Greece Action Plan on Pricing and Reimbursement of

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Greece: Action Plan on Pricing and Reimbursement of Pharmaceuticals LSE Health, London School of Greece: Action Plan on Pricing and Reimbursement of Pharmaceuticals LSE Health, London School of Economics Athens, 28 August 2013

Outline 1. Background and process 2. Action Plan Overall Objectives 3. Action Plan Key Outline 1. Background and process 2. Action Plan Overall Objectives 3. Action Plan Key Highlights 4. Action Plan Objectives and Activities • Establishing a National Drug Policy • Pricing policy • Reimbursement rules and criteria • Prescribing & rational use • Dispensing • Cost sharing 5. Proposed Timelines (to be discussed) 2

1. Background and Process • How did we get to this point - A 1. Background and Process • How did we get to this point - A personal trajectory – Assessment mission, P&R cttee – observer (December 2012) – Reviewer of assessment mission report on behalf of WHO-EURO (April 2013) – Task Force for Greece contact (May 2013) – Action Plan for P&R of pharmaceuticals on behalf of TFGR (end-May 2013) – Meeting with institutional stakeholders (Mo. H, EOF, EOPYY), as part of special P&R cttee, to discuss problems of current system and obtain buy-in for specific actions (11 June 2013) – Preparation of draft Action Plan (1 June – 25 August, 2013) and informal consultations 3

2. Action Plan Overall Objectives • • Strong institutions (significant element of urgency) Quality 2. Action Plan Overall Objectives • • Strong institutions (significant element of urgency) Quality of care responsive to population needs Retain the benefit of universal access (availability and affordability) Obtain value for money and ensure efficiency (cost-effectiveness) Maximise health gain (outcomes) with reliance on best practice Provide incentives for preventive health care Connectivity between institutions and actions/components (e. g. supply and demand) • Credibility, to be achieved through – – Robustness in evaluation Simplicity Stability Predictability • Financial and fiscal sustainability (take into account constraints) • Industrial policy • Monitoring and evaluation 4

3. Action Plan Key Highlights – Bird’s eye view 1. Institutional strengthening and/or establishment 3. Action Plan Key Highlights – Bird’s eye view 1. Institutional strengthening and/or establishment of strong institutions with clear remit, roles and responsibilities, To. Rs, tasks and background support 1. 2. Pricing of pharmaceutical products (EOF) Reimbursement of and coverage decisions for pharmaceutical products (EOPYY) 2. Inter-connectivity across and within institutions and functions 1. 2. Between competent authorities (e. g. EOF & EOPYY) Within functions (e. g. link supply- with demand-side) 3. Comprehensiveness and linkages as part of national drug policy 1. Price-setting, reimbursement, prescribing, dispensing, cost-sharing 4. Increased reliance on and inclusion of modern tools (for the Greek setting) and techniques to achieve objectives 1. 2. 3. Clinical guidelines and protocols Price-volume agreements, HTA, risk-sharing Negotiation skills (potentially) 5. Capacity-building/training to strengthen and improve skills in a variety of new tools 5

4. Action Plan Objectives and Activities 6 4. Action Plan Objectives and Activities 6

4. 1. A National Pharmaceutical Policy 7 4. 1. A National Pharmaceutical Policy 7

A National Drug Policy - Why is it needed? • to present a formal A National Drug Policy - Why is it needed? • to present a formal record of values, aspirations, aims, decisions and medium- to long-term government commitments; • to define the national goals and objectives for the pharmaceutical sector, and set priorities; • to identify the strategies needed to meet those objectives, and identify the various actors responsible for implementing the main components of the policy; • to create a forum for national discussions on these issues.

