The Evolution of Medical Device Procurement in Italy

2019-06-18T13:55:15-05:00January 31st, 2019|Categories: Recent News|Tags: , |

The Evolution of Medical Device Procurement in Italy

January 2019

Assobiomedica, the body representing the medical device sector in Italy, published an update to the report ‘Public Policies for the Purchase of Medical Devices’ in October 2018. The report outlines four types of acquisitions for medical devices in Italy:

  1. Single acquisitions, made by separate healthcare facilities;
  2. Group acquisitions, made by groups of healthcare facilities, with specific characteristics for every group;
  3. Centralized regional acquisitions, made by the regional centers for procurement; and
  4. Purchases made through Consip, a public company in charge of public procurement.

The publication found:

  • That between 2007 and 2017, the total amount awarded in public tenders for single or group acquisitions decreased by 60 percent (down from 95% in 2007 to 35% in 2017) and in the same timeframe, increased by the 60 percent for centralized regional acquisitions.
  • A negative trend to the number of healthcare facilities participating in one tender, wherein 2009, an average of eight entities engaged in centralized regional acquisitions, while the average for 2017 was three.
  • A faster rate for accomplishing acquisitions up from 30 percent over one year in 2007 to 55 percent in six months in 2017.
  • High variability for centralized regional acquisitions. 
Implications for innovators

Such a robust regional purchasing system may have an undesirable long term effect, negating the immediate decrease in public expenditure.

Some long term impacts on the sector may include:

  • The potential exclusion of medium and small companies from the tender process – even if the process is efficiently working and providing innovation –  weakening the level of market competition.
  • A slowdown to the update of innovative technologies.

Medical device companies seeking to launch innovative products in Italy face a complex reimbursement landscape, with regional and local health authorities having oversight of reimbursement for a new or existing product.

Discussions between companies and Italian decision makers are required to promote value-based procurement mechanisms.

Do you need support with understanding the reimbursement landscape and development of a reimbursement strategy in Italy? Contact us for more information.

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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.

Access our presentations: MedTech Access Leaders Forum, EU

2019-06-18T14:03:19-05:00December 4th, 2018|Categories: Recent News|Tags: , , |

Boston Healthcare’s Presentations From MedTech Access Leaders Forum, EU

Boston Healthcare spoke at the MedTech Access Leaders Forum in Berlin, Germany on 3-5 December 2018. Vice President, Rob Wenthold spoke on maximizing the organizational impact of the market access function, and CEO, Joe Ferrara spoke on global considerations for companion diagnostics. If you would like a copy of these presentations, please register your details here.

Health Policy Insights: Germany

2018-10-17T15:40:57-05:00August 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.

Policy Update: Brazil

2018-10-17T15:38:15-05:00July 30th, 2018|Categories: Uncategorized|Tags: , |

Brazil: Health System Update

July 2018

Both the public and private sectors deliver healthcare in Brazil, with over 70 percent of the population accessing care through the government led National Healthcare System, known as the Universal Health System. The private system covers approximately 23 percent of the population and is usually funded by employers. Currently, both systems are facing financial difficulties creating challenges for innovators seeking to introduce new health technologies into the market.

Health Technology Assessments

Led by the federal Commission for Incorporation of Technologies (CONITEC), the public health system uses Health Technology Assessments to incorporate new technologies and drugs. In the private sector, the Permanent Committee for Regulation of Health Attention evaluates new procedures for incorporation in the list of mandatory coverage for private payers and has recently released an update on the incorporation process – currently under public consultation.

Clinical and economic data of the new technologies are mandatory for incorporation requests. Additionally, if new incorporated procedures demand the use of a specific medical device, its coverage is granted. COSAUDE does not define the reimbursement price for specific procedures, device, or brand. This is negotiated between payers and providers.

Medical device pricing and purchasing

Medical device manufacturers are continuing to face criticisms over prices and use of devices following a 2015 investigation that uncovered widespread misconduct amongst stakeholders, including financial incentives for uptake of specific products. These activities left stakeholders questioning the optimal purchasing method for medical devices, leading to a shift from fee for service models to a Diagnosis-Related Group (DRG). More recently, a police investigation in Rio de Janeiro has uncovered a number of fraudulent tenders for public sales of medical equipment since 1996, leading to estimated losses to the public system of R$ 600 million. The image of medical devices and equipment manufacturers compromised due to these recent scandals.

Changes in purchasing practices for medical devices have also disrupted the supply chain. Group purchasing for medical devices in the public sector is being flagged as a way to centralize the process and combat malpractice.

Introducing a new health technology or drug into Brazil’s healthcare system is a complex and interactive process involving many stakeholders, demanding in-country expertise. Contact us for more information.