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Latest Trends in Orphan Drug Pricing and Reimbursement

$2,995.00

It is now some 35 years since the passage of the first law designed specifically to encourage investment in the discovery and development of rare disease treatments. Activity in the sector has been transformed since then.
February 1, 2018
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US Pricing and Reimbursement

$2,995.00

Historically, few pricing controls have been implemented in the US; however, there is greater pressure to implement controls to help contain costs associated with the expansion of public healthcare provision.
November 2, 2016
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Biosimilars Market Access in Psoriatic Arthritis

$2,995.00

Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriatic arthritis market. These market leaders, however, face patent expirations and consequent biosimilar launches.
March 6, 2017
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UK Generics and Biosimilars

$2,995.00

Prescribing by international non-proprietary name, pharmacist incentives, and the high price differential between the brands and their generic alternatives are the key drivers of the generics market in the UK.
November 2, 2016
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Russia Generics and Biosimilars

$2,995.00

Despite high volume uptake, generics still account for only a small proportion of the total market value in Russia, driven by a lack of incentives for generic substitution and the significant originator/generic price differential.

November 3, 2016
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Biosimilars Market Access in Psoriasis

$2,995.00

Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriasis market; however, these market leaders face patent expirations and consequent biosimilar launches
March 6, 2017
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Gene Editing: The Next Breakthrough in Regenerative Medicine

$2,995.00

Believed to be one of the great biotechnology breakthroughs, gene editing is a powerful tool in pharmaceutical research that could radically change how certain diseases are treated.
September 1, 2017
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Digital Pharma: Are We Nearly There?

$2,995.00

Digital’s potential to transform every aspect of the pharmaceutical value chain, from discovery to commercial, is widely documented.
August 14, 2018
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Orphan Drug Access and Pricing in Emerging Markets

$2,995.00

This analysis covers the four major emerging regions of the Middle East and Africa, Latin America, Eastern Europe, and Asia-Pacific. Within these regions, relatively wealthier markets with a proven marketplace for orphan medicines have been prioritized.
January 12, 2018
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2019 Biomedtracker / Datamonitor Healthcare Post-AAN Report

$2,995.00

The 71st Annual Meeting of the American Academy of Neurology (AAN) was held in Philadelphia, Pennsylvania, from May 4-10, 2019.

May 28, 2019
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The Growing Impact of Real-World Evidence

$2,995.00

Real-world evidence (RWE) has become increasingly important in proving the value of drugs and differentiating them from their competition.
July 14, 2017
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Key Potential Drug Launches in 2021

$2,995.00

As a supplement to our well-known quarterly Outlook report, Biomedtracker is pleased to present a longer-term look at some key late-stage drugs projected to hit the market in 2021.

1.

July 24, 2020
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Renal Cell Cancer Pricing, Reimbursement, and Access

$2,995.00

There is moderate concern among payers regarding spend on renal cell cancer (RCC) drugs, but access restrictions remain mild.
August 22, 2018
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CRO Snapshot: Clinical Outsourcing in 2012

$5,000.00

By any standards, last year was a turbulent one for the pharmaceutical sector. The patent cliff claimed some of the industry’s most profitable properties and with the market share of these drugs losing ground to generics, put even more pressure on the top- and bottom-line performance of key players such as Eli Lilly and AstraZeneca, to name just two of the worst hit.

Such pressure – and the drive to cut fixed costs that goes with it – has been a boon for clinical CROs, which have become increasingly indispensable to the business of drug discovery, as clinical development is outsourced and specialist units, such as clinical laboratories, are offloaded to CROs in long-term guaranteed strategic partnerships.
November 3, 2016
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Biosimilars in Emerging Markets

$2,995.00

Follow-on biologics have been embraced enthusiastically in most emerging markets, where they promise to deliver much-needed improvements in access to a generation of products that remains beyond the reach of many patients.
April 20, 2017
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Germany Regulatory Issues

$2,995.00

Data indicates that companies often favor Germany when choosing a reference member state (RMS) in order to gain approval under the decentralized procedure, perhaps reflecting overall a fast pace of regulatory review.
November 2, 2016
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Bladder Cancer Pricing, Reimbursement, and Access

