Clinical Insights — January Issue 1

    Welcome to the January 2017 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

    Spinraza™ (nusinersen) – December 23, 2016 – The U.S. Food & Drug Administration (FDA) approved Spinraza™ (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza™ is an injection administered into the fluid surrounding the spinal cord. Read More. 

    Rubraca™ (rucaparib) – December 19, 2016 – The FDA granted accelerated approval to rucaparib (Rubraca™, Clovis Oncology Inc.) for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. RxS Clinical Insight: Rubraca™ has an orphan drug designation. As a PARP inhibitor Rubraca™ will compete versus Lynparza™ for market share. Read More.

    Eucrisa™ (crisaborol) – December 14, 2016 – The FDA approved Eucrisa™ (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. Read More.

    Soliqua™ 100/33 (insuling glargine and lixisenatide) – November 21, 2016 – Sanofi announced that the FDA approved once-daily Soliqua™ 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide. Soliqua™ 100/33 is the combination of Lantus® (insulin glargine 100 Units/mL) and lixisenatide, a GLP-1 receptor agonist. Read More.

    Darzalex® (daratumumab) – Nov. 21, 2016 – The FDA approved daratumumab (Darzalex®, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Read More.

    Xultophy® 100/3.6 (insulin degludec and liraglutide) – Nov. 21, 2016 – Novo Nordisk announced that the FDA approved the New Drug Application for Xultophy® 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Xultophy® 100/3.6 is a once-daily, combination of Tresiba® (insulin degludec injection) and Victoza® (liraglutide) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily. Read More.

    Intrarosa™ (prasterone) – November 17, 2016 – The FDA approved Intrarosa™ (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). Read More.

    Bonjesta™ (doxylamine/pyridoxine) – November 7, 2016 – The FDA has approved Bonjesta™ (doxylamine succinate and pyridoxine HCl extended-release tablets; Duchesnay), a fixed-dose combination drug product for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Read More.

    Vemlidy® (tenofovir alafenamide) Tablets – Nov. 10, 2016 – Gilead Sciences, Inc. announced that the FDA has approved Vemlidy® (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Read More.

    Zinplava™ (bezlotoxumab) Injection – October 21, 2016 – The FDA has approved Zinplava™ (bezlotoxumab) Injection 25 mg/mL. Zinplava™ (bezlotoxumab) is a selective, fully-human, monoclonal antibody that binds to Clostridium difficile toxin B, indicated to reduce recurrence of Clostridium difficile infection (CDI) in patients 18 years of age or older. Read More.

    Lartruvo™ (olaratumab) Injection – October 19, 2016 – The FDA granted accelerated approval to Lartruvo™ (olaratumab) with doxorubicin to treat adults with certain types of soft tissue sarcoma (STS), which are cancers that develop in muscles, fat, tendons or other soft tissues. Read More.

    Carnexiv™ (carbamazepine) Injection – October 08, 2016 – H. Lundbeck A/S (Lundbeck) announced that the FDA has approved Carnexiv™ (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. Carnexiv™ has received orphan drug designation from the U.S. FDA for this indication and will be the first available intravenous (IV) formulation of the antiepileptic drug (AED) carbamazepine. Read More.

    New Formulation Approval

    Synjardy® XR (empagliflozin/metformin) – December 12, 2016 – The FDA has approved Synjardy® XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. When used along with diet and exercise, SYNJARDY XR is indicated to improve blood sugar in adults with type 2 diabetes when both empagliflozin and metformin can be taken. It is marketed by Boehringer Ingelheim and Eli Lilly and Company. Read More.

    Selzentry® (maraviroc) – November 4, 2016 – ViiV Healthcare received approval from the FDA to market Selzentry® for the treatment of only CCR5-tropic HIV-1 infection, in combination with other antiretroviral agents, in pediatric patients 2 years of age or older who weigh at least 10 kilograms (kg). Read More.

