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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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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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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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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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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 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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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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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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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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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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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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Spotlight on Antibody-Drug Conjugates

$2,995.00

The first antibody-drug conjugate (ADC), Mylotarg, reached the market almost two decades ago. Since this time, the ADC field has undergone slow but transformative enhancements, with improvements to technologies and advancements in the pipeline leading to an invigoration of the field. The past couple of years have seen the approvals of three new ADCs: Polivy, Lumoxiti, and Besponsa, increasing the total number of ADCs approved by regulators worldwide to six. These approvals mark the start of a new era in which the ADC field is finally beginning to realize its full potential. With the ADC pipeline swelling to around 250 novel candidates in various stages of preclinical and clinical development, approvals for more ADCs appear firmly on the horizon.

September 20, 2019
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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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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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Trends in CNS Dealmaking, 2012–16

$2,995.00

Diseases of the central nervous system (CNS) offer considerable opportunity to drug developers and marketers.
August 8, 2017
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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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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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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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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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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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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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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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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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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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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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US Specialty Drug Market Access

$2,995.00

High-touch specialty drugs for complex, chronic, high-cost, or rare diseases are an increasingly significant component of the US pharmaceutical market. A sharp growth in regulatory approvals accompanied by high prices has driven rapid increases in expenditure on specialty therapies by both public and private payers.
November 4, 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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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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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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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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