Supporting Value-Based Purchasing Through Changes in Medicaid Best Price
(9/10, National Pharmaceutical Council: E.V.I.dently Today) comments “...As the United States attempts to shift its health care system from volume to value, payers and biopharmaceutical manufacturers have devised innovative value-based purchasing arrangements. But these arrangements often are challenged to reach their full potential due to legislative and regulatory barriers. One of those barriers is Medicaid Best Price (MBP), set up over 30 years ago by Congress to ensure that Medicaid paid the lowest price available to any payer...In a recent column for Pharma Boardroom, Michael Ciarametaro, vice president for research at the National Pharmaceutical Council, elaborated on the ways in which MBP presents a barrier to creative payment methodologies in the United States. “ Full
Supporting Value-Based Purchasing in the US Through Changes in Medicaid Best Price
(9/8, Michael Ciarametaro, Pharma Boardroom) comments “...Despite setbacks to creative financing mechanisms due to MBP, stakeholders are still working toward potential solutions until the barriers can be addressed. The National Pharmaceutical Council has partnered with MIT's NEWDIGS FoCUS (Financing and Reimbursement of Cures in the U.S.) to craft some new pricing mechanisms designed to encourage payer-manufacturer collaboration in negotiating and completing value-based purchasing agreements. It is in the best interest of healthcare stakeholders to incentivize and promote payment innovation through multifaceted approaches that dismantle the barriers posed by Medicaid Best Price and other outdated regulations.” Full
Natalizumab More Effective Than Fingolimod, BRACETD in RES RRMS
(9/10, Brandon May, Neurology Advisor) reports “Natalizumab was more effective than fingolimod or BRACETD (interferon beta, glatiramer acetate, dimethyl fumarate, or teriflunomide) in reducing relapses in patients with rapidly evolving severe relapsing-remitting multiple sclerosis, according to study results presented at the 8th Joint American Committee for Treatment and Research in Multiple Sclerosis and European Committee for Treatment and Research in Multiple Sclerosis MSVirtual2020 event...” Full
How Real-World Data Augments What We Know About SGLT-2 Inhibitors for Cardiovascular Risk Reduction
(9/9, Adam J Nelson, MBBS and Ann Marie Navar, MD, PhD, American College of Cardiology) reports “...[W]hile randomized clinical trials remain the gold standard for determining efficacy of a new treatment, multiple factors can impact the degree to which these results translate into effectiveness in populations treated outside of a trial. This includes differences in the population studied in the trial compared with the population treated, variability in adherence and persistence to therapy in routine use, and differences in background therapies. Understanding the ‘real world’ effectiveness of therapy requires an assessment of treatments outside of the controlled environment of a trial.” Full
European Regulatory Strategy ‘Should Prioritize Real World Evidence'
(9/10, Francesca Bruce, Pink Sheet) reports “...A third priority is the implementation of a real world evidence use cases/pilot program. In its consultation response, EFPIA proposes that this could be used to build an EU RWE framework. This would set out the principles for data use and standards, regulatory acceptance and also best practicse for the application of analytical methods. This would be in alignment with international efforts. EFPIA also wants to see the EMA expand its collaboration to more international regulators.” Paid Subscription Required
The UK's Future As Innovator In A Post-Brexit, Post-Coronavirus World
(9/10, Ian Schofield, Pink Sheet) reports “...Noting the change of leadership at NICE – Gillian Leng was appointed chief executive in March this year and Sharmila Nebhrajani took up the post of chair in May – [UK BioIndustry Association CEO Steve Bates] said there was the ‘chance for modernization and harmonization and some new players who may bring fresh approaches, and this is one reason why this is a really interesting time.’ As for efforts to harmonize HTA evaluations across Europe, he said he was ‘keen to hear more from the new NICE leadership on how they see the opportunities here.’” Paid Subscription Required
Comparative Effectiveness of Microdecompression Alone vs Decompression Plus Instrumented Fusion in Lumbar Degenerative Spondylolisthesis
Ivar Magne Austevoll, MD, et al.
September 10, 2020, JAMA Network Open
JAMA Network Open