Low-cost Generics Research Articles

Patients Abandon Antidepressants, Deterred by High Costs

Back to table of contents Previous article Next article Professional NewsFull AccessPatients Abandon Antidepressants, Deterred by High CostsRich DalyRich DalySearch for more papers by this authorPublished Online:19 Nov 2010https://doi.org/10.1176/pn.45.22.psychnews_45_22_018AbstractAn increasing number of insured patients with diagnosed depression are leaving their prescriptions unretrieved at the pharmacy counter, according to a recent analysis.A review of private-insurance claims data released to Psychiatric News showed that so-called abandonment increased from a little more than 3 percent of all antidepressant prescriptions (brand name and generic) tracked in 2008 to more than 4 percent of such prescriptions in the first half of this year. The data were collected by Wolters Kluwer Pharma Solutions, a health care data company.The rising rate of antidepressant abandonment came even as the total number of prescriptions written for antidepressants increased from 2008 to 2009 among private-insurance beneficiaries by 2.9 percent, to a total of about 240,000 new antidepressant prescriptions. Data were unavailable for the first half of 2010.Among all categories of brand-name drugs only, the rate of abandonment for new prescriptions increased from 6.5 percent at the beginning of 2008 to nearly 10 percent in the second quarter of 2010.Data on abandonment rates were derived from an analysis of 80 million claims that pharmacies submit each month for payment, or about 40 percent of the total market. Wolters Kluwer collects the data from more than 24,000 independent and chain pharmacies to help pharmaceutical manufacturers assess the reasons for lost sales.Patients' failure to pick up their prescribed antidepressants is being driven, in part, by rising costs for the medications, according to Wolters Kluwer officials and a mental health researcher.The data on abandoned antidepressant rates were similar to those for unfilled prescriptions reported by Medicare beneficiaries in a 2008 study. Jae Kennedy, Ph.D., an associate professor in the Department of Health Policy and Administration at Washington State University, and colleagues found that more than 5 percent of prescriptions that beneficiaries reported not filling were for antidepressants.“Our research shows that an increasing number of patients in the United States are unable to fill their prescriptions due to medication cost, including critical prescriptions for chronic-disease management like antidepressants,” Kennedy told Psychiatric News.Jesse Wright, M.D., Ph.D., a professor of psychiatry and behavioral sciences at the University of Louisville, said in an interview that because of the large number of low-cost antidepressant generics now available, cost should be less of a factor in whether patients decide to fill their prescriptions. He advised clinicians to raise the issue of affordability with their patients and prescribe a generic substitute when suitable.“I wouldn't have been surprised if the [Wolters] data had found higher [abandonment] rates,” he said.Kennedy gave similar advice to Wright's, noting that clinicians should routinely ask patients about their prescription insurance coverage. If patients cannot afford the medication, psychiatrists can suggest alternatives for obtaining it, such as programs offered by pharmaceutical manufacturers that provide medications for free or at low cost.The 2008 Kennedy study, “Unfilled Prescriptions of Medicare Beneficiaries: Prevalence, Reasons, and Types of Medicines Prescribed,” is posted at <http://www.amcp.org/data/jmcp/JMCPMaga_553-560.pdf>. ISSUES NewArchived

Cuban Health Care: Benefits Without Costs

The suggestion by P. K. Drain and M. Barry (“Fifty years of U.S. embargo: Cuba's health outcomes and lessons,” Policy Forum, 30 April, p. [572][1]) that Cuba can provide the United States with the know-how to provide high-quality care at low cost is suspect. Cuba's system is specific to a small, centrally controlled country. This is not necessarily translatable to a large, heterogeneous nation profoundly focused on individual liberties, including the personal freedom to eschew preventive care. Many countries can provide medicine and other medical technologies at lower cost than the United States. Missing is the fact that these low-cost generics are based on discoveries mostly made in the United States and a handful of other developed nations. The United States bears the substantial burden of direct development costs as well as the general costs for development of an educational system and an infrastructure that has yielded an astounding array of medical advances over the past several decades. Others, such as Cuba, reap the benefits while avoiding most of the costs. Perhaps the authors would like to speculate on what the quality of health care in Cuba would be were it only based on discoveries and medical advances originating in Cuba. [1]: /lookup/doi/10.1126/science.1189680

