• Like
PPT Rizzardini "HAART, sostenibilità di un miracolo"
Upcoming SlideShare
Loading in...5
×

Thanks for flagging this SlideShare!

Oops! An error has occurred.

PPT Rizzardini "HAART, sostenibilità di un miracolo"

  • 158 views
Published

 

Published in Health & Medicine
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Be the first to comment
    Be the first to like this
No Downloads

Views

Total Views
158
On SlideShare
0
From Embeds
0
Number of Embeds
0

Actions

Shares
Downloads
6
Comments
0
Likes
0

Embeds 0

No embeds

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
    No notes for slide

Transcript

  • 1.                                                                               HAART  sostenibilità  di  un  miracolo   Milano,  22  marzo  2013   Giuliano Rizzardini Dipartimento Malattie Infettive Ospedale Luigi Sacco, Milano School of Clinical Medicine, Faculty of Health Science, University of the Witwatersrand, Johannesburg  
  • 2. L’  inizio  della  storia  
  • 3. L’inizio  della  speranza  
  • 4. L’inizio  del  miracolo  
  • 5. Il  compimento  del  miracolo  
  • 6. Per-person survival gains with treatment in patients with AIDS compared with gains associated with interventions for other common diseases in the United States Walensky  RP,  et  al.  J  Infect  Dis,  2006  
  • 7.       Ma  il  miracolo  è  sostenibile  ?  
  • 8. Il contesto di riferimento: la crisi economica mondiale
  • 9. CRISI DEL WELFARE STATE IL SISTEMA SANITARIO E’ DIFFICILMENTE SOSTENIBILE
  • 10. AL 2030 G-7 Eu (ITA, FRA, GER, UK) : +3 p.p. sul Pil Canada: oltre +3 p.p. di Pil Giappone: +3 p.p. Usa: poco meno di +4,5 p.p. AL 2050 G-7 Eu: circa +9 p.p. sul Pil Usa: poco meno +13 p.p. Proiezioni FMI costo sistemi sanitari
  • 11. Spesa  pro  capite  in  $  PPP   $0,00   $1.000,00   $2.000,00   $3.000,00   $4.000,00   $5.000,00   $6.000,00   $7.000,00   $8.000,00   $9.000,00   $10.000,00   1995   1996   1997   1998   1999   2000   2001   2002   2003   2004   2005   2006   2007   2008   2009   2010   2011   Australia     Brasile   Russia   India   Cina   Sudafrica   Canada   Giappone   USA   Italia   Francia   Germania   Spagna   Regno  Unito   Norvegia   Svezia   Svizzera   Fonte: WHO, National Health Accounts, 2013, rielaborazione CREMS BRICS USA
  • 12. E  l’Italia?  
  • 13. Anno Debito   Pubblico   (milioni   di  €) PIL   (milioni   di  €) 2007 1.602.115 1.546.177 2008 1.666.603 1.567.761 2009 1.763.864 1.519.702 2010 1.843.015 1.548.816 Fonte:  Ministero  dell'economia  e  delle  finanze   PIL/debito  pubblico  italiano  
  • 14. 1980   Cossiga,   Forlani   21,1%   118.038   58,0%   1981   Forlani,   Spadolini   18,7%   146.410   60,1%   1982   Spadolini,   Fanfani   16,3%   186.961   65,0%   1983   Fanfani,  Craxi   15,0%   235.520   70,3%   1984   Craxi   10,6%   284.825   74,4%   1985   Craxi   8,6%   346.005   80,5%   1986   Craxi   6,1%   401.499   84,5%   1987   Craxi,  Fanfani,   Goria   4,6%   460.418   88,6%   1988   Goria,  De  Mita   5,0%   522.732   90,5%   1989   De  Mita,   Andreo]   6,6%   589.995   93,1%   1990   Andreo]   6,1%   667.848   94,8%   1991   Andreo]   6,4%   755.011   98,1%   1992   Andreo],   Amato   5,4%   849.920   105,0%   1993   Amato,  Ciampi   4,2%   959.713   115,1%   1994   Ciampi,   Berlusconi   3,9%   1.069.415   121,2%   Anno     Presidente   Consiglio   Inflazi one   Debito   (milioni  €)   Rapporto  debito/PIL   1995   Berlusconi,   Dini   5,4%   1.151.489   120,9%   1996   Dini,  Prodi   3,9%   1.213.508   120,2%   1997   Prodi   1,7%   1.238.172   117,4%   1998   Prodi,  D'Alema   1,8%   1.254.388   114,2%   1999   D'Alema   1,6%   1.281.550   113,0%   2000   D'Alema,   Amato   2,6%   1.300.269   108,5%   2001   Amato,   Berlusconi   2,7%   1.358.351   108,2%   2002   Berlusconi   2,4%   1.368.897   105,1%   2003   Berlusconi   2,5%   1.394.339   103,9%   2004   Berlusconi   2,0%   1.445.826   103,4%   2005   Berlusconi   1,7%   1.514.408   105,4%   2006   Berlusconi,   Prodi   2,0%   1.584.093   106,1%   2007   Prodi   1,7%   1.602.114   103,1%   2008   Prodi,   Berlusconi   3,2%   1.666.637   105,8%   2009   Berlusconi   0,7%   1.763.676   116,1%   2010   Berlusconi   1,6%   1.842.856   118,7%   2011   Berlusconi,   Monb   2,7%   1.897.946   120,1%                   Fonte:  Banca  d'Italia,  Istat  
