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Webinar for IADB

Value-based drug reimbursement: Introduction to the main features of the German pharmaceutical policy. Webinar for IADB. Bielefeld (Germany), September 29th, 2015 Prof. Dr. Wolfgang Greiner. Country cluster by drug prices and economic power. Source: mod. Nach Shankar 2011.

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Webinar for IADB

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  1. Value-based drug reimbursement: Introduction to the main features of the German pharmaceutical policy Webinar for IADB Bielefeld (Germany), September 29th, 2015Prof. Dr. Wolfgang Greiner

  2. Country clusterbydrugpricesandeconomic power Source: mod. Nach Shankar 2011

  3. German Pharmaceutical Market in International Comparison Development of expenses for drugs per capita (in US-$-PPPs) Expenses per capita in US-$-PPP Germany OECD average year (Source: OECD 2014)

  4. Concepts of regulating prices and reimbursement

  5. Main Regulation Instruments forthePharmaceuticalSector in Germany Regulation on industrylevel: Central benefitassessmentandpricingof innovative drugs(AMNOG) Price moratorium Obligatorydiscountsforsicknessfunds Public tendersforgenerics Reference pricesfor (mainly) genericdrugs Regulation on physicianlevel: Drugs budgets (regional and individual) Effciencyaudit Target agreementswithphysicians‘ associations Negative list Regulation on pharmacylevel: Prohibition on discountsforpharmacies Aut-idem regulation Regulation on patientlevel: Co-payments (10 %, max. 10 €) Noco-paymentfordiscountedgenerics

  6. What is meant by „reference pricing“? Reference price = • Maximum level of reimbursement • Refers to a group of drugs • If the price exceeds the fixed level, patients have to pay the difference out of pocket.

  7. Internal Reference Price Groups Price Potential for A to raise! the price to the RP level Additional out of pocket payment One possibility: lowering price of C to the RP level RP Included pharmaceuticals A B C

  8. German benefitevaluationandremunerationprocessaccordingto AMNOG Source: German Advisory Council on the Assessment of Developments in der Health Care System (2014)

  9. Additional BenefitsCategoriesaccordingto AMNOG Significant additional benefit: Healing, significant prolongation of life time, long-term absence of severe symptoms or avoidance of severe adverse events Considerable additional benefit: Dilution of severe symptoms, moderate prolongation of life time, for patients noticeable relief of illness Marginal additional benefit: Reduction of not severe symptoms of illness Not quantifiable additional benefit No additional benefit: benefit smaller than the comparison therapy Influence on pricing not yet known

  10. Price is negotiated and set on the basis of three factors : Magnitude of additional benefit Price of appropriate comparison treatment Average European price Unfortunately not on the basis of: cost-effectiveness

  11. Experienceswith AMNOG: Additional Benefit c) With additional benefit Additional benefit by proportion in patient population Additional benefit by molecul Additional benefit by sub group Without additional benefit Signifi-cant Con-siderable No additio. benefit Not quatifiable Lower benefit Mode-rate

  12. Challenges in the AMNOG process • Bypass of benefit assessment • Choice of appropriate comparison treatment • Quality of life • Inclusion of Companion Diagnostics in benefit assessment • Pricing on the basis of sub groups • Temporary free pricing in the first year after launch • No cost-benefit analysis • Benefit assessment of drugs which were launched before AMNOG • Routinely „late“ benefit assessment

  13. Experienceswith AMNOG: Quality of Life Data about quality of life in benefit assessment of IQWiG till 2009 (Source: Wieseler 2014) AMNOG Dossiers with information about quality of life 2011-2013 Wieseler B (2014): Nutzenbewertung gemäß AMNOG – Erkenntnisse zum Zusatznutzen bei Markteintritt. Expertenforum AMNOG vom 26.11.2014, Berlin.

  14. Experienceswith AMNOG: Comparator Proportion of comparators in AMNOG assessments (n=75, per: 01.02.2015) Generic comparator Generic and patent protected comparators Patent protected comparator

  15. ExperienceswithAMNOG: Market exit („Opt-Out“) Reimbursement status of all compounds which have been assessed till end of 2014 (n=83). per: 08.06.2015 Price was successfully negotiated Price has been fixed by arbitration board Reference price group Opt-out

  16. Influence of additional benefit on prescription behaviour No additional benefit Not quantifiable moderate considerable Increase of prescribed volume (DDD) in %

  17. Summary ofexperienceswithvaluebasedpricing in Gernany • Price regulation for generics and innovative drugs with additional benefit has be very differently. • Value Based pricing should not only be seen as cost containment instrument, but to improve quality of patient care. • Increase of data quality in studies • Savings and prescription behaviour modifications rather small until now. • „Learning system“: A lot of discussions about methods are still going on. • Especially: choice of comparator, integration of quality of life values, introduction of cost-benefit-analysis Thanks for your attention. Prof. Dr. Wolfgang Greiner University of Bielefeld School of Public Health Health Economics and Health Care Management Bielefeld / Germany

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