Indian Generics Producers, Access to Essential Medicines and Local Production in Africa: An Argument with Reference to Tanzania

Much analysis of the supply chain for essential medicines to Africa assumes broad sustainability of low-cost generics supply from Indian manufacturers. We use Indian data and interviews to question this assumption. In a case study of Tanzania, we then argue for the necessity and feasibility of enhanced local production of essential medicines. We identify key industrial policy interventions, including industrial protection and active government purchasing; public goods including legislative and regulatory frameworks and training; and encouragement and facilitation of joint ventures. We show that a basis has been laid for these activities, and identify the urgency and difficulty of the policy challenge. There are lessons for the Tanzanian case from Indian industrial history, and policy space is provided by Tanzania's Least Developed Country status. Industrial and health policy can be further integrated to the benefit of Tanzania's citizens. The Tanzanian case has broader implications for African policymakers.

Commentary: Will generic drug stores improve access to essential medicines for the poor in India?

Policymakers in developing countries are challenged to increase the availability and affordability of essential medicines. To improve access to medicines, the Government of India recently opened Generic Drug Stores in a few public facilities. These stores sell generic medicines manufactured by the public sector manufacturers. The prices are lower than market price. We examine the premise of these stores; where will they fit in the landscape. What can be learned from their early operation and problems encountered? Will selling a small number of generic medicines at public hospitals really improve access to medicines for poor populations? Poor patients are intended to receive medicines free of charge at public facilities. Generic drugs are typically less expensive than brand-name drugs and contain the same active ingredient as the original brand name product.1 Thus generic medicines may be an affordable alternatives to more costly, patented brand name versions of the product.2 World Health Organization's (WHO) essential medicines list is based on generic medicines.3 In most OECD countries, generic medicines are promoted by competition-enhancing policies operating through health-care reimbursements to contain expenditures and encourage efficient use of resources.4 India is well known for its prolific pharmaceutical industry that offers low-cost generics to the world. At home India faces the challenge of equal access to affordable and quality essential medicines for its own people.5 Despite pharmaceutical industry growth in the last two decades, access to essential medicines remains

Molecule of the Month

The most prescribed and top selling drugs of 2006: generics, biologics and, of course, Lipitor™. In the spring of 2007, data for the top 200 prescription drugs, in terms of both sales and number of dispensed prescriptions, was released [1-3]. Total sales of prescription drugs reached $275 billion in 2006, an impressive 8.3% increase from 2005; in contrast, sales only increased 5.3% over 2004. The number of dispensed prescriptions also increased in 2006 to 3.7 million (a 4.6% increase from 2005) [1-3]. These data are very encouraging for the pharmaceutical industry, especially considering that 2006 witnessed the loss of patent protection for blockbusters Zocor™, Zoloft™, Plavix™, Provochol™ and Mobic™ which fell victim to generic competition. In fact, the overriding theme of the 2006 was a significant increase in generic prescriptions and sales. While many factors play a role, the 8.3% increase in sales is primarily due to the successful launch of the full Medicare Part D benefit which extended prescription drug coverage benefits to US citizens that historically had little to no coverage. Medicare Part D encompasses every major class of pharmaceuticals and, in 2006, 63% of all prescriptions dispensed to Medicare Part D beneficiaries were generic products [1-3]. Alarmingly for big Pharma, the number of generic products is growing (the FDA approved 371 new generic products in 2006 and their number is expected to further increase in 2007), and drug plans can be expected to elect lower cost generics in preference to name brand drugs. What is the effect of generic competition for a well established, safe and effective drug? Mercks Zocor™ is a good example. In 2005, the statins Lipitor™ and Zocor™ were ranked No.1 ($7.6 billion) and No.2 ($ 4.5 billion) in sales, and No. 1 and No. 11 in prescriptions dispensed, respectively. After generic variants of Zocor™ entered the market mid-year 2006, Pfizers Lipitor™ remained No. 1 in terms of both sales ($ 8.6 billion) and prescriptions dispensed (74,020) while Zocor™ slid to No.7 in sales ($3.2 billion) and No. 25 in prescriptions dispensed. It will be interesting to see impact of generic Zocor™ on Lipitor™ sales in 2007, as drug plans steer towards the cost savings of generic statins. Also in 2007, the industry will witness first time generic competition for a number of other ‘blockbuster’ drugs such as Prevacid™ (No. 5 in 2006 sales at $3.6 billion) [1-3]. In 2006, the top 10 products in the US market by sales were: 1) Lipitor™ ($ 8.6 billion), 2) Nexium™ ($ 5.1 billion), 3) Advair Diskus™ ($ 3.95 billion), 4) Aranesp™ ($ 3.94 billion), 5) Prevacid™ ($ 3.5 billion), 6) Epogen™ ($ 3.2 billion), 7) Zocor™ ($ 3.1 billion), 8) Enbrel™ ($ 3.08 billion), 9) Seroquel™ ($ 3.02 billion), and 10) Singulair™ ($ 3.0 billion) [1]. These 10 products accounted for 15% of total sales of the top 200 drugs in 2007, and three of the top 10 (Aranesp™, Epogen™, Enbrel™) are biologics. Indeed, 2006 witnessed an increase not only in generic drug sales and prescriptions dispensed, but also biologics. Amgens Aranesp™ significantly led all top 20 earners with a 42% increase in revenue over 2005 [1-3]. IMS Health forecasts continued sales growth in the pharmaceutical sector in the 6% to 9% range through 2010 and predict that both generic and biologic sales will grow more rapidly and lead the market [1-3]. How will these emerging trends impact big Pharma, the biotech industry, branded drugs and non-biologic small molecule drug sales? Only time will tell, but there are clear challenges to an already struggling pharmaceutical industry. REFERENCES [1] Lamb, E. Top 200 prescription drugs of 2006. Pharmacy Times, May 2007, pp.1-4, and reference therein. [2] IMS Health. Press release. March 8, 2007, www.imshealth.com [3] For more information on generic drug approvals and impact on sales see the US Food and Drug Adminstration: www.fda.gov.

