additional patient related benefits are the key to price
Transcription
additional patient related benefits are the key to price
ADDITIONAL PATIENT RELATED BENEFITS ARE THE KEY TO PRICE NEGOTIATION IN GERMANY – PRACTICAL EXPERIENCE WITH BENEFIT DOSSIERS AND THE ASSESSMENT PROCESS Dr. Olaf Pirk Dec 15 2012 © 2012, Olaf Pirk Consult • 1 Agenda of today’s workshop Along the process last years experience is presented by “process ow ners” Note: Pharmaceuticals that are already on the market may also become subject of a benefit assessment. Ins titute for Quality and Efficiency in H ealth Care Benefit assessment Report Commis s ion pos s ible G-BA Dr. Meriem Bouslouk Market launch Additional benefit H earing D os s ier M anufacturer Federal Joint Committee (G BA) Federal Joint Committee (G BA) Benefit assessment Benefit assessment GKV-SV Sorry – n.a. Dr. Olaf Pirk (D ecis ion) (internet Publication) No additional benefit Manufacturer´ s price Reference price not pos s ible FRP Reference price M anufacturer AB Prof. Dr. Cost/benefit Frank-Ulrich Fricke Decision assessment No agreement H ead as s ociation of the SH I s cheme (G KV) Rebate negotiations Not accepted Arbitration Panel Ins titute for Quality and Efficiency in H ealth Care (e.g. bas ed on international prices) Agreement Discounted ‘net’ price D ecis ion Retroactive Discounted ‘net’ Price Valid until the end of the process (s et freely) Market launch 3 months 6 months 12 months 15 months FRP = fixed reference price © 2012, Olaf Pirk Consult • 2 1 Agenda of today’s workshop After the presentations and your questions we plan to simulate a hearing at the G-BA Physicians © © 2012, 2012,Olaf OlafPirk PirkConsult• Consult 3 • Manufacturer (and others) Your part SHI 3 AMNOG – Benefit Assessment by the G-BA Dr Meriem Bouslouk Desk Officer Pharmaceuticals Department Federal Joint Committee (G-BA) 2 The Federal Joint Committee = The G-BA Since 1 July 2012: Mr Josef Hecken Dr Regina Klakow-Franck Dr Harald Deisler 5 The G-BA and its subcommittees 6 3 The early benefit assessment - Course Publication of the dossier and the assessment Submission of the dossier Resolution on the benefit 6 months 3 months 3 months Benefit assessment (proposal by the IQWiG) Hearing procedure and resolution 7 Zoomed in: Hearing procedure and resolution Publication of the assessment = Start of the hearing procedure Resolution on the benefit Oral hearing 3 months 3 weeks Written statements 2-3 weeks Overview of the statements Analysis of the w ritten and oral statements / decision making 8 4 Resolution in the plenary session Plenum = decision-making body of the Federal Joint Committee 9 Resolution on the additional benefit The extent of the additional benefit over the appropriate comparator and the therapeutic importance of the additional benefit taking into account the severity of the disease: 1) Major additional benefit--------------2) Considerable additional benefit 6) Non-quantifiable 3) Minor additional benefit--------------4) No additional benefit 5) Less benefit than the appropriate comparator 10 5 G-BA resolution • Resolution is part of the Pharmaceutical Directive and includes: • Additional benefit over appropriate comparator • Number of patients • Requirements for quality-assured administration • Costs of treatment, also in comparison with the appropriate comparator …for each therapeutic indication • Resolution is published on the website of the G-BA and in the Federal Gazette. • Resolution can be time-limited. 