The Official Medtipster Blog

www.Medtipster.com Source: Drug Channels, 3/6/2013

Express Scripts just released the latest iteration of its long-running Drug Trend Report. This year’s report includes both Express Scripts and legacy-Medco covered lives, so it’s the most comprehensive look at pricing and utilization.

Study findings

• Specialty drug trend of 18.4% dominated traditional drug trend of -1.5%.
• Drug trend for traditional drugs fell to a record-low -1.5%, due largely to the growing substitution of less-expensive generic drugs.
  • Utilization increased by 0.6%, but costs decreased by 2.2%.
• Drug trend for specialty drugs was 18.4%, consistent with its high growth rate over the past six years.
  • Utilization decreased by 0.4%, while costs increased by 18.7%.
• Specialty spending is concentrated in a few conditions. For traditional drugs, treatments for the top three conditions of diabetes, high blood cholesterol, and high blood pressure–accounted for 30% of total per-member, per year (PMPY) spend.
• For specialty drugs, treatments for the top three conditions–inflammatory conditions, multiple sclerosis, and cancer–accounted for 58% of total PMPY spend.
• Trend reflects two primary components
• Change in Utilization (the total quantity of drugs obtained by plan members)–Utilization varies with changes in the number of plan members on drug therapy, the degree to which plan members are adherent to their drug therapy, and a change in the average number of days of treatment.
• Change in Unit Costs–Unit costs vary with:
• 1) the rate of inflation in brand-name drugs prices,
• 2) shifts to different drug options within a therapeutic class,
• 3) a shift in mix of therapeutic classes utilized by plan members, or
• 4) the substitution of generic drugs for brand-name drugs.

www.Medtipster.com Source: US Government Accountability Office, January 31 2012

What GAO Found

Our review identified articles that used varying approaches to estimate the savings associated with generic drug use in the United States. One group of studies estimated the savings in reduced drug costs that have accrued from the use of generics. For example, a series of studies estimated the total savings that have accrued to the U.S. health care system from substituting generic drugs for their brand-name counterparts, and found that from 1999 through 2010 doing so saved more than $1 trillion. A second group of studies estimated the potential to save more on drugs through greater use of generics. For example, one study assessed the potential for additional savings within the Medicare Part D program—which provides outpatient prescription drug coverage for Medicare—and found that if generic drugs had always been substituted for the brand-name drugs studied, about $900 million would have been saved in 2007. A third group of studies estimated the effect on health care costs of using generic versions of certain types of drugs where questions had generally been raised about whether substituting generic drugs for brand-name drugs was medically appropriate. Unlike the other two groups which focused on savings on drugs only, these studies compared savings from the lower cost of generic drugs to other health care costs that could accrue from their use, such as increased hospitalizations. The studies had mixed results regarding the effect of using these generics in that some found they raised health care costs, while others found they led to cost savings.

Why GAO Did This Study

Prescription drug spending in the United States reached $307 billion in 2010—an increase of $135 billion since 2001—and comprised approximately 12 percent of all health care spending in the country. Until the early 2000s, drug spending was one of the fastest growing components of health care spending. However, since that time, the rate of increase has generally declined each year, attributable in part to the greater use of generic drugs, which are copies of approved brand-name drugs. Generic versions of brand-name drugs become available to consumers when brand-name drugs’ patents and periods of market exclusivity expire and generic manufacturers obtain approval to market their drug. The competition that brand-name drugs face from generic equivalents is associated with lower overall drug prices, particularly as the number of generic manufacturers grows and price competition among them increases. On average, the retail price of a generic drug is 75 percent lower than the retail price of a brand-name drug.

Increased use of generic drugs can partly be attributed to the regulatory framework that was established in the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act. The Hatch-Waxman Act facilitated earlier, and less costly, market entry of generic drugs, while protecting the patent rights of brand-name drug manufacturers, to encourage continued investment in research and development. When the act was enacted in 1984, the generic utilization rate—which is the share of all drugs dispensed that are generic—was about 19 percent. Today it is about 78 percent for drugs dispensed in retail settings, such as independent, chain, and mail-order pharmacies, as well as in long-term care facilitates. The generic utilization rate is expected to continue to grow over the next few years as a number of blockbuster drugs come off patent through 2015.

For a complete copy of the GAO report, visit: www.gao.gov/assets/590/588064.pdf

www.Medtipster.com Source: WalletPop.com, by Barbara Thau – 2.15.2011

As the economy still muddles through a funk, the price of prescription drugs continues to soar. in fact, drug prices are the fastest growing chunk of consumers’ healthcare expenses, according to the non-profit Families USA.

