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Prof. Karina JAHNZ-RÓŻYK MD, Ph.D.

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. 8 th country in Europe by area: 312,000 km 2. 6 th country in Europe by population: 38,500,696 (July 2008 est.).

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Prof. Karina JAHNZ-RÓŻYK MD, Ph.D.

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  1. ACCESS TO THE BIOLOGICAL TREATMENT IN POLAND Prof. Karina JAHNZ-RÓŻYK MD, Ph.D. ISPOR POLAND CHAPTER, ATLANTA 2010

  2. 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

  3. Poland - general info Republic of Poland GDP = 567,400 bn USD (rank 18) GDP per capita in 2008 = 17,482 USD (rank 50)

  4. POLAND MACROECONOMICS2009 • GDP growth (annual) 3,1% • Inflationrate 2, 6% • Unemployment 12,9% • Salary (mean) 1081,2 USD

  5. ISPOR POLAND CHAPTER Polish Society of Pharmacoeconomics (PTFE) • Established in January 2005 • 140 members

  6. 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

  7. BIOLOGICS Structurallysimilar to autologousproteins, largepeptide/proteins Aredigested and processed, but not metabolized Parenteralapplicationrequired Immunemediatedeffectsareinherentintheiractivity, but hypersensitivitiesarerare and mainlydue to immunoglobulins (IgE, IgG)

  8. BIOLOGICS • VACCINES • BLOOD & BLOOD COMPONENTS • ALLERGENICS • SOMATIC CELLS • GEN THERAPY • TISSUES • RECOMBINANT THERAPEUTIC PROTEINS

  9. BIOLOGICALS – tools to affectinflammatoryormalignatcells CYTOKINES ANTI - CYTOKINES BLOCKING LIGANDS DEPLETING CELLS BY ANTIBODIES

  10. KEY DIFFERENCES between BIOLOGICS and SMALL MOLECULE DRUGS A follow-onbiologiccannot be exactlyidentical to itsreference products because of thelargesize and complexity of themolecules Biologicshavespecificsafetyriskinvolvingimmunogenicity Biologicstend to be moreexpensivethansmallmoleculedrugs Prices for biologicshaveincreasedmorerapidlythanprices for smallmoleculedrugs

  11. BIOLOGICSIMPACT ON MEDICAL FIELDS • RHEUMATOLOGY • ONCOLOGY • CARDIOLOGY • DERMATOLOGY • NEUROLOGY • PNEUMONOLOGY

  12. IMS HEALTH : Biotechnology in global pharmacutical market in 2009 (bln USD)

  13. IMS HEALTH : Biologics Sales –top three categories in 2009 (blnUSD)

  14. Monoclonal antibodies – 80% of SALES

  15. BiologicalagentsSubclassification of adversesideeffectsbased on immunopathology & actions of compounds • Type  - high cytokine & cytokinereleasesyndrome • Typeβ – hypersensitivity (immediate & delayed) • Typeγ– immuneorcytokineimbalancesyndromes (e.gautoimmunity, allergicdisorders) • Typeδ – cross-reactant • Typeε – non - immunologicalsideeffects Pichler, Allergy 2006

  16. 85 Xolair – anaphilacticshock • Fewcases of anaphilacticshockevenafterfollowingdoses • 30 min to > 24 h afterinjection • Longerobservationrequired • Suitableequipment of healthcareinsitutionsrequired

  17. BIOLOGICS –CIS (typeγ)CytokineImbalanceSyndromes • 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

  18. Biologics – side effectscytokine storm

  19. BIOLOGICS –sideeffectsTNF-alfablockers • Allergy (acuteinfusion SSLR) • Autoimmunity (pancytopenia, demyelitatingdisease • Immunodeficiency (e.g. loss of control of intracellularbacteria- Mycobacteriosis) • Cutaneous (vasculitis) • Malignancylymphoma • Seizuredisorders • Aggravation of heartfailure

  20. 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

  21. NHF (National Health Fund)THERAPEUTIC PROGRAMSQUALIFICATION • Application of National Consultantinspecial field of medicine • Submission of theapplication to theMinistry of Health • Recommendation of HTA (AOTM) incooperationwithConsultativeCouncil (CC) commissioned by theMinistry of Health

  22. AOTM Recommendation • Description of medical problem • Description of existingclinicalpractice • Clinicaleffectiveness • Safetyanalysis • Costeffectiveness • Budgetimpactanalysis • Pricenegotiations and risksharingrecommendationsoptionally

  23. RheumatoidarthritisONE YEAR of ANTI- TNF IN POLAND (USD)

  24. 250 000 200 000 Omalizumab 150 000 100 000 standard 50 000 0 380 dni 360 340 320 300 280 Cost-effectivenessanalysis of omalizumabv.s. standard therapyinthe management of severeasthma Cost –effectiveness – daysfree of symptoms USD Martinez-RevellesM.etall ., ISPOR 2007, Novartis, Mexico

  25. XOLAIR What was thepricein 2008 ? 1150,99 USD/amp (150 mg/1.2 ml) USA 647,58 GBP/amp (180 mg/1.2 ml) UK 971,62 USD/amp (150 mg/1.2 ml) Canada 633 PLN/amp (150 mg/1,2 ml) Poland

  26. Ig E level (IU/ml) Weight (kg) 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 4 weeks

  27. IgE level (IU/ml) Weight (kg) 30 - 60 > 60 - 70 > 70 - 90 > 90 - 150 > 30 - 100 Look at previous slide > 100 - 200 225 mg(1 1/2 amp.) > 200 - 300 225 mg(1 1/2 amp.) 225 mg(1 1/2 amp.) 300 mg(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.) Xolair – every 2 weeks

  28. One year of antiTNF-alfa and antiIgE( USD mean) v.s. GDP & Salaryin Poland (2009)

  29. NHF - costs of therapeutic programs in 2010 (PLN )

  30. THANK You

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