11 Appropriate comparator • Determined by the G-BA • Defined criteria (Chapter 5, section 6, Rules of procedure of the G-BA) • Can be requested within a consultation with the G-BA • Advice by the G-BA upon request also on endpoints, patient groups, AMNOG procedure, etc. 12 6 Consultations with the G-BA: course Pharm aceutical com pany G-BA Office PEI BfArM (before phase 3) Pharmaceuticals Subcommittee Consultation Draft minutes of the meeting Comments, addendums Final minutes of the meeting 8 weeks 13 Example : Rilpivirine Resolution: 5 July 2012 Indication: HIV 1 infection (combination therapy, treatment naïve patients) Dossier: Major additional benefit • (+) Neurological AE • (+) Skin AE IQWiG: Considerable additional benefit • (+) Virological response (men) • (+) Neurological AE Hearing procedure: Importance of AE, virological response (effect over time, gender?) G-BA : Minor additional benefit • (+) Neurological AE 14 7 Example: Vemurafenib Resolution: 6 September 2012 Indication: unresectable or metastatic melanoma (BRAF V600 mutation-positive) Dossier: Major additional benefit • (+) Overall survival IQWiG: Considerable additional benefit • (+) Overall survival • (−) Harm because of AE Hearing procedure: AE manageable? G-BA : Considerable additional benefit • (+) Overall survival • (+) AE significant, but manageable 15 Consequences of the G-BA resolution • Major, considerable, minor or non-quantifiable additional benefit Negotiations between SHI and pharmaceutical company • No additional benefit Negotiations, price then not higher than appropriate comparator Possible allocation to a reference price group? Cost-benefit analysis upon request of the company (€ and time!) • Benefit is less than benefit of the appropriate comparator Possible requirement of studies Possible exclusion from/restriction on reimbursement 16 8 www.g-ba.de [email protected] The Negotiation Process with the National Association of Statutory Health Insurance Funds (GKV-SV) Dr. Olaf Pirk Dec 15 2012 © 2012, Olaf Pirk Consult • 18 9 All new drugs will be freely priced at launch for max. 6 months; drugs with additional benefit will have up to 12 months free pricing Ins titute for Quality and Efficiency in H ealth Care GBA Early assessment period Benefit assessment Report Commis s ion pos s ible (Assessment for orphan drugs with revenue H earing D os s ier < 50 mill Euro (in 12 months) submit a Federal Joint M anufacturer dossier but do not need toCommittee prove(Gadditional BA) benefit ) Market launch (Publication) (D ecis ion) No additional benefit No agreement Price fixed by arbitration retroactive to 1yr post launch (s et freely) 3 months M anufacturer No agreement H ead as s ociation of the SH I s cheme (G KV) Not accepted Arbitration Panel Ins titute for Quality and Efficiency in H ealth Care Cost/benefit assessment Decision Rebate negotiations (e.g. bas ed 1. Max. reimbursed price determined by prices) fixed reference on international Reference price not pos s ible group (no direct restrictions on MNF list price) price Agreement D ecis ion FB Reference price Market launch +6 months free pricing Additional benefit Benefit assessment Manufacturer´ s price Agreement Reimbursed at negotiated discounted net price Federal Joint Committee (G BA) Benefit assessment +6 months free pricing GKV-SV Rebate negotiation 2. If no FRP possible: price must not exceed annual treatment costDiscounted of comparator Discounted GKV-SV Rebate Valid until the end of the Retroactive price Price process negotiation (direct restriction) 6 months 12 months * No assessment for drugs with GKV-revenue < 1 mill Euro in 12 months 15 months GKV = SHI = Statutory Health Insurance; FRP= fixed reference price; MNF = manufacturer © 2012, Olaf Pirk Consult • 19 The Negotiation Process with the National Association of SHI (GKV-SV) has started in January 2012 • GKV-SV will schedule the dates for the negotiation • Negotiation language is German; interpreters allowed • GKV-SV will host the meetings • Length of one meeting is 4 hours 2 Month: 1 First meeting within 4 weeks after G-BA decision 3 4 5 There are two further meetings planned, between the first and the last meeting. Upon agreement of parties another meeting is possible: Meaning 4 are planned, 5 are possible Negotiation Each party is allowed to send 5 participants into negotiation; 2 in addition are allowed Upon agreement. 