Interface Management of Pharmacotherapy october 2016, Barcelona

Transcripción

1 Interface Management of Pharmacotherapy october 2016, Barcelona 1

2 The Catalan model for access and use of medicines based on health outcomes Antoni Gilabert-Perramon Managing Director of Pharmacy and Medicines Interface Management of Pharmacotherapy WHO Collaborating Centre for Research and Training in Pharmacoepidemiology Piperska Group Barcelona, 17th October 2016

3 HORIZON SCANNING: ONCOLOGY DRUGS Colorectal cancer Prostate cancer Melanoma Soft tissue sarcoma Commercialization Myeloma Renal cell carcinoma Breast cancer Chronic lymphocytic leukemia Ovarian cancer 1. IMS Health knowledge link, drugs pending since

4 3 1 Innovating in management and financing access to new drugs Why not? 1) To have a strategic vision 2) To develop and adopt metodology 4

5 1) Strategic Vision 5

6 The challenge: a new vision 1) Improve health outcomes ; 2) Stay into the budget Expenditure Investment Health outcomes 6

7 2)

8 Market access, innovation and sustainability Managing uncertainty Collaborative model 8

9 Our aim is certain Improve health outcomes in a sustainable financing environment But we face uncertainties 9

10 Access How to program minimize for the pharmaceutical uncertainty to Who is it intended for? What are the most pertinent alternatives? What are the criteria for use? What is the prescription variability? What are the follow-up indicators? What are the ultimate results for success? How can equity of acces be guaranteed? guarantee innovation access in Catalonia to innovation 1 Evaluation Criteria for eligibility, follow-up and outcomes Financing What is the proposed cost of treatment? What should the fair cost of treatment be? What is the value for money in terms of healh? How is the budget impacted? How should the risk be shared? 3 Co-responsability and sharing risks Clarity Methodology Meticulousness Transparency Collaborative Predictibility Real world evidence: - How effective is it? - How safe is it? How many people does it affect? How variable are the outcomes? How are the recommendations adhered to? Patient registries and outcomes monitoring Monitoring 2 10

11 Formula for access to innovation I + S = MU = CU + MO + SR I = Innovation S = Sustainability MU = Managing uncertainty CU = Criteria for using MO = Monitoring outcomes SR = Sharing 11

12 Access program Stage 3:Financing Sharing risks (SR) 12

13 Access program. Stage 3: Financing Payment systems ongoing Payment by product Price volum agreements Payment according to criteria of use and follow up Ceiling expenditure / patients (caps) Pharmacological fixed rate pricing Pathology fixed rate pricing Payment by results (Risk Sharing Schemes) Variable rate pricing according to outcomes Payment by a health care solution 13

14 Access program. Stage 3: Financing Risk sharing based on health outcomes New approach endorsed by CatSalut. Several experiences ongoing: - Gefitinib in lung cancer - Erlotinib in lung cancer - Afatinib in lung cancer - Cetuximab in metastatic colorectal cancer - Bevacizumab in metastatic colorectal cancer - Panitimumab in metastatic colorectal cancer - Cetuximab in metastatic colorectal cancer - Aflibercept in metastatic colorecal cancer - Certolizumab in rheumatoid arthritis - / Guideline to identify possible drug suitable for this approach Guidance for RSS and payment by results 14

15 Agenda for risk-sharing schemes policy in Catalonia Key milestones Standardization the profile of drugs tributary of RSA Identification drugs to be proposed Define the approach to pharmaceutical industry Objectives Identifying drugs Identification of centers for a RSA Definie the technical and economic conditions of the ARC Signature and dissemination Conditions of the agreement Monitoring clinical outcomes Arbitration Identification, adaptation of information systems Clinical outcomes Follow-up and evaluation Guide RSA/PRS Systemic Implantation PAYING BY RESULTS SQUEMES 15

