Q&A: A new drug for Type 2 diabetes — Wa’el Hashad, Boehringer Ingelheim
Last month, the Food and Drug Administration approved Tradjenta (linagliptin), an oral Type 2 diabetes drug made by German drug maker Boehringer Ingelheim and Indianapolis-based Eli Lilly. The drug belongs to the class known as dipeptidyl peptidase-4 inhibitors, which also includes Merck’s Januvia (sitagliptin). With diabetes affecting some 26 million Americans and growing rapidly, Drug Store News spoke with Wa’el Hashad, BI’s VP cardiovascular and metabolic disorders marketing, about what the approval of Tradjenta means for the diabetes market.
Drug Store News: What do you see as Tradjenta’s biggest advantages over other diabetes drugs in general, as well as over other DPP-4 inhibitors on the market?
Wa’el Hashad: Tradjenta is the first in its class to be approved at one dosage strength, so there is only one dose to remember for all patients. Tradjenta can be used as a stand-alone therapy or in combination with other commonly prescribed medications for Type 2 diabetes — including metformin, sulfonylurea or pioglitazone* — and has demonstrated reductions in hemoglobin A1C levels of up to 0.7% compared with placebo. The recommended dose of Tradjenta is 5 mg once daily, and it can be taken with or without food. With Tradjenta, no dose adjustment is recommended for patients with kidney or liver impairment. Tradjenta should not be used in patients with Type 1 diabetes or for the treatment of diabetic ketoacidosis, a disease that causes increased ketones in the blood or urine. It has also not been studied in combination with insulin.
We are confident in Tradjenta’s potential to compete effectively in the Type 2 diabetes market and are very excited to make Tradjenta available to the millions of people whose diabetes is not adequately controlled. The FDA’s approval of Tradjenta means physicians will have another option for treating their patients with Type 2 diabetes whose blood sugar is uncontrolled. Alternative treatment options are important because Type 2 diabetes can be difficult to manage, and it is often very personal, meaning treatment regimens need to address individual patient needs.
DSN: What is the drug’s greatest advantage from a patient and pharmacist perspective?
Hashad: Tradjenta is the first in its class to be approved at one dosage strength, so there is only one dose to remember for all patients. We recognize pharmacists play an important role in further educating patients about Tradjenta. Boehringer Ingelheim Pharmaceuticals and Eli Lilly are committed to ensuring primary care practitioners and pharmacists are aware of when Tradjenta becomes available and are able to educate patients appropriately.
DSN: What prompted BI and Lilly to develop Tradjenta together?
Hashad: Tradjenta was discovered by Boehringer Ingelheim. In January 2011, BI and Lilly formed a strategic alliance in diabetes. This cooperation gives BI and Lilly the combined benefits of Lilly’s expertise in the diabetes market and two basal insulin analogs, as well as BI’s rich and innovative late-stage pipeline. The alliance leverages the collective scientific expertise and business capabilities of two leading research-driven pharmaceutical companies to address patient needs arising from the growing global diabetes epidemic.
DSN: How will the launch of Tradjenta affect the diabetes market in the years to come?
Hashad: The oral diabetes market is a $15 billion market, and DPP-4s are the fastest- growing segment of this market. We believe Tradjenta will further expand this growing market and bring a new treatment option to patients, healthcare providers and pharmacists.
* Pioglitazone is the generic name of Takeda’s Actos.
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Specialty Rx, diabetes to drive drug trend
The overall growth in drug spending for 2010 was 3.7%, according to the latest drug trend report by pharmacy benefit manager Medco Health Solutions. The lower increase was primarily due to higher rates of generic drug dispensing — more than 71% of drugs dispensed were generics.
Drugs for diabetes have continued to drive drug trend for the fourth year in a row as the largest therapeutic category driving overall spending growth, with a drug trend of 7.6%, according to Medco’s drug trend report. The large number of diabetes patients — which most experts expect to significantly grow over the next several years — resulted in the category contributing nearly 17% of the overall growth in drug spending in 2010.
However, the real driver of drug trend is specialty drugs. IMS Health found that while money spent on branded drugs around the world will decrease as patents expire and generic usage increases, spending on branded drugs in developed countries will remain more or less the same in 2015 as it was in 2010. At the same time, spending growth on drugs for such conditions as lipid disorders, asthma and chronic obstructive pulmonary disorder is expected to slow.
