Welcome to the April edition of RxStrategies Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy market place.
New Drug Approval
April 11, 2016 – The U.S. Food and Drug Administration approved Venclexta™ (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. Venclexta™ is the first FDA-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with CLL. RxS Clinical Insight: Venclexta™ was approved with an orphan drug indication. Read More.
March 30, 2016 – The U.S. Food and Drug Administration approved Defitelio® (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation (HSCT). This is the first FDA-approved therapy for treatment of severe hepatic VOD, a rare and life-threatening liver condition. RxS Clinical Insight: Defitelio® was approved with an orphan drug indication. Read More.
March 23, 2016 – The U.S. Food and Drug Administration approved Cinqair® (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair® is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines. Cinqair® is a humanized interleukin-5 antagonist monoclonal antibody produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. Cinqair® reduces severe asthma attacks by reducing the levels of blood eosinophils. Read More.
March 22, 2016 – The U.S. Food and Drug Administration approved Taltz® (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. Taltz®’s active ingredient is an antibody (ixekizumab) that binds to a protein (interleukin (IL)-17A) that causes inflammation. By binding to the protein, ixekizumab is able to inhibit the inflammatory response that plays a role in the development of plaque psoriasis. Read More.
March 18, 2016 – The U.S. Food and Drug Administration approved Anthim® (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim® is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate. Anthim® is a monoclonal antibody that neutralizes toxins produced by B. anthracis. Anthim® was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct efficacy trials in humans. Read More.
Idelvion® (coagulation factor IX (recombinant)
March 4, 2016 – The U.S. Food and Drug Administration approved Idelvion®, Coagulation Factor IX (Recombinant), Albumin Fusion Protein, for use in children and adults with Hemophilia B. Idelvion® is the first coagulation factor-albumin fusion protein product to be approved, and the second Factor IX fusion protein product approved in the U.S. that is modified to last longer in the blood. Read More.
New Formulation Approval
April 25, 2016 – The U. S. Food and Drug Administration approved cabozantinib (Cabometyx™, Exelixis, Inc.) for the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy. The approval was based on a randomized study in which patients with advanced renal cell carcinoma who had received prior anti-angiogenic therapy received either cabozantinib 60 mg orally once daily (N=330) or everolimus 10 mg orally once daily (N=328). RxS Clinical Insight: Cabometyx™ was approved with an orphan drug indication. Cabozantinib is a kinase inhibitor that was approved in 2012 with the name Cometriq™ for metastatic medullary thyroid cancer (MTC). Read More.
Photrexa® Viscous (riboflavin 5’)
April 18, 2016 – Avedro, Inc., received approval from the U.S. Food and Drug Administration for Photrexa® Viscous, Photrexa® and the KXL System. Photrexa® Viscous and Photrexa® are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus. Avedro’s Photrexa® Viscous, Photrexa® and the KXL System represent a first-in-class therapeutic treatment for this sight threatening indication. Read More.
April 8, 2016 – The U.S. Food and Drug Administration has given its approval for Sun Pharma’s eye inflammation drug BromSite™ (bromfenac ophthalmic solution). BromSite™ is the first non-steroidal anti-inflammatory drug (NSAID) to obtain FDA approval for the treatment of post-operative inflammation and prevention of ocular pain in patients undergoing cataract surgery. Developed by InSite Vision, BromSite™ is said to be the first bromfenac ophthalmic solution formulated in DuraSite, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability, and residence time as compared to conventional topical therapies. Read More.
Inflectra™ (infliximab-dyyb) Injection
April 5, 2016 – The U.S. Food and Drug Administration approved Inflectra™ (infliximab-dyyb) for multiple indications. Inflectra™ is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra™ is biosimilar to Janssen Biotech, Inc.’s Remicade® (infliximab), which was originally licensed in 1998. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. Read More.
Descovy® (emtricitabine and tenofovir)
April 4, 2016 – Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration has approved Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg, F/TAF), a fixed-dose combination for the treatment of HIV. Descovy® is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. Descovy® is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. Read More.
