Managed Entry Agreements in Belgium

Managed Entry Agreements in Belgium

BeNeLuxA experience and Belgium value based pricing Francis Arickx NIHDI Belgium National Institute for Health and Disability Insurance Social Security Manages Compulsory Health Insurance Stakeholders and Management Reimbursement of Medicines The Process 3 -

step process HTA assessment technical proposal appraisal decision Ministerial decision science, financing and politics Reimbursement of Medicines The Process MARKETING AUTHORIZATION REIMBURSEMENT procedure

Claimreimbursement evaluation applicant day 0 day 90 Commission for Reimbursement CRM Min ECONOM. AFF. procedure pricing Proposal CRM day 150

decision day 180 Minister Reimbursement of Medicines The Process Negotiations are embedded in reimbursement legislation Managed Entry Procedure max. 120 days No separate process MARKETING AUTHORIZATION

REIMBURSEMENT procedure Claimreimbursement evaluation applicant day 0 day 90 Commission for Reimbursement CRM Min ECONOM. AFF. procedure pricing

Proposal CRM day 150 decision day 180 Minister Reimbursement of Medicines The Basics - offer based, not demand driven positive list nomenclature (un)conditional reimbursement temporary enlisting

Real World Evidence The Basics - offer based, not demand driven positive list nomenclature (un)conditional reimbursement temporary enlisting Chapter IV: conditions on selected indications, duration, dosage, target population, required expertise,.. Real World Evidence Conditional reimbursement is evolving from a mere control mechanism

(quality and budget) towards collection of Real World Evidence in real and virtual registries Real World Evidence the future is now electronic health record (patient and physician accountability) IT harvests disease registry Scientific Community processes

Real World data (evidence ?) recommendations policy development/adjustment outcome based policy) (alternative Managed Entry Agreements and applied Real World Evidence electronic health record (patient and physician accountability) IT harvests

disease registry Scientific Community processes Real World data (evidence ?) recommendations policy development/adjustment outcome based policy) (alternative Managed Entry Agreements and applied Real World Evidence price.. what is on the price tag..

value.. whats it worth.. cost.. of goods.. Managed Entry Agreements and applied Real World Evidence price.. what is on the price tag.. value.. whats it worth.. cost.. of goods.. Mark Rothko (1903-1970)

famous for his broad brushstrokes colors and little difficulty interpretation for non-experts in art, is the best example of definition of value. The Masterpiece "Orange, Red, Yellow (1961) 2m x 2m. During a tender was estimated 35-45 mil dollars. It

was purchased for 86.882.500 dollars. His paintings fetch incredible prices always growing, to the point that itsSource :Luca notPani, The 7th European Conference on Rare Diseases & Orphan Products Managed Entry Agreements and applied Real World Evidence price.. what is on the price tag..

value.. whats it worth.. cost.. of goods.. Managed Entry Agreements and applied Real World Evidence value/outcome/performance based reimbursement risk sharing willingness to pay (patient level) willingness to pay (societal perspective) Managed Entry Agreements and applied Real World Evidence value/outcome/performance based reimbursement.. added value, based on hard

evidence risk sharing.. clinical trial evidence versus real life treatments.. willingness to pay (patient level).. if confirmed performance willingness to pay (societal perspective).. taking into account budget limitations/allocations, prioritization, preferences,..

Managed Entry Agreements and applied Real World Evidence price = 1.000 outcome/ performance evidence = 75 % based component risk sharing component estimate = 90 % reimbursement = willingness to 5.062 pay willingness to

(patient level) pay (societal component perspective) value = 7.500 decision = 100 % component Managed Entry Agreements and applied Real World Evidence in practice.. Managed Entry Agreements and applied Real World Evidence in practice.. Rationale New generation pharmaceutical specialties (orphan drugs, biotechnological or personalized based medicines, ..) that often meet Unmet Medical Need but associated with exuberant price tags while

having a significant degree of clinical uncertainty Growing need for alternative (financing) systems that can limit their budgetary impact while ensuring early access for patients Managed Entry Agreements and applied Real World Evidence in practice.. General Principles By negotiations a contract can be concluded between NIDHI and a pharmaceutical company Agreements try to set a justifiable cost relating to the expected added value and risk linked to uncertainty Temporary enlisting based on conditions set out in contract Objectives Access to promising therapies for patients Access to the market for pharmaceutical

companies Managed Entry Agreements and applied Real World Evidence in practice.. Scope Medicines with a reimbursement application in class 1 (claim for added therapeutic value) Medicines with a reimbursement application as orphan drug Medicines with a reimbursement application for a new indication for which a therapeutic or social need exists Medicines for which reference drug is reimbursed by MEA (incl. class 2 applications, art. MEDICAL 81 only ) UNMET

NEED Managed Entry Agreements and applied Real World Evidence in practice.. Execution term Temporary enlisting (1 3 years max. + 1 year prolongation) during which gathering of new and/or additional clinical evidence or information on the balance price/cost versus added (therapeutic) value OUTCOME ASSESSMENT Managed Entry Agreements and applied Real World Evidence in practice.. Key sources of uncertainty

Source: Panos Kanavos, Advance-HTA Capacity building workshop, Warsaw 2014. Managed Entry Agreements and applied Real World Evidence in practice.. Types of compensation models Preferably simple / not too complicated Provide certainty over budget spent and cost/price Cost reduction, paid but with original list price (eg rebate

percentage of turnover) Fixed amount per unit Reduction price other drugs applicant (cross deal) Budget cap Price-Volume Pay for performance scheme Diminution list price in combination with one of above Compensation data collection and combinations FLEXIBLE BUDGETING Managed Entry Agreements and applied Real World Evidence in practice..

