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Japan Regulatory Issues

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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Latest Trends in Orphan Drug Pricing and Reimbursement

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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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Trends in CNS Dealmaking, 2012–16

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Diseases of the central nervous system (CNS) offer considerable opportunity to drug developers and marketers.

August 8, 2017

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Orphan Drug Access and Pricing in Emerging Markets

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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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Drug Pricing in the US

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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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Spotlight on Antibody-Drug Conjugates

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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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Key Trends in European Market Access

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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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Psoriatic Arthritis: Market Access Pricing & Reimbursement

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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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Ovarian Cancer Pricing, Reimbursement, and Access

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Ovarian cancer medicines have traditionally been subject to low restrictions, as most patients usually start and remain on inexpensive platinum-based therapies. However, beginning with the launch of vascular endothelial growth factor inhibitor Avastin, followed by poly (ADP-ribose) polymerase (PARP) inhibitor Lynparza, payers are seeing an uptick in spend for the indication.

March 5, 2018

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Spain Healthcare System and Drug Regulatory Analysis

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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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CER, HEOR, and Value-Based Frameworks in the US

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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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Generics: Regulatory Update

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Regulatory measures continue to shape the generics landscape. Cost-containment strategies continue to impact generics.

November 4, 2016

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France Generics and Biosimilars

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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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Psoriasis Pricing, Reimbursement, and Access

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Launch of multiple IL inhibitors with impressive efficacy has significantly reduced unmet need in the disease, and also provided payers with leverage in price negotiations as they seek to control growing treatment cost.

March 28, 2019

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US Specialty Drug Market Access

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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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