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So far Sam Barnum has created 23 blog entries.

Germany Paves the Way for Reimbursement of Digital Health Care Apps

2019-11-01T15:38:36-05:00October 22nd, 2019|Categories: Recent News|

Germany Paves the Way for Reimbursement of Digital Health Care Apps

October 2019

In Germany, doctors could potentially be prescribing health apps as medicines as early as 2020. This is one of the main objectives of the draft bill on the “Law for better provision through digitalization and innovation” (Digitale Versorgung Gesetz – DVG), which is expected to be approved by the parliament early November.

The law plans a rapid market access for health apps classified as low-risk. After an initial review of an app’s safety, quality, privacy, transparency and usability, an app will be provisionally reimbursed by statutory health insurance (SHI) for one year. During this time, the manufacturer must prove to the Federal Institute for Drugs and Medical Devices (BfArM) that the service has positive effects on care. If there is a proven benefit, the reimbursement and price are negotiated between the manufacturer and the National Association of SHI Funds (GKV-SV).

The new law brings improvements for health apps, which are approved as medical devices of low-risk class (class I and IIa). But the future for high-risk health apps remains uncertain. The EU Medical Devices Directive (MDD) points to a possible solution. The MDD envisages that medical products designated as high-risk require improved post-market surveillance studies – after the CE certification. The head of the G-BA argued for that clinical evidence-based review process, which would require a lengthy assessment as “new treatment methods” by the Joint Federal Committee (G-BA).

Contact us to learn how our Berlin office can guide health care app developers by supporting evidence generation that shows the benefit of the application when the law comes into effect in January 2020.

Medical Disposables & Consumables Players Face Challenge of Government-Initiated Price Cuts in China

2019-08-30T11:57:02-05:00August 29th, 2019|Categories: Recent News|

Winter Is Coming… Medical Disposables & Consumables Players Face Challenge of Government-Initiated Price Cuts in China

September 2019

When the Chinese government started to slash drug prices in 2018, it was only a matter of time before medical consumables would be affected. Then the payment reform – from the FFS payment model to DRGs is intended to change the providers’ behaviors in managing their finances by increasing their sense of cost ownership. Now the storms of direct price cuts on consumables initiated by local governments are expanding rapidly across the country.

The government-led price cut campaign started with Anhui province (a province in East China adjacent to Shanghai) in July where orthopedic implants (spinal implantation only) and ophthalmologic consumables (intraocular lenses) were chosen for applying the mechanism known as the “volume-based procurement”, which consolidates the annual volume from all the public hospitals in the province to only those tender winners. In the past, the provincial tendering process was merely a supplier and price registry process as procurement decision still largely sits with the individual hospitals.

It happened so quickly that many manufacturers didn’t have time to react. The news was released on July 3 and the results could be seen on July 30 with a dramatic price reduction of 53.4% on average with an estimated annual saving of RMB400 million (approximately $57 million USD). Further detail is provided in the table below.

Medical Disposables & Consumables Players Face Challenge of Government-Initiated Price Cuts in China

The Jiangsu province has chosen a slightly different approach from the Anhui province that, in addition to products selected for a price reduction on a provincial level, such as stents and pacemakers, cities are also encouraged to create their own plans for the remaining products. For example, Nanjing, the capital city of the Jiangsu Province, has initiated a procurement alliance with two nearby cities for injection-based products such as disposable precision infusion sets, peripheral intravenous catheters and implantable venous access ports with an average reduction of 72.61% equivalent of estimated annual saving of RMB413 million (approximately $59 million USD).

Even as we write this article, more provinces are preparing to launch their initiatives.

This is certainly very disruptive to the device industry because the manufacturers must fight the sudden surge of provincial and local governments’ price negotiations and on most occasions, there is nothing to negotiate when payers are determined to slash prices by 30% to 50%. While the provincial payers are excited about the rigorous price cuts on disposables and consumables, the central government is also doing the groundwork to increase its scrutiny on healthcare spending. The NHSA (National Healthcare Security Administration) created a national database with a standardized coding system for medical services and products as well as providers such as hospitals, pharmacies, and individual healthcare professionals, nurses and doctors. Understandably this database is designed to enable the payer to have a direct look into the behavior down to the individual level through data sets.

Currently, the database is ready for the registry for medical consumables. Suppliers or their appointed agents are required to register and validate the information of their CFDA (now known as NMPA – National Medical Products Administration) approved products by end of September 2019.