But there are myriad ways to meaningfully trim your prescription drug bill. From generic drugs to assistance programs — here’s how to save on your meds — and do so safely.

Avoid Brand Names

To slash as much as 70% off the price of your medications, buy generic.

“If you are given a prescription for a brand name drug from your doctor, it’s always good to ask, ‘Is there a generic equivalent for this drug?’ ” says Jody Rohlena, senior editor at Consumer Reports’ ShopSmart.

A recent report by Best Buy Drugs, a division of Consumers Union (Consumer Reports’ parent company), examined the safety and effectiveness of prescription medications and found that generics are as safe and effective as brand names.

Tap Low-Cost Prescription Programs (Located On Medtipster.com)

Take advantage of the price war being waged among national discounters and supermarket chains for generic prescription medications.

Walmart, Target and Kroger charge $4 for a month’s supply on hundreds of generic drugs. Some other options, recommends ShopSmart, include Costco, Kmart, Drugstore.com and Walgreens, which also run reputable and highly-affordable discount drug programs.

To save a few extra dollars, ask your doctor for 90-day prescriptions. Walmart, for example, offers $4 for a month’s supply and $10 for a 90-day supply. With buying in bulk, the savings will add up as you fill more prescriptions and it will also save you trips to the drugstore.

‘Splitting’ the Cost

If you take prescription drugs to treat a chronic illness, you might be able to save money by splitting your pills — literally cutting them in half. With prescription medication costs soaring, many doctors are advising patients to do just that.

Pill-splitting can save money because pharmacies routinely charge roughly the same amount for a particular medication, regardless of the dose. But don’t go it alone: It’s crucial to consult your doctor about splitting your pills as not all medicines can be safely divided.

For example, a once-a-day drug may cost $100 for a month’s supply in either a 100-milligram dose or a 50-mg dose. If your doctor prescribes the 50-mg pill, it will set you back $100. But if your doctor prescribes the 100-mg pill and instructs you to cut it in half, $100 will get you two months worth of the medication, according to The Shoppers Guide to Prescription Drugs: Pill Splitting, a report from Best Buy Drugs.

Pill-splitters cost between $5 and $10 and can be found in most drugstores.

Although the American Medical Association opposes the practice, they acknowledge that many pills can be split safely if done correctly, the Best Buy Drugs report says.

Ask for Help

If you’re having trouble paying for medication, let your doctor know.

A physician can help spell out your options, such as financial help through your insurer, if you have one, and patient-assistance programs that you might qualify for.

Some pharmaceutical companies also provide free and low-cost medications to people who cannot afford to pay for medications.

RxAssist offers a database of such programs, as well as ways to manage your prescription drug expenses. DestinationRx is another source, with price comparison tools and guidance on drug-purchasing options.

Rx Savings for Seniors

The quest for affordable medication takes on a heightened sense of urgency when it comes to seniors: Most seniors are on a fixed income and are among the biggest consumers of prescription drugs, representing 34% of the prescriptions filled in the U.S., according to Families USA.

High costs mean that many seniors “have had to make some tough decisions in terms of taking their medicines,” says David Allen, a spokesman for AARP.

Now the government is offering some relief. A provision in the new healthcare law is designed to take a bite out of what’s known as “the doughnut hole,” and over time close the coverage gap on prescription medications.

As things were last year, once seniors spent $2,830 on medication, they had to pay 100% for their prescriptions until they reached the $3,610 threshold — a financial hardship for many older Americans. Now, when they reach the $2,830 threshold, the government will chip in 50% of the cost for brand-name drugs and 7% for generics, Allen says. By 2020, the doughnut hole will cease to exist, says Allen.

If you’re on Medicare, keep track of your particular prescription costs with AARP’s Doughnut Hole Calculator.

Use it to alert you when you’re nearing the coverage gap. It also will offer a list of alternative, lower-cost drugs based on your prescription drug profile that you can take to your doctor to discuss whether switching to a lower-cost drug will work for you.

In addition, AARP provides a handy Drug Savings Tool link where consumers can compare a drug’s efficacy and price against alternative medications listed by Best Buy Drugs.

Buyer Beware: Pharmacy Fraud

Pharmacy fraud is alive and well and living on the Internet. Scam artists are there seeking money, or personal information to commit identity theft.

These types of predators mostly hunt their prey online, says Sally Hurme, senior product manager of education and outreach for AARP, who tracks pharmacy scams that target the entire drug-purchasing population.

