Brand-name Products Research Articles

Using Multiple Authorized Generics to Maintain High Prices: The Example of Entacapone

Brand-name drug manufacturers can market or license authorized generics (AGs), which are the same product sold under a generic name. By contrast, independent generics (IGs) are made by other manufacturers. The brand-name manufacturer of entacapone, a treatment for Parkinson's disease, established 4 AGs before IGs emerged. We used this case study to understand how AGs can affect the length of brand-name exclusivity and robustness of generic competition. Using public Food and Drug Administration and court records, we identified the regulatory and legal history for generic entacapone products marketed through 2021. We used Medicare Part D data to estimate trends in use, prices, and spending on entacapone products from 2011 to 2020, comparing actual spending with projected spending if IG competition had begun after expiration of the key patent protecting entacapone (October 2013) and prices had fallen consistent with levels observed for other generic drugs. From 2012 to 2014, 3 potential entacapone IG manufacturers instead launched AG versions after settlement agreements with the brand-name manufacturer; the brand-name manufacturer additionally introduced its own AG. Four different IG versions were marketed beginning in 2015. From 2011 to 2020, average Medicare prices declined by 62%, less than the projected 74% to 92% price decline expected for a drug with 8 generics. Over this period, Medicare spent $1.1 billion on entacapone products, which could have been reduced by an estimated $137 to $449 million through typical IG competition. The case of entacapone demonstrates how licensing multiple AGs in place of IG competition can increase spending. Government regulators should more rigorously monitor AGs to prevent such strategies.

The Inflation Reduction Act: A boon for the generic and biosimilar industry.

After more than a year of negotiation, a $740 billion climate and health care bill known as The Inflation Reduction Act (IRA) became law on 16 August 2022. In addition to its impact on the environment, job creation and reducing inflation, a key focus is to reduce the burden of Medicare by over $100B per year and other benefits to 65 million Medicare patients. A fixed number of top expenditures drugs that have stayed as single-source chemical products for 8 years and the biologicals for 12 years; 2 years more are allowed if the approval of a generic or biosimilar is imminent. Once a second source appears, as a generic or biosimilar, the price reduction is removed. The number of products negotiated for price reduction goes from 10 to 20 over the years and stays fixed at this number. Reaching any significant number out of the 14,000 reimbursed will take forever if biosimilars and generics keep entering. The IRA does not apply to private markets. The IRA legislation and related statutes were analysed in consultation with legal teams; the spending data were derived from the CMS portals and the FDA databases to rank the most likely products selected when the selection process is initiated. The savings to Medicare will come from reducing the price of only a few products, primarily with $1B and upward spending; when Plan B product scheduling enters, these will be at the bottom of the selection because of their lower expenditure. The total number of products subject to price reduction may be negligible if generics and biosimilars are introduced after the exclusivity period of the listed drug or reference product. The private market with an 80% share may benefit due to price spillover but mainly by the expedited entry of generics and biosimilars. The entry of generics and biosimilars will now be encouraged by brand-name product companies, reducing the intellectual property hurdles like the "patent dance" for biosimilars. The IRA includes restrictions to prevent the brand name companies from exploiting the entry of generics and biosimilars to assure their independence.

Medicare coverage and cost-sharing for abiraterone following generic entry.

13 Background: Generic competition lowers drug prices, but may not reduce out-of-pocket costs for patients. Abiraterone, first approved by the United States Food and Drug Administration in 2011, has two commonly used dosage units (250mg and 500mg) with multiple generic market entrants over the last 5 years. This makes it ideal to evaluate the association between generic competition and changes in product coverage and cost-sharing. Methods: We studied 4 abiraterone products (tablets): generic 250mg, generic 500mg, brand-name 250mg, and brand-name 500mg. We used the FDA’s Orange Book to identify market entry of generic products until May 2022. We used Part D formulary data from 2018 to 2022 to identify changes in product coverage and expected annual out-of-pocket costs for the average Part D beneficiary (daily dose of 1000mg). We also calculated “best-case” cost-sharing in 2022, using the Part D Plan Finder. Results: During 2018-2022, 12 generic 250mg and 4 generic 500mg abiraterone formulations came to market. The first 250mg generic came to market in October 2018, and 10 of the 12 formulations came to market by 2019. The first 500mg generic formulation came to market in December 2020. The proportion of Part D plans that covered generic products increased from 0% in 2018, to 100% for 250mg and 79% for 500mg in 2022. Expected annual out-of-pocket costs for a Part D beneficiary ranged from $7,491 to $10,148 across products and years. In 2022, the average out-of-pocket costs for generic 500mg tablets was $10,148, greater than that for brand-name 500mg tablets, which was $9,298. The same was true when using the Part D plan finder (generic, $11,093, brand-name, $9,476). For the 250mg product, however, out-of-pocket costs were much higher for the brand-name versus generic product (> $150,000 versus $1,139). Conclusions: During 2018-2022, market entry of generic abiraterone products led to their preferential coverage over brand-name products on Part D formularies, but this was associated with only modest savings for beneficiaries. In fact, in 2022 for the 500mg product, average out-of-pocket costs were higher for generic, versus brand-name products. For the 250mg generic product, a patient able to price-shop could pay approximately $1,100, 1/7th of what the average beneficiary spent. These data indicate that Part D beneficiaries do not immediately benefit from price reductions associated with generic entry of specialty drugs. Part D beneficiaries’ out-of-pocket costs with generics can be higher despite lower list prices (vs. brand-name). Proposals to redesign Part D correct this fundamental flaw that makes high-cost generic drugs more expensive to patients than brands. Affordable medications should be available to all patients, not just the most resourced and able to price-shop. Limitations include that formulary files capture data from the prior 3 months, and expected out-of-pocket costs are averaged across beneficiaries and plans.

