Overview of P&R

in Europe June 2011

1.Netherlands

2.Sweden

3.Poland

4.Italy

5.Germany

Netherlands

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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)

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

• 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

Typ

ical

ly

3 m

on

ths

Health technology assessment (HTA) increasingly important

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)

Medicines Evaluation Board

MARKET AUTHORISATION

Added to the register of medicinal products and

the manufacturer receives a commercial licence for the product

3

Netherlands follows a classification system of “therapeutic interchangeable drugs” (GVS), and cost-effectiveness is considered by Dutch pricing authorities only for non-clustered drugs

4

• 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

Sweden

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Typical timescale is 36 months

REIMBURSEMENT Reimbursement and inclusion on Pharmaceutical Benefit Scheme’s (PBS) positive list of reimbursed drugs is assessed on 3 criteria:

• Cost-effectiveness • Human value • Need and solidarity (available alternative treatments)

Rx drugs for out-patient care; some OTCs

Dental and Pharmaceutical Benefits Board Expert Board decides on reimbursement and price based on recommendations from

civil servants Decision within 180 days (target 120 days)

PRICING

•No national price decisions •Prices negotiated between

manufacturers and county councils (who have responsibility for the hospitals)

• This applies to in-hospital drugs also available through the PBS and those used exclusively in hospitals

Hospital-only products

PRICING Prices are not negotiated – they are integral to cost-effectiveness No price referencing is used

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MARKET AUTHORISATION

Negotiations can begin before market

authorisation and require cost-benefit analysis for

new products

Typ

ical

ly

3 -

6 m

on

ths

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 7

Poland

8

REIMBURSEMENT (Ministry of Health, MoH)

Process provided by MoH who provide a public reimbursement list

4 levels of reimbursement:

100% Generally the World Health Organization (WHO) essential drug list

70% Includes supplementary drugs such as those to treat Parkinson’s disease and Alzheimer’s disease

50% Includes those to treat menopausal symptoms and hypertension

0% Non-reimbursed

Typ

ical

y >

6 m

on

ths

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

Funding National Health Fund (NFZ) provides coverage under the universal public health system free at the point of delivery but few patented drugs are reimbursed by the NFZ

Health technology assessment (HTA)

Agency for Health Technology

Assessment (AOTM) established but has

not proved very effective and its advice has been

ignored

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MARKET AUTHORISATION

ATC: Anatomical Therapeutic Chemical ; DDD: Defined Daily Dose

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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Italy

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Reimbursable

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REIMBURSEMENT AIFA

Technical Scientific committee (CTS)

Class A (Chronic and critical) Class H (Hospital)

100% NHS-reimbursed pharmaceutical (Prontuario – positive list)

Class C

No reimbursement

Free pricing

PRICING NEGOTIATION AND DECISION AIFA

Committee for pricing and reimbursement (CPR)

Non-Reimbursable

No agreement

Company can request non-

reimbursement

MARKET AUTHORISATION

Typ

ical

ly 1

0

12

mo

nth

s

Typ

ical

y >

6 m

on

ths

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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Germany

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The Federal Institute for Pharmaceuticals and Medical products (all other drugs) & Paul Ehrlich-Institute (blood, blood products, sera and vaccines)

Ministry of Health (BMG) (Bundesgesundheitsministerium) and Federal Joint

Committee (G-BA)

IQWiG

Institute for Quality and Efficiency in Health Care

The Federal Association of Sick Funds (GKV Spitzenverband Bund

der Krankenkassen; GKV-SV)

Negative List

Federal Association of SHI Physicians

(KBV) German Hospital Federation (DKG)

Covered by SHI (KKs) & co-pays

INEK (DRGs & innovative funding product coverage)

Costly medicines and devices financed through “specific additional payments” (Zusatzentgelte)

Retail Product Hospital product

Initial free pricing (reference pricing for non-

innovative products)

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MARKET AUTHORISATION

Re

imb

urs

em

en

t au

tom

atic

at

lau

nch

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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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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Researched and produced by

SALVADOR GEA SANCHEZ, MSc @ Salva_gea@hotmail.com

• 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 official bodies at a retail scale

• Salvador has a Degree in Pharmacy with clinical 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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THANK YOU

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