Six noteworthy recently approved specialty drugs

October 28, 2015

A senior clinical consultant at Express Scripts says it's critical for healthcare executives to keep an eye on recently approved specialty medications. Here are six to watch.

The high price of specialty medications, combined with the high number that have recently been approved and likely will be approved in 2016, could significantly shake up managed care pharmacy.

That's according to Aimee Tharaldson, PharmD, Express Scripts, who presented a session “Specialty Pharmaceuticals in Development," on Tuesday, October 27, at the Academy of Managed Care Pharmacy Conference Nexus 2015 in Orlando, Florida.

Tharaldson, a senior clinical consultant in emerging therapeutics at Express Scripts, says it's critical for healthcare executives to keep an eye on these recently approved specialty medications, as they are very expensive and account for a significant portion of the prescription drug spend.

"It's important to know what's going to the market and how [these medications] will potentially impact the market," she recently told Managed Healthcare Executive.

Here are six recently approved specialty drugs that Tharaldson says managed healthcare executives should watch:

1. Cancer drug: Ibrance

On February 3, 2015, Pfizer received accelerated approval from FDA for Ibrance (palbociclib), in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2(HER 2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. Ibrance is an oral cyclin-dependent kinases 4 and 6 inhibitor.

2. Orphan drug: Orkambi

On July 2, 2015, FDA approved Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) for the treatment of people with cystic fibrosis ages 12 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Orkambi contains lumacaftor and ivacaftor. Lumacaftor is a CFTR corrector, which helps CFTR proteins reach the cell surface. Ivacaftor, the active ingredient in Vertex’s Kalydeco, is known as a CFTR potentiator, which helps keep the CFTR protein channels on the cell surface open longer to increase the flow of salt and water into and out of the cell.

3. PCSK9 inhibitor:Praluent

On July 24, 2015, FDA approved Sanofi and Regeneron’s Praluent (alirocumab) for the treatment of high cholesterol among patients with heterozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein “bad” cholesterol. Praluent is used along with diet and maximally tolerated HMG Co-reductase inhibitor (statin) therapy.

Next: 3 more recently approved drugs

 

4. Hepatitis C drug: Daklinza

FDA approved Bristol-Myers Squibb’s Daklinza (daclatasvir) on July 24, 2015, for the treatment of patients with hepatitis C virus genotype 3 infection in combination with Sovaldi (sofosbuvir, Gilead). The recommended dose is one 60-mg tablet of Daklinza with one 400-mg tablet of Sovaldi once daily for 12 weeks.

5. Hepatitis C drug: Technivie

On July 24, 2015, FDA approved AbbVie’s Technivie (ombitasvir, paritaprevir and ritonavir) for use in combination with ribavirin for the treatment of hepatitis C virus genotype 4 infection in patients without cirrhosis (scarring and poor liver function). The recommended dose is two Technivie [ombitasvir/paritaprevir/ritonavir (12.5 mg/75 mg/50 mg)] tablets once daily (in the morning) with weight-based ribavirin twice daily.

6. PCSK9 inhibitor: Repatha

On August 27, 2015, FDA approved Amgen’s Repatha for the treatment of high cholesterol among patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia or patients with clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein “bad” cholesterol. Repatha is used along with diet and maximally tolerated HMG Co-reductase inhibitor (statin) therapy.