The Official Medtipster Blog

have your healthcare and afford it, too
Subscribe

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.

How Can You Help the Medicine Go Down?

March 30, 2011 By: Nadia Category: HealthCare, Medicine Advice, Medtipster, Prescription News, Prescription Savings

www.Medtipster.com Source: The Wall Street Journal, 3.28.2011 -by Katherine Hobson

Too many people don’t take the drugs they’re supposed to. Tackling that problem could save a lot of money and a lot of lives.

Medication can do great things for people—but only if they take it. And a lot of people aren’t taking it.

Half of patients in the developed world don’t properly take their drugs for chronic conditions, according to the World Health Organization. The additional costs for treating diseases that progress unchecked run into the hundreds of billions of dollars a year. One study estimates nearly 90,000 people die prematurely in the U.S. each year because of poor adherence to high-blood-pressure treatment alone.

So how do you get people to take their medicine? There isn’t one answer, because there isn’t one reason people aren’t sticking to their regimens. Cost, forgetfulness, side effects and doubts about effectiveness can all be factors, among others. And for many people the health-care system isn’t designed to monitor or encourage adherence to drug prescriptions.

But there are plenty of health-care professionals and researchers tackling this issue, and they have some ideas about what can be done and what should be done. Here are some of those ideas.

More Refill Information

Doctors and other health-care providers need “some way of tracking to know if patients are refilling their medications, so we can step in and help people” if they aren’t, says Robert Reid, a physician and researcher at Group Health Cooperative, a Seattle-based nonprofit health-care system that coordinates care and coverage.

Providers like Group Health and Kaiser Permanente, a large managed-care consortium based in Oakland, Calif., can track refills because they manage all aspects of their patients’ care, so all information for each of their patients is collected in one easy-to-access electronic record. Alec Does, a family-medicine physician at Kaiser Permanente Anaheim Hills, says that when he shows patients records indicating they haven’t been consistently filling their prescriptions, “90% of the time, they’ll open up” and start talking about any issues they’re having.

But most people don’t get their care from such comprehensive providers, so their doctors rarely have access to their pharmacy records.

The technology to fix that problem exists, says Valerie Fleishman, executive director of NEHI, a national health-policy research institute based in Cambridge, Mass. “Physicians are sending prescriptions to the pharmacy, so we have the capability to close that feedback loop,” she says. The problem, she says, is that most doctors are paid for specific services, like office visits and medical procedures—not for managing their patients’ health outcomes. So there is no financial incentive for them to take on the cost of tracking prescription refills.

There is no quick fix for this problem, Ms. Fleishman says, but the recently passed health-care overhaul bill includes funding for new models for care and payment that might do a better job of rewarding providers for doing whatever it takes to keep patients healthy.

Get Pharmacists Involved

“Retail pharmacists appear to be able to play a really substantial role in encouraging patients to use their medications better,” says William Shrank, an assistant professor of medicine in the division of pharmacoepidemiology at Brigham and Women’s Hospital in Boston. “They are an underutilized resource.”

At Stamford, Conn.-based customer-communications company Pitney Bowes Inc., on-site pharmacist Antonio Tierno says he talks with patients about their conditions and medications. If a patient is picking up a refill behind schedule, he’ll ask what’s up. “If a person is late, you need to find out why,” he says.

Mr. Tierno says he always asks patients if they know why they’re taking a drug. That conversation can help ensure that patients will take their medication, he says, by making the drug’s benefits clearer to them and by making them feel more involved in their care.

A study by researchers at the Walter Reed Army Medical Center in Washington, D.C., published in the Journal of the American Medical Association, found that a pharmacy-care program for 200 people age 65 and older who were taking at least four medications for chronic conditions boosted adherence to 97% from 61% after six months. Patients were educated about their medications, including usage instructions; medications were dispensed in blister packs that made it easier to keep track of whether they had taken their pills for the day; and pharmacists followed up with patients every two months.

After 12 months, those who continued to get the pharmacy care kept their adherence at about 96%, while adherence among those for whom the program was discontinued dropped to 69%.

Another review of efforts to improve adherence—sponsored by CVS Caremark Corp. and carried out by Dr. Shrank and other researchers from Brigham and Women’s Hospital, Harvard University and CVS—found that nurses talking with patients as they were discharged from the hospital were right behind pharmacists in terms of how often they successfully encouraged patients to take their medications as directed.

Treat Patients as Individuals

Every patient’s story is different—so every solution has to be tailored to the individual.

