- Pharmacy Benefit Management Tools Could Save Billions Over the Next Decade (ajpb.com)
Pharmacy benefit managers have been the target of scrutiny lately, in the media and even in proposed legislation. Detractors have called for more transparency for PBMs, accusing them of passing unnecessary drug costs along to plan sponsors and beneficiaries...To educate the public about the significant cost savings PBMs actually produce for plan sponsors and patients, the Pharmaceutical Care Management Association recently launched a national ad campaign..."This campaign is focused on educating policymakers and opinion leaders on how PBMs reduce costs, expand access and improve the quality of prescription drug..." said PCMA President and CEO Mark Merritt...today’s average level of PBM tool utilization yields a 10% to 20% cost savings for payers, and that a higher level of use could save payers an additional 10%.
- How Do PBM Tools Work?
- The Extent of PBM Tools in Current Practice
- Projected PBM Savings
- How Could PBM Savings Impact Employment?
- Pharma exec pleads guilty in VA bribery conspiracy (seattlepi.com)
Federal prosecutors...say VA doctors took kickbacks to promote ‘biologic’ bandage to colleagues...A former pharmaceutical company executive accused of bribing Veterans Affairs Department doctors to promote his firm’s product...Advanced BioHealing Inc. executive Todd Clawson pleaded guilty...to a bribery-related charge brought by federal prosecutors...Prosecutors say Clawson...paid kickbacks to VA podiatrists and clinicians who promoted the company’s product...According to prosecutors, Clawson...and VA physicians conspired to "defraud the United States by impeding and impairing the governmental functions of the VA, including those intended to regulate the ethical practice of physicians working for the VA."...Details of the plea were sealed by the court...Clawson is currently scheduled to be sentenced...
- Lawyers consider judicial review of consultation on community pharmacy (pharmaceutical-journal.com)Hundreds of local chemists set to close leaving sick and elderly without vital lifeline (express.co.uk)
Lawyers have given health minister Alistair Burt a deadline of 4pm on 18 March 2016 to respond to claims that the consultation on proposed cuts to the pharmacy budget in England is illegal and should be abandoned...If the government does not accept that the consultation is illegal then lawyers will consider going to the High Court to seek a judicial review of the consultation process and the content of the consultation document...The prospect of legal action comes three months after the Department of Health first outlined its proposals for the community pharmacy sector in England in a letter to the Pharmaceutical Services Negotiating Committee. The letter...set out plans to cut the community pharmacy contractual framework by 6.1% in 2016. As well as the funding cuts, the proposals include a range of measures to make efficiency savings in the sector while extending clinical roles for the profession...Healthwatch England told the government that there is a "clear appetite" for community pharmacy to play a greater role in health prevention, the treatment of minor ailments and supporting people with long-term conditions. It says consumers value pharmacy’s accessibility and some believe co-locating pharmacies to GP surgeries makes sense...However, the organisation gives a cautious welcome to the idea of ‘hub-and-spoke’ dispensing and says that where medicines are assembled centrally, patients will still need local access to expert pharmacy advice.
- Drug Diversion and Appropriate Opioid Use (pharmacypodcast.com)
Dr. Thomas S. Franko discusses drug diversion and prescription drug abuse (podcast 30:10m).
- Organ-on-a-chip startup Emulate raises $28.75M Series B (medcitynews.com)
Cambridge organ-on-a-chip startup Emulate has raised $28.75 million in a Series B round, with aims to commercialize its "Human Emulation System" on the R&D circuit. The idea, as with most lab-on-a-chip technologies, is to enhance in vitro research so as to make animal and in-human studies more efficient – using algorithms and microfluidics to accurately predict human response to medicines, chemicals and diseases...The financing will help expand Emulate’s organ-on-a-chip portfolio. Currently, it’s got organ emulations of the lung, liver, intestine and skin – but it plans to branch into organs like the kidney, heart and brain. Beyond that, however, is the concept of developing specific labs-on-chips to address important disease states, such as cancers, disorders of the intestine and microbiome, and infectious disease...Emulate wants its technology to operate as a plug-and-play system in the hands of product development teams at pharmaceutical, chemical, food and consumer products companies...
