Česky
What is your experience with Section 16, or how do you perceive the approval of exempted medicines?
The so-called Section 16 is, of course, used by our doctors, otherwise it is not possible today as the reimbursement system is set up. § Section 16 of Act No. 48/1997 does not only apply to medicines, but basically to all health care, as it allows to cover care from the public health insurance system if it is unreimbursed and is the only option for treatment. Otherwise, the insured would have to pay for it himself. Which was originally a good idea to punish any "loopholes" in the system so that the insured could get the necessary care and be reimbursed by the insurance company. Today, it seems more likely that this institution is no longer working in the way it was intended. However, it is a more complex issue.
Is the use of Section 16 being overused?
It depends on how one perceives it. However, "Section 16" must be seen as an option - a legal one at that - to be resorted to when the normal routes fail or are not available. There is no doubt that the number of applications for Section 16 treatment has increased significantly compared to, say, 10-15 years ago. However, the system of determining the conditions for reimbursement of medicines has also changed - previously, through the Medicines Commission at the Ministry of Health, the reviewing physician had the power to approve more expensive medicines - marked with prescription symbols Z, X, including the assessment of possible atypia in the patient. The way in which the conditions for reimbursement are set or defined by the SÚKL was supposed to make the approval process easier for the administration, however, in practice it turns out that the opposite is the case, as the definitions are inherently unable to cover all possibilities and think about deviations or atypia. And the insurer is left with only "§16", which was or is intended to serve only as an exceptional institute when it is the only treatment option, otherwise not covered by the insurer. At the moment, when meeting the condition given by the SUCL is a statutory criterion for reimbursement, you are trapped, in case you do not 100% fit the wording of the condition or the criteria are already outdated and have not yet been changed in accordance with the new recommendations of the professional society. Then there is no choice but to apply for reimbursement by way of Section 16. However, addressing even these cases was not the original intent of the legislature in 1997.
What should be the criteria for approving expensive but highly effective treatments?
Highly effective treatments should reach all patients who need them, there is no doubt about that. If it does not work, or does not work with sufficient effect, it should not be covered by public health insurance. We like the idea of corporate participation, at least in the initiation of treatment - if it works and is effective, it will be covered by the insurance company; if it is not, it should not be covered by the solidarity money of all of us.
Do you foresee that the number of approvals for exempted medicines will continue to rise?
Today's system of what is covered and under what conditions, what the insurance company will deny you for not meeting the conditions, whether for objective or interpretive subjective reasons, what can or cannot be given with regard to a medical condition, is opaque and full of changes. The provider is always at risk of being reimbursed for the drugs he or she has prescribed at the slightest deviation from the conditions (often unclear in interpretation or already outdated). In the case of comprehensive cancer centres (CCCs), this can involve millions of Czech crowns. Unfortunately, medicine cannot be simply pigeonholed, it is full of specifics and exceptions that need to be considered in their entire context and with some empiricism, and are difficult to bundle definitively into rules - as long as strict compliance with the wording of the conditions and rules is followed, you cannot protect yourself other than by asking the payer to allow reimbursement, even for a minor deviation. So yes, it will go up.
