Dataset Information

Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

ABSTRACT: To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world.Observational study.Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017.Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions.Number of additional manufacturers that had obtained approval from any of seven non-US regulators with similar standards (European Medicines Agency (European Union), HealthCanada (Canada), Therapeutic Goods Association (Australia), Medsafe (New Zealand), Swissmedic (Switzerland), Medicines Control Council (South Africa), and the Israel Health Ministry). Association with drug characteristics including US orphan drug designation for drugs treating rare diseases, World Health Organization essential medicine designation, treatment area, drug product complexity (that is, with attributes that could complicate establishing bioequivalence or manufacturing), and total Medicaid spending in 2015.Of 170 eligible study drugs, more than half (109, 64%) had at least one manufacturer approved by a non-US regulator and 32 (19%) had four or more. Among 44 (26%) drugs with no FDA approved generic versions, 21 (48%) were available from at least one manufacturer approved by one of the seven non-US regulators, and two (5%) by four or more manufacturers. Across all drugs and regulators (including the FDA), 66 (39%) drugs were available from four or more total manufacturers. Of 109 drugs with at least one non-US regulator approved manufacturer, 12 (11%) were approved for patients with rare diseases and 29 (27%) were WHO designated essential medicines; only 12 (11%) were complex products that might be more complicated to import. The highest numbers of drugs were indicated for treating cardiovascular diseases, diabetes, or hyperlipidemia (19, 17%); psychiatric disease (16, 15%); and infectious diseases (15, 14%). In 2015, Medicaid alone spent nearly US$700m (£508m; €570m) on generic drugs without adequate US competition that could have had a manufacturer approved by non-US peer regulatory agencies.In this study, more than half the off-patent drugs with no generic competition in the USA had at least one independent manufacturer approved by a non-US peer regulatory agency; slightly fewer than half had four or more total manufacturers. Facilitating US patient access to such manufacturers could help sustain affordable access to essential off-patent drugs.

SUBMITTER: Gupta R

PROVIDER: S-EPMC5858606 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

Gupta Ravi R Bollyky Thomas J TJ Cohen Matthew M Ross Joseph S JS Kesselheim Aaron S AS

BMJ (Clinical research ed.) 20180319

<h4>Objectives</h4>To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world.<h4>Design</h4>Observational study.<h4>Setting</h4>Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017.<h4>Study cohort</h4>Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no lo ...[more]

PMID: 29555641

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Project description:ImportanceSome sole-source, off-patent drugs in the United States have undergone substantial price hikes in recent years. Despite increased attention by lawmakers, there are limited data to guide policy.ObjectivesTo describe key attributes of sole-source, off-patent, off-exclusivity drugs; to characterize the prevalence of price increases; and to identify attributes associated with price increases.Design, setting, and participantsIn this cross-sectional study, 300 sole-source, off-patent, off-exclusivity drug products met inclusion criteria and were selected for analysis from January 1, 2008, to December 31, 2018. Attributes were identified from multiple sources, and yearly wholesale acquisition cost prices were determined from First Databank.Main outcomes and measuresThe association of drug attributes with the following 2 price change thresholds was measured after adjusting for inflation: 25% or more price increase in a calendar year (wholesale acquisition cost) and 50% or more price increase in a calendar year. The rate of annual price increase over time was also measured.ResultsOf the 300 drug products and 2242 observations analyzed, the overall inflation-adjusted mean increase in drug prices was 8.8% (95% CI, 7.8%-9.8%) per year. Ninety-five drugs (31.7%) increased by 25% or more during any calendar year, and 66 drugs (22.0%) increased by 50% or more during any calendar year. An initial price of less than $2 per unit (adjusted odds ratio [aOR], 2.36; 95% CI, 1.69-3.29), antineoplastic and immunomodulatory class (aOR, 2.72; 95% CI, 1.31-5.65), dermatologic class (aOR, 2.95; 95% CI, 1.80-4.84), oral route (aOR, 2.01; 95% CI, 1.45-2.79), and US Food and Drug Administration (FDA) approval before 1990 (aOR, 1.52; 95% CI, 1.14-2.03) were attributes of drugs that were more likely to be associated with a 25% or more price increase in a calendar year after adjusting for by initial price. Similarly, an initial price of less than $2 per unit (aOR, 2.68; 95% CI, 1.76-4.09), antineoplastic and immunomodulatory class (aOR, 3.07; 95% CI, 1.54-6.12), oral route of administration (aOR, 1.70; 95% CI, 1.11-2.60), and FDA approval before 1990 (aOR, 2.02; 95% CI, 1.40-2.94) were attributes of drugs that were more likely to be associated with a 50% or more price increase in a calendar year after adjusting for by initial price. Price increases of 25% or more were most common in 2014, and price increases of 50% or more were most common in 2013.Conclusions and relevancePrice increases among sole-source, off-patent drugs are common, and policy interest in this practice is warranted. These findings should inform state drug pricing legislation.