When an online offer seems too good to be true, it probably is. An email offer for prescription medications at bargain basement prices (that does not come directly from a well-known retailer or your health insurance company) is most likely a scam, Hurme says. And email that says “Viagra for $10″ or “Prilosec for $5,” for example, should go right in your email trash — chances are that it will wind up in your spam folder anyway.

Scam artists often masquerade as online pharmacists. They woo consumers to pay upfront in exchange for a supposed drug discount card. Shoppers who “order” their medications receive nothing at all, or drugs that are compromised in some way — be they expired or at the wrong dosage.

Be skeptical. Before filling a prescription online, be sure that the pharmacy requires a doctor’s prescription. And never provide your personal information — such as your Social Security number, credit card or health history — to a website unless you’ve verified that it’s secure, says AARP.

www.Medtipster.com Source: www.post-gazette.com, 12.16.2010

Generic-drug companies, led by Teva Pharmaceutical Industries, would face fewer factory inspections and save as much as a year developing products in exchange for paying fees for the first time under a Food and Drug Administration proposal.

The plan grew out of talks between the FDA and drug makers to speed reviews of low-cost copies of medicines, according to Russell Wesdyk, scientific coordinator in the FDA’s Office of Pharmaceutical Science.

Generic-drug reviews take 15 months longer on average than evaluations of brand-name products, according to the Generic Pharmaceutical Association, a Washington lobbying group. Inspections take as many as 12 months to complete, especially for products made outside the U.S., said Richard Stec, vice president of global regulatory affairs with Perrigo Co., an Allergan, Mich.-based member of the trade group.

“Getting the inspection scheduled in a timely manner is probably the biggest challenge both for FDA and for industry,” Mr. Stec said.

The FDA may waive “preapproval inspections” done after companies submit generic-drug applications, Mr. Wesdyk said last Thursday. Instead, it would rely on periodic inspections that focus on firms’ broader manufacturing practices.

The agency would still carry out preapproval inspections under the proposal when drugs are made with untested technologies or produced at a site the FDA hasn’t inspected.

More generic-drug companies are moving operations outside the U.S., making it harder for the FDA to keep pace, Janet Woodcock, director of the agency’s Drug Center, said during a September meeting to discuss the fees. The FDA inspects U.S. plants once every 30 months, compared with once every nine years for foreign plants, a September Government Accountability Office report states.

The FDA receives 800 to 900 generic-drug applications each year, compared with about 100 applications for new brand-name drugs, Mr. Wesdyk said.

The volume of work means “even with additional resources, it would be very difficult to do the number of preapproval inspections,” said Peter Beckerman, a senior adviser in the FDA’s Office of Policy, who is leading the generic-drug user fee negotiations for the agency.

Brand-name drug makers have paid the FDA fees since 1992 to help fund faster reviews.

The FDA hasn’t presented the proposal to generic-drug companies, Mr. Stec said. In addition to the Generic Pharmaceutical Association, groups involved in the fee talks include the Generic User Fee Coalition — consisting of Perrigo; Teva, Hospira of Lake Forest, Ill.; and Apotex of Toronto — and Mylan, which developed its own fee proposal.

The Generic Pharmaceutical Association and the User Fee Coalition have agreed on a system that would set targets for drug reviews and deal with the backlog of applications through separate funding, Mr. Stec said. He declined to discuss other details.

Mylan, based in Canonsburg, has pressed for a plan in which manufacturers and suppliers of active ingredients pay inspection fees in addition to fees for new applications. Mylan President Heather Bresch said her company’s proposal would generate $30 million for the FDA to standardize the frequency of inspections in the U.S. and overseas.

“You’ve got to level the playing field,” Ms. Bresch said in an interview in Washington last month. “I’m just realistic about the economic situation. Our industry is going to have to subsidize the globalization of the FDA.”

The generic-drug association and the user-fee coalition are considering Mylan’s proposal and want to reach a consensus early next year, Mr. Stec said.

The FDA plans to begin discussions with the industry early next year, Mr. Wesdyk said. Any agreement would have to be approved by Congress.

www.Medtipster.com Source: Medtipster Client Data: August 1, 2009 – November 30, 2010

Medtipster.com, working with it’s employer sponsored benefit plan members, found that offering a waiver of generic drug co-payments led to more switches to generics from their brand equivalents and that plan members were more likely to remain on their generic drugs after the switch was made.

The waiver program resulted in savings of about $500,000. to the sponsor and about $750,000. to the plan members during the observation period.

To improve generic dispensing rates, Medtipster offered plan members using brand medications in 40 therapeutic classes up to two co-pay waivers if they switched to a preferred generic drug. Information about the waiver was mailed to plan members, alerting them that all they needed to do was switch within six months of receiving the communication.