Objectives of a National Drug Policy • The general objectives of a national drug Objectives of a National Drug Policy • The general objectives of a national drug policy are to ensure: • Access: equitable availability and affordability of essential drugs • Quality: the quality, safety and efficacy of all medicines • Rational use: the promotion of therapeutically sound and cost-effective use of drugs by health professionals and consumers. • Other national objectives and metrics: As needed for the Greek context

4. 2. Pricing policy 10 4. 2. Pricing policy 10

Pricing policy – Governnance and Process Interests/Options • Pricing committee – Strong Governance – Pricing policy – Governnance and Process Interests/Options • Pricing committee – Strong Governance – – – Who has responsibility? (EOF) Who participates? How many? What stakeholders are represented? What are its terms of reference? • • • Actions needed (a) Technical Assistance • Pricing Re-pricing & Updates Price (and volume) database – What skills mix is needed? Help establish a functioning Pricing Cttee with appropriate staff levels and competences and an appropriately staffed secretariat to perform necessary tasks related to pricing of pharmaceutical products, maintain and update data and databases, and link above tasks with regulatory process • Pricing cttee – Process – What are the documents mnfs need to • submit? Cross-validation – How long does the validation process • last for? Compliance with EU directives – What data sources does it use? Ensure validity – What are its outputs and how are they 11 reported? IT connectivity (b) Legislation Establish its function in legislation along with To. Rs, data sources, governance and processes, staff competences, remit and include in EOF organogram

Pricing & price setting policy – Overall guiding principles Objectives • • • Fairness Pricing & price setting policy – Overall guiding principles Objectives • • • Fairness Transparency (with IT connectivity) Robust process (disputed by certain stakeholders) Availability (no shortages) Affordability and cost to payer and society Administrative simplicity Timeliness (publication of price lists) Stability Predictability 12

Pricing policy – Branded, originator, in-patent products Interests/Options Actions needed (a) Technical Assistance • Pricing policy – Branded, originator, in-patent products Interests/Options Actions needed (a) Technical Assistance • External price referencing – Objectives • Fairness, effectiveness, transparency, simplicity, access, stability predictability • • – Remit: • Price setting + monitoring + re-pricing – Coverage • New drugs, including orphans, possibly biosimilars – Operational responsibility: EOF – Purpose (determines other parameters) • To guide (NOT set) reimbursement – Operational requirements • Staff levels and competences Overall admin capacity Pricing data and databases Define purpose in relation to reimbursement • Other operational criteria of EPR: frequency of updates, avoidance of launch delays, etc staff levels & competences – Basket (several options): • Euro only, possibly minus Cyprus/Malta? Other currencies esp. if fixed pegs? (b) Legislation • May Need re-calibration of ERP to be enshrined into legislation 13

Pricing policy – Branded, originator, in-patent products Interests/Options Actions needed (a) Technical Assistance • Pricing policy – Branded, originator, in-patent products Interests/Options Actions needed (a) Technical Assistance • External price referencing – List price limitations/cannot capture • • Confidential agreements in most countries Applicable to expensive products An increasing number of expensive/orphans >>> These need to be addressed at reimbursement level – Average of 3 lowest? Lowest? – Three country rule for pricing? – Frequency of updates? • • • What is the purpose? Implications for stability and predictability Fusing need for reasonable price with some implicit industrial policy, e. g. Twice annually for first 2 years post-launch, annually thereafter • Consider other pricing options over the longer-term? – HTA 14 • Define characteristics of EPR system • Define purpose in relation to reimbursement • Build awareness on list price limitations

Pricing policy – Branded, originator patent-expired products and generic products Interests/Options Actions needed (a) Pricing policy – Branded, originator patent-expired products and generic products Interests/Options Actions needed (a) Technical Assistance • Continue with External Price Referencing at least over the • medium-term, incl. biosimilars • • Reduction of originator brand price to generic level (-50%)? – Through patent expiry • • How to identify correct patent? – Through data exclusivity • Legal issues if DE expiry before patent expiry? – Access issues – Shortages • • How are biosimilars to be treated? How to treat patent-expired originator brands from a pricing perspective? If patent expiry is a criterion then manufacturers need to submit data related to their patent expiry Data exclusivity expiry needs to be explored from a legal perspective (b) Legislation How many generics for -50% to take effect? – Strength of generic competition postpatent expiry • Biosimilars • Other aspects related to generics • Pricing model for generic medicines – Will managed competition work? 15