Kovaltry® (antihemophilic factor [recombinant])
March 17, 2016 – The U.S. Food and Drug Administration has approved Bayer’s Kovaltry® Antihemophilic Factor (Recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. Kovaltry® can be used two or three times per week in adolescents and adults, and two or three times per week or every other day in children. Read More.
March 15, 2016 – Spectrum Pharmaceuticals, announced that the U.S. Food and Drug Administration granted approval of Evomela™ for use in two indications: 1) Use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation (ASCT) in patients with multiple myeloma (MM), and 2) For the palliative treatment of patients with MM for whom oral therapy is not appropriate. This is the first product to be FDA-approved for the high-dose conditioning indication in MM. Read More.
Odefsey® (emtricitabine, rilpivirine and tenofovir)
March 1, 2016 – Gilead Sciences, Inc., announced that the U.S. Food and Drug Administration has approved Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. Emtricitabine and tenofovir alafenamide are from Gilead Sciences and rilpivirine is from Janssen Sciences Ireland UC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen). Odefsey is Gilead’s second TAF-based regimen to receive FDA approval and represents the smallest pill of any single tablet regimen for the treatment of HIV. Read More.
New Indication Approval
April 15, 2016 – Boehringer Ingelheim announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) tablets for the treatment of patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy. Gilotrif®, an oral, once-daily EGFR-directed therapy, is currently approved in the U.S. for the first-line treatment of specific types of EGFR mutation-positive NSCLC. Read More.
March 11, 2016 – The U. S. Food and Drug Administration approved crizotinib capsules (Xalkori®, Pfizer, Inc.) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Crizotinib was first approved in 2011 for the treatment of patients whose tumors are anaplastic lymphoma kinase (ALK)-positive. The current approval was based on a multicenter, single-arm trial in patients with metastatic ROS1 rearrangement-positive NSCLC. RxS Clinical Insights: This new indication for Xalkori® is an orphan indication. Read More.
March 4, 2016 – AbbVie, announced the U.S. Food and Drug Administration approved Imbruvica® (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL).1 The approval is based on data from the randomized, multi-center, open-label Phase 3 Resonate™-2 (PCYC-1115) trial, which evaluated the use of Imbruvica® versus chlorambucil in 269 treatment-naïve patients with CLL or small lymphocytic lymphoma (SLL) aged 65 years or older. Read More.
March 2, 2016 – AstraZeneca announced that the U.S. Food and Drug Administration has approved a new indication expanding the use of Faslodex® (fulvestrant) to include use in combination with palbociclib. The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy. Faslodex® has been approved since 2002 as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy. Read More.
February 26, 2016 – The U. S. Food and Drug Administration approved everolimus (Afinitor®, Novartis) for the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. Read More.
February 26, 2016 – The U.S. Food and Drug Administration approved obinutuzumab (Gazyva® Injection, Genentech, Inc.) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Obinutuzumab was previously approved for use in combination with chlorambucil for the treatment of patients with previously untreated chronic lymphocytic leukemia. Read More.