Members who took advantage of the waivers early in the six-month period were able to use it twice, while members who acted later in the window were only able to use the waiver once.

The recently enacted health care reform law has a provision in it that will allow Medicare Part D plan sponsors, beginning with the 2011 plan year, to reduce or waive the first co-pay for a generic drug when a plan member switches from its corresponding brand product.

Medtipster examined how many of the plan members remained on the generic drug after receiving one or two co-pay waivers. Findings among the top four therapeutic classes (HMG CoA reductase inhibitors, antihypertensive combinations, proton pump inhibitors and beta blockers cardio-selective) showed that plan members who took advantage of two co-pay waivers had higher generic dispensing rates in the fill immediately after the waivers and had higher sustained GDRs during the months after the generic dispensing conversion program began compared to those only using one waiver.

For example, 94.9 percent of members using beta blockers filled the next prescription with a generic following the use of two waivers, compared to 59.5 percent who used only one waiver. Members who used two waivers had a sustained generic dispensation rate of 89.5 percent, compared to 58.5 percent who only used one waiver.

The drug that showed the highest difference in sustained GDR between the use of two waivers and one waiver was AstraZeneca’s high blood pressure medication Toprol XL (metaprolol succinate), which had sustained GDR of 91.5 percent for members using two waivers, compared to 62.5 percent for members who used only one waiver.

Of the top 10, the drug that had the lowest difference was AstraZeneca’s cholesterol lowering drug Crestor (rosuvastatin), which had a sustained GDR of 82.7 percent for members using two waivers versus 78.1 percent for members who used one waiver.

www.Medtipster.com Source: Health Care Uncovered, by Brandi Funk – 9.30.2010 (http://ow.ly/2N3Sp)

It looks like government isn’t the only thing that Americans are increasingly dependent on.

A new report from the Centers for Disease Control earlier this month shows that prescription drug use in the U.S. is on the rise, with half of all Americans currently on at least one prescription drug.

Who pays for these drugs? In 2009, U.S. prescription drugs sales topped $300 billion .

Sadly, as the number of people without health insurance rise and as more insurance companies get pickier about the drugs they cover, many cannot afford to pay for these drugs.

There is no question that the rising use and cost of prescription drugs is a major cause of rising health care costs in this country so if we want affordable health care and reform, we must start here, looking for alternatives.

According to the Generic Pharmaceutical Association, generic drugs have saved Americans $734 billion in the last 10 years so ask your health care provider if switching your prescription drug to generic is a good alternative for you.

Websites such as Medtipster allow you to search for discounted generic drug programs available at pharmacies throughout the USA.

Many of these drugs are available for as little as $4 or less.

• If your medication is available through one of these programs, you will see a list of pharmacies with pricing, in your neighborhood.
• If your medication is not on one of the discount generic drug programs they will notify you when it is, or they will suggest a ttherapeutic drug equivalent.
• If your medication is not available in generic form, they will search for drug brand coupons you can print and take to your local pharmacy.

Why pay more than you have to?

Other Prescription Drug Assistance Websites

http://www.xubex.com

http://www.needymeds.com

http://www.pparx.og

http://www.rxoutreach.com

www.Medtipster.com Source: Dow Jones Newswires, By Dinah Wisenberg Brin – 8.11.10

The U.S.’s big pharmacy benefit managers continue to offer clients better deals this year as they compete for business, but they don’t appear to be sliding into a frenzy of unreasonable pricing.

In the current “selling season,” when PBMs look to sign customers for the following year, discounts on new contracts have deepened by one or two percentage points, on average, from a year ago. While PBMs are still lowering their pricing, the pace is slower than a year ago, when PBMs were willing to expand discounts by as much as five percentage points, according to benefit consultants who guide employers on choosing a vendor.

It is unclear how the lower prices will impact margins next year at large PBMs like Medco Health Solutions Inc. (MHS), CVS Caremark Corp. (CVS) and Express Scripts Inc. (ESRX). The increased use of generic drugs, which lowers PBMs’ costs, allows them to be more flexible with prices. That accounts for some of the discount.

The big PBMs have reported lower margins this year, citing a variety of reasons. Medco, though, specifically mentioned lower pricing on renewing contracts, among other items.

PBMs “are taking a little bit of a hit to margin, not much, but they are taking one,” said Michael Jacobs, national clinical practice leader at Xerox Corp.’s (XRX) Buck Consultants. He said the companies have ways of making up elsewhere for client discounts — through greater operating efficiency, cost-shifting to members or raising prices on other drugs.