6 Last meeting max. 3 weeks prior to price publication Publication in official price list: Lauer Taxe Negotiation Guest of the national association of private health insurances; upon proposal he is allowed to ask questions and to talk if all parties agree. Private health insurance has to “agree” within 5 working days after last negotiation date to Rebate / reimbursement price. © 2012, Olaf Pirk Consult • 20 10 The Negotiation process is fixed in the framework agreement between Pharmacos and GKV-SV • D os s ier modules 1 to 4 , the I Q WiG assessment and the G - BA decision as published in the internet are regular parts of the negotiation proc es s • Furthermore the P harmaco has to provide − real drug prices for other European countries − planned annual s ales according to patient group − c osts of c omparable drugs • T he information has to be provided 5 working days prior to the firs t negotiation date • T he form of provis ion mus t be according to the dos s ier as defined by G - BA P arts of module 5 c an be us ed during negotiation if parties agree on − earliest in first meeting the information needed from module 5 s hould be dis cussed C riteria for setting the reimbursement price 1 . D ec ision of G - BA regarding additional benefit 2 . Benefit as s essment inc luding the dos sier of the pharmac o 3 . Real P rices of the drug in E uropean c ountries 4 . A nnual treatment costs of c omparable drugs © 2012, Olaf Pirk Consult • 21 All Criteria to Set the Reimbursement Price are Known Criteria on which the price negotiation is based (§ 130b SGB V) Additional criteria which might influence the price negotiation if parties agree to use in negotiation • Outcome from the early benefit assessment acc. § 35a SGB V • Extent of additional benefit: none, minor, considerable, major, nonquantifiable. • Affected GKV-target population • Annual GKV-cost of product and appropriate comparator in affected target population • Cost-benefit-analysis / cost-offset data / budget impact from GKV perspective National rebate negotiation • Data on compliance, persistence or other patient-relevant outcomes • …Others not yet considered? • Real prices of the product in other European countries • Annual treatment costs of comparable drugs • Any data available on treatment reality or product benefit which were not selected for further analysis in module 4 First negotiation has started Jan 23 2012 Attention: Supportive data should be already described in the dossier and listed at least in module 5 GKV = Statutory Health Insurance; SGB V = 5 th Book of Social Code © 2012, Olaf Pirk Consult • 22 11 The basket of European reference price countries for price negotiation is valid since March 2012 1 . A us tria 2 . Belgium 3 . C zec h Republic 4 . D enmark 5 . Finland 6 . Franc e 7 . G reec e 8 . I reland 9 . I taly 10 . N etherlands 11 . P ortugal 12 . Sweden 13 . Slovakia 14 . Spain 15 . U K © 2012, Olaf Pirk Consult • 23 © Grafik: OPG, Presseagentur für Gesundheit In the Rebate Negotiation the Price Will Be Set as Surplus on the Price of the Appropriate Comparator Additional benefit Rebate negotiation • Negotiation starts earliest 6 months after launch • Price vs. comparator depends on different criteria • Discounted ‘net’ price will be published directly in the price list (so called Lauer-Taxe); two prices will be presented: list price and reimbursed price Launch price 2 The surplus in € is then recalculated to a rebate (percentage) on the original launch price 1 The price range is set by European reference prices as upper and appropriate comparators price as lower level Negotiation in that range is based on the extent of additional benefit, the comparable prices and further data of module 