Implications for Innovators

Be prepared for a period of turmoil given the local and central policymakers’ intention to cut prices on medical supplies as one of the many attempts to control ever-increasing health care expenditures while the Chinese economy is expected to slow down.

Key Takeaways
  • Innovators with existing products in the China market should make sure that they or their partners register the products with the NHSA’s database prior to the September 30, 2019 deadline.
  • Work closely with your local colleagues and business partners to develop pricing plans both tactically and strategically to handle local price reductions. To compromise, or not, in the price reduction negotiation, is the question.
  • Innovators, as individual companies or as a group, need to work on a strategic and innovative plan and engage the various stakeholders to influence future policy settings that still recognize and encourage medical innovation amidst the ongoing pressure on payment.

Boston Healthcare has a deep understanding of the evolving healthcare landscape in China. Please contact us to see how we can help.

Possibility for Examination to be Included in the SHI Fee Scale Brings More Certainty for Reimbursement for New Diagnostics in Germany

2019-08-06T12:24:47-05:00August 1st, 2019|Categories: Recent News|

Possibility for Examination to be Included in the SHI Fee Scale Brings More Certainty for Reimbursement for New Diagnostics in Germany

July 2019

Manufacturers can now have more certainty about the process of inclusion of a new laboratory, new human-genetic, or new tumor-genetic diagnostics in the SHI reimbursement fee scale EBM.

In the past, the inclusion of new diagnostic tests in the EBM was not transparent, with unclear timelines and requirements and manufacturers were unable to drive the process. As of July 2019, organizations of medical professional associations and medical societies at the federal level, national associations of manufacturers of diagnostic services or medical devices, as well as the stakeholders in evaluation committees are now entitled to apply at the start of the consultation to accept new medical diagnostic services to the EBM. Available scientific evidence and expectations of budget impact and economic efficiency has to be submitted to inform decision making on the medical background and technical aspects of the test. The duration of the process is up to 24 months, with a one-time possibility for an extension of 6 months.

Within 4 months after the submission, the applicant will be informed about the status of the test: whether it is already included in the EBM, if the test can undergo the inclusion process, or if the new test is regarded as a new scientific method. In this case, a formal lengthy method assessment by the G-BA would be required.

If the diagnostic test is required as a companion diagnostic (CDx) on the label of a new a drug, the CDx has be included in the fee scale when the AMNOG early benefit assessment of the drug is completed, which is 6 months after the drug approval.

This new evaluation process supports manufacturers’ strategic planning and defines the criteria and requirements for positive decision making. The novelty of this standardized process implies that experience in practice is still necessary.

BHA can guide manufacturers through the process and forms. To learn more, please contact us.

Germany Healthcare News

Escalated DRG Payment Model Pilot in China Expected to Pose a Genuine Threat to Innovators

2019-08-06T12:23:45-05:00July 31st, 2019|Categories: Recent News|

Escalated DRG Payment Model Pilot in China Expected to Pose a Genuine Threat to Innovators

August 2019

As a critical element of accelerating the healthcare payment reform, the pilot of Diagnosis Related Groups (DRGs) in 30 major cities across China was officially announced in June by state administrations including National Healthcare Security Administration (the administration in charge of public health insurance), National Health Commission (aka Ministry of Health) and Ministry of Finance. The ambition is to switch from the current Fee-for-Service model to the DRG payment scheme in 2021 after a 3-year simulation from now on in those pilot cities.

Despite the overwhelming bias of the mainstream media to promote the benefits of DRGs as a more efficient way to spend healthcare resources, the industry, i.e., the medical suppliers, the manufacturers as well as the providers, i.e., the hospitals in China are seriously concerned, as this is just another cost containment measurement from the government payers among the very various attempts only that this is a much more radical and systematic change. We believe the policy makers’ intention to introduce the DRGs model to replace FFS is to push the cost ownership to the hospitals in order to slow down the ever-increasing healthcare expenditure.

Traditionally under the FFS model, the hospitals and the suppliers have shared interests in overuse of examinations, medications and disposables and pushing up the prices whenever possible. The Chinese government has purposely set the charges of medical services offered by the public hospitals superficially low in order to achieve the accessibility objective of a social healthcare system. Recognizing there is no sufficient funding from the government to the public hospitals to provide the needed medical care, a practical solution adopted by the previous healthcare reform was to allow hospitals to add a small markup on the purchase prices of medications and disposables they’ve used in the diagnosis and treatment process. That explains why the big hospitals in big cities have become the “sweet spot” for suppliers of medical technologies with premium price.

