Authors: Kateřina Slavíková, Václav Audes, Sabina Skoumalová
On 14 September 2021, the Chamber of Deputies approved the long-awaited amendment to Act No. 48/1997 Coll., on Public Health Insurance (the “Act”), as returned by the Senate (the “Amendment”). It now awaits signing by the President of the Czech Republic. The Amendment brings a wide range of changes and innovations, such as rules for the entry of innovative drugs and orphan drugs into the reimbursement system, the creation of centres for rare diseases and mental health centres, and the introduction of a definition of a patient organisation.
The most significant change will affect so-called highly innovative medicinal products (“HIMP“) and orphan drugs. The availability of these medicinal products is often very limited and their entry into the system is very complicated due to their specific nature.
For HIMP, which have also received an updated definition, the Amendment should streamline reimbursement approvals, making these medicinal products more accessible for patients.
The Amendment will extend the period for temporary reimbursement (from the original 2 years with the possibility of an extension by another year to the new 3 years with the possibility of an additional 2-year extension).
A legal mechanism will also be set up to allow patients who have been treated with this medicinal product to be treated at the expense of the marketing authorisation holder (the “holder“), pending a switch to comparably effective and safe treatment covered by health insurance. The Senate’s amending bill limited that period to a maximum of 24 months. Patients’ right to receive treatment arises directly from the Act, and it does not therefore require a contract to be concluded between the health insurance company and the holder.
Regarding orphan drugs, the Amendment introduces a completely new system for approving their reimbursement.
Until now, these medicinal products have in practice been funded by health insurance through an extraordinary reimbursement under Section 16 of the Act. At the request of the holder or the health insurance company, the reimbursement will be approved in a special procedure by the State Institute for Drug Control (in Czech Státní ústav pro kontrolu léčiv) (the “SIDC“).
The parties to the proceedings will also be scientific societies and patient organisations, an element that is completely new to the Czech reimbursement system. The law defines so-called soft criteria, which should be used for the assessment of an application for orphan drugs reimbursement (including the importance of the possibility of affecting a disease throughout society). After the SIDC has issued its assessment report, the Ministry of Health (within which a new advisory body is being set up for this purpose) will issue an opinion binding on the SIDC. At the same time, the SIDC will be required to initiate a procedure to review the maximum price of the product within a maximum of 3 years.
For both the HIMP and orphan drugs, the cost of their reimbursement from health insurance must not exceed the amount indicated in the budget impact analysis. If an overrun occurs, the holder will be required to reimburse the amount that exceeded the budget impact analysis figure. It is for this purpose that each health insurance company enters into a contract with the holder containing a provision on how to compensate for costs that would exceed the anticipated level of reimbursement.
On the other hand, thanks to the Senate amendment, the Amendment does not exempt the SIDC from basing the so-called reference basket on foreign prices for actual medicinal products sold on the market and from verifying their actual presence on the market.
The legislative proposal specifically sought to relieve the SIDC of this obligation, in response to judicial practice which criticised the SIDC for taking into account the price of a medicinal product in a given foreign database without examining whether the product was actually marketed in that country. In response to Brexit, the Amendment places Germany among the countries of the so-called reference basket as a replacement for the exiting United Kingdom.
In response to the growing number of mass-produced advanced therapy medicinal products, the reimbursement of these medicinal products will be re-established in the standard administrative procedure after the Amendment enters into force, that is to say, no longer through measures of a general nature.
The Amendment further makes uniform the decision-making process for individual health insurance companies regarding applications for extraordinary reimbursement under Section 16 of the Act and promises to speed up the procedure, reduce administrative burdens for health insurance companies and improve the status of the insured person.
As a matter of fact, clear rules are currently absent for situations where the provision of health services is linked to a prior decision of the medical officer, with a large number of such requests being made annually. These applications relate not only to non-reimbursed health services, but also to medicinal products and medical devices. The Amendment introduces the possibility of providing some health services without prior approval by a health insurance company, for example in the case of urgent care.
An application for reimbursement under Section 16 of the Act will be sent to the health insurance company by
(i) the patient himself/herself or
(ii) the health service provider (in practice, the treating physician will act on behalf of the health service provider).
This reflects current practice, given that it is usually the treating physician who makes the claim for reimbursement.
The Amendment gives the insured person the opportunity to defend himself/herself if the health insurance company rejects his/her claim for reimbursement under Section 16 of the Act. Now, many insured people go to the general courts, but they decide on this matter in a highly ambiguous way. This procedure will now be brought first and foremost to the level of an administrative procedure, and each health insurance company will have to set up an appeal body, a so-called review board.
The Amendment also provides a definition of a patient organisation, meaning “a registered association whose main activity is to help patients and protect their rights and interests”[1]. The patient organization status pertains not only to associations, but also to other legal forms of non-profit organizations, such as an institute or a beneficiary society.
Nurses will be given the authority to prescribe certain medical devices and physicians the authority to prescribe new medicinal products under the Amendment.
The Amendment further increases women’s limit age for paid IVF by one year, from 39 to 40. The age of patients to receive a reimbursed vaccination against meningococcal infections has also been extended. It could also bring more affordable care to patients with severe orthodontic defects, such as clefts, congenital or systemic defects, and extend reimbursement to non-basic dental replacements.
The Amendment also legislated highly specialized health care centres for patients with rare diseases, mental health centres, emergency admissions, and screening centres.
Finally, it is worth mentioning that some other laws will be amended in connection with the Amendment, notably Act No. 592/1992 Coll., on Public Health Insurance Premiums, and Act No. 372/2011 Coll., on Health Services and Conditions for their Provision.
You can read about other events in the Life Sciences world on our blog here.
[1] New provision of Section 113f of Act No. 372/2011 Sb., on Health Services and Conditions for their Provision.
