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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 - PowerPoint PPT Presentation
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Rafał Zyśk
Financing of therapy with highly expensive medicinFinancing of therapy with highly expensive medicineses by the by the
National Health FundNational Health Fund
Rafał Zyśk
Medicines Management DepartmentNational Health Fund
Rafał Zyśk
Services, under which highly expensive medicines technologies may be financed
Therapeutic programmes Non-standard pharmacotherapy Non-standard chemotherapy
Rafał Zyśk
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)
Rafał Zyśk
Features of a good register
1. Maintained on the grounds of a protocol,
2. directed to primary endpoints (survival, recovery/symptoms
arduous for patients, quality of life) ,
3. collects data regarding important events, which generate costs,
4. covers – if possible – the whole population covered by
treatment,
5. monitored / external audit,
6. connected to other similar registers in other countries –
COLLECTIVE RESULTS!
Rafał Zyśk
Within the framework of therapeutic programmes catalogue, NFZ finances two Orphan Medicinal Products
officially authorised by the EU:
PROGRAMME FOR GAUCHER DISEASE TREATMENT WITH IMIGLUCERASE (56 patients),
PROGRAMME FOR HURLER DISEASE TREATMENT WITH LARONIDASE (13 patients)
Rafał Zyśk
LIST OF RARE DISEASES FINANCED BY THE NFZ UNDER PT
2005 2006 2007
Name of PT Value of services provided
Value of services provided
Estimated value of
contracted services
Amount per PT in the whole country
573,000,610 618,467,170 640,000,000
CHANGE dymanics in 2005/2006
CHANGE dymanics
in 2006/2007
PROGRAMME FOR GAUCHER DISEASE TREATMENT WITH IMIGLUCERASE
26,071,790 30,886,790 34,000,000 18.47% 10.08%
PROGRAMME FOR HURLER DISEASE TREATMENT WITH LARONIDASE
4,627,700 8,076,700 9,545,980 74.53% 18.19%
TOTAL 30,699,490 38,963,490 43,545,980
% of the whole amount 5.36% 6.30% 6.80%
Rafał Zyśk
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
Rafał Zyśk
Not recommended for public financing
by the Polish HTA Agency:
TREATMENT OF MUCOPOLYSACCHARIDOSIS TYPE VI WITH NAGLAZYME MEDICINE
Rafał Zyśk
Therapeutical programs in 2007 1. Treatment of breast cancer with docetaxel
2. Treatment of breast cacner with capecitabine
3. Treatment of breast cancer with trastuzumab
4. Treatment of colorectal cancer with irinotecan
5. Treatment of colorectal cancer with capecitabine
6. Treatment of glioma with temozolomide
7. Treatment of ovarian cancer with topotecan
8. Treatment of chronic myeloid leukaemia with imatinib
9. Treatment of gastrointestinal stromal tumours (GIST ) with imatinib
10. Treatment of malignant lymphoma with rituxmab
11. Treatment of ovarian cancer with paclitaxel
12. Treatment of idiopathic thrombocytaemia with anagrelide
13. Treatment of ovarian cancer with paclitaxel
14. Treatment of children with primary immune deficiency with immunoglubulin
15. Treatment of myodystonia with botulin toxin
16. Treatment of infantile cerebral palsy with botulin toxin
17.Treatment of sclerosis multiplex with glatiramer
18. Treatment of sclerosis multiplex with interferon beta19. Treatment of chronic virus hepatitis type B with lamivudine
20. Treatment of myocardial infarction with abciximab
21. Treatment of rheumatoid arthritis with infliximab
22. Treatment of sepsis with activated protein C
23. Treatment of anaemia of non-dialysed patients with chronic renal disease
24. Enzyme replacement therapy of Gaucher disease with imiglucerase
25.Treatment of dwarfish chldren with somatotropin hypopituitarism with growth hormone
26. Treatment of dwarfish chlidren with Turner syndrome with growth hormone
27. Treatment of dwarfish chlildren with chronic renal disease with growth hormone
28. Enzyme replacement therapy of Hurler disease with laronidase
29. Treatment of rheumatoid arthritis with leflunomide
30. Treatment of rheumatoid arthritis and juvenile arthritis with etanercept
31. Treatment of virus hepatitis C or B with pegylated interferon alpha
32. Treatment of virus hepatitis B or C with natural interferon alpha
