Emergency access to medicines

26 November 2020 saw the entry into force of the Act of 7 October 2020 on the Medical Fund (Journal of Laws of 2020, item 1875), amending the provisions of the Act of 27 August 2004 on healthcare services financed from public funds (Journal of Laws of 2020, item 1398 as amended), including in respect of the regulation on emergency access to drug technologies, hereinafter referred to as the “RDTL”.

According to the new regulations, decisions regarding the administration of a drug under the RDTL are the responsibility of healthcare providers – not of the Minister of Health, which was the case before 26 November 2020.

A drug financed under the RDTL procedure may be administered in line with the new regulations if all of the following conditions are met:

• there is a justified need, based on current medical knowledge, to administer a drug that is not financed from public funds to the recipient with a given indication,
• a drug is necessary to save the recipient’s life or health for an indication occurring in individual patients,
• all available medical technologies financed from public funds and possible to be used for this indication have already been exhausted for the given recipient,
• the recipient has obtained a positive opinion of the national consultant specialising in the area of medicine relevant to the disease or health problem of the recipient or a positive opinion of the provincial consultant specialising in such area of medicine, which should include the assessment of the appropriateness of using the medicinal product for the recipient,
• financing applies only to a drug that is authorised under Article 3 of the Act of 6 September 2001 – Pharmaceutical Law or remains on the market under Article 29 sec. 5 or 6 of that Act and is available on the market.

A drug under the RDTL may be administered for a treatment period of no more than 3 months or three treatment cycles.

If there is an intention to continue administering the drug under the RDTL after the treatment period of no more than 3 months or three treatment cycles, the effectiveness of the recipient’s treatment with the drug must be confirmed by a medical specialist specialising in the area of medicine relevant to the disease or health problem of the recipient.

Pursuant to the new RDTL regulations, the President of the Agency for Health Technology Assessment and Tariff System does not give opinions on the appropriateness of public funding of a drug under the RDTL. The last opinion was given on 10 March 2021 and concerned an application for approval of reimbursement of costs for a drug under the RDTL procedure submitted before 26 November 2020.

To provide as much support for healthcare providers and physicians as possible in terms of making decisions on financing drugs under the RDTL procedure, the President of the Agency has made all data and analyses used by the President of the Agency to give opinions available at rdtl.aotm.gov.pl.

Legal status for RDTL applications submitted before the entry into force of the Act on the Medical Fund (Journal of Laws of 2020, item 1875), amending the provisions of the Act of 27 August 2004 on healthcare services financed from public funds (Journal of Laws of 2020, item 1398 as amended), including in respect of the regulation on emergency access to drug technologies, hereinafter referred to as the “RDTL”.

Emergency Access to Drug Technologies is a mechanism for financing drugs in situations where the prolongation of patient survival or significant improvement to his/her health can be obtained and when all available reimbursable drug technologies have been exhausted. It was launched on 23 July 2017. It is a chance for many patients to obtain individual treatment reimbursement.

The Minister of Health may give an individual approval for reimbursement of costs of such drugs if:

• the treatment is necessary to save the patient’s life or health,
• the use of the treatment is justified and supported by current medical knowledge,
• the drug is authorised in Poland,
• all available medical technologies financed by the National Health Fund have been used in the patient,

The hospital in which a given Patient is treated submits an application for the implementation of the RDTL procedure. The application is analysed and assessed by the national or provincial consultant, the Agency for Health Technology Assessment and Tariff System, and the Minister of Health,

Under the Emergency Access to Drug Technologies mechanism, individual reimbursment is granted for 3 months. For the treatment to be continued, the effectiveness of the treatment under the RDTL procedure must be confirmed by a medical specialist specialising in the area of medicine and another application must be submitted to the Minister of Health.

The assessment of a drug under the RDTL procedure is also a chance for subsequent reimbursement of a given treatment for all patients with a particular indication.

Emergency access to medicines (RDTL) is a financing mechanism for medicines used when a patient’s life can be prolonged, or his/her health can be significantly improved, and the available medicines reimbursed in Poland have already been used. The programme, in operation since 23 July 2017, means an opportunity for individual treatment reimbursement for many patients.

The Minister of Health may give individual approval to cover the costs of such medicines in the event that:

• it is necessary to save a patient’s life or health,
• its use is justified and supported by current medical knowledge,
• the medicine has a market authorisation in Poland,
• all available health technologies financed by the NHF have been used unsuccessfully.

The application for emergency access to medicines is submitted to the Minister of Health by the hospital in which a particular Patient is treated. The physicians’ application is subject to analysis and assessment by a regional or national consultant, the Agency for Health Technology Assessment and Tariffs System and the Minister of Health.s

Individual reimbursement is granted within the framework of emergency access to medicines for a period of 3 months. In order to continue the therapy, it is necessary to confirm effectiveness of the treatment provided under the RDTL by a specialist in the given branch of medicine and to re-submit the application to the Minister of Health.

The evaluation of a medicine reimbursed under this procedure also increases the chances of subsequent reimbursement of the therapy in question for all patients with the given condition.