- NCPA Asks U.S. Senate and House Leadership to Hold Hearings on Pharmacy DIR Fees Bills (ncpanet.org)
The National Community Pharmacists Association recently requested Congressional hearings on legislation, the Improving Transparency and Accuracy in Medicare Part D Spending Act, that would stop the unfair practice of pharmacy direct and indirect remuneration (DIR) fees being applied retroactively under Medicare Part D...Retroactive pharmacy DIR fees are creating a system of winners and losers...While pharmacy benefit managers profit, the unpredictable timing and amount of these clawbacks are wreaking financial havoc on pharmacies, seniors, and taxpayers...By requiring PBMs to divulge the costs of prescription drugs for Medicare beneficiaries at the point of sale, these bills fix a problem even the Centers for Medicare & Medicaid Services acknowledges has contributed to rising costs in Medicare Part D.
- DIR fees are pushing seniors into the donut hole coverage phase faster, where seniors absorb all of the costs for their prescriptions;
- DIR fees are also pushing seniors into the ensuing catastrophic coverage phase faster, where the government's costs have risen from $10 billion in 2010 to $33 billion in 2015;
- In both of those instances, the PBMs' co-pay burden disappears, which is not the case in the initial phase of coverage;
- Independent community pharmacies' ability to plan in advance is being undermined by how PBMs currently apply DIR fees, threatening patient access to these pharmacies, especially in underserved communities; and
- All of this is occurring while PBMs continue to operate in a non-transparent manner when it comes to DIR fees.
- 5 trends changing clinical trials (biopharmadive.com)
Clinical trials have become increasing costly ventures, adding to the overall cost of developing a drug and, ultimately, the price that patients pay for drugs. A 2016 estimate by the Tufts Center for the Study of Drug Development, for example, pegged average clinical trial costs across all three phases of development at roughly $340 million in out-of-pocket expenses. Big pharmas and small biotechs alike are looking for innovative ways to improve trial outcomes and, in turn, lower trial costs — this means increasing the efficiency in which they recruit patients, monitoring more closely how drugs are supplied and being more flexible about trial design. Here’s a look at some of the tools that are optimizing clinical trials today:
- Patient centricity
- Tapping into technology
- Data you can wear
- Flexibility
- Automated site supplies
- Pharmacy Week in Review: March 10, 2017 (pharmacytimes.com)
Ned Milenkovich, PharmD, JD, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Pharmaceutical Inspections in Europe, US to Get New Framework (pharmacytimes.com)
The US FDA and the European Union took an important step forward this week in pharmaceutical manufacturer inspection collaboration, completing an exchange of letters that will allow the FDA and EU drug inspectors to rely upon information from drug inspections conducted within each other’s borders...the letters, which will amend the Pharmaceutical Annex to the US-EU Mutual Recognition Agreement, will enable the FDA and EU to "avoid the duplication of drug inspections, lower inspection costs and enable regulators to devote more resources to other parts of the world where there may be greater risk...The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high quality drugs…
- Indian Drugmakers Seek to Sway Trump Over Cheap Generic Imports (bloomberg.com)
India’s largest pharmaceutical firms are looking to convince U.S. President Donald Trump that his promise to lower drug costs should take priority over his vow to make sure the medicines are made in America...Savings from cheaper imported drugs will outweigh the jobs created by producing them in the U.S., the Indian Pharmaceutical Alliance...said in a report...One goal could be to win an exemption for generic drugs under any border-tax policy that is enacted in the U.S….Indian companies recommend their government highlight the firms’ investments in the U.S., where the largest companies have increased their presence in recent years in an attempt to diversify their manufacturing base...Closer collaboration with the FDA is also recommended to help the industry solve deficiencies in manufacturing practices that have prompted a wave of sanctions from the regulator in recent years, hurting the industry’s reputation and sales…..The approach should be to project India as a reliable and trustworthy source for access to safe and quality medicines at affordable prices.
- This Week in Managed Care: March 10, 2017 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- NFL abuse of painkillers and other drugs described in court filings (washingtonpost.com)
National Football League teams violated federal laws governing prescription drugs, disregarded guidance from the Drug Enforcement Administration on how to store, track, transport and distribute controlled substances, and plied their players with powerful painkillers and anti-inflammatories each season, according to sealed court documents contained in a federal lawsuit filed by former players...testimony and documents by team and league medical personnel, describes multiple instances in which team and league officials were made aware of abuses, record-keeping problems and even violations of federal law and were either slow in responding or failed to comply...
- Disregarding federal laws
- Reliance on pharmaceuticals
- Lining up for the ‘T Train’
- Express Scripts challenges Gilead in pricing blame game (biopharmadive.com)
Comments from Gilead Sciences’ head of worldwide commercial operations last week to Bloomberg have reignited a furious debate within the industry over who is to blame for rising drug costs...Gilead’s Jim Meyers told the publication that pharmacy benefit managers are to blame for keeping drug prices high...But PBM Express Scripts fired back this week with a letter to Gilead CEO John Milligan urging the company to cut the cost of its hepatitis C drugs and even pay back the difference retroactively...Meyers' comments insinuated PBMs keep drug prices high in order to inflate their own revenues through the cut they take from rebates and discounts given by manufacturers...Express Scripts...has taken particular offense to these accusations...The request from Express Scripts was a bold one and unlikely to materialize in Gilead paying back its profits. Yet, the public back-and-forth adds another dynamic to who may be to blame for high drug prices...
- R&D Costs For Pharmaceutical Companies Do Not Explain Elevated US Drug Prices (healthaffairs.org)
That pharmaceutical companies charge much more for their drugs in the United States than they do in other Western countries has contributed to public and political distrust of their pricing practices. When these higher US prices...are challenged, the pharmaceutical industry often explains that the higher prices they charge in the US provide them with the funds they need to conduct their high-risk research...This claim—that premiums earned from charging US patients and taxpayers more for medications than other Western countries funds companies’ research—is empirically testable...We found...charging substantially higher prices...in the US compared to other Western countries generates substantially more than the companies spend globally on their research and development...Importantly, our analysis cannot inform the question whether or not it is appropriate for US patients, taxpayers, and businesses to bear the burden of funding pharmaceutical research for the world...
- Drug Costs Too High? Fire the Middleman (bloomberg.com)
Caterpillar’s lowered drug bills show why pharmacy benefit managers are under fire. A decade ago, Caterpillar Inc. looked at its employee drug plan and sensed that money was evaporating... By hiring its own doctors and pharmacists, among other changes, Caterpillar has saved tens of millions of dollars a year...The model is as successful today as it’s ever been...Caterpillar’s move away from benefit managers started when it suspected that as much as a quarter of its $150 million drug spending was wasted. The company devised its own list of drugs to offer its U.S. health-plan members and negotiated deals with pharmacies. It promoted generics and discouraged use of expensive heartburn and cholesterol medicines. The changes have saved the company $5 million to $10 million per year on cholesterol-lowering statins alone...Drug spending at Caterpillar...has dropped per patient and per prescription since the company started the program...