Le prix, le coût et la valeur de l’insuline

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1 Le prix, le coût et la valeur de l’insuline
David Beran MSc PhD Service de médecine tropicale et humanitaire

2 Déclarations d’intérêts
Aucun financement de l’industrie pharmaceutique Présentation en mon nom Ne représente pas le point de vue des institutions auxquels je suis affilié

3 La détermination du prix de l’insuline

4 L’offre: Domination de trois multinationales
Identification de 39 autres fabricants d’insuline Valeur du marché de l’insuline (2012): US$ 20.8 milliards Schultz Novo Nordisk 2011; Etude ACCISS 2016

5 Domination = détermination des produits sur le marché

6 Domination = détermination des produits sur le marché (rouge: humaine; bleu: analogue; vert: animale) High Income Upper Middle Income Lower Middle Income Low Income Beran et al. 2016

7 Liste des médicaments essentiels de l’OMS

8 Cochrane 'Human' insulin versus animal insulin in people with diabetes mellitus A comparison of the effects of human and animal insulin as well as of the adverse reaction profile did not show clinically relevant differences. Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high-quality randomised clinical trials. The story of the introduction of human insulin might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety. Our analysis suggests only a minor benefit of short acting insulin analogues in the majority of diabetic patients treated with insulin. Until long term efficacy and safety data are available we suggest a cautious response to the vigorous promotion of insulin analogues. For safety purposes, we need a long-term follow-up of large numbers of patients and well designed studies in pregnant women to determine the safety profile for both the mother and the unborn child. Our analysis suggests, if at all only a minor clinical benefit of treatment with long-acting insulin analogues for patients with diabetes mellitus type 2 treated with "basal" insulin regarding symptomatic nocturnal hypoglycaemic events. Until long-term efficacy and safety data are available, we suggest a cautious approach to therapy with insulin glargine or detemir.

9 Cochrane Short acting insulin analogues versus regular human insulin in patients with diabetes mellitus A comparison of the effects of human and animal insulin as well as of the adverse reaction profile did not show clinically relevant differences. Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high-quality randomised clinical trials. The story of the introduction of human insulin might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety. Our analysis suggests only a minor benefit of short acting insulin analogues in the majority of diabetic patients treated with insulin. Until long term efficacy and safety data are available we suggest a cautious response to the vigorous promotion of insulin analogues. For safety purposes, we need a long-term follow-up of large numbers of patients and well designed studies in pregnant women to determine the safety profile for both the mother and the unborn child. Our analysis suggests, if at all only a minor clinical benefit of treatment with long-acting insulin analogues for patients with diabetes mellitus type 2 treated with "basal" insulin regarding symptomatic nocturnal hypoglycaemic events. Until long-term efficacy and safety data are available, we suggest a cautious approach to therapy with insulin glargine or detemir.

10 Cochrane Long acting insulin analogues versus NPH insulin (human isophane insulin) for type 2 diabetes mellitus A comparison of the effects of human and animal insulin as well as of the adverse reaction profile did not show clinically relevant differences. Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high-quality randomised clinical trials. The story of the introduction of human insulin might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety. Our analysis suggests only a minor benefit of short acting insulin analogues in the majority of diabetic patients treated with insulin. Until long term efficacy and safety data are available we suggest a cautious response to the vigorous promotion of insulin analogues. For safety purposes, we need a long-term follow-up of large numbers of patients and well designed studies in pregnant women to determine the safety profile for both the mother and the unborn child. Our analysis suggests, if at all only a minor clinical benefit of treatment with long-acting insulin analogues for patients with diabetes mellitus type 2 treated with "basal" insulin regarding symptomatic nocturnal hypoglycaemic events. Until long-term efficacy and safety data are available, we suggest a cautious approach to therapy with insulin glargine or detemir.

11 Cochrane Short-acting insulin analogues versus regular human insulin for type 1 diabetes mellitus A comparison of the effects of human and animal insulin as well as of the adverse reaction profile did not show clinically relevant differences. Many patient-oriented outcomes like health-related quality of life or diabetes complications and mortality were never investigated in high-quality randomised clinical trials. The story of the introduction of human insulin might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety. Our analysis suggests only a minor benefit of short acting insulin analogues in the majority of diabetic patients treated with insulin. Until long term efficacy and safety data are available we suggest a cautious response to the vigorous promotion of insulin analogues. For safety purposes, we need a long-term follow-up of large numbers of patients and well designed studies in pregnant women to determine the safety profile for both the mother and the unborn child. Our analysis suggests, if at all only a minor clinical benefit of treatment with long-acting insulin analogues for patients with diabetes mellitus type 2 treated with "basal" insulin regarding symptomatic nocturnal hypoglycaemic events. Until long-term efficacy and safety data are available, we suggest a cautious approach to therapy with insulin glargine or detemir.

