Defining the value of innovative treatment methods in Germany

2019-06-17T11:57:12-04:00January 31st, 2019|Categories: Recent News|Tags: |

Defining the value of innovative treatment methods in Germany

January 2019

Healthcare innovators would see accelerated adoption of new methods for treatment provided through the Statutory Health Insurance (SHI) program in Germany if a recent proposal by Jens Spahn, Federal Minister for Health, to limit the decision-making power of the Joint Federal Committee (G-BA) is approved.

The proposal seeks to transfer power of attorney to the Ministry from the G-BA to bring innovative treatment methods to the public health system faster, even for those treatment methods that have not received a formal assessment by the G-BA.

Under current regulations, assessments and processes for including new therapies into the reimbursement catalogue are lengthy and challenging to navigate, holding implications for manufacturers, patients, and providers.

A key driver to Spahn’s proposal is the potential that liposuction holds for the treatment of lipedema. Prior discussion on the inclusion of this treatment in the reimbursement catalogue was based on insufficient evidence to prove value. A reimbursement decision has been pending since 2014 and, in July of last year, the G-BA decided to support a clinical trial, with expected inclusion of patients in 2020 and results for decision making after 2024.

If Spahn succeeds, barriers for the consideration of innovative products as potential treatment alternatives would be lowered, removing the requirement for national associations of SHI funds and SHI accredited physicians to determine method assessment. The change would also impact the G-BAs excessive clinical evidence demands through randomized controlled trials (RCTs), and promote new evidence approaches for healthcare decision making, like real-world evidence (RWE), for example.

Liposuction in the treatment of lipedema serves as a strong example for the ministry to request authorization to establish this therapy as a SHI benefit. In the planned changes in legislation, Spahn intends not only to be authorized for the inclusion of treatments in the benefit catalogue but also to regulate quality requirements for the provision of services and specifications for remuneration.

The G-BA is the highest decision-making body for coverage of treatments in the German SHI and also specifies measures for quality assurance for inpatient and outpatient areas of the health care system. The joint self-government of physicians, dentists, hospitals, and health insurance funds also issue directives for the benefit catalogue for reimbursement.

Spahn’s request has intensified the discussion about the role of the G-BA and the problems with the introduction of innovative therapies and diagnostics in the German SHI system.

New developments across Germany’s healthcare industry provide significant opportunities for global digital health, medical device, and diagnostics innovators, however many hurdles and barriers to entry still exist. If you are interested in learning more about gaining access to Germany’s healthcare market, please contact us.

Regulatory Approvals of LDTs

October 1st, 2018|Comments Off on Regulatory Approvals of LDTs

The Diagnostic Accuracy and Innovation Act (DAIA), introduced last year in the House of Representatives, would allow the Food and Drug Administration (FDA) to regulate laboratory developed tests with a new category of in vitro clinical tests (IVCTs).

Digital Health Expands in Germany

October 1st, 2018|Comments Off on Digital Health Expands in Germany

Germany has introduced two different approaches to increase digital health access for patients, providers, and health insurance companies, the Electronic Health Card Network and the Patient Accessible Electronic Health Records.

Digital Health Expands in Germany

2018-10-31T15:56:11-04:00October 1st, 2018|Categories: Uncategorized|Tags: , |

Digital health expands in Germany, providing new opportunities for global medical device and diagnostics innovators

Health information systems have the potential to not only improve access to health care but also improve quality, with Electronic Health Records (EHR) playing a pivotal role in the development of digital health services. Germany has introduced two different approaches to increase digital health access for patients, providers, and health insurance companies – the Electronic Health Card Network and the Patient Accessible Electronic Health Records.

Electronic Health Card network

Germany has been developing the national digital health care network since the early 2000s. Even with the project subject to controversies and delays, the system will be operating in 2019. The Electronic Health Card network (elektronische Gesundheitskarte or eGK) will connect all public health stakeholders, including patients, doctors, pharmacists, therapists, health insurance companies, and hospitals. The network will improve efficiency in the delivery of health care services, enhance patient safety, increase access to health care services and reduce medical expenditure.