    Pertzye® (pancrelipase) – October 11, 2016 – Digestive Care, Inc. announced the FDA approval for an infant-specific dose of Pertzye® (pancrelipase) in a 4,000 USP lipase units capsule. The new capsule strength will enable guideline-recommended dosing and administration of Pertzye® for infants (up to 12 months) with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions. Read More.

    Orkambi® (lumacaftor/ivacaftor) – September 28, 2016 – Vertex Pharmaceuticals Incorporated announced that the FDA approved Orkambi® (lumacaftor/ivacaftor) for use in children with cystic fibrosis (CF) ages 6 through 11 who have two copies of the F508del mutation. People with this mutation represent the largest population of those with CF, a rare, life-threatening disease. Orkambi® is the first and only medicine to treat the underlying cause of CF for people with this mutation. Read More.

    New Indication Approval

    Adynovate® [Antihemophilic Factor (R), PEGylated] – December 27, 2016 – Shire plc, announced that the FDA has approved Adynovate® [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, in pediatric patients under 12 years of age. The FDA also approved Adynovate® for use in surgical settings for both adult and pediatric patients. Read More.

    Tresiba® (insulin degludec injection) – December 19, 2016 – Novo Nordisk, announced that the FDA approved an expanded indication for Tresiba® (insulin degludec injection 100 U/mL, 200 U/mL), a once-daily, long-acting basal insulin, to be used in children and adolescents with diabetes. Read More.

    Avastin® (bevacizumab) – December 6, 2016 – Genentech, announced that the FDA has approved Avastin® (bevacizumab), either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine chemotherapy, followed by Avastin® alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Read More.

    Jardance® (empagliflozin) – December 5, 2016 – The FDA approved a new indication for Jardiance® (empagliflozin) tablets to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease. Jardiance® is the first type 2 diabetes treatment approved with this additional indication and the only oral type 2 diabetes medicine shown in a clinical trial to provide a life-saving cardiovascular benefit. Read More.

    FluLaval® Quadrivalent (influenza vaccine) – November 18, 2016 – GSK announced it has received approval from the FDA’s Center for Biologics Evaluation and Research expanding the indication for FluLaval® Quadrivalent (Influenza Vaccine) to include use in children 6 months and older. Prior to this, the vaccine was only approved for active immunization against influenza A subtype viruses and type B viruses, in persons 3 years of age and older. Read More.

    Opdivo™ (nivolumab) – November 8, 2016 – Bristol-Myers Squibb Company announced that the FDA has approved Opdivo® (nivolumab) injection, for intravenous use, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. Read More.

    Enbrel® (etanercept) – November 4, 2016 – Amgen announced that the FDA approval of Enbrel® (etanercept) for the treatment of patients 4 years or older with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy. Read More.

    Selzentry® (maraviroc) – November 4, 2016 – On November 4, 2016, ViiV Healthcare received approval from the FDA to market Selzentry® for the treatment of only CCR5-tropic HIV-1 infection, in combination with other antiretroviral agents, in pediatric patients 2 years of age or older who weigh at least 10 kilograms (kg). Read More.

    Keytruda® (pembrolizumab) – October 24, 2016 – Merck, announced that the FDA has approved Keytruda® (pembrolizumab), the company’s anti-PD-1 (programmed death receptor-1) therapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. Read More.

    Tarceva® (erlotinib) – October 18, 2016 – The FDA approved Tarceva® (erlotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Read More.

    Zemplar® (paricalcitol) – October 18, 2016 – The FDA announced the approval of AbbVie’s Zemplar® (paricalcitol) capsules for pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stages 3 and 4 and CKD stage 5 in patients on hemodialysis or peritoneal dialysis. Read More.

    Tecentriq® (atezolizumab) – October 18, 2016 – Genentech, announced that the FDA approved Tecentriq® (atezolizumab) for the treatment of people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities. Read More.

