Risk sharing - bbg and ja.ppt

Risk sharing arrangements –
considerations for the future
Presentation to Piperska Course Brian Godman - Mario Negri Institute for Pharmacological Research, Milan, and University of Liverpool 4. Issue and concerns Jakub Adamski – Ministry of Health, Poland 5. Group discussion 1 Risk sharing presentation 2 Risk sharing presentation The following definition is proposed based on
developments in Poland

 ‘Risk sharing' schemes for pharmaceuticals should be considered as agreements concluded by ‘payers' and pharmaceutical companies to diminish the financial impact of medicines brought about by:  the uncertainty of the value of the medicine  or the need to work within finite budgets  ‘Risk sharing' schemes can be categorised into either financial/financial-based models or outcome/performance- 4. Issue and concerns  Even this division may be misleading because it suggests that outcome or performance-based models have little to do with 5. Group discussion expenditure. In fact, the opposite can be true 3 Risk sharing presentation 4 Risk sharing presentation Risk sharing schemes can be divided into two

 Financial/financial-based models:  Price: volume agreements (PVAs) for new and existing drugs – typically pay back/ rebate mechanisms if volumes and/ orexpenditure exceed agreed limits for the drug, class, or overall pharmaceutical expenditure  Price cap schemes – whereby companies will cover the additional costs above agreed limits. This includes both 3. Case History
patients and payers in the US  Performance based or outcome models: 4. Issue and concerns  ‘No cure, no pay' schemes including rebates if drugs fail to produce desired outcomes  Drugs provided free until their effectiveness is demonstrated 5. Group discussion  Prices modulated if new drugs to not produce the desired patient benefits in reality 5 Risk sharing presentation 6 Risk sharing presentation Examples of price: volume arrangements include
Examples of price cap schemes in Europe and the
Australia and Europe, e.g.
US include:
Current schemes and arrangements
 Pharmaceutical companies refund a percentage if expenditure  Costs of bevacizumab in approved cancers can not exceed on a new product exceeds agreed limits. This also includes a €25,941 per patient per year future price decrease  This is in addition to other schemes to reduce costs for  Currently over 14 agreements in place bevacizumab and other anti-cancer drugs in Italy  Annual price: volume agreements are mandatory for all  Under the RANIBIZUMAB Reimbursement Scheme additional pharmaceuticals in the positive list costs of injections above 14/ patient reimbursed by the  This includes the rationale supporting the figures company either as free drug or a credit note  Rebates and/ or price reductions if expenditure exceeded and Wales  Discounts given for TARCEVA to ensure similar costs to docetaxel for patients with NSC lung cancer  Contracts are signed annually – innovative and orphan drugs  MCOs have instigated maximum dose policies to reduce their  Agreements take into account dosing and utilisation of single exposure to new expensive drugs, e.g. United Healthcare drugs as well as classes, with compensation if agreementsexceeded  Companies introducing general schemes for patients, e.g.:  Rebates in 2004 were €670mn – 3% of total pharmaceutical  Pfizer – MAINTAIN scheme – if recently unemployed  Amgen – Oncology Assistance Programme (AOA) if costs over 5% of gross income in the year 7 Risk sharing presentation 8 Risk sharing presentation Examples of performance based or outcome
Examples of performance based or outcome
models include (continued):
Current schemes and arrangements
Current schemes and arrangements
Beta interferon for multiple sclerosis
 NICE initially rejected funding for the β interferons in MS on
Atorvastatin for CHD prevention
clinical and cost-effectiveness grounds with a cost/ QALY of£42,000 to £98,000  The company agreed to fund the health authority for wasted  Under the proposed scheme, patients would be followed for resources if atorvastatin failed to reduce LDL-C levels to over 10 years with prices reduced or refunds if the cost/ QALY agreed targets amongst specified patients when properly was over £36,000/ QALY in reality  Scheme heavily criticised as unscientific and impractical  In reality, no refunds were given as all properly titrated leading to only a limited number of patients recruited patients reached target lipid levels helped by the recruitment and Wales Bortezomib for multiple myeloma
 The nurses worked with GPs and practice nurses to improve  Scheme based on a 50% reduction in serum paraprotein levels compliance, although a 20% adjustment was built into the by the fourth cycle. NHS will fund treatment in responders with the cost/ QALY reduced to £20,700/ QALY. J & J will  GP and patient participation was helped by CHD being a high refund drug costs if a 50% reduction in levels not achieved priority disease area in the UK with national initiatives to  Prices remain at the launch price although discounts given  Concerns though whether M-protein reliable surrogate and 10- 15% of patients have no measurable levels 9 Risk sharing presentation 10 Risk sharing presentation AIFA has also recently launched two ‘risk
First risk sharing scheme for new anti-cancer
sharing' schemes to help achieve their aims
drugs in Italy. Prices subsequently modulated
 The Italian Medicines Agency (AIFA) has recently launched two risk-sharing arrangements for new anti-cancer medicines to enhance reimbursement. The schemes were based on: 50% price
Reimbursed by NHS
 Epidemiological data for the disease reduction for NHS
 The possibility to clearly define a subset of the population responsive to the treatment versus list price
 Results from the submitted clinical trials  Six products are currently included - Bevacizumab, Dasatinib, Erlotinib, Nilotinib, Sorafenib and Sunitinib number of cycles of
treatment for new
 Prices and guidance will be modulated as more data becomes available on the effectiveness and safety of the new drugs in Withdrawal of the
practice. This is similar to the new PPRS scheme in the UK 11 Risk sharing presentation Ref: P. Folino 2008
12 Risk sharing presentation Ref: P. Folino 2008
Second risk sharing scheme for new anti-cancer
AIFA has also recently launched innovative
drugs in Italy. Prices subsequently modulated
schemes to help achieve their aims (continued)
 AIFA has also introduced a conditional reimbursement Reimbursed by NHS
scheme for ivabradine - chronic angina pectoris, and exenatide, sitagliptin and vildagliptin - Type 2 diabetesresistant to current oral treatments  Under the scheme, AIFA fully reimburses the new drugs until re-evaluation. The main objectives of the scheme are to:  evaluate their utilisation in routine clinical practice number of cycles of
 collect epidemiologic data on the diseases treatment for new
 obtain data on their effectiveness and safety in practice Withdrawal of the
 By the end of October 2008, 16750 patients had been Previous treatment costs
entered into the scheme with 7% withdrawals due to fully paid for by the
13 Risk sharing presentation Ref: P. Folino 2008
14 Risk sharing presentation Ref: P. Folino 2008
There are a number of considerations with
schemes potentially limiting their number

