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
Vosevi™ (sofosbuvir/velpatasvir/voxilaprevir) – July 18, 2017 – The U.S. Food and Drug Administration approved Vosevi™ to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis. Vosevi™ is a fixed-dose, combination tablet containing two previously approved drugs – sofosbuvir and velpatasvir – and a new drug, voxilaprevir. Vosevi™ is the first treatment approved for patients who have been previously treated with the direct-acting antiviral drug sofosbuvir or other drugs for HCV that inhibit a protein called NS5A. Read More.
Nerlynx™ (neratinib) – July 17, 2017 – The U.S. Food and Drug Administration approved neratinib (Nerlynx™, Puma Biotechnology, Inc.) for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Read More.
Tremfya™ (guselkumab) – July 13, 2017 – Janssen Biotech, Inc. (Janssen) announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA™ (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. TREMFYA™ is the first and only approved biologic therapy that selectively blocks only IL-23, a cytokine that plays a key role in plaque psoriasis. Read More.
New Formulation Approval
Benlysta® (belimumab) – July 21, 2017 – GSK announced that the U.S. Food and Drug Administration (FDA) has approved a new subcutaneous formulation of Benlysta® (belimumab) for the treatment of adult patients with active, autoantibody-positive SLE who are receiving standard therapy. Read More.
New Indication Approval
Fycompa® (perampanel) – July 26, 2017 – Eisai Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) for Fycompa® (perampanel) CIII as monotherapy use for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. In addition to the new monotherapy use in POS, Fycompa® is approved for adjunctive use for POS and primary generalized tonic-clonic seizures (PGTC) in patients with epilepsy 12 years of age and older. Read More.
New Drug Shortage
July 27, 2017
July 26, 2017
- Atenolol Tablets (New – Currently in Shortage)
New Drug Recall Alert
Cyclobenzaprine HCl and Amantadine HCl by Apace Packaging – July 28, 2017 – Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been recalled due to a potential mislabeling. Read More.
Sterile Drug Products by Cantrell Drug Company – July 25, 2017 – Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and Vermont. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. Read More.
New First Time Generic
No new updates.
Clinical and Pharmacy News
Hospitals to See 7.61 Percent Rise in 2018 Prescription Drug Rates – July 28, 2017 – Hospitals and health systems should anticipate a 7.61 percent increase in prescription drug rates in 2018, researchers predicted in a recent Vizient study. Using the group purchasing organization’s 2016 and 2017 data on hospital and non-acute facility purchasing, researchers found that the provider organizations should see a 0.46 percent boost in prescription drug rates for contracted products and a 7.15 percent growth in non-contracted product prices. Read More.
FDA Head Seeks Unlikely Allies in Opioid Fight: Insurers and PBMs – July 27, 2017 – Scott Gottlieb, MD, commissioner of the Food and Drug Administration, plans to meet with insurance administrators and pharmacy benefit managers in September to see if the organizations can help reduce the amount of opioids dispensed in the U.S., according to Bloomberg. Read More.
Older Patients Often Don’t Ask Pharmacists for Lower-Cost Drug Options – July 26, 2017 – More than a quarter of Americans aged 50 years and older say their drug costs cause financial strain, but many of them don’t ask their pharmacist or other health care professionals to help them find lower-cost options. Read More.
The Role of Pharmacists in the Health Care Ecosystem – July 26, 2017 – The high demand of primary care physicians and the surplus of pharmacists in today’s market is a clear sign that pharmacists are already in the race for provider status. Not to mention, pharmacists are currently doing point-of-care testing, vaccination shots, and collaborative practice agreements with physicians. If we pay close attention, the shifting role of the pharmacist slowly chipping away at the tasks physicians are already doing, could be a sign of some sort. Read More.
Ingestible Drug Delivery Materials May Improve Adherence – July 26, 2017 – Around half of all medications for chronic diseases are not taken as prescribed, costing the U.S. health care system more than $100 billion in avoidable hospital stays each year. Read More.
NCPA Rebuts Misleading PBM Research Paper on DIR Fees – July 26, 2017 – The Pharmaceutical Care Management Association’s (PCMA) research paper suggesting that accounting for fees on pharmacies at the point-of-sale would increase Medicare costs is based on dubious assumptions, said National Community Pharmacists Association (NCPA) CEO B. Douglas Hoey in a statement. Read More.
Increasing Competition Can Reduce Prescription Drug Prices – July 21, 2017 – Reducing prescription drug prices for payers requires market-based solutions that increase competition and deregulate federal drug policies, the Pharmaceutical Care Management Association (PCMA) wrote in a letter to HHS secretary Tom Price. Read More.
What’s New in Pharmacy Management Systems – July 21, 2017 – Many pharmacies are still scrambling to get their staff up to speed on working with electronic health records and their functionality. But beyond the fundamental capabilities that must be available in pharmacy software to meet the federal government’s meaningful use standards for EHRs, there is a host of advanced technologies now on the market, or on the horizon, that could take your pharmacy operations to the next level. Read More.