The first step is to engage the patient with a simple, open-ended question, says Elizabeth Oyekan, area pharmacy director at Kaiser Permanente South Bay Medical Center: What’s getting in the way of picking up your medications?

“That will give you some concrete information, and then you target the solution to the individual patient,” she says. Kaiser has created a set of online tutorials to help doctors and others engage more effectively with patients who are skipping their medications.

If a patient is worried about side effects, a health-care provider might offer a substitute for the medication, or a lower dose. For the forgetful, it could be as easy as using a simple pillbox, or maybe something more technologically advanced, such as text-message reminders or souped-up pillboxes with audio or visual alerts.

If money is the problem, the solution may be generic substitutes, a mail-order program (which not only provides drugs at a lower cost but also helps those who have trouble getting to a pharmacy), or a drug company’s assistance program.

In many cases, though, problems can be addressed only by looking at medication adherence as a behavioral issue with often complex roots, says Alan Christensen, chairman of the psychology department at the University of Iowa. As with diet and exercise, getting people to change their behavior can be difficult.

“There’s more and more interest in how to better motivate and engage patients beyond just simply reminding them or reducing financial barriers or simplifying therapy,” says Dr. Shrank. Multifaceted programs that entail various combinations of those elements and education delivered by health-care professionals have shown promise in studies, but “we don’t have a good sense of what precisely is the right mix,” Dr. Shrank says. And, he says, if that ideal mix turns out to involve a lot of expensive face time, someone will have to figure out how to implement those efforts in a cost-effective way.

Generics Companies Weigh In on Biological Drugs

February 01, 2011 By: Nadia Category: HealthCare, Medicine Advice, Medtipster, Prescription News, Prescription Savings

www.Medtipster.com Source: The Wall Street Journal, 1.31.2011 – By Goran Mijuk

Generic drug makers are expecting copies of complex biological drugs to become a multibillion dollar market in the near future. But a lack of clear regulation, intense scrutiny from makers of the original drugs and the high cost of research may damp their prospects.

Hopes that the U.S. and European market for these copies, known as biosimilars, will thrive are based on the fact that biological drugs with more than $60 billion in annual sales will lose patent protection by 2015, according to research firm Datamonitor.

Should the market develop according to plan, copies of these complex drugs alone could make up around 50% of the expected $10 billion biosimilars market by 2016, according to data compiled by Capgemini Consulting. The rest will come from simpler biosimilars, such as copies of insulin and human growth hormone.

Biological drugs are made of larger molecules than chemical drugs. They are generally more effective in treating diseases such as cancer but are more expensive because of the high costs involved in making them.

Among those with patents due to expire soon are Roche Holding AG’s blood cancer and rheumatoid arthritis medicine Rituxan, also known as MabThera, anti-inflammatory drug Remicade, which is co-marketed by Merck & Co. and Johnson & Johnson, and Amgen Inc.’s and Pfizer Inc.’s rheumatoid-arthritis drug Enbrel. Each drug had more than $5 billion in annual peak sales.

The European expiry in 2014 of Roche’s Rituxan, a complex monoclonal antibody, which allows for the direct targeting of affected cells, has recently prompted three generic players to start research on a copy. Novartis AG’s generics unit, Sandoz, said it has started midstage trials for the drug, following similar steps by U.S.-based Spectrum Pharmaceuticals Inc. in early January and Israel-based Teva Pharmaceutical Industries last year.

Sandoz, which is leading the market for biosimilars with a roughly 50% market share, ahead of Teva and U.S.-based Hospira Inc., expects the entire biosimilars business could reach more than $20 billion by 2020, up from a current $250 million. Swiss chemicals company Lonza Group AG, which is teaming up with Teva in its biosimilars venture, expects solid growth because patients, insurance companies and governments want drugs to be cheaper.

The generics companies base their argument on the high price of many complex biological medicines. Treatment with Roche’s lung and kidney cancer drug Avastin and the colorectal cancer drug Erbitux from Germany’s Merck KGaA can cost thousands of dollars a month. But some experts question the generics companies’ pricing rationale, saying the current constraints could even force larger generic producers such as Sandoz or Teva to rethink their operating models.

“Much will depend on how the price of these drugs will develop,” says David Kaegi, pharmaceuticals analyst at Bank Sarasin. “Depending on the price, operating models will have to be adjusted.”

He says prices for biosimilars could be just 30% lower than the prices of the originals, because only a couple of generics firms will compete against an original drug. “It thus won’t be like in the case of the simple generics, where many firms moved into the market and prices were aggressively cut. It will be more difficult,” he says.

Since generics of chemical drugs, which are made of small molecules, are relatively simple to copy, the market for generic drugs attracted a flurry of players and this brought prices down sharply.

