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
Moxidectin – June 13, 2018 – Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) announced that the United States (U.S.) Food and Drug Administration (FDA) approved moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older. The FDA has also awarded MDGH a priority review voucher (PRV). Read more.
New Formulation Approval
No new updates.
New Indication Approval
Keytruda® (pembrolizumab) – June 13, 2018 – The Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck) for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after two or more prior lines of therapy. Read more.
Avastin® (bevacizumab) – June 13, 2018 – The Food and Drug Administration approved bevacizumab (Avastin, Genentech, Inc.) for patients with epithelial ovarian, fallopian tube or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. Read more.
New Drug Shortage
June 21, 2018
- Olmesartan Medoxomil and Hydrochlorothiazide Tablets (Discontinuation)
June 20, 2018
- Norethindrone and Ethinyl Estradiol Tablets (Discontinuation)
- Norethindrone Tablets (Discontinuation)
June 19, 2018
- Alfuzosin Hydrochloride Tablets (Discontinuation)
- Benazepril Hydrochloride Tablets (Discontinuation)
- Bisoprolol Fumarate and Hydrochlorothiazide Tablets (Discontinuation)
- Bupropion Hydrochloride Tablets (Discontinuation)
- Clonidine Hydrochloride Tablets (Discontinuation)
- Desvenlafaxine Succinate Tablets (Discontinuation)
- Doxycycline Hyclate Capsules (Discontinuation)
- Doxycycline Monohydrate Capsules (Discontinuation)
- Famotidine Tablets (Discontinuation)
- Felodipine Tablets (Discontinuation)
- Fenofibrate Capsules (Discontinuation)
- Galantamine Hydrobromide Tablets (Discontinuation)
- Glipizide and Metformin Hydrochloride Tablets (Discontinuation)
- Glyburide Tablets (Discontinuation)
- Hydroxyzine Hydrochloride Tablets (Discontinuation)
- Lorazepam Tablets (Discontinuation)
- Meclizine Hydrochloride Tablets (Discontinuation)
- Memantine Hydrochloride Tablets (Discontinuation)
- Nifedipine Tablets (Discontinuation)
- Nitrofurantoin Capsules (Discontinuation)
- Norgestimate and Ethinyl Estradiol (Discontinuation)
- Norgestimate and Ethinyl Estradiol Tablets (Discontinuation)
- Ondansetron Hydrochloride Tablets (Discontinuation)
- Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets (Discontinuation)
- Pioglitazone Hydrochloride Tablets (Discontinuation)
- Progesterone Capsules (Discontinuation)
- Quinine Sulfate Capsules (Discontinuation)
- Repaglinide Tablets (Discontinuation)
- Risperidone Tablets (Discontinuation)
- Rosuvastatin Calcium Tablets (Discontinuation)
- Terazosin Hydrochloride Capsules (Discontinuation)
- Venlafaxine Hydrochloride Tablets (Discontinuation)
- Zolpidem Tartrate Tablets (Discontinuation)
- Zonisamide Capsules (Discontinuation)
June 15, 2018
- Fluorescein Injection (Currently in Shortage)
June 14, 2018
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
June 13, 2018
- Aspirin and Omeprazole (Yosprala) Tablets (Discontinuation)
- Lidocaine Hydrochloride (Xylocaine) Injection (Currently in Shortage)
- Mometasone Furoate (Elocon) 0.1% Ointment (Discontinuation)
New Drug Recall and Safety Alerts
Triamcinolone-Moxifloxacin by Guardian Pharmacy Services – New Drug Safety Alert – June 14, 2018 – At least 43 patients reported adverse events after receiving eye injections of Guardian’s Pharmacy Services compounded triamcinolone-moxifloxacin product during cataract surgery. The patients reportedly experienced various symptoms, including vision impairment, poor night vision, loss of color perception and significant reductions in best-corrected visual acuity and visual fields. Read more.
New Generic Launch
Buprenorphine and Naloxone (Suboxone®) – June 14, 2018 – The U.S. Food and Drug Administration approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. RxS Insight: The FDA granted generic approval to Dr. Reddy’s and Mylan. Inidivior, the manufacturer of Suboxone®, has filed a temporary restraining order and patient infringement suits again both generic manufacturers. Date of generic launch is unknown. Read more.
