Prof. Karina JAHNZ-RÓŻYK MD, Ph.D.

Prof. Karina JAHNZ-RÓŻYK MD, Ph.D.

ACCESS TO THE ACCESS TO THE BIOLOGICAL BIOLOGICAL

TREATMENT TREATMENT IN IN POLANDPOLAND

ACCESS TO THE ACCESS TO THE BIOLOGICAL BIOLOGICAL

TREATMENT TREATMENT IN IN POLANDPOLAND

ISPOR POLAND CHAPTER, ATLANTA 2010ISPOR POLAND CHAPTER, ATLANTA 2010

Poland - general infoPoland - general info

8th country in Europe by area: 312,000 km2

8th country in Europe by area: 312,000 km2

Republic of PolandRepublic of Poland

6th country in Europe by population: 38,500,696 (July 2008 est.)

6th country in Europe by population: 38,500,696 (July 2008 est.)

7th country by size of pharmaceutical market: 4,8 bln EUR

7th country by size of pharmaceutical market: 4,8 bln EUR

Poland - general infoPoland - general info

GDP = 567,400 bn USD (rank 18)

GDP = 567,400 bn USD (rank 18)

Republic of PolandRepublic of Poland

GDP per capita in 2008 = 17,482 USD

(rank 50)

GDP per capita in 2008 = 17,482 USD

(rank 50)

POLAND MACROECONOMICS

2009

POLAND MACROECONOMICS

2009

• GDP growth (annual) GDP growth (annual) 3,1%3,1%

• Inflation rate Inflation rate 2, 6%2, 6%

• Unemployment Unemployment 12,9 12,9%%

• SalarySalary (mean) 1081,2 USD (mean) 1081,2 USD

Established in January 2005

Established in January 2005

ISPOR POLAND CHAPTERISPOR POLAND CHAPTER

140 members 140 members

Polish Society of Pharmacoeconomics (PTFE)

Polish Society of Pharmacoeconomics (PTFE)

WHAT IS BIOLOGICSWHAT IS BIOLOGICS

• BiologicBiologic- - a a medicinal product medicinal product that is synthesized from a that is synthesized from a living organism or its productsliving organism or its products

• Small molecule drugSmall molecule drug: a drug : a drug synthesized via a chemical synthesized via a chemical processprocess

Immune mediated effects are inherent in their Immune mediated effects are inherent in their activity, but hypersensitivities are rare and activity, but hypersensitivities are rare and mainly due to immunoglobulins (IgE, IgG)mainly due to immunoglobulins (IgE, IgG)

BIOLOGICSBIOLOGICS

Structurally similar to autologous proteins, large Structurally similar to autologous proteins, large peptide/proteinspeptide/proteins

Are digested and processed, but not metabolizedAre digested and processed, but not metabolized

Parenteral application required Parenteral application required

BIOLOGICSBIOLOGICS

• VACCINESVACCINES• BLOOD & BLOOD COMPONENTSBLOOD & BLOOD COMPONENTS• ALLERGENICSALLERGENICS• SOMATIC CELLSSOMATIC CELLS• GEN THERAPYGEN THERAPY• TISSUESTISSUES• RECOMBINANT THERAPEUTIC PROTEINSRECOMBINANT THERAPEUTIC PROTEINS

DEPLETING CELLS BY DEPLETING CELLS BY ANTIBODIESANTIBODIES

BIOLOGICALS – tools to affect inflammatory or malignat cellsBIOLOGICALS – tools to affect inflammatory or malignat cells

CYTOKINES CYTOKINES

ANTI - CYTOKINESANTI - CYTOKINES

BLOCKING LIGANDSBLOCKING LIGANDS

Prices for biologics have increased more rapidly Prices for biologics have increased more rapidly than prices for small molecule drugsthan prices for small molecule drugs