  • 15. Pil 2010 Euro/mld 1.556,00 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 Pil reale (Euro/mld) 1.565,34 1.534,03 1.538,63 1.546,98 1.559,14 1.575,17 1.595,19 1.619,35 1.647,79 1.680,75 Pil reale var % 0,60% -2,00% 0,30% 0,54% 0,79% 1,03% 1,27% 1,51% 1,76% 2,00% Pil pro-capite (Euro) 25.819,36 25.182,62 25.149,93 25.187,94 25.295,50 25.472,44 25.719,22 26.036,99 26.427,50 26.893,27 Pil pro-capite var % -2,47% -0,13% 0,15% 0,43% 0,70% 0,97% 1,24% 1,50% 1,76% 2021 2022 2023 2024 2025 2026 2027 2028 2029 2030 Pil reale (Euro/mld) 1.713,69 1.746,60 1.779,43 1.812,17 1.844,79 1.877,26 1.909,55 1.941,63 1.973,47 2.005,05 Pil reale var % 1,96% 1,92% 1,88% 1,84% 1,80% 1,76% 1,72% 1,68% 1,64% 1,60% Pil pro-capite (Euro) 27.361,39 27.831,21 28.302,09 28.773,43 29.244,69 29.715,40 30.185,11 30.653,41 31.119,88 31.584,09 Pil pro-capite var % 1,74% 1,72% 1,69% 1,67% 1,64% 1,61% 1,58% 1,55% 1,52% 1,49% -2,00% = acquisito = proiezioni di crescita riportate nel Programma di Stabilità (contenuto in Def-2011) = più recente stima di consuntivo = stima di consenso non ancora incorporata in documenti uffiicali di finanza pubblica La crescita
  • 16. Fondo  Monetario  Internazionale:  previsioni  per  l’Italia   Maggio  2012  
  • 17. FUNZIONI   1990   2009   Variazione   Servizi  generali   12,8%   13,4%   0,6%   Difesa   6,8%   7,1%   0,3%   Ordine  pubblico  e  sicurezza   8,9%   7,9%   -­‐1,1%   Affari  economici   5,1%   4,5%   -­‐0,6%   Protezione  dell'ambiente   2,9%   3,3%   0,4%   Abitazioni  e  territorio   1,7%   1,9%   0,0%   Sanità   32,3%   37,0%   4,7%   Protezione  sociale   4,2%   5,0%   0,8%   A]vità  ricr.,  culturali,  di  culto   2,2%   2,4%   0,1%   Istruzione   23,1%   17,7%   -­‐5,4%   Piero  Giarda, Elementi per una revisione della spesa pubblica spesa  per  consumi  colleOvi,     produzione  di  servizi  pubblici  cedub  a  btolo  gratuito  al  cigadino  (2012)    
  • 18. 71,3 75,7 80,6 82,4 93,2 93,2 97,6 101,6 104,2 105,6 106,9 108,0 107,0 107,9 70 75 80 85 90 95 100 105 110 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 Importo  del  finanziamento  (€/miliardi) Italia, fonte ministero della salute 106.213.749
  • 19. 24 Un ulteriore preoccupazione: la sanità regionalizzata
  • 20. Il  costo  dell’HIV/AIDS  
  • 21. Mean annual expenditure per patient for selected chronic diseases in France
  • 22. Mean annual expenditure per patient for selected chronic diseases in France
  • 23. Il  contesto  lombardo  (punto  di  vista  RL)   0.00 2,000.00 4,000.00 6,000.00 8,000.00 10,000.00 12,000.00 2004 2005 2006 2007 Total cost and percentage impact per year Euros HAART Outpatient visits Admission Other drugs
  • 24. Il  contesto  lombardo  (punto  di  vista  RL)   The cost of HIV disease in Northern Italy 2007-2009 Year Euros P<0.0001 P=0.0002
  • 25. Andamento  spesa  annua  pazienP  HIV+  e  totale  pazienP  traRaP  HIV+  dal   2004  al  2012   2004   2005   2006   2007   2008   2009   2010   2011   2012   N°   pz.   HIV+   tragab   17.955   18.544   19.849   20.917   21.721   22.653   23.803   24.920            26.222     Spesa   pro   capite   pz.   HIV+   tragab   [€]   5.135   5.747   5.960   6.682   7.113   7.484,16  (1)   7.351,74  (2)   7.886,32  (1)   7.749,60  (2)   7.782,16  (1)   7.556,80  (2)    7.681,45  (1)   7.839,84  (2)     Spesa   totale   p z .   H I V +   tragab  [€]   92.200.976   106.566.894   118.295.815   139.758.191   154.503.861   169.538.677   187.718.193   193.931.438    201.423.090     Incremento   della   spesa   totale   -­‐   15,58%   11,01%   18,14%   10,55%   9,73%   10,72%   3,31%   3,86%   (1)  Dato  medio,  (2)  Dato  mediano.   .  
