Reimbursement of Medicines. 5 years experience with CRM procedure. SRBGE Brussels Oct 2007

Transcription

1 Reimbursement of Medicines 5 years experience with CRM procedure SRBGE Brussels Oct 2007 Philippe Van Wilder RIZIV - INAMI Head Reimbursement of Medicines Dept. Disclaimer: The opinions of the author do not necessarily reflect those of the institution he represents 1

2 Structure 1. Market authorisation versus reimbursement decision 2. Reimbursement procedure 3. Reimburement facts & figures 2

3 Product life-cycle 3

4 1. Marketing Authorization versus Reimbursement Evaluation Marketing Application Authorization (MAA) > Reimbursement decision > 1. European Centralized or Mutual Recognition 2. Dossier based on Efficacy Safety Pharmaceutical quality 3. Benefit/risk balance of the drug on its own 1. Per member state 2. Dossier goes beyond MAAelements: + Effectiveness + Convenience + others 3. Relative therapeutic value as compared to alternatives 4. Relative economic value as compared to alternatives C/ E 4

5 Expected to go bankrupt according to this report: US Medicare Trust Fund by 2019 French healthcare system by

6 Data 6

7 2. Reimbursement procedure 7

8 Reimbursement Key Features Positive list based on dossier submitted by applicant Claiming added (class 1 price premium) or similar value (class 2) Reimbursement granted within SPC Reimbursement may be limited to specific subgroups Different reimbursement categories (A B C Cs Cx D) 2 phases in reimbursement procedure: Evaluation of scientific evidence Concrete Reimbursement proposal Conditional listing in case of cl I >>> Review! (18-36m) 8

9 Procedures (Eur Dir 105/89) MA procedure reimbursement reimbursement request day 0 evaluation day 90 proposal day 150 decision day 180 9

10 Composition of the CRM/CTG 30 members 22 voting members : 7 academics 8 sick funds 4 physicians association 3 pharmacists association 8 non voting members : 4 ministry rep. 1 INAMI/RIZIV 2 Pharma.be 1 Febelgen academics sick funds physician's assoc pharmacists assoc non voting members 10

11 Reimbursement Evaluation Process : Belgium MAA > Submission of dossier Econ Aff. CRM D8 Acceptance D30: 1st evaluation D60 main evaluation First Proposal Final Proposal Hearing! (cli) Reimbursement decision Applicant D180: Minister Decision 11

12 Evaluation criteria Therapeutic value Price and proposed reimbursement level Cl III Position of the drug in medical practice (therapeutic and social needs) Cl III Budgetary impact to National Insurance Agency class I only: Efficiency (cost / therapeutic value) 12

13 Therapeutic value Efficacy Safety Effectiveness Applicability Convenience > class I added value > class II comparable value class III copy/generic R.D Dec.21st, 2001 via: = sum of elements As determined by : Morbidity Mortality Quality of life 13

14 Questions addressed by reimbursement procedure: Clinical data (RCT) Epidemiological data Real Life data Health economics data Budget impact data Efficacy controlled setting Effectiveness daily practice Efficiency cost-effective = Can it work? = Does it work? = Is it worthwile? 14

15 Eur member state B Submission for reimbursement in Belgium, France and the Netherlands Elements included in (A)TV: Other: Source: Reimbursement agencies: B RIZIV FR HAS NL CVZ MAA EMEA Efficacy Safety Effectiveness Applicability Convenience Disease severity Experience: Conditional: Added value: 15

16 Class I medicines: Conditional reimbursement / review procedure R.D. of Dec 21st 2001 : Art.16, 62, & 63 Elements & timelines > specified in CRM proposition Timelines: within 18m to 36m Aim = Confirmation y/n of assumptions at initial approval Criteria : Those applicable to therapeutic value assessment but special emphasis on : effectiveness, PE in daily practice Sales volume Reimbursement modalities in European Member States Additional elements: Recent documents/guidelines from CRM Scientific studies (peer reviewed) Yearly cost evolution within therapeutical class Prescribed daily dose Other elements relating to applicability and effectiveness Consensus reports 16

17 3. Reimburement facts & figures 17

18 Belgium, CRM procedure, data Number of unique* finished submissions in the period * unique = same DCI same day0 same decision Year of submission 2002 cl 1 cl 2 cl 3 orphan Type of submission Change in reimburse. other Revision cl 1 Total Total Note: 2006 is an underestimate because only finished files are considered 18

19 Crosstabulation Minister Decision split per type of submission Minister Type of submission Decision N (%) chng rev cl cl 1 cl 2 cl 3 orphan reim other 1 Total pos Count % column 63,0% 76,0% 91,5% 71,4% 64,6% 71,1% 70,6% 77,7% neg Count % column 32,0% 15,2% 2,4% 19,0% 23,0% 15,4% 5,9% 13,2% no dec Count % column 2,0% 5,4% 4,3%,0% 5,5% 13,2%,0% 6,0% closed Count % column,0%,0%,0%,0%,7%,0%,0%,1% missing Count % column 3,0% 3,4% 1,7% 9,5% 6,2%,4% 23,5% 3,1% Total Count Count % row % column 100,0% 100,0% 100,0% 100,0% 100,0% 100,0% 100,0% 19

20 USA : Schultz report to Congress 20

21 USA : Schultz report to Congress 21

22 USA : Schultz report to Congress 22

23 Drop in innovation? 23

24 Drop in innovation? 24

25 Eur member state B Voir site H.A.S. 25

26 Extrait du Rapport INAMI

27 Extrait du Rapport INAMI

28 IMS Health LMPB per ATC main class Euro (PP) A APP DIGESTIF.METABOLISME B SANG.ORGANES HEMATOPOIET C APP. CARDIOVASCULAIRE D DERMATOLOGIE G APP GENIT-URIN.HORM.SEX. H HORMONES J ANTIINFECTIEUX V GENERALE K SOLUTIONS PR HOPITAUX L ANTINEOPLAS..IMMUNOMODUL. M APPAREIL LOCO MOTEUR N SYSTEME NERVEUX P ANTIPARASITAIRES R APPAREIL RESPIRATOIRE S ORGANES DES SENS T AGENTS POUR DIAGNOSTIC V DIVERS 0 JUL 05 SEP 05 N0V 05 JAN 06 MAR 06 MAY 06 JUL 06 SEP 06 NOV 06 JAN 07 MAR 07 MAY 07 JUL 07 Month 28

29 IMS Health BHA: sales per ATC main class Euro (ex fact) QTR3/02 QTR4/02 QTR1/03 QTR2/03 QTR3/03 QTR4/03 QTR1/04 QTR2/04 QTR3/04 QTR4/04 QTR1/05 Quarter QTR2/05 QTR3/05 QTR4/05 QTR1/06 QTR2/06 QTR3/06 QTR4/06 QTR1/07 QTR2/07 V DIVERS T AGENTS POUR DIAGNOSTIC S ORGANES DES SENS R APPAREIL RESPIRATOIRE P ANTIPARASITAIRES N SYSTEME NERVEUX M APPAREIL LOCO MOTEUR L ANTINEOPLAS.,IMMUNOMODUL. K SOLUTIONS PR HOPITAUX J ANTIINFECTIEUX V GENERALE H HORMONES G APP GENIT-URIN.HORM.SEX. D DERMATOLOGIE C APP. CARDIOVASCULAIRE B SANG,ORGANES HEMATOPOIET A APP DIGESTIF,METABOLISME 29

30 Officine ouverte: dépenses INAMI 30

31 Officine hospitalière: ventes IMS 31

32 Thank you! Philippe Van Wilder RIZIV Reimbursement of Medicines 32