Market Access

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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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Biosimilar Insulin Market Access

$2,995.00

Biosimilar competition is providing payers with opportunities to contain costs in a category that accounts for a significant proportion of total drug expenditure. The launch of the biosimilar insulin Basaglar is a threat to the insulin-based product market, which includes long-time reference product Lantus as well as newer entrants Toujeo and Tresiba. More aggressive payers are excluding branded insulin products in favor of the less expensive biosimilar, forcing switches in existing patient populations. As such, manufacturers of branded insulin products will need to offer deeper discounts to remain on payers’ formularies and contracts.
June 19, 2017
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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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Orphan Drug Pricing and Reimbursement

$2,995.00

Orphan drugs account for a growing portion of payers’ budgets – and comprise some of the most expensive treatments available.
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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Managed Entry Agreements

$2,995.00

Managed entry agreements (MEAs) describe a range of mechanisms by which pharmaceutical firms and payers share some of the financial and clinical risk associated with the introduction of a new medicine.
November 4, 2016
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HER2+ Breast Cancer Pricing and Reimbursement

$2,995.00

Despite their high prices, Kadcyla and Perjeta are widely reimbursed in the US and have experienced fast uptake as payers have limited options for cost control in this indication.
November 4, 2016
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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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Generics: Regulatory Update

$2,995.00

Regulatory measures continue to shape the generics landscape. Cost-containment strategies continue to impact generics.
November 4, 2016
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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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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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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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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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France Generics and Biosimilars

$2,995.00

Traditionally considered an immature generics market, France has seen the introduction of measures aimed at increasing generics use in order to cut healthcare costs.
November 3, 2016
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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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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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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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Russia Pharmaceutical Market Dynamics

$2,995.00

With the Russian economy recovering from the recession experienced in 2009, the pharmaceutical market has also returned to growth.
November 2, 2016
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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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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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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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India Pharmaceutical Market Dynamics

$2,995.00

India is one of the most important emerging pharmaceutical markets, and the market is forecast to more than double between 2011 and 2017, growing at a compound annual growth rate of 16.1%.
November 2, 2016
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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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Access in Emerging Markets: HTA is Making Inroads

$2,995.00

Generally considered the domain of developed markets, health technology assessment (HTA) is increasingly being used by developing countries as a means of reconciling growing demand for access to health technologies with limited resources. Expanding public health insurance programs, coupled with aging populations and growing patient empowerment, have led in some cases to the fast establishment […]
November 2, 2016
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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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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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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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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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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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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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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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Indonesia Regulatory Issues

$2,995.00

Challenges for foreign pharma companies in relation to Indonesia’s pharma system include lengthy and variable approval periods, compulsory licenses, and counterfeits.
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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Turkey Regulatory Issues

$2,995.00

The mandatory requirement imposed by the Turkish authorities for overseas manufacturers exporting pharmaceutical products to Turkey to obtain Good Manufacturing Practice (GMP) certification issued by the Turkish Ministry of Health is causing inordinate delays in the registration of new pharmaceutical products in Turkey. However, these delays can be resolved once the US Food and Drug […]
November 1, 2016
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CER, HEOR, and Value-Based Frameworks in the US

$2,995.00

It is no secret that Americans spend heavily on healthcare – in 2013, US healthcare expenditure totaled nearly $3bn ($9,255 per person) and accounted for 17.4% of gross domestic product.
October 17, 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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Psoriatic Arthritis: Market Access Pricing & Reimbursement

$2,995.00

Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriatic arthritis market.
October 17, 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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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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Multiple Myeloma Pricing, Reimbursement, and Access

$2,995.00

Highlights: The budget impact of multiple myeloma is set to increase While multiple myeloma represents a relatively small patient population in comparison to other cancers, payers are concerned about the rising spend on the indication. New biologic therapies are increasingly gaining label expansions in earlier treatment lines, and with life expectancies improving, patients are requiring […]
March 5, 2019
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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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US Healthcare System Overview

$2,995.00

Continued growth in healthcare expenditure and the high number of individuals without health insurance coverage were the key drivers of the passage of the healthcare reform law.
November 2, 2016
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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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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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