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The Academy of Managed Care Pharmacy's 24th Annual Meeting and Showcase: Specialty pharmaceutical pipeline rich with multiple sclerosis, rheumatoid arthritis, hepatitis C, cancer agents
Forecasts from AMCP's annual meeting indicate a full pipeline for specialty medications.
Approximately $35 billion in brand-name biologics are expected to lose patent protection by 2019. Forecasted at her last talk on this topic in October 2011, Dr Tharaldson noted that biosimilar agents are now coming to market.
Furthermore, FDA has since published draft guidance on biosimilars, to assist manufacturers in bringing these agents to market, and has said that it will work with manufacturers throughout the process.
In addition to more oral agents for RA, MS, and HCV, other specialty agents to treat inflammatory conditions such as psoriasis, systemic lupus erythematosus, and gout, also are on the horizon.
Potential blockbuster tofacitinib (Pfizer), an oral JAK inhibitor for the treatment of moderate-to-severe active RA, is expected to be approved this year, according to Dr Tharaldson. It will be competing with injectable tumor necrosis factor (TNF) inhibitors etanercept (Enbrel, Amgen and Pfizer) and adalimumab (Humira, Abbott).
Relapsing remitting multiple sclerosis (RRMS) is another area that will bring new treatment options to the market. One example is oral MS candidate BG-12 (Biogen Idec), which likely will be the most significant specialty medication approved this year. "BG-12 is an oral, twice-daily medication that has the potential to be used as a first-line agent, and develop blockbuster status," said Dr Tharaldson.
There is also hope in the coming years of a treatment for secondary-progressive multiple sclerosis (SPMS), which currently has no FDA-approved therapy. SPMS is primarily considered a progressive disease course because it marks the transition from the inflammatory process that occurs in RRMS to a process characterized by gradual destruction and loss of nerve fibers. Of the 85 % of people initially diagnosed with RRMS, approximately half will transition to SPMS within 10 years, and 90% will transition within 25 years.
As for HCV, more direct-acting, oral antivirals with different mechanisms of action will become available in the next 3 years, and within a few years, an all-oral regimen will be used to treat HCV, similar to how HIV is now treated. The HIV market will likely see Gilead Sciences' once-daily "quad" tablet which combines emtricitabine/tenofovir (Truvada) with elvitegravir (a novel integrase inhibitor) and cobicstat (booster agent).
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
