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Financing of therapy with highly expensive medicin es by the National Health Fund Rafał Zyśk

Financing of therapy with highly expensive medicin es by the National Health Fund Rafał Zyśk Medicines Management Department National Health Fund. Services, under which highly expensive medicines technologies may be financed. Therapeutic programmes Non-standard pharmacotherapy

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Financing of therapy with highly expensive medicin es by the National Health Fund Rafał Zyśk

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  1. Financing of therapy with highly expensive medicines by the National Health Fund Rafał Zyśk Medicines Management Department National Health Fund

  2. Services, under which highly expensive medicines technologies may be financed • Therapeutic programmes • Non-standard pharmacotherapy • Non-standard chemotherapy

  3. Assumptions for therapeutic programmes • intended for most expensive therapies • intended for small patient populations • intended for indications with clearly defined criteria – inclusions and exclusions of patients • monitoring of the number of patients and therapy effectiveness (planned) • medical technologies of proven clinical effectiveness • medical technologies, which are most cost-effective among the available options • taking the public payer budget into account • improvement of the reporting and financial settlements system – monitoring of patients in PT in accordance with the rules of clinical register! and verification of the legitimacy of financing technologies after 1-3 years on the grounds of factual data (plans for the future)

  4. Features of a good register • Maintained on the grounds of a protocol, • directed to primary endpoints (survival, recovery/symptoms arduous for patients, quality of life) , • collects data regarding important events, which generate costs, • covers – if possible – the whole population covered by treatment, • monitored / external audit, • connected to other similar registers in other countries – COLLECTIVE RESULTS!

  5. Within the framework of therapeutic programmes catalogue, NFZ finances two Orphan Medicinal Productsofficially authorised by the EU: • PROGRAMME FOR GAUCHER DISEASE TREATMENT WITH IMIGLUCERASE(56 patients), • PROGRAMME FOR HURLER DISEASE TREATMENT WITH LARONIDASE (13 patients)

  6. LIST OF RARE DISEASES FINANCED BY THE NFZ UNDER PT

  7. In the course of assessment by the Polish HTA Agency: • TREATMENT OF POMPE DISEASE WITH MYOZYME MEDICINE • TREATMENT OF FABRY DISEASE WITH FABRAZYME MEDICINE • TREATMENT OF NEWMANN-PICK DISEASE WITH ZAVESCA MEDICINE

  8. Not recommended for public financing by the Polish HTA Agency: • TREATMENT OF MUCOPOLYSACCHARIDOSIS TYPE VI WITH NAGLAZYME MEDICINE

  9. Therapeutical programs in 2007

  10. New therapeutical programs in 2008

  11. Financing of therapy under procedure „non-standard pharmacotherapy” or” non-standard chemotherapy” • service allowing for the therapy of patients, whose treatment may not be qualified under other items of Hospital treatment catalogue, • requirement of obtaining individual authorization of the Director of Voivodeship Branch of NFZ each time • financing does not increase the volume of the contract of Voivodeship Branch of NFZ against the hospital • Director if the Voivodeship Branch, when issuing authorization, should take account of the financial condition of the applying hospital.

  12. MEDICINE ECONOMY Economic development vs. Development of medicine

  13. Sense of the application of medical technology • Brings more benefit than harm • Brings more harm than benefit • Effect unknown

  14. Market authorization – legal term • On label in accordance with the authorization indications, results of Phase III, RCT • Off labelnon-compliant with authorization indications • Soft labelnon-compliant with authorization indications, but there are premises regarding the effectiveness of therapy on the basis of research with methodological restrictions • MARKET AUTHORISATION  REIMBURSEMENT

  15. Compliant with indications or not?

  16. Position of the Minister of Health of 14.12.2006

  17. The Helsinki declaration distinguishes between a medical experiment and application of a medicine non-compliantly with the authorization indications • In relation to the position of the Ministry of Health and ethical principles covered by the Helsinki Declaration of 1964 (as amended), in the case, where a medicinal product is applied non-compliantly with the authorization indications, the National Health Fund (NFZ) requires the service provider to: • confirm prior to the application, whether there are optional procedures with proven clinical effectiveness in a given indication, • obtain – prior to application – a written, conscious consent of the patient (pursuant to the specimen provided) to administer treatment non-compliant with authorization indications, • monitor the condition of the patient; in all cases new information regarding the effectiveness of a medicine and patient's condition need to be registered.

  18. Ethics • A modern doctor no longer has a moral right to perceive medicine in terms of „I do not care what I do to save the life and health of the patient”. Each decision is a trade-off – when I save X, I reduce the Y’s chances to be treated (which odes not mean recovery) – pretending longer, escaping the vital dilemma is simply burying your head in the sand. • Marek Kokot

  19. PLN 5 million 300 adults with cancer and high health benefit – extension of life by 10 years on average 3 children and low health benefit Cost of therapy has become an issue of ethics! Queue is a factor of proven harmfulness Restriction of availability

  20. What does the decision-maker want to know (including doctors)? • Is it a technology of proven effectiveness? • What is its intervention power as compared to other options? (which of the options is most effective and to what extent does it exceed other options?) • Which of the options is most cost-effective and how does it exceed other options? • Is the financing of technologies from available funds justified? What changes would the introduction of a privilaged market position for a given technology bring?

  21. Prescrire International – effectiveness of new medicines

  22. 2007/056 NICE guidance on bortezomib (Velcade) is a win-win solution for multiple myeloma patients and the NHS • The National Institute for Health and Clinical Excellence (NICE) has published final guidance to the NHS in England and Wales on the use of bortezomib (Velcade) for the treatment of multiple myeloma. • The guidance confirms the response-rebate scheme which will allow patients at first relapse who show a full or partial response to bortezomib to carry on with the treatment, fully funded by the NHS, and patients who show no or minimal response to be taken off the drug and the drug costs refunded by the drug’s manufacturer. • Andrew Dillon, NICE Chief Executive, said: “Providing expensive new cancer drugs is a challenge for the NHS, particularly when it is not possible to identify those patients who will benefit most from treatment. The scheme proposed by the manufacturer and amended by NICE will ensure that patients at first relapse, who have had one prior therapy and who have had or are unsuitable for a bone marrow transplantation will get the chance to see if the drug works well for them. This is a win-win situation for patients and the NHS.”

  23. Thank you for your attention

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