Formulary Watch |

Specialty tier falls out of favor because of access issues

Spending growth for specialty drugs rose 19.6% between 2009 and 2010, while growth of traditional drugs decreased by 1.4%, according to Express Scripts' 2010 Drug Specialty Report. Payers are struggling to appropriately manage high-cost drugs while ensuring their members get the care they need. One strategy is introducing a specialty drug tier to the formulary, which raises a red flag on access issues.

Asian Conference on Clinical Pharmacy scheduled

The 12th Asian Conference on Clinical Pharmacy will be held July 7-9, 2012, at the Hong Kong Convention and Exhibition Centre.

FDA advisory committee votes to extend use of pneumococcal vaccine to adults

FDA’s Vaccines and Related Biologics Advisory Committee recently voted in favor of expanding the indication for the pneumococcal 13-valent conjugate vaccine (Prevnar 13) for the prevention of pneumococcal disease in adults age 50 years and older, Pfizer Inc, the drug’s manufacturer, said in a statement.

Formulary Digital Edition December 2011

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First generic version of cholesterol-lowering Lipitor approved

FDA approved the first generic version of the cholesterol-lowering drug Lipitor (atorvastatin calcium tablets).

FDA approves first insomnia drug for middle-of-the-night waking followed by difficulty returning to sleep

FDA approved zolpidem tartrate sublingual tablets (Intermezzo, Transcept Pharmaceuticals) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

FDA changes label for Trilipix

FDA has changed the label for fenofibric acid (Trilipix, Abbott). It now carries a warning that the agent may not lower the risk of myocardial infarction or stroke.

NHLBI panel recommends universal pediatric screening for cholesterol

All children and adolescents should be screened for high cholesterol, and children as young as aged 10 should be considered for treatment with statins, according to the latest update from an expert panel convened by the National Heart, Lung, and Blood Institute.

AHA, ACC release updated guidelines on secondary prevention of atherosclerotic vascular disease

The American Heart Association and American College of Cardiology Foundation have issued new guidelines for secondary prevention and risk reduction in patients with atherosclerotic vascular disease.

Cancer drugs are in short supply in United States

Some essential chemotherapy drugs are in short supply for the first time in the United States, according to the October 3 New England Journal of Medicine.

FDA mandates enhanced safety check on TNF blockers

FDA is requiring that manufacturers of tumor necrosis factor blockers perform enhanced safety surveillance, the agency said on November 3 in an ongoing safety review of this class of biologic products.

FDA approves aflibercept for patients with wet AMD

FDA has approved aflibercept (Eylea Injection, Regeneron), known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular (wet) age-related macular degeneration in patients aged 60 and older at a recommended dose of 2 mg every 4 weeks (monthly) for the first 12 weeks, followed by 2 mg every 8 weeks (2 months).

FDA approves first drug to treat a rare bone marrow disease

FDA approved ruxolitinib (Jakafi, Incyte) for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.

FDA revokes breast cancer indication for Avastin

FDA Commissioner Margaret A. Hamburg, MD, announced the agency's decision to revoke the breast cancer indication for bevacizumab (Avastin), noting that the benefits do not outweigh the potentially life-threatening side effects, such as heart attack or heart failure, high blood pressure, bleeding and hemorrhaging, and the development of perforations in different parts of the body, such as the nose, stomach, and intestines.

Formulary Digital Edition November 2011

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Drug Watch: Epilepsy and Parkinson’s disease

Epilepsy and Parkinson’s disease

Tapentadol (Nucynta ER): A mu-opioid receptor agonist for the management of moderate-to-severe chronic pain

New formulation: Tapentadol extended release tablets were FDA approved for the management of moderate-to-severe chronic persistence pain requiring continuous maintenance in adults.

Anticoagulation prophylaxis practice patterns in patients having total hip, total knee replacement in a US health plan

This study aims to illuminate anticoagulation prophylaxis practice patterns in the United States after total joint replacement surgery.

FDA requires several changes to bevacizumab label to include safety information

Safety information chagnes to the package insert for bevacizumab were issued by FDA on September 30, 2011.

Drug shortages challenge the healthcare community, FDA, and pharmaceutical manufacturers

The outcry from physicians, pharmacists, and patients over disruptions in supplies of vital medicines to treat cancer, pain, and other serious conditions is drawing attention from the White House, Congress and the broader healthcare system.

Switching patients from IV to oral form of drugs could save millions, reduce adverse events

Switching hospitalized patients able to take medication by mouth from intravenous to pill forms of the same drugs could safely save millions of dollars a year.

Decision-makers urged to put personalized medicine into action

Pharmacogenomics can change the way patients are treated.

Better medication adherence leads to better outcomes in hepatitis C

Patients with hepatitis C virus (HCV) who were more adherence to their pegylated interferon and ribavirin treatment were more likely to achieve both an early and sustained virologic response.

Removing anthracyclines from HER2-positive breast cancer treatment reduces cardiac toxicity

When an anthracycline is not used concomitantly with adjuvant trastuzumab to treat HER2-positive breast cancer, cardiac toxicity is reduced.

Specialty drug category grows with new approvals

Specialty pharmaceutical research and development spending is expected to increase with the focus on "biobetters", biosimilars, and novel therapies.

Creative contracting initiatives key for pharma as competition in RA market increases

The rheumatoid arthritis payer market has experienced increasingly competitive forces, prompting RA drug manufacturers to experiment with new contracting initiatives to gain preferred formulary placement.

FDA Actions in Brief November 2011 (Xarelto, Combivent Respimat Inhalation Spray, Exparel, Byetta, Onfi, Euflexxa, Cialis, Clindamycin injection, Ferriprox)

Recent FDA Approvals (through October 2011) related to Xarelto, Combivent Respimat Inhalation Spray, Exparel, Byetta, Onfi, Euflexxa, Cialis, Clindamycin injection, Ferriprox

Ezogabine (Potiga): Oral potassium channel opener indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older

New molecular entity: Ezogabine was FDA approved for use as an add-on medication to treat partial-onset seizures associated with epilepsy in adults.

Rosato appointed new AMCP CEO

Edith Rosato, RPh, has recently been appointed new CEO of the Academy of Managed Care Pharmacy.

FDA Pipeline Preview, November 2011 (NuPathe, Teva, Wilex, Atox Bio, Biovest, Dr. Reddy's Laboratories, Apotex, Par Pharmaceuticals)

Recent FDA action (through October 2011) related to golimumab expanded label, meningococcal and Hib combination vaccine, desvenlafaxine, rivaroxaban anticoagulant, deferiprone oral iron chelator, glucarpidase experimental treatment, doxidopa, QLT091001, NP-001,cyclophosphamide, resminostat oral pan HDAC inhibitor, TXA127