Risk Sharing Pracitces conditional Pricing of Pharmaceutical

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Risk Sharing PracticesConditional Pricing of
Pharmaceutical How to deal with
uncertaintyHildrun SundsethHead of EU Policy
Nothing About Us, Without Us! www.ecpc-online.org
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HL Pharmaceutical ForumPricing and Reimbursement

• Find a balance between innovation and
  sustainability of healthcare
• Pricing and Reimbursement is national
• Member States 3 objectives
• Optimal use of resources to maintain sustainable
  financing of healthcare
• Reward for innovation
• Access to medicines for patients

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Risk Sharing Practices Conditional PricingHow
to deal with uncertainty

• Conditional pricing and reimbursement
• Build clinical experience with highly
  innovative medicines
• Risk sharing methods
• Provide access to patients
• Examples - The Netherlands, Belgium, UK

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Dutch Model for highly innovative medicines

• Conditional reimbursement in hospitals
• Healthcare Insurance Council advises
• Dutch Healthcare Authority decides for temporary
  additional funding

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Dutch Model

• Criteria for temporary funding
• Added value
• Exceed certain threshold of cost-prognosis
• List of open unanswered research questions

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Dutch Mechanism

• Medicine can be used for patients in clinical
  settings
• Subsidy for collecting clinical data on
  therapeutic value and cost-effectiveness
• Data generated is expected to provide answers to
  therapeutic value and cost effectiveness
• Duration maximum 3 years

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Dutch Outcome

• If cost-effectiveness ratio acceptable further
  funding will be provided
• If cost-effectiveness is not proven, funding stops

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Dutch Experience

• Set up in 2006
• 23 medicines
• 6 orphan drugs
• Cancer, Auto-immune diseases, Muscular
  degeneration
• Appraisal end 2008

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Potential Benefits for Patients

• Fast access to innovative medicines for often
  life -threatening conditions while establishing
  therapeutic and economic benefit in real life
  situation
• Criteria for therapeutic value,
  cost-effectiveness, impact on public health
• Patients included in setting criteria and
  evaluation?

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Belgium Conditional Reimbursement

• Separate class of medicines eligible for
  premium price (Class 1)
• Claimed added value
• Specific benefits over existing therapies

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Belgian Mechanism

• Class 1 hypothetical unknown factors
• Effectiveness in clinical practice
• Pharmaco-economics in clinical practice
• Size of target group sales volume
• Reimbursement status in other EU Member states
• Yearly cost evolution in therapeutic class

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Belgian Outcome

• Duration 18 - 36 months
• Company expected to deliver additional data
• Authority decides either
• Limit target group
• Restrict group of prescribers
• Withdraw from Reimbursement list

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Belgian Experience

• Missing evidence always about effectiveness in
  clinical practice and cost-effectiveness
• 18 medicines appraised so far
• For some, reimbursement conditions were adapted
• 1 only withdrawn from reimbursement

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Belgian Experience

• Need for good upfront communication on expected
  deliverables
• Preferably through formal meeting with
  Reimbursement Committee (CRM/CTG) and company
• Support from company headquarters

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UK Cost Sharing

• NICE decision that Velcade for relapsed Multiple
  Myeloma without possibility of bone marrow
  transplantation is not cost-effective
• Company proposed risk-sharing scheme
• DoH and NICE decision to prescribe under certain
  conditions
• Scheme developed with haematologist and
  pharmacists
• Duration until reviewed by NICE

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UK Mechanism

• Eligible patients with progressive Multiple
  Myeloma
• Patients with first relapse, after trying out one
  prior therapy, when bone marrow transplant is not
  an option
• Immediately available, NHS foresees initial
  funding

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UK Mechanism

• NICE Guidelines for medical doctors about
  eligibility of patients for treatment
• After 4 cycles impact is measured by serum
  protein test.
• If 50 reduction, treatment is considered
  effective

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UK Outcome

• If serum protein test shows effectiveness after 4
  cycles with Velcade treatment continues
• Funded by NHS
• If not sufficiently effective, treatment stopped
  and company refunds cost of 4 cycles

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Common Findings

• Controlled Utilisation Provides
• Therapeutic Value Assessment
• Cost Effectiveness Data
• Justification for Reimbursement
• Incentive for Innovative Drug Development
• Early Access for Patients with life-threatening
  Conditions, or no effective current treatment
  options

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Patients Perspective?

• Opportunity to have early access and collect data
  in clinical settings
• Patients to be included in criteria setting and
  evaluation
• Need clear agreed parameters, defined
  expectations
• Concern if all or nothing decision
• Increase inequalities across the EU
• Fits cancer strategy with budget