Evaluation reports from the Commission on Reimbursement of Medicines (CRM) and the Medical Pharmaceutical Committee (MFC) as specific target group

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1 Evaluation reports from the Commission on Reimbursement of Medicines (CRM) and the Medical Pharmaceutical Committee (MFC) as specific target group Philippe Van Wilder RIZIV-INAMI Belgian National Health Insurance Agency Reimbursement of Medicines Department Brussels, 05/12/08 Disclaimer: the opinions expressed in this presentation may not reflect the official position of RIZIV / INAMI 1

2 Table of Contents : 1. The CRM reimbursement procedure 2. The CRM evaluation of the therapeutic value of medicines 3. The published CRM evaluation report and the MFC as target group Thanks to Prof. Dr. M. Casteels for providing presentation slides Comm / Dec.08 2

3 1. The CRM reimbursement procedure Comm / Dec.08 3

4 In Belgium: positive list of reimbursed medicinal products Applying for reimbursement: - mostly initiative of sponsor - mostly after MAA / after CHMP + if added value claim - only within SmPC - may be more restricted than SmPC Comm / Dec.08 4

5 Marketing Authorisation > < Reimbursement Evaluation Marketing Application Authorisation (MAA) > Reimbursement decision > 1. Mostly European Perspective 1. Per member state 2. Evaluation based on Efficacy Safety Pharmaceutical quality 3. Benefit/risk balance of the drug on its own 2. Additional elements: + Effectiveness + Convenience + Applicability 3. Relative therapeutic value as compared to alternatives 4. Relative economic value as compared to alternatives C/ E Comm / Dec.08 5

6 Reimbursement Evaluation Process R.D. of Dec 21st 2001 Submission of dossier Reimbursement decision Econ Aff. Commission D8 Acceptance D30: 1st evaluation D60 main evaluation First Proposal Final Proposal Applicant D180: Minister Decision Comm / Dec.08 6

7 2. The CRM evaluation of the therapeutic value of medicines Comm / Dec.08 7

8 Reimbursement Evaluation criteria Therapeutic value Price and proposed reimbursement level Cl III Position of the drug in medical practice (therapeutic and social needs) Budgetary impact to National Insurance Agency Cl III class I only: Efficiency (cost health insurance / therapeutic value) Comm / Dec.08 8

9 Therapeutic value Efficacy Safety Effectiveness Applicability Convenience > class I added value > class II * comparable value class III * copy/generic * with subtypes R.D Dec.21st, 2001 via: = sum of elements As determined by : Morbidity Mortality Quality of life Comm / Dec.08 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 Comm / Dec.08 10

11 n of unique CRM submissions per semester class 1 class 2 class 3 orphan individual revision modification sem sem sem sem sem sem sem sem sem sem sem sem sem 1 Less class 1 submissions in 2008: but only 17 New Mol.Entities approved by FDA in 2007 Comm / Dec.08 11

12 Class 1: outcome of CRM evaluations : Submission year Total Class 1 Added therapeutic value submission yes no Total Count Row % 37,5% 62,5% 100,0% Count Row % 71,4% 28,6% 100,0% Count Row % 40,0% 60,0% 100,0% Count Row % 55,6% 44,4% 100,0% Count Row % 70,0% 30,0% 100,0% Count Row % 60,0% 40,0% 100,0% Count % within yr_d0 55,1% 44,9% 100,0% Comm / Dec.08 12

13 Outcome of CRM evaluations : time lines! ISPOR 2008, Athens: Comm / Dec.08 13

14 Outcome of CRM evaluations : time lines! (cont.) ISPOR 2008, Athens: Comm / Dec.08 14

15 3. The published CRM evaluation report and the MFC as target group Comm / Dec.08 15

16 Publication of CRM evaluation reports on the web Modified Royal Decree applicable from April 2007 Transparence (EU dir 89/105).. Every decision to exclude a certain group of medicines from the national reimbursement system has to contain a motivation based on objective and verifiable criteria, and this is announced in an appropriate way. Other competent authorities preceeding us: NICE via College voor Zorgverzekeringen via Haute Autorité de Santé via Comm / Dec.08 16

17 Publication of CRM evaluation reports on the web Published reports are different from CRM reports only for confidentiality reasons : on applicant s request: manufacturing details, marketing info, economic models copyright policy on published manuscripts Per file 3 documents: approved day 60 evaluation report of CRM comment by applicant on this report evaluation of the comments of applicant by CRM The language used for the evaluation report is dependent on the applicant s geographic origin; Published reports can by no means be used for marketing purposes. Only evaluation reports adopted after April 2007 are published. Comm / Dec.08 17

