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Pharma Pricing & Market Access

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Veröffentlicht am

Thomas Müller, MD & Pharmacist, Head of Pharmaceuticals Dept Federal Joint Committee.

Pharma Pricing & Market Access Congress 2017
22 February 2017
London

Veröffentlicht in: Einzelhandel
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Pharma Pricing & Market Access

  1. 1. Pharma Pricing & Market Access Congress 2017 London, 22. February 2017 Thomas Müller M.D. and Pharmacist, Head of Pharmaceuticals Department Federal Joint Committee (G-BA)
  2. 2. Seite 3 | © 2017 | Thomas Müller Substantial 2 Considerable 47 Minor 38 No additional benefit8 87 Reference price group 4 Non-quantifiable 33 Less additional benefit 0 Highest category of additional benefit /benefit assessment in accordance with the German Social Code Book Five (SGB V), section 35a Erheblich Beträchtlich Gering Kein Zusatznutzen Festbetrag Nicht quantifizierbar Geringerer Nutzen Status: 02.02.2017 Total.: 211 assessments  Substantial  Considerable  Minor  No additional benefit  Reference price group  Non-quantifiable  Less benefit
  3. 3. Seite 4 | © 2017 | Thomas Müller Early scientific advice with the participation of regulatory authorities (including international advices) 2011 2012 2013 2014 2015 2016 Total Early scientific advice national Total 42 82 134 136 190 204 788 Early scientific advice European Total 1 8 9 17 28 10 73 EMA 1 5 3 11 23 10 53 (HAS) SEED/EUnetHTA 0 3 6 6 5 0 20 Participation RA 1 5 12 20 34 30 102 BfArM (Federal Institute for Drugs and Medical Devices) 1 4 4 9 10 18 46 PEI (Federal Institute for Vaccines and Biomedicines) 1 8 11 24 12 56
  4. 4. Seite 5 | © 2017 | Thomas Müller Reimbursement price negotiations in accordance with§130b SGB V (Status: February 2017) • Agreed reimbursement prices1: 106 • Reimbursement prices determined by arbitration board 1: 21 • Market exits2: 19 • 1Notice: no consideration of negotiation results with re-importers, consideration of pharmaceuticals no longer placed on the market • 2Notice: no distinction between “Opt-Out” and market withdrawal following set reimbursement pricing, no consideration of hospital use, combination therapies, global market withdrawal
  5. 5. Orphan Drugs
  6. 6. Seite 7 | © 2017 | Thomas Müller Substantial 1 Considerable 0 Minor 14 No additional benefit 0 Reference price group 0 Non-quantifiable 28 Less additional benefit 0 Erheblich Beträchtlich Gering Kein Zusatznutzen Festbetrag Nicht quantifizierbar Geringerer Nutzen 19.01.2017Status: Total : 43 assessments Highest category of additional benefit /benefit assessment in accordance with SGB V, section 35a - Orphan drugs  Substantial  Considerable  Minor  No additional benefit  Reference price group  Non-quantifiable  Less benefit
  7. 7. Seite 8 | © 2017 | Thomas Müller Orphan Drugs: Number of G-BA-resolutions including extent of additional benefit (2012-2016) 1 2 3 6 13 2 2 3 7 2 1 1 0 2 4 6 8 10 12 14 16 2012 2013 2014 2015 2016 non-quantifiable minor considerable
  8. 8. Seite 9 | © 2017 | Thomas Müller G-BA-resolutions: Orphan Drugs (chronological since December 1st, 2016) extent of additional benefit time considerable substantial minor non- quantifiable no additional benefit less benefit Multiplemyeloma HaemophiliaB DuchenneMuscular Dystrophy Fabrydisease HaemophiliaB 30–40 20–490 580-660 2300 580-660 790-940Follicularlymphoma 230-500Malabsorption syndrome Non-24-Hour Sleep-WakeDisorder Multiplemyeloma Narcolepsy Hodgkin's lymphoma 7000 15000-30000 4700-7000 40-60 Chroniclymphoid leukemia Primarybiliary cirrhosis Multiplemyeloma Softtissuesarcoma ? ? ? ?
