Category:

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

Aaron Steffenhagen, PharmD, BCPS, clinical pharmacy manager at University of Wisconsin Hospital and Clinics, discusses some ways pharmacists have helped in cardiopulmonary resuscitation efforts.

U.S. deaths from drug overdoses hit a record high in 2014, propelled by abuse of prescription painkillers and heroin, the Centers for Disease Control and Prevention said on Friday...Drug overdoses increased 6.5 percent in 2014 from a year earlier, killing 47,055 people. The highest rates of death from overdose were seen in West Virginia, New Mexico, New Hampshire, Kentucky, and Ohio, the CDC report said...Deaths from opioids such as prescription pain killers and heroin accounted for 61 percent of overdose deaths and increased 14 percent in 2014, the CDC said...Lower heroin prices, wider availability and higher purity are causing more overdoses, the agency reported. It recommends stricter guidelines for prescribing pain killers, expanded availability and wider access to naloxone, an antidote for opioid-related overdoses.

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

Health-system pharmacists will inevitably face growing ethical challenges as their roles in patient care continue to evolve...ethical dilemmas embedded in health-system pharmacists’ everyday practice include competing interests, limited resources due to drug shortages, and an evolving health care delivery system that has shifted their role from dispensing medications to actively participating in direct patient care...One of the hot-button ethics issues in pharmacy currently is the trend of skyrocketing prescription costs and the lack of transparency in drug pricing decisions. Extremely high prices and lagging reimbursement may preclude health-systems from providing necessary medications to all patients who would otherwise benefit..."Patient welfare is at risk when the ethical perspective in health care is smothered by business and financial perspectives,"..."Patient well-being often hinges on the ability of health professionals to heed the ethical precepts of their calling."...Pharmacists are currently vying to gain support for an expanded role in patient care in the form of provider status, which will likely be more easily garnered if they are perceived as being on the side of patient care rather than the side of business interests.

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.

SPECIALTY PHARMACEUTICALS featured prominently in the FDA’s new drug approval and expanded indications list once again in 2015. Below is the first of a 2-part summary of specialty pharmacy–related FDA approvals and expanded indications that took place this year...Part 2, which will be featured in the next issue of Specialty Pharmacy Times, will include oncology drugs and late-breaking FDA actions...

Bleeding Disorders

• Ixinity (coagulation factor IX (recombinant), Emergent BioSolutions Inc)
• Nuwiq (coagulation factor VIII (recombinant), Octapharma)
• Coagadex (coagulation factor X (human), Bio Products Laboratory Ltd)
• Adynovate (antihemophilic factor [recombinant] pegylated, Baxalta Inc)

Inflammatory Conditions

• Cosentyx (secukinumab, Novartis Pharmaceutical Corp.)
• Humira (adalimumab, AbbVie)

Cystic Fibrosis

• Kalydeco (ivacaftor, Vertex Pharmaceuticals)
• Orkambi (lumacaftor/ivacaftor, Vertex Pharmaceuticals )

HIV

• Evotaz (atazanvir/cobicistat, Bristol-Myers Squibb Co)
• Prezcobix (darunavir/cobicistat, Janssen Therapeutics)
• Genvoya (cobicistat/elvitegravir/emtricitabine/tenofovir alafenamide, Gilead Sciences, Inc)

Hepatitis C

• Technivie (ombitasvir/paritaprevir/ritonavir, AbbVie Inc)
• Daklinza (daclatasvir, Bristol-Myers Squibb)
• Harvoni (ledipasvir/sofosbuvir, Gilead Sciences, Inc.)

• Glatopa (glatiramer acetate injection, Sandoz, Inc.)
• Betaconnect (Bayer HealthCare’s electronic auto injector - Betaseron (interferon beta-1b)

Specialty Ophthalmics

• Lucentis (ranibizumab, Genentech)
• Eylea (aflibercept, Regeneron Pharm)

Hypercholesterolemia

• Praluent (alirocumab, Sanofi-Aventis)
• Repatha (evolocumab, Amgen Inc)

Miscellaneous Specialty Approvals

• Natpara (parathyroid hormone, NPS Pharmaceuticals, Inc)
• Cresemba (isavuconazonium sulfate, Astellas Pharma US, Inc)
• Cholbam (cholic acid, Asklepion Pharmaceuticals LLC)
• Jadenu (deferasirox, Novartis Pharmaceuticals)
• Anthrasil (anthrax immune globulin intravenous [Human], Cangene Corp)
• Rapamune (sirolimus, Wyeth Pharmaceuticals)
• Promacta (eltrombopag, GlaxoSmithKline and Novartis Pharmaceuticals)
• Envarsus XR (tacrolimus extended-release tablets, Veloxis Pharmaceuticals A/S)
• Dysport (abobotulinumtoxinA, Medicis and Ipsen)
• Keveyis (dichlorphenamide, Taro Pharmaceutical Industries Ltd)
• Procysbi (cysteamine bitartrate, Raptor Pharmaceutical)
• Xuriden (uridine triacetate, Wellstat Therapeutics Corporation)