The Official Medtipster Blog

www.Medtipster.com Source: Dow Jones Newswires – Philadelphia Bureau, April 22,2010

New prescription drugs just don’t fly off the pharmacy shelves as quickly as they used to. That’s a problem for an industry facing a wave of patent expirations for its current blockbusters.

Drug makers are having a tougher time convincing drug-benefit plans to provide favorable reimbursement soon after the introduction of new drugs. While several factors have contributed to slow launches, a big hurdle is insurers’ insistence that manufacturers prove the cost-effectiveness of new drugs, in addition to efficacy and safety.

One example is Effient, a new blood-thinning treatment for heart patients co-marketed by Eli Lilly & Co. (LLY) and Daiichi Sankyo Co. (4568.TO). A prominent warning about bleeding risks on the drug’s prescribing label and less-than-ideal reimbursement by insurers have hampered its growth.

From its introduction last year through March 31, Effient has generated only about $36 million in sales for Lilly–an inauspicious start for a drug once viewed as likely to exceed $1 billion in annual sales. The gold standard anticlotting drug, Plavix from Bristol-Myers Squibb Co. (BMY) and Sanofi-Aventis SA (SNY), seems immune to Effient’s challenge.

“It’s getting increasingly difficult for new products to demonstrate value to a broad set of stakeholders,” said Rob Harold, senior principal with IMS Health Inc.’s consulting unit, which advises drug makers on product-launch strategies.

Other numbers from prescription-data provider SDI help tell the story: From 2000 through 2004, five drugs exceeded 700,000 monthly prescriptions each within a year of their respective U.S. launch dates. These included AstraZeneca PLC’s (AZN) Nexium heartburn pill, now the third best-selling drug in the world. But from 2005 through 2009, only one drug reached that threshold so quickly: Teva Pharmaceutical Industries Ltd.’s (TEVA) ProAir HFA asthma inhaler.

“I do think there’s a little bit more rigor around what constitutes value in health care,” said Tim Heady, chief executive of UnitedHealth Group Inc.’s (UNH) Pharmaceutical Solutions unit.

The UnitedHealth unit has placed Effient on the third tier of its preferred-drug list, which means members pay a higher copay for Effient than for other drugs listed on the first or second tiers, partly because of the bleeding risk.

Ronika Pletcher, head of Lilly’s investor relations, acknowledged Monday the uptake of Effient was slower than planned, but told analysts on a conference call the company was encouraged by recent signs of demand. The company has honed its marketing pitch to focus on certain patient populations for which Effient is a good choice, such as diabetics. Lilly also has conducted research to support its cost-effectiveness.

In some cases, new launches are hampered if a drug isn’t the first of its kind to reach the market. That appears to be the case with Onglyza, a diabetes drug launched last year by Bristol-Myers Squibb Co. (BMY) and AstraZeneca. Its modest sales since launch have contrasted with the quick uptake for Merck & Co.’s (MRK) Januvia, which was the first of its kind and had a three-year head start.

“It’s increasingly challenging to successfully differentiate your next-in-class product,” said BMO Capital Markets analyst Robert Hazlett.

Drug makers have adjusted, shifting resources from sales representatives who call on doctors to reps who pitch to insurers. Some have narrowed the focus of their research-and-development efforts to searching for treatments for diseases with high unmet medical needs, like Alzheimer’s disease and cancer. Breakthroughs in these areas are less likely to face obstacles to brisk launches.

“All the drug companies are experiencing the same phenomenon,” Bristol-Myers Chief Executive James Cornelius said in a recent conference call with reporters. “We, with others, are experimenting with our marketing mix to get faster product uptake.”

www.Medtipster.com Source: Wall Street Journal, April 20, 2010

Drug companies sharply raised prices last year, ahead of increased rebates they must pay to Medicaid and other expenses tied to the federal health overhaul passed last month.

Prices for brand-name pharmaceuticals rose 9.1% last year, the biggest increase in at least a decade, according to pharmacy-benefit manager Express Scripts Inc., which included the recent number in its annual drug-trend report. The boost for specialty drugs, a category that is largely biotech products, was even sharper: 11.5%. In 2008, the price rise had been 7.4% for traditional pharmaceuticals, and 9.4% for specialty drugs.