Clinical and Pharmacy News
Massive Rise in Out-Of-Pocket Branded Drug Costs for U.S. Patients With a Deductible – June 21, 2018 – Spending on medicines is growing at the slowest rate in years, but according to a new IQVIA Institute for Human Data Science article, at the pharmacy, commercially insured patients with a deductible have their seen out-of-pocket costs for brand medicines increase 50 percent since 2014, according to a web posting by trade group American Pharmaceutical and Research Manufacturers. Read more.
Millions More Get Flu, Pneumonia Vaccines Because of Pharmacy Services – June 20, 2018 – Pharmacists might wonder if their immunization efforts are making a real difference in U.S. healthcare. A new study published in the Journal of the American Pharmacists Association answers that concern, pointing out that pharmacy-based immunization services increased the likelihood of immunization for influenza and pneumococcal diseases, which resulted in millions of additional immunizations. Read more.
Moving Healthcare into the Future: Proposal for Pharmacist-led Refill Authorizations – June 20, 2018 – Over recent decades, the role of the pharmacist has grown to include various direct patient care activities as the profession becomes more integrated into healthcare provider teams. With the increasing shortage of primary care physicians in America, the FDA is considering the expansion of pharmacists’ scope of practice. Pharmacists in Canada and the United Kingdom are already permitted to authorize medication refills, which has not only led to a reduction in medication-related errors but has also relieved pressure from overwhelmed providers. Read more.
Patients’ Satisfaction Scores Unaffected by Lowering of Opioid Dosages – June 20, 2018 – Concerns about alienating patients keep many providers from prescribing from lower opioid dosages, but a new study suggests that fear is misplaced. The study, published in The American Journal of Managed Care, found that patients’ satisfaction with care didn’t drop with their opioid levels. To come to that conclusion, Kaiser Permanente researchers conducted a study of nearly 2,500 patients who used high doses of opioids for at least six months. Read more.
What’s Holding Back Market Uptake of Biosimilars? – June 20, 2018 – Specialty biologics are currently the biggest driver of pharmaceutical cost growth. In the U.S., nine patents for the top 20 selling biologics are set to expire by 2020. Given that biosimilars are cheaper than the originator biologics, more use of biosimilars will lead to cost savings. But, thus far biosimilars have failed to gain widespread traction. Read more.
What’s in the Administration’s 5-Part Plan for Medicare Part D and What Would it Mean for Beneficiaries and Program Savings? – June 20, 2018 – Today more than 43 million older adults and people with disabilities have prescription drug coverage under Medicare Part D. Part D helps people with Medicare afford their medications by subsidizing the purchase of drug coverage from private stand-alone prescription drug plans (PDPs) and Medicare Advantage drug plans (MA-PDs), and offering additional financial help to people with low-incomes. Although premiums for Part D plans have been stable in recent years, cost-sharing requirements for drugs covered by plans have increased over time. Read more.
Another Adverse Effect of the Opioid Epidemic: Hepatitis C Infections – June 19, 2018 – Amid the ongoing opioid epidemic, hepatitis C virus (HCV) infection should be at the forefront of healthcare providers’ minds. Although HCV has been widely viewed as predominantly affecting baby boomers—those born between 1945 and 1965—a younger generation is experiencing increased incidence of infection. Read more.
Study: Many Diabetics Forgo Care Because of High Costs – June 19, 2018 – Nearly half of people living with diabetes have, at times, gone without care because they can’t afford it, according to a report recently released by UpWell Health, a provider of healthcare services, support and solutions for people living with chronic conditions. Read more.
CREATES Act Will Lower Prescription Drug Costs – June 19, 2018 – Everyone should be able to get affordable coverage and care. Businesses, insurance providers, doctors, hospitals and others continue to work on new ways to reverse healthcare cost trends, as we help patients get better faster — and stay healthier longer. Prescription drug costs have been a particular challenge, as they continue to represent the greatest percentage of every healthcare dollar with prices that continue to go up year after year. Read more.
A Deeper Dive: What the Trump Administration Blueprint to Lower Drug Prices Might Mean for Medicaid – June 19, 2018 – It has been a few weeks since the publication of the Trump Administration’s Blueprint to Lower Drug Prices, and Secretary Azar’s Request for Information (RFI) on the Blueprint. We previously posted about the Blueprint’s focus on the 340B Drug Discount Program. Read more.