16 Risk sharing schemes (outcomes based) (19 RSA, 11 drugs, 29 hospitals, 10 laboratories) Àrea Terapèutica Medicament Indicació Laboratori Hospital Data Inici Estat de situació Gefitinib (Iressa ) Càncer de pulmó no microcític (CPNM) AstraZeneca Xarxa ICO Juliol 2011 En Curs Afatinib (Giotrif ) Càncer de pulmó no microcític (CPNM) Boehringer Ingelheim Xarxa ICO 15 Abril 2015 En Curs Erlotinib (Tarceva ) Càncer de pulmó no microcític (CPNM) Roche Xarxa ICO Gener 2015 En curs Oncologia Bevacizumab (Avastin ) Glioblastoma multiforme (GBM) Roche Xarxa ICO Novembre 2012 En Curs Bevacizumab (Avastin ) Càncer colorectal metastàtic (CCRm) 1a L Roche Xarxa ICO Desembre 2013 En Curs Bevacizumab (Avastin ) Càncer colorectal metastàtic (CCRm) 2a L Roche Xarxa ICO Desembre 2014 En Curs Cetuximab (Erbitux ) Càncer colorectal metastàtic (CCR m) 1a L Merck SL Xarxa ICO Desembre 2013 En Curs Panitumumab (Vectibix ) Càncer colorectal metastàtic (CCRm) 1a L Amgen Xarxa ICO Juliol 2014 En Curs Aflibercept (Zaltrap ) Càncer colorectal metastàtic (CCRm) 2a L Sanofi Xarxa ICO Desembre 2014 En Curs Everolimus (Afinitor ) Càncer de mama avançat Novartis Xarxa ICO Juny 2015 En curs Hematologia Lenalidomida (Revlimid ) Mieloma múltiple (MM) recaigut o refractari Celgene Xarxa ICO Desembre 2014 En Curs Artritis reumatoide (AR) de moderada a UCB greu (naïves) H. Clínic Novembre 2012 Finalitzat AR de moderada a greu (naïves i switch) UCB H. de Bellvitge Maig 2013 En Curs AR de moderada a greu (naïves i switch) UCB H. Vall d Hebron Juny 2014 En Curs Certolizumab (Cimzia ) Reumatologia AR de moderada a greu (naïves i switch) H. Mútua de UCB Juny 2014 En Curs Terrassa AR de moderada a greu (naïves i switch) UCB H. Sant Rafael Juny 2014 En Curs AR de moderada a greu (naïves i switch) UCB H. Viladecans Juny 2014 En Curs AR de moderada a greu (naïves i switch) UCB Consorci Sanitari Integral Octubre 2014 En curs Golimumab (Simponi ) AR de moderada a greu (naïves i switch) MSD H. Sant Joan de Reus 13 Març 2015 En Curs 16

17 Exemple RSA/PRS: Oncology drug First follow-ùp Second follow-up Results - RESPONSE RESPONSDER P EXITUS 7 (10,1%) 8 (11,5%) Refund 100 % 18 % patients Drugs OD 108 patients Efficacy evaluation Week 8 + RESPONSE SD 16 (23,1%) Efficacy evaluation Week RESPONSE P EXITUS 7 (10,1%) 5 (7,2%) 1 (1,4%) + RESPONSE SD CR PR Refund 100 % 7 % patients Funding 100% 22% patients 7 (10,1%) 5 (7,2%) 1 (1,4%) + RESPONSE CR PR 1 (1,4%) 37 (53,6%) Funding 100% 53 % patients 17

18 RSS based on health outcomes They are: An innovative option to promote access to new drugs A clear commitment to results and to ensure that new treatments are an investment, not an expense. Alternative to traditional drug payment 18

19 RSS based on results What have we learned? Allow delineate the uncertainties of economic and health impact of pharmaceutical innovation It allows more flexible access to innovation by sharing risks Create incentives for cost effective use of medicines Aling industrial and health system incentives: results Develop information systems oriented to record results in a valid and reliable way The ARC on results are difficult to apply and require a clear strategic positioning, maturity and confidence in the relationship There must be clear outcome preferably short term It requires a new organizational culture with high value of positive externalities 19

20 Expenditure CONCLUSION Sustainability Efficiency (Harmonization, Pricing and purchasing) Health outcomes (Patients registries) Co-responsability (Risk sharing, Stakeholders partnership) COLLABORATIVE MODEL Innovation Investment 20

21 Thank you! 21