Cardiology 2018 – From Basic Science to High Performance Medicine

Cardiology 2018 – From Basic Science to High Performance Medicine

“Cardiology 2018 – From Basic Science to High Performance Medicine” was the theme of the 84th Annual Meeting of the DGK – Deutsche Gesellschaft für Kardiologie – Herz- und Kreislaufforschung (German Cardiac Society) that took place in Mannheim from April 4th to 7th 2018. More than 8,000 delegates met to discuss the newest developments in European cardiology.
Kalms Consulting’s experts, Dr. Katja Schröder and Dr. Holger Schaffrath, participated in the meeting; there they met with clients as well as important stakeholders in German and European cardiology.

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“Seen from the perspective of innovative medical devices, new diagnostic modalities for established treatment methods and interdisciplinary as well as personalized care concepts in cardiology, the German market offers world class scientific and medical expertise. This makes Germany the preferred target market for launching medical device innovations. The challenges of securing sufficient reimbursement for new technologies can overcome these by using sophisticated, yet practical, market access strategies”

 Dr.-Ing. Holger Schaffrath

Dr.-Ing. Holger Schaffrath

Kalms Consulting Newsletter 01/2018

Kalms Consulting Newsletter 01/2018

out-patient reimbursement code received/

SUCCESSFUL SUPPORT FOR ALLERGAN

Kalms Consulting is happy to announce the successful support and execution of our client Allergan’s reimbursement strategy to receive an outpatient reimbursement code for the physicians treating the over-active bladder with BOTOX® injections. Starting on 1st January 2018, physicians get an extrabudgetary add-on payment for the treatment on top of the insufficient codes that could be used until 2017.

BOTOX® is FDA approved to treat overactive bladder symptoms such as a strong need to urinate with leakage, urgency and frequency in adults when another type of medication (anticholinergic) does not work well enough or cannot be taken. The transurethral injections can be done in an inpatient as well as in an outpatient setting for suitable
patients. 

Over three years, Kalms Consulting was involved in Allergan’s efforts to initiate a dialogue with relevant stakeholders of the decision-making process –

convincing them of the benefit for patients and of potential cost-cutting for health funds by shifting a part of the cases from the hospital to the outpatient setting. Furthermore we have supported selective contracts between single public health funds and regional physicians associations - to put pressure on the process on the federal level and bridge reimbursement until a nationwide solution. 

Receiving an outpatient reimbursement code is a long-term project in the German public health system. Contrary to the formalized procedures in hospital reimbursement, the process in the outpatient sector is based on open negotiations between the federal association of health funds and the federal physicians association. In most cases – contrary to the Botox case – a prior formalized benefit assessment is obligatory. 

Kalms consultants are happy to inform you about the details of the rules and the necessary steps to take.

 

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MARKET ACCESS STRATEGY WITH SELECTIVE CONTRACTS/

AN ALTERNATIVE APPROACH IN ACCESSING THE GERMAN HEALTHCARE SYSTEM

The German healthcare system has two comprehensive Reimbursement systems, one being the DRG-Catalogue in Hospitals, the other being the EBM-Catalogue for the outpatient sector. These catalogues value diagnostics and therapeutical interventions for reimbursement. In the private
sector, there is a further catalogue, the honorary table for physicians (GOÄ).

These catalogues are final. There are several approaches for new methods to be included in one of the catalogue and thereby obtain a reimbursement value. Due to the strong
regulation of the German healthcare system and in particular due to the strict separation of hospital and outpatient care, lawmakers in Germany created an additional instrument to give patients access to integrated care or special outpatient care. This instrument is called selective contracts and creates opportunities for additional reimbursement or use of methods not approved for the regular outpatient care.  In a selective contract, one or more
medical provider (physicians, doctors’ offices or hospitals) negotiate with one or more health funds on a special care pathway with the respective payment of a specific treatment or diagnostics.

This care is accessible for all patients insured with this health fund.  Selective contracts are a relatively „fast“ track into the German healthcare system, especially if the method is positioned at the boundary between hospital and outpatient care or if an outpatient method is creating special economic benefits for the health fund.  The negotiation of selective contracts is complex. A vigorous and complete preparation is necessary. Economic and medical advantages need to be evaluated and clearly explained for the negotiating partners. Equally important is the selection of the service providers and health funds for the initial negotiations. Moreover, any selective contract should always be seen in context of a broader market access strategy to align on mid-term goals. For example, negotiating an open contract with the possibility to allow other service providers and health funds to enter the contract is enlarging the potential market.