    Orkambi® (lumacaftor/ivacaftor) – September 28, 2016 – Vertex Pharmaceuticals Incorporated announced that the FDA approved Orkambi® (lumacaftor/ivacaftor) for use in children with cystic fibrosis (CF) ages 6 through 11 who have two copies of the F508del mutation. People with this mutation represent the largest population of those with CF, a rare, life-threatening disease. Orkambi® is the first and only medicine to treat the underlying cause of CF for people with this mutation. It was previously approved by the FDA for use in people ages 12 and older with two copies of the F508del mutation. With today’s approval, approximately 11,000 people with CF are eligible for treatment with Orkambi® in the United States. Read More.

    Stelara™ (ustekinumab) – September 26, 2016 – Janssen Biotech, Inc., announced today that the FDA has approved Stelara® (ustekinumab) for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers. Read More.

    New Generic Drugs

    Generic Brand Name Date of Approval
    Lopinavir and Ritonavir Oral Solution USP Kaletra (Lopinavir and Ritonavir) Oral Solution 12/27/16
    Pitavastatin Calcium Tablets Livalo (Pitavastatin Calcium) Tablets 12/20/16
    Dexmethylphenidate Hydrochloride Extended-Release Capsules Focalin XR (Dexmethylphenidate Hydrochloride) Extended-Release Capsules 11/30/16
    Iloperidone Tablets Fanapt (Iloperidone) Tablets 11/28/16
    Quetiapine Fumarate Extended-Release Tablets Seroquel XR (Quetiapine Fumarate) Extended-Release Tablets 11/1/16
    Mycophenolate Mofetil Hydrochloride for Injection USP Cellcept (Mycophenolate Mofetil Hydrochloride) for Injection 10/28/16
    Olmesartan Medoxomil and Hydrochlorothiazide Tablets Benicar HCT (Olmesartan Medoxomil and Hydrochlorothiazide) Tablets 10/26/16
    Olmesartan Medoxomil Tablets Benicar (Olmesartan Medoxomil) Tablets 10/26/16
    Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tablets Tribenzor (Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide) Tablets 10/26/16
    Amlodipine and Olmesartan Medoxomil Tablets Azor (Amlodipine and Olmesartan Medoxomil) Tablets 10/26/16
    Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets Safyral (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium) Tablets 10/11/16
    Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets Beyaz (Drospirenone, Ethinyl Estradiol and Levomefolate Calcium) Tablets 10/11/16
    Ribavirin for Inhalation Solution USP Virazole (Ribavirin) for Inhalation Solution 10/6/16
    Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets 9/30/16
    Memantine Hydrochloride Extended-Release Capsules Namenda (Memantine Hydrochloride) Extended-Release Capsules 9/28/16

    Source

    Seroquel XR® (quetiapine) – November 1, 2016 – Par and Accord launched generic versions of AstraZeneca’s Seroquel XR (quetiapine) extended-release (ER) tablets. Read More.

    Azor® (amlodipine/olmesartan), Tribenzor™ (olmesartan/amlodipine/hydrochlorothiazide) – November 7, 2016 — The FDA has approved Teva’s generic of Tribenzor (olmesartan medoxomil, amlodipine and hydrochlorothiazide) tablets, the company announced Monday. Read More.

    Benicar® (olmesartan), Benicar HCT® (olmesartan/hydrochlorothiazide) – October 26, 2016 – Mylan and Sun Pharmaceuticals launched generic versions of Daiichi Sankyo’s Benicar (olmesartan) 5 mg, 20 mg and 40 mg tablets and Benicar HCT (olmesartan/hydrochlorothiazide) 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg tablets. Read More.

    Vagifem® (estradiol) – October 17, 2016 – Amneal Pharmaceuticals announced the launch of Yuvafem™ (estradiol), an AB-rated generic version of Novo Nordisk’s Vagifem (estradiol) 10 mcg vaginal tablets. Read More.

