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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 • • • • • • • 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 • • • • • • 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 • • 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) • • • • • • • 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 • • • • • • 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 )