The main risk, analysts say, is that if prices don’t come down much, original drug producers will be able to retain a large market share. On the other hand, if prices fall too fast, generics firms’ margins could suffer.

A Sandoz spokesman said the company expects pricing to continue to vary according to product and market, saying the entry bar for complex products would be high, which would limit competition and keep prices from falling too fast. Lonza’s chief executive, Stefan Borgas, said that even if prices fell by 50%, margins and growth would still be healthy.

Industry insiders and management consultants are also concerned the market may need longer than expected to establish itself, as research and development for these complex drugs is difficult and costly, and doctors and patients may be wary about their safety.

One of the main problems with generic versions of complex biological drugs is that, unlike simple-to-produce generics of chemical drugs, which are identical to the originator product, these medicines aren’t exact copies. Complex biological drugs such as Rituxan are genetically engineered and consist of large molecules produced in live cells.

Because the manufacturing process is difficult, requiring extensive genetic expertise, and it is also prone to errors, continuous testing and controlling is needed. At best, a generic copy can only be similar to the original protein.

Because biosimilars aren’t identical copies, “biotech and big pharma are looking to squash the movement by throwing bioequivalent issues and quality-control issues,” says Mary Ann Crandall, an independent pharmaceutical analyst at research firm Kalorama Information. “I think that will continue to hinder things. These products are too much of a cash cow to just let generics come in and cannibalize it.”

World-wide sales of all biological drugs reached $130 billion in 2009, according to research firm IMS Health, and are expected to grow much faster than conventional chemical drugs.

Another factor keeping the biosimilars market in check is the lack of clear regulatory guidelines.

While the European Medicines Agency has so far approved 13 simpler biosimilar drugs such as insulin, final guidelines for complex biosimilars are still pending. Analysts say they may be introduced next year.

In the U.S., regulators are currently working to establish how intensive testing for biosimilars needs to be and how the traditional three-phase drug-approval process for originals can be abbreviated. A key concern is to make sure that biosimilar drugs are safe and effective.

“I had predicted that it would be in place by 2009 but now, although there has been progress, there are still numerous regulatory hurdles. Big pharma is very influential and not about to go quietly,” Ms. Crandall says.

Roche, which has already prepared for generics competition but expects the impact from biosimilars on Rituxan to be limited, says that while it supports the development of regulatory frameworks for biosimilars, patient safety is of the utmost importance.

“Specific processes, data, research and experience are needed to ensure that a biosimilar monoclonal antibody has the same profile, efficacy and safety as the originator product,” Roche says.

This may prove too difficult for many players. Michael Frizberg, vice-president of Lonza Generics, said that developing a complex biosimilar can take up to eight years and cost more than $100 million.

Sandoz’s head, Jeff George, put the cost as high as $250 million for difficult-to-copy large-molecule drugs.

Although small U.S. biotech Spectrum Pharmaceutical, which has teamed up with Viropro Inc., says it has enough funds to develop a copy of Roche’s Rituxan—financial constraints may keep many smaller firms from entering the market. “It may cost too much time and money for a number of small to midsized generics manufacturers to embark on biosimilars production,” says Stephane Dutu, asset manager at Vernes & Associés in Geneva.

“Furthermore,” Mr. Dutu says, “doctors may be reluctant to use biosimilars as it is a new class of products with no track record in terms of safety and benefits.” A poll conducted in summer 2010 by GMS Dr. Jung GmbH, Gesellschaft für Markt- und Sozialforschung, found that more than 50% of physicians in Germany have heard or read little or nothing about biosimilars.

Almost Half of Americans Took a Prescription Drug in Past Month

September 03, 2010 By: Nadia Category: HealthCare, Medtipster, Prescription News

www.Medtipster.com Source: Health Blog – Wall Street Journal Blogs, By Katherine Hobson – 9.02.10

The government today released some new stats on prescription-drug use through 2008. The headline finding: Over the previous decade, the proportion of Americans (of all ages) reporting they took a prescription drug in the past month rose to 48% from 44%.

Some other key findings:

The percentage of people reporting the use of multiple prescription drugs in the last month also rose, to 31% for two or more prescriptions and 11% (a near-doubling of the previous 6%)) for five or more drugs.

As you’d expect, prescription-drug use varied by age, with about 20% of kids under 12 and 90% of older Americans (defined as age 60 and over — sorry, Mom!) reporting the use of at least one drug in the past month.