However, since 2009 when the current healthcare reform started, a series of cost control measurements and policies have been introduced as the government tried to expand the healthcare coverage in terms of population. Discontinuing the mark-up practice is an obvious first step taken by the government to stop encouraging public hospitals from using the more expensive medical products. Then introduction of quota on disposable and medication spending as well as annual healthcare expenditure growth, global budget, bundled payment, etc. all with a very clear goal, i.e., cost control.

Now finally the adoption of DRG payment model for the inpatient setting. The reason we are particularly concerned of this reform, from an industry’s perspective, is because it will turn hospitals to an opposite side of the industry as for the first time public hospitals will have direct financial losses if the costs of medical products needed to treat a particular patient exceed the payment cap set by the government. And there is no reason to believe or hope a government that has the obligation to provide health care to almost 1.4 billion people and try to stand by the equality principle has the willingness or ability to set that payment cap on a level desired by the suppliers, especially those in the premium category.

Exhibit: Select examples of bundled payment introduced by provincial government payers for lung disease procedures.

China Select Bundled Payment (aka case payment) Examples

This is an alarming new movement not only in terms of creating new challenges for the industry as customers’ (public hospitals) procurement behavior would change as a result of change of their financial model and probably more so from a patient’s perspective –  who are there to make sure quality of care are not compromised should the providers go to the extremes that they would only go for the cheapest available products to maximize their own financial gains.

Boston Healthcare Associates works for innovative medical technology players to help our clients unlock the value of innovation. Our in-market experts closely monitor the policy and market trends on the strategic markets like China to help clients stay on top of industry trends and develop strategies and action plans to tap into the opportunities or tackle the issues. Our involvement in China’s payment reform dated back as early as 2015 with a BHA branded international DRG forum co-hosted by the government stakeholders such as payers and health policy makers. BHA will pay close attention on the further development of DRG payment reform and its pilot in China.

Source

First Meeting of the Italian Regional Purchasing Centers

2019-06-26T10:37:27-05:00June 24th, 2019|Categories: Recent News|

First Meeting of the Italian Regional Purchasing Centers

June 2019

Italian public healthcare structures can buy medical devices only via tenders. Up to 2016, competitive pricing was the main rule for tender winners. Since then, the Price/Quality criteria can be applied in the rate of 70/70, 50/50, usually 30/70. Quality is not anymore limited to the functional and esthetic products features and its handling use. The attention is now focused on the commercialization phase, innovative and efficacy features, profitability and usability of instruction for final users, as well as Eco-friendly features. Companies’ organization procedures and professional training can be also valued in tenders protocols.

How has quality declined in the regional tenders over the last 3 years? This was discussed in the first regional Purchasing Centers conference in May 2019 in Florence.

The main Italian regional purchasing centers, representing 78% of them (Azienda Zero- Veneto Region; SCR-Piemonte Region; Intercent-er Emilia Romagna Region; Soresa, Campania Region; Centro per gli Acquisti Lazio Region, SUA Abruzzo Region, Estar Toscan Region), under the framework of FARE (Federazione delle Associazioni Regionali Economi e Provveditori della Sanità), the Italian Association of purchasing managers, selected their subject for the conference from the National Catalogue of Medial Devices and compared protocols of performed tenders using the same template. Diabetes micro pumps, endoprosthesis, stents, stomia medical devices, and defibrillators were some the conference subjects.

Reading in parallel the results, it showed that tenders protocols were homogeneously drafted in some of their main chapters: medical devices need definition (mostly based on epidemiological or healthcare structures local database data collection/estimates), implementation of the companies hearing phase (mostly web-based or email based), application of the so-called Accordo Quadro.

This latter is widely chosen as tender strategy. It is a specific purchasing pattern in which Companies, selected on the basis of the tender protocol, can participate to a specific agreement with the Purchasing Centers defining only selling price and quality parameters: the next purchasing contract is locally defined. This agreement has the main advantage of not excluding any Companies from the “winners” and allows healthcare structures to provide to patients the appropriate medical devices they need in the framework of a tender.

A further common action is the presence Clinicians in the Technical Committees: they play a key role in the identification and definition of tenders’ minimum, potentials and not fungible criteria. Pharmacists, Purchasing Managers and Administrative Personnel mostly decline Clinicians requirements in technical items.

Diversity regarded timing to perform the tender which depended from the complexity of the medical devices to be discussed. Moreover, diversity regarded the specific task of the Purchasing Center. For example, Estar also has function of storage of medical devices and drugs. This is absolutely a great advantage in the estimation of products need due to the availability of data from the regional database.

