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Michigan Based Retail Pharmacy, Meijer, Offers Generic Cholesterol Reducing Prescription Drug, Lipitor, For Free

September 04, 2012 By: Nadia Category: Cholesterol, Free Prescriptions, HealthCare, Medtipster, Prescription News, Prescription Savings

www.Medtipster.com Source: Drugstore News, 9.4.12 – By Alaric Dearment

In what could symbolize the so-called “patent cliff” that an executive from healthcare market research firm IMS Health spoke of at a recent trade show, a regional mass merchandise chain is taking what used to be the world’s top-selling drug and giving it away for free.

Meijer announced Tuesday that it would offer generic versions of Pfizer’s cholesterol drug Lipitor (atorvastatin calcium) for free at all of its 199 pharmacies, saying it would be the first retailer in the Midwest to offer such a program. The program is the fourth free-drug program offered by the retailer over the last six years.

“We’re pleased to announce that our customers will now be able to fill their generic cholesterol-lowering atorvastatin calcium prescriptions for free in all of our pharmacies,” co-chairman Hank Meijer said. “In keeping with our commitment to provide low-cost solutions for the families we serve, the free cholesterol-lowering medication program is another way to help the customers who rely on our pharmacies.”

Before it lost patent protection, in November 2011, Lipitor had sales exceeding $7 billion per year in the United States. Ranbaxy Labs was the first to launch a generic version when the drug’s patents expired, and Ranbaxy’s own market-exclusivity period expired in May of this year. At the National Association of Chain Drug Stores’ Pharmacy and Technology Conference last month, IMS VP industry relations Doug Long said during a presentation that “We’re in the teeth of the patent cliff,” which refers to a period taking place over the next few years when a wave of expirations of several top-selling drugs’ patents will occur, eventually leaving many therapeutic indications such as cholesterol heavily commoditized and dominated by multiple generics.

“This initiative will have a huge impact because the cost of pharmaceuticals is frequently a barrier to getting appropriate treatment,” West Michigan Heart cardiologist and Spectrum Health Meijer Heart Center Cardiac Catheterization Labs director David Wohns said. “The biggest way to reduce the risk of heart disease comes from treating cholesterol. To have that drug available for free has the ability to impact countless lives.”

How Much Money Will Generic Lipitor Save?

January 03, 2012 By: Nadia Category: Cholesterol, HealthCare, Medicine Advice, Medtipster, Prescription News, Prescription Savings

www.Medtipster.com Source: Wall Street Journal – Katherine Hobson, 12.12.11

We’ve written about some of the most common consumer questions about the newly launched generic version of Pfizer’s cholesterol-lowering Lipitor.

One remaining question is how much money will be saved from the generic iterations of the name-brand blockbuster — the U.S. sales of which were $7.8 billion in the year ended Sept. 30, according to IMS Health.

A group of researchers takes a stab at that issue in a perspective piece published online by the New England Journal of Medicine. Their conclusion: “the overall cost savings from the availability of generic atorvastatin are projected to reach $4.5 billion annually by 2014, equivalent to 23% of total expenditures on statins in that year.” (The aging population could mean another $30 million of cost savings annually by 2014, they note.)

To make their calculations, they looked at what happened after Merck’s Zocor lost patent protection in 2006, and also considered how the aging of the population would drive future demand for statin drugs. They predict that generic atorvastatin will “dominate the statin market as a result of patients’ switching to it from simvastatin [generic Zocor] and from [AstraZeneca’s] Crestor, and it will have an estimated market share of 44% by 3 years after market entry.”

The researchers, from institutions including the Western University of Health Sciences and Yale University, project that the price of generic atorvastatin will be 82% of the pre-generic Lipitor at the time of market entry and 49% of the brand-name after the first six months.

However, these projections come with an asterisk: they “estimate what would happen with the rapid availability and timely uptake of generic atorvastatin.” The researchers say “aggressive business tactics” used by Pfizer to keep people using name-brand Lipitor, including deals with pharmacy-benefit managers and discounts to patients, may prevent switches to the generic.

“In order to capitalize on this opportunity for cost savings from the expiration of Lipitor’s patent, there must be a rapid, concerted effort by many players in the health-care system to facilitate awareness of and access to the generic,” they write.

Generic Drug Delay Fight May Be Nearing Turning Point

June 21, 2010 By: Nadia Category: HealthCare, Medtipster, Prescription News, Prescription Savings

Generic Drug Delay Fight May Be Nearing Turning Point, FTC’s Leibowitz Says
06/21/2010
www.Medtipster.com Source: Bloomberg News – Washington DC Bureau

The U.S. government’s decade-long fight to limit drugmakers’ ability to keep generic medicines off the market may reach “a turning point” soon, Federal Trade Commission Chairman Jonathan Leibowitz said.

