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

1. Overview of
P&R
1.Netherlands
2.Sweden in Europe
3.Poland
4.Italy
June 2011
5.Germany

2. Netherlands
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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)
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4. Netherlands follows a classification system of “therapeutic
interchangeable drugs” (GVS), and cost-effectiveness is considered
by 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
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5. Sweden
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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 PRICING
Reimbursement and inclusion on Pharmaceutical Benefit 36 months
Scheme’s (PBS) positive list of reimbursed drugs is • No national price decisions
assessed 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
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7. P&R is a joint decision that is cost-
effectiveness driven, and includes societal
perspective
• 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
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8. Poland
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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
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10. Reimbursement happens prior to pricing,
however the applications are similar and
it 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
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11. Italy
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12. MARKET
AUTHORISATION
Company can REIMBURSEMENT
request non-
Typically 1012 months
AIFA
reimbursement Technical Scientific committee (CTS)
Typical y >6 months
Reimbursable
Non- PRICING NEGOTIATION AND DECISION
Reimbursable 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)
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13. AIFA is the main player in market authorisation
and 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
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14. Germany
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15. MARKET
AUTHORISATION
The 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)
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16. In 2011 AMNOG Law comes into force
implementing 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
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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
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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 and
SALVADOR 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
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19. THANK YOU
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