New Generic Approvals
Generic Drug Name
|ROSIGLITAZONE MALEATE AND GLIMEPERIDE TABLETS, 4 MG/1 MG 4 MG/2 MG 4 MG/4 MG 8 MG/2 MG 8 MG/8 MG||TEVA PHARMACEUTICALS USA||AVANDARYL TABLETS||4/1/2016|
|FLURANDRENOLIDE CREAM USP, 0.05%||TELIGENT PHARMA, INC.||CORDRAN SP CREAM||4/13/2016|
|FOSAMPRENAVIR CALCIUM TABLETS, 700 MG||MYLAN PHARMACEUTICALS, INC.||LEXIVA TABLETS||4/15/2016|
Generic Drug Name
|MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION USP, 1G/100 ML||HQ SPECIALTY PHARMA CORPORATION||MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION||3/2/2016|
|OXICONAZOLE NITRATE CREAM, 1%||TARO PHARMACEUTICALS USA, INC.||OXISTAT CREAM||3/7/2016|
|SILDENAFIL CITRATE TABLETS, 25 MG (BASE), 50 MG (BASE), 100 MG (BASE)||TEVA PHARMACEUTICALS USA, INC.||VIAGRA (SILDENAFIL CITRATE) TABLETS, 25 MG, 50 MG, 100 MG||3/9/2016|
|MAGNESIUM SULFATE IN WATER FOR INJECTION, 40 MG/ML, 80 MG/ML||FRESENIUS KABI USA, LLC||MAGNESIUM SULFATE IN WATER FOR INJECTION||3/15/2016|
|DICLOFENAC SODIUM TOPICAL GEL, 1%||AMNEAL PHARMACEUTICALS||VOLTAREN GEL, 1%||3/18/2016|
|MOMETASONE FUROATE NASAL SPRAY, 50 MCG||APOTEX CORP||NASONEX NASAL SPRAY||3/22/2016|
|BENDAMUSTINE HYDROCHLORIDE FOR INJECTION, 25 MG/VIAL, 100 MG/VIAL (SINGLE DOSE VIAL)||GLENMARK PHARMACEUTICALS LIMITED||TREANDA FOR INJECTION, 25MG/VIAL, 100MG/VIAL||3/24/2016|
|BENDAMUSTINE HYDROCHLORIDE FOR INJECTION, 25 MG/VIAL, 100 MG/VIAL (SINGLE DOSE VIAL)||INNOPHARMA LICENSING LLC||TREANDA FOR INJECTION, 25MG/VIAL, 100MG/VIAL||3/24/2016|
|DAPTOMYCIN FOR INJECTION, 500 MG/VIAL||TEVA PHARMACEUTICALS USA||CUBICIN FOR INJECTION||3/24/2016|
New Drug Shortage
April 26, 2016
- Fluphenazine Tablets (Discontinuation)
April 17, 2016
- Bleomycin Sulfate for Injection (Currently in Shortage)
April 07, 2016
- Theophylline Extended Release Tablets and Capsules (Currently in Shortage)
April 05, 2016
- Theophylline Extended Release Tablets and Capsules (Currently in Shortage)
March 23, 2016
- Sodium Acetate Injection, USP (Currently in Shortage)
March 17, 2016
- Rivastigmine Tartrate Capsules (Discontinuation)
March 11, 2016
- Didanosine Delayed-Release Capsules USP (Discontinuation)
- Telithromycin (Ketek) Tablets (Discontinuation)
New Drug Safety Alert
April 26, 2015 – The FDA is evaluating the results of a Danish study that conclude there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections. The FDA is also reviewing additional data and will communicate final conclusions and recommendations when the review is complete. Read More.
Sterile Drug Products from Pharmakon Pharmaceuticals, Inc.
April 16, 2016 – Pharmakon issues nationwide issued a voluntary nationwide recall of all sterile compounded products. All recalled products have a label that includes the Pharmakon Pharmaceuticals name, address and expiration date. The sterile products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016. Read More.
50 Percent Magnesium Sulfate Injection, USP by Hospira
April 14, 2016 – Hospira, Inc. is voluntarily recalling one lot of 50% Magnesium Sulfate Injection, USP, 10 g/20 mL (0.5 g/ml), 20 mL Single-dose vials, Lot 50-343-DK, Expiration 01FEB2017, NDC 0409-2168-02, to the hospital level due to a confirmed customer complaint for the presence of particulate matter, within one single-dose fliptop vial. A recall was previously executed for this lot on March 23, 2016 due to a confirmed high out of specification (OOS) result for pH. Read More.
Opioid Pain Medicines
March 22, 2016 – The FDA is warning about several safety issues with the entire class of opioid pain medicines. See the FDA Drug Safety Communication for a complete listing. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring changes to the labels of all opioid drugs to warn about these risks. Read More.
March 8, 2016 – The FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. Read More.
New Drug Recall Alert
Fluconazole Injection, USP, (in 0.9 Percent Sodium Chloride) 200mg per 100ml
March 5, 2016 – Sagent has initiated a voluntary recall of one lot of Fluconazole Injection, USP, 200mg per 100mL to the user level due to the discovery of an out of specification impurity result detected during routine quality testing of stability samples at the 18-month interval. This impurity has been identified as Metronidazole. Read More.