Some individual drugs saw double-digit increases in the first quarter compared with a year earlier, including 12.1% on Zetia, a cholesterol drug from Merck & Co., and 13.6% for Cymbalta, an antidepressant from Eli Lilly & Co., according to data from Credit Suisse. The firm, which tracks the pricing of brand-name drugs made by the biggest U.S. manufacturers, found wholesale prices went up 7.8% in the first quarter, compared with a year earlier.

The increases were “exacerbated by the health-care reform debate,” said Steve Miller, senior vice president and chief medical officer of Express Scripts, although drug makers disputed that notion.

An Eli Lilly spokesman said its pricing policies last year weren’t affected by the health bill, and such decisions take into account benefits for patients as well as “marketplace conditions and recovery of our R&D costs.”

But Lilly did caution shareholders Monday that rebates to Medicaid, as well as other provisions in the law, would lower its 2010 revenue by $350 million to $400 million, and 2011 revenue by $600 million to $700 million.

A Merck spokesman said its “price adjustments are independent of health-care reform,” and are instead driven by an approach that aims to “ensure patient access and enable Merck to invest in research and development.”

Zetia’s pricing for most of last year was controlled by an independent joint venture involving Merck and Schering-Plough Corp., which are now merged, the company added. Both Merck and Lilly said the pricing numbers didn’t reflect the effects of rebates and discounts granted to many health-care payers.

The health law will also require the drug industry to knock off half the price paid by Medicare beneficiaries in their “doughnut hole” coverage gap starting in 2011, among other expenses, though the pharmaceutical companies will also benefit from an influx of newly insured consumers that will kick in later.

The effects of the price increases on overall drug spending are being tempered by the availability and aggressive promotion of cheaper generic alternatives, among other factors.

In its report, which reflects the drug benefits it administers for corporate clients, Express Scripts also said drug spending went up only 6.4% in 2009, slightly more than last year but lower than five years earlier.

Indeed, a report this month from IMS Health said that the number of prescriptions dispensed for generic drugs rose 5.9% last year, but those for branded drugs fell 7.6%.

Overall spending on prescription drugs rose just 5.1% according to IMS, which looks at different data than Express Scripts.

Another reason for price increases is probably that insurers, employers and pharmacy-benefit managers have become “much more difficult gatekeepers,” said Credit Suisse analyst Catherine Arnold. Discounts and rebates used to promote branded drugs precipitate price increases to offset those marketing costs.

Also, as drugs go generic, companies mark up the prices of the brand-name versions, assuming that patients who stick with those “are the people for whom price doesn’t matter,” said Mark McClellan, who formerly oversaw the Medicare and Medicaid programs for the Bush administration and is now at the Brookings Institution.

Express Scripts, which is based in St. Louis and has 36 million people in its commercial client group, said the actual drug-spending increase — as opposed to the price markup — was 4.8% for traditional pharmaceuticals, to $800.23 per member per year, and 19.5% in specialty drugs, to $111.10 per member per year.

Big increases in spending occurred in several areas, including diabetes, driven by the growing number of people diagnosed with the disease, and antiviral drugs, due to flu concerns.

The pharmacy-benefit manager said its clients were able to help keep the increase in check through use of generics and other moves. But it argued that, across the entire U.S. market, there could be significantly greater health-care savings tied to how drugs are taken.

The company estimated the savings at $163 billion a year, which could be achieved with greater use of generics and better adherence by patients prescribed drugs, both tactics that Express Scripts pitches to clients as among services it can provide.

www.Medtipster.com Source: Journal of the American Medical Association. Vol. 303 No. 14, April 14, 2010, JAMA Abstract

Metformin is the recommended initial drug therapy for patients with type 2 diabetes mellitus (DM). However, the optimal second-line drug when metformin monotherapy fails is unclear.

The study followed 11,198 individuals for an average of 32 weeks.  Researchers sought to determine the comparative efficacy, risk of weight gain, and hypoyglycemia associated with noninsulin antidiabetic drugs in patients with type 2 DM not controlled by metformin alone.  Data used included duration of patient follow-up; drug, dose, and schedule used; use of concurrent lifestyle modification; and baseline characteristics (age, sex, anthropometrics, glycated hemoglobin A1c [HbA1c], duration of DM, and metformin dose). End points collected included mean change in HbA1c, proportion of patients achieving HbA1c goal of less than 7%, change in weight, and incidence of hypoglycemia.

Study findings

• Although use of thiazolidinediones, sulfonylureas, and glinides were associated with weight gain (range, 1.77-2.08 kg, approximatley 2 to 4 lbs.),
• glucagon-like peptide-1 analogs, -glucosidase inhibitors, and dipeptidyl peptidase-4 inhibitors were associated with weight loss or no weight change.
• Sulfonylureas and glinides were associated with higher rates of hypoglycemia than with placebo.