As top-selling drugs for such conditions as high cholesterol and gastroesophageal reflux disease now are losing patent, new drugs for treating such therapeutic conditions as lipid disorders and GERD will probably still be developed, but they’re not guaranteed to reach sales comparable to Pfizer’s Lipitor (atorvastatin calcium), the cholesterol-lowering medication that, according to IMS Health, had sales of more than $7 billion last year. As a result, such companies as Pfizer, Merck and Bristol-Myers Squibb are moving into specialty drugs and treatments for such complex, chronic conditions as rheumatoid arthritis, multiple sclerosis and cancer.
Medco’s latest drug trend report also attests to this trend; the pharmacy benefit manager predicted that expensive cancer drugs would become the second- or third-largest drug-trend-driving category by 2015. Specialty drugs, mostly branded biologics, accounted for 70.1% of the overall drug trend, with especially strong growth in cancer drugs, whose drug trend reached 21.2%.
“New cancer drugs reaching the market are expected to double during the next several years,” Medco chief medical officer Glen Stettin said. “Early diagnosis, evidence-based treatment and enhanced coordinated care have essentially turned some forms of the condition into chronic illnesses that can be managed in the longer term. Continued innovation, including companion diagnostic or pharmacogenomic testing, can help ensure the right person is getting the right drug at the proper dose and reduce waste.”
Newly introduced drugs for cancer increased inflation in the category to 11.5% last year, and according to the Journal of the National Cancer Institute, more than 90% of cancer drugs approved since 2004 cost more than $20,000 for a 12-week course of therapy. Higher prescribing of drugs, such as Celgene multiple myeloma treatment Revlimid (lenalidomide) and Novartis leukemia and gastrointestinal tumor drug Gleevec (imatinib mesylate), drove the increases. Medco noted that many of the newer drugs are oral medications that patients can administer by themselves, thus shifting the dynamic of cancer care delivery toward the home instead of physicians’ offices and infusion centers.
“It’s an exciting time in the area of cancer treatment, but as these new, targeted treatments come to market, it is vital to ensure that each patient and caregiver understands the importance of adherence and the detailed dosing instructions associated with them,” Medco Oncology Therapeutic Resource Center national practice leader Milayna Subar said. “Helping patients manage the unique needs of their disease across the continuum of care with specialists and a personalized medicine program will help to improve outcomes for the patient and could help to manage down the projected drug trend of 15% to 17% for these new specialty medications.”
A number of drug companies appear to see specialty drugs for chronic, complex disease states as the next frontier, as the wave of expirations of patents covering treatments for more widespread conditions — known as the patent cliff — upends the blockbuster drug model that long guaranteed high profits. Pfizer and Merck have leveraged the biotech capabilities they garnered through their respective acquisitions of Wyeth and Schering-Plough to become leading developers of biotech drugs, while Bristol-Myers Squibb has built up its own biotech infrastructure and Sanofi has taken a lead in treatments for rare, genetic diseases by acquiring Genzyme.
As Medco’s forecasts would suggest, specialty drugs will see significant growth over the next few years. In addition to citing recent and upcoming launches of drugs for multiple sclerosis and cancer, IMS predicted that spending on biosimilars will exceed $2 billion per year by 2015, compared with $311 million in 2010. New biosimilars are expected to enter the U.S. market by 2014, and globally, biosimilars will account for about 1% of total spending on biologics.
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CDC: Retail settings become popular alternative for flu shots
ATLANTA — Many adults across the United States opted to visit their local drug store or supermarket to receive their flu shot during the 2010-2011 influenza season, according to the Centers for Disease Control and Prevention’s "Morbidity and Mortality Weekly Report."
Although most adults received their flu vaccination at a doctor’s office (39.8%), the CDC found that retail settings, including supermarkets and drug stores, were used by 18.4% of adults. This compared with the 1998-1999 and 2006-2007 influenza seasons, when 5% and 7% of adults, respectively, were vaccinated in stores, the CDC said. The agency partly attributed the increase in retail setting use to changes in state laws allowing pharmacists to administer influenza vaccinations to adults and, subsequently, more pharmacies offering influenza vaccinations.
The third most common place where adults were vaccinated during the 2010-2011 season was at their place of work.
The CDC said that the report was comprised in order to provide a baseline for places where adults received their influenza vaccination since the Advisory Committee on Immunization Practices recommended individuals ages 6 months and older should be immunized, as well as to help vaccination providers plan for the 2011-2012 influenza season.
The CDC analyzed information on influenza vaccination among adults ages 18 years and older from 46 states and the District of Columbia during the 2010-2011 season. Data were collected from January to March 2011 by the Behavioral Risk Factor Surveillance System, the CDC noted.
This was always a great idea, but unfortunately all of these retail operations do not use good sterile technique. They work from card tables, don't disinfect the tables and do not wear or change gloves between patients.