  9. 9. Seite 10 | © 2017 | Thomas Müller Annual therapy costs of orphan drugs at market access Maximum annual therapy costs according to G-BA-resolutions 0 € 200,000 € 400,000 € 600,000 € 800,000 € 1,000,000 € 1,200,000 € >1 Mio. € >1 Mio. €
  10. 10. Seite 11 | © 2017 | Thomas Müller Orphan Drugs: PLOS One, Hughes et al (Oct 2016) • Orphan drugs are more profitable compared to Non-Orphans. • Incentives are effective: market exclusivity, reduced / waived regulatory fees, protocol assistance, German Act on the Reform of the Market for Medicinal Products (AMNOG) guarantees patient relevant additional benefit (below € 50 Mio. annual turnover). • Cost of Orphan drug clinical trials are less compared to Non- Orphan trials (average phase III clinical trial: Orphan USD 95 Mio. vs. Non-Orphan USD 219 Mio. • Pricing of Orphan drugs 6x higher compared to Non-Orphans: mean annual therapy cost: TUSD 137 vs. TUSD 21 Non-Orphans. Despite smaller patient numbers revenue generating potential is similar to non-orphans. • Long-term effects on management of research investments ?
  11. 11. Seite 12 | © 2017 | Thomas Müller Orphan Drugs: German drug bulletin „Arzneimittelbrief“ August 2016; JAMA Oct 24, 2016: „Arzneimittelbrief“: • Analysis of orphan drugs having received accelerated regulatory approval in 2004 shows: evidence of efficacy and safety are still insufficent 10 years following approval • Clear requirements for complementary clinical trials and effective sanctions for lacking clinical evidence by EMA and HTAbodies are needed following EMA regulatory approval JAMA:“Partial Solution could be adoption of novel regulatory models, such as limited approval with intensive collection of new clinical evidence, before a drug becomes universally available. As a further step, drugs that have not yet shown clinical outcome benefit could be made available at just the cost of production, or most profits could be kept in escrow, until adequate trials are completed.“
  12. 12. Oncology / Diabetes
  13. 13. Seite 14 | © 2017 | Thomas Müller Highest category of patient relevant additional benefit /benefit assessment in accordance with SGB V, section 35a: indication-based Substantial 1 Considerable 26 Minor 12 No additional benefit 16 Reference price group 0 Non- quantifiable 16 Less benefit 0 Considerable 1 Minor 3 No additional benefit 19 e.g. Diabetes: 23 Status: 15.12.2016 e.g. Oncology: 71, including 16 orphan drugs Status: 02.02.2017
  14. 14. Seite 15 | © 2017 | Thomas Müller time considerable substantial minor NSCLC: Non-small-cell lung carcinoma CLL: Chronic lymphocytic leukemia ? ? ? ? NSCLC6300–7700 gastric/gastro- esophagealjunct. adenocarzinoma 5900–7900 1) 2) NSCLC 1)2100–5520 2)4620–6900 1)1200–3300 NSCLC Renalcell carcinoma2)max.8%oftotalpopulation 1)3700–9700 2)8130–12130 Multiple myeloma Liposarcoma Melanoma Melanoma CLL ? NSCLC 4700–7000 5900–7900 1) 2) 1a)230-690 1a)270-810 2)2000–3000 1a)1810 1b)810 2)220 1a)35-100 1a)40-120 2)300-450 NSCLC Colorectal- carzinoma CLL G-BA-resolutions: Oncology (chronological since September 15th, 2016) extent of additional benefit non- quantifiable no additional benefit less benefit Renalcell carcinoma
  15. 15. Seite 16 | © 2017 | Thomas Müller 0 20000 40000 60000 80000 100000 120000 140000 160000 Melanom NSCLC RCC Nivolumab vor Preisverhandlungen Nivolumab nach Preisverhandlugen Pembrolizumab vor Preisverhandlungen Pembrolizumab nach Preisverhandlungen AnnualtherapycostsinEuro Considerable additional benefit Costs of Immunotherapy (Germany) 1 1 G-BA-resolution January 7th, 2016; indication for substantial additional benefit over Dacarbazin 2 Based on information from Lauer-Taxe regarding reimbursement pricings (in accordance with§78, section 3a AMG; calculations standardized to one year) 3 G-BA-resolution February 4th, 2016; hint for substantial additional benefit over Ipilimumab and indication for substantial additional benefit over a patient-individualized therapy according to the treating physician‘s choice (Ipilimumab) 4 G-BA-resolution October 20th, 2016; non-squamous epithelial histology; indication for substantial additional benefit over Docetaxel 5 G-BA-resolution October 20th, 2016; indication for substantial additional benefit over Everolimus 2 2 23 2 4 5 Considerable additional benefit Considerable additional benefit Pembrolizumab – prior to price negotiations Nivolumab – following price negotiations Nivolumab – prior to price negotiations Pembrolizumab – following price negotiations
