Market Access

Key Trends in European Market Access

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

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

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.

Psoriatic Arthritis: Market Access Pricing & Reimbursement

Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriatic arthritis market.

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Chronic Obstructive Pulmonary Disease (COPD): Market Access Pricing & Reimbursement

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Long-acting beta 2 agonist/long-acting muscarinic antagonist (LABA/LAMA) combination inhalers have been gaining traction due to an expanding evidence base for their wider use, and competitive pricing.

Asthma Pricing, Reimbursement, and Access

The next wave of key therapies in asthma includes biologics, with interleukin (IL)-5 inhibitors first to reach the market.

Key Trends in BRICMIST Market Access

Brazil, Russia, India, China, Mexico, Indonesia, South Korea, and Turkey – known collectively as the BRIC/MIST countries – have been a source of welcome growth for a pharmaceutical industry struggling to generate significant gains in its traditional core markets.

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

India Regulatory Issues

The drug approval process in India is not complex, although poor patent protection and government policies favoring generic companies make multinational companies (MNCs) wary of launching new drugs in the country.

November 1, 2016

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

Indonesia Regulatory Issues

Challenges for foreign pharma companies in relation to Indonesia’s pharma system include lengthy and variable approval periods, compulsory licenses, and counterfeits.

Indonesia Healthcare System Overview

With only 2.6% of GDP spent on healthcare in 2010, the healthcare system in Indonesia has huge potential for growth.

Germany Regulatory Issues

Data indicates that companies often favor Germany when choosing a reference member state (RMS) in order to gain approval under the decentralized procedure, perhaps reflecting overall a fast pace of regulatory review.

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.

Germany Pricing and Reimbursement

The German pharmaceutical market has historically been the most attractive European market due to high prices and high drug utilization. However, this is changing, with comparability assessment requirement raising the bar for achieving a higher price point.

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.

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 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.

Germany Healthcare System Overview

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.

France Healthcare System Overview

France spent more of its gross domestic product (GDP) on healthcare in 2010 than the average of other key developed markets.

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.

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.

Access in Emerging Markets: HTA is Making Inroads

Generally considered the domain of developed markets, health technology assessment (HTA) is increasingly being used by developing countries as a means of reconciling growing demand for access to health technologies with limited resources. Expanding public health insurance programs, coupled with aging populations and growing patient empowerment, have led in some cases to the fast establishment […]

Argentina Regulatory Issues

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

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.

Spain Healthcare System and Drug Regulatory Analysis

The market environment in Spain is extremely challenging, with cost-containment measures introduced in 2010–12 contributing to an overall reduction in pharmaceutical spending.

India Pharmaceutical Market Dynamics

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%.

EGA Biosimilars Conference 2015

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.

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.

Beyond-the-Pill Services and Solutions: Pharma’s Next Frontier?

Payers and governments are striving toward cost-effective treatment outcomes and more efficient care, and waves of new digital health technologies are offering patients unprecedented opportunities to be more engaged in their own health management.

Russia Pharmaceutical Market Dynamics

With the Russian economy recovering from the recession experienced in 2009, the pharmaceutical market has also returned to growth.

Indonesia Pharmaceutical Market Dynamics

Kalbe Farma is the leading player by some margin, with a market share of 13% in 2011, while GlaxoSmithKline is the largest foreign player with a 3% share.

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.

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”).

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.

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.

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.

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.

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).

Generics: Regulatory Update

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

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.

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.

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.

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.

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.