The federal political pressure on drug pricing may have stalled on Washington gridlock, but as we previously covered here at CBPartners, it is driving real change at the state level. State lawmakers are better positioned to develop laws that regulate pharmaceutical stakeholders, given the more manageable scope of state markets,…
The past 18 months have ushered in momentous healthcare policy events – spanning from anxiety about the ACA’s repeal and its resulting vacuum of coverage to value frameworks and demands for policy action on price controls for companies that inflate pricing without apparent innovation. Products in the crosshairs of disenchantment…
The Chinese National Reimbursement Drug List (NRDL), which, before February, was last updated in 2009, has received a much-needed modernisation. On February 21, 2017, the NRDL was updated, and then officially published two days later. The new version of the NRDL can be found here. FIGURE 1. Formulary Structure of…
On September 19, 2016, the USA FDA granted accelerated approval to $SRPT (SAREPTA THERAPEUTICS) lead product, EXONDYS 51™(eteplirsen), the first targeted treatment for (DMD), a devastating rare disease. What makes the case unusual is that in approving EXONDYS 51™, the FDA went against the recommendation of its Advisory Committee, a…
The recently published Access to Medicines Index (ATM) has revealed interesting trends which support the fact that while most companies tend to rush to reduce price when thinking of achieving greater access in the emerging markets (EMs), transparency in pricing (even at the level of corporate and brand level pricing…
By all appearances, RUS has remembered its substantial international reference pricing (IRP) rule that, until now, was largely ‘bark’, and no ‘bite’. The set of countries was renewed by the 979 order in October 2015, but authorities in RUS have decided to ramp up its use in order to lower…
Lu Yong, a Chinese CLL patient who purchased an unlicensed counterfeit version of NVS’ GLIVEC (imatinib) from India, was finally released without charge from local authorities. The case set off raucous debates in China over the lack of government coverage and patients’ inability to afford high-cost oncology therapies. Due to…
Over the past two years, the Cnn classification has become a tried and true method of achieving temporary, sub-nationally reimbursed access in Italy. In these cases, hospitals and patients shoulder the burden of financing in the interim, which requires them to negotiate the price of the therapy directly with manufacturers….
During the last five years, we have seen many changes in the managed care arena, driven in part by healthcare reform, but also by changes to technology, shifts in drug expenditure, and greater scrutiny around healthcare costs in general. In order to advance the discussion around the evolving USA healthcare…
The emergence of economic appraisals conducted by the Commission Évaluation Économique et de Santé Publique (CEESP) represents an important development in attaining market access to France. As of October 2013, manufacturers of certain innovative products are required to submit to an economic evaluation from the (CEESP) in addition to the…