Physicians' attitudes toward direct-to-consumer prescription drug marketing

This paper examines attitudes of physicians toward direct-to-consumer advertising (DTCA) of prescription drugs. Physician awareness of DTCA continues at a very high level, although, negative attitudes may impair its usefulness. This study identified shortcomings of DTCA and physician concerns that could be addressed by marketers. For example, three quarters of physicians agree strongly or somewhat that DTCA does not provide adequate information on the risks and benefits of advertised products. More than half of the physicians (53 per cent) believe DTCA results in many patients requesting unnecessary prescriptions and an even greater percentage (66 per cent) believe DTCA creates a preference for brands when lower-cost generics would be sufficient. The negativism of physicians should cause marketers to ask if their return on DTCA is worth the cost.

Generic Pharmacia Drug For Poor Nations

Pharmacia plans to license its AIDS drug to generics manufacturers that would market a low-cost treatment only in the poorest countries. According to the Pharmacia plan, Rescriptor (delavirdine) would first be licensed to the nonprofit International Dispensary Association. The Dutch organization would in turn broker nonexclusive deals with generics firms to produce the drug for sale in 78 countries. Pharmacia hopes to break through an impasse in which efforts by Merck, Pfizer, and GlaxoSmithKline to donate drugs or sell them at discounted prices have been criticized for not supplying sufficient quantities of drugs, or for prices that are still too high. Michael Friedman, senior vice president of medical and public policy at Pharmacia, says that, under the proposed plan, IDA would ensure competition in order to keep prices low. Penalties in the licensing agreement would discourage the infiltration of low-cost generics into developed countries. Pharmacia does not currently market Rescriptor; in 1999, the co...