  16. 16. Seite 17 | © 2017 | Thomas Müller 0 20000 40000 60000 80000 100000 120000 140000 160000 Pembrolizumab vor Preisverhandlungen Pembrolizumab nach Presiverhandlungen aim:±€27800 Costs of Immunotherapy (Germany) e.g. Pembrolizumab (Melanoma) JahrestherapiekosteninEuro reimbursement rejected aim:±€50000 negotiations terminated § # 1 G-BA-resolution February 4th, 2016; hint for substantial additional benefit over Ipilimumab and indication for substantial additional benefit over a patient-individualized therapy according to the treating physician‘s choice (Ipilimumab) 2 Based on information from Lauer-Taxe regarding reimbursement pricings (in accordance with§78, section 3a AMG; calculations standardized to one year) 3 http://www.apmhealtheurope.com; Merck & Co aiming to make Keytruda available in France 'as soon as possible'; October 13th, 2016 4 http://www.apmhealtheurope.com; UK's NICE rejects MSD's Keytruda in advanced lung cancer; October 4th, 2016 §cost per QALY > £ 50 000 (> € 55 550 ) # cost limit per QALY: £ 20 000 - 30 000 (€ 22 255 - 33 383) 1 2 3 4 34 negotiations ongoing Pembrolizumab – prior to price negotiations Pembrolizumab – following price negotiations AnnualtherapycostsinEuro negotiations terminated
  17. 17. Seite 18 | © 2017 | Thomas Müller time 470.000 78.000–170.000 a)374.000–918.000 a)20.000 b)200 Type1diabetesmel. Type2diabetesmel. Type2diabetesmel.582.000-800.000 Prophylaxisofstroke/ systemicembolisms/ phlebothrombosis/ pulmonaryembolisms 926.000-1.093.000 241.000 Heterozygous hypercholesterolemia Homozygous hypercholesterolemia a1)270.000 a2)1.750 a3)1.500 b)60-70 Heterozygous hypercholesterolemia a)270.000 b)1.750 c)1.500 Heartfailure b)176.000–432.000 a)220.000 b1) c2) b2) c1) Prevention atherothrombotic events 105.000 1,0–1,4Mio. c)550.000-760.000 a)523.000 b)635.000 550.000-750.000 extent of additional benefit substantial considerable minor non- quantifiable no additional benefit less benefit G-BA-resolutions: Metabolism/Diabetes/Cardiovascular (chronol. since July 16th, 2015) Type2diabetesmel. Type2diabetesmel. Type2diabetesmel. Type2diabetesmel.
  18. 18. AM-VSG
  19. 19. Seite 20 | © 2017 | Thomas Müller • Section 35: The issue of resistance for the treatment of bacterial infectious diseases (antibiotics) shall be given special consideration. Reserve antibiotics can be exempted when defining reference price groups. • AM-NutzenV: The issue of resistance shall be taken into account in assessing the additional benefit of antibiotics. AM-VSG draft key points (1)
  20. 20. Seite 21 | © 2017 | Thomas Müller • Evidence transfer for pediatric marketing authorizations shall be examined for patient groups or subindications covered by the marketing authorization, but which are not (or not sufficiently) represented in the study population and for which marketing authorization has been granted based on evidence transfer. The G-BA can recognize additional benefit if the transfer of evidence conforms to and can be justified by the standard of current scientific knowledge. AM-VSG draft key points (2)
  21. 21. Seite 22 | © 2017 | Thomas Müller • Pharmaceuticals without additional benefit shall be banned from reimbursement to patient groups when the resolution in accordance with the German Social Code, Book Five (SGB V), section 35a is passed, if this is necessary to ensure adequate care for individual patient groups. Pharmaceutical companies can submit a petition to the G-BA. • Consideration of new evidence upon request during proceedings shall be streamlined; repeated proceedings can be initiated one year after the resolution is passed. AM-VSG draft key points (3)
  22. 22. Seite 23 | © 2017 | Thomas Müller • Benefit assessment of pharmaceuticals with active ingredients that are not new can be initiated in exceptional cases and if certain prerequisites are met. • Accompanying diagnostics: doctors’ fee schedule shall be revised soon after the resolution. AM-VSG draft key points (4)
  23. 23. Seite 24 | © 2017 | Thomas Müller • Machine-readable versions of the resolutions shall be published within one month after passing (6 months after Rules of Procedure are amended for older resolutions). • AMNOG resolutions shall be implemented into the physician's information system. Details, in particular on cost-effectiveness requirements of prescriptions of pharmaceuticals as compared to other treatment options, shall be defined in a regulation passed by the Federal Ministry of Health. AM-VSG draft key points (5)
