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

Jennifer Barrett, Associate Editor

Articles

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

FDA OKs Treatment for Episodic Cluster Headache in Adults

First Generic Naloxone Nasal Spray is Granted FDA Approval

FDA Oks 2-Drug HIV Therapy for Previously Untreated Patients