Market Access

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

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

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 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.

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.

US Healthcare System Overview

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.

UK Regulatory Issues

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.

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.

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.

Turkey Regulatory Issues

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

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).

November 4, 2016

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

The Evolution of Pharmaceutical Sales Strategies Continues

Pharmaceutical sales forces have evolved from the traditional structure, which was dominated by considerable numbers of field-based representatives detailing a range of products to different physicians on a regular basis.

November 1, 2016