ◽  
Roberto Rodriguez-Ibeas
Keyword(s):  
Health Authority ◽  
Risk Sharing ◽  
Treated Patient ◽  
Low Cost ◽  
Regulatory Decision ◽  
Pharmaceutical Firms ◽  
Health Authorities ◽  
Monitoring Costs ◽  
Pricing And Reimbursement ◽  
The One

AbstractIn this paper, we characterise the risk-sharing contracts that health authorities can design when they face a regulatory decision on drug pricing and reimbursement in a context of uncertainty. We focus on two types of contracts. On the one hand, the health authority can reimburse the firm for each treated patient regardless of health outcomes (non risk-sharing). Alternatively, the health authority can pay for the drug only when the patient is cured (risk-sharing contract). The optimal contract depends on the trade-off between the monitoring costs, the marginal production cost and the utility derived from treatment. A non-risk-sharing agreement will be preferred by the health authority, if patients who should not be treated impose a relatively low cost to the health system. When this cost is high, the health authority would prefer a risk-sharing agreement for relatively low monitoring costs.

scholarly journals PP022 New Models Are Needed To Optimize The Management Of New Medicines

2017 ◽  
Vol 33 (S1) ◽  
pp. 79-80
Author(s):  
Brian Godman ◽  
Eduardo Diogene ◽  
Jurij Fürst ◽  
Kristina Garuoliene ◽  
Augusto Guerra ◽  
...  
Keyword(s):  
Risk Sharing ◽  
Clinical Care ◽  
Cost Effective ◽  
Extensive Literature ◽  
Health Authorities ◽  
Horizon Scanning ◽  
Level Data ◽  
Long Term Follow Up ◽  
Working Together ◽  
Pricing And Reimbursement

INTRODUCTION:Countries are struggling to fund new premium priced medicines with ever increasing prices. In addition, there are substantial savings as medicines lose their patents. This requires coordinated approaches. Models are being developed centering on three pillars: pre-launch including horizon scanning; peri-launch including pricing and reimbursement (P & R)/ risk sharing; and post-launch including assessing effectiveness (1,2). This will continue to enable access to safe, effective and affordable medicines.METHODS:Desk research of regulatory and other relevant policy documents as well as a thorough and extensive literature search in peer-reviewed databases were conducted.RESULTS:Models to optimize the use of new medicines are being developed. These center on three pillars: pre-launch activities including horizon scanning with a specific focus on unmet needs, drugs expected place in therapy, drugs preliminary budget impact and forecasting (including medicines likely to lose their patents); peri-launch activities including P & R assessment and assessments of risk sharing arrangements; and post-launch activities include assessing the effectiveness and safety of new medicines in routine clinical care (1,2). Pre-launch activities to agree the number of potential patients for new cancer medicines resulted in hospitals staying within budget (3); and health authorities that had instigated activities pre-launch saw limited excess bleeding with dabigatran (3). Risk-sharing arrangements have increased access to new medicines; however, concerns with their confidential nature and administrative burden (2,3). Qualitative and/or quantitative approaches are also being developed to better value (new) medicines. There is also growing use of patient level data post launch, for example, studies highlighted concerns with dabigatran prescribing in Spain and anti-obesity medicines in Sweden. Long-term follow-up studies have shown greater effectiveness of ciclosporin versus tacrolimus for transplants despite the rhetoric.CONCLUSIONS:Stakeholders in the healthcare field are working together and developing methods to increase funding for new valued medicines whilst restricting their use where there are concerns to optimize resource use. This will (need to) continue to enable access to safe, (cost-) effective and affordable medicines.

scholarly journals Time to reimbursement and negotiation condition in Italy for drugs approved by the European Medicines Agency during the period 2014-2019

ABOUTOPEN ◽  
2020 ◽  
Vol 7 (1) ◽  
pp. 89-94
Author(s):  
Mariangela Prada ◽  
Letizia Rossi ◽  
Matteo Mantovani
Keyword(s):  
European Medicines Agency ◽  
Official Journal ◽  
Patient Access ◽  
Medicinal Products ◽  
Factors Influencing ◽  
Human Use ◽  
Managed Entry Agreements ◽  
Pricing And Reimbursement ◽  
Innovative Drugs ◽  
Active Substances

Introduction: The main purpose of this study was comparing median time (TTR, time to reimbursement) between the first Agenzia Italiana del Farmaco (AIFA) pricing and reimbursement (P&R) dossier’s evaluation and patient access in Italy and to observe the key P&R negotiation results for all new active substances approved by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use between January 2014 and December 2019. We analysed the different factors influencing TTR. Methods: A panel of medicines for human use approved by the EMA in the period 2014-2019 was considered. All information about authorisation and reimbursement in Italy, including timelines and results from the negotiation, were gathered through EMA and Italian Official Journal databases. Results: Of 213 new active substances approved from January 2014 to December 2019, 137 obtained reimbursement in Italy, with a median TTR of 7.6 months (228 days). Even if orphan designation, oncology indication, application of Managed Entry Agreements (MEAs; both outcome and financial based) or a discount did not show an impact on TTR, recognition of full innovativeness (n = 27; 20%) was associated with a reduction of 1 month in median TTR. Interestingly, drugs reimbursed with a lower price/daily defined dose showed a reduced TTR (−22%). Conclusions: Even if the lack of impact of some negotiation conditions was predictable (e.g. oncology indication or orphan status) or the application of a MEA helped to manage possible uncertainties, it did not lead to a quicker completion of the negotiation procedure. Likewise, full innovative drugs showed a shorter TTR underlying the AIFA commitment in recognising, promoting and rewarding innovation.

Risk-sharing agreements for innovative drugs

2006 ◽  
Vol 7 (3) ◽  
pp. 155-157 ◽  
Author(s):  
Gérard de Pouvourville
Keyword(s):  
Risk Sharing ◽  
Innovative Drugs

Protecting All: Risk Sharing for a Diverse and Diversifying World of Work

2019 ◽  
Author(s):  
Truman Packard ◽  
Ugo Gentilini ◽  
Margaret Grosh ◽  
Philip O’Keefe ◽  
Robert Palacios ◽  
...  
Keyword(s):  
Risk Sharing

Lending to the Borrower from Hell

2017 ◽  
Author(s):  
Mauricio Drelichman ◽  
Hans-Joachim Voth
Keyword(s):  
United States ◽  
Sixteenth Century ◽  
Sovereign Debt ◽  
Risk Sharing ◽  
The United States ◽  
Philip Ii ◽  
Loan Contracts ◽  
The Right ◽  
Intelligent Model ◽  
New Evidence

Why do lenders time and again loan money to sovereign borrowers who promptly go bankrupt? When can this type of lending work? As the United States and many European nations struggle with mountains of debt, historical precedents can offer valuable insights. This book looks at one famous case—the debts and defaults of Philip II of Spain. Ruling over one of the largest and most powerful empires in history, King Philip defaulted four times. Yet he never lost access to capital markets and could borrow again within a year or two of each default. Exploring the shrewd reasoning of the lenders who continued to offer money, the book analyzes the lessons from this historical example. Using detailed new evidence collected from sixteenth-century archives, the book examines the incentives and returns of lenders. It provides powerful evidence that in the right situations, lenders not only survive despite defaults—they thrive. It also demonstrates that debt markets cope well, despite massive fluctuations in expenditure and revenue, when lending functions like insurance. The book unearths unique sixteenth-century loan contracts that offered highly effective risk sharing between the king and his lenders, with payment obligations reduced in bad times. A fascinating story of finance and empire, this book offers an intelligent model for keeping economies safe in times of sovereign debt crises and defaults.

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