Clinical Insights: August 30, 2018

    Welcome to the weekly 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

    AltrenoTM (tretinoin) – August 24, 2018 – Ortho Dermatologics, one of the largest prescription dermatology healthcare businesses in the world, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for AltrenoTM (tretinoin 0.05%) lotion, indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. AltrenoTM is the first formulation of a tretinoin in a lotion, and has been shown to be effective and generally well-tolerated. Read more.

    TakhzyroTM (lanadelumab-flyo) – August 23, 2018 – Shire plc announced that following priority review, the U.S. Food and Drug Administration (FDA) has approved TakhzyroTM (lanadelumab-flyo) injection, for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent attacks of edema (swelling) in various parts of the body. Read more.

    InveltysTM (loteprednol etabonate) – August 23, 2018 – Kala Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved InveltysTM (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery. InveltysTM is the first twice-daily (BID) ocular corticosteroid approved for this indication. Read more.

    OxervateTM (cenegermin) – August 22, 2018 – The U.S. Food and Drug Administration approved the first drug, OxervateTM (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea (the clear layer that covers the colored portion of the front of the eye). Read more.

    Diacomit (stiripentol) – August 20, 2018 – BIOCODEX SAS announced the Food and Drug Administration (FDA) has approved Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome (DS) in patients two years of age and older taking clobazam. Diacomit is expected to be available in U.S. pharmacies in early January 2019. Read more.

    CequaTM(cyclosporine) – August 16, 2018 – Sun Pharmaceutical Industries Ltd. announced that Sun Pharma has received approval for CequaTM(cyclosporine ophthalmic solution) 0.09%, from the U.S. Food and Drug Administration (FDA). CequaTMis indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). Read more.

    OnpattroTM (patisiran) – August 10, 2018 – The U.S. Food and Drug Administration approved OnpattroTM (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients. This is the first FDA-approved treatment for patients with polyneuropathy caused by hATTR, a rare, debilitating and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart and other organs. It is also the first FDA approval of a new class of drugs called small interfering ribonucleic acid (siRNA) treatment. Read more.

    GalafoldTM (migalastat) – August 10, 2018 – The U.S. Food and Drug Administration approved GalafoldTM (migalastat), the first oral medication for the treatment of adults with Fabry disease. The drug is indicated for adults with Fabry disease who have a genetic mutation determined to be responsive (“amenable”) to treatment with Galafoldäbased on laboratory data. Read more.

    AnnoveraTM (ethinyl estradiol and segesterone acetate) – August 10, 2018 – The U.S. Food and Drug Administration approved AnnoveraTM (segesterone acetate and ethinyl estradiol vaginal system), which is a combined hormonal contraceptive for women of reproductive age used to prevent pregnancy and is the first vaginal ring contraceptive that can be used for an entire year. Read more.

    ArakodaTM (tafenoquine) – August 9, 2018 – Degrees Pharmaceuticals (60P) announced the U.S. Food and Drug Administration (FDA) approval of ArakodaTM (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older. For the first time in more than eighteen years, the U.S. FDA approved a new drug for the prevention of malaria. Read more.

    Jornay PMTM (methylphenidate hydrochloride) – August 9, 2018 – Ironshore Pharmaceuticals & Development, Inc. (“Ironshore”), a wholly owned subsidiary of Highland Therapeutics Inc. (“Highland”), announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Jornay PMTM (methylphenidate) (formerly known as HLD200) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years and older. Jornay PMTM is a novel formulation of methylphenidate which is taken in the evening and has demonstrated improvement in the severity of ADHD symptoms in the early morning and throughout the day. Read more.

    Poteligeo® (mogamulizumab-kpkc) – New Orphan Drug Approval – August 8, 2018 – The U.S. Food and Drug Administration approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. This approval provides a new treatment option for patients with MF and is the first FDA approval of a drug specifically for SS. Mycosis fungoides and Sézary syndrome are rare, hard-to-treat types of non-Hodgkin lymphoma and this approval fills an unmet medical need for these patients. Read more.

