Market Access

Trends in CNS Dealmaking, 2012–16

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

August 8, 2017

The Growing Impact of Real-World Evidence

Real-world evidence (RWE) has become increasingly important in proving the value of drugs and differentiating them from their competition.

July 14, 2017

Drug Pricing in the US

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

Integrated Delivery Networks in the US

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

Biosimilar Insulin Market Access

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

From R&D Investment to Externalization: Where is the Pharma Industry Maximizing Value?

Pharmaceutical companies are attempting to maximize value from all angles, including internal investment in R&D and externalization via deal-making.

June 8, 2017

NOACs Pricing, Reimbursement, and Access

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

Biosimilars in Emerging Markets

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

Biosimilars Market Access in the U.S.

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

Biosimilars Market Access in Psoriatic Arthritis

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

Biosimilars Market Access in Psoriasis

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

Hemophilia Pricing, Reimbursement, and Access

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

US Specialty Drug Market Access

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.

India Pricing and Reimbursement

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.

Turkey Pricing and Reimbursement

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).

Orphan Drug Pricing and Reimbursement

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

Japan Pricing and Reimbursement

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.

Poland Pricing and Reimbursement

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.

Managed Entry Agreements

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.

HER2+ Breast Cancer Pricing and Reimbursement

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.

Value-Based Pricing – Evolution Rather Than Revolution

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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.

Generics: Regulatory Update

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

China Regulatory Update

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).

CRO Snapshot: Clinical Outsourcing in 2012

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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.

Argentina Healthcare System Overview

With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America.

Russia Generics and Biosimilars

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.

France Generics and Biosimilars

Traditionally considered an immature generics market, France has seen the introduction of measures aimed at increasing generics use in order to cut healthcare costs.

Indonesia Generics and Biosimilars

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”).

Germany Generics and Biosimilars

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