Researchers conclude that when added to maximal metformin therapy, all noninsulin antidiabetic drugs were associated with similar HbA1c reductions but differed in their associations with weight gain and risk of hypoglycemia.

www.Medtipster.com Source: Managed HealthCare Executive, April 16, 2010

Survey: employers to encourage generic medications

CVS Caremark has announced the results of its annual employer client benefit survey about priorities for pharmacy benefit management (PBM) services in the coming year. The majority of employers surveyed (94%) said they will seek opportunities to improve savings even more in 2010, while they look for ways to improve the overall member experience. Employers listed price (86%), customer service (86%), trust and reliability (84%) and consumer engagement capabilities (46%) as key priorities for their PBM procurement strategy.

The economic environment continues to impact companies, with 66% of respondents answering that reducing overall healthcare costs is their No. 1 success measure, says Jack Bruner, executive vice president, Strategic Development, CVS Caremark Pharmacy Services.

Survey results show that the majority of employer clients are strongly considering adopting some of the more progressive strategies to encourage the use of lower-cost generic medications. For example, almost half of employers surveyed are considering implementing plan designs that require using a generic medication first before moving to a branded drug (50%) and those that provide members a co-pay waiver to switch to generic medications (56%).

“For our book of business, approximately 35% of brand-spend medications have a generic opportunity,” says Bruner. “Our strategy is to focus on specific therapeutic classes (e.g., proton pump inhibitors, HMG reductase inhibitors, angiotensin II receptor blockers, hypnotic sleep aids, migraine agents, nasal steroids, non-sedating antihistamines, selective serotonin reuptake inhibitors, etc.) where ample generics are available.

According to the survey, a majority of employer clients (88%) and health plan clients (97%) are taking an aggressive or moderate approach toward maximizing generic dispensing in key therapeutic classes as a strategy to increase savings opportunities.

Through 2012, nearly 30 brand-name medications in a variety of classes are expected to become available as generics, including some popular drugs such as Lipitor for treating high cholesterol, according to Bruner.

“We anticipate this will have an impact on opportunities for increasing generic dispensing rate for our clients, resulting in increases savings for clients and their members,” he says.

Bruner expects the rate of employees actually taking advantage of generic substitution/lower-cost alternatives to vary depending on the type of intervention program that is implemented.

“For example, if a client adopts a mandatory generic use program such as step therapy, we see greater than 80% brand to generic substitution/conversion within a therapeutic class,” he says. “If the client implements a generic co-pay waiver to incent brand users to switch to generics, the behavior change rate is less than 10%. However, when a pharmacist counsels a patient at retail or mail about a generic opportunity, the conversion rate is over 30%.”

Compared to the 2009 survey results, the survey found there has been an increase in employers who are adopting or considering solutions to improve medication adherence. In particular, many employer clients are considering programs that impact adherence through counseling and intervention with the member, including: counseling to improve adherence the first time a member fills a maintenance medication (62%), outreach to prescribers to resolve gaps in care (56%) and outreach to members and prescribers to provide counsel about therapy drop-off (65%).

The CVS Caremark client survey was conducted online from Oct. 5, 2009 through Dec. 31, 2009 and includes responses from current CVS Caremark clients representing 285 employers.

www.Medtipster.com Source: Los Angeles Times, 04/09/2010

For many of the one-in-three American adults who have high blood pressure, a cheaper alternative to brand-name medications is about to become available.

Losartin, the angiotensin II receptor blocker marketed under the brand names Cozaar and Hyzaar (the latter of which combines losartin with the diuretic hydrochlorothiazide) for more than a decade, will become available in generic formulations, following a Food and Drug Administration decision announced this week.

Four drugmakers have won the FDA’s blessing to make and market the hypertension drugs in generic forms.

Wasting no time, the first company to receive broad FDA approval to market the generic drug, Teva, announced yesterday the launch of its losartin potassium-film-coated tablets in 25-milligram, 50-milligram and 100-milligram strengths.

If you’re a patient being treated with other brand-name angiotension receptor blockers for hypertension — Atacand, Avapro and Diovan — you may have to wait for less expensive drugs.

Atacand won’t be available in generic form before 2011 at the earliest, and Avapro and Diovan are not expected to reach the market in generic form before 2012.