Drug Makers Make a Difference

All drugs, the law says, must be safe and effective. Food and Drug Administration knows whether drugs are safe. It does not always know whether they are effective. But mounting pressure on Capitol Hill for low-cost generic rather than brand name prescribing may make it imperative that FDA know. Behind the consumer's desire to buy low-cost generics instead more expensive brand name drugs is the assumption that the drugs are equLal. This assumption is false. A pill is more than just an amount an active drug. All kinds ingredients are mixed with usually small quantities a chemical to make a tablet or capsule, and these ingredients can be as important to the way it works as the drug itself. There are 32 factors that can significantly alter drug behavior in the body, according to Dr. Max S. Sadove, noted University Illinois anesthesiologist. Among them are solubility, purity, particle size and even tablet size. Careful control these variables is the domain the manufacturer whose skill as a drugmaker is directly related to the uniformity his product. It is a tricky business. In one case, the manufacturer an anticoagulant called Dicumarol found that a number doctors were prescribing half-doses the drug. To make things easier for the patient, the company increased the size tablet so it could be broken in two, but did not increase the active ingredient. Patients who switched from smaller to larger pills suddenly had to take larger doses in order to get the same therapeutic effect. Studies showed the drug dissolved more slowly from the larger tablets. FDA's Dr. Frances Kelsey suggests a patient on long-term drug therapy learn the manufacturer, size and form his medicine and get the same thing each time his prescription is filled. It's not necessarily a question brands being better or worse than generics, she says. It's a question getting the same thing every time to maintain a consistent level effectiveness. Many doctors. having successful experience with a trademarked drug and no facilities to determine equivalency themselves, will continue to prescribe by brand name even though a similar or chemically identical compound may be available at less cost under its generic name. Promotional campaigns by the drug houses also play an undoubted part in brand name prescribing. Two major bills now before the Senate call for generic naming-and thus lower pricing-of drugs paid for by the Federal Government under its health programs. Senator Joseph M. Montoya (D-N. Mex.) has introduced legislation to include drugs in Medicare benefits. Senator Russell Long (D-La.) is sponsoring a bill to assure economical drug-buying in all Social Security programs. Both bills would set up an independent Formulary Committee to evaluate brand name and generic drugs to guarantee high quality in those dispensed in Government programs. FDA Commissioner James L. Goddard, who will become chairman the Formulary Committee if either bill passes, points out that very few generics would be on the approved list at first. For one thing, he says, of the 200 most frequently prescribed drugs, only about 34 have generic counterparts. But the list would surely grow as clinical tests efficacy are made. Added fuel for the controversy is expected next month with the publication The Handbook Prescription Drugs by Richard Burack, M.D., which will list trademarked drugs and their generic counterparts, with manufacturers and prices. publisher, Pantheon, offers it as a buying guide designed to help people get prescription drugs cheaper. Quite apart from the generic vs. trademark struggle, and from the subtle differences that creep in between apparently identical products, the quality drugs across the board leaves quite a bit to be desired. Consider the Department Defense, with its $125 million drug bill each year. It finds itself turning down more than half the drugs offered it; they Smith Kline and French

Scientific body measurements needed

Compression stockings are commonly prescribed by physicians for lower extremity edema and venous insufficiency. However, no data are available for clinicians to assess the relative quality of various brands, particularly low-cost generics now available directly to consumers through the Internet. We examined the actual compression provided by gradient stockings from multiple manufacturers.A total of 36 class 2 (20-30 mm Hg) men's medium-sized below-knee compression stockings from six different manufacturers (n = 6 of each brand) with approximately the same quality and materials were chosen to be studied. Identifying brand names were removed, and they were randomly and blindly tested by a technician in accordance with accepted industry standards. A calibrated constant rate of extension tensile instrument (Zwick Z010; Zwick Roell, Ulm, Germany) was used, and the tension generated by the stockings at the ankle and calf was measured using minimum, average, and maximum circumference sizes. All measurements were performed in duplicate.The compression pressures generated by the stockings were almost all within the stated range of 20 to 30 mm Hg at the ankle, but all except one were below 20 mm Hg at the calf. There were also significant differences between manufacturers at both the ankle and the calf (P < .0001). The expected pressure reduction between the two locations varied, but one stocking had only a minimal 2 mm Hg (8%) gradient, which was significantly less than all of the other tested brands and below the recommended 20% to 50% reduction. Cost analysis demonstrated that the discount brands were significantly lower in price but provided absolute compression and pressure gradients similar to those of the more expensive brands.There is significant variability among stockings, both in the absolute pressures and in the pressure gradients generated from the ankle to the calf, thought to be functionally important for venous flow. The cheaper stockings offered the same degree of compression and pressure gradient as the more expensive brands. These results suggest the need for manufacturing standards in the United States and a revision in labeling requirements to mandate more accurate and complete pressure disclosures.