    Rajani™ (drospirenone/ethinyl estradiol/levomefolate and levomefolate) – October 12, 2016 – Teva announced the launch of Rajani (drospirenone/ethinyl estradiol [EE]/levomefolate calcium and levomefolate calcium) tablets, a generic equivalent of Bayer’s Beyaz (drospirenone/EE/levomefolate calcium and levomefolate calcium) tablets. Read More.

    Xopenex HFA® (levalbuterol tartrate) – October 3, 2016 – Teva launched an authorized generic version of Sunovion’s Xopenex HFA (levalbuterol tartrate) 45 mcg/actuation inhalation aerosol. Read More.

    Epzicom® (abacavir/lamivudine) – September 29, 2016 – Teva announced the FDA approval of an AB-rated generic version of ViiV Healthcare’s Epzicom (abacavir/lamivudine) 600 mg/300 mg tablets. Read More.

    New Drug Shortage

    January 5, 2017        

    December 22, 2016

    December 20, 2016

    December 9, 2016

    December 8, 2016

    New Drug Safety Alert

    Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication – Mental Health Side Effects Revised – December 16, 2016 – Based on FDA review of a large clinical trial that FDA required the drug companies to conduct, the FDA determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. Read More.

    General Anesthetic and Sedation Drugs: Drug Safety Communication – New Warnings for Young Children and Pregnant Women – December 14, 2016 – The FDA is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the       development of children’s brains. Read More.

    Pioglitazone-containing Medicines: Drug Safety Communication – Updated FDA Review, Increased Risk of Bladder Cancer – December 12, 2016 – As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and FDA has approved label updates to describe the additional studies reviewed. Read More.

    New Drug Recall Alert

    Cantrell Drug Company Issues Voluntary Recall of Select Sterile Drug Products Due to Lack of Sterility Assurance – November 18, 2016 – Cantrell Drug Company is voluntarily recalling certain unexpired sterile drug products due to lack of sterility assurance. The recalled products, distributed nationwide to health care facilities from May 25 to October 31, 2016, can be found here. Read More.

    Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility Assurance – November 18, 2016 – Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry due to FDA’s concerns over the lack of sterility assurance of the drugs named in this recall. Complete list of drugs can be found here. Read More.

    Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication – Risk of Hepatitis B Reactivating – October 4, 2016 – The FDA is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any patient who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus. In a few cases, HBV reactivation in patients treated with DAA medicines resulted in serious liver problems or death. HBV reactivation usually occurred within 4-8 weeks. Read More.

    Clinical and Pharmacy News

    How Hospitals Can Fight the Cost of Budget-Busting Drugs – January 9, 2016 – Drug price increases have been making headlines for the last two years and have reached a fever pitch as Congress tries to penalize companies that are participating in predatory pricing practices. Yet, the implications of high drug prices are far-reaching and are sending ripples across the hospital landscape. Read More.

    Challenges and Solutions in Reducing Opioid Misuse and Abuse – January 9, 2017 – Initiatives aimed at reducing opioid misuse and abuse include mining claims data to identify patients at high risk for substance abuse, promoting wearable technologies to improve monitoring of patients with chronic pain, placing limitations on the prescribing and dispensing of opioids, and increasing patient and provider awareness of alternative pain management options. Read More.

    Guidelines for HIV/AIDS Diagnosis and Treatment – January 8, 2017 – More than 35 years after the medical community first recognized acquired immunodeficiency syndrome (AIDS), the disease, and the human immunodeficiency virus (HIV), that causes it remain a serious global health challenge. HIV attacks the body’s immune system by destroying T cells and leaving the person susceptible to opportunistic infections or infection-related cancers, which signal that the patient has AIDS, the last stage of HIV infection. Read More.