5. Publication in official price list: Lauer Taxe % € European reference price Appropriate comparator price © 2012, Olaf Pirk Consult • 24 12 19.4% Rebate for Ticagrelor Will Replace 16% Manufacturers Rebate Ex factory Prices for DDD €3.00 Ti ca grelor €2.50 0,15€ -19,4% -16% 0,40€ Euro €2.00 Cl opi dogrel 0,08€ • -3,4% Basis of the negotiation result is – – ex manufacturers price 100 tablet package á 90 mg at 124,00 ex manufacturer price – DDD €1.50 Reduction of mandatory rebate end of 2013 to 6% €1.00 €0.50 €- old DDD Clopidogrel ex manu. Price Brilique ex manu. Price old DDD old DDD 16% 6% new DDD DDD manuf. manuf. (generic) - 19,4% rebate Rebate €0.22 €2.48 €2.08 €2.00 DDD (Iscover) DDD (Plavix) €2.00 €2.01 • • DDD is 2 tablets: 2.48 €/day Price reduction is from 2.48 to 2.00 new rebate 19.4% • Mandatory rebate was 16% on the old price: 0,40€/DDD €2.33 GKV-SV and AZ negotiated on basis of DDD and manufacturers price ist a price reduction of 0,48€ The contract is valid until end of 2014. Meaning, the real rebate is for 2012 – 2013: 3.4% (0,08€ based on daily costs). For 2014 the real rebate is: 13.4% (0,33€ based on daily costs). First Price Negotiation for an Orphan Drug Resulted in a “Stepwise” Rebate: -27% Before negotiation: 98.90 € Daily treatment costs (€) -16% Rebate in total: -27% Before negotiation: 83.08 € After negotiation: 72.20 € C ompany did not negotiate on replac ing the manufac turer‘s rebate of 1 6 % : 1 1% are initially granted on top! When by law the manufac turer‘s rebate is reduc ed c ompany will additionally grant this 16%! Source: GKV SV; APU=ex-manufacturer price © 2012, Olaf Pirk Consult • 26 13 Status of negotiations so far: 13 rebated prices • 11 prices by direct negotiation • 1 by agreement prior to arbitration decision • 1 by arbitration decision A dditional Benef it M C M (N Q ) M C M (N Q ) Rebat e • 4 „opt outs“ © 2012, Olaf Pirk Consult • 27 Zentrum für Gesundheitsökonomie Neumarkt Prof. Dr. Frank-Ulrich Fricke If the negotiation with the GKV-SV fails it will start THE ARBITRATION PROCESS Seite 28 14 Zentrum für Gesundheitsökonomie Neumarkt Prof. Dr. Frank-Ulrich Fricke § 130b (5) SGB V Der Spitzenverband Bund der Krankenkassen und die für die Wahrnehmung der wirtschaftlichen Interessen gebildeten maßgeblichen Spitzenorganisationen der pharmazeutischen Unternehmer auf Bundes ebene bilden eine gemeinsame Schiedsstelle. Sie besteht aus einem unparteiischen Vorsitzenden und zwei weiteren unparteiischen Mitgliedern sowie aus jeweils zwei Vertretern der Vertragsparteien nach Absatz 1. Die Patientenorganisationen nach § 140f können beratend an den Sitzungen der Schiedsstelle teilnehmen. Über den Vorsitzenden und die zwei weiteren unparteiischen Mitglieder sowie deren Stellvertreter sollen sich die Verbände nach Satz 1 einigen. Kommt eine Einigung nicht zustande, gilt § 89 Absatz 3 Satz 4 und 5 entsprechend. Seite 29 Center for Health Economics Prof. Dr. Frank-Ulrich Fricke The Independent Members of the Arbitration Board Independent Chairman Independent Member Industry Associations Independent Member SHI Dr. Manfred Zipperer Dr. Jörg Ludwig Pfletschinger Dr. Herbert Reichelt Deputies Deputies Deputies Gerhard Schulte Erika Behnsen Dr. Ottfried Zierenberg Prof. Dr. Frank-Ulrich Fricke Dr. Leonhard Hansen Prof. Dr. Eckart Fiedler Seite 30 15 Center for Health Economics Prof. Dr. Frank-Ulrich Fricke Members of the Arbitration Board for Compound-specific Arbitrations 2 Vertreter 2 representatives of the Herstellermanufacturer unternehmen 2 Vertreter representatives GKV-SpV of the SHI Arbitration Schiedsstelle panel (7 Mitglieder) (7 members) 3 impartial 3 unparteiische members MItglieder Seite 31 Center for Health Economics Prof. Dr. Frank-Ulrich Fricke Objectives of the Arbitration Process n Definition of an appropriate reimbursement price valid as of month 13 after market introduction