18 report_crm_cgt/index.htm#repport Comm / Dec.08 18

19 Evaluatierapporten CTG, reactie van het bedrijf en de CTG Geneesmiddel Evaluatierapport Reactie van het bedrijf Reactie van de CTG ALOXI (FR) (Palonosetron) ALOXI J60 ALOXI R60 ALOXI J120 ASADISP (NL) (nieuwe benaming: MERCKASA) (Acetylsalicylzuur) ASADISP J60 - ASADISP J120 BINOCRIT(NL) (Epoetin alfa) BINOCRIT J60 BINOCRIT R60 BINOCRIT J120 CERVARIX (FR) (Humaan papillomavirus type L1 eiwit) CERVARIX J60 CERVARIX R60 CERVARIX J120 EVOLTRA (NL) (Clofarabine) EVOLTRA J60 - EVOLTRA J120 FLEMOXIN SOLUTAB (NL) (Amoxicilline) FLEMOXIN SOLUTAB J60 FLEMOXIN SOLUTAB R60 FLEMOXIN SOLUTAB J120 FOSTIMON 75 IU/1 ml (FR) (urofollitropine) FOSTIMON 75 J60 FOSTIMON 75 R60 FOSTIMON 75 J120 FOSTIMON 150 IU/1 ml (FR) (urofollitropine) FOSTIMON 150 J60 FOSTIMON 150 R60 FOSTIMON 150 J120 GARDASIL (FR) (Humaan papillomavirus type 6, 11, 16, 18) GARDASIL J60 GARDASIL R60 GARDASIL J120 INVEGA (NL) (Palipéridone) INVEGA J60 INVEGA R60 INVEGA J120 INCRELEX (NL) (mecasermine) INCRELEX J60 INCRELEX R60 INCRELEX J120 ISENTRESS (FR) (Raltegravir) ISENTRESS J60 ISENTRESS R60 ISENTRESS J120 MIRCERA (FR) (Epoetin bèta) MIRCERA J60 MIRCERA R60 MIRCERA J120 Comm / Dec.08 19

20 Evaluatierapporten CTG, reactie van het bedrijf en de CTG NEXAVAR (NL) (Sorafenib) NEXAVAR J60 NEXAVAR R60 NEXAVAR J120 OCTANATE (FR) (Stollingsfactor VIII, humaan) OCTANATE J60 - OCTANATE J120 OCTAPLEX (FR) (Stollingsfactoren II, VII, IX et X, combinatie) OCTAPLEX J60 OCTAPLEX R60 OCTAPLEX J120 REMODULIN (FR) (Trésprostinil) REMODULIN J60 REMODULIN R60 REMODULIN J120 REVLIMID (FR) (Lenalidomide) REVLIMID J60 REVLIMID R60 REVLIMID J120 THELIN (FR) (Sitaxentan) THELIN J60 THELIN R60 THELIN J120 TORISEL (FR) (Temsirolimus) TORISEL J60 TORISEL R60 TORISEL J120 TYSABRI (NL) (Natalizumab) TYSABRI J60 TYSABRI R60 TYSABRI J120 VASOVIST (NL) (gadofosveset-trinatrium) VASOVIST J60 VASOVIST R60 VASOVIST J120 Comm / Dec.08 20

21 CRM evaluation reports and MFC: extract from R.D. on MFC 4 MAART Koninklijk besluit houdende vaststelling van de normen waaraan een ziekenhuisapotheek moet voldoen om te worden erkend. Bron : VOLKSGEZONDHEID EN LEEFMILIEU Publicatie : Inwerkingtreding : Dossiernummer : /33 Afdeling 1. - Het medisch farmaceutisch comité. Art. 25. ( 1.) Het medisch farmaceutisch comité heeft als taken : <KB /33, art. 2, 004; Inwerkingtreding : > 1 het opstellen en het bijhouden van een Therapeutisch Formularium. Dit is een verplichte lijst van geneesmiddelen, gekozen op overwogen en economisch verantwoorde wijze, die permanent beschikbaar zijn teneinde aan de diagnostische en therapeutische behoeften te kunnen voldoen; 4 het voorstellen van maatregelen met het oog op een beter geneesmiddelenverbruik en op het vermijden van voorschrijffouten;) <KB /33, art. 2, 004; Inwerkingtreding : > Comm / Dec.08 21

22 CRM evaluation reports and MFC: content of D60 report 1 Id entification of the speciality 2 Characteristics of the speciality / Econom ic A ffairs 3 Characteristics of the speciality / Pub lic H ealth 4 A proposal regarding the reimbursement the therapeutic added-value class (class 1, class 2 or class 3) the conditions for reimbursement - reimbursement reserved for hospitals or reimbursement also in an am bulatory setting - reimbursement under chapter I, chapter III and/or chapter IV; if reimbursement under chapter IV is proposed, the paragraph in - application of the exception provided for in article 92 of the Act of the basis for reimbursement the category of reimbursement the reimbursement group Comm / Dec.08 22

23 CRM evaluation reports and MFC: content of D60 report (cont.) 5 Justification of the proposal regarding reimbursement 5.1 Field of application Presentation of the disease Epidemiological data: Current therapeutic modalities and therapeutic and social needs 5.2. Mechanism of action, place in the pharmacotherapeutic group and proposed posology 5.3. Experience with the substance Conditions of reimbursement in other European countries at the time 5.4 of the present application (optional) Positioning of the substance compared with the existing therapeutic 5.5 modalities and rationale for the development of the speciality Clinical data Epidemiology Medical need Clinical trial data Daily practice data Economic and financial data 5,6,2 Health-economical data 5.7 Budget impact 5.8 Justification of the proposal regarding the reimbursement D60 evaluation: therapeutic value & level of evidence Comm / Dec.08 23

24 CRM evaluation reports and MFC: example of D60 report MIRCERAJ60.pdf MIRCERAR60.pdf MIRCERAJ120.pdf See separate pdf document Comm / Dec.08 24

25 CRM evaluation reports and MFC: exchange of information & comments Any comment? Please reply to: > scientific data / assessment details > administrative & regulatory issues > general infodesk on medicines Comm / Dec.08 25

26 Thank you for your attention! Comm / Dec.08 26

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