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First Meeting of the Italian Regional Purchasing Centers

2019-06-26T10:37:27-04:00June 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.

  • Italian Flag on pole

First Meeting of the Italian Regional Purchasing Centers

June 24th, 2019|0 Comments

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...

  • german flag flying on flag pole

New Independent Medical Review Board for Germany

April 1st, 2019|Comments Off on New Independent Medical Review Board for Germany

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.

  • Chinese Flag graphic

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

January 31st, 2019|Comments Off on Winter Has Come – Aggressive National Programs To Drive Down Drug Costs

China: 2018 was another eventful year for the pharmaceutical industry, highlighted by the Chinese government’s radical attempts to slash drug prices by the annual national drug price negotiation and along with the introduction of a national procurement program.

New Independent Medical Review Board for Germany

2019-06-17T12:01:23-04:00April 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.

  • Italian Flag on pole

First Meeting of the Italian Regional Purchasing Centers

June 24th, 2019|0 Comments

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...

  • german flag flying on flag pole

New Independent Medical Review Board for Germany

April 1st, 2019|Comments Off on New Independent Medical Review Board for Germany

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.

  • Chinese Flag graphic

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

January 31st, 2019|Comments Off on Winter Has Come – Aggressive National Programs To Drive Down Drug Costs

China: 2018 was another eventful year for the pharmaceutical industry, highlighted by the Chinese government’s radical attempts to slash drug prices by the annual national drug price negotiation and along with the introduction of a national procurement program.

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

2019-06-26T12:25:15-04:00January 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

2019-06-18T13:55:15-04:00January 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

2019-06-17T11:57:12-04:00January 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.

FDA Issues New Draft Guidance on Class Labeling of Companion Diagnostics

2019-06-18T13:55:47-04:00December 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.

Access our presentations: MedTech Access Leaders Forum, EU

2019-06-18T14:03:19-04:00December 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.

Top Chinese Think Tank Visits Boston for Study on Health Information Technology

2019-06-18T14:09:11-04:00November 27th, 2018|Categories: Recent News|Tags: , |

Top Chinese Think Tank Visits Boston for Study on Health Information Technology

28 November 2018

Earlier this month, Boston Healthcare Associates hosted a delegation from the China Development Research Foundation (CDRF), a public foundation initiated by the Development Research Center of the State Council of the People’s Republic of China, with the mission to provide policy research support for policy making on a national level.

CDRF supports evidence-based policy research, leadership training, high-level forums and symposiums to promote economic cooperation and development, and the promotion of responsible public policy.

The delegation visited Boston to learn more about the role that Health Information Technology (HIT) plays in the healthcare system, how its development has progressed, and future opportunities for improving efficiency and quality of care. Boston, as a global leader in the healthcare and life sciences industry, and home to some of the world’s leading hospitals and community health centers, health IT, and digital health companies, was chosen as one of the field study sites.

The delegation heard from innovative leaders in the HIT space from Partner’s Healthcare, Watson Health, and Harvard Pilgrim Healthcare on day one of the trip during a half day Forum at the Royal Sonesta in Cambridge. Speakers provided the delegation with an in-depth overview of the application of health information technology in healthcare delivery and management.

While in Boston, the delegation also visited and toured Boston Children’s Hospital, the MIT-IBM Watson AI Lab, and Massachusetts General Hospital.

With the Chinese government seeking to improve efficiency and quality of healthcare services and health insurance, especially at the community level, the exchange of information between innovative health organizations is timely.

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

Germany’s Approach to Biosimilars

2019-06-18T13:47:25-04:00November 27th, 2018|Categories: Recent News|Tags: |

Germany’s Biosimilar Policies

28 November 2018

Germany’s Health Minister, Jens Spahn has called for the faster adoption of cheaper copies of biotech drugs to cut the cost of healthcare in Germany.

In recent years, biotechnologically produced drugs have become a significant driver of drug spending in Germany, with 6.7 billion Euro in Statutory Health Insurance (SHI) funds spent on the treatment of rheumatic diseases alone between January and September 2018. Biosimilars are recognized as a way to contain such costs.

The National Association of SHI accredited Physicians recommend quotas for biosimilars to improve prescription uptake, with the SHI providing incentives to physicians to prescribe biosimilars through quotas, budgeting, and monitoring programs.

With quotas being difficult to manage in Germany, Spahn favors a policy based on price, requiring pharmacists to deliver the cheapest biosimilar,  in a similar way as generics are dispensed. If consistent use of biosimilars were enforced, the health ministry has estimated that this would have saved the healthcare system 279 billion euro in 2017. Projected savings are expected to rise due to many expiring patent protections for several biologics in the coming years.

Details of the proposal will be issued in the revision of the German Medicines Act (AMG), which was presented as a draft earlier this month.  This move once again demonstrates the cost-oriented approach of the governments’  health policy, which is seconded by both providers and health insurance funds.

New developments across Germany’s healthcare industry provide significant opportunities for global 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.

The growing role of Artificial Intelligence in Healthcare

2019-06-18T14:11:55-04:00October 31st, 2018|Categories: Recent News|Tags: |

The growing role of Artificial Intelligence in Healthcare

The digitalization of healthcare has changed how the industry manages diseases, with artificial intelligence (AI) providing the industry with the opportunity to capture and analyze data in a new way that is beneficial to patients, physicians, and the broader healthcare community.

In October, Boston Healthcare connected with the innovators of AI-enabled companies at the AI in Healthcare Conference. Discussions focused on the use cases of AI in healthcare, barriers to adoption, as well as measures to ensure successful integration of AI.

Also discussed were the many value propositions of AI in healthcare, including:

  • Improving workflow efficiencies,
  • Reducing or controlling healthcare costs and spending,
  • Lessening the time and cost of developing new personalized treatments, and
  • Avoiding repeat visits and readmissions.

Despite clear use cases for AI in healthcare, many barriers to adoption still exist.

For successful AI adoption, there needs to be increased and secure data sharing as well as communication between AI innovators and physicians, lab technicians, and other potential users of AI technologies.

Increased communication between AI innovators and AI technology users is particularly important as the value and utility expectations for an AI product or service may vary amongst different stakeholders. In AI, as is in other healthcare fields, being able to bypass or pass FDA regulations does not guarantee product adoption. Being able to understand the unmet needs that are important to healthcare stakeholders will ultimately create value and demand for AI healthcare products and services.

Boston Healthcare is aware of the growing market for AI in healthcare and is prepared to help AI innovators realize the value of their product and navigate AI adoption and implementation barriers in the healthcare landscape.