More relevant is the different link with the Regions. Estar for instance must comply the purchasing assessment to the regional guidelines, if delivered: for example, the stomia medical devices tender was based on the regional guidelines. Others also work in perfect alignment with the regional government: Intercent-er could create ad hoc technical committees including regional politicians (example: endoprosthesis tenders), the Centro per gli Acquisti Lazio Region implemented the diabetes medical devices tender in agreement with the Region and Federfarma (i.e. the regional retail pharmacies network).

In conclusion, this first experience of networking of the regional Purchasing Centers was the first step to identify appropriateness and improvement areas in the Quality definition in the purchasing patterns of medical devices in Italy. Thus, it implies for Manufactures the possibility to better understand and interact with the Purchasing Centers and consequently align with their Quality requirements.

Boston Healthcare Associates assists our clients with market access challenges in Italy due to our long-term partnership with local consultants. To learn more, please contact us.

  • germany healthcare news

Possibility for Examination to be Included in the SHI Fee Scale Brings More Certainty for Reimbursement for New Diagnostics in Germany

August 1st, 2019|Comments Off on Possibility for Examination to be Included in the SHI Fee Scale Brings More Certainty for Reimbursement for New Diagnostics in Germany

In the past, the inclusion of new diagnostic tests in the EBM was not transparent, with unclear timelines and requirements and manufacturers were unable to...

New Independent Medical Review Board for Germany

2019-06-17T12:01:23-05:00April 1st, 2019|Categories: Recent News|

Federal Health Minister Proposes Independent Medical Review Board

May 2019

For medical device and diagnostic innovators, a planned organizational change in review boards for Germany’s Statutory Health Insurance (SHI) could lead to new opportunities for market access of their products.

The Federal Ministry of Health in Germany is seeking to reform the regional medical review boards of the SHI funds (Medizinischer Dienst der Krankenversicherung – MDK), and the medical review board of the National Association of SHI funds (Medizinischer Dienst des Spitzenverbandes der Krankenkassen – MDS). The verification of hospital bills and assessment of medical necessity, efficacy, and efficiency of inpatient treatments are amongst a range of areas under review.

Currently, these review boards are organized as working groups of the SHI funds, with questions raised as to the level of independent advice provided. A draft bill presented by the Federal Ministry of Health plans to convert the MDK/MDS into an independent body and broadens representatives on the board to include patients, consumers, physicians, and nursing professions.

The MDK/MDS  undertakes case-by-case reviews procedures, which are not covered regularly by the SHI. Both groups also conduct internal SHI reviews (not published) of new treatment and diagnostic methods. Independent recommendations, which are not influenced by the financial interests of the SHI funds, could lead to fewer rejected applications for cost assumptions, and more clinical driven decisions in the NUB process.

If the proposed change becomes law, it will establish the MDK/MDS as an independent assessment body in addition to the IQWiG and IQTIG, with direct implications for reimbursement decision making. An increase in transparency of decision-making could also be expected.

Boston Healthcare has successfully guided hundreds of life science clients from around the world in commercializing their medical devices in Germany. To learn more, please contact us.

  • germany healthcare news

Possibility for Examination to be Included in the SHI Fee Scale Brings More Certainty for Reimbursement for New Diagnostics in Germany

August 1st, 2019|Comments Off on Possibility for Examination to be Included in the SHI Fee Scale Brings More Certainty for Reimbursement for New Diagnostics in Germany

In the past, the inclusion of new diagnostic tests in the EBM was not transparent, with unclear timelines and requirements and manufacturers were unable to...

Winter Has Come – Aggressive National Programs To Drive Down Drug Costs

2019-06-26T12:25:15-05:00January 31st, 2019|Categories: Recent News|

Winter Has Come – Aggressive National Programs To Drive Down Drug Costs

January 2019

National Drug Price Negotiation

Towards the end of 2018, pharmaceutical companies were invited to bid for contracts to supply 31 drugs to hospitals in 11 cities in China under a new, highly competitive tender process. After two months of negotiations, 17 anti-cancer drugs have been included in the National Reimbursement Drug List (NRDL) with an average price reduction near 50 percent.

Through this process, there can be only one ‘winner’ to supply a drug, which includes high blood pressure and cholesterol treatments, and allergy and cancer medication.

The new process, which allows the Chinese government to cherry-pick drugs and slash drug prices in exchange for reimbursement status, was introduced in 2016. In the same year, three drugs out of five candidates managed to reach an agreement with the Chinese government after slashing their prices by almost two-thirds.