     

    New Formulation Approval

    Orkambi® (lumacaftor/ivacaftor) – August 7, 2018 – Please refer to Orkambi® (lumacaftor/ivacaftor) below in New Indication Approval section.

     

    New Indication Approval

    Keytruda® (pembrolizumab) – August 20, 2018 – The Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations. Read more.

    Eylea® (aflibercept) – August 17, 2018 – Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Eylea® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). The sBLA was based on second-year data from the Phase 3 VIEW 1 and 2 trials in which patients with wet AMD were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks, and additional doses as needed). Read more.

    Opdivo® (nivolumab) – August 16, 2018 – The Food and Drug Administration granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb Company Inc.) for patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. Read more.

    Lenvima® (lenvatinib) – August 16, 2018 – The Food and Drug Administration approved lenvatinib capsules (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Read more.

    Kalydeco® (ivacaftor) – August 15, 2018 – Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco® based on clinical and/or in vitro assay data. Read more.

    Orkambi® (lumacaftor/ivacaftor) – New Expanded Indication and Formulation Approval – August 7, 2018 – Vertex Pharmaceuticals Incorporated announced the U.S. Food and Drug Administration (FDA) has approved Orkambi® (lumacaftor/ivacaftor) to include use in children ages two through five years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first medicine approved to treat the underlying cause of CF in this population. Orkambi® oral granules are available in two dosage strengths (lumacaftor 100mg/ivacaftor 125mg and lumacaftor 150mg/ivacaftor 188mg) for weight-based dosing. Read more.

     

    New Drug Shortage

    August 27, 2018 

    August 24, 2018 

    August 22, 2018 

    August 21, 2018 

    August 17, 2018 

     

    New Drug Recall and Safety Alerts

    Hydrochlorothiazide Tablets – New Drug Recall Alert – August 27, 2018 – Accord Healthcare Inc. is voluntarily recalling One lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of Hydrochlorothiazide Tablets USP, 12.5 mg, to the consumer level. A 100-count bottle of Hydrochlorothiazide Tablets USP 12.5 mg has been found to contain 100 Spironolactone Tablets USP 25 mg. Since the individual lot, PW05264, of the product is involved in a potential mix-up of labeling, Accord is recalling this individual lot from the market. Read more.

    Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan – Updated Drug Recall Alert – August 23, 2018 – Torrent Pharmaceuticals Limited is voluntarily recalling ALL LOTS within expiry of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals.Read more.

    Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan – New Drug Recall Alert – August 17, 2018 – Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. Read more.

    Levothyroxine and Liothyronine (Westminster Pharmaceuticals) – New Drug Recall Alert – August 9, 2018 – Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. Read more.

    Valsartan – New Drug Recall Alert – August 8, 2018 – As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg and 320mg to the hospital, retail and consumer level. This recall of multiple batches of Valsartan Tablets was prompted due to the detection of trace amounts of N-Nitrosodimethylamine (NDMA), a possible process impurity or contaminant in an active pharmaceutical ingredient. Read more.

     

    New Generic Launch

    Epinephrine (EpiPen and EpiPen Jr) – August 16, 2018 – The U.S. Food and Drug Administration approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths. Read more.

    Potassium Chloride Oral Solution – August 8, 2018 – The U.S. Food and Drug Administration approved several strengths of potassium chloride oral solution as the first generic drugs to receive a Competitive Generic Therapy (CGT) designation. This new approval pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment that is indicated for the treatment and prevention of hypokalemia (low potassium blood levels) in patients who are on diuretics, and when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible. Read more.

     

    Clinical and Pharmacy News

    Pharmacies and Policy Makers Are Clawing Back at DIR Fees – August 28, 2018 – They’re hard to explain. They’re impossible to predict. But ask an independent community pharmacist what keeps them up at night, and chances are direct and indirect remuneration (DIR) fees are at the top of the list. For years, community pharmacies have been screaming into the void about retroactive clawbacks from PBMs working with Medicare Part D plan sponsors. Now, it looks like the ears of the federal government—on the hunt for solutions to high drug prices—are perking up. Read more.