    $35K Grants Available for Better Pain Management – January 6, 2017 – Through Generation Rx grant funding, the Cardinal Health Foundation with The Ohio State University College of Pharmacy are offering grants of up to $35,000 to hospitals and health care providers that can help reduce the number of opioids prescribed while producing better patient outcomes and improving pain management. Read More.

     Top 5 Drugs with Confusing Formulations – January 5, 2017 – The following list are medications that in practice I see most often confused often by prescribers, nurses, and (yes, even) pharmacists. I would like to provide some depth into their formulation differences and hopefully prevent errors. Here, in my opinion, are the top 5: Read More.

     ASHP Offers Guidance for Controlling Diversion – January 5, 2017 – The ASHP published the first set of national guidelines designed to help health care organizations devise and implement strategies to prevent the diversion of controlled substances. Read More.

    Walgreens Expects 2017 Rebound as New PBM Deals Take From CVS – January 5, 2017 – Walgreens Boots Alliance said profits will jump in the second half of this year thanks to new relationships it negotiated last year to manage pharmacy benefits with major insurers and the U.S. government. Read More.

    Will Walgreens’ Plan for Sales Growth Work? – January 5, 2017 – Walgreens (WBA) reported an in-line quarter, with moderate revenue growth and flat profit expansion. These results fall within our expectations, and we are reiterating our $70 fair value estimate. The firm is dealing with a rapidly shifting pharmacy retail market as a fundamental change takes hold throughout the entire U.S. healthcare ecosystem. Read More.

    US Department of Defense to Study Impact of Dispensing Opioids in Locking Vials; Federal Funding Available for States to Study Effect on Preventing Teen Drug Abuse & Opioid Addiction – January 5, 2017 – President Obama recently signed the 2017 National Defense Authorization Act (NDAA), which contains a provision requiring the Secretary of Defense to study the feasibility and effectiveness of dispensing opioid medications in locking packaging designed to prevent pilfering, the theft of a controlled substance in undetectable amounts for non-medical use. Read More.

    Updated Guideline for Oral Pharmacologic Treatment of Type 2 Diabetes – January 4, 2017 – The American College of Physicians (ACP) recommends that clinicians prescribe metformin to patients with type 2 diabetes when pharmacologic treatment is required to improve glycemic control, according to the guideline update published in the Annals of Internal Medicine. Read More.

    The Cost of Biogen’s New Drug: $750,000 Per Patient – December 29, 2016 – When it comes to expensive pharmaceutical treatments, there’s a new entry that’s likely to renew the debate about drug prices. Biogen’s (BIIB) new medication Spinraza, which treats a rare spinal disorder in children and adults called spinal muscular atrophy (SMA), will carry a price tag of $750,000 for the first year of treatment, with subsequent annual treatments dropping to $375,000 per year per patient. The first year of treatment is more costly because it requires six doses, while only three doses are required in the following years. Read More.

    What happens when your hospital pharmacy gets in trouble? – December 27, 2016 – Patients from a wide surrounding area come to Augusta Health’s central campus in Fishersville. Their children are born there. Cancers are treated, the critically wounded and sick are brought in for surgery. Emergency cases arrive. In many of these situations, life-sustaining intravenous fluids are necessary. A physician’s IV order eventually finds its way to a single unmarked door, behind which sits a pharmacy the likes of which none of us has seen. Read More.

    5 Tips for Pharmacists to Make the Most of 2017 – December 27, 2016 – The New Year can be an exciting time filled with celebration, family, and friends. It is also a great time to set goals for the upcoming year. You may ask yourself the question, what can I do this year to help enhance my career? Check out these 5 tips to make the most of the New Year. Read More.

    The Hidden Costs of Prescription Drug Coupons – December 26, 2016 – You may have noticed that some drug companies offer coupons to consumers — which slash copayments for brand-name medications. The coupons are good news for people who face expensive copayments at the counter. But they frustrate insurance companies and are even banned in some states. Read More.