Unfortunately, the development and implementation of the eGK has not kept pace with technical developments and rising patient expectations to manage their health data through smartphone applications, and connecting medical with further health-related information, for example, activity trackers and other health apps. With patients responsible for their data through the eGK, decisions on the types of data saved and who has access to it should also be managed by the patient.

The telematics infrastructure and data protection requirements will initially affect accessibility to the eGK for patients, requiring some modifications in the future.

Patient Accessible Electronic Health Records

Some German health insurance funds have developed and implemented Patient Accessible Electronic Health Records (PAEHR), with the largest PAEHR (Vivy) employed in mid-September by 13 Statutory Health Insurance (SHI) funds.

These funds have partnered with two private health insurance companies to provide PAEHR, enabling 13.5 million patients to manage their health data via a smartphone application.

The PAEHR provides an opportunity for private health insurers to become more involved in patient healthcare management. When all systems are operational, 70 percent of patients will be able to manage health-related data on their own through smartphone applications.

It is important to note that this is not a stand-alone solution to patient data management and interfaces for data transfer between physicians and labs, along with the integration of data with medical office software is agreed. With rising acceptance by patients and providers, the need for integration in the eGK system will emerge.

Opportunities for the medical device and diagnostic industry

With the increased availability of PAEHR in Germany, the management and communication of health data is changing towards a more patient-related approach. Manufacturers should consider these developments by capturing patient-friendly outcome data, which can be transferred into PAEHR and empower patients’ involvement in decision-making.

In addition, health care services and apps, which utilize the new infrastructure, improve efficiency and increase cost saving, are favored by both SHI and the private health insurance system, providing exciting business opportunities for the industry.

Learn more about our capabilities in Europe here.

Health Policy Insights: Germany

2018-10-17T15:40:57-04:00August 30th, 2018|Categories: Uncategorized|Tags: , , , |

Health Policy Insights: Germany

August 2018

Digital Health in Germany

Earlier this year, the German Medical Assembly removed restrictions on the use of telemedicine, paving the way for greater innovation in the provision of health services in Germany. This move, along with new calls by Germany’s Health Minister, Jens Spahn to increase access to digital health infrastructure, including the reimbursement of health apps through statutory health insurance (SHI), present growth opportunities for the German healthcare market.

Health Ministry Rejects Results of NUB HTAs

Since the beginning of 2017, notably invasive or active implants in risk classes IIb or III must undergo a benefit assessment by the G-BA before being granted a New Methods for Treatment and Screening (NUB) add-on payment.

During the first year of this new requirement, none of the eight products assessed provided sufficient evidence for reimbursement through the NUB process. Two of the eight products were assigned a “potential” benefit, resulting in the government co-sponsoring studies to evaluate the benefit. The other six products were excluded primarily due to lack of clinical evidence. However, the Federal Ministry of Health filed an office action against this decision and contested the assessment criteria, indicating that the evidence requirements for being a “potential alternative” were too high.

The court’s decision will affect the entire benefit assessment for medical devices and diagnostics in Germany, creating uncertainty of coverage for innovative therapies. A decision of the office action is expected in early 2020.

Laboratory Reimbursement Reform

Although Germany has the lowest prices for laboratory tests and a competitive laboratory landscape, cost-containment practices continue.

With a rise in spending on diagnostics tests (5% annual increase), the regional association of SHI accredited physicians (KV) agreed to a reform to keep test costs within budget. The reform has enhanced options available to the KV to control the costs of medical diagnostic tests, including:

  • The ability to set individual laboratory budgets and reduce reimbursement amounts, and
  • Incentives for physicians to order fewer tests than other comparable medical practices.

Pathology lab services are not currently affected by the reform.

New developments across Germany’s healthcare industry provide significant opportunities for global digital health, medical device, and diagnostics innovators, however many hurdles and barriers to entry still exist. If you are interested in learning more about gaining access to Germany’s healthcare market, please contact us.