n Arbitration between the parties (manufacturer/ head association of the SHI) and their conflicting positions Seite 32 16 Center for Health Economics Prof. Dr. Frank-Ulrich Fricke Initiation of the Arbitration Process n Application by the parties n Based on the dossier and the evidence submitted with the application n Additional evidence can be requested by the arbitration board Seite 33 Center for Health Economics Prof. Dr. Frank-Ulrich Fricke Criteria for the Arbitration Board Without Additional Benefit n Reimbursement price is subject to § 130b (3) SGB V (annual treatment cost of the appropriate comparator) n (no reset of the appropriate comparator) n (no re-assessment of the additional benefit) With Additional Benefit Additional benefit as defined by the G-BA annual treatment cost of the appropriate comparator Prices of comparable drugs European reference prices Seite 34 17 Center for Health Economics Prof. Dr. Frank-Ulrich Fricke Character of the Procedure Arbitration is based on applications and collateral evidence If the parties agree during the arbitration process the arbiration ceases Otherwise the board tries to understand the conflicting positions and comes up with an arbitration based on the criteria mentioned above The arbitration is not another negotiation Seite 35 Summary AMNOG in a nutshell • Since the beginning of 2011, each NCE must be supported by a benefit dossier defining the additional benefit of the drug in relation to the appropriate comparator. • If a benefit is shown, the new reimbursed price after one year on the market w ill be a surplus on the reimbursed comparator price, according to the additional benefit. If no additional benefit is shown, the reimbursed price after one year may not be higher than that of the appropriate comparator. © 2012, Olaf Pirk Consult • 36 18 Summary AMNOG in a nutshell • The decision is based on a dossier submitted by the manufacturer, which draws on all the available clinical trials. • An incomplete dossier means no additional benefit is shown, in w hich case the reimbursement price will be set and/or negotiated by the head association of the sick funds. • If the negotiation fails, an arbitration body will determine the reimbursed price on the basis of international reference prices. No health economic data are requested during the entire process. The negotiation is based on the drug price accruing for the sick funds plus extra costs, based on additional resources used as mentioned in the physician’s information leaflet. © 2012, Olaf Pirk Consult • 37 Interactive: The Hearing Physicians Manufacturer (and others) Your part SHI © © 2012, 2012,Olaf OlafPirk PirkConsult• Consult 38 • 38 19 Interactive: Hearing at the G-BA Subcommittee Drugs You are the main actors in this hearing • You act as the follow ing stakeholder with following aim − GKV-SV (SHI representative) no new budget impact − SHI accredited physician no money to waste for drugs, but more money for physicians‘ services − Hospital physician no money to waste for drugs, but more money for hospitals‘ services − Patients‘ representative safe and highly efficient drugs at low prices − Manufacturer of new drug show the high additional benefit − Other Manufacturer support or fight the comparator © 2012, Olaf Pirk Consult • 39 Interactive: Hearing at the G-BA Subcommittee on Drugs The case: Dolorex®, a new drug against headache • Pivotal study against placebo showed − 50% pain relief within 30 minutes lasting for 24 hours − Qol increase by 50% − Adverse events are minor with exemption of an enormous foot perspiration lasting 24 hours • Appropriate comparator was named as aspirin − Indirect comparison showed a 10% pain relief • IQWiG proposed a clue for minor benefit regarding pain that is outweighed by the additional harm by the adverse events: no additional benefit © 2012, Olaf Pirk Consult • 40 20