5 Percent Dextrose Injection USP in PAB Container by B. Braun Medical
April 29, 2016 – B. Braun Medical Inc. is recalling one lot of 5% Dextrose Injection USP 100/150mL container (Lot #J5J706, catalog #S5104-5264, NDC 0264-1510-32) to the consumer level. B. Braun recently identified an adverse quality trend in customer complaints reporting that some containers in lot J5J706 exhibited leakage and, in a few instances, visible particulate matter identified to be microbial growth. Read More.
Compounded Products by Reliable Drug Pharmacy
April 28, 2016 – Reliable Drug Pharmacy is recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. All unexpired lots are subject to the recall. All recalled products were distributed to patients and veterinarians within California. A few products were shipped to Hawaii, New Mexico and Michigan. Read More.
Sodium Bicarbonate Injection, USP by Hospira
March 21, 2016 – Hospira, Inc. is recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry 1AUG2017) at the hospital/retail level due to the presence of a particulate within a single–dose glass fliptop vial. The issue was identified through a confirmed complaint. Read More.
Amikacin Sulfate Injection USP, 1 gram/4mL (250 mg/mL) Vials by Teva
March 10, 2016 – Teva Pharmaceuticals announced a voluntary recall of one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of particulate matter identified as glass in one vial. The recalled lot number is 4750915, Expiration Date 9/2017. Read More.
Clinical and Pharmacy News
The Complex Math Behind Spiraling Prescription Drug Prices
April 27, 2016 – The soaring cost of prescription drugs has generated outrage among politicians and patients. Some cancer drugs carry price tags of more than $100,000 a year, and health plans are increasingly asking people to shoulder a greater share of the cost. Read More.
Expert Panel Evaluates Role of Osteoporosis Medications in Fracture Healing
April 27, 2016 – In people with osteoporosis, one fracture often leads to more fractures, and potentially a future of pain, disability and poor quality of life. While studies have shown that such high-risk patients benefit from appropriate medication to reduce future fracture risk, more research is needed on the effect of osteoporosis medications on fracture healing. Read More.
Data-Driven Change Management: Controlling Hospital Drug Costs Through Data Analysis
April 26, 2016 – Data by itself may simply be a tool; yet, when applied in the right way, it can be a powerful ally. A large health system in the Northeast recently used the power of data analysis, and an ability to work synergistically with other hospital departments to drive impressive results. The move reduced drug costs by more than $2.8 million over 2 years across 2 of its member hospitals. Care quality measures improved, too, as the hospital pharmacy effectively shared its pharmaceutical and clinical knowledge with physicians and nurses in ways that shaped treatment decisions. Read More.
Common Allergy Drugs May Raise Dementia Risk
April 25, 2016 – Anticholinergic agents commonly used for colds and allergies have been linked with brain atrophy and dysfunction. The researchers behind a recent study that found this association suggested that anticholinergic drug use among older adults should be discouraged if no alternative therapy is available. Read More.
New Guidelines for Treatment of Migraine with Botox
April 25, 2016 – In 2010, the Food and Drug Administration approved the use of onabotulinumtoxinA (Botox) for the treatment of chronic migraine in patients. However, the use of Botulinum neurotoxin (BoNT) for chronic migraine has lacked professional consensus—until now. Read More.
FDA Issues Guidance for Hospitals and Health Systems Engaged in Drug Compounding
April 21, 2016 – On Friday, April 15, 2016, the U.S. Food and Drug Administration announced the availability of three new Draft Guidance documents relating to drug compounding under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FDCA). These proposals are particularly relevant to hospitals and health systems operating under these sections of the law, and they would pose potential challenges to health systems using a “central-fill” pharmacy. Read More.
Three Drug Trends Impacting Specialty Pharmacy
April 21, 2016 – Aimee Tharaldson, PhamD, senior clinical consultant, emerging therapeutics, Express Scripts, set the pace for Wednesday morning, April 21, at the Academy of Managed Care and Specialty Pharmacy Annual Meeting 2016 with the session, “Specialty Pharmaceutical in Development.” Read More.