  • 26. Costo  tragamento     farmacologico  per  HIV   in  Lombardia  (file  F)   200   milioni   di   euro,   per   il   s e r v i z i o   s a n i t a r i o   e q u i v a l e n t e   a l   finanziamento   dell’Azienda   Ospedaliera   della   Provincia   di  Lodi   1.         Presidio  di  Casalpusterlengo   2.         Presidio  di  Codogno   3.         Presidio  di  Lodi   4.         Presidio  di  Sant'Angelo  Lodigiano  
  • 27. HIV-COI (Cost of Illness) •  Il costo complessivo della malattia (trattamento File F, ricoveri, farmaceutica territoriale, specialistica ambulatoriale, prevenzione e test) dal punto di vista della Regione Lombardia (senza il costo delle giornate di lavoro perse o l’indennità per inabilità/reddito di sostegno) si aggira (stima CREMS) su quasi 300 milioni di € pari all’1,7% delle intere risorse a disposizione dal SSR. •  Di questi, circa due terzi sono determinati da farmaci antiretrovirali.
  • 28. Le  risposte  per  una  sostenibilità  
  • 29. The squeeze on health spending (UK)
  • 30. Annual  UK  HIV  treatment  and   care  costs  could  reach  £750   million  by  2013  
  • 31. ClinicoEconomics and Outcomes Research New strategies for lowering the costs of antiretroviral treatment and care for people with HIV/AIDS in the United Kingdom Brian Gazzard1 Christiane Moecklinghoff2 Andrew Hill3 1 St Stephens Centre, Chelsea and Westminster Hospital, London, UK; 2 Janssen, Neuss, Germany; 3 Department of Pharmacology and Therapeutics, University of Liverpool, UK Abstract: In the UK, the annual cost of treatment and care for people with human immunodeficiency virus (HIV)/acquired immune deficiency virus (AIDS) rose by over 600% from £104 million in 1997 to £762 million in 2010; approximately two-thirds of the £762 million cost of treatment and care in 2010 was for the procurement of antiretrovirals and other related drugs.The number of people accessing care for HIV/AIDS rose from 22,000 in 2000 to 65,000 in 2009.Adoption of “test and treat” guidelines for treating all HIV-infected people with antiretro- virals would further increase the burden of costs. Given the current economic situation, there is now a new focus on strategies for treatment and care of people with HIV-1 infection which can maintain efficacy but at a lower cost. In this review, we propose three strategies which could potentially lower the costs of treatment and care, ie, stopping testing CD4 counts for patients with full HIV RNA suppression on antiretroviral treatment and recent CD4 counts above 350 cells/ L; more widespread use of generic antiretrovirals as replacements for patients currently taking patented versions; and use of darunavir-ritonavir monotherapy as a switch option for patients with full HIV RNA suppression on other antiretrovirals and no history of virological failure. However, it is important that high standards of clinical care are maintained despite cost-saving measures.Antiretrovirals with generic alternatives may have toxicity issues, eg, zidovudine and nevirapine. There could be ethical issues in starting patients on these drugs if they are currently tolerating other treatments. The use of darunavir-ritonavir monotherapy is not consistently recommended in international HIV treatment guidelines. Keywords: health economics, generics, darunavir-ritonavir monotherapy, nucleoside analogs, non-nucleoside reverse transcriptase inhibitors Dovepress R E V I E W open access to scientific and medical research Open Access Full Text Article