KEY DIFFERENCES between BIOLOGICS and SMALL MOLECULE

DRUGS

KEY DIFFERENCES between BIOLOGICS and SMALL MOLECULE

DRUGS

A follow-on biologic cannot be exactly identical A follow-on biologic cannot be exactly identical to its reference products because of the large to its reference products because of the large size and complexity of the moleculessize and complexity of the molecules

Biologics have specific safety risk involving Biologics have specific safety risk involving immunogenicityimmunogenicity

Biologics tend to be more expensive than small Biologics tend to be more expensive than small molecule drugsmolecule drugs

BIOLOGICSIMPACT ON MEDICAL

FIELDS

BIOLOGICSIMPACT ON MEDICAL

FIELDS• RHEUMATOLOGYRHEUMATOLOGY• ONCOLOGYONCOLOGY• CARDIOLOGYCARDIOLOGY• DERMATOLOGYDERMATOLOGY• NEUROLOGYNEUROLOGY• PNEUMONOLOGYPNEUMONOLOGY

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

Biological agents Subclassification of adverse side effectsbased on immunopathology & actions of

compounds

Biological agents Subclassification of adverse side effectsbased on immunopathology & actions of

compounds

• Type Type - high cytokine & cytokine release - high cytokine & cytokine release syndromesyndrome

• Type Type ββ – hypersensitivity (immediate & – hypersensitivity (immediate & delayeddelayed))

• Type Type γγ – immune or cytokine imbalance – immune or cytokine imbalance syndromes syndromes (e.g autoimmunity, allergic (e.g autoimmunity, allergic disorders)disorders)

• Type Type δδ – cross-reactant – cross-reactant

• Type Type εε – non - immunological side effects – non - immunological side effects

Pichler, Allergy 2006

Few cases of anaphilactic shock even after following dosesFew cases of anaphilactic shock even after following doses

30 min to > 24 h after injection30 min to > 24 h after injection

Longer observation required Longer observation required

Suitable equipment of healthcare insitutions requiredSuitable equipment of healthcare insitutions required

85

Xolair – anaphilactic shockXolair – anaphilactic shock

BIOLOGICS –CIS (type γγ))

Cytokine Cytokine Imbalance Syndromes Imbalance Syndromes

BIOLOGICS –CIS (type γγ))

Cytokine Cytokine Imbalance Syndromes Imbalance Syndromes

• 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 effectscytokine storm

BIOLOGICS –side effectsTNF-alfa blockers

BIOLOGICS –side effectsTNF-alfa blockers

• Allergy (acute infusion SSLR)Allergy (acute infusion SSLR)• Autoimmunity (pancytopenia, demyelitating Autoimmunity (pancytopenia, demyelitating

diseasedisease• Immunodeficiency (e.g. loss of control of Immunodeficiency (e.g. loss of control of

intracellular bacteria- Mycobacteriosis)intracellular bacteria- Mycobacteriosis)• Cutaneous (vasculitis)Cutaneous (vasculitis)• Malignancy lymphomaMalignancy lymphoma• Seizure disordersSeizure disorders• Aggravation of heart failureAggravation of heart failure

NHF (National Health Fund)THERAPEUTIC PROGRAMS

(n=41)

NHF (National Health Fund)THERAPEUTIC PROGRAMS

(n=41)

• Ca mammae - Ca mammae - TrastuzumabTrastuzumab• Chronic mieloblastic leucemia – Chronic mieloblastic leucemia – ImatinibImatinib• GIST – GIST – Imatinib or SunitinibImatinib or Sunitinib• Multiple sclerosis – Multiple sclerosis – Interferon betaInterferon beta• Hepatitis B or C – Hepatitis B or C – Interferon alfaInterferon alfa• Kidney carcinoma - Kidney carcinoma - SunitinibSunitinib• Rheumatoid arRheumatoid artthritis – hritis – Infliximab or Infliximab or

Etanerceptum or AdalimumabEtanerceptum or Adalimumab

NHF (National Health Fund)THERAPEUTIC PROGRAMS

QUALIFICATION

NHF (National Health Fund)THERAPEUTIC PROGRAMS

QUALIFICATION

• Application of National Consultant in Application of National Consultant in special field of medicinespecial field of medicine