The FTC is counting on a review by an appeals court to break a deadlock over agreements made by brand-name drugmakers that it says delay the introduction of lower-priced generic medicines. The focus is on the 2nd U.S. Circuit Court of Appeals in New York, which may decide by August whether to review a deal between Bayer AG and Teva Pharmaceutical Industries Ltd.’s Barr unit on when a generic version of the antibiotic Cipro can go on the market.

The Cipro case “signals a renewed concern about these pay-for-delay deals, and hopefully it will mark a turning point towards a legal rule that prohibits brand pharmaceutical companies from paying off their generic competitors to sit it out,” Leibowitz, 52, said in an interview. The review could bring the issue of agreements before the Supreme Court.

The fight pits drugmakers against the FTC, the Justice Department, pharmacies such as CVS Caremark Corp. and President Barack Obama, who cited the greater availability of generic drugs as a way to reduce health-care costs. There also is an effort in Congress to restrict the settlements.

Licensing Deals

The FTC contends brand-name makers offer generic-drug companies licensing rights on a product or other compensation in exchange for an agreement on when cheaper drugs are introduced. The agency said it supports settlements, except when there is some sort of financial consideration.

Medicines that generate about $92 billion in sales will face generic competition through 2014 because of expiring patents, according to the research firm IMS Health Inc. Medicines accounted for $250.3 billion in U.S. sales for brand- name drugmakers in 2009 and $35.8 billion for generic firms, according to Norwalk, Connecticut-based IMS.

Defending valid patents is vital, said Jerry Pappert, general counsel of Frazer, Pennsylvania-based Cephalon Inc. “If the branded company loses, it loses its franchise.”

Cephalon is being sued by the FTC, which contends the drugmaker paid more than $200 million for generic companies to drop their challenge to patents on its sleep-disorder drug Provigil. Cephalon says the settlements are in accordance with patent law.

No Delay

In the Cipro case, CVS and other pharmacies said Bayer paid $398.1 million for Barr to drop its patent challenge. David Stark, general counsel for Teva’s North America unit, said generic-drug makers aren’t delaying marketing products as a result of financial incentives. The agreements are no different than patent deals in other industries, he said.

Leibowitz said the agreements add to health-care costs. If some settlements between companies aren’t prohibited, “you’re going to pay seven, eight, 10 times as much as you otherwise would,” he said. The FTC said the deals cost consumers $3.5 billion annually, a figure disputed by economists such as Jonathan Orszag, senior managing director at the economic consulting firm Compass Lexecon in Washington and the brother of White House Budget Director Peter Orszag.

Courts have allowed the settlements as long as they don’t prevent entry of the generic beyond a patent’s lifespan.

In the Cipro case, the agreement allowed a generic drug to be sold six months before the patent expired, said Kathleen Jaeger, chief executive officer of the Generic Pharmaceutical Association, a Washington trade group.

‘Tremendous Value’

“The FTC doesn’t see the tremendous value the patent settlements have brought to the system,” she said.

Since February, courts have thrown out antitrust lawsuits over Bristol-Myers Squibb Co.’s blood-thinner Plavix and AndroGel, a testosterone ointment now made by Abbott Laboratories. The FTC lost a case over a settlement involving Schering-Plough Corp.’s K-Dur heart medication.

A three-judge panel in April upheld the Cipro settlement, though it recommended opponents seek a review by the full court.

The potential court review, along with legislation Leibowitz predicted Congress would pass this year, add momentum to efforts to limit deals. Senators Herb Kohl, a Wisconsin Democrat, and Charles Grassley, an Iowa Republican, introduced an anti-deal measure. House legislation would bar the settlements.

‘Winds Are Shifting’

“The winds are shifting on the legal front, shifting on the commission front and on the legislative front,” said Robert Doyle, a former FTC official.

Ken Johnson, a senior vice president at the Pharmaceutical Research and Manufacturers of America, a Washington trade group, said brand-name drug companies need patent protection to justify the investments required to develop medicines. Drugmakers said the settlements also provide certainty as to when generics will enter the market.

Stark said a court review may not be significant.

“I don’t think it’s a foregone conclusion just because they take it up that they reverse the trend,” he said.

Marcy Funk, a spokeswoman for Leverkusen, Germany-based Bayer, declined to comment.

All parties are watching if the 2nd Circuit agrees to hear the Cipro case. The decision may come in August, said David Balto, a lawyer representing consumer groups.

Leibowitz said he believes the FTC has a strong hand. “I have yet to see an issue that’s as black and white,” he said.

The 2nd Circuit case is In Re Ciprofloxacin Hydrochloride Antitrust Litigation, 05-2851 and 05-2852, 2nd U.S. Circuit Court of Appeals (New York).

Slow Uptake Of New Drugs Clouds Industry Outlook

April 22, 2010 By: Nadia Category: Medicine Advice, Medtipster, Prescription News, Prescription Savings

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.”

U.S. Drug Sales Saw Growth In 2009; Indicate Economy’s Comeback

April 05, 2010 By: Nadia Category: Medtipster, Prescription News

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.

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