Market Access

US Regulatory Issues

Key regulatory developments include the new Prescription Drug User Fee Act (PDUFA-V), which aims to improve interaction between the FDA and drug developers.

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.

November 4, 2016

France Regulatory Issues

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.

Vaccines Market Access in Emerging Markets

$3,000.00

Emerging markets account for approximately 18% of the global vaccines market, which is valued at more than $24bn. However, there are indications that this is an underestimate, and some observers forecast that the overall marketplace will reach $50bn by the mid2020s.

August 29, 2019

UK Generics and Biosimilars

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.

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.

November 4, 2016

US Pricing and Reimbursement

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.

Multiple Myeloma Pricing, Reimbursement, and Access

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

Ovarian Cancer Pricing, Reimbursement, and Access

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

Latest Trends in Orphan Drug Pricing and Reimbursement

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

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

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.

November 3, 2016

UK Healthcare System Overview

Reform of the NHS is underway despite widespread controversy and opposition from physicians, and will necessitate a change in the way pharmaceutical companies work with key stakeholders.

Psoriasis Pricing, Reimbursement, and Access

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