Author: Peter

Drug companies have taken too great a share of the benefits of new drug treatments but are moving to different models involving sharing more with health systems and insurers..."We need to transition into a system in which pharmaceutical manufacturers share the benefits of new drugs"..."At the moment, we still keep too much of that benefit for ourselves."..."I'm not saying pricing in the United States is not an issue ... Something will change. But I don't think the government will bring that change, I think it will come from the private sector,"...

Patients getting chemotherapy or other complex medications may have a sudden panic when shopping for health insurance: Their drugs often don’t appear to be covered...Despite advice to shop around before selecting a plan, consumers may find that getting answers about drug coverage can be an exercise in frustration, despite a federal health law requirement that insurers provide lists of the prescription medications included in their plans...That’s because many treatments — particularly intravenous treatments like those used in cancer, hemophilia or multiple sclerosis — are covered under a separate part of an insurance plan, not the pharmacy benefit. And details of that medical-benefit drug coverage can be hard or impossible to find online. But the information is important to know because the drugs tend to be costly, so if they’re not covered, patients might have to pay out of pocket, switch to different treatments or appeal to the plan...

An independent nonprofit organization (Institute for Clinical and Economic Review) that evaluates clinical and cost effectiveness of new medicines found the price of GlaxoSmithKline's new drug for severe asthma should be as much as 76 percent lower to justify its value, according to the group's latest draft report... analysis indicated that Glaxo's Nucala (mepolizumab) should be priced at $7,800 to about $12,000 a year, far below the drug's list price of $32,500 a year...once-monthly injectable Nucala...significantly reduces asthma attacks and symptoms and decreases the need for oral steroids. However, it found that the price was not cost-effective, and that there is uncertainty about whether the benefits will persist over the long term because of the short duration of clinical trials...ICER President Steven Pearson, in a statement, said its analyses aim "to help the health care community determine what should be used, which patients benefit most, and at what price innovative treatments represent a reasonable value."

India's largest drugmaker Sun Pharmaceutical Industries Ltd has been warned by U.S. health regulators for violating manufacturing standards at its Halol plant in India, even as it has been working on fixing issues at the plant for over a year...Food and Drug Administration's "warning letter" to Sun Pharma indicates the agency is dissatisfied with the remedial measures the company has implemented since last September, when the FDA first notified the company of its concerns after an inspection...That inspection report highlighted nearly two dozen issues the FDA staff found, including problems with aseptic practices and water leaks in the ceiling of the manufacturing area...the agency could ban imports from the plant if the problems are not resolved...The Halol plant makes up about 15 percent of Sun Pharma's sales in its largest market, the United States.

Teresa Rubio, PharmD of the FDA Office on Health and Constituents Affairs describes the types of adverse drug events that pharmacists should report to MedWatch.

Concerned about the quality of the pharmaceutical supply chain, several congressional lawmakers want the US Government Accountability Office to review Food and Drug Administration oversight of foreign manufacturing plants...In a letter...members of the House Energy and Commerce Committee asked the GAO to assess the progress the FDA has made inspecting foreign facilities since the agency undertook a new "risk-based" approach in 2010. They noted the United States imports more than $52 billion in medicines each year, but that "many of these products come from countries with less sophisticated regulatory systems."...The lawmakers went on to note that there’s a "history" of counterfeiting, adulteration, substandard manufacturing, and data falsification over the past 20 years in China and India, specifically. As a result, they suggest there may be "inadequate oversight" and an "unequal playing field" compared with US drug makers that are subject to "more frequent and rigorous inspections."...The FDA has begun working with the Indian government to bolster domestic oversight...India’s drug makers have bristled at the attention paid by the FDA to ongoing shortcomings, which have prompted the agency to issue a steady stream of import alerts that ban products from being shipped to the United States.

All MTM (medication therapy management) services may be billed for, but the question remains: which insurance companies will reimburse them? Many studies have validated the value of the pharmacist in providing MTM services solely as a cost-avoidance model for any specific medical group. Ideally, MTM services would be billed and reimbursed while cost-avoidance would be documented through an increasingly positive outcome of care for these specific patients...MTM services may be focused on specific situations such as a targeted medication review or discharge education, or they may be provided as complete comprehensive medication reviews...The following are general descriptions of the different forms of MTM services:

• Comprehensive Medication Review
• Target Medication Review
• Bedside MTM
• As Time Permits
• Inpatient MTM Program
• Outpatient MTM Program
• Complete MTM Program
• Billing for MTM Services
• MTM Implementation
• Conclusion

The beauty boutique at 1946 Village Center Circle, inside Summerlin's Trails Village Center, has seen walk-in traffic tumble as much as 75 percent since the closure of grocer Haggen (Haggen Food & Pharmacy) next door, said owner Donna Catalfamo...Catalfamo's story illustrates how the closure of an anchor tenant in a neighborhood shopping center ripples down to small companies nearby. And a number of smaller businesses are feeling that effect today: Three of Haggen's seven Southern Nevada stores — locations at 1940 Village Center Circle, 820 S. Rampart Blvd. and 1031 Nevada Highway in Boulder City — remain empty, with few suitors in sight..."Traffic was down the minute the Haggen sign went up (in June)," Catalfamo said. "We started to feel the effects after the first week."...litigation can complicate leasing. Haggen is in Chapter 11 bankruptcy, and in August, it sued Albertsons, which sold Haggen 146 stores across the West for $300 million, alleging that Albertsons sabotaged its market debuts.

Even for people whose job requires them to know this stuff, drug pricing is hopelessly complex. That helps explain why, for all the debate over drug costs these days, there’s surprisingly little detail about what anybody actually is paying for prescription medicines..."We have list prices, wholesale prices, average wholesale prices, rebates, supplemental rebates, mark-ups, outpatient vs. inpatient, formularies, patent expirations,"..."Most of that information is not available or well understood by the public."...This all raises the question: Just what the heck is the point of the list price anyway?...The short answer is that the list price is a drug company’s opening bid in negotiations with the insurance plans, government programs, and health care providers that purchase its medicines...The list price helps establish that initial starting point...In other words, the list price is not dissimilar from sticker prices on new cars...

Key Elements

• Remuneration based on pre-established transparent criteria including incentives for quality
• Greater communication – to allow others to better understand what pharmacists actually do
• Reduced complexity to allow the system to be interpreted and communicated clearly to the public and the political decision makers