33. Treatment of virus hepatitis B or C with recombinant interferon alpha
34. Immunosupressive treatment with mycophenolate mofetil
35. Immunosupressive treatment with sirolimus
36. Immunosupressive treatment with tacrolimus
37. Treatment of children with Prader Willi syndrome with growth hormone
Rafał Zyśk
New therapeutical programs in 2008
Breast cancer - adjuvant therapy with trastuzumab or docetaxel
Chronic myeloid leukaemia - second line therapy with double dose of imatinib or dasatinb
Myocardial infarction - eptifibatide or tirofiban
RA and JA - first line therapy with infliximab or adalimumab
RA and JA - second line therapy with rituximab or abatacept
Gaucher desease – enzyme replacement therapy with miglustat
Lamivudine- resistant chronic hepatitis B - therapy with entecavir or adefovir
Plasmocytoma - therapy with bortezomib
Crohn’s disease in children - therapy with infliximab
Crohn’s disease in adults - therapy with budesonide or adalimumab or infliximab
Pulmonary arterial hypertension - first line therapy - sildenafil - second line therapy - iloprost
Rafał Zyśk
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.
Rafał Zyśk
Sense of the application of medical technology
Brings more benefit than harm
Brings more harm than benefit
Effect unknownEffect unknown
Rafał Zyśk
Market authorization – legal term
On label in accordance with the authorization indications, results of Phase III, RCT
Off label non-compliant with authorization indications
Soft label non-compliant with authorization indications, but there are premises regarding the effectiveness of therapy on the basis of research with methodological restrictions
MARKET AUTHORISATION REIMBURSEMENT
Rafał Zyśk
Compliant with indications or not?
AUTHORIZATION STATUS CLINIC REGULATOR’S „PROBLEMS”
On label On label Current medicine development
Off label
Soft labelApplication in accordance with the
current medicine development while there are no authorization indications
Off label Medical experiment
Rafał Zyśk
Position of the Minister of Health of 14.12.2006
1. The „application of a medicine in accordance with the indications of the current
medicine development” is the application, which meets one of the following premises:
a) therapy is based on medicinal products provided with appropriate indications in
the summary of product characteristics, or
b) therapy is based on long-term and well grounded clinical practice, described in
current pharmacology manuals or manuals of a given medical specialisation, or
c) therapy is based on reliable sceintific evidence published in renowned scientific
magazines, confirming the effectiveness and legitimacy of the procedure.
In case of any doubt regarding the agreement that given application of a medicinal product is „in accordance with the current medicine development” the opinion of voivodeship or national consultant in a given branch od medicine shall have the decisive power.
Rafał Zyśk
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:
1. confirm prior to the application, whether there are optional procedures with proven clinical effectiveness in a given indication,
2. obtain – prior to application – a written, conscious consent of the patient (pursuant to the specimen provided) to administer treatment non-compliant with authorization indications,
3. 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.
Rafał Zyśk
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
Rafał Zyśk
Cost of therapy has become an issue of ethics!
PLN 5 million
3 children and low health benefit
300 adults with cancer and high health benefit – extension of life by 10 years
on average
Queue is a factor of proven harmfulness
Restriction of availability
Rafał Zyśk
What does the decision-maker want to know (including doctors)?
1. Is it a technology of proven effectiveness?
2. 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?)
3. Which of the options is most cost-effective and how does
it exceed other options?
4. Is the financing of technologies from available funds
justified? What changes would the introduction of a
privilaged market position for a given technology bring?
Rafał Zyśk
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.”