 There are a number of issues and concerns that need to be addressed before considering risk sharing schemes; these  Whether patients initially prescribed drugs under PVA schemes are those most likely to benefit – guidance and monitoring can help  Do PVA schemes adequately address issues such as adherence and compliance - crucial for all key stakeholder groups. Atorvastatin scheme in UK considered this 4. Issue and concerns
 Whether sufficient evidence base to embark on schemes including the robustness of the surrogate marker(s) 5. Group discussion  Are the logistics and administration adequately addressed, e.g. concerns with the beta interferon scheme in the UK 15 Risk sharing presentation 16 Risk sharing presentation Payer considerations for successful
implementation of risk sharing schemes

 Factors that should be considered amongst payers to enhance successful implementation of any risk sharing scheme include:  Are appropriate professionals in place to evaluate and implement proposed schemes including clinical and IT to develop and implement registries for the scheme(s)  Are the rebate/ price reduction schemes fully transparent  Do the scheme(s) have realistic timescales for the disease/  Are there unambiguous and easily measured ‘evidence based' effectiveness criteria to reduce abuse among eitheror both parties 4. Issue and concerns  Are probity and clinical governance issues fully addressed including safeguards surrounding funding and monitoring  Are payers actually funding a significant proportion of the 5. Group discussion
clinical development plan including comparative 17 Risk sharing presentation 18 Risk sharing presentation Thank You
19 Risk sharing presentation

Source: http://piperska.sidi.se/sites/default/files/23_Risk_sharing.pdf


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