Welcome to the second post in the quality assurance series, focusing on the hot topic of ATMPs!
Next week, I’ll be focusing on another aspect of G-BA’s quality assurance in German health care, quality controls for hospitals and minimum case numbers.
What are ATMPs?
Cell and gene therapies are classed as Advanced Therapy Medicinal Products (ATMPs) due to the way they are produced and act in the body. They contain components of living cells or nucleic acids and represent innovative therapies for various diseases.
But using these treatments is associated with high risks. Thus, the G-BA can stipulate QA requirements for outpatient clinics and hospitals offering ATMPs. The legal basis is § 136a paragraph 5 SGB V.
Quality requirements for ATMPs
The requirements have the aim to increase the treatment quality and patient safety by minimizing complications. For example, we can expect centres offering these treatments more routinely, rather than only in rare cases, to have better outcomes. But on the other hand, these requirements limit the number of clinics and hospitals being able to offer ATMPs.
The quality requirements for ATMPs are covered in this directive (called ATMP-QS-RL). The directive describes, among other things, the minimum requirements for treatment facilities, such as certain professional qualifications of the staff, spatial and medical equipment, and a minimum number of cases. Only if the hospitals and clinics meet these minimum requirements, the SHI funds will reimburse the ATMPs. The G-BA based the directive also on the real-world experience of the use of Zolgensma and the CAR-T treatments.
This directive defines consistent requirements for all cell and gene therapies. In addition, it specifies how the centres should prove that they meet the requirements. It also lists consequences that apply if hospitals or clinics do not meet the quality requirements.
The directive has the following structure:
- Qualification of the care provider:
- Medical staff: e.g. specialist qualification, several years of professional experience in a specialized institution/department/clinic, the minimum number of cases for treatment with specific diagnoses, participation in a study
- Care staff and other staff: e.g. specialized training (e.g. intensive care), codes for staff
- Structure and processes:
- Structures: e.g. specialist departments/clinics, operating theatre equipment and capacity, rooms meeting special hygiene requirements
- Process and organization: e.g. surgery teams, on-call services, diagnosis (e.g. by treatment team / interdisciplinary case conferences), preparation, production, transport, treatment of complications
- Other quality assurance measures: use to generate knowledge, e.g. registries (for quality assurance purposes)
Quality controls for ATMPs
The staff of the “medical services” (German: “Medizinischer Dienst”) will check whether hospitals and clinics follow these strict quality requirements. The medical service is the socio-medical advice and assessment service for statutory health and long-term care insurance. It ensures that the services of the SHI and care insurances benefit all insured persons under the same conditions according to objective medical criteria.
On 19 Nov 2021, the G-BA published the rules for these quality controls as new section 4 for the directive, called MD-QK-RL. The BMG is currently reviewing the new section, and the quality controls have not come into force yet.
Controls can happen on certain occasions, e.g. before the first service is provided, but also if there are specific reasons. After the checks, the “medical services” team summarizes the results of all required quality requirements in a control report.
If the minimum requirements are met, they will also issue a corresponding certificate. Hospitals and clinics will have to renew this certificate after the first year and then every two years.
Hospitals also can request a new control check to prove that they have eliminated any deficiencies that the “medical services” may have previously identified.
Further reading related to QA in Germany
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