$2,995.00

Payers are not overly worried about the cost of bladder cancer, due to the relatively small patient population in comparison to other solid tumors.
September 27, 2018
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Spain Healthcare System and Drug Regulatory Analysis

$2,995.00

The market environment in Spain is extremely challenging, with cost-containment measures introduced in 2010–12 contributing to an overall reduction in pharmaceutical spending.
November 2, 2016
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Argentina Regulatory Issues

$2,995.00

With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America.
November 2, 2016
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Prostate Cancer: Market Access Pricing & Reimbursement

$2,995.00

The prostate cancer market has become saturated in the metastatic castration-resistant prostate cancer (CRPC) setting; the approval of second-generation antiandrogens, radiotherapies, and chemotherapies has resulted in a great deal of development targeting earlier stages of the disease.
June 1, 2018
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France Healthcare System Overview

$2,995.00

France spent more of its gross domestic product (GDP) on healthcare in 2010 than the average of other key developed markets.
November 2, 2016
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Acute Myeloid Leukemia Pricing, Reimbursement, and Access

$2,995.00

The level of concern surrounding the budget impact of acute myeloid leukemia (AML) has traditionally been low due to the relatively small size of the population in comparison to solid tumors, the high severity of the disease, and a lack of branded treatment options. As a result, few access controls are utilized for AML therapies. […]
December 15, 2017
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EGA Biosimilars Conference 2015

$2,995.00

With the entry of the first monoclonal antibody biosimilar in most European markets and approval of the first biosimilar in the US, 2015 promises to be a landmark year for the biosimilars market. The savings potential of biosimilars in a time of constrained healthcare budgets is an attractive value proposition for many payers, and regulators’ positive stance in terms of making the approval and development process as efficient as possible is advantageous for the sector.
November 2, 2016
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Crohn’s Disease and Ulcerative Colitis Pricing, Reimbursement, and Access

$2,995.00

Payers view spending on inflammatory bowel disease (IBD) drugs as significant, as there is a large patient base requiring expensive biologic therapies. The market has been long dominated by the TNF-alpha inhibitors Humira and Remicade, but more recent biologic launches such as Entyvio and Stelara have focused on novel mechanisms of action.
March 16, 2018
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First-In-Class Therapies’ Shrinking In-Class Monopolies

$2,995.00

Competition from drugs in the same class (with the same mechanism of action and treating the same disease) presents a clear challenge to a first-in-class market entrant. And the speed with which these competitors arrive impacts market dynamics, commercial strategies, and, increasingly, drug prices. Therapies that enjoy extended monopolies as sole entrants in a particular class have greater commercial flexibility in negotiating with payers. Multiple drugs in the same class give payers better leverage with which to negotiate rebates and discounts with drug companies.
November 15, 2018
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UK Regulatory Issues

$2,995.00

Recently there have been several new regulatory changes in the UK aimed at reducing the regulatory burden and allowing earlier access to medicines which are seen as a positive development for the pharmaceutical industry.
November 2, 2016
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NOACs Pricing, Reimbursement, and Access

$2,995.00

A combination of the high cost of novel oral anticoagulants (NOACs) (relative to highly genericized vitamin K antagonists) and the large patient populations these drugs address, has resulted in this class of compounds being a top priority for European payers.
May 10, 2017
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ISPOR Europe 2018 Whitepaper

$2,995.00

Datamonitor Healthcare attended the ISPOR 21st Annual European Congress held in Barcelona on 10–14 November. Here, we present some of the hot topics discussed at the event.

November 23, 2018
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Beyond-the-Pill Services and Solutions: Pharma’s Next Frontier?