  • 32. La riduzione dell’ offerta
  • 33. London consortium Efavirenz   Preferred  first  line  treatment  in  all   naïve  paPents    unless:   §  Pabent  has  baseline  resistance   §  Pabent  wants  to  become   pregnant   §  Concern  over  CNS  side  effects   (previous  history  or  current   psychological  state)   If  switching    due  to  toxicity   recommend:   §  Boosted  atazanavir   §  Nevirapine    (within  CD4  criteria)   Kivexa   Preferred  first  line  treatment  in  all   naïve  paPents  unless:   §  HLA  B-­‐5701  posibve   §  Baseline  HIV  viral  load  >  100,000   copies/mL   §  Cardiovascular  (CVD)  risk  over  10   years  >10%  (before  adjustment   for  DAD  abacavir  risk)   §  Hepabbs  B:  HBsAg  +ve  or  HBV   DNA  +ve   §  Hepabbs  C:  Expecbng  to  start   HCV  treatment   Recommendabons  by  the  London  HIV  Consorbum  for    prescribing  anbretrovirals,  April  2011  
  • 34. Antiretroviral Treatment of Adult HIV Infection 2012 Recommendations of the International Antiviral Society–USA Panel Melanie A. Thompson, MD Judith A. Aberg, MD Jennifer F. Hoy, MBBS, FRACP Amalio Telenti, MD, PhD Constance Benson, MD Pedro Cahn, MD, PhD Joseph J. Eron Jr, MD Huldrych F. Gu¨nthard, MD Scott M. Hammer, MD Peter Reiss, MD, PhD Douglas D. Richman, MD Giuliano Rizzardini, MD David L. Thomas, MD Donna M. Jacobsen, BS Paul A. Volberding, MD S INCE THE FIRST ANTIRETROVIRAL drug was approved 25 years ago, improvements in the potency, tolerability, simplicity, and avail- ability of antiretroviral therapy (ART) have resulted in dramatically reduced numbers of opportunistic diseases and deaths where ART is accessible.1 New data show that viral suppression due to ART results in decreased human immu- nodeficiencyvirus(HIV)transmissionon individual2 and population levels1 and that, when used consistently by HIV- sions of the “beginning of the end of AIDS.”6 This revision of the Interna- tionalAntiviral(formerlyAIDS)Society– USA (IAS-USA) guidelines reflects new data informing consideration of when to initiate ART, new options for initial and Context New trial data and drug regimens that have become available in the last 2 years warrant an update to guidelines for antiretroviral therapy (ART) in human immu- nodeficiency virus (HIV)–infected adults in resource-rich settings. Objective To provide current recommendations for the treatment of adult HIV in- fection with ART and use of laboratory-monitoring tools. Guidelines include when to start therapy and with what drugs, monitoring for response and toxic effects, special considerations in therapy, and managing antiretroviral failure. Data Sources, Study Selection, and Data Extraction Data that had been pub- lished or presented in abstract form at scientific conferences in the past 2 years were sys- tematically searched and reviewed by an International Antiviral Society–USA panel. The panel reviewed available evidence and formed recommendations by full panel consensus. Data Synthesis Treatment is recommended for all adults with HIV infection; the strength of the recommendation and the quality of the evidence increase with decreasing CD4 cell count and the presence of certain concurrent conditions. Recommended initial regi- mens include 2 nucleoside reverse transcriptase inhibitors (tenofovir/emtricitabine or aba- cavir/lamivudine)plusanonnucleosidereversetranscriptaseinhibitor(efavirenz),aritonavir- boosted protease inhibitor (atazanavir or darunavir), or an integrase strand transfer inhibitor (raltegravir). Alternatives in each class are recommended for patients with or at risk of certain concurrent conditions. CD4 cell count and HIV-1 RNA level should be