Drug Update - August 2015
Posted: Aug 14 2015

FDA Drug Approvals

Each month the FDA approves new medications, and below is a highlight of the most relevant new approvals and/or drugs which have the potential to impact your prescription plan. While the medications below have been evaluated and approved by the FDA, they may not enter the marketplace for several weeks or months.

New Approvals
Drug Name Uses/TreamentPlan Impact & CCC Management Strategy
PraluentTreatment of certain types of high cholesterolHighly anticipated first in class: Praluent is the first agent in the highly anticipated PCSK9 class. It is approved only for those who have already maximized statin therapy and have either heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease. It is administered by injection every two weeks.
Formulary Management: Concidered non-preferred upon market entry.
Cost (AWP): $1,345 per month.
BIC SpecialtyRx: Subject to comprehensive clinical management through MedTrak''s BIC Specialty program and obtained with a comprehensive discount.
Clinical Concierge: Subject to prior authorization as a specialty medication. Drug-specific and evidence-based criteria developed and applied by MedTrak''s Clinical Care Center to ensure appropriate utilization.
Entresto Treatment of heart failureBlockbuster potential: Entresto is the first agent in a new drug class used in the treatment of heart failure. The FDA granted approval six weeks ahead of schedule because it significantly reduced the risk of cardiovascular death in clinical trails. Entresto has blockbuster drug potential due to the large number of people who may be eligible for therapy.
Formulary Management: Considered non-preferred upon market entry.
Cost (AWP): $450 per month.
Clinical Concierge: Subject to prior authorization under MedTrak''s Enhanced Management program. Drug-specific and evidence-based criteria developed and applied by MedTrak''s Clinical Care Center to ensure appropriate utilization.
OrkambiTreatment of cystic fibrosisDrug Information: Orkambi is an oral tablet for use in cystic fibrosis patients with a specific gene mutation.
Formulary Management: Considered non-preferred upon market entry.
Cost (AWP): Approximately $24,000 per month.
BIC SpecialtyRx: Subject to comprehensive clinical management through MedTrak''s BIC Specialty program and obtained with a competitive discount.
Clinical Concierge: Subject to prior authorization as a specialty medication. Drug-specific and evidence-based criteria developed and applied by MedTrak''s Clinical Care Center to ensure appropriate utilization. 
DaklinzaTreatment of hepatitis C infectionDrug Information: Daklinza is used in the treatment of chronic hepatitis C, genotype 3 infections. The usual treatment duration is 12 weeks.
Formulary Management: Considered non-preferred upon market entry.
Cost (AWP): $25,200 per month.
BIC SpecialtyRx: Subject to comprehensive clinical management through MEdTrak''s BIC Specialty Program and obtained with a competitive discount.
Clinical Concierge: Subject to prior authorization as a specialty medication. Drug-specific and evidence-based criteria developed and applied by MedTrak''s Clinical Care Center to ensure appropriate utilization.
TechnivieTreatment of hepatitis C infectionDrug Information: Technivie is used in the treatment of chronic hepatitis C, genotype 4 infections. The usual treatment duration is 12 weeks.
Formulary Management: Considered non-preferred upon market entry.
Cost (AWP): $30,660 per month.
BIC SpecialtyRx: Subject to comprehensive clinical management through MedTrak''s BIC Specialty program and obtained with a competitive discount.
Clinical Concierge: Subject to prior authorization as a specialty medication. Drug-specific and evidence-based criteria developed and applied by MedTrak''s Clinical Care Center to ensure appropriate utilization.
Memantine (generic for Namenda)Treatment of Alzheimer's diseaseDrug Information: Namenda is not in MedTrak''s Top 200 drugs, but ranked as the 16th most frequently prescribed drug nationwide in 2014. Multiple generic manufacturers for memantine entered the market during the second week of July.
Formulary Management: Considered preferred upon market entry.
Cost (AWP): AWP for most manufacturers is approximately $6.00 per tablet. However, because of the competition between multiple manufacturers, the average cost per tablet is expected to decline rapidly.
Control Trak: Subject to Max Dollar and Max Dose edits.

The Clinical Care Center (CCC) is MedTrak’s comprehensive clinical solution to control costs and increase adherence for our Clients and Members. The Clinical Care Center is made up of 7 Steps to Improved Outcomes: Generics Plus, Formulary Management, Member & Client Education, RightChoice, Control Trak, Best-In-Class (BIC) SpecialtyRx, and Clinical Concierge.