Watch Your Co-Pays; Your Pharmacy May Be Overcharging You
April 18, 2016 – After recently joining a Medicare Part D prescription drug plan, I was happy to see that one of its member pharmacies was a small, family-owned business. I have a fondness for neighborhood drugstores, as my late pharmacist father owned one when I was growing up. We lived in an apartment above the store, and I remember my father getting up in the middle of the night to go downstairs and fill emergency prescriptions. Read More.
Current Status of Clinical Practice Guidelines in Schizophrenia
April 18, 2016 – Schizophrenia is a chronic, often disabling illness, with onset in early adulthood affecting approximately 24 million people worldwide. There is significant heterogeneity in the etiopathology, symptomatology, and course of the disease. Read More.
Three New FDA Draft Guidance Documents for Drug Compounders
April 15, 2016 – The U.S. Food and Drug Administration released three draft guidance documents for drug compounders. The guidance describes the FDA’s interpretation of the prescription requirement in section 503A of the Food Drugs & Cosmetics Act (FD&C Act), how the agency intends to apply such a requirement to compounding for hospitals or health system pharmacies, and the definition of the term “facility,” in reference to section 503B of the FD&C Act. Read More.
Building an Integrative Pharmacy Practice: Learn as You Go
April 10, 2016 – I hope you have become at least mildly interested in the concept of “The New Pharmacy.” I’ve tried to share some resources for obtaining knowledge, focusing on the most common aspects of the functional pharmacy approach to health; how to set up your practice; how and when to follow up with patients; and what to expect from patients, doctors, and the community. Read More.
Specialty Pharmacy Drives Prescription Growth
April 13, 2016 – It’s no secret that the category of drugs drawing the most attention — and money — in recent years has been specialty pharmacy. And it shouldn’t be surprising that the growth the category has experienced in the past several years — pushed more recently by hepatitis C and oncology treatments — isn’t expected to slow anytime soon. Read More.
How to Cut Pharmacy Staff Without Layoffs or Reduced Services
April 10, 2016 – In these cost-conscious times, health-system pharmacies are often asked to cut staff while keeping up with increasing workloads. It can be done, through good planning and an eye for opportunities to redeploy centralized pharmacists, expand pharmacy services in ways that do not require an additional pharmacist, and make best use of technology to improve efficiency in the pharmacy. Read More.
Telepharmacy Pulls Hospital Through Storm
April 10, 2016 – Winter Storm Jonas hit North Carolina pretty hard. In January, the storm dumped ice and snow across the state. Flights were grounded, classes were canceled at major universities and many schools were closed. During the storm, surgeries at the North Carolina Specialty Hospital in Durham were canceled and no new patients were admitted. However, there were patients in the hospital who required the services of a pharmacist. Read More.
New Tool Tailors Drug Dosing for Patients
April 7, 2016 – A new computational tool successfully tested in a small pilot trial harnesses clinical data to predict the optimal drug dose for an individual (Sci Transl Med 2016 Apr 6. [Epub ahead of print]). The mathematical approach underlying the tool promises to take the educated guesswork out of prescribing medications for immunosuppression, cancer, heart disease, bacterial infections and other conditions that require tightly controlled treatment regimens. Read More.
Walgreens Unlikely to Make Rite Aid’s PBM A Priority
April 6, 2016 – Walgreens Boots Alliance will inherit a pharmacy benefit manager once its deal with Rite Aid RAD +0.06% closes in the second half of this year, but don’t look for the drugstore giant to make big investments in the PBM’s growth even if it decides to keep it. Read More.
As U.S. Pharmacy Sales Slow, Walgreens Says Rite Aid Deal On Track
April 5, 2016 – Walgreens Boots Alliance reported improving profits as it cuts costs in its U.S. pharmacy business ahead of its Rite Aid RAD -0.06% acquisition that executives expect to close in the second half of this year. Walgreens growth continues to be hampered by slowing U.S. retail pharmacy sales due in part to reimbursement pressures and a weaker-than-expected flu season with far fewer reported cases across the country. Read More.