    First Immunotherapy Treatment Guidelines Published for Hematologic and Prostate Cancers – December 21, 2016 – The first evidence-based consensus statements for the use of cancer immunotherapy to treat patients with hematologic malignancies (multiple myeloma, acute leukemia, and lymphoma) and prostate cancer were published today by the Society for Immunotherapy of Cancer (SITC) in the society’s open access Journal for ImmunoTherapy of Cancer (JITC). Read More.

    PBMs: Higher Profile Puts Them in The Crosshairs – December 20, 2016 – It wasn’t that long ago that the buzz in health care circles was about Express Scripts flexing its muscle to negotiate deep discounts for the new hepatitis C drugs. CVS Caremark and UnitedHealthcare’s OptumRx followed suit. Unfamiliar to the public, PBMs seemed to be emerging as the new heavy hitters of American health care, doing the good work of knocking down drug prices. Read More.

    Walgreens Boots Alliance and Rite Aid agree to sell 865 Rite Aid stores to Fred’s Pharmacy – December 20, 2016 – Walgreens Boots Alliance and Rite Aid have entered into an agreement to sell 865 Rite Aid stores and certain assets related to store operations to Fred’s for $950 million. The transaction is subject to Federal Trade Commission approval, the approval and completion of the pending acquisition of Rite Aid by Walgreens Boots Alliance, and other customary closing conditions. Read More.

    Why Drug Costs Will Keep Rising in 2017 – December 20, 2016 – At the start of 2016, we made 10 healthcare predictions for the year ahead. Overall, we were 50% right, which is either a failing grade in high school or a great average in baseball. In the win column, we predicted that the Federal Trade Commission (FTC) would block a major hospital merger, and they did just that with Advocate and NorthShore health systems in Chicago. We predicted that the technology-enabled insurance startup craze would be a bust, and Oscar promptly lost a ton of money. Read More.

    Plan to Reduce Medicare Drug Costs Is Withdrawn After Bipartisan Criticism – December 16, 2016 – The Obama administration said on Thursday that it had scrapped one of its most significant efforts to rein in spending on prescription drugs: a plan for a nationwide experiment in which Medicare would have reduced payments for many drugs given to patients in doctors’ offices and hospital clinics. Read More.

    Pharmacies Miss Half of Dangerous Drug Combinations – December 15, 2016 – The Tribune reporter walked into an Evanston CVS pharmacy carrying two prescriptions: one for a common antibiotic, the other for a popular anti-cholesterol drug. Taken alone, these two drugs, clarithromycin and simvastatin, are relatively safe. But taken together they can cause a severe breakdown in muscle tissue and lead to kidney failure and death. Read More.

    More States Urged to Mandate Physician Use of Prescription Drug Monitoring Databases – December 15, 2016 – As the number of drug overdose deaths linked to prescription painkillers continues to rise, experts are calling on more states to set mandates requiring prescribers to check state prescription drug monitoring programs prior to writing a prescription. Read More.

    The Harm of High Drug Prices – December 12, 2016 – The problem of high cancer drug prices in the United States was highlighted in 2013, following a decade during which the average annual price of newly introduced cancer drugs increased from less than $10,000 to more than $100,000 in 2012. In a for-profit health care industry, drug companies need to make reasonable profits. Annual drug industry profits average 20 percent to compensate for the riskiness of drug research. But the aim of maximizing profits has crossed the line into profiteering at the expense of patients. Read More.

    Treatment Guidelines Updated for Patients with Rosacea – November 21, 2016 – For patients with rosacea, phenotype-based treatments should be given for presenting signs and symptoms, according to updated treatment guidelines published online Nov. 12 in the British Journal of Dermatology. Read More.

    Diagnosis and Management of Gout: Clinical Practice Guidelines from the American College of Physicians – November 15, 2016 – The signs and symptoms of gout usually happen suddenly, without warning, and at night. This is called an “attack.” The symptoms get better in a few days or sometimes a few weeks. Read More.