Kalms Consulting has been part of negotiations and execution of selective contracts and possesses the right amount of experience to embed the element of a selective contract into a market access strategy. This ensures that this vital instrument is used at the right time.

 
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ROADSHOW TO CHINA/

SIGNIFICANT INTEREST OF CHINESE INVESTORS IN EUROPEAN AND US MED TECH AND LIFE SCIENCE COMPANIES

For the first time in the company’s history, Kalms Consulting was on a roadshow to China mid of
October. Starting in Shanghai and continuing to Beijing, we met with various important players on the Chinese med tech and life science market, including distributors and investors.

The Chinese healthcare market for European and US med tech and life science companies

The Chinese healthcare market is of growing importance and (by overall volume) already on the third place worldwide. Presence on this market can significantly increase revenue and company valuation. With the right partner in place, market access in China will be successful and the time needed for regulatory obligations can be minimized. There is a fast-growing interest of strong and  countrywide distributors for new and innovative products – capital goods as well as expensive disposables and consumables. Various kinds of agreements, including risk sharing and market development activities executed by the distributor, are possible.

 

Significant interest of Chinese investors in European and US med tech and life science companies

The interest of Chinese investors in med tech and life-science companies in Europe and in the US is tremendous. Investments can range from minority to majority or even acquisition of the entire company. In the past, investors tended to move IP and infrastructure to China. This has significantly changed in the past years. In most cases the European / US business remains
unchanged, but new sales channels in China and other countries with strong links to China become accessible.

Our roadshow to China took place in collaboration with Taylor Wessing, a full-service international law firm, working with clients in the world’s most dynamic industries. Taylor Wessing attorneys can support our clients with protecting their IP, all needed contracts and legal advice when entering the Chinese market.

In case of any interest in the Chinese market, you are very welcome to contact Stephan Binder at Kalms Consulting.

 
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SHORT NEWS/

RESULTS OF THE 2018 NUB APPLICATIONS

On January 30th, 2018, the Institute for the Reimbursement System in Hospitals (InEK) published the results of the 2018 applications for extra reimbursement for New Diagnostic and Treatment Methods (NUB).

The annual procedure of hospitals’ submissions of NUB Inquiries to InEK has the purpose to achieve the opportunity to negotiate extra reimbursement, if the new method requires funding exceeding the level of the existing DRG yields for standard of care treatments. For new methods which constitute a new theoretical scientific concept and use  medical devices with specific risk class and invasive approach, the Joint Federal Committee (G-BA) is obliged by law (§137h SGB V) to conduct an early benefit assessment on the new method. Especially the latter assessment requires distinct preparation.

Kalms Consulting is advising clients in the phases of NUB draft preparation and conduct of the NUB procedures with and without required §137h assessments.

In both cases, our primary target is a positive NUB status for our client. Therefore, profound submission documents must be prepared for hospitals. The client must be guided to support hospitals through the NUB negotiation steps with the health funds to finally agree on a sufficient NUB extra fee value. 

The results of the 2018 NUB applications are available at www.kalmsconsulting.com

Kalms Consulting services include the analysis of likelihood of success as well as risk assessment and risk management. Next to this, we support you and your customers in hospitals at all stages of the application process including support of budget
negotiations in case of a successful NUB application.

You are very welcome to contact us to discuss if your product(s) might be applicable for the next NUB application period.

Results of the 2018 NUB applications

Results of the 2018 NUB applications

On January 30th, 2018, the Institute for the Reimbursement System in Hospitals (InEK) published the results of the 2018 applications for extra reimbursement for New Diagnostic and Treatment Methods (NUB). 
The annual procedure of hospitals’ submissions of NUB Inquiries to InEK has the purpose to achieve the opportunity to negotiate extra reimbursement, if the new method requires funding exceeding the level of the existing DRG yields for standard of care treatments. For new methods which constitute a new theoretical scientific concept and use  medical devices with specific risk class and invasive approach, the Joint Federal Committee (G-BA) is obliged by law (§137h SGB V) to conduct an early benefit assessment on the new method. Especially the latter assessment requires distinct preparation.

Kalms Consulting is advising clients in the phases of NUB draft preparation and conduct of the NUB procedures with and without required §137h assessments. In both cases, our primary target is a positive NUB status for our client. Therefore, profound submission documents must be prepared for hospitals. The client must be guided to support hospitals through the NUB negotiation steps with the health funds to finally agree on a sufficient NUB extra fee value. 