Recent Trends in Prescription Drug Costs
April 5, 2016 – This Visualizing Health Policy infographic spotlights national spending on prescription drugs and the public’s views on pharmaceutical prices. Prescription drug spending rose sharply in 2014, driven by growth in expenditures on specialty drugs, including medications to treat cancer and hepatitis C. Medicare’s spending on prescription pharmaceuticals also has risen: between 2004 and 2014, the program’s share of US drug expenditures increased from 2% of $193 billion to 29% percent of $298 billion. Read More.
Analysis Uncovers Huge Spike in Prescription Drug Prices
April 5, 2016 – An investigation into the cost of prescription drugs reveals huge price hikes over the past five years. Several brand name medications more than doubled in price. The Reuters analysis of the 10 most popular drugs found the increases added billions to the nation’s health care spending for common conditions like arthritis, asthma and abnormal cholesterol. Read More.
ACC: Nonstatin Therapies May Be Appropriate for Certain High-Risk Patients
April 4, 2016 – A new expert consensus document states that health care providers might consider adding nonstatin therapies to help reduce cholesterol in patients at high risk for cardiovascular events (JACC 2016 Apr 1. [Epub ahead of print]). The document is intended to address current gaps in recommendations for reducing low-density lipoprotein cholesterol (LDL-C) and to provide practical guidance for clinicians in situations that were not covered by the 2013 guideline issued by the American College of Cardiology (ACC) and the American Heart Association (AHA) on reducing atherosclerotic cardiovascular disease (ASCVD) risk in adults. Read More.
FDA Releases Draft Guidance for Labeling Biosimilar Products
April 1, 2016 – In a move that is bound to be as controversial as any other in the field of biosimilars, the FDA released draft guidance for industry about the labeling of biosimilar products that innovator product data can now be used, in part, for biosimilar labeling. Read More.
ACP Calls on Government to Curb Drug Prices
March 31, 2016 – Reining in the cost of prescription drugs in the U.S. will mean going beyond setting list prices, and looking at issues of regulatory approval, patents and intellectual property, assessment of value and cost-effectiveness, and health plan drug beneﬁts, according to the American College of Physicians (ACP). Read More.
FDA Takes Important Step to Increase the Development of, And Access to, Abuse-Deterrent Opioids
March 24, 2016 -The U.S. Food and Drug Administration issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. These actions are among a number of steps the agency recently outlined in an action plan to reassess its approach to opioid medications. The plan is focused on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief. Read More.
New Guidelines on Blood-Thinning Therapy
March 29, 2016 – Many of the approximately 15.5 million Americans with coronary heart disease will receive new advice regarding whether and how long to take aspirin combined with another blood-thinning antiplatelet to prevent clotting under updated guidelines released by the American College of Cardiology (ACC) and the American Heart Association (AHA). Read More.
Big Data-Driven Method Could Save Money, Increase Efficiency in Pharmaceutical Management
March 29, 2016 – Researchers at Binghamton University and pharmacy solutions provider Innovation Associates have developed an optimized approach for determining prescribed medication associations within a high-volume pharmacy environment that could save money and time. Read More.
340B in the News
Hospital Compliance with ACA Nonprofit Requirements Mixed at Best, Study Finds
April 26, 2016 – Hospitals participating in the Affordable Care Act’s 340B drug pricing program are failing to comply with several key requirements of the law, according to a recent study by the Berkeley Research Group. The drug pricing program allows certain hospitals and other health care providers to obtain discounted prices on covered outpatient drugs, including prescription drugs and biologics other than vaccines, from drug manufacturers. 340B hospitals receive additional financial benefit because of their access to discounted drugs through the program. Read More.
New Report Finds 340B Hospitals Have Low Compliance with ACA Charity Care Requirements
April 25, 2016 – The Alliance for Integrity and Reform of 340B (AIR340B) released a new report from the Berkeley Research Group (BRG) examining hospitals’ compliance with the Affordable Care Act’s (ACA) charity care requirements. The report, which expands on a study published in the New England Journal of Medicine (NEJM) last year, found large numbers of both 340B and non-340B hospitals not complying with key ACA protections for low-income patients. Read More.