    Using Generic Combination Drugs Could Have Drastically Reduced Medicare Spending – August 27, 2018 – Spending for the 10 most expensive brand name combination drugs could have been reduced by an estimated $2.7 billion between 2011 and 2016 if lower-cost generics had been prescribed, according to researchers from Brigham and Women’s Hospital and Harvard Medical School. In 2016 alone, $925 million may have potentially been saved in Medicare if generic medications were used in place of their more expensive brand-name counterparts, according to the study. Read more.

    Presentation: Leverage Social Media to Grow Retail Pharmacy Market – August 25, 2018 – The digital era has generated a concern for the future of retail pharmacists. With smart phones that place any product a consumer could possibly want at their fingertips, and e-commerce giant Amazon’s recent purchase of PillPack, some pharmacists are concerned about what the future of pharmacy looks like. Read more.

    FDA Draft Guidance for Waivers of REMS Requirement Draws Mixed Reactions – August 24, 2018 – A recent U.S. Food and Drug Administration (FDA) draft guidance on a requirement under the Risk Evaluation and Mitigation Strategy (REMS) program for pharmaceutical sponsors was met with mixed reactions from a Rutgers law professor and Novartis in new comments. The draft guidance that set the stage for how sponsors’ requests for waivers of the single, shared system (SSS) requirement would be evaluated by FDA was issued earlier this year, along with a separate guidance newly drafted for the development of a REMS for multiple prescription drugs. Read more.

    FDA to Re-Examine Rational Opioid Prescribing, Starting with Acute Pain – August 24, 2018 – The U.S. Food and Drug Administration continues to seek ways to curb the opioid epidemic—with the agency’s latest efforts turned toward preventing diversion, misuse or abuse at the acute level. “Many people who become addicted to opioids will first be exposed to these drugs through a lawfully prescribed medication,” said FDA Commissioner Scott Gotlieb, MD, in an August 22, 2018 statement. “Unfortunately, the fact remains that there are still too many prescriptions being written for opioids. Read more.

    The Health 202: Here’s Why Rural Independent Pharmacies are Closing Their Doors – August 23, 2018 – Local independent pharmacies, particularly those in rural communities, are steadily closing their doors. And the closures are leaving some of the most vulnerable populations in the country with few options to obtain medication and other health services. More than 16 percent of the independently owned rural pharmacies in the United States shut down between March 2003 and March 2018, according to a policy brief published last month by the RUPRI Center for Rural Health Policy Analysis at the University of Iowa. The report found a drop of more than 1,200 independently owned retail pharmacies during that time, bringing the total down to 6,393. Read more.

    Pfizer Lawsuit Could Clear Path for Biosimilars – August 23, 2018 – As more biosimilars enter the market, makers of these complex, copycat drugs have struggled to compete with their branded equivalents. But an antitrust action involving Pfizer and Johnson & Johnson, still in its early stages, could change that. Pfizer alleges J&J brokered exclusive — and anti-competitive — contracts with insurers and providers to prioritize its immunosuppressant drug Remicade over Pfizer’s biosimilar Inflectra. A Pennsylvania judge recently denied J&J’s motion to dismiss the lawsuit. Read more.

    Flipping the Script: The State of The Pharmacy Industry – August 23, 2018 – What’s driving the pharmacy business these days? Besides the usual concerns about government legislation, sales and profits, and the endless battle to find the right pharmacist to man the counter, retailers and suppliers point to a number of other trends that could — if properly developed — help pharmacy operators streamline their operations, increase efficiencies and improve the quality of patient care.  Read more.