The results of the 2018 NUB applications are available at
http://www.g-drg.de/G-DRG-System_2018/Neue_Untersuchungs-_und_Behandlungsmethoden_NUB/Aufstellung_der_Informationen_nach_6_Abs._2_KHEntgG_fuer_2018

Kalms Consulting services include the analysis of likelihood of success as well as risk assessment and risk management. Next to this, we support you and your customers in hospitals at all stages of the application process including support of budget negotiations in case of a successful NUB application.

You are very welcome to contact us to discuss if your product(s) might be applicable for the next NUB application period.

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Roadshow to China - Significant interest of Chinese investors in European and US med tech and life science companies

Roadshow to China - Significant interest of Chinese investors in European and US med tech and life science companies

ROADSHOW TO CHINA/

For the first time in the company’s history, Kalms Consulting was on a roadshow to China mid of October. Starting in Shanghai and continuing to Beijing, we met with various important players on the Chinese med tech and life science market, including distributors and investors.

 

The Chinese healthcare market for European and US med tech and life science companies

The Chinese healthcare market is of growing importance and (by overall volume) already on the third place worldwide. Being present on this market can significantly increase revenue and company valuation. With the right partner in place market access in China will be successful and the time needed for regulatory obligations can be minimized.

There is a fast-growing interest of strong and countrywide present distributors for new and innovative products – capital goods as well as expensive disposables and consumables. Various kinds of agreements, including risk sharing and market development activities executed by the distributor are possible.

Significant interest of Chinese investors in European and US med tech and life science companies

The interest of Chinese investors in med tech and life-science companies in Europe and in the US, is tremendous. Investments can range from minority to majority or even acquisition of the entire company. While in the past investors tend to move IP and infrastructure to China, this has significantly changed in the past years. In most cases the European / US business remains unchanged but new sales channels in China and other countries with strong links to China become accessible.

Our roadshow to China was in collaboration with Taylor Wessing, a full-service international law firm, working with clients in the world’s most dynamic industries. Taylor Wessing attorneys can support our clients with protecting their IP and all needed contracts and legal advice when entering the Chinese market.

In case of any interest in the Chinese market you are very welcome to contact me.

Stephan Binder

Kalms Consulting Newsletter 01/2017 - The new American Division of Kalms Consulting

Kalms Consulting Newsletter 01/2017 - The new American Division of Kalms Consulting

THE NEW AMERICAN DIVISION OF KALMS CONSULTING/

PROVIDING AMERICAN FIRMS FASTER ACCESS TO THE EUROPEAN HEALTH CARE MARKET 


Kalms Consulting is pleased to announce that it is opening two new American offices in the most vibrant healthcare technology regions of the United States: San Francisco and Minneapolis.

Navigating FDA approval can be a significant investment in time and dollars. Executing a dual pathway strategy via the European market can provide a streamlined opportunity that quickly allows manufacturers to jumpstart revenue gains, develop a strong health economics story, and aggregate additional clinical data needed to successfully gain approval in the U.S. The European market is also an attractive target for well-established companies looking to expand beyond their native country. Kalms Consulting enjoys longstanding relationships with small, mid-cap and large, US-based medical device, biotech, biopharma and life science clients who continue to benefit from broadening their revenue pathways in Europe. Establishing permanent offices in the United States to better serve existing and future clients made perfect sense. The Kalms Consulting team is comprised of experienced and highly qualified experts who deliver affordable, data-driven solutions to clients worldwide. The U.S. division will specifically focus its efforts on market access, strategic business development, technology assessment and market analysis while working in concert with their European counterparts.

MARCO KALMS
Founder & CEO

“It is my pleasure to introduce the American Division of Kalms Consulting. With these offices we’re giving American firms a better opportunity to access the German and European market.” 

 

Kalms Consulting GmbH
Rheinstrasse 45–46 Aufgang 1
12161 Berlin | GERMANY


KALMS CONSULTING SAN FRANCISCO/

HEALTH CARE IS THE BIGGEST INDUSTRY IN THE BAY AREA 

San Francisco is the cultural, commercial, and financial center of Northern California.
California has a great history of innovation in life sciences, developing new technologies to solve health problems.

As the birthplace of biotechnology California stands for the innovation in life sciences in particular. Genomic technologies help detect diseases, while new therapies and devices help to treat them. Digital health technologies help prevent diseases and provide patients with better tools to manage their conditions.

