In proceedings concerning changes to the amount and conditions of reimbursement of a medicinal product, the applicant requested an extension of the prescribing restrictions to include medical specialty J9. The State Institute for Drug Control (the Institute) proposed maintaining the existing reimbursement amount and conditions and rejecting the application, despite considering the request clinically justified.
The Institute acknowledged that physicians working in specialised J9 centres possess the necessary expertise and provide a higher level of specialised care than the medical specialties already authorised to prescribe the medicinal product. The Institute also agreed with the opinions of the Medical Societies supporting the extension of prescribing rights to specialty J9. It considered the proposed extension to be administrative and organisational in nature, without expanding the population of patients eligible for treatment. Therefore, the submission of pharmacoeconomic analyses was not required.
The reason for the proposed rejection was that the previously concluded financial agreements limiting the budget impact covered only the existing scope of prescribing restrictions. At the time the assessment report was issued, it had not been demonstrated that these agreements would also apply to the proposed extension of prescribing rights to specialty J9.
Consequently, the Institute considered that it had not been sufficiently demonstrated that extending the prescribing restrictions would not result in increased expenditure from the public health insurance system.
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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).
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