• Submission of the application to the Submission of the application to the Ministry of HealthMinistry of Health

• Recommendation of HTA (AOTM) in Recommendation of HTA (AOTM) in cooperation with Consultative Council cooperation with Consultative Council (CC) commissioned by the Ministry of (CC) commissioned by the Ministry of HealthHealth

AOTM Recommendation

AOTM Recommendation

• Description of medical problemDescription of medical problem• Description of existing clinical practiceDescription of existing clinical practice• Clinical effectivenessClinical effectiveness• Safety analysisSafety analysis• Cost effectivenessCost effectiveness• Budget impact analysisBudget impact analysis• PriPricce negotiatione negotiationss and risk sharing and risk sharing recommendations recommendations

optionallyoptionally

Rheumatoid arthritisONE YEAR of ANTI- TNF IN POLAND (USD)

No of DOSeS/YEAR

POINTS/MG HOSPITALISATION/one day

COST /YEAR TOTAL COST

ETANERECEPT50mg/week

51 2,1 0 19 626 19 626ADALIZUMAB40mg/2 weeks

26 5,3 0 20 020 20 920INFLIKSIMAB

200mg/dosis8

(3+5) 2,1 1224 12 427 13 651INFLIKSIMAB

300mg/dosis8

(3+5) 2,1 1224 18 641 19 865

standardstandard

Cost-effectiveness analysis of Cost-effectiveness analysis of omalizumab v.s. standard therapy in omalizumab v.s. standard therapy in the management of severe asthmathe management of severe asthmaCost –effectiveness – days free of symptomsCost –effectiveness – days free of symptoms

Martinez-Revelles M.et all ., ISPOR 2007, Novartis, MexicoMartinez-Revelles M.et all ., ISPOR 2007, Novartis, Mexico

USD USD

250 000250 000

200 000200 000

150 000150 000

100 000100 000

50 00050 000

00

280280 300300 320320 340340 360360 380 380 dnidni

OmalizumabOmalizumab

XOLAIR XOLAIR What was the price in 2008 What was the price in 2008 ??

USAUSA

UKUK

CanadaCanada

Poland Poland

1150,99 USD/amp (150 mg/1.2 ml)1150,99 USD/amp (150 mg/1.2 ml)

647,58 GBP/amp (180 mg/1.2 ml)647,58 GBP/amp (180 mg/1.2 ml)

971,62 USD/amp (150 mg/1.2 ml) 971,62 USD/amp (150 mg/1.2 ml)

633 PLN/amp (150 mg/1,2 ml)633 PLN/amp (150 mg/1,2 ml)

Xolair – every 4 weeks

> 500 - 600

> 400 - 500

> 300 - 400

300 mg(2 amp.)

> 200 - 300

300 mg(2 amp.)

300 mg(2 amp.)

300 mg(2 amp.)

> 100 - 200

300 mg(2 amp.)

150 mg(1 amp.)

150 mg(1 amp.)

150 mg(1 amp.)

> 30 - 100

> 90 - 150> 70 - 90> 60 - 7030 - 60

Weight (kg)

Ig E level (IU/ml)

Xolair – every 2 weeks

375 mg(2 1/2 amp.)

> 600 - 700

No treatment

375 mg(2 1/2 amp.)

300 mg(2 amp.)

> 500 - 600

375 mg(2 1/2 amp.)

300 mg(2 amp.)

300 mg(2 amp.)

> 400 - 500

300 mg(2 amp.)

225 mg(1 1/2 amp.)

225 mg(1 1/2 amp.)

> 300 - 400

300 mg(2 amp.)

225 mg(1 1/2 amp.)

225 mg(1 1/2 amp.)

> 200 - 300

225 mg(1 1/2 amp.)> 100 - 200

Look at previous slide

> 30 - 100

> 90 - 150> 70 - 90> 60 - 7030 - 60

Weight (kg)IgE level

(IU/ml)

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 )