    Medicare Identifies Which Prescription Drugs Were Costliest in 2015 – November 14, 2016 – Medicare released new data identifying prescription medicines that had sharp price increases and those that accounted for its largest total spending in 2015. Read More.

    New guidelines recommend use of antiplatelet therapy and exercise program for treatment of PAD – November 13, 2016 – New guidelines for the treatment of peripheral artery disease (PAD), include recommendations on the use of antiplatelet therapy to reduce the risk of blood clots and statin drugs to lower cholesterol and advise PAD patients to participate in a structured exercise program. The joint American Heart Association/American College of Cardiology guidelines are published in the American Heart Association journal Circulation and the Journal of the American College of Cardiology. Read More.

    At Small, Rural Hospitals, Telepharmacy Technology is Advancing Pharmacy Practice – November 3, 2016 – Just as with many other areas of hospital operations, healthcare leaders are increasingly adopting and implementing IT solutions within pharmacy departments to streamline medication-management systems, improve workflow and increase patient safety. Read More.

    Palliative care should be standard in cancer treatment: guideline – November 2, 2016 – For patients with advanced cancer, palliative care should start early and be an integral part of treatment, not just something added on near the end of life, according to a new practice guideline from the American Society for Clinical Oncology (ASCO). Read More.

    340B in the News

    Obamacare Repeal Could Push Rural Hospitals to the Brink – January 5, 2017 – Many of the rural hospitals and health centers serving 62 million Americans have operated on a shoestring for years. Since January 2010, 80 rural hospitals and health care facilities that provided treatment to large numbers of elderly and low-income families were forced to close for financial reasons. More than 670 of the remaining 2,078 facilities are vulnerable or “at risk” of closure, according to hospital industry experts. Read More.

    HRSA Adds $5K Fines for 340B Prescription Drug Rate Overcharging – January 5, 2016 – Under a new 340B Program rule, HRSA created penalties for drug companies who overcharge prescription drug rates and developed a ceiling price methodology for new drugs. Drug manufacturers participating in the 340B Drug Pricing Program who intentionally charge hospitals prescription drug rates higher than established ceiling prices will face a $5,000 penalty per instance, a new Health Resources and Services Administration (HRSA) final rule stated. Read More.

    Why Data Will Grow in Importance for Drug Pricing – January 4, 2016 – The 340B drug pricing program, enacted in 1992, provides discounts on outpatient drugs to safety-net providers (called 340B covered entities) who meet certain qualifications. Covered entities use the savings from the program to stretch scarce federal resources and invest in patient care. With new requirements around Medicaid managed care patients who are also 340B eligible, this a good time to make sure you understand how your 340B solution is managing important program compliance elements. Read More.

    Drug Companies Will Be Fined for Overcharging 340B Hospitals – January 4, 2016 – The Obama administration has finalized a rule that imposes fines on drug companies that overcharge hospitals and clinics for medication purchased under the government’s 340B drug discount program. Drug companies must reimburse providers that overpaid for products and they are subject to fines of up to $5,000 per instance if they overcharged “knowingly and intentionally.” Read More.

    340B Card Helps Lower Drug Costs, Helps Others – December 29, 2016 – For the uninsured and the underinsured, the costs of medical treatment don’t stop with a doctor’s visit and the diagnosis. The next stop, if the funds are available, is the pharmacy, where the cost of treatment can be prohibitive. Heartland Health Care Clinic has a program to help bring the prescriptions closer to an affordable range for many people. At the same time, people who do have prescription coverage can benefit others in the community simply by having the card. Read More.

    Drug Industry, Hospitals Differ on Future of 340B Program – December 23, 2016 – The drug industry wants changes to the federal 340B drug discount program in 2017, but safety-net providers want the program to be protected. Pharmaceutical companies are concerned about the program’s expansion and are hoping for legislative and regulatory changes to ensure the program is serving what they call “its original intent.” But safety-net providers such as hospitals say the program should be protected because what they see as threats to indigent patients—including ACA repeal and potential block grants for Medicaid—make it a bad time to clamp down on the 340B program. Read More.

