The Roche experience in innovative win-win schemes between industry and payers

Transcription

1 The Roche experience in innovative win-win schemes between industry and payers Giovanni Giuliani Pricing and Health Economics Oncology coord. Roche SpA - Italy

2 Summary The different types of Pricing & Reimbusement schemes Evolution of P/R schemes in Italy Scope and key parameters of P/R schemes The Roche experience: strenghts and areas for improvement The Roche idea of partnership with payers

3 Introduction Risk-sharing agreements are becoming a more prevalent trend as pharmaceuticals regulators become more cost conscious. Risk-sharing agreements can guarantee payers that they can recoup money if a drug does not perform in the same manner in the real world as in clinical trials. Italy, thanks to the AIFA patient registry availability, has been a pioneer country in the definition of risk-sharing schemes.

4 P/R schemes - definitions Cost-sharing (Cs), Risk-sharing (Rs) e Payment by results (Pbr) Cost-sharing (Cs) - fixed discount on the first cycles of treatment for all patients Risk-sharing (Rs) 50% discount on the cost of treatment for patients with early interruption of the treatment (progression or toxicities) at the first evaluation Payment by results (Pbr) 100% discount on the cost of treatment for patients with early interruption of the treatment (progression or toxicities) at the first evaluation

5 AIFA Risk-Sharing procedure Initial cycles of treatment for new patients Progressive disease Treatment ex-post evaluation CR / PR / SD Treatment is stopped Treatment is continued Risk-sharing 50% payback for treatment costs Payment by results 100% payback for treatment costs 100% paid by NHS

6 Italian background Scope and key parameters of Risk-sharing deals Roche partnership with payers Conclusions

7 The National Oncologic Plan strongly recommends implementation of risk-share concept National Oncology Plan (recommendations) Currently, several anticancer drugs are registered early by EMeA when the risk/benefit ratio is not yet been sufficiently defined. The concept of "risk sharing has been defined so that payers can share with the companies the risks of failures if there are no data at the beginning of therapy to identify patients who are most likely to benefit In order to guarantee that the right patient is treated with the best drug, it is essential to put in place measures that are based on biological criteria (ex ante; e.g.: biomarkers) and/or reimbursement criteria (ex post; e.g.: risk-sharing, payment by results) Source: National Oncologic Plan, Ministry of Health; Jan 2010

8 Risk sharing deals (partial or full pay back for patients with early disease progression) are becoming the norm for high priced therapies Financial based Performance based Fixed discounts Cost-sharing Risk-sharing AIFA registry Bevacizumab Cetuximab Lapatinib Pemetrexed Nelarabina Panitumumab Lenalidomide Ranibizumab Ofatumumab Bevacizumab mcrc Fulvestrant Dasatinib Sunitinib Pegaptanib Temsirolimus Azacitidine Herceptin GC Cetuximab 2nd L Sorafenib Nilotinib Gefitinib Pemetrexed 2nd L Erlotinib Sorafenib HCC Azacitidine Fixed discount Cost-sharing Cost-sharing + Cap Risk sharing / PbR

9 Scope and key parameters of Risk-sharing deals Roche partnership with payers Conclusions

10 Scope of Risk Sharing deals Italian Risk-sharing deals: Pay-back for patients with early disease progression / early interruption Scope of R/S deals Serious diseases High unmet need Need to further assess effectiveness in real practice High budget impact potential Lack of biomarkers / prognostic factors Early disease progression evaluation

11 Key parameters driving financial impact of Risk sharing schemes Italian Risk-sharing deals: Pay-back for patients with early disease progression / early interruption Clinical parameters Timing for treatment evaluation - Clinically releavant - Financially sustainable Early progressions rates Availability of data 2 /3rd line early progressions rates can be high Avg treatment duration Real life treatment duration can be lower than RCTs Financial parameters Risk-sharing vs payment by results (50% vs 100% payback for early progressions)

12 Roche partnership with payers Conclusions

13 Roche experience in P/R schemes Specialità Indicazione Determina AIFA Tipologia accordo Tarceva (erlotinib) Ca Polmone metastatico 1^ linea (GU 27/07/2006) Cost-sharing Avastin (bevacizumab) Ca Mammella metastatico 1^ linea Ca Polmone metastatico 1^ linea (GU 24/06/2008) Cost-sharing + cap (11 g) Ca Renale metastatico 1^ linea Ca Colon-retto Ava + oxa. metastatico 1^ linea Herceptin (trastuzumab) Ca Gastrico 1^ linea (GU 30/12/2010) Payment by results

14 Roche partnership with payers activities Implementation phase AIFA Registry forms are discussed with the company Methods for payback requests is shared and simulations are done The system is checked after the first month Operational phase Pay backs are requested by hospital to Roche Roche verifies requests Credit notes or free goods are paid back to the hospital 1-2 days Information and support is given to clinicians, hospital pharmacists, regional payers AIFA registry data is constantly reviewed and analysed by the company (access through password)

15 Roche partnership with payers - challenges An additional risk is assumed by the company A risk is taken in case of lower effectiveness but a higher price is not allowed in case of incremental effectiveness in real life («value based pricing») Need for competencies and additional resources to manage the administrative phase Change in communicating the value of the drugs to payers P/R schemes need to be clearly explained Need for rigourous accounting procedures to manage credit notes and free good (VAT provisions audits from authorities)

16 Roche partnership with payers - opportunities Market access «Fast track» opportunities? The drug is made available at a sustainable cost for the society Appropriateness of use Ex-post evaluation of effectiveness Cost/effectiveness ratio is improved Additional data are collected through the AIFA patient registry

17 Conclusions

18 Conclusions (1) AIFA-like risk-sharing deals can be a win-win situation for payers and manufactures allowing patients to access innovative drugs when: There is uncertainty in terms of treatment benefit (i.e.: lack of biomarkers) Objective and short-term success/failure indicators can be identifyed (i.e.: early progression for metastatic tumour, early virological response for HCV drugs, visual acuity gain for AMD drugs) Proper infrustructure is in place (AIFA patient registry) Open collaboration between Regulatory Autorities and manufacturers exists Risk-sharing deals can not help when: Treatment benefit is considered not relevant by payers Objective and short-term success/failure indicators can NOT be identifyed (i.e.: adjuvant /maintenance settings)

19 Conclusions (2) -What does it mean «to be a partner» for Roche Sharing objectives (access of innovative therapies) and methods (AIFA registry P/R schemes) Looking for innovative solutions Full support to the payer in the implementation phase Assuming responsabilities in terms of: Trainings (to internal and external stakeholders) Communication (with the involvment of KAM, RAM, FF) Economics (Organizational changes Contributions to the AIFA Registry)

20 Thanks for your attention

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