12 La demande: accroissement de la prévalence du diabète
Fédération Internationale du Diabète 2015

13 Type 1 versus Type 2 Besoin absolu pour le Type 1
Type % des patients utilisent de l’insuline (Etude ACCISS 2016) Comment définir le « besoin » pour les Types 2 Qui définit les besoins?

14 Les résultats: prix de l’insuline à différents points du système de santé
Etude ACCISS 2016

15 Et les pays riches? Langreth 2015 ? compétition
In 13 instances since 2009, prices of Lantus and Levemir -- which dominate the global market for long-acting injectable insulin with $11 billion in combined sales -- have gone up in tandem in the U.S., according to SSR Health, a market researcher in Montclair, New Jersey. Langreth 2015

16 Le coût ou les coûts de l’insuline
Le coût de fabrication? La question… Le coût pour qui? Patient Système de santé Pas seulement le coût mais l’abordabilité – un coût accessible Pour quelqu’un en France Pour quelqu’un au Mali

17 En France Haute Autorité de Santé

18 Au Royaume-Uni 2000 2008 Dépenses pour l’insuline 2008: € 360 millions
86.3% de l’insuline humaine; 10.7% insuline analogue 2008 23.2% insuline humaine; 76.1% insuline analogue Dépenses pour l’insuline 2008: € 360 millions 51% du budget total des médicaments pour le diabète 4% budget total

19 Les prix de remboursement = les coûts pour les systèmes de santé

20 Les coûts pour les individus
2.2% des dépenses totale de la santé en Suisse (1998), ou € 2,710 par personne avec le diabète (Schmitt-Koopmann et al. 2004) Beran et Yudkin 2010

21 Les résultats: le coût de l’insuline en comparaison à d’autres médicaments
Etude ACCISS 2016

22 La valeur de l’insuline 1922: L’insuline et Leonard Thompson
“A new race of diabetics has come upon the scene” – E. Joslin (1922) “Now modern discoveries, particularly insulin, have completely changed the outlook. There is no reason why a diabetic should not if he can be taught to do so, lead a long normal life.” – R.D. Lawrence (1925)

23 La valeur d’un miracle Insulin era Pre-insulin era
Life expectancy (years) Pre-insulin era At age 10 Overall Gale Lancet 2003; USA Today 2011

24 Une valeur mais pas pout tous
Quelle est la cause plus fréquente de décès chez un enfant avec le diabète? La réponse d’une perspective mondiale est le manque d'accès à l'insuline Lancet novembre 2006

25 Comparaison Boston (1897-1945), Mozambique (2003) et Nicaragua (2007)
Insulin era Life expectancy (years) Pre-insulin era At age 10 0-14 Gale 2003; Beran 2005; Beran 2007

26 Pas seulement les pays pauvres
L’autre côté du scandale In the US, insulin discontinuation was the leading precipitating cause of diabetic ketoacidosis, and was responsible for 68% of admissions in a US inner city setting.20 Among those who stopped taking insulin, 27% reported lack of money to buy it and 5% were making their insulin supplies last longer by taking smaller doses.

27 Les valeurs de l’insuline 1921: la découverte de l’insuline
Pas de brevets Mission de sauver des vies

28 Les valeurs de l’insuline
La société comme un tabouret Société civile Secteur privé Mintzberg 2015 Gouvernement

29 Le secteur privé Innovation? Responsabilité sociale versus marketing
Analogues Stylos Protection intellectuelle (Luo and Kesselheim 2016) Responsabilité sociale versus marketing Pas seulement les 3 grands mais aussi les intermédiaires Les Pharmacy Benefit Management Services Les grossistes

30 Les gouvernements Couverture universelle
Rationalisation de l’utilisation des insulines analogues P.ex. Nouvelle-Zélande, Allemagne Réglementation des biosimilaires Réglementation des prix Taxes et autres hausses de prix Financement pour le diabète National International Rôle de l’Organisation Mondiale de la Santé Une seule personne au niveau global pour le dossier diabète

31 La société civile Lancet September 2012

32 Rétablir l’équilibre du tabouret
Le rôle du secteur privé au sens large Un « business case » pour les pays / patients pauvres Une segmentation du marché Biosimilaires = / ≠ Génériques Les gouvernements Leurs rôles Leurs responsabilités Manque de société civile indépendante Exemple VIH Equité

33 Rétablir l’équilibre du tabouret
Aussi Le rôle des médecins Vision de mon patient versus du système de santé Les conflits d’intérêts Le rôle des Universitaires Recherche – faire avancer la science / réalité des besoins La voix critique Le rôle des patients / individus Utilisateur du système de santé / médicaments Membre de la société

34 Questions? David.Beran@unige.ch http://haiweb.org/what-we-do/acciss/
Merci Questions?