Prescription Drug News of Note - September 2017

Prescription Drug News of Note - September 2017


 Prescription Drug News of Note September 2017

Each month, we round up the latest FDA approvals and regulations to give you an expert take on what you need to know.

Benlysta Subcutaneous Injection Approved

Systemic Lupus Erythematosus (SLE) affects 170,000-200,000 Americans and is the most common form of lupus, a chronic, incurable autoimmune disease that attacks body systems. In response, the FDA has approved a subcutaneous (injected under the skin) form of Benlysta (belimumab) for adults with active, autoantibody‑positive SLE who are receiving standard therapy. Benlysta is the only medication specifically approved for SLE. Benlysta is a biologic drug that inhibits the protein B-lymphocyte stimulator (BLyS). It has been on the market since 2011 as a one-hour intravenous (IV) infusion given every four weeks following induction. With proper training by healthcare provider, patients will be able to administer belimumab as a once-weekly 200-mg injection from either a single-dose prefilled syringe or from a single-dose autoinjector.  The subcutaneous formulation of belimumab will be available in specialty pharmacies in the United States in late August.  This offers a great new choice for patients, allowing them to self-administer their medicine at home rather than going to hospitals or clinics for their infusions. 

Why is this important:

One thing that will change is payer coverage. The IV formula is covered under medical benefit by insurers, while the subcutaneous version is likely to be covered under pharmacy benefits.


FDA approves Mavyret for Hepatitis C

The U.S. Food and Drug Administration recently approved Mavyret (glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both.  This approval was shortly followed by approval of Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir).  Mavyret is the first treatment of eight weeks duration approved for all HCV genotypes 1-6 in adult patients without cirrhosis who have not been previously treated. Standard treatment length was previously 12 weeks or more. It’s the first pan-genotypic (work against every genotype) hep C drug with an eight-week treatment duration, according to the FDA. Other options cure the disease in 12 weeks or longer. Gilead also has pan-genotypic drugs Vosevi and Epclusa, though those have a longer treatment duration.

This approval provides a shorter treatment duration. 

Why is this important:

Mavyret’s price is $13,200 per month or $26,400 per treatment course. That’s significantly lower than other monthly prices, such as $28,000 per month for Sovaldi, $31,500 per month for Harvoni and $27,773 for AbbVie’s own Viekira Pak and Viekira XR. Merck’s Zepatier is priced at $18,200 per month.  Vosevi is priced at $24,920 for a 28-day bottle.  All prices listed are before discounts and rebates.


Kymriah Approved as First U.S. CAR-T Cell Therapy

This is a new approach to the treatment of cancer and other serious and life-threatening diseases. The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL). Kymriah is a genetically-modified T-cell immunotherapy customized for each patient using their own T-cells, a type of white blood cell.  Each dose of Kymriah is a customized treatment created using an individual patient’s own T-cells, a type of white blood cell known as a lymphocyte.

Why is this important:

Exciting news, as the U.S. Food and Drug Administration approved the first U.S. cell-based gene therapy. Medicine is entering a new frontier in medical innovation with the ability to reprogram a patient’s own cells to attack a deadly cancer.


Cyltezo: Boehringer Ingelheim Gets Approval on Their First Biosimilar

 Cyltezo (adalimumab-adbm) is an anti-TNF-α monoclonal antibody biosimilar to Humira, approved in a pre-filled syringe for the treatment of various inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis. It can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs. (DMARDs).  It was approved based on a comprehensive data package comprised of analytical, pharmacological, non-clinical and clinical development studies. The other biosimilar to adalimumab is Amgen’s Amjevita (adalimumab-atto).

Why is this important:

This marks another important step towards the common goal of providing new and more affordable treatment options to healthcare providers and patients.  This is the 6th FDA-approved biosimilar; the second for Abbvie’s Humira.  One of the most highly-anticipated new drugs in recent years took a huge step toward public availability with its recent FDA approval. Amjevita, first biosimilar to Humira. Rheumatoid Arthritis is a monster drug category, which by itself accounts for about 25% of all specialty drug spending.  Despite being approved, Amjevita is not yet for sale and remains in complex patent litigation. Years may pass before Amjevita makes it to market.

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Posted by

Irina Prosmushkin

Senior Product Manager
Irina holds a Bachelor Degree in Pharmacy from Temple University, and brings over 17 years of experience bringing healthcare solutions to payers. Irina started her pharmacy career at a leading PBM in 1999, and has held a variety of management roles in mail service pharmacy operations, pharmacy compliance, clinical pharmacy, and clinical support. Irina’s focus at Truveris is to oversee current product offerings with a focus on improving clinical outcomes and managing costs. In the past, Irina held roles at OptumRx, and Express Scripts.