monitored, as should engagement in care, ART adherence, HIV drug resistance, and quality-of-care indicators. Reasons for regimen switching include virologic, immunologic, or clinical fail- ure and drug toxicity or intolerance. Confirmed treatment failure should be addressed promptly and multiple factors considered. Conclusion New recommendations for HIV patient care include offering ART to all patients regardless of CD4 cell count, changes in therapeutic options, and modifica- tions in the timing and choice of ART in the setting of opportunistic illnesses such as cryptococcal disease and tuberculosis. JAMA. 2012;308(4):387-402 www.jama.com d persons. eginterferon alfa n routinely used nfected persons. ed with didano- ng toxicity with clear whether ribavirin is less th abacavir than itionoftheHCV previr to pegin- virin improves for genotype 1 drug interaction profile.106 Recomm dations for initial regimen in the ab specific circumstances are sum rized in BOX 2. MONITORING Suppression of plasma HIV-1 RN less than 50 copies/mL by 24 w should occur with effective therapy gardless of prior treatment exp ence. No recent work has defined optimal frequency of monitoring i source-rich economies, despite the g monitor- s (telapre- used with actions are known to sed or de- he drugs. or drug in- s is impor- s been fo- surements, e entry into nitoring of e ART ad- ationshave virologicfailuretoconfirmsuppression of viremia below 50 copies/mL (AIa). CD4 cell count should be moni- toredatleastevery3monthsafterini- tiation of therapy, especially among patients with less than 200/µL, to de- termine the need for primary oppor- tunistic infection prophylaxis (BIII). Onceviralloadissuppressedfor1year andCD4cellcountisstableat350/µL or greater, HIV-1 RNA and CD4 cell countcanbemonitoredatintervalsof up to 6 months in patients with de- pendable adherence (CIII). Detectable HIV-1 RNA (Ͼ50 copies/ mL) during therapy should be con- firmedinasubsequentsamplebetween e end of Interna- Society– USA (IAS-USA) guidelines reflects new data informing consideration of when to initiate ART, new options for initial and www.jama.com rtium of At- w York Uni- d Columbia urgeons (Dr red Hospital lia (Dr Hoy); ne, Switzer- a San Diego an) and Vet- System (Dr Fernandez/ ol and Fun- a (Dr Cahn); University of North Carolina at Chapel Hill (Dr Eron); University Hospital Zurich, Zurich, Switzerland (Dr Gu¨n- thard); Academic Medical Center University of Am- sterdam, Amsterdam, the Netherlands (Dr Reiss); Os- pedale Luigi Sacco-Milano, Milan, Italy (Dr Rizzardini); The Johns Hopkins University School of Medicine, Bal- timore, Maryland (Dr Thomas); International Antivi- ral Society–USA (Ms Jacobsen) and University of Cali- fornia San Francisco (Dr Volberding), San Francisco. Corresponding Author: Melanie A. Thompson, MD, AIDS Research Consortium of Atlanta, 131 Ponce de Leon Ave NE, Ste 130, Atlanta, GA 30308 (drmt @mindspring.com). JAMA, July 25, 2012—Vol 308, No. 4 387
  • 35. I  farmaci  equivalenP   Principio Attivo Nome Commerciale Scadenza CCP* lamivudina Epivir® 8/8/2011 ritonavir Norvir® 9/9/2012 nevirapina Viramune® 4/2/2013 lamivudina/AZT Combivir® 18/3/2013 efavirenz Sustiva® 20/11/2013 abacavir Ziagen® 9/7/2014 lopinavir/ritonavir Kaletra® 14/12/2015 emtricitabina Emtriva® 31/1/2016 enfuvirtide Fuzeon® 30/4/2018 efavirenz/emtricit./ tenofovir Atripla® 3/8/2018 darunavir Prezista® 24/8/2018 *certificati complementari di protezione
  • 36. Market share mercato internazionale anno 2010 % sul volume totale delle prescrizioni Fonte:  Assogenerici  
  • 37. PI monotherapy
  • 38. PDT  Regione  Lombardia  2012  
  • 39. ??????   Ci  sono  poi  gli  altri  dubbi….e  la  cruda  realtà  
  • 40. Italia vs USA: spectrum of engagement in HIV care USA Italia
  • 41.   …..e  quindi?