    Study: Higher Medication Spends for Insurers Saves Money Later – August 22, 2018 – Making patients’ medication costs more affordable helps ensure compliance, a new review shows. And the investment can avoid costlier care in the future. Taking a daily medication in the hopes that it will prevent some long-range potential health catastrophe — such as a heart attack or kidney failure — isn’t easy. Many people skip doses or don’t refill their prescriptions on time. Others neglect them entirely. Read more.

    Closing the Medicare Part D Coverage Gap: Trends, Recent Changes and What’s Ahead – August 21, 2018 – As of 2019, Medicare beneficiaries enrolled in Part D prescription drug plans will no longer be exposed to a coverage gap, sometimes called the “donut hole”, when they fill their brand-name medications. The coverage gap was included in the initial design of the Part D drug benefit in the Medicare Modernization Act of 2003 in order to reduce the total 10-year cost of the benefit. Subsequent legislative changes are phasing out the coverage gap by modifying the share of total costs paid in the gap by Part D enrollees and plans and requiring drug manufacturers to provide a discount on the price of brand-name drugs in the gap. Read more.

    Retail Chain Deals to Improve Patient Care Access, Care Coordination – August 21, 2018 – A new partnership between healthcare payer Anthem and Walmart will improve patient care and more affordable access to over-the-counter (OTC) medications. The program, set to launch in January 2019, will allow beneficiaries of Anthem’s Medicare Advantage plans to access Walmart OTC medications using OTC allowances. This will cut down on the out-of-pocket costs patients incur when purchasing these medication.Read more.

    Exploring the Path of the Specialty Dollar – August 21, 2018 – Throughout the past few years, the topic of drug pricing in the United States has become increasingly controversial. The rise in patient out-of-pocket costs coupled with growing drug spending for plan sponsors has drawn the attention of stakeholders throughout the healthcare space, along with politicians and the news media. Everyone is trying to understand the source of rising drug costs. It seems that many suggest changes or point fingers without truly understanding the complexity of the system and the challenges that these intricacies cause for all stakeholders.Read more.

    FDA In Brief: FDA Takes Additional Action to Mitigate Shortages of Epipen By Extending Expiration Date For Specific Lots Of Medication – August 21, 2018 – The U.S. Food and Drug Administration took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending the expiration date of specific lots of 0.3 milligram products marketed by Mylan by four months beyond the labeled expiration date. This change beyond the approved 20-month shelf life is based on stability data provided by Mylan and reviewed by the FDA.Read more.

    Medicare Could Save Nearly $1B By Buying Generics Over Brand Names – August 21, 2018 – Medicare could be saving a lot of cash by switching to generic constituents for some drugs—maybe as much as a billion dollars. A recent study estimated spending in 2016 on 29 brand-name combination products would have been $925 million more than spending for generic counterparts. The eye-popping difference revealed that generic substation and therapeutic interchange can achieve substantial savings. Read more.

    U.S. Health Secretary Says Agency Can Eliminate Drug Rebates – August 20, 2018 – U.S. Health and Human Services Secretary Alex Azar said it was within his agency’s power to eliminate rebates on prescription drug purchases, a key element of the Trump administration’s plan to lower prescription medicine costs. Such rebates are negotiated in the United States by pharmacy benefits managers (PBMs) to lower the cost of medicines for their clients, including large employers and health plans that cover tens of millions of Americans. Read more.

    A Patient Paid $285 for a $40 Drug: Here’s Why – August 20, 2018 – Gretchen Liu, a 78-year-old patient, was prescribed telmisartan two years ago to manage her blood pressure after a transient ischemic attack, also known as a mini stroke. A 90-day supply cost her $285 with insurance, when the drug itself was just $40, according to PBS News Hour. Ms. Liu’s experience of finding a copay higher than the cost of the drug is not uncommon. In fact, insurance copays are higher than the drug itself about 25 percent of the time, according to a study published in March by the University of Southern California’s Schaeffer Center for Health Policy and Economics in Los Angeles. Read more.

