P&R Europe (June 2011)


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Overview of pricing and reimbursement in Europe (Netherlands, Sweden, Poland, Italy, Germany)

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P&R Europe (June 2011)

  1. 1. Overview of P&R1.Netherlands2.Sweden in Europe3.Poland4.Italy June 20115.Germany
  2. 2. Netherlands 2
  3. 3. MARKET AUTHORISATION Added to the register of medicinal products and Medicines the manufacturer receives a commercial Evaluation Board licence for the product PRICING (Ministry of Health Welfare and Sports, MoHWS)• For each group or therapeutic class a maximum reimbursement price is established• Maximum price determined by referencing prices in Belgium, France, Germany and UK Typically 3 months • International Price Referencing (IPR) is the critical factor used in the price setting process • Price recalculated every 6 months (based on IPR)• Manufacturers are free to set and revise their price, but this cannot exceed the maximum price Health technology assessment (HTA) increasingly important REIMBURSEMENT (MoHWS)• Reimbursement decisions made by the MohWS with advice from the Healthcare Insurance Board (CVZ) which will include advice from the Committee on Pharmaceutical Care (CFH)• Products assessed on the grounds of efficacy, efficiency, side-effects, applicability and ease of use. The CFH also assessed the new pharmaceutical product’s impact on the Medicine Reimbursement System (GVS)Reimbursement lists: Annex 1A for reference priced products Annex 1B for ‘unique’ products (not clustered) Annex 2 for drugs reimbursed in specific circumstances (restricted reimbursement) 3
  4. 4. Netherlands follows a classification system of “therapeuticinterchangeable drugs” (GVS), and cost-effectiveness is consideredby Dutch pricing authorities only for non-clustered drugs• There is a fixed refund price based on the average list price of drugs belonging to the same cluster, defined by groups if interchangeable drugs (GVS) [Annex 1A]• Any new drug that cannot be clustered, is not reimbursed, unless there is a clinical benefit compared to standard therapy and the new drug is cost –effective [Annex 1B]• Besides the cost-effectiveness of a new drug, reimbursement will also be based on the budgetary impact of a new drug on the Annual Healthcare budget (JOZ) – Descriptive epidemiology, target population, the use and price of the drug, off-label use, plus variables influencing the total treatment costs• New drugs with prescription restrictions such a patient sub-group or administered by a specialised centre , or reimbursed after approval of the Health Insurance are listed in Annex 2 4
  5. 5. Sweden 5
  6. 6. MARKET AUTHORISATION Negotiations can begin before market authorisation and require cost-benefit analysis for new products Dental and Pharmaceutical Benefits Board Expert Board decides on reimbursement and price based on recommendations from civil servants Typically 3 -6 months Decision within 180 days (target 120 days) Rx drugs for out-patient care; Hospital-only some OTCs products Typical timescale is REIMBURSEMENT PRICINGReimbursement and inclusion on Pharmaceutical Benefit 36 monthsScheme’s (PBS) positive list of reimbursed drugs is • No national price decisionsassessed on 3 criteria: • Prices negotiated between • Cost-effectiveness manufacturers and county councils • Human value (who have responsibility for the • Need and solidarity (available alternative treatments) hospitals) • This applies to in-hospital PRICING drugs also available through Prices are not negotiated – they are integral to cost- the PBS and those used effectiveness exclusively in hospitals No price referencing is used 6
  7. 7. P&R is a joint decision that is cost-effectiveness driven, and includes societalperspective• Amongst another criteria a drug must be cost-effective to get reimbursement, and hence the price is drawn from the cost-effectiveness analysis – No price referencing is applied• Patients have to pay for drugs that are fully reimbursed, however there are payment thresholds that operate on a yearly basis – If they pay more than 1800 SEK(~€196) per year they receive a free card that exclude them from paying more than the fixed threshold• In some cases drugs can have a restricted reimbursement – i.e. medicines that are only cost-effective for a limited and specific group of patients• A reimbursement drug review applies to all drugs since 2002, in 2009 TLV managed to assess 9 out of 49 therapeutic groups 7
  8. 8. Poland 8
  9. 9. MARKET AUTHORISATION REIMBURSEMENT (Ministry of Health, MoH) Funding National Health Process provided by MoH who provide a public reimbursement Fund (NFZ) Health technology list provides assessment (HTA) 4 levels of reimbursement: Typical y >6 months coverage under Agency for Health 100% Generally the World Health Organization (WHO) the universal Technology essential drug list public health Assessment (AOTM) system free at 70% Includes supplementary drugs such as those to treat the point of established but has Parkinson’s disease and Alzheimer’s disease delivery but few not proved very 50% Includes those to treat menopausal symptoms and patented drugs effective and its hypertension are reimbursed advice has been by the NFZ ignored 0% Non-reimbursed PRICING (MoH)• Reimbursement price set through negotiation with a special unit (Drug Management Team) of the MoH• International reference pricing and internal reference pricing that follows ATC classification and DDD• Free pricing for non-reimbursed drugs ATC: Anatomical Therapeutic Chemical ; DDD: Defined Daily Dose 9
