Tuesday, March 13, 2007

HumaPen LUXURA™ HD: What The Hell Is Lilly Thinking?

The following press release was in today's news. While the portion about Lilly's HumaPen MEMOIR™ is old news at this point, starting in the third paragraph of this release is news pertaining to the HumaPen LUXURA™ HD, which will apparently be available by prescription starting in April 2007. As I've noted previously, the device (the HumaPen LUXURA™ HD) will enable delivery of anywhere from 1-to-30 units of Humalog in 1/2 unit increments (beginning after the first unit). However, as the following photos will demonstrate, I wanted to pass along the following piece of additional information that I received from Lilly's PR firm:

"I wanted to clear up any lingering confusion about the HumaPen LUXURA™ HD's features - currently, it does not have the memory function that the HumaPen MEMOIR™ has."

Its very unclear why on earth Lilly would choose NOT to enable the memory function in a pen that doses in 1/2 unit increments, and I would dare suggest that the price would need to be significantly lower before patients are willing to rush out to buy a pen like this. It seems that this was obviously an afterthought, not an integrated piece of the company's marketing strategy, which it really needs to be.

As you can see in the photograph below, the HumaPen LUXURA™ HD is the teal-colored device and notice that it does NOT have an LCD screen which does appear as a part of the HumaPen® MEMOIR™ (pictured immediately below).

A photograph of the Lilly HumaPen LUXURA™ HD is pictured above. Note the absence of an LCD screen, which indicates that this pen device lacks the memory function.

By comparison, the Lilly HumaPen MEMOIR™ is pictured here, and as you can see, the LCD screen is where patients can access information on their recent dosages.

I'm not a pharmaceutical analyst for Wall Street, but I would say that Lilly has some additional work to do if they believe these new pen devices are going to help turn its floundering insulin business around any time in the immediate future. The new pens are attractive and appear to be solid and well-made (they are manufacturered, according to the press, in Clinton, Massachusetts, rather than in China as virtually all glucose meters and most test strips are). Still, if there is no memory function, then the HumaPen LUXURA™ HD has few advantages over Lilly's disposable insulin pens other than having the ability to deliver more precise dosages and being more attractive, but is it worth the price? I would suggest a far less costly option might be to consider a Wright Pre-filled Syringe Case instead.

All I can say is what the hell was Lilly thinking? What's so difficult about having a pen that can dose in 1/2 unit increments AND capture the date, time and amount of the last 16 dosages? Its not rocket science here, it involves having a finer thread on the piston in the pen device, and developing a chip that can count in 1/2 unit increments rather than full unit increments. While Lilly notes that 4 million Americans use insulin, I would just note that approximately 1.1 million of them (or about 27%) are insulin-sensitive type 1 patients who are likely to need greater dosing precision.

Also in today's news, Representative Henry A. Waxman, Democrat of California and chairman of the House Oversight and Government Reform Committee sought information about allegations of inappropriate marketing by Eli Lilly and Company.

The letter to Eli Lilly requested information about a schizophrenia drug, Zyprexa, citing allegations that the company "misled physicians and inappropriately promoted off-label uses" of the drug. The company's efforts to encourage Zyprexa for off-label uses like treating dementia was the subject of an article last year in The New York Times.

He asked Lilly for lists of studies conducted on Zyprexa as well as documents related to marketing plans, among other information.

Meanwhile, the afforementioned press release follows.

Lilly Introduces World's First Digital Insulin Pen With Memory
March 13, 2007

Eli Lilly and Company today announced the launch of the first insulin pen with memory, HumaPen® MEMOIR™, to help simplify the daily management of diabetes.

MEMOIR is designed to meet the needs of people with diabetes who take several shots of mealtime insulin each day. It presents sophisticated technology and features in a consumer-friendly "push-to-know" digital display that allows patients to record and review their last 16 insulin doses, including the priming doses.

Many insulin users need multiple shots per day, so the ability to record doses and the time of the dose may help simplify the daily management of diabetes. This is especially important for both patients and physicians when developing a diabetes treatment plan that utilizes accurate recording of mealtime doses. MEMOIR is now available by prescription in pharmacies nationwide for use with Humalog® (insulin lispro injection [rDNA origin]), the most-prescribed mealtime insulin in the United States.

Lilly also announced today that it will launch an insulin pen that delivers Humalog in smaller increments, HumaPen® LUXURA™ HD, in April 2007. LUXURA HD is a reusable pen that can deliver from 1-to-30 units of Humalog in half-unit increments, beginning after the first unit. This type of pen may be attractive to people with diabetes that do not need large amounts of insulin, or parents of some children with diabetes. LUXURA HD will require a prescription.

