The Context in which we operate

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Dulcie Carroll
5 years ago
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Prof. Sergio Pecorelli Presidente Agenzia

rights One single Medicines System Increasing

1 Prof. Sergio Pecorelli Presidente Agenzia Italiana del Farmaco Rettore Università degli Studi di Brescia The Context in which we operate Limited Resources Population Ageing Healthcare rights One single Medicines System Increasing Health Demand Healthcare Access and Treatment appropriatness Safety 1

Increasing development costs but decreasing the return on investment How to ensure access to new treatments in relation to the

2 How to ensure the appropriate use of new treatments without validated clinical outcomes? The Challenge How to manage uncertainty during the pricing and reimbursement phase of the drug? Increasing development costs but decreasing the return on investment How to ensure access to new treatments in relation to the sustainability of the overall budget? Diagnosing the decline in pharmaceutical R&D efficiency Jack W. Scannell, Alex Blanckley, Helen Boldon & Brian Warrington Nature Reviews Drug Discovery 11, (March 2012) 2

3 Different Realities in EU Healthcare growth in 27 EU countries exceeds average GDP 3

4 Germany Irleand Finland Belgium Uk France Spain Austria Italy Portugal Greece Millions euros milioni di euro Laspeyres index (Italy=100) Pharmaceutical Expenditure in Italy AIFA drug pricing: among most efficient in Europe Prices across European Countries in 2013 (Laspeyres index has been applied to ex-factory prices) ,7 124,5 122,8 121,6 120,4 109,1 107,1 106,4 100,0 90,8 86, * Territorial public pharmaceutical expenditure Out-of-pocket private pharmaceutical expenditure Spesa territoriale pubblica^ Spesa privata Spesa ospedaliera^^ * Hospital pharmaceutical expenditure * Without Hospital Data 4

5 Current scenario and challenges (1) Current scenario and challenges (2) Regulatory authorities face stretched health care budgets, increasing availability of potentially life-saving high-cost drugs and increasing patient expectations. Manufacturers seeking inclusion in reimbursement lists need to demonstrate that their drugs can provide additional benefit in relation to current therapies and value-for-money in order to obtain coverage. Data and the overall evidence available at registration are often insufficient to accurately estimate the clinical and cost-effectiveness of a drug in clinical practice or its budget impact in real life. Uncertainty, due to lack of information on effectiveness, may delay reimbursement decisions and patient access. Against this background, formal agreements between payers and manufacturers with the aim of sharing the financial risk due to uncertainty surrounding the introduction of new technologies have been developed and introduced by AIFA in order to enable access to new medicines. 5

The regulatory challenge Countries are facing: Limited general financial resources Increasing costs in healthcare budgets High-cost therapies How to cope with uncertainty when deciding on pricing and

6 The regulatory challenge Countries are facing: Limited general financial resources Increasing costs in healthcare budgets High-cost therapies How to cope with uncertainty when deciding on pricing and reimbursement? Refusal Italian Experience: Managed Entry Agreements Reimbursement (without conditions) Managing budget impact Non-Outcome based MEAs Volume Agreements Managing uncertainty relating to clinical benefit and cost-effectiveness. Monitoring Registers Oncologicals Outcome based MEAs Payment by Results Managing utilisation to optimize performance Therapeutic plan AIFA Notes What is the cut-off to be considered between therapeutic utility of a new medicine and its major cost? Cost sharing Budget cap Orphans Psoriasis Risk Sharing How can we make difficult decisions in the absence of ideal information? Antidiabetics Cardiovascular 11 Antireumatics 6

How to cope with Uncertainty There is a need to balance the Uncertainty of costs and treatment outcomes with the patients demand for cure and care

7 How to cope with Uncertainty There is a need to balance the Uncertainty of costs and treatment outcomes with the patients demand for cure and care Guarantee Patients Access to best Treatments Guarantee best Cost/Benefit Ratio, limiting Uncertainty with access to cure The New Model to evaluate innovation 7

Towards a full valorization of the innovation A proper valorization of the innovation requires the

terms of quality of life for the patient Effects on the cost of care: resources used for the development

to costs Criteria 1. Population 2. Endpoint 3. Comparator 4.

8 Towards a full valorization of the innovation A proper valorization of the innovation requires the assessment of Effects on quality of care: reducing mortality and morbidity, pain relief, benefits in terms of quality of life for the patient Effects on the cost of care: resources used for the development and for providing medical care to the patient Effects on the value of care: quality improvement related to costs Criteria 1. Population 2. Endpoint 3. Comparator 4. Duration of Effect Until now, most innovation has been evaluated primarily in terms of quality of care and the cost to achieve innovation is often ignored. 15 8

9 The meaning of a decision-making algorithm Drug evaluation becomes a continuum Clearness in the interaction of the assessment components Transparency in the evaluation process Easy identification of the critical elements Easy revaluation following the acquisition of new evidences The knowledge of drugs is not binary but continues to evolve over time. The single magic moment between non-approval and approval is replaced with progressive management and reduction of uncertainty. 9

10 Gap between efficacy and effectiveness Traditional drug licensing approaches Hans Georg Eichler 20 10

11 Adaptive licensing scenario Challenges What are the implications and costs of this new business model? Are the other Stakeholders ready? Is the Industry ready? 21 11

The Important Role of HTA The Challenge for the Pharma System is the balance between Availability and Access AIFA a Leader in HTA PRE-MKT MKT POST-MKT Protect and Promote Public Health,

12 The Important Role of HTA The Challenge for the Pharma System is the balance between Availability and Access AIFA a Leader in HTA PRE-MKT MKT POST-MKT Protect and Promote Public Health, authorizing Medicines with Safety and Efficacy Regulate Public Expenditure for Medcines and Guarantee equal Access to all and to every Drug HTA analysis for HTA in the supporting pricing & appropriateness reimbursement of utilization decisions HTA analysis for evaluating riskbenefit profile HTA analysis for supporting pricing & reimbursement renegotiation HTA analysis for supporting decision of new therapeutic indications A useful approach that helps policy makers to make decisions HTA analysis for assessing risk-benefit profile following adverse events signals 12

13 From the perspective of Public Health Care Service The cups to pharmaceutical expenditure should be linked more to a long-term health planning, than cost containment needs The governance of appropriateness in the medicine s use may save a lot of money but new innovative medicines are too much costly Further improve the price adjustment through reassessments after the reimbursability, based on the effectiveness of medicine in the real world practice From the perspective of Pharmaceutical company Since in the medium-long term, the health care systems cannot sustain the incremental costs of pharmaceutical expenditure, a new overall business model should be considered. The business model in the pharmaceutical companies is always the same, today the only difference respect to the mee-too era is an extreme segmentation of the market A transparent definition of medicine s price from the pharmaceutical company should be solicited and welcome 13

14 A synergic relation Equal access for patients to new therapies, technologies and diagnostic tests Resources optimization The healthcare system should consider resources globally 31 14

15 THANK YOU! 15

AIFA s post-marketing registries and accelerated patient access. Opportunities and challenges in the context of MAPPs

AIFA s post-marketing registries and accelerated patient access. Opportunities and challenges in the context of MAPPs Entela Xoxi Can RWD accelerate patient access to medicines? London, 7th July 2016 Since