Faced with pressure from stakeholders – particularly patients – governments, regulators, and some countries have introduced new options and/or processes to speed up access to medicines. This includes access before marketing authorization, and speeding up the marketing authorization, or less often, the health technology assessment processes.
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.
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.
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.
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).
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.
This strategy report focuses on Malignant Melanoma Pricing and Reimbursement including how immunotherapies are changing melanoma treatment paradigms with market conext in the US, Japan, and five major EU markets.
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).
Pharmaceutical companies are attempting to maximize value from all angles, including internal investment in R&D and externalization via deal-making.
With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America.
Believed to be one of the great biotechnology breakthroughs, gene editing is a powerful tool in pharmaceutical research that could radically change how certain diseases are treated.
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.
As a supplement to our well-known quarterly Outlook report, Biomedtracker is pleased to present a longer-term look at some key late-stage drugs projected to hit the market in 2020.
The market environment in Spain is extremely challenging, with cost-containment measures introduced in 2010–12 contributing to an overall reduction in pharmaceutical spending.
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.
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.
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.
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.
The 71st Annual Meeting of the American Academy of Neurology (AAN) was held in Philadelphia, Pennsylvania, from May 4-10, 2019.
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.
Real-world evidence (RWE) has become increasingly important in proving the value of drugs and differentiating them from their competition.
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
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.
Integrated delivery networks (IDNs) are a growing approach to streamlined healthcare in the US, providing support from the cradle to the care home.
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.
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
The US healthcare environment has been witnessing a slow albeit continuous shift from volume- to value-based reimbursement over the past couple of decades
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.
This report provides an in-depth analysis of the market access climate in emerging pharmaceutical markets. Focusing in particular on the E7 countries (Brazil, Russia, India, China, Mexico, Indonesia, and Turkey), it charts recent developments, assesses their potential impact on market access, and pinpoints areas in which further change is anticipated.
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