Most Handwritten Opioid Prescriptions Violate Best Practices – July 19, 2017 – This likely will come as no surprise to pharmacists, but nearly 90 percent of opioid prescriptions written by hand weren’t in line with “best practice” guidelines, a new study reveals. Read More.
Which Types of Insulin Offer Lower Risk of Hypoglycemia in Diabetes? – July 19, 2017 – Hypoglycemia, common in patients with type 1 diabetes and a relatively routine issue for those with type 2 diabetes, is a dangerous condition that makes it difficult to achieve good glycemic control. Read More.
Switch to Generic Eye Drugs Could Save Medicare Millions – July 19, 2017 – Eye care providers prescribe more brand medications by volume than any other provider group, data show, making them big influencers of prescription drug spending in the United States. University of Michigan Kellogg Eye Center researchers analyzed the prescribing patterns behind the $2.4 billion in annual Medicare Part D prescription costs generated by eye care providers. Read More.
New Study Shows Pharmacists-Involvement Can Dramatically Improve Vaccination Rates – July 14, 2017 – A new pilot study from the American Pharmacists Association Foundation found that when pharmacists are given the right tools to access patient vaccination history, they can significantly improve the number of vaccines administered to the patients they serve. According the results of the pilot, known as Project IMPACT Immunizations, community pharmacists who had access to a bidirectional State Immunization Information System (IIS) at the point of care were able to improve the number of vaccines administered by 41.1 percent. Read More.
340B in the News
Controversial 340B Drug Discounts Linked to Drug Pricing Issues – July 26, 2017 – Pharma companies have been protesting expansion of the federal program that provides deeply discounted prescription drugs to certain hospitals and health providers serving low-income, uninsured patients. The program has grown notably since it was expanded under the Affordable Care Act (ACA) to include cancer centers and other providers. Read More.
Witnesses at Congressional Hearing on 340B Urge Congress to Give HRSA Broader Regulatory Authority – July 25, 2017 – On July 18, 2017, just days after CMS went public with its proposal to reduce Medicare Part B reimbursement to certain 340B covered entities, Congress held its first hearing on 340B Program Oversight since March 2015. Read More.
Proposed Rule Would Slash Medicare Payment for 340B Drugs – July 20, 2017 – The Centers for Medicare and Medicaid Services (CMS) has proposed reducing the Medicare payment rate to hospitals for most separately payable drugs purchased under the 340B program from average sales price (ASP) plus six percent to ASP minus 22.5%. Read More.
Congress Squares Off Over Drug Pricing and A Controversial Drug Discount Program – July 18, 2017 – House Democrats are calling foul on Republican assertions that cuts to a little-known discount drug program will eventually reduce skyrocketing drug prices. At a hearing Tuesday, Rep. Diana DeGette (D-Colo.) said high drug prices should be investigated separately from the focus on oversight of the drug discount program, known as 340B. Read More.
Hospitals Question Feds’ Proposed $900 Million IOU Tied To 340B Cuts – July 18, 2017 – Hospital officials say they’re worried the CMS won’t fairly distribute savings the agency says would be generated by a $900 million cut to the 340B drug discount program. Last week, the CMS proposed paying hospitals 22.5 percent less than the average sales price for drugs acquired under the federal program, which aims to reduce operating costs for hospitals that see a disproportionate share of low-income patients. Read More.
Study: 340B Program Doesn’t Cause Drug Price Increases – July 18, 2017 – Though drug costs are on the rise, discounts offered through the 340B program are an unlikely factor, according to a new study. 340B Health, a group that includes 1,300 hospitals in the drug discount program from across the country and advocates for organizations in the 340B program, commissioned a study (PDF) on the financial impacts of the program and found that the 340B discount accounts for just 1 percent of the drug market. Read More.
Hospitals Oppose Cuts To 340B Drug Program, But Oncology Group Says They’re Abusing the Discount Program – July 17, 2017 – Hospital groups oppose a proposed federal rule to cut 340B drug payments, but a group representing oncologists applauds the effort it said will curb the abuse of the discount drug program. The Centers for Medicare and Medicaid Services has released a proposed rule to cut payment by about 27 percent for certain Medicare Part B drugs purchased through the 340B program. Read More.
Hospitals, ASCs, 340B Drugs Face Medicare Reimbursement Changes – July 17, 2017 – CMS recently proposed a rule that would update Medicare reimbursement rates for hospitals and ambulatory surgical centers as well as change some prescription drug rates to 340B hospitals. Hospitals would see a 2 percent Medicare reimbursement increase in 2018 for services paid under the Hospital Outpatient Prospective Payment System (OPPS), the rule stated. Read More.
CMS Proposes More Than 22 Percent Drop in 340B Drug Reimbursement in 2018 OPPS Rule – July 14, 2017 – The 2018 OPPS proposed rule is one of the shortest, and latest, in recent memory, being released July 13 at only 663 pages, but it contains major proposed policy changes for the 340B drug discount program, new modifiers, and expands packaging to drug administration for the first time. Read More.