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ACCESS TO THE
BIOLOGICAL
TREATMENT IN POLAND
Prof.
Karina JAHNZ-RÓŻYK MD, Ph.D.
ISPOR POLAND CHAPTER, ATLANTA 2010
Poland - general info
Republic of Poland
8th country in Europe by area:
312,000 km2
6th country in Europe by
population: 38,500,696
(July 2008 est.)
7th country by size of
pharmaceutical market: 4,8
bln EUR
Poland - general info
Republic of Poland
GDP = 567,400 bn USD
(rank 18)
GDP per capita in 2008 =
17,482 USD
(rank 50)
POLAND MACROECONOMICS
2009
• GDP growth (annual)
3,1%
• Inflation rate
2, 6%
• Unemployment
• Salary (mean)
12,9%
1081,2 USD
ISPOR POLAND CHAPTER
Polish Society of Pharmacoeconomics
(PTFE)
 Established
in January 2005
 140 members
WHAT IS BIOLOGICS
• Biologic- a medicinal product
that is synthesized from a living
organism or its products
• Small molecule drug: a drug
synthesized via a chemical
process
BIOLOGICS
Structurally similar to autologous proteins, large
peptide/proteins
Are digested and processed, but not metabolized
Parenteral application required
Immune mediated effects are inherent in their
activity, but hypersensitivities are rare and mainly
due to immunoglobulins (IgE, IgG)
BIOLOGICS
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VACCINES
BLOOD & BLOOD COMPONENTS
ALLERGENICS
SOMATIC CELLS
GEN THERAPY
TISSUES
RECOMBINANT THERAPEUTIC PROTEINS
BIOLOGICALS – tools to affect
inflammatory or malignat cells
CYTOKINES
ANTI - CYTOKINES
BLOCKING LIGANDS
DEPLETING CELLS BY ANTIBODIES
KEY DIFFERENCES between
BIOLOGICS and SMALL MOLECULE
DRUGS
A follow-on biologic cannot be exactly identical to its
reference products because of the large size and
complexity of the molecules
Biologics have specific safety risk involving
immunogenicity
Biologics tend to be more expensive than small
molecule drugs
Prices for biologics have increased more rapidly than
prices for small molecule drugs
BIOLOGICS
IMPACT ON MEDICAL FIELDS
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RHEUMATOLOGY
ONCOLOGY
CARDIOLOGY
DERMATOLOGY
NEUROLOGY
PNEUMONOLOGY
IMS HEALTH : Biotechnology in global
pharmacutical market in 2009 (bln USD)
IMS HEALTH : Biologics Sales –top three
categories in 2009 (blnUSD)
Monoclonal antibodies – 80% of
SALES
Oncology
Avastin
Herceptin
Rituxan
AI / ID
Humira
Remicade
Rituxan
Biological agents
Subclassification of adverse side effects
based on immunopathology & actions of compounds
• Type - high cytokine & cytokine release syndrome
• Type β – hypersensitivity (immediate & delayed)
• Type γ – immune or cytokine imbalance syndromes
(e.g autoimmunity, allergic disorders)
• Type δ – cross-reactant
• Type ε – non - immunological side effects
Pichler, Allergy 2006
85
Xolair – anaphilactic shock
 Few cases of anaphilactic shock even after following doses
 30 min to > 24 h after injection
 Longer observation required
 Suitable equipment of healthcare insitutions required
BIOLOGICS –CIS (type γ)
Cytokine Imbalance Syndromes
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They are not allergic side effects and are clinically
characterised by different symptoms which do not
