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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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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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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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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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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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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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Indonesia Generics and Biosimilars

$2,995.00

In 2011, branded generics accounted for 89% of Indonesia’s overall prescription pharmaceutical market, which was valued at IDR25.04tn ($2.84bn). The overwhelming dominance of generics – both branded and unbranded – leaves very little room for innovative products, other than those whose patents have already expired (i.e. “long-listed drugs”).
November 3, 2016
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Drug Pricing in the US

$2,995.00

Drug prices in the US have been the subject of intense debate over the past 2–3 years, following a surge in spending on prescription medicines and steep price increases in some categories
July 5, 2017
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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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Key Trends in European Market Access

$2,995.00

This strategy report focuses on Key Trends in European Market Access including accelerating access to medicines, health technology assessment and harmonization, developments in health technology assessment, pricing, and reimbursement delays.
January 26, 2016
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Asthma Pricing, Reimbursement, and Access

$2,995.00

The next wave of key therapies in asthma includes biologics, with interleukin (IL)-5 inhibitors first to reach the market.
October 17, 2016
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Japan Pricing and Reimbursement

$2,995.00

Pricing and reimbursement processes are closely connected in Japan, with drug pricing largely dependent on innovation. However, achieving premium pricing is difficult, thereby limiting sales potential.
November 4, 2016
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Turkey Pricing and Reimbursement

$2,995.00

To contain overall healthcare expenditure and to rein in the rapid growth of pharmaceutical expenditure, in 2004 Turkey introduced price-setting procedures using an external reference system based on 5–10 reference countries (all from the EU).
November 4, 2016
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Key Potential Drug Launches in 2020

$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 2020.

May 28, 2019
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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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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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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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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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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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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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Indonesia Pharmaceutical Market Dynamics

$2,995.00

Kalbe Farma is the leading player by some margin, with a market share of 13% in 2011, while GlaxoSmithKline is the largest foreign player with a 3% share.
November 2, 2016
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India Regulatory Issues

$2,995.00

The drug approval process in India is not complex, although poor patent protection and government policies favoring generic companies make multinational companies (MNCs) wary of launching new drugs in the country.
November 1, 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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Indonesia Healthcare System Overview

$2,995.00

With only 2.6% of GDP spent on healthcare in 2010, the healthcare system in Indonesia has huge potential for growth.
November 2, 2016
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Value-Based Reimbursement in the US

$2,995.00

The US healthcare environment has been witnessing a slow albeit continuous shift from volume- to value-based reimbursement over the past couple of decades
August 22, 2018
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US Regulatory Issues

$2,995.00

Key regulatory developments include the new Prescription Drug User Fee Act (PDUFA-V), which aims to improve interaction between the FDA and drug developers.
November 2, 2016
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Chronic Heart Failure Pricing, Reimbursement, and Access

$2,995.00

Payers were originally extremely worried about the potential cost burden of Entresto, however, the level of concern surrounding the drug is currently moderate as physician uptake has been lower than expected.
April 13, 2018
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Japan Regulatory Issues

$2,995.00

Historically Japan has been plagued with delays, with new drug approvals sometimes taking three or four years longer than in the US and EU.
November 2, 2016
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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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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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Biosimilars Market Access in the U.S.

$2,995.00

The route to a formal US regulatory pathway for biosimilar approval was established with the creation of the Biologics Price Competition and Innovation Act of 2010. However, it took five more years for the first biosimilar to be launched in the US through this pathway, namely Zarxio.
March 13, 2017
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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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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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Biosimilars in the US and Europe

$2,995.00

Biosimilars have been available in Europe for over a decade, and have offered the opportunity to vastly reduce the cost of treatment for a large number of biologic agents.
June 25, 2019
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Biosimilar Commercial Strategies and Tactics

$2,995.00

The challenges faced by biosimilar developers are not unlike those confronting their branded counterparts. First, companies must develop high-quality biosimilars and obtain regulatory approval. Next, they must then navigate the vast array of commercial nuances that exist at the national level in order for their products to be used in the clinical setting.
May 14, 2019
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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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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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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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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 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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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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2019 Post-ADA Report

$2,995.00

The American Diabetes Association (ADA) 79th Scientific Sessions was held in San Francisco, CA from 7–11 June 2019.

July 22, 2019
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Germany Generics and Biosimilars

$2,995.00

The German generics industry is feeling the effects of recent efforts to control drug spending by exerting downward pressure on drug prices.
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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