The FDA’s Office of Generic Drugs states flatly that generic drugs are the same as the brand-name first-to-market drugs they copy — same active ingredient, same means of action, same safety and effectiveness profile — they’re just much cheaper. But the formulations in which those active ingredients are packaged do change when they are reproduced as generics.

For a very small number of people and with a few types of drugs, pharmacologists acknowledge that that can make a difference in how — or even how well — a drug works.

So, if the size, shape, color or brand marking of your regular prescription blood pressure medication changes in the next few months (and if it suddenly becomes less expensive), rejoice over your lower bill. But also, be sure to ask the pharmacist if you have been switched to a generic version of the drug your physician originally prescribed.

And for a couple of weeks after switching to a generic, check your blood pressure a bit more regularly to make sure your hypertension is still under control with the medication.

One more warning: There are five other classes of medications used to treat high blood pressure, and all do so by different means than the angiotension II receptor blockers.

Insurance companies and pharmacy benefits managers are aggressive in trying to switch patients to a new generic drug if it can save money, even if it means switching a patient to a new class of drugs.

The practice is called therapeutic substitution. Sometimes, it can often save you money while managing your condition just fine.

But for some individuals, another class of medication won’t work as well or may not be recommended.

Again, ask your pharmacist if you don’t recognize the medication you’re getting, and check with your physician if the switch is something you haven’t discussed.

Meijer Pharmacies To Dispense Metformin Immediate Release At No Cost To Prescription Holders

Type 2 Diabetes Treatment Added To The Meijer Free Antibiotics And Free Pre-Natal Vitamins Programs

Meijer announced plans to begin offering Metformin Immediate Release, the most commonly prescribed treatment for type 2 diabetes, at no cost to those with a medical prescription. Meijer’s program will include doses prescribed in 500mg, 850mg and 1000mg tablets.

According to American Diabetes Association estimates for 2007, more than 24 million Americans have diabetes, with type 2 diabetes accounting for 90-95 percent of all cases.  

Diabetes is a disease that has no cure. Currently, more than 80 million American children and adults have some form of diabetes. The Centers for Disease Control and Prevention estimates that one in three children born today will develop diabetes in their lifetime. The numbers are even worse for minorities.

Metformin Immediate Release is now believed to be the most widely prescribed anti-diabetic drug in the world. In 2008, more than 80 million prescriptions for Metformin were filled in the United States alone.

Meijer’s addition of Metformin Immediate Release to its free medication program comes just weeks after Florida-based grocer Publix led the industry by announcing it would provide free Metformin prescriptions in its pharmacy.

Find a Meijer Pharmacy carrying free Metformin at: www.medtipster.com

www.medtipster.com blog article source: www.nytimes.com – Author: Jackie Calmes

Health Secretary Warns of Insurance Scams

The secretary of health and human services, Kathleen Sebelius, wrote to state officials on Tuesday to urge that they take action against “scam artists” reportedly marketing fake insurance policies to exploit the new law overhauling the health care system.

“Unfortunately, scam artists and criminals may be using the passage of these historic reforms as an opportunity to confuse and defraud the public,” Ms. Sebelius said in a letter to state insurance commissioners and attorneys general.

In the letter and in a speech at the National Press Club, she described reports of people setting up toll-free telephone numbers and going door-to-door peddling phony policies, in some cases falsely claiming that the new law established a limited enrollment period for buying government-subsidized insurance.

Ms. Sebelius compared the alleged scams to reports during the H1N1 flu epidemic of sales of counterfeit flu treatments, and called on the state officials to investigate and prosecute any reported cases of insurance rip-offs.

She also said her department was alerting seniors groups to beware of fraudulent sales pitches. The insurance exchanges to be established under the law do not take effect until 2014, although states can get federal aid in the meantime to set up insurance pools for high-risk individuals to buy policies more cheaply than they can on their own.

In her speech, Ms. Sebelius described additional steps that her department is taking this week to implement the health insurance overhaul that President Obama signed into law last month. The department is issuing guidelines for private Medicare Advantage plans to include cost-sharing protections for seniors and new options for Medicaid to cover low-income adults.

She also announced a “Medicare dashboard” on the department’s Web site where users can search Medicare data on spending for inpatient hospital care and sort it by state, hospital and condition “to give consumers, purchasers and providers the health information they need to make smarter choices.”

www.medtipster.com blog article source: www.drugstorenews.com – author: Alaric DeArment

U.S. Drug Sales Saw Growth In 2009, IMS Health Says

Pharmaceuticals appear to be slowly making a comeback, as 2009 saw drug sales almost three times as high as in 2008, according to a new report by IMS Health.