Pricing policy – OTC medicines Interests/Options Actions needed (a) Technical Assistance • Clear definition Pricing policy – OTC medicines Interests/Options Actions needed (a) Technical Assistance • Clear definition of an ‘OTC product’ that falls outside the jurisdiction of reimbursement? • Can OTC products be reimbursed if prescribed? • Establish an OTC-switch framework • Pricing options – – EPR rules Market prices Principles that control excessive profits Availability of OTCs; • Competence on OTC products that clearly defines OTCs and separates them from reimbursement by EOPYY • Establish criteria for the reimbursement of select products that are classified as OTCs; OTC switch • Pricing, availability • What OTCs to include in + list? (b) Legislation 16 • Need OTC policy in national legislation or amendments to existing policy?

4. 3. Reimbursement rules and criteria 17 4. 3. Reimbursement rules and criteria 17

Reimbursement policy – Governance Interests/Options Actions needed (a) Technical Assistance • Positive List and Reimbursement policy – Governance Interests/Options Actions needed (a) Technical Assistance • Positive List and Reimbursement committee – Governance • • • What people? What stakeholders to be represented • – Mo. H, EPYY, EOF, pharmacologist/pharmacist, medical practitioner, health economist, patient representative • • • What To. Rs What skills Where is it based and who has oversight Who is it accountable to Establish functioning appeals process Appropriate governance structure with clear accountability and reporting criteria; backup support & secretariat Relevant sub-committees (Negotiations [in future]; Appeals, etc) incorporation into EOPYY organogram (b) Legislation • 18 Introduce legislation on this; ringfence competence on reimbursement to the relevant competent authority

Reimbursement policy – Processes Interests/Options Actions needed (a) Technical Assistance • Positive List and Reimbursement policy – Processes Interests/Options Actions needed (a) Technical Assistance • Positive List and Reimbursement Committee – Processes • • • Appropriate processes with clear accountability and reporting criteria What documents does the list cttee (b) Legislation need to consider putting a drug on the • Introduce legislation on this list? What are the appraisal criteria? Do decisions made by the List cttee need to come out in a FEK? (delays) Are there clear criteria assigning drugs to ATC 4 and ATC 5? 19

Reimbursement – Drug Lists Interests/Options • Rationale for having several subreimbursement lists? – – Reimbursement – Drug Lists Interests/Options • Rationale for having several subreimbursement lists? – – – • • TA in + list re-structuring? Cost to insurer or to patient? Reimbursement status? Utilisation restriction(s)? Setting restrictions? Other? (b) Legislation • Interest in simplifying current system into a single positive list for all reimbursed products? – – • Actions needed (a) Technical Assistance • All products irrespective of price level or patent status All products irrespective of whether they are used OP or IP Uniform reimbursement policy for all insurees; determine cost-sharing Exclusion criteria from paying co-payments ATC 4 and ATC 5 classification: re-visit if further clarity needed 20 Legislation or procedure on inclusion and exclusion in the different lists Competencies of Committees and Mo. H

Reimbursement – Criteria for admission into + list Actions needed (a) Technical Assistance Interests/Options Reimbursement – Criteria for admission into + list Actions needed (a) Technical Assistance Interests/Options • • Clearly set reimbursement policy that is simple to understand by insurees and relies on universal principles by the payer as well as being administratively simple Criteria for inclusion of new products – – – – – • • Clinical as a proxy to define value Economic (price, cost effectiveness)? Fiscal (budget impact) Industrial policy? Utilisation restrictions and patient eligibility based on sub-populations? (sub-indication) Positive reimbursement decisions elsewhere? Risk sharing? (MEAs) Volume? (P/Q deals) Overall budget cap? (define clawback) Other (depending on each case) • Best evidence, practice and capacity defining patient eligibility and sub-populations Best evidence, practice and capacity on P/Q deals and risk sharing Best evidence, practice and capacity on utilisation restrictions (b) Legislation - - 21 Legislation or procedure on inclusion and exclusion in the different lists Competencies of Committees and Mo. H esp. re: the above