    What a Trump Administration Could Mean for the 340B Drug Program – December 8, 2016 – A Republican White House and a Republican-run Congress could bring significant changes to the 340B Drug Pricing Program (“the 340B program”). Many in Washington believe that the new administration and Republicans in Congress will favor the concerns of drug manufacturers over the concerns of providers or health plans. If the price of drugs becomes an issue for the new Congress, it is very likely that drug manufactures will ask Congress to “scale back” or potentially even eliminate the 340B program as the “quid pro quo” for imposing even the most modest forms of drug price regulation. Read More.

    Drugmakers Want Tough Scrutiny of 340B Discount Program – December 7, 2016 – A federal drug discount program for safety-net providers is experiencing rapid growth and deserves tough scrutiny, a group linked to drug makers said Dec. 6. The group, AIR 340B, said in a report the federal 340B drug pricing program is expected to reach $23 billion in total drug sales by 2021, up from the estimated program sales for 2016 of $16.1 billion. AIR 340B said the program’s growth has gone unchecked for too long and policymakers should re-examine it to ensure the program is serving its original intent to improve access to drugs for uninsured or vulnerable patients. Read More. 

    New Study Finds Unprecedented 340B Growth Likely to Continue – December 6, 2016 – A new study released by the Alliance for Integrity and Reform of 340B (AIR 340B) projects the 340B Drug Pricing Program will continue to expand at an unprecedented rate through 2021, by which time it is expected to exceed $23 billion in total purchases at the 340B price. This rapid expansion would see 340B purchases surpass current Medicare Part B drug reimbursement purchases over the next five years. The new study – based on analysis of data on total drug purchases through 340B from 2005 to 2015 – found many of the same factors that led the 340B program to more than double in size from 2010 to 2015, and expand by 66 percent between 2013 and 2015, are likely to continue for at least the next five years. Read More. 

    Federal Discount Drug Program Metrohealth Relies on May Be in Jeopardy – November 15, 2016 – In 1992, the government established a federal drug discount program that required the pharmaceutical industry to provide discounted drugs for public and non-profit hospitals and clinics that serve high numbers of the poor. It’s called 340B and MetroHealth relies on it to give lifesaving medicine to patients for little or no cost. Read More.

    ‘Safety-net’ hospitals ask for federal probe of possible EpiPen overcharges – November 4, 2016 – Will Mylan have to cut another very big check because of the way it’s classified its EpiPen for sales to poor people? A group that represents more than 1,200 “safety-net” hospitals is asking the U.S. Justice Department’s fraud section to investigate whether big drug maker Mylan “improperly” overcharged them for sales of its pricey EpiPen anti-allergy device. Read More.

    Big Pharma’s Crusade Against Rural America – November 1, 2016 – The fight between the corporatist drug industry and hospitals serving the most vulnerable Americans has finally spilled into the mainstream media. Recently, the Washington Post covered the issue in a profile of former Democratic congressman Henry Waxman. Waxman is surely an unlikely hero to fight corporate welfare, yet according to the Post, that’s exactly what he’s doing. Specifically, he’s now devoting his time to protecting the 340B drug pricing program. It requires pharmaceutical companies who wish to sell into the Medicare Part B and Medicaid markets to also provide those drugs at a reduced price to hospitals that serve large numbers of vulnerable patients. Read More.

    This drug discount program is good for Americans. But pharma wants to gut it – November 1, 2016 – Sticker shock over the cost of drugs isn’t going away any time soon. Drug prices spiked 7 percent last year, the highest rate since 1992. Compare that with the modest increase of just 0.8 percent in hospital care costs. So why is the pharmaceutical industry working to gut a federal program that helps make medicines and hospital services affordable to the most vulnerable among us? Read More.