Life Sciences is a cornerstone of California’s economy and contributes to a healthier society and advances new medical technologies.
California’s life sciences community continues to grow, with 3,040 life sciences companies – 192 more than the previous year – producing new technologies and boosting the state’s economy. In 2015, the Golden State’s life sciences industry employed more than 287,000 people. This highly trained and diverse workforce helped develop novel drugs, devices and diagnostics, while also exploring other applications, such as leveraging biotechnology to produce sustainable energy. “Life sciences companies have been incredibly successful. As of September 7, 2016, 1,269 drugs from Californian companies were in the FDA pipeline. In 2015, 264 new devices developed by Californian companies were approved. Academic excellence, forward-thinking public policy and the commitment of thousands of entrepreneurs and business leaders has translated into new ways to address some of the world’s most severe medical conditions: cancer, hepatitis, HIV, rare diseases and many others. These efforts help power our economy and provide health for millions around the world.”1

1CLSA California Life Sciences Association/ 2017 California Life Sciences Industry Report 

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ADRIAN NUNN
Business Development U.S.

“Being the center of technological innovation on the West Coast San Francisco is the perfect location for opening a Kalms Consulting office. We are going to provide start ups with easier access to the rich European market.” 

 

Kalms Consulting US, Inc.
San Francisco Office
101 Montgomery Street Suite 2050
San Francisco | CA 94104

KALMS CONSULTING MINNEAPOLIS/

A HEALTH AND MEDICAL INDUSTRY HUB WITH TRADITION 

Minneapolis is the county seat of Hennepin County, and the larger of the Twin Cities.
Minneapolis and Saint Paul anchor the second-largest economic center in the Midwest, after Chicago. Minneapolis lies on both banks of the Mississippi River, just north of the river’s con uence with the Minnesota River, and adjoins Saint Paul, the state’s capital. The city is abundantly rich in water, with thirteen lakes, wetlands, the Mississippi River, creeks and waterfalls.

Minneapolis has a great tradition of making an impact on the health eld and continues to do that today. It hosts the University of Minnesota, which ranks in the top three research universities in the USA. Medical device research is robust at the University of Minnesota. One of the most innovative health providers in the nation, Mayo Clinic, is just an hour and a half drive to the south in Rochester.

Multiple Fortune 500 companies in the health eld were founded in Minneapolis, and the impression these companies have left via innovations reverberates throughout the world.
According to the Minnesota-based Medical Alley Association more than two-thirds of last year’s PMAs out of FDA went to applicants out of California and Minnesota. 

TIMOTHY ZIAJA
Business Development U.S.

“With Minneapolis’ history of Medical Innovation and achievement the founding of the Minneapolis division of Kalms Consulting will provide existing firms and start ups a gateway to the international stage.” 

 

JIM KAZMIERKOSKI
Business Development U.S.

“The location of Minneapolis in the midwest region provides easy access to firms in Cleveland, Madison and Milwaukee.” 

 

Kalms Consulting US, Inc.
Minneapolis Office
701 N. 3rd Street
Suite 202 | North Loop Minneapolis | MN 55401


EVENTS

GERMANY FIRST, AMERICA SECOND?
TAKING THE FASTER ROUTE TO MARKET FOR HEALTH CARE COMPANIES

May 23rd, 2017 | wework Transbay | San Francisco

An expert panel discussion about what challenges healthcare companies will face, but the experts also addressed the rewards that lie in international expansion. What is the best way to set up a company, how do you go about reimbursements and tax issues? For those in the initial planning phase of expansion there was a general discussion about strategic decisions a healthcare company needs to make when discovering new markets and how to approach this. Michael Kauch, Associate Partner Strategy & Public Affairs to Kalms explained in his talk the current situation of “Reimbursement and developments in Health Policy in Germany“. The panel discussed key factors for succeeding and investing in the German market as a starting point for further international expansion.

Organized by: Kalms Consulting, Osborne Clarke, Rueter und Partner, Invest in Bavaria and GACC 

 

KALMS CONSULTING SUPPORTING VISITS OF
GERMAN BUSINESS DELEGATIONS TO INTUITIVE SURGICAL 

May 25th, 2017 | Intuitive Headquarter | Sunnyvale

Supported by Kalms Consulting, high level German business delegations have visited our client Intuitive Surgical in the headquarter in Sunnyvale, California. 60 entrepreneurs, VC companies and supporting agencies were part of the Silicon Valley tour of the German start-up association (Bundesverband Deutsche Startups). Also the German Ministry of Economic Affairs had been represented. Furthermore, a delegation of the Vodafone Enterprise Forum, led by a Vodafone Germany board member, came to see the latest technological developments in robotic assisted surgery. Both groups were impressed how Intuitive Surgical has made its way from a start-up to a market leader - and how Intuitive Surgical is constantly improving its technologies for the benefit of surgeons, hospitals and patients. 