While a speedier approval process may be an achievement for the industry, particularly to innovative players who lobbied for accelerated and positive reimbursement decisions for new drugs following Chinese approvals, slashing prices by half, or even more, creates new coverage and price challenges.

This event is being described as an earthquake to both the domestic and foreign pharmaceutical industry, and both innovative and generic drug manufacturers will experience slimmer profit margins and a change in business activities with hospitals as a result.

The procurement pilot program comes at a time when China is pushing for broader adoption of generic drugs to drive down overall health spending and to make room to adopt innovative medicines in a national drug reimbursement system.

Multinational pharmaceutical companies will be the hardest hit by this change as a result of only two imported products winning the bid, and also with a significant compromise on their prices – over 80 percent price reduction on gefitinib (AstraZeneca) and more than 60 percent on fosinopril sodium tablet from BMS, an ACE inhibitor.

For the generic players, this new mechanism featuring “all-or-nothing” and “lowest-price-wins” sends a strong signal that the central government is determined to accelerate industry consolidation by pushing out smaller players.

 
Just how important is the national procurement program?

Boston Healthcare has been routinely involved in comparative studies of healthcare policies and market dynamics between China and the United States and regularly reviews price differences (Table 1). The following table highlights price differences for specific drugs following negotiations.

However, not all companies are able to meet the expectations of the Chinese government.

For example, Bosentan (Tracleer®), a drug indicated for Pulmonary Arterial Hypertension, was approved by the China Food and Drug Administration (CFDA) in 2006 but was not included on the NDRL. In 2016 the manufacturer made a voluntary price reduction to drop the retail price from $2,854 to $571 per box. In 2017 the manufacturer rejected the government’s proposal to reduce the price by another 80 percent (to $114 per pack). As a result, the drug will not be reimbursed.

Table 3 shows the extreme examples where hundreds of drug manufacturers used to divide the market.

In less than three years, Gefitinib (brand name: Iressa®), a lung cancer drug of AstraZeneca has dropped its price to about only 10 percent of its original price to survive the two events discussed in this article, national price negotiation, and national procurement (Graph 1).

Very much like the journey of the national drug negotiation mechanism the industry is now learning that a consolidated procurement program will only expand over time, particularly in the dimensions of the number of drugs, or the areas, or both.

What can innovators do?

For multinational or domestic pharmaceutical companies, Boston Healthcare recommends the following:

  • For those with commercial responsibilities:
    • Review negotiations and price cuts applied to drugs within their relevant therapeutic area since 2016 to prepare pricing strategies and tactics for the next round of negotiations – if seeking market access in China
  • For those with policy, market access, government affairs or business development responsibilities
    • Gain an in-depth understanding of the events occurring in China to inform global pricing, market access, and lobbying strategy development and execution.

For pharma companies entering the Chinese market, these recent changes require companies to develop a well-informed, validated market access approach to ensure success.

Boston Healthcare has a deep understanding of the evolving value and access landscape in China. Please contact us for more information.

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Table 1: US and China drug prices comparison
Table 2: failed negotiation example 
Table 3: Bidding that has more than 100 bidders    
Graph 1

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.

Defining the value of innovative treatment methods in Germany

2019-06-17T11:57:12-05:00January 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.

FDA Issues New Draft Guidance on Class Labeling of Companion Diagnostics

2019-06-18T13:55:47-05:00December 18th, 2018|Categories: Recent News|

FDA Issues New Draft Guidance on Class Labeling of Companion Diagnostics

21 December 2018

New draft guidance for the labeling of drug and diagnostic products released earlier this month by the Food and Drug Administration (FDA) aims to expand the labeling of a companion diagnostic (CDx) across a specific group or class of therapeutics, rather than a specific drug, as is current practice.

The guidance, entitled, “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” is part of a broader agency focus on personalized medicine.

Central to the guidance is the consideration of when broader labeling of a CDx would be appropriate. Oncology companion diagnostics with broader evidence-based indications will facilitate optimal access to testing, promoting better patient care.

The FDA is accepting public comments on the guidance, due by February 5, 2019.

Our CEO and President, Joe Ferrara outlines the oncology CDx landscape and key considerations for developing a CDx commercialization strategy in a presentation given in Berlin earlier this month.

To learn more about the FDA’s new draft guidance and implications for innovators please contact us.

Boston Healthcare has been successfully advising both emerging and established diagnostics companies on how best to commercialize their products for 25 years.

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.