Reimbursement – Clinical benefit, value assessment and HTA Interests/Options • Value assessment – – Reimbursement – Clinical benefit, value assessment and HTA Interests/Options • Value assessment – – • Actions needed? (a)Technical Assistance Criteria: safety, efficacy, quality; Effectiveness? (registries) Efficiency? Cost-effectiveness Other? Bo. D, severity • Capacity building on HTA and budget impact • Set up (a) HTA function w/in EOPYY or (b) HTA agency at Clinical benefit/HTA and budget impact arms’ length – How will this be implemented in • Generating evidence on practice? effectiveness – Who will be in charge of this ? – How will information from other countries be used ? – Integrated procedure or arms length ? – Selection criteria: all drugs, drugs with high clinical need, expensive drugs? – Budget impact: how will this be done ? – Monitoring ? Implementation? 22 – Patient registries – Phase IV trials/studies (b) Legislative interventions • • Legislation or procedure on inclusion of HTA or the drug’s clinical benefit in the reimbursement process Competencies and responsibilities

Reimbursement policy – Reimbursement price Interests/Options Actions needed? (a) Technical Assistance • Differentiation between Reimbursement policy – Reimbursement price Interests/Options Actions needed? (a) Technical Assistance • Differentiation between patentprotected, patent-expired and • Develop competence on generic drugs negotiation skills and on other • Internal reference pricing at ATC 4 pricing mechanisms (e. g. priceand ATC 5 volume agreements, risk – Functioning well? sharing, CED, OG) • Fixed price (internal reference pricing) (b) Legislation – Groups/categories (ATC 4 -ATC 5) – Multiple indications, or several substances – Reimbursement price calculation • Legislation and procedure of reimbursement price setting • Non-fixed price (price negotiations) • Empowerment of negotiators - Procedure, on what basis - Who is responsible for negotiating ? What will be used in the negotiation process ? What defines a good outcome for EOPYY? 23

Reimbursement policy – tendering Interests/Options • • Actions needed (a) Technical Assistance Price observatory Reimbursement policy – tendering Interests/Options • • Actions needed (a) Technical Assistance Price observatory and lack of process; • Capacity to evaluate options in governance? Not continuoulsy tendering, their implementation and updated or correctly updated. Tender performance assessment prices available – may need to be a closed database May want to explore tendering for out(b) Legislation patient drugs under conditions –Patent expired • Framework for tenders in out–Criteria? Price? Volume? Ability to supply? patient drugs –Who is the winner? Lowest price only or 2/3 lowest? • For in-patient drugs –National? –Regional? –Hospital-based? –Monitoring performance? 24

Reimbursement policy – risk sharing Interests/Options Actions needed (a) Technical Assistance • Dealing with Reimbursement policy – risk sharing Interests/Options Actions needed (a) Technical Assistance • Dealing with risk and uncertainty: risk sharing and MEAs? • • For some drugs in ATC 5 • Pre-conditions: ability to have a functioning reimbursement list cttee that can evaluate value of new drugs based on certain criteria • • Outcomes based MEA – CED – OG – DM Increase capacity on a sustainable basis on the various options available to conduct risk-sharing negotiations, their advantages and disadvantages and the way they could apply in the Greek setting Skills of negotiators & other capacitybuilding (b) Legislation • • Budget based MEA – P/Q – Price cap – Dose cap • 25 Legal framework needed to introduce these in the list of criteria for coverage decisions Legal framework needed to empower team of negotiators to negotiate on behalf of the state/EOPYY

Reimbursement policy – Co-payments • • Interests/Options Actions needed Clear definition of which (a) Reimbursement policy – Co-payments • • Interests/Options Actions needed Clear definition of which (a) Technical Assistance disease areas go in each co- • Establish reimbursement criteria applicable to all drugs and copayment level, and on what payments for all insurees criteria? • Consider exemption criteria Differential co-payments? • Capacity-building Increase in the burden to the (b) Legislation patient seen since November • Re-think cost-sharing policy 2012, how can this be further avoided ? Negative list: 100% copayment, unless exemption – clear definition on exemption to be added with co-payment 26