PBMs handle prescription-drug benefits for employers and health plans, negotiating pricing — including rebates and discounts — with drug makers and pharmacies. They also run their own profitable mail-order pharmacies. The competitive industry has come under increasing pressure to pass along rebates and discounts and improve transparency.

Currently, the industry is engaged in its selling season for 2011 contracts, with billions of dollars in new and renewing business up for grabs or already won.

“Pricing got more competitive this year,” said Kristin Begley, national pharmacy practice leader at benefits consultant Hewitt Associates Inc. (HEW), who didn’t see much switching among her large, national clients, many of which contract with CVS Caremark or Medco.

Rebates got better, and there were “overall better deals across the board,” Begley said. Also, she said, most Hewitt client bids this year required full transparency on pricing structure, with PBMs earning an administrative fee and making money on mail-order while forgoing a margin on drugs dispensed at retail.

PBMs are offering clients better discounts on generic drugs, said David Dross, partner and managed pharmacy practice leader at the Marsh & McLennan Cos. (MMC) Mercer LLC consulting business. Dross added that he has seen some bigger discounts for brand-name drugs as well, although underlying costs on branded drugs generally are increasing.

PBM managements have indicated pricing trends are rational, even though a Sanford C. Bernstein & Co. employer survey earlier this summer suggested a “notable deterioration of the PBM pricing environment,” with more than 40% of respondents noting a decrease in prices.

“Our pricing disciplines have been applied consistently for the past several years as well as going forward to 2011,” Medco spokesman Lowell Weiner said. Medco CEO David Snow Jr., who earlier this year noted instances of aggressive pricing, said last month that he was feeling more comfortable with the competitive marketplace.

Meanwhile, Express Scripts CEO George Paz has said that while “pricing has always been extremely aggressive,” the company uses clinical tools to help drive out costs.

Per Lofberg, who heads CVS Caremark’s PBM operation, recently told analysts that pricing is “intensely competitive like it always … has been, but it’s fundamentally very similar to the past. When plans go out for bid, they are always looking for better economics, and that’s a very important part of the negotiations.”

John Malley, eastern region pharmacy practice leader at Towers Watson & Co. (TW), said PBM pricing isn’t irrational, although it is changing in structure so that players offer better pricing without necessarily losing margin.

“So more simply put, the level of discounts off prescription drugs is not that different between last year and this year, but the overall value of this year’s deals, all in, is better than last year” for the clients, Malley said.

Pricing will become less important a competitive factor as more drugs go generic, Mercer’s Dross predicted. PBMs already are trying to differentiate their clinical offerings, which aim to close gaps in care, customize prescriptions based on genetics and improve compliance to produce better health outcomes and lower costs.

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).

www.Medtipster.com Source: FDAnews.com – Washington Drug Letter, 5.25.2010

AARP: Generic Drug Prices Drop, Brand Prices Continue Rising

The prices of brand-name prescription drugs most often used by Medicare beneficiaries increased nearly 10 percent over the 12-month period ending in March, an AARP report says.

While generic drug prices fell during the April 2009 to March 2010 period, the average price of top brand drugs used by Medicare beneficiaries rose 9.7 percent, continuing an upward trend in annual drug price increases, according to the AARP Public Policy Institute Rx Watchdog Report released last week.

Prices of generic drugs most widely used by Medicare beneficiaries dropped 9.7 percent while prices for widely used specialty drugs rose by 9.2 percent.
“These trends resulted in an average annual rate of increase of 5.3 percent for manufacturer drug prices during the 12 months ending with the first quarter of 2010 despite an extremely low rate of general inflation for all consumer goods and services,” the report says.

Drug companies raised the price of about two-thirds (90 of 144) of specialty drugs studied in the one-year period. Two of the 144 specialty drugs had a drop in price, and both were generics. For an individual taking one specialty medication, the average annual increase in cost of therapy rose by $2,760 during the study period.

AARP’s analysis echoes that of pharmacy benefit managerExpress Scripts’ 2009 Drug Trend Report, released last month. Prices of drugs in the most popular therapeutic classes increased 9.1 percent in 2009, according to that report.

PhRMA, however, said the AARP report is misleading and based on incomplete information. The report fails to take into account discounts and rebates generally negotiated between drug manufacturers and payers, which can significantly lower the cost of brand-name medicines, ultimately benefiting patients, Senior Vice President Ken Johnson said.

“Also, the report’s conclusions ignore the reality that prescription medicines represent a small and decreasing share of growth in overall health care costs in the United States,” Johnson said. “Not only is the current rate of growth for prescription medicines historically low, but the recent decline in drug spending growth has contributed to the lowest rate of total health care growth in almost 50 years.”

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.