Germany first, America Second? Panel Discussion in San Francisco, May 23, 2017

Germany first, America Second? Panel Discussion in San Francisco, May 23, 2017

„Please join us for a panel discussion on how to enter the European market via Germany as a life sciences company. We will discuss key factors for succeeding and investing in the German market as a starting point for further international expansion.

Our experts will discuss what challenges healthcare companies will face, but will also address the rewards that lie in international expansion. What is the best way to set up a company, how do you go about reimbursements and tax issues? For those in the initial planning phase of expansion there will be a general discussion about strategic decisions a healthcare company needs to make when discovering new markets and how to approach this.

After the panel discussion we hope you join us for little bit less of a 'healthy' happy hour with appetizers and drinks. We look forward to seeing you there!“

Organized by:

Kalms Consulting GmbH, Osborne Clarke, Rueter und Partner, Invest in Bavaria and GACC West

Agenda and more information

Market Access Workshop, 12.05.2017, Berlin

Market Access Workshop, 12.05.2017, Berlin

Von der erfolgreichen Produktentwicklung zur rechtzeitigen Reimbursement-Planung

Powered by Kalms & Partner und NAMSA

Berlin, Rheinstraße 45 – 46, Aufgang 1, 12161 Berlin
12.05.2017

Die Teilnahmegebühr beträgt 99 € pro Person und wird in vollem Umfang an Ärzte ohne Grenzen e.V. gespendet
Die Teilnehmerzahl ist begrenzt
Anmeldungen bitte mit Name, Firma und Branche an info [at] kalmsconsult.com
Anmeldeschluss 17.04.2017

Programm:

9:00 Uhr              Registrierung

9:30 Uhr              Zulassungsstrategie – Wichtige Eckpfeiler für eine erfolgreiche Produktentwicklung und Vermarktung by NAMSA

10:15 Uhr            Frühstückspause

10:45 Uhr             Marktzugang und -akzeptanz in Deutschland: Systeme verstehen und Herausforderungen meistern by Kalms Consulting

11:30 Uhr            Mittagspause mit Zeit zum Networking

13:15 Uhr             Neue Innovationskultur im Gesundheitssystem - Medizintechnischer Fortschritt 2.0. Erwartungen und Angebote der Medizintechnologie-Branche an die Politik by BVMed

Ab 14:00 Uhr      gibt es die Möglichkeit persönliche Face-to-Face Gespräche mit den Referenten zu führen. (Bei Interesse, bitte in der Anmeldung angeben, da es nur sehr begrenzte Plätze gibt.)

Anreise:

Ab Bahnhof Zoologischer Garten mit der U9 bis Walter Schreiber Platz
Ab Hauptbahnhof mit der U55 bis Brandenburger Tor von dort mit der S 1 bis Feuerbachstraße

 
 

Referenten:

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Olaf Winkler
BVMed

ist seit 2001 Leiter des Referats Gesundheitssystem im BVMed. In dieser Zeit war er zudem für das BMGS, das DIMDI und für die Deutsche Wirbelsäulengesellschaft in unterschiedlichen Ausschüssen tätig.

Des Weiteren hat er einige Artikel zu den Themen Budgetierung, Marktetablierung und Vergütung von Medizinprodukten verfasst. 

Stephan Buttron
NAMSA

ist seit 2016 Principal Medical Research Manager bei NAMSA. Er hat über 20 Jahre Berufserfahrung in EU-US-FDA und Weltweiter Zulassung von Produkten aus dem Bereich Medizintechnik und leitete bereits einige Workshops und Trainings im Bereich des Risikomanagements und Marktzugangs.

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Dr.Benjamin Schulz
Kalms Consulting

 ist bei Kalms Consulting der Experte für bio-physikalische- und medizinische Technologie sowie für Marktanalyse und strategisches Business Development.

Er hat sowohl im Sektor der erneuerbaren Energien wie auch in dem der Medizintechnik als Strategie- und Technologischer Berater gearbeitet. 

J.P. Morgan 35th Annual Healthcare Conference 2017 in San Francisco

J.P. Morgan 35th Annual Healthcare Conference 2017 in San Francisco

Kalms & Partner Consulting will participate in the J.P. Morgan 35th Annual Healthcare Conference 2017 in San Francisco. At this event, investors and executives from all over the world meet with companies presenting their latest innovations and new partnerships are decided.

35th Annual J.P. Morgan Healthcare Conference
Monday, January 9 - Friday, January 13, 2017

For more information visit https://www.jpmorgan.com/country/US/en/jpmorgan