correspond to classical allergy
Are dependent on the underlying homeostasis/immune
balance of the individual patient
Biologics – side effects
cytokine storm
BIOLOGICS –side effects
TNF-alfa blockers
• Allergy (acute infusion SSLR)
• Autoimmunity (pancytopenia, demyelitating disease
• Immunodeficiency (e.g. loss of control of
intracellular bacteria- Mycobacteriosis)
• Cutaneous (vasculitis)
• Malignancy lymphoma
• Seizure disorders
• Aggravation of heart failure
NHF (National Health Fund)
THERAPEUTIC PROGRAMS
(n=41)
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Ca mammae - Trastuzumab
Chronic mieloblastic leucemia – Imatinib
GIST – Imatinib or Sunitinib
Multiple sclerosis – Interferon beta
Hepatitis B or C – Interferon alfa
Kidney carcinoma - Sunitinib
Rheumatoid arthritis – Infliximab or Etanerceptum
or Adalimumab
NHF (National Health Fund)
THERAPEUTIC PROGRAMS
QUALIFICATION
• Application of National Consultant in
special field of medicine
• Submission of the application to the
Ministry of Health
• Recommendation of HTA (AOTM) in
cooperation with Consultative Council (CC)
commissioned by the Ministry of Health
AOTM
Recommendation
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Description of medical problem
Description of existing clinical practice
Clinical effectiveness
Safety analysis
Cost effectiveness
Budget impact analysis
• Price negotiations and risk sharing recommendations
optionally
Rheumatoid arthritis
ONE YEAR of ANTI- TNF IN POLAND (USD)
No of
HOSPITALI
SATION/one
day
51
2,1
0
19 626
19 626
26
5,3
0
20 020
20 920
8
(3+5)
2,1
1224
12 427
13 651
8
(3+5)
2,1
1224
18 641
19 865
DOSeS/YEAR
ETANERECEPT
50mg/week
COST /YEAR
POINTS/MG
TOTAL
COST
ADALIZUMAB
40mg/2 weeks
INFLIKSIMAB
200mg/dosis
INFLIKSIMAB
300mg/dosis
Cost-effectiveness analysis of omalizumab
v.s. standard therapy in the management
of severe asthma
Cost –effectiveness – days free of symptoms
USD
250 000
200 000
Omalizumab
150 000
100 000
standard
50 000
0
280
300
320
340
360
380
dni
Martinez-Revelles M.et all ., ISPOR 2007, Novartis, Mexico
XOLAIR
What was the price in 2008 ?
USA
1150,99 USD/amp (150 mg/1.2 ml)
UK
647,58 GBP/amp (180 mg/1.2 ml)
971,62 USD/amp (150 mg/1.2 ml)
Canada
633 PLN/amp (150 mg/1,2 ml)
Poland
Xolair – every 4 weeks
Weight (kg)
Ig E level (IU/ml)
30 - 60
> 60 - 70
> 70 - 90
> 90 - 150
> 30 - 100
150 mg
(1 amp.)
150 mg
(1 amp.)
150 mg
(1 amp.)
300 mg
(2 amp.)
> 100 - 200
300 mg
(2 amp.)
300 mg
(2 amp.)
300 mg
(2 amp.)
> 200 - 300
300 mg
(2 amp.)
> 300 - 400
> 400 - 500
> 500 - 600
Xolair – every 2 weeks
IgE level
(IU/ml)
Weight (kg)
30 - 60
> 60 - 70
> 70 - 90
> 90 - 150
> 30 - 100
Look at previous slide
225 mg
(1 1/2 amp.)
> 100 - 200
> 200 - 300
225 mg
(1 1/2 amp.)
225 mg
(1 1/2 amp.)
> 300 - 400
225 mg
(1 1/2 amp.)
225 mg
(1 1/2 amp.)
300 mg
(2 amp.)
> 400 - 500
300 mg
(2 amp.)
300 mg
(2 amp.)
375 mg
(2 1/2 amp.)
> 500 - 600
300 mg
(2 amp.)
375 mg
(2 1/2 amp.)
No treatment
> 600 - 700
375 mg
(2 1/2 amp.)
300 mg
(2 amp.)
One year of anti TNF-alfa and anti IgE
( USD mean) v.s. GDP & Salary in Poland (2009)
NHF - costs of therapeutic programs
in 2010 (PLN )