The Impact of AMNOG onGlobal Market Access Strategies     IHS Webcast, 28 June 2011   Gustav Ando, Director, Healthcare an...
The Impact of AMNOG on                                             Global Market Access Strategies                        ...
Agenda        AMNOG At A Glance        Impact on National and Global Market Access         Strategies        Impact on ...
Methodology        Analysis based on primary and secondary research        Telephone interviews with 2 policy makers and...
German Healthcare Reform At A Glance           Early benefit assessment for eligible new market entrants and selected    ...
Early Benefit Assessment        Eligible Medicines:                   – Based on formulation and revenues for new market ...
Early Benefit Assessment        Scores:                   – Major additional therapeutic benefit                   – Sign...
Pricing Process Under AMNOG        Three pricing options under AMNOG          – Pricing negotiation          – Arbitratio...
AMNOG Impact on National and    Global Market Access Strategies        A medicine’s innovation level will influence marke...
Case Study: Market Access Strategy    for Highly Innovative Market Entrants        Objective: Maximise global product rev...
AMNOG Impact on Clinical Trial Design        Challenges:                   – Meet information needs of regulators and pay...
Possible Clinical Trial Protocols        Clinical trial protocols:                           Randomised, two-arm, active...
AMNOG: An Innovative Reform?        Therapeutic benefit score déjà vu:                   – E.g. in France, Austria, Switz...
AMNOG: An Innovative Reform?   Perceived level of innovation as a driver of price: also déjà vu              – E.g. in Fr...
Concluding Remarks        AMNOG brings price control to one of the last unregulated         European pharmaceutical marke...
Visit the IHS Healthcare & Pharma Blog                                           Get weekly insights on the events        ...
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AMNOG - Germany's Healthcare Reform and The impact on Global Pharmaceutical Market Access Strategies

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These slides were presented at the recent IHS webcast: The Impact of AMNOG on Global Market Access Strategies on 28 June 2011.

In this webcast we examined the German healthcare reform and what it means for the global pharmaceutical industry.

Topics included:

• The impact of the reform on national and global market access strategies for medicines subject to early benefit assessment

• How the reform may impact your clinical trial development

• How innovative the reform is from an international perspective

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Transcript of "AMNOG - Germany's Healthcare Reform and The impact on Global Pharmaceutical Market Access Strategies"