Outcome based schemes Why outcome based schemes are so hot. Clinically justified reimbursement Focus on both Budget Control and Therapeutic Value Less political criticism for any loss of societal welfare if the product is later found cost effective; or for any misused resources if the product provides little or no benefit to patients Managed Entry Agreements and applied Real World Evidence in practice.. Outcome based schemes So why the cold feet ?... Logistic & financial reasons inherent to outcome based schemes:

Administrative burden for all parties Restricted timelines (120 days of negotiation + max. 2.5 years data collection) Involvement of Health Care Professionals to collect data / patient tracking Who will collect data ? Who will analyse them ?(issue of trust) Funding and ownership of data collection and analysis ? What with extra costs due to hospital care, pharmacy dispensing, side effects of drug in non-responder ? Managed Entry Agreements and applied Real World Evidence in practice.. Outcome based schemes So why the shivering ?... Scientific reasons inherent to outcome based schemes: Hard to reach consensus across all stakeholders on Responder definition / key clinical features /outcome /

performance How to measure the defined clinical endpoint Time when to evaluate patients response Managed Entry Agreements and applied Real World Evidence in practice.. Outcome based schemes Always be aware of EMOTIONS Managed Entry Agreements and applied Real World Evidence in practice.. Outcome based schemes Part of the question remains WHAT IF all logistic, financial and scientific key features are fulfilled, and expectations are met

What cost will be an acceptable cost for a responder (remaining issue of value versus price) Managed Entry Agreements and applied Real World Evidence in practice.. SWOT Conflicting interests Common ground In practice: Defending Trenches & Bunkers Solution: Need for mandate BeNeLuxA in practice.. proof of concept for the coalition of the willing Main goal: To ensure access to innovative drugs at

affordable cost Cooperation is part of the policy-mix Information gathering on global markets benefits from joint approach National context determines course of action Joint negotiations only in select cases What works? Setting clear, common goals Mutual benefit needs to be clear Pragmatic approach Focus on desired outcomes Lean organisational structure BeNeLuxA in practice.. coalition of the willing on 4 domains Health Technology Assessment Horizon Scanning

Exchange of information on pharmaceutical markets, prices and disease specific cross border registries Pricing and reimbursement including joint negotiation BeNeLuxA in practice.. Joint Health Technology Assessment Based on previous experience/expertise with MEDEV, EUnetHTA, JA2, informal collaboration,... Coherent and compatible with Joint Action 3 testing models for implementation: Mutual recognition of Assessments (operational) Joint writing/editing (operational) Sharing expertise (operational), eg. Dutch Wetenschappelijke AdviesRaad of ZIN acts as external expert in Belgian reimbursement procedure

BeNeLuxA in practice.. Joined Horizon Scanning Prioritisation potential to improve access Costs Allows for prioritisation of policy-making Allows for capacity planning for HTA bodies Allows for earlier planning for guidelines and registries Benefits Budget planning potential for savings Flags potential issues of displacement. Allows for better tools for budg allocation Efficiency gains potential to improve access Allows for streamlining procedures

Level playing field potential for savings Allows for sharing earlier and lessening the current information asymm with industry Early dialogue strengthens collaboration Allows for stakeholders to share information at an earlier stage, e.g. Beneluxa BeNeLuxA in practice.. Joined Horizon Scanning High impact reports deliverables Dataset 1 (baselist)

Filter Dataset 2 (filtered list) Defined variables Dataset 3 (high impact) High impact Dataset 4 Withdrawn / failed pharmaceuticals Dataset 5

Registered pharmaceuticals Real time database *AHRQ high impact report 2015 https://effectivehealthcare.ahrq.gov/sites/default/files/cancer-horizon-scan-high-impa ct-1512.pdf BeNeLuxA in practice.. Joined Horizon Scanning IHSI International Horizon Scanning Initiative

BeNeLuxA in practice.. Information Sharing Drug consumption Prevalence and burden of disease Best practices in (health budget) management (e.g. hep. C approach, reference pricing, generic policy, biosimilar policy,..) Post marketing evidence gathering (e.g. registries) Policy questions (e.g. KCE-ZIN Study 2013-03HSR_on drug pricing scenarios) BeNeLuxA in practice.. Pricing and Reimbursement, including joint negotiations By structural exchange of information and testing through pilots of procedures or scenarios for joint negotiations that lead to financial arrangements and contracts That are compatible with and respect national legislation and competence and responsibility of the different stakeholders in the decision making process