IMS reported 5.1% sales growth in ethical pharmaceuticals and insulins through retail and nonretail channels, with sales reaching $300.3 billion, compared with 1.8% growth in 2008.

“In 2009, demand for pharmaceuticals proved stronger than in the prior two years, yet remained at historically low levels,” IMS SVP Healthcare Insight Muray Aitken said. “While the 32 innovative products launched last year brought important new treatment options to patients in a number of disease areas – including cancer, thrombosis and atrial fibrillation – they drove only a limited increase in drug spending. Access for the first time to lower-cost generic treatment options in the areas of epilepsy, migraine and immune system disorders had a more moderate impact on market growth than generic launches in previous years.”

Greater use of specialty drugs accounted for much of the growth, growing 7.5% last year and now constituting 21% of U.S. market value, and sales of monoclonal antibodies for treating cancer – such as Genentech’s Avastin (bevacizumab) and Herceptin (trastuzumab) and Rituxan (rituximab), by Genentech and Biogen Idec – grew by 9%.

Meanwhile, economic conditions didn’t dampen demand for prescription drugs, as the volume of dispensed prescriptions grew by 2.1%, to 3.9 billion, compared with 1% growth in 2008; while the volume of new therapy starts in 17 major chronic disease areas declined by around 1%, the volume of add-on therapy starts, switches and refills rose by almost 2%. Use of generic drugs has continued to rise, and generics now represent 75% of all dispensed prescriptions in the United States, with the total number of prescriptions having increased in 2009 by 5.9%.

“The greater availability of generic options, growing differentials in co-pays between brands and generics and efforts by patients, insurers and employers to encourage appropriate use of lower-cost alternatives were all factors in the changing mix of medicines used in patient treatment last year,” Aitken said.

Prescription sales of antipsychotics remained unchanged compared with 2008, at $14.6 billion, but the class remained the top-selling one in the United States. Measured by dispensed prescription volume, lipid regulators remained the largest therapy class, with prescriptions growing by 5%, to 212 million. At the same time, proton-pump inhibitors replaced lipid regulators as the second-largest therapeutic class in terms of sales, with sales of $13.6 billion, though that represented a 2% year-over-year decline. Lipid regulators had sales of $13.1 billion, a 10% decline from 2008 that resulted from an ongoing shift to generics.

WHAT IT MEANS AND WHY IT’S IMPORTANT

The uptick in prescription drug sales growth may or may not be yet another indicator of improvement in the U.S. economy, but it is, without a doubt, indicative of a return to growth for the prescription drug market and, by extension, an indicator of growth among retail pharmacies.

When IMS Health reported that prescription drug sales had $300.3 billion in sales in 2009, a 5.1% increase over 2008, the figure included every distribution channel. But the bulk of those sales, $164 billion, were through retail channels, including retail pharmacy chains, independents and supermarket pharmacies.

The biggest increase between 2008 and 2009 was in chain stores, which saw a 3.6% increase in prescription drug sales, from $101.8 billion to $105.5 billion. Sales in supermarkets increased by 1.4%, from $20.9 billion to $21.2 billion. Meanwhile, independents had a 2.1% decrease, from $38.1 billion to $37.3 billion. A similar trend appears when figures for dispensed prescriptions are broken down by distribution channel, with a large increase in chain stores, a smaller increase in supermarkets and a decrease in independents.

Sales of specialty drugs went up as well. With $8 billion in sales, compared with $7.5 billion in 2008, monoclonal antibodies for treating cancer rank sixth in IMS’ list of the top 15 therapeutic classes, compared with their seventh-place ranking last year. Biotech drugs for treating arthritis and inflammatory diseases rank eighth and fourteenth, respectively, though erythropoietins, for treating anemia, had a $900 million decrease in sales.

IMS doesn’t have a specific category for the specialty channel, but it does have them for mail service and home health care, two channels used extensively by specialty pharmacies. Though drug sales through the home healthcare channel had a slight decrease, from $2.6 billion in 2008 to $2.5 billion in 2009, mail-service sales increased from $46 billion to $51.5 billion, placing the channel in second place, below retail pharmacy chains, even though it ranked last when measured by U.S. dispensed prescriptions, which also decreased slightly, from 238.4 million in 2008 to 237.5 million in 2009.