  10. 10. Reimbursement happens prior to pricing,however the applications are similar andit can be done in a joint dossier• Reimbursement criteria are: – necessity to provide health care for the society – making medicines accessible – safety – importance of a drug in a treatment of conditions associated with high epidemiological threat – influence of a drug on direct medical costs – affordability for the public payer obliged to finance healthcare services• There exists a special pricing form, very similar to the reimbursement application form and these can be submitted jointly• Data on clinical effectiveness, cost–effectiveness and budget impact are required with reimbursement and pricing submission, but are not taken into consideration within the price setting process 10
  11. 11. Italy 11
  12. 12. MARKET AUTHORISATION Company can REIMBURSEMENT request non- Typically 1012 months AIFAreimbursement Technical Scientific committee (CTS) Typical y >6 months Reimbursable Non- PRICING NEGOTIATION AND DECISIONReimbursable AIFA Committee for pricing and reimbursement (CPR) No Class C agreement Class A (Chronic and critical) Class H (Hospital)No reimbursement 100% NHS-reimbursed pharmaceutical Free pricing (Prontuario – positive list) 12
  13. 13. AIFA is the main player in market authorisationand the P&R of all pharmaceuticals• Reimbursement is decided before a pricing negotiation and decision are made  In case of absence of an agreement about the price as a result of the negotiation, the reimbursement decision made by the Technical Scientific Committee (CTS) is amended and the pharmaceutical is classified as non-reimbursable and listed in Class C• Criteria to be included in the positive list are: – product-specific criteria (essential pharmaceuticals policy, medical and therapeutic value, safety, lack of alternative therapies, prescription status, patent status) – economic criteria (cost-effectiveness, reference price, internal market forecasts) – disease-specific criteria (severity of illness, special medical needs, number of potential patients)• The pricing negotiation procedure is conducted following criteria based on: – product therapeutic value – pharmacovigilance data – price in other European Union (EU) Member States – price of similar products within the same pharmaco-therapeutic group – internal market forecasts number of potential patients – therapeutic innovation 13
  14. 14. Germany 14
  15. 15. MARKET AUTHORISATIONThe Federal Institute for Pharmaceuticals and Medical products (all other drugs) &Paul Ehrlich-Institute (blood, blood products, sera and vaccines) Reimbursement automatic at launch IQWiG Ministry of Health (BMG) Institute for Quality and (Bundesgesundheitsministerium) and Federal Joint Negative List Efficiency in Health Care Committee (G-BA) The Federal Association of Sick Federal Association German Hospital Funds (GKV Spitzenverband Bund of SHI Physicians Federation (DKG) der Krankenkassen; GKV-SV) (KBV) Initial free pricing Retail Product (reference pricing for non- Hospital product innovative products) INEK (DRGs & innovative funding product coverage) Covered by SHI (KKs) & co-pays Costly medicines and devices financed through “specific additional payments” (Zusatzentgelte) 15
  16. 16. In 2011 AMNOG Law comes into forceimplementing changes on the P&R of new drugs• For drugs launched before January 2011 the value dossier submission has to be submitted only if requested by G-BA within the next three months• For drugs launched after January 2011 it is compulsory at day of launch• G-BA with the scientific support of IQWig will assess the additional benefits to the appropriate comparative therapy – Cost-effectiveness is not required, but the applicant company must provide all the clinical and economic data available• If the new treatment is not deemed innovative free pricing will be denied and referenced to the comparative therapy – Manufacturer can ask for re-assessment only after 12 months after the publication of the initial assessment 16
  17. 17. Sources• ISPOR HTA road maps www.ispor.org/htaroadmaps• PPRI country reports http://ppri.oebig.at/• www.cbg-meb.nl• www.cvz.nl• www.lakemedelsverket.se/• www.sbu.se/sv/• www.aotm.gov.pl/• www.agenziafarmaco.gov.it/it• “Market access in Germany after major P&R reform” conference• AMNOG 17
  18. 18. Researched and produced by • Salvador Gea Sánchez is currently working as an Analyst in Bridgehead International since 2009 and is currently working towards his dissertation for his MSc in Economic Evaluation in Health Care at City University in London • Salvador has eight years experience as a registered pharmacist and qualified orthopaedist in community pharmacy and worked in Andorra, Spain and the UK. He has been responsible for delivering patient care at a clinical level and negotiating with reimbursement authorities andSALVADOR GEA SANCHEZ, MSc official bodies at a retail scale • Salvador has a Degree in Pharmacy with clinical@ Salva_gea@hotmail.com specialisation, from Universidad de Valencia, and has an MSc in quality control for the pharmaceutical industry from Instituto de Ciencia y Tecnología (Barcelona) and a Postgraduate certificate in orthopaedic specialisation for pharmacists from Universidad de Barcelona • Salvador is a native Spanish and Catalan speaker and fluent in English 18
  19. 19. THANK YOU 19