That respect confidentiality of the commonly negotiated financial details (..nothing changes compared with today..) THIS IS NOT JOINT PROCUREMENT THIS IS NOT LIMBO DANCING.. how low can you go.. BeNeLuxA in practice.. Pricing and Reimbursement, including joint negotiations Eligibility for a joint procedure An assessment and if applicable, a negotiation should fit within the national legislations, eg: intramural (hospital) pharmaceuticals eligible for the lock procedure in the Netherlands pharmaceuticals submitted as Class 1 or orphan application in Belgium .. Pharmaceutical not explicitly reimbursed for that particular indication in a country of the collaborating HTA partners The Steering

Committee needs to agree with the selection Positive elements in selection Negative elementsofinthe selection pharmaceutical previous refusal of reimbursement high unmet medical need in a country of the collaborating recent date of EMA-registration/EMAHTA partners positive opinion unwillingness of the manufacturer expected added value to commercialize the

satisfactory degree of evidence pharmaceutical in a country of the willingness of the manufacturer to collaborating HTA partners after a submit a draft submission file positive decision on reimbursement .. .. BeNeLuxA in practice.. Pricing and Reimbursement, including joint negotiations Projectedtiming A timeline will be established takinginto account national procedures and calendars of implied countries. Days mentioned below act as an indication. Timingin all implied countries will be aligned. All parties commit to give maximumeffort to reach on optimal timing. Day minus 90: Kick-offmeeting offi cial confirmation bythe company

to start joint HTA procedure Day minus 60: Submission of concept file to implied countries Day 0 : Reimbursement claim submitted by the company Day 90: Final Assessment Report Day 60: DraftAssessment Report Day 120 (after decision/request to negotiate): offi cial confirmation bythe company Start of negotiations to start joint negotiation procedure Day 180: Final decisions and signing of separate conventions

BeNeLuxA in practice.. Pricing and Reimbursement, including joint negotiations Key Succes factors (general) Mutual and common understanding on value and appraisal assessments. Benefits must be clear for all partners (economies of scale and knowledge building; timely access;). Pragmatic approach, trust and mutual commitment. Political support (responsibility and accountability). Solid founded and well documented framework. BeNeLuxA in practice.. Pricing and Reimbursement, including joint negotiations

Key Succes factors (general) Sufficient investment in project development: horizon scan, priority setting, topic selection, establishing value framework for negotiations, synchronizing national procedures, project monitoring and management, communication Managed Entry Agreements An example the situation Current treatment Surgery - Overall Survival 12.2 months ca. 30,000 / patient

No pharmaceutical alternative Fictivumab Registered EMA indication: inventitis stage 3 Oral drug, first in class EPAR RCT fictivimub versus surgery in inventitis stage 3 patients Less surgery needed Median Overall survival: 19.1 months (increase of 56,6% versus surgery) Manageable side effects, outweighed by benefits No long-term data

Submission by applicant 80,000 /patient ICER 97,000/QALY 250 patients per year budget impact: 20 mio /year the evaluation HTA - evaluation of the claim Evaluation on therapeutic value, price, importance in clinical practice, budgetary impact & ratio cost / therapeutic value Conclusion: Added value BUT high cost per patient + high overall budget impact

clinical Uncertainties uncertainty Effect on surgery in real life? Number of patients? Extension of indications of fictivumab within 2 to 3 years Future treatments for inventitis stage 3 Molecule with similar mechanism of action and similar risk/benefit profile as fictivumab; expected EMA registration within 1 to 2 years Proposal HTA body Conditional reimbursement: fictivumab can only be used in

specialized centers MEA procedure financial framework = 47,000 /patient (rationale: increase of 56.6% in OS + ICER 38,000/QALY) budgeta ry uncertai nty the negotiation Taskforce MEA Framework negotiations = proposal HTA-body Reimbursement conditions: as proposed by HTA-body (modifications possible)

Uncertainties: how to address them ? Less surgery Registry High budget impact Rebate of 90% above estimated sales High cost per patient Rebate of 37.5% on total sales Future indication Reimbursed from registration Evaluation by CRM may lead to increase of cap Future alternatives Limited duration of convention (2 years) + budget cap on indication the compensation mechanism Theory translated into Practice if only fictivumab is

concerned Turnover 0 20 mio > 20 mio if alternative s are coming soon

Less surgery Registry High budget impact Rebate of 90% above estimated sales High cost per patient Rebate of 37.5% on total sales Future indication Reimbursed from registration Evaluation by CRM may lead to increase of cap Rebate 37.5% 90.0% Future alternatives Limited duration of convention (2 years) + budget cap on indication all concerned applicants rebate a % of their sales till all have the same net cost of 47,000/patient = individual compensation

if net total cost of 12.5 mio /year is exceeded (in total by all drugs): 90% rebate of overshoot, diveded by market share between concerned applicants = structural financing method the complexity What if. an alternative with an added value compared to fictivumab arrives under cap of 12.5 mio : higher cost per patient; less individual rebate above cap of 12.5 mio : compensation unrelated to added value, fair ? only related to market share

an alternative, also reimbursed through a structural too complex ? financing method for another indication, gets registration for inventitis stage 3 ? thx

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