The 71st Annual Meeting of the American Academy of Neurology (AAN) was held in Philadelphia, Pennsylvania, from May 4-10, 2019.
The 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) was held in Chicago, IL from May 31st through June 4th, 2019. This year’s conference was highly varied, with key data presented for drugs in numerous different classes and indications.
The American Diabetes Association (ADA) 79th Scientific Sessions was held in San Francisco, CA from 7–11 June 2019.
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 […]
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.
The level of concern surrounding the budget impact of acute myeloid leukemia (AML) has traditionally been low due to the relatively small size of the population in comparison to solid tumors, the high severity of the disease, and a lack of branded treatment options. As a result, few access controls are utilized for AML therapies. […]
With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America.
The next wave of key therapies in asthma includes biologics, with interleukin (IL)-5 inhibitors first to reach the market.
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.
The challenges faced by biosimilar developers are not unlike those confronting their branded counterparts. First, companies must develop high-quality biosimilars and obtain regulatory approval. Next, they must then navigate the vast array of commercial nuances that exist at the national level in order for their products to be used in the clinical setting.
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.
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.
Biosimilars have been available in Europe for over a decade, and have offered the opportunity to vastly reduce the cost of treatment for a large number of biologic agents.
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
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.
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.
Payers are not overly worried about the cost of bladder cancer, due to the relatively small patient population in comparison to other solid tumors.
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.
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).
Payers were originally extremely worried about the potential cost burden of Entresto, however, the level of concern surrounding the drug is currently moderate as physician uptake has been lower than expected.
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.
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.
Payers view spending on inflammatory bowel disease (IBD) drugs as significant, as there is a large patient base requiring expensive biologic therapies. The market has been long dominated by the TNF-alpha inhibitors Humira and Remicade, but more recent biologic launches such as Entyvio and Stelara have focused on novel mechanisms of action.
Digital’s potential to transform every aspect of the pharmaceutical value chain, from discovery to commercial, is widely documented.
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
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.
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.
Competition from drugs in the same class (with the same mechanism of action and treating the same disease) presents a clear challenge to a first-in-class market entrant. And the speed with which these competitors arrive impacts market dynamics, commercial strategies, and, increasingly, drug prices. Therapies that enjoy extended monopolies as sole entrants in a particular class have greater commercial flexibility in negotiating with payers. Multiple drugs in the same class give payers better leverage with which to negotiate rebates and discounts with drug companies.
Traditionally considered an immature generics market, France has seen the introduction of measures aimed at increasing generics use in order to cut healthcare costs.
France spent more of its gross domestic product (GDP) on healthcare in 2010 than the average of other key developed markets.
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 companies are attempting to maximize value from all angles, including internal investment in R&D and externalization via deal-making.
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.
A robust deal-making market has enabled gene therapy drug development to be advanced and adequately funded through alliances and financings, and in many cases has provided exits for investors through acquisitions.
Regulatory measures continue to shape the generics landscape. Cost-containment strategies continue to impact generics.
The German generics industry is feeling the effects of recent efforts to control drug spending by exerting downward pressure on drug prices.
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.
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.
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.
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.
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.
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%.
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.
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