Jennifer Barrett, Associate Editor

Brand-name prescription drug costs are likely to continue to rise, with the biggest increases seen in insulins and tumor necrosis factor (TNF) inhibitors, according to a new study published in

Over a 6-year period, the analysis mapped out drugs cost patterns for the 49 top-selling brand-name medications in the United States based on pharmacy claims data from a health insurance database. Top selling medications were identified as drugs that exceeded $500 million in US sales or $1 billion in worldwide sales.

From January 2012 through December 2017, the researchers found a median 76% increase in costs, or a 9.6% annual compounded increase. Of the 36 drugs that have been available since 2012, 78% have seen an increase in insurer and out-of-pocket costs by more than 50% and 44%, respectively, according to the study. In total, 35% of the drugs more than doubled in costs. The authors noted that insulin products and TNF inhibitors specifically demonstrated highly correlated price increases and made up some of the largest price hikes in the industry.

In many cases, cost increases for most of the drugs were observed 1 to 2 times per year, according to the study. Only 1 drug, hepatitis C medication ledipasvir/sofosbuvir (Harvoni), decreased in cost over time; however, the decrease was no more than 1% annually.

According to the study, the researchers estimated that costs for popular brand-name drugs would double every 7 to 8 years.

A version of this article was originally published by Specialty Pharmacy Times. Visit

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Over a 6-year period, the analysis mapped out drugs cost patterns for the 49 top-selling brand-name medications in the United States based on pharmacy claims data from a health insurance database.

Study Predicts Costs for Brand-Name Drugs Will Continue to Rise

Officials with the FDA have approved galcanezumab-gnlm (Emgality, Eli Lilly) injectable solution for the treatment of episodic cluster headache in adults, according to a press release.

Galcanezumab-gnlm is a human immunoglobulin G4 monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) receptor, which has been used as a target for migraine treatment. The drug was first approved by the FDA in September 2018 for the prevention of migraine in adults. Galcanezumab-gnlm is now the only CGRP antibody approved for both indications.

Episodic cluster headaches represent 85% to 90% of cluster headache prevalence, with approximately 250,000 adults living with the condition in the United States, according to Lilly.

In cluster headache, individuals experience an abrupt onset of severe-to-very severe pain on 1 side of the head, typically around or above the eye and/or temple. Other symptoms, such as eye redness, tearing, nasal congestion, rhinorrhea, forehead and facial sweating, miosis, ptosis and/or eyelid edema, and/or restlessness or agitation can also occur.

This approval was based on efficacy data from a clinical trial evaluating galcanezumab-gnlm for the treatment of episodic cluster headache in 106 patients. For the study, patients were randomized to receive either once-monthly injection of galcanezumab-gnlm 300 mg or a placebo. Baseline number of weekly cluster headache attacks were 17.6 for galcanezumab-gnlm and 17.3 for the placebo group.

According to the study, patients who received galcanezumab-gnlm experienced an average of 8.7 fewer weekly cluster headache attacks over weeks 1 to 3 versus 5.2 fewer weekly attacks for patients on a placebo. Additionally, treatment with galcanezumab-gnlm cut weekly cluster headache attacks in half or more from baseline at week 3 in 71.4% patients, compared with 52.6% of patients in the placebo arm.

Galcanezumab-gnlm’s safety profile observed in patients with episodic cluster headache treated with 300 mg was similar to those with migraine treated with 120 mg.

“For years, there have been few therapeutic options to offer patients for the treatment of episodic cluster headache,” David Kudrow, MD, director of California Medical Clinic for Headache, said in a statement. “With today’s approval, physicians are now armed with an FDA-approved medication that has the potential to help patients living with this condition by reducing the frequency of cluster attacks.”

The recommended dosage of galcanezumab-gnlm is 300 mg, administered as 3 consecutive subcutaneous injections of 100 mg each, at the onset of the cluster period and then monthly until the end of the cluster period, according to Lilly. The drug is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. Patients can self-administer galcanezumab-gnlm after training by a health care professional.

Galcanezumab for the Preventative Treatment of Migraines

FDA Approves Emgality (galcanezumab-gnlm) as the First and Only Medication for the Treatment of Episodic Cluster Headache that Reduces the Frequency of Attacks [news release]. Eli Lilly. https://investor.lilly.com/news-releases/news-release-details/fda-approves-emgalityr-galcanezumab-gnlm-first-and-only. Accessed June 5, 2019.

Episodic cluster headaches represent 85% to 90% of cluster headache prevalence, with approximately 250,000 adults living with the condition in the United States.

