Health technology assessments (HTAs) have become an integral part of procedures employed to inform new drug coverage and pricing decisions across Europe. Methodological approaches to HTA vary, however, while disparities are also apparent in the pertise and financial resources to conduct multidisciplinary assessments, and in the relative weight accorded to recommendations issued by national (or regional) HTA agencies (ICOM, 2017)
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.
Payers are not overly worried about the cost of bladder cancer, due to the relatively small patient population in comparison to other solid tumors.
The US healthcare environment has been witnessing a slow albeit continuous shift from volume- to value-based reimbursement over the past couple of decades
There is moderate concern among payers regarding spend on renal cell cancer (RCC) drugs, but access restrictions remain mild.
Digital’s potential to transform every aspect of the pharmaceutical value chain, from discovery to commercial, is widely documented.
The prostate cancer market has become saturated in the metastatic castration-resistant prostate cancer (CRPC) setting; the approval of second-generation antiandrogens, radiotherapies, and chemotherapies has resulted in a great deal of development targeting earlier stages of the disease.
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.
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.
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.
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.
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.
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.
This analysis covers the four major emerging regions of the Middle East and Africa, Latin America, Eastern Europe, and Asia-Pacific. Within these regions, relatively wealthier markets with a proven marketplace for orphan medicines have been prioritized.
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. […]
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