4. 4. Prescribing and rational use 27 4. 4. Prescribing and rational use 27

Physician responsibility Options • Need to address prescription volume which is main component of Physician responsibility Options • Need to address prescription volume which is main component of high drug expenditure (esp. antibiotics prescribing) • Link prescribing to clinical guidelines & protocols • INN prescribing Actions needed (a)Technical Assistance – Retain compulsory nature and monitor through Rx audits and feedback at regular intervals – Apply changes in tertiary education of future physicians? • Financial and non-financial incentives • Clinical protocol adaptation from other settings based on clinical cost effectiveness principles • Develop expertise in non-financial incentives and specific measures such as PA; within-indication Rx • Capacity-building (b) Legislation • Retract limit of 2 drug prescriptons/per patient per month • Any other legislation changes for ensuring current and future INN prescribing? • Changing future physicians’ culture by altering university education • Strict promotional limits on advertising – Prior authorisation – Drug budgets – Physician remuneration (e. g. P 4 P system linked to clinical guidelines) – Other penalties/ sanctions? – Monitoring (electronic, audit) 28

E-prescribing system Options • Ability to prescribe within indication based on clinical and cost E-prescribing system Options • Ability to prescribe within indication based on clinical and cost effectiveness criteria • Monitoring and review of prescription patterns (by volume, value, generic vs. branded, antibiotics) - Audit reports Publicly available transparent reports Naming only outliers? Actions needed (a) Technical Assistance • Prescribing guidelines/ protocols? • Admin burden? • How often to follow-up? • Apply automatic blockage mechanism once branded prescriptions reach a specified level? (b) Legislation • ? 29

4. 5. Dispensing 30 4. 5. Dispensing 30

Payment options and Generic Substitution Options Actions needed (a) Technical Assistance • Wide substitution Payment options and Generic Substitution Options Actions needed (a) Technical Assistance • Wide substitution rights to pharmacists - Ensure that pharmacists dispense the cheapest generic alternative when available • Overall pharmacy services – complementarity principle • Financial and non-financial incentives • Special case for domestically developed generics? • Methods of paying pharmacy services and application to the Greek reality • Seek advice from other countries with experience (e. g. UK)? (b) Legislation • What legislative changes do we need? 31

4. 6. Cost sharing 32 4. 6. Cost sharing 32

Cost-sharing Options • How to define the level of patient contribution that applies across Cost-sharing Options • How to define the level of patient contribution that applies across conditions? • Simplify and consolidate taking into account – Exceptions? Based on what criteria? – Socio-economic criteria (e. g. income, age) – Burden of Disease (e. g. severity, prevalence) Actions needed? (a) Technical Assistance • • Staff levels and competences Overall admin capacity Databases Other operational criteria: frequency of updates, ensure patient access (b) Legislation • As needed • What about other cost-sharing mechanisms? -Deductibles, Coinsurance, Copayment 33

4. 7. Other issues 34 4. 7. Other issues 34

Other issues Interests/Options Actions needed? (a) Technical Assistance 1. Who provides information to prescribers? Other issues Interests/Options Actions needed? (a) Technical Assistance 1. Who provides information to prescribers? 2. Are uniform standards of clinical guidance available based on 1. 2. • • EBM? EBM and CE? 3. Is there a monitoring function to measure performance based on available data? Information Clinical guidelines Monitoring Performance measurement (b) Legislation • As needed 35

5. Timelines 36 5. Timelines 36

Action Plan Timelines • Objective 1 - National Pharmaceutical Policy: September 2013 – February Action Plan Timelines • Objective 1 - National Pharmaceutical Policy: September 2013 – February 2014 • 2. Objective 2 - Pricing: October/November 2013 – July 2014 • 3. Objective 3 - Coverage/Reimbursement decisions: November 2013 – October/November 2014 • 4. Objective 4 - Prescribing: January – November 2014 • 5. Objective 5 - Dispensing: January – July 2014 • 6. Objective 6 - Cost-sharing: January – August 2014 • Includes a max of 2 month slack per Objective 37




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