$2,995.00

Payers and governments are striving toward cost-effective treatment outcomes and more efficient care, and waves of new digital health technologies are offering patients unprecedented opportunities to be more engaged in their own health management.
November 2, 2016
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Gene Therapy Deal-Making Trends, 2012–17

$2,995.00

A robust deal-making market has enabled gene therapy drug development to be advanced and adequately funded through alliances and financings, and in many cases has provided exits for investors through acquisitions.
February 14, 2018
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Market Access Trends in Europe

$3,000.00

Health technology assessments (HTAs) have become an integral part of procedures employed to inform new drug coverage and pricing decisions across Europe. Methodological approaches to HTA vary, however, while disparities are also apparent in the pertise and financial resources to conduct multidisciplinary assessments, and in the relative weight accorded to recommendations issued by national (or regional) HTA agencies (ICOM, 2017)
November 16, 2018
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Integrated Delivery Networks in the US

$2,995.00

Integrated delivery networks (IDNs) are a growing approach to streamlined healthcare in the US, providing support from the cradle to the care home.
June 27, 2017
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France Regulatory Issues

$2,995.00

The much-criticized delay in the removal of marketing authorization for Servier’s Mediator in France has had profound implications for reform of the country’s regulatory system.
November 2, 2016
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Key Trends in BRICMIST Market Access

$2,995.00

Brazil, Russia, India, China, Mexico, Indonesia, South Korea, and Turkey – known collectively as the BRIC/MIST countries – have been a source of welcome growth for a pharmaceutical industry struggling to generate significant gains in its traditional core markets.
October 17, 2016
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Hemophilia Pricing, Reimbursement, and Access

$2,995.00

Over the last two decades, clinical care of hemophilia has improved significantly, extending the life expectancy for this patient population closer to that of the general population. The emergence of virally inactivated plasma-derived clotting factors and then of recombinant clotting factor replacement therapy in the 1980s has revolutionized care for these patients.
January 18, 2017
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Value-Based Pricing – Evolution Rather Than Revolution

$5,000.00

A new value-based assessment (VBA) process is scheduled to come into effect in the UK in late 2014. There have been significant delays in determining how this would work in practice, reflecting VBA’s complexity.
November 4, 2016
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Poland Pricing and Reimbursement

$2,995.00

The average drug price in Poland is the lowest in the EU, mainly due to the high proportion of generic pharmaceuticals, low availability of innovative drugs, and high price pressure on reimbursed drugs.
November 4, 2016
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India Pricing and Reimbursement

$2,995.00

Affordability of healthcare is a serious challenge for the majority of the population in India. The lack of properly funded and effective public health services drives a large number of people to receive health services from the private sector.
November 4, 2016
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2019 Biomedtracker / Datamonitor Healthcare Post-ASCO Report

$2,995.00

The 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) was held in Chicago, IL from May 31st through June 4th, 2019. This year’s conference was highly varied, with key data presented for drugs in numerous different classes and indications.

June 13, 2019
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China Regulatory Update

$2,995.00

China has recently completed its 2009–11 healthcare reform. The reform has come at a high cost: although the Ministry of Health intended to invest CNY850bn ($135bn) in the plan, total investment has now exceeded CNY1,100bn ($175bn).
November 4, 2016
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Germany Healthcare System Overview

$2,995.00

Already high and rising healthcare expenditure coupled with unfavorable demographic dynamics are prompting the German government to introduce changes in order to ensure healthcare system sustainability.
November 2, 2016
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Germany Pricing and Reimbursement

$2,995.00

The German pharmaceutical market has historically been the most attractive European market due to high prices and high drug utilization. However, this is changing, with comparability assessment requirement raising the bar for achieving a higher price point.
November 2, 2016
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Argentina Healthcare System Overview

$2,995.00

With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America.
November 3, 2016
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The Evolution of Pharmaceutical Sales Strategies Continues

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Pharmaceutical sales forces have evolved from the traditional structure, which was dominated by considerable numbers of field-based representatives detailing a range of products to different physicians on a regular basis.
November 1, 2016
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Chronic Obstructive Pulmonary Disease (COPD): Market Access Pricing & Reimbursement

$7,000.00

Long-acting beta 2 agonist/long-acting muscarinic antagonist (LABA/LAMA) combination inhalers have been gaining traction due to an expanding evidence base for their wider use, and competitive pricing.
October 17, 2016
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