Viewpoint: A Shield
April 25, 2016 – Getting diagnosed with cancer is devastating. Being unable to afford expensive medications to fight it is worse. Luckily, many Hoosiers get the help they need from a federal program they’ve never heard of: the 340B drug pricing program. Congress created the program in 1992 with bipartisan support to allow health providers that serve large numbers of low-income patients to receive discounted medications from drug companies. In turn, these safety-net providers supply low-cost or no-cost medicines to the community. The program also helps fund cancer, diabetes, HIV/AIDS, dental and primary-care clinics. Read More.
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; Reopening of Comment Period
April 19, 2016 – This document reopens the comment period for the June 17, 2015, proposed rule entitled “340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation.” The comment period for the proposed rule, which ended on August 17, 2015, is reopened for 30 days. Read More.
Viewpoint: Health Care Program Needs a Refresh
April 9, 2016 – Patients, providers and policymakers agree: Health care in the United States today is drastically different than it was 25 years ago — especially in the oncology field. Oncology providers and patients have access to an abundance of new therapies and technologies, and as a result, more people are surviving cancer every day. Despite all the assessments, reforms and overhauls the industry has been through during the past two decades, there remains significant volatility in the practice landscape due to policy, economic and workforce issues that have led to soaring cancer care costs. Meanwhile, some aspects of our health care system have remained largely unchanged. The 340B drug pricing program is one example. Read More.
Hot Topics at 340B Coalition Conference
April 5, 2016 – Implementing the 340B Drug Pricing Program can be daunting, with many covered entities lacking an in-depth understanding of the program’s complex rules, regulations and reporting requirements, which often result in lost savings opportunities and increased risks. That was the heady backdrop for the 340B Coalition Winter Conference, the largest 340B meeting to date, where experts from around the country gathered to provide insights, solutions and debate on high-risk issues facing 340B managers. Read More.
340B Drug Discounts: Potential HRSA Policy Shift May Limit Eligibility for Preferred Pricing
April 1, 2016 – The 340B drug pricing program requires drug makers to offer covered outpatient drugs to safety net hospitals and certain other designated healthcare providers at discounted prices. A potential shift in how the governing agency interprets 340B eligibility could result in reduced benefits from the program and the necessity to undertake compliance measures. Read More.
Discounted Prescription Drugs Could Save Patients from Making Deadly Medical Decisions
March 29, 2016 – Nine out of ten Americans now have health care coverage, but that doesn’t mean they can afford their medication. With the rising cost of drugs, many say they’re forced to choose between their prescriptions and other necessities like food or rent. Read More.
HRSA Wants to Audit Your 340B Program. Are You Ready? Five Best Practices for Operating a Compliant 340B Program
March 28, 2016 – It’s Friday afternoon and your hospital receives an email from the Health Resources and Services Administration (HRSA), notifying you that your hospital has been selected for a 340B program audit. As part of a team that has helped numerous hospitals prepare for HRSA audits, I can tell you that the single-most important thing any hospital can do to answer “yes” to that question is to develop a culture of 340B compliance that permeates the entire organization. Read More.
MedPAC Publishes Report to Congress on 2017 Policies, Recommends Payment Reforms and Cuts to Part B Payments to Hospitals for 340B Drugs
March 25, 2016 – On March 15, 2016, MedPAC submitted its 2016 annual report to Congress on Medicare payment policies for 2017. In the report, MedPAC makes a number of recommendations to Congress pertaining to payment under Medicare fee-for-service (“FFS”), including recommendations that have been published by the Commission in the past. Read More.
AHF Lauds Congressman Hal Rogers for Supporting Preservation of the 340B Drug Discount Program
March 1, 2016 – The AIDS Healthcare Foundation espouses the statement made by House Appropriations Committee Chairman Hal Rogers (R-KY) condemning the Obama administration’s proposal to finance the 340B program with user fees. According to the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA), the drug-pricing program “…requires drug manufacturers to provide outpatient drugs to eligible health care organizations/covered entities at significantly reduced prices. The 340B Program enables covered entities to stretch scarce Federal resources as far as possible, reaching more eligible patients and providing more comprehensive services.” Read More.