- Novartis and the feds squabble over 80,000 ‘sham’ speaking events (statnews.com)
Novartis and the Department of Justice are squabbling over documents that allegedly contain details of nearly 80,000 "sham" events that the drug maker used to encourage doctors to prescribe several blood pressure medicines...The tussle comes as part of a run-up to a planned trial this summer in which the feds plan to argue that Novartis violated federal antikickback laws...the drug maker has maintained the government is unfairly expanding the scope of its inquiry...The trial is an outgrowth of a whistleblower lawsuit filed five years ago by Oswald Bilotta, a former Novartis sales rep, and was joined by the Justice Department in 2013...the feds wrote that "this case implicates issues of enormous public concern: whether Novartis defrauded federal health care programs of hundreds of millions of dollars by systematically providing inducements to doctors across the country...in an effort to influence the drugs they prescribed to patients in their care."...
- Sanofi science chief on Zika: It’s time to disrupt traditional vaccine development (fiercevaccines.com)
The World Health Organization has warned that the Zika R&D frenzy may not culminate in a vaccine in time for the current outbreak, but Sanofi Chief Scientific Officer Gary Nabel won't take that for an answer. Nabel says it can be done, but it means turning the traditional vaccine development model on its head...In an interview...Nabel highlighted that the classic response to emerging and infectious diseases, such as MERS and Ebola, has been inadequate...We just run from one crisis to another…That's no way to protect the world's population...The traditional vaccine development timeline typically takes 5 years or more to produce a marketable vaccine... To have a chance at accelerating this for emerging diseases, biotechs and pharmas, regulators and government agencies need to come together and unpack this model, identifying where time can be saved and exploring different ways to go about clinical trials...(Nabel) identified WHO as "symptomatic of the problem." While it has "the best of intentions," it doesn't have the wherewithal to follow through...The agency has declared Zika a global public health emergency and in February called for $56 million in funding to combat the virus. Just over a month later, only $3 million--5%--in funding has trickled in...
- Substances Doubtful for Bulk Drug Substances List Could Be INDs (ashp.org)Individual Patient Expanded Access Applications: Form FDA 3926 (fda.gov)
Pharmacists, physicians, and advocacy groups that want patients to use substances unlikely to be on the upcoming "bulk drug substances list" for compounders should consider submitting "treatment" investigational new drug applications, FDA personnel recently suggested...FDA-cleared treatment IND applications...offer a legal workaround that can benefit many patients...a compounding pharmacy, could submit a treatment IND, which once that was in place could be expanded to treat a large number of patients...ASHP stated, absent "significant" revision, FDA's current expanded-access IND application process will not facilitate access to any drug available only from compounders...Jarow (Jonathan Jarow, from the Center for Drug Evaluation and Research)...acknowledged that submission of an IND application has seemed difficult to many individual healthcare providers seeking a drug for a single patient..."There's now a special form in development that has not been finalized—it's available in draft form—that caters to that specific type of IND rather than the general form that's used for all types of INDs, which looks very complicated," he said...Form FDA 3926, also known as "Individual Patient Expanded Access Investigational New Drug Application," went on display in February 2015 as part of a draft guidance for the pharmaceutical industry....
- iMedicare launches RefillReport.com (drugstorenews.com)
iMedicare, a company that provides Medicare Part D plan comparison software to pharmacies, announced recently that it had launched RefillReport.com, a platform that aims to help patients connect with local pharmacies to save money on their Medicare plan...The site is looking to help patients compare plans at different community pharmacies and potentially save money on a Medicare plan. It also features information about how Medicare Part D works, answers frequently asked questions and keeps information updated about different challenges that could affect patients throughout the year...
- China, in typical fashion, arrests dozens as drug oversight draws attention (fiercepharmamanufacturing.com)
In a typical response to publicity that its pharma supply chain has been breached, China has rounded up dozens of suspects as it investigates an operation said to have illegally sold vaccines that may not have been safely stored or shipped...Citing China's official news agency, Xinhua, Reuters reports that authorities arrested 37 people in the crackdown. The report said the arrests were made after Premier Li Keqiang called for a complete investigation but that it wasn't clear that everyone picked up was tied to the operation that reportedly sold $88 million worth of vaccines over 5 years...China has been beefing up its drug and food safety apparatus for several years after being embarrassed internationally over a number of cases where tainted products showed up in China or were shipped to other countries. It is pretty common for authorities to respond with a police sweep that nabs lots of people...