Insulin pens were developed on the premise that delivery devices that are more acceptable to patients could improve patient compliance and make a positive contribution to long-term diabetes control.1 Unlike traditional insulin pens or vial and syringe, MEMOIR doesn't resemble a medical instrument. MEMOIR, which is reusable, is sleek and designed to resemble a writing pen, enabling the potential for more discreet injections in public compared to using a vial and syringe.

In a clinical study of experienced pen users, 81% of patients preferred MEMOIR over the pen they were using before joining the study. MEMOIR was considered easier and more convenient to use than the pre-study pen and rated higher for certain pen features and most tasks related to dosing. MEMOIR was developed in partnership with Battelle Medical Device Solutions, a leader in device innovation based in Columbus, Ohio.

Of the 21 million people with diabetes in the United States, more than four million currently use insulin to help manage their blood sugar.

"I see real advantages in a new tool such as MEMOIR that remembers recent insulin doses, including the priming doses. The daily routine of balancing meals and blood sugar readings with multiple insulin injections can be cumbersome and overwhelming for patients," said Linda Siminerio, PhD, assistant professor of medicine and executive director, University of Pittsburgh Diabetes Institute. "Anything that helps simplify the management of this disease and puts patients in a better position to self-manage is beneficial."

"As a busy college student, I'm not always thinking about how much insulin I took at my last meal," said Reuben Bresler, a 20-year-old from Columbus, Ohio, with type 1 diabetes and one of the first people in the U.S. to receive a MEMOIR pen. "MEMOIR helps me keep track of my insulin doses if I forget whether I've taken it - or how much I took. I also like that it looks like a writing pen instead of a medical instrument. I can just take it out, use it and not feel self-conscious."

Patient Needs Drive Innovation in Device Technology

Precise meal-by-meal blood sugar management is important in diabetes management. However, despite new treatment options that have become available during the past few years, the American Diabetes Association's recommended blood sugar goal - an A1C level of less than 7% - remains elusive for many with diabetes (A1C is a measure of average blood glucose levels over a two-to-three-month period). Fewer than half (43%) of Americans who have been diagnosed with and are being treated for diabetes are actually achieving this A1C target. [Editor note: as my 2006 year-end review indicates, this is a slight misrepresentation of the data. Although the actual number is correct, as the Quest Diagnostics Health Trends™ Diabetes Report indicates, among patients who regularly see their doctors and have hemoglobin A1C's done by a lab, control has actually improved.]

To understand current behaviors and how specific pen features could help patients manage their diabetes, Lilly sponsored a national, 1,000-person telephone survey of people with diabetes who inject insulin at least once a day. The survey, conducted by Kelton Research in January 2007, showed that, not surprisingly, respondents were interested in new tools that could help them better manage their disease:

Memory can help

-- Two-thirds of respondents said a reusable pen that tracks the date, time and dose of insulin would be valuable.

-- One-third of patients reported that they forgot whether they took their insulin dose at least once a month; of these, 84% said a memory feature would be valuable.

-- More than 9 in 10 (94%) said it is important to know if they missed an insulin dose

Looks matter too: Style and design considerations

-- 58% of those surveyed said they would be interested in using an insulin delivery device that looked like a writing pen instead of a medical instrument.

-- More than four in 10 said that a stylish looking pen would make them feel more comfortable injecting insulin in a public place.

"Individuals with diabetes face unique challenges in managing this highly complex and personal disease. Practical and innovative solutions such as Lilly's new MEMOIR pen can help ease the management of diabetes at mealtimes," said Matt Beebe, Humalog brand team leader, Lilly USA. "Our goal is to help patients more accurately and discreetly manage their use of mealtime insulin such as Humalog."

Lilly continues to develop new insulin delivery devices to meet the needs of people with diabetes. To learn more about Humalog and HumaPen MEMOIR, visit Humalog.com.


Humalog is for use in patients with diabetes to control high blood sugar and should be used with a longer-acting insulin, except when used in combination with sulfonylureas in patients with type 2 diabetes.

Important safety information for Humalog

Humalog should not be used during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients. Safety and effectiveness in patients less than three years of age have not been established. There are no clinical studies of the use of Humalog in pregnancy or nursing mothers. Potential side effects associated with the use of all insulins include low blood sugar, weight gain, low blood potassium, changes in fat tissue at the site of injection, and allergic reactions, both general and local. Starting or changing insulin therapy should be done cautiously and only under medical supervision.