Among the 60-plus crowd, more than 76% used at least two drugs in the past month and 37% used at least five. Of that finding — which stems, of course, from the fact that older folks often have multiple diseases — the report says that “excessive prescribing or polypharmacy is also an acknowledged safety risk for older Americans, and a continuing challenge that may contribute to adverse drug events, medication compliance issues and increased health-care costs.”

The type of drugs used most often were asthma meds for kids, central nervous system stimulants (such as those used to treat ADHD) for teens, antidepressants for the middle-aged and cholesterol-lowering drugs for older people.

The Pharmaceutical Research and Manufacturers of America (PhRMA), the trade association for drug makers, said in a statement that “as we learn more about disease, prescription medicines are justifiably playing an increasingly important role.” The group noted that many patients still lack access to needed medications, and that in many cases early interventions and improved compliance would improve health outcomes. “The best solution for all patients is to strike the right medical balance between proper and effective use of prescription medicines and other therapies and interventions,” it said.

A few months back, the pharmacy-benefits manager Medco issued its own figures for prescription-drug use and spending, covering 2009. It reported that use among adults held fairly steady, edging up slightly among those over 65 and dropping a bit for those aged 50-64 — but use among those 19 and under rose by 5%.

Pediatric Versions of Tylenol, Motrin, Zyrtec and Benadryl Recalled

May 03, 2010 By: Nadia Category: Medicine Advice, Medtipster, Prescription News

www.Medtipster.com Source: Wall Street Journal, May 3, 2010

Consumer complaints about certain over-the-counter children’s medications spurred an investigation that led to a recall of more than 40 different products because of manufacturing problems, according to officials at a unit of Johnson & Johnson.

The recall, announced over the weekend by the company and the U.S. Food and Drug Administration, prompted drug stores and other merchants to pull the medicines off their shelves and caused concern among parents who took steps to avoid giving the products — largely pain and allergy remedies — to their children.

A spokesman for J&J’s McNeil Consumer Healthcare unit wasn’t more specific about what issues consumers raised that led to the internal probe.

“We always receive some consumer inquiries about our products and those inquiries led to the investigation that ultimately led to this recall,” the spokesman, Marc Boston, said.

The company said there haven’t been any serious side effects reported, and the company and the FDA said the potential for harm is remote. Still, the company and the agency said the products shouldn’t be given to children for precautionary reasons.

The recall involved at least 1,000 lots of products, including pediatric versions of Tylenol, Motrin, Zyrtec and Benadryl.

Some of the liquid formulations may contain a higher concentration of their active ingredient than they should while others may contain inactive ingredients at inappropriate levels, or tiny metallic particles that are a residue of the manufacturing process, the company said.

The medicines were sold in the U.S. and Canada as well as in countries as far away as Fiji and Kuwait. All were made at a factory in Fort Washington, Pa., the FDA and the company said. Neither the company nor the FDA could say how many bottles of medicine were involved.

At English Drug, an independent pharmacy in Bethel, Conn., staffers removed several products from the store’s shelves Sunday morning after learning about the recall on the Internet. “These are very popular products, but we pulled them” out of safety concerns for consumers, said Denise McMahon, a pharmacist at the store.

In New York City, Natalia Carin said she recently gave her 2-year-old son Cole children’s Zyrtec and Motrin. He appears to be fine, she said, but added, “I’d like some information about what kind of substance this was and how dangerous it might be and what we can expect.”

Kenneth Polin, a pediatrician at Town and Country Pediatrics, with offices in Chicago and its suburbs, had heard from few worried parents Sunday, but says his advice is to turn to generic versions of the medicines. He recommended that before consumers buy a generic, they make sure to ask a pharmacist whether J&J manufactured it.

The recall is another dent in J&J’s reputation as a model of corporate responsiveness. That harks back to the deadly Tylenol poisonings in the early 1980s, when the company reacted swiftly to recall the product and inform the public.

More recently U.S. regulators have criticized J&J’s handling of product-quality issues, because of a widening series of recalls of over-the-counter medicines that accelerated late last year.

In November, the company recalled a limited number of certain bottles of Tylenol arthritis-pain caplets after identifying an uncharacteristic smell or taste associated with the products.

In December, J&J had to expand the recall to include all lots of the product. A month later, J&J widened the recall again to include other brands such as Motrin and Benadryl.

That resulted in the FDA sending J&J a warning letter saying the company had violated good-manufacturing rules at its Las Piedras, Puerto Rico, plant.

Drug Makers Raised Prices Sharply in ’09

April 20, 2010 By: Nadia Category: Medtipster, Prescription News

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.

Get Adobe Flash playerPlugin by wpburn.com wordpress themes