Study: Almost Half of Diabetics Skip Medical Care Due to Costs – June 18, 2018 – Almost half of diabetics are cutting back on treatment because of costs, according to a new survey that comes as the skyrocketing price of insulin is prompting lawmakers and physicians to call for more oversight. Read more.
More Biosimilars on the Market Could Decrease Drug Prices, Panelists Say – June 16, 2018 – In a webcast hosted by the Alliance for Health Policy that took place earlier this week, Robert Langreth, senior health reporter for Bloomberg News, Dora Hughes, MD, MPH, senior policy advisor at Sidley Austin, LLP, and Sameer Awsare, MD, associate executive director of the Permanente Medical Group at Kaiser Permanente, came together to discuss the best ways to bring down the steadily increasing drug prices in the United States. The panel was moderated by Mary Ella Payne, RN, MSPH, president of the Alliance for Health Policy. Read more.
Harvard, MIT Launch Effort to Make the FDA More Efficient – June 15, 2018 – When the U.S. Food and Drug Administration began monitoring drug safety in 1937, the industry looked markedly different than it does today. Genetic therapies and enzyme treatments had not been invented, much less analyzed for their safety. Read more.
Pharmaceutical Companies Should Focus on Medication Adherence to Improve Revenue – June 14, 2018 – A more concerted effort by pharmaceutical companies to drive medication adherence could help improve outcomes, lower overall healthcare spending and also help pharma’s sales growth and margin profile. That’s the finding of a recent Credit Suisse report, which posits that pharma would do well to look at strategies in use in other industries, including retail. Read more.
Fred’s Hires Firm to Sell Retail Pharmacies – June 14, 2018 – Red’s Inc. said it has hired investment bankers to examine the value of its ‘retail pharmacy script portfolio’ for potential buyers. The announcement Thursday by the retailer to hire PJ Solomon comes as Fred’s attempts its latest financial turnaround while reporting first-quarter profits fell to $111.6 million compared to $128.6 million last year on weaker sales. Read more.
Current Prescription Drug Pricing Practices: Lessons in Obfuscation – June 14, 2018 – Across most markets in our economy consumers can easily obtain and process information regarding products for sale. So when, for instance, Ford launches the latest version of the F-150, based on consumer reports and comparative price information, customers can evaluate whether the price is worth it to them. Here, the conditions for an efficiently functioning market are met. There is competition, free flow of information regarding the product’s characteristics, and transparency regarding pricing. Not so with prescription drugs. Read more.
Opioid-Related Adverse Events Have High Costs for Inpatients, Hospitals – June 13, 2018 – Opioid-related adverse drug events occur more often than expected with hospital-based surgical and endoscopic procedures and tend to lead to worse patient outcomes, a new study reports. Read more.
E-prescribing Bill Clears Senate Panel – June 13, 2018 – An e-prescribing bill backed by the National Association of Chain Drug Stores has cleared a key hurdle in the Senate. The Senate Finance Committee has passed the Every Prescription Conveyed Securely Act, little more than a month after the House Energy and Commerce Committee passed its House counterpart. Read more.
340B in the News
Senate Panel Considers Giving HHS Office Authority to Beef Up 340B Requirements – June 19, 2018 – A key Senate panel is eying new reporting requirements for 340B hospitals and clinics, in line with the Trump administration’s push to shake up the drug discount program that critics accuse hospitals of exploiting for the savings. Read more.
340B Audit Imbalances Under Fire at Senate Panel – June 19, 2018 – The 340B Drug Pricing Program took center stage at the Senate’s HELP panel for the third time in several months on Tuesday, this time turning the focus to audits of hospitals and drug manufacturers conducted by the Health Resources and Services Administration. HRSA Director Krista Pedley said that in the past five years, 12 of 600 program manufacturers faced audits compared to 981 of 12,700 of hospitals, also known as covered entities. Read more.
An Insider’s View of the Myths and Misconceptions Behind 340B ‘Reform’ – June 19, 2018 – I hardly recognize the 340B Drug Discount Program when I read the pharmaceutical industry’s criticisms about it. They say that 340B has grown too big, is without oversight and transparency, and is in desperate need of reform. Having spent more than a decade working with this program at the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs, I know that such attacks on the program are unfounded, unfair and dangerous. Read more.