Humalog starts working quickly because it is absorbed quickly. That's why you should use it at mealtime and take it within 15 minutes before or immediately after your meal. Because Humalog is a mealtime insulin, you may also need a longer-acting insulin to get the best blood sugar control (except when using an insulin pump).

For complete user instructions for HumaPen MEMOIR, please refer to the full user manual provided with the pen. Humalog, HumaPen MEMOIR and HumaPen LUXURA HD require a prescription.

For additional important safety information, visit http://www.humalog.com.

About Diabetes

According to the Centers for Disease Control and Prevention, diabetes affects nearly 21 million Americans; of that, nearly one-third, or approximately six million people, do not know they have the disease. Diabetes is the sixth leading cause of death in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.

About Lilly Diabetes

Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help health care professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. Lilly also strives to recognize the personal and professional contributions of those with and without diabetes through the annual LillyforLife™ Awards. For information about the Awards program, visit www.lillyforlife.com. For more information about Lilly's diabetes products, visit http://www.lillydiabetes.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Information about Lilly is available at http://www.lilly.com.

Humalog® is a registered trademarks of Eli Lilly and Company. HumaPen® MEMOIR™ and HumaPen® LUXURA™ HD are trademarks of Eli Lilly and Company.

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kath said...

Actually all the need to do is have the ability to divide by 2, which I believe is fairly easy -- I haven't designed a chip in years, but neither operation is that hard!

Anonymous said...

Scott, I fail to see the logic here, as well. Why go through the trouble and development cost to introduce two different pens, when all the features could have been incorporated into one. If the Luxura HD had the memory, as well as the half-unit capability, I might have considered begging up a coupon from my doctor or CDE, and paying $45 for the pen. But having either of those features by themselves has nowhere near the benefit for me, at least not enough to make me part with my hard earned $$, particularly at the full retail price of about $100.

Of interest though, remembering a comment posted here earlier, is the D-Tron pump cartridges being interchangable with Lilly's 3ml cartridge. Hmmmm..... could I get my Lantus into a half-unit Lilly pen?


Anonymous said...

Hi,i am Sushant Kathuria.I am 13yrs old.I am diabetic since last 5yrs.My father and paternal aunt also have this disease.Currently i
and my paternal aunt are using humapen ergo2.I am from a middle class family.My father uses disposable syringes.I have requested him several times to buy a humapenbut he says that its insulin is too costly for him to afford.So i request the manager of lilly to provide us a humapen and its syringes

Scott S said...

The cost of insulin pens (both the pens themselves, as well as the insulin cartridges) are significantly more expensive than syringes and a vial of insulin.

Something your father might consider is looking into the Lilly Cares program. Lilly Cares is a patient assistance program provided by Eli Lilly and Company through the Lilly Cares Foundation. As part of the company's efforts to provide access to our products for legal U.S. residents regardless of their ability to pay, Lilly created a program to offer free medication, through physicians, to patients who are otherwise unable to obtain our products. Lilly Cares assists patients who are uninsured and whose income is less than 200% of the federal poverty level.


Katy said...

I'd do anything to get hold of a pink one, a black one or a fancy one. I just hate the hospital burgandy and beige colours and i dont like green. I want something girlie and pretty or funky. please give us more choice in colour.

Katy said...

I'd do anything to get hold of a pink one, a black one or a fancy one. I just hate the hospital burgandy and beige colours and i dont like green. I want something girlie and pretty or funky. please give us more choice in colour.

Unknown said...

I've been using the HumaPen Luxura HD for well over a year now. I love this pen! The fact that it dispenses in 1/2 unit doses is very important to me. I like the added control I get by get that bit more of insulin with the worry of to much. I feel this pen is worth the added cost!

Gustav said...

Seems this company has a solution for pens without a memory function: mobivita.com They have a pouch with a (mechanical) memory function for up to four injections per day.

Jay said...

You poor Americans. We get all our diabetic consumables free here in the UK. I simply asked my GP for both the Humapen Luxura HD and the Humapen Memoir . No problem got them the next day, its all free over here, including the insulin of course.
I thought America was supposed to be the land of the free.
Obviously not!

Anonymous said...

Jay... It all depends on your health insurance and your doctor.

Some doctors can give you the pen for free... They get a lot of Samples.

Also, Does GB have high taxes? If so, you are paying for the "free" stuff.