  1. 1. The Impact of AMNOG onGlobal Market Access Strategies IHS Webcast, 28 June 2011 Gustav Ando, Director, Healthcare and Pharma Gaëlle Marinoni, Senior Healthcare Analyst Anne-Charlotte Honore, Healthcare Analyst
  2. 2. The Impact of AMNOG on Global Market Access Strategies IHS Webcast, 28 June 2011 View the on-demand replay of this webcastCopyright © 2011 IHS. All Rights Reserved.
  3. 3. Agenda  AMNOG At A Glance  Impact on National and Global Market Access Strategies  Impact on Research and Development Programmes  AMNOG From An International Perspective  Concluding RemarksCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  4. 4. Methodology  Analysis based on primary and secondary research  Telephone interviews with 2 policy makers and regulatory affair specialists, 5 industry representatives with extensive experience in planning and executing pharmaceutical launches  Conference and workshop attendance – Market Access in Germany after Major Pricing & Reimbursement Reform, 14-15 March 2011, Berlin, Germany – ISPOR 16th Annual International Meeting, 21-25 May 2011, Baltimore, Maryland, USA  Desk-based research: national governmental agencies, IHS Global Insight Healthcare and Pharmaceutical services (World Markets Healthcare and World Markets Pricing and Reimbursement).Copyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  5. 5. German Healthcare Reform At A Glance  Early benefit assessment for eligible new market entrants and selected established medicines  End of free pricing after 6 or 12 months of commercialisation  Price negotiations, or  Reference pricing  Limited recourse to cost-benefit assessment Registration 0 - 3 Months 4 - 6 Months 7 - 12 Months 13 - 15 Months Process Product Additional Price Launch Discounted Price Patient-related Negotiation Outcome with GKV Submission of Reimbursement Cost-benefit Early Benefit Arbitration Dossier Assessment Assessment body by IQWiG (G-BA) No Added Reference Discounted Price Free Price Value PricingCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  6. 6. Early Benefit Assessment  Eligible Medicines: – Based on formulation and revenues for new market entrants – Based on new approved indication or G-BA/industry request for established medicines  Exceptions: – Orphan drugs launched post 1 January 2011 with expected 12- month turnover in all indications lower than 50 million euro (retail prices inclusive of VAT) – Hospital-only medicines – Reimbursable new active ingredient with estimated budget impact on Statutory Health Insurance of less than 1 million euroCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  7. 7. Early Benefit Assessment  Scores: – Major additional therapeutic benefit – Significant additional therapeutic benefit – Slight additional therapeutic benefit – Additional but unquantifiable therapeutic benefit – No demonstrated additional therapeutic benefit – Less therapeutic benefit than appropriate comparator  Outcome: – Pricing negotiations – Inclusion into the reference pricing systemCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  8. 8. Pricing Process Under AMNOG  Three pricing options under AMNOG – Pricing negotiation – Arbitration – Cost-benefit evaluation – Global repercussions through international reference pricingCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  9. 9. AMNOG Impact on National and Global Market Access Strategies  A medicine’s innovation level will influence market access strategies at the local and global level  Achievable German added therapeutic benefit score will influence: – Launch timing in Germany – Market entry price in Germany – Discounted price in Germany – Launch Sequence  Market access strategies and launch sequences should be planned based on maximum achievable global product revenuesCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  10. 10. Case Study: Market Access Strategy for Highly Innovative Market Entrants  Objective: Maximise global product revenues  Strategy: – Early German and International launch – German market entry with high (yet reasonable) price to impact international prices through reference pricing – Favourable early benefit assessment could positively impact global reimbursement decisions and influence global prices – Upon pricing negotiations, the German price is expected to be at worse the European average price. Global prices remain in high range Launch Year 1 Discounted Price (at worst average Free Price GERMANY price in nominated countries) International prices positively Global prices remain in impacted by high German price high range GLOBALCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  11. 11. AMNOG Impact on Clinical Trial Design  Challenges: – Meet information needs of regulators and payers:  Endpoints need to integrate patient-relevant outcomes  Clinical trial design  Therapeutic benefit score based on relative efficacy or relative effectiveness data: – Ideally head-to-head comparison or:  Meta analysis  Sensitivity analysis  Subgroup analysis and other effect modifiers  Indirect comparison – Surrogate endpoints not accepted, except for oncology drugs – Randomised clinical trials preferred – German-specific dataCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  12. 12. Possible Clinical Trial Protocols  Clinical trial protocols:  Randomised, two-arm, active-controlled, superiority trial  Randomised, two-arm, active-controlled, non-inferiority clinical trial  Active- and placebo-controlled randomised clinical trial  Pragmatic clinical trial  Common reference indirect comparison based on RCT information  Observational studies  Adaptive design, three –arm, randomised clinical trial  Appropriate comparator:  Utilisation criteria: standard therapy in Germany  Not limited to pharmaceutical treatmentsCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  13. 13. AMNOG: An Innovative Reform?  Therapeutic benefit score déjà vu: – E.g. in France, Austria, Switzerland, Italy, Japan Table: German Therapeutic Benefit Scores – Comparison with France and Switzerland Germany France Austria Major added therapeutic Major therapeutic advance – Substantial added therapeutic benefit ASMR I benefit Significant improvement in Great improvement in Added therapeutic benefit efficacy or side effects efficacy or side effects – ASMR II Slight but not minor Modest improvement but Similar to current standards improvement in efficacy or added value – ASMR III side effects Additional but unquantifiable Minor improvement with added therapeutic benefit slight benefit – ASMR IV No demonstrated added Similar products including therapeutic benefit generics – ASMR V Less therapeutic benefit than comparatorCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  14. 14. AMNOG: An Innovative Reform?  Perceived level of innovation as a driver of price: also déjà vu – E.g. in France, Austria, Switzerland, Italy, Japan France ASMR ratings I, II and III • Pricing negotiations: price typically fixed at the reference country average ASMR rating IV • Pricing negotiations: price typically set just above that of therapeutic comparator(s) ASMR rating V • Price set below therapeutic comparator(s) Austria Substantial added therapeutic benefit • Prices based on average EU prices (EU25) Added benefit in the majority of the patient population • Price set at most 10% above that of therapeutic comparator Added benefit in a defined patient sub population • Price set at most 5% above that of therapeutic comparator Similar to current standards • Price set at least 10% below that of therapeutic comparator Germany Major, significant, slight, and • Pricing negotiations: algorithm in development additional but unquantifiable • Under the arbitration process, the price is expected to reflect European price None demonstrated • Price set at the price of the appropriate therapeutic comparator • Comparator ideally be included reference pricing system Below comparator • Price can be set below that of the appropriate therapeutic comparator(s) • Usage restricted via G-BAs prescription guidelinesCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  15. 15. Concluding Remarks  AMNOG brings price control to one of the last unregulated European pharmaceutical market  AMNOG brings a never-seen-before level of transparency to the pricing and reimbursement process  AMNOG increases market access barriers, especially for products with limited added therapeutic benefit  AMNOG is expected to affect launch sequences and global R&DCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.
  16. 16. Visit the IHS Healthcare & Pharma Blog Get weekly insights on the events and trends shaping the industry: www.ihs.com/healthcareblogCopyright © © 2011 IHS. All Rights All Rights Reserved Copyright 2011 IHS Global Insight. Reserved.

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