  24. 24. Seite 25 | © 2017 | Thomas Müller • No dossier or documents (“additional benefit has not been proved”) leads to a lower reimbursable price than appropriate comparator. • Pharmaceuticals without additional benefit but with several alternatives for the appropriate comparator: reimbursable price shall (formerly: “must”) not lead to greater costs than the most economical alternative. AM-VSG draft key points (6)
  25. 25. Seite 26 | © 2017 | Thomas Müller • The reimbursable price agreed must not be listed publicly. It may be shared only with those institutions that require this information in order to fulfil their statutory obligations. The Federal Ministry of Health shall be authorized to pass regulations, with the consent of the Federal Council in mutual agreement with the Federal Ministry of Economics, detailing the invoicing of the reimbursable price. • The price moratorium shall be continued. • If revenues from a pharmaceutical exceed €250m in the first year of market authorization, the reimbursable price shall apply from the month following (not only from month 13). AM-VSG draft key points (6)
  26. 26. EUnetHTA
  27. 27. Seite 28 | © 2017 | Thomas Müller Cross-Border Healthcare Directive (2011/24/EU) provides a detailed legal framework focused on three main areas: • rules concerning the reimbursement of costs of cross-border healthcare • responsibilities of the Member States with regard to cross- border healthcare • cooperation between healthcare systems EU Objectives in HTA Article 15 Directive 2011/24: • Support cooperation between national HTA Authorities • Support MS in the provision of objective, reliable, timely, transparent , comparable and transferable information […] to enable effective exchange of information • Avoid duplication of assessments
  28. 28. Seite 29 | © 2017 | Thomas Müller Cross border health directive provides legal basis for HTA network EUnetHTA JA3 runs under the Third EU Health Programme (2014-2020), legal basis: Regulation (EU) No 282/2014 HTA Network (political-strategic) EUnetHTA (scientific-technical) HTA Network and EUnetHTA
  29. 29. Seite 30 | © 2017 | Thomas Müller EUnetHTA timeline EUnetHTA Collaboration Joint Action 1 Joint Action 2 Joint Action 3 Putting into practice Strengthening practical application Turning pilots into standard practice Develop a sustainable model for cooperation 2006 2016 - 2020 EUnetHTA Project Inception
  30. 30. Seite 31 | © 2017 | Thomas Müller Project Coordinator: The Dutch National Health Care Institute (ZIN) EUnetHTA JA3 Participants 79 partners consisting of national, regional and non- for-profit agencies that produce or contribute to HTA
  31. 31. Seite 32 | © 2017 | Thomas Müller Work Package Organization Work package 1 Network Coordination Work package 5 Evidence generation (e.g., Early Dialogues) Work package 7 National implementation Work package 2 Dissemination Work package 3 Evaluation Work package 6 Quality management Scientific guidance Tools Work package 4 Joint production Pharmaceuticals Health Technologies
  32. 32. Seite 33 | © 2017 | Thomas Müller EUnetHTA Early Dialogues – status quo Launch of multi-HTA Early Dialogues on January 26th 2017 http://www.eunethta.eu/news/call-expression-interest-multi-hta-early-dialogues- pharmaceuticals Call available on EUnetHTA website:
  33. 33. Seite 34 | © 2017 | Thomas Müller EUnetHTA Early Dialogues – status quo
  34. 34. Seite 35 | © 2017 | Thomas Müller EUnetHTA Early Dialogues – status quo • Procedure for Early Dialogues together with the EMA (parallel Early Dialogues) currently under review • Goal: merging of PSA (EMA plus few selected HTABs) and EUnetHTA parallel Early Dialogues (EMA plus permanent working party of HTABs, collaborative approach)
  35. 35. Seite 36 | © 2017 | Thomas Müller • Inception impact assessment launched, together with various surveys The future of HTA in the EU
  36. 36. Seite 37 | © 2017 | Thomas Müller The future of HTA in the EU • Portrayal of five policy options (mix and match possible)
  37. 37. Seite 38 | © 2017 | Thomas Müller The future of HTA in the EU
  38. 38. Seite 39 | © 2017 | Thomas Müller German position towards the future of HTA in the EU • cooperation on HTA only voluntary • building a lasting platform for exchange and cooperation at scientific and technical levels • ‘reuse’ of other HTA’s national (regional) reports • Potential for EU ED replacing national one under certain conditions
  39. 39. Seite 40 | © 2017 | Thomas Müller www.g-ba.de arzneimittel@g-ba.de

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