FDA OKs Treatment for Episodic Cluster Headache in Adults

Officials with the FDA have granted final approval to the first generic naloxone hydrochloride nasal spray for the treatment of opioid overdose, according to a press release. Teva previously received tentative approval by the FDA for the generic product in June 2018.

The name-brand nasal spray, Narcan (ADAPT Pharma), was approved by the FDA in November 2015.

Generic injectable naloxone products have been available for years; however, this approval marks the first generic naloxone nasal spray for use in a community setting by individuals without medical training. The approval comes after

held by the FDA in December 2018 that addressed new ways to improve the availability of naloxone, such as the development of over-the-counter naloxone products and additional generic options.

As part of ongoing efforts to quell the growing opioid epidemic, agency officials are seeking ways to improve accessibility of emergency overdose reversal treatments, according to Douglas Throckmorton, MD, deputy center director for regulatory programs in the FDA’s Center for drug Evaluation and Research.

“In addition to this approval of the first generic naloxone nasal spray, moving forward we will prioritize our review of generic drug applications for naloxone,” Dr Throckmorton said in the statement. “The FDA has also taken the unprecedented step of helping to assist manufacturers to pursue approval of an over-the-counter naloxone product and is exploring other ways to increase the availability of naloxone products intended for use in the community, including whether naloxone should be co-prescribed with all or some opioid prescription to reduce the risk of overdose death.”

Additionally, as part of the US Department Health and Human Services’ public health emergency to address the opioid crisis, the FDA will grant priority review to all abbreviated new drug applications for products indicated for the emergency treatment of known or suspected opioid overdose.

According to the press release, naloxone nasal spray does not require assembly and delivers a consistent, measured dose when used as directed. The product is available for use in adults or children. Patients who are opioid-dependent may experience severe opioid withdrawal as a result of naloxone nasal spray use.

FDA approves first generic naloxone nasal spray to treat opioid overdose [news release]. FDA.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm636333.htm

This approval marks the first generic naloxone nasal spray for use in a community setting by an individual without medical training.

First Generic Naloxone Nasal Spray is Granted FDA Approval

Officials with the FDA have approved the first 2-drug complete HIV treatment regimen, dolutegravir and lamivudine (Dovato, ViiV Healthcare), for adults who have never received HIV therapy, according to a press release.

To be eligible for dolutegravir and lamivudine, patients must have no history of antiretroviral therapy (ART) and no known or suspected substitutions associated with resistance to the individual components of the regimen.

With this approval, patients who have never been treated have the option of a 2-drug regimen in a single tablet, as opposed to the standard-of-care 3-drug regimen for HIV.

“Having a drug-sparing treatment available that uses fewer drugs is beneficial to patients who may have issues taking multiple medications over a long period of time,” Debra Birnkrant, MD, director of the Division of Antiviral Products, said in a statement.

The approval is based on efficacy and safety clinical trial data from the GEMINI 1 and 2 studies for dolutegravir and lamivudine. The studies, which included 1433 adults with HIV with no prior ART history, showed that the drug regimen produced similar efficacy in reducing the amount of HIV in the blood compared with a 3-drug, first-line regimen of dolutegravir plus emtricitabine and tenofovir.

According to the study, treatment was considered successful if the patient maintained low levels (less than 50 copies/mL) of HIV RNA in their blood for at least 48 weeks.

The labeling for dolutegravir and lamivudine includes a Boxed Warning recommending that patients infected with both HIV and hepatitis B should add additional treatment for their hepatitis B or consider a different drug regimen.

The most common adverse effects reported in the trial for dolutegravir and lamivudine included headache, diarrhea, nausea, insomnia, and fatigue. Patients are also advised to avoid use of dolutegravir and lamivudine at the time of conception through the first trimester of pregnancy, due to a known risk for neural tube defects with dolutegravir, according to the FDA.

FDA approves first two-drug complete regimen for HIV-infected patients who have never received antiretroviral treatment [news release]. Silver Spring, MD; April 8, 2019: FDA website.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm635526.htm

FDA Oks 2-Drug HIV Therapy for Previously Untreated Patients

Officials with the FDA have approved cladribine (Mavenclad, EMD Serono), a new oral treatment for relapsing forms of multiple sclerosis (MS) in adults including relapsing-remitting disease and active secondary progressive disease, according to a press release.

With this approval, cladribine is the first oral MS treatment to provide 2 years of proven efficacy with a maximum of 20 days of treatment, according to manufacturer EMD Serono.

just a few days prior. Siponimod was approved as an oral treatment specifically for patients with active secondary progressive MS, as well as other relapsing forms of disease.