Project description:BackgroundMalaysia's stable health care system is facing challenges with increasing medicine costs. To investigate these issues a survey was carried out to evaluate medicine prices, availability, affordability, and the structure of price components.Methods and findingsThe methodology developed by the World Health Organization (WHO) and Health Action International (HAI) was used. Price and availability data for 48 medicines was collected from 20 public sector facilities, 32 private sector retail pharmacies and 20 dispensing doctors in four geographical regions of West Malaysia. Medicine prices were compared with international reference prices (IRPs) to obtain a median price ratio. The daily wage of the lowest paid unskilled government worker was used to gauge the affordability of medicines. Price component data were collected throughout the supply chain, and markups, taxes, and other distribution costs were identified. In private pharmacies, innovator brand (IB) prices were 16 times higher than the IRPs, while generics were 6.6 times higher. In dispensing doctor clinics, the figures were 15 times higher for innovator brands and 7.5 for generics. Dispensing doctors applied high markups of 50%-76% for IBs, and up to 316% for generics. Retail pharmacy markups were also high-25%-38% and 100%-140% for IBs and generics, respectively. In the public sector, where medicines are free, availability was low even for medicines on the National Essential Drugs List. For a month's treatment for peptic ulcer disease and hypertension people have to pay about a week's wages in the private sector.ConclusionsThe free market by definition does not control medicine prices, necessitating price monitoring and control mechanisms. Markups for generic products are greater than for IBs. Reducing the base price without controlling markups may increase profits for retailers and dispensing doctors without reducing the price paid by end users. To increase access and affordability, promotion of generic medicines and improved availability of medicines in the public sector are required.

Project description:ImportanceDespite their increasingly important role in health care delivery, little is known about the availability, and characteristics, of community pharmacies in the United States.Objectives(1) To examine trends in the availability of community pharmacies and pharmacy characteristics (24-hour, drive-up, home delivery, e-prescribing, and multilingual staffing) associated with access to prescription medications in the U.S. between 2007 and 2015; and (2) to determine whether and how these patterns varied by pharmacy type (retail chains, independents, mass retailers, food stores, government and clinic-based) and across counties.MethodsRetrospective analysis using annual data from the National Council for Prescription Drug Programs. Pharmacy locations were mapped and linked to the several publically-available data to derive information on county-level population demographics, including annual estimates of total population, percent of population that is non-English speaking, percent with an ambulatory disability and percent aged ≥65 years. The key outcomes were availability of pharmacies (total number and per-capita) and pharmacy characteristics overall, by pharmacy type, and across counties.ResultsThe number of community pharmacies increased by 6.3% from 63,752 (2007) to 67,753 (2015). Retail chain and independent pharmacies persistently accounted for 40% and 35% of all pharmacies, respectively, while the remainder were comprised of mass retailer (12%), food store, (10%), clinic-based (3%) or government (<1%) pharmacies. With the exception of e-prescribing, there was no substantial change in pharmacy characteristics over time. While the number of pharmacies per 10,000 people (2.11) did not change between 2007 and 2015 at the national-level, it varied substantially across counties ranging from 0 to 13.6 per-capita in 2015. We also found that the majority of pharmacies do not offer accommodations that facilitate access to prescription medications, including home-delivery, with considerable variation by pharmacy type and across counties. For example, the provision of home-delivery services ranged from less than <1% of mass retailers to 67% of independent stores and was not associated with county demographics, including ambulatory disability population and percent of the population aged ≥65 years.ConclusionsDespite modest growth of pharmacies in the U.S., the availability of pharmacies, and pharmacy characteristics associated with access to prescription medications, vary substantially across local areas. Policy efforts aimed at improving access to prescription medications should ensure the availability of pharmacies and their accommodations align with local population needs.

Dataset Information

Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

Publications

Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

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