    Drug Company Rebates Don’t Have That Much of an Impact on Costs – August 20, 2018 – The blame game continues regarding the escalating cost of drugs, with AHIP this time brandishing a study by Milliman that AHIP commissioned and that says that the rebates pharmaceutical companies offer for certain drugs don’t really have that much of an impact on costs. The drugs that generated the biggest rebates for insurers and PBMs represented only 10 percent of total Part D prescriptions, according to the study by Milliman. Read more.

    FDA Updates Prescribing Information for Keytruda and Tecentriq – August 16, 2018 – The Food and Drug Administration updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. FDA approved two different companion diagnostic tests, one for use with Keytruda and one for use with Tecentriq. Read more.

     

    340B in the News

    A Little-Known Windfall for Some Hospitals, Now Facing Big Cuts – August 29, 2018 – Most hospitals are nonprofit and justify their exemption from taxation with community service and charity care. But the Trump administration could require some of them to do more to help the poor, and the hospitals that are in the cross-hairs are those benefiting from an obscure drug discount program known as 340B. The 340B program requires pharmaceutical manufactures to sell drugs at steep discounts to certain hospitals serving larger proportions of low-income and vulnerable people, such as children or cancer patients. Read more.

    OIG Testimony Focuses on Longstanding 340B Program Vulnerabilities – August 28, 2018 – On May 15, 2018, Ann Maxwell, Assistant Inspector General for Evaluation and Inspections for the Office of Inspector General (OIG) delivered testimony before the U.S. Senate Committee on Health, Education, Labor and Pensions to discuss recommendations to protect the integrity of the 340B Drug Pricing Program (340B Program). Read more.

    AHF to Congressman Peters: Drop Your Sponsorship of 340B Legislation Tainted by Indictment of Rep. Chris Collins – August 27, 2017 – AIDS Healthcare Foundation (AHF) again demanded U.S. Rep. Scott Peters (D-CA) drop his sponsorship of H.R. 4710, a bill designed to help drug industry profits and which will harm nonprofit safety net hospitals participating in the 340B Drug Discount Program. The bill, also known as the PAUSE Act, is cosponsored by U.S. Rep. Chris Collins (R-NY), the leading voice in Congress to gut the lifesaving drug pricing program. Read more.

    Administrative Actions to Address Drug Prices could Shrink the 340B Drug Pricing Program and Limit Hospital Savings – August 23, 2018 – In its efforts to address the issue of high drug prices, the Trump Administration has, among other things, set its sights on the 340B Drug Pricing Program. The 340B program, enacted by Congress in 1992 under Section 340B of the Public Health Service Act (42 U.S.C. § 256b), requires drug manufacturers to sell outpatient drugs at discounted rates to certain public and nonprofit hospitals—those that treat high volumes of low-income patients or are located in rural areas—and other safety net providers that receive federal grant funding, collectively referred to as “covered entities.” Read more.

    INSIGHT: Administrative Actions to Address Drug Prices Could Shrink the 340B Drug Pricing Program and Limit Hospital Savings – August 22, 2018 – In its efforts to address the issue of high drug prices, the Trump Administration has, among other things, set its sights on the 340B Drug Pricing Program. The 340B program, enacted by Congress in 1992 under Section 340B of the Public Health Service Act (42 U.S.C. § 256b), requires drug manufacturers to sell outpatient drugs at discounted rates to certain public and nonprofit hospitals—those that treat high volumes of low-income patients or are located in rural areas—and other safety net providers that receive federal grant funding, collectively referred to as “covered entities.” Read more.

    New Analysis Finds 340B Medicine Sales Hit Record High in 2017 and Continue to Grow as a Share of Total Drug Spending – August 20, 2018 – How big is the 340B program and what share of the prescription medicine market does it represent? Those are popular questions of late as stakeholders discuss ways to improve the 340B program. In fact, all three Senate HELP Committee hearings this year included a number of questions about the program’s true size as policymakers attempt to gain a better understanding of the inner workings of 340B and how it may be impacting the broader prescription medicine market. Read more.