The clinical trial program evaluating cladribine included 1976 patients who received therapy for a total of 9509 patient years, of which mean time on study including follow up was approximately 4.8 years and 24% of follow-up was for 8 years.

Patients experienced a 58% relative reduction in the annualized relapse rate (ARR) with cladribine compared with placebo (0.14 versus 0.33, p<0.001).

Eighty-one percent of patients were free of relapses after 2 years of short-course oral treatment with cladribine, compared with 63% of patients who received placebo (p<0.05).

Patients treated with cladribine had a 33% reduction in risk of 3-month confirmed disability progression as measured by Expanded Disability Status Scale (EDSS) compared with placebo (p<0.05).

Patients taking cladribine experienced a lower median number of T1-weighted gadolinium-enhanced brain lesions and new or enlarging T2 brain lesions compared with patients with placebo (0 versus 0.33 and 0 versus 0.67, p<0.001).

“As an investigator in the clinical trial program, I am pleased Mavenclad will now be available to patients in the US,” Thomas Leist, MD, PhD, director, Comprehensive Multiple Sclerosis at Jefferson University Hospital, said in a statement. “With short treatment courses with pills taken for no more than 10 days in a year and no injections or infusions, Mavenclad is an efficacious new treatment option for MS. Nearly 1 million individuals are afflicted with MS in the US alone, according to a recent National MS Society sponsored study. Mavenclad is a welcome new oral treatment option for this heterogenous and often unpredictable disease.”

The most commonly reported adverse effects in the phase 3 CLARITY trial were upper respiratory tract infection, headache, and lymphopenia.

Cladribine is generally recommended for patients who have had an inadequate response, or are unable to tolerate an alternate drug indicated for the treatment of MS, and is not recommended for use in patients with clinically isolated syndrome. Cladribine has a boxed warning for an increased risk of malignancy and fetal harm.

FDA Approves Mavenclad (Cladribine) Tablets as First and Only Short-Course Oral Treatment for Relapsing-Remitting and Active Secondary Progressive Multiple Sclerosis [news release]. EMD Serono.

http://media.emdserono.com/2019-03-29-FDA-Approves-MAVENCLAD-R-Cladribine-Tablets-as-First-and-Only-Short-Course-Oral-Treatment-for-Relapsing-Remitting-and-Active-Secondary-Progressive-Multiple-Sclerosis

THE FDA has approved cladribine (Mavenclad, EMD Serono), a new oral treatment for relapsing forms of multiple sclerosis (MS) in adults including relapsing-remitting disease and active secondary progressive disease.


FDA OKs First Short-Course Oral Therapy for Relapsing Forms of MS

Officials with the FDA have granted Priority Review status to the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) as an add-on maintenance treatment for adults with inadequately controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP), according to a press release.

If approved, dupilumab would be the first FDA-approved biologic for the treatment of CRSwNP. CRSwNP is a chronic disease, in which individuals with severe disease typically experience recurrent inflammation of the upper airway despite previous surgery and/or systemic corticosteroids.

The sBLA submission is based on data from 2 phase 3 trials, SINUS-24 and SINUS-52, evaluating the efficacy and safety of 300 mg dupilumab every 2 weeks with standard-of-care mometasone furoate nasal spray (MFNS) compared with a placebo injection plus MFNS. Study participants had recurring severe CRSwNP and had been previously treated with surgery and/or systemic corticosteroids. In addition, SINUS-52 included a third patient group who switched from dupilumab every 2 weeks to dupilumab every 4 weeks after week 24. In the trials, approximately 60% of patients had comorbid asthma, with most of them receiving asthma controller medications.

Data from these trials were presented at the Annual Meeting of the American Academy of Allergy, Asthma, and Immunology in February 2019.

According to Regeneron, key data from the trial showed:

42% and 27% improvement in sinus opacification versus 4% and 0% with a placebo at 24 weeks in SINUS-24 and SINUS-52, respectively.

146% and 108% improvement in ability to identify different smells versus 19% and 7% with placebo at 24 weeks in SINUS-24 and SINUS-52, respectively.

60% and 51% improvement in health-related quality of life versus 18% and 18% with placebo at 24 weeks, respectively.

0.21L improvement in lung function versus placebo at 24 weeks in SINUS-24 in the subset of patients with asthma at baseline and 0.21L improvement in lung function versus placebo in SINUS-52.

73% reduction in rescue treatment with systemic corticosteroids or nasal polyp surgery compared with placebo at 24 weeks SINUS-24 and 76% reduction at 52 weeks in SINUS-52.

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Dupilumab (Dupixent, Regeneron and Sanofi) would be the first FDA-approved biologic for the treatment of severe chronic rhinosinusitis with nasal polyps. 