Clinical effectiveness of branded versus generic piperacillin-tazobactam for treating severe community-acquired pneumonia

PurposeTo compare the clinical effectiveness of branded versus generic piperacillin-tazobactam for treating severe community-acquired pneumonia (CAP). Patients and methodsWe identified patients with severe CAP who received piperacillin-tazobactam based on a nine-center registry database. Furthermore, we classified the patients in three hospitals, which used only branded piperacillin-tazobactam as the study group, and the patients in six other hospitals, which used both branded and generic products as the control group. ResultsA total of 472 patients (n = 263 in the study group and n = 209 in the control group) with severe CAP were included. The study group using branded piperacillin-tazobactam had higher odds of clinical cure (adjusted odds ratio [OR] = 3.77, 95 % confidence interval [CI], 1.93–7.37) and lower odds of treatment failure (adjusted OR = 0.28, 95 % CI, 0.13–0.58) than the control group receiving either branded or generic piperacillin-tazobactam. In addition, the study group was associated with higher odds of clinical effectiveness (adjusted OR = 2.95, 95 % CI, 1.46–6.11), less odds of clinical ineffectiveness (adjusted OR = 0.39, 95 % CI, 0.18–0.81), and lower risk of in-hospital mortality (adjusted OR = 0.39, 95 % CI, 0.21–0.73). ConclusionBased on the findings of the present study using indirect comparison, the clinical effectiveness of generic piperacillin-tazobactam for treating patients with severe CAP might not be as good as that of brand-name products.

Determinants of carriers' intentions to use electric cargo vehicles in last-mile delivery by extending the technology acceptance model: a case study of Vietnam

PurposeThis study aimed two objectives: The first objective was to explore carriers' intentions to use cargo electric vehicles (EVs) and the factors influencing these intentions in last-mile delivery (LMD). The other objective was to provide recommendations for policymakers and manufacturers to promote and customize cargo EVs to meet the requirements of carriers in the LMD sector.Design/methodology/approachIn this study the authors constructed a research framework that adjusted and extended the original technology acceptance model (TAM). The proposed model combines eight psychological factors, including attitude, perceived usefulness, perceived ease of use, perceived risk, public engagement, face consciousness, financial incentive policy and carrier intention, in which four factors, namely attitude, perceived usefulness, perceived ease of use and intention, were obtained from the original TAM and the four remaining factors, namely perceived risk, public engagement, face consciousness and financial incentive policy, were added.FindingsThe results showed that psychological factors such as attitude, perceived ease of use, perceived risk, public engagement and face consciousness might affect carriers' intentions to use electric cargo vehicles in LMD service in Vietnamese cities. These results agree with the previous studies and confirm that attitude, perceived ease of use, perceived risk, public engagement and face consciousness might be important for shaping intention to use electric cargo vehicles in emerging markets.Research limitations/implicationsThis study has several limitations, first, the data were collected in Vietnam, a country with weak academic contributions. Therefore, these findings might not be generalizable to other areas. The authors expect to apply the same research framework to other countries to explore the similarities and differences across the countries. Second, the authors conducted the surveys in three cities; except for Hanoi, the other two cities are not really large markets in the LMD service sector. Third, the authors ignored the relationship between the demographic characteristics and electric cargo vehicles. Further studies should address this gap.Practical implicationsBased on the findings, manufacturers should ensure the high-quality performance of electric cargo vehicles in terms of extending driving range and shortening recharging time. Policymakers should develop the roadmaps for electric cargo vehicles, starting from switching from conventional cargo motorcycles to electric motorcycles. In addition, developing public charging infrastructure should be prioritized, which is the fundamental basis for operating electric cargo vehicles. Finally, manufacturers should research and develop a product that would improve the reputation of carriers because carriers with higher face consciousness are more likely to pursue brand-name and high-priced products in order to enhance their reputation.Originality/valueThis study contributes to the literature in two aspects: First, the authors investigated intentions to use electric cargo vehicles in LMD service, which is rare from other studies, and they further identified the psychological determinants of carriers' intentions. Second, the findings increase the knowledge of carriers' intentions and suggest implications for policymakers and manufacturers to promote the adoption of electric cargo vehicles in last-mile deliver service.

Nestle, A Staple Brand in Everyone's Life: A Case Study on Brand Loyalty

Nestle is one of the leading food companies in the world. We aim to investigate how product quality, brand name, advertisement, and product price influence customer loyalty. We tested our hypotheses by examining 100 Malaysian consumers. We found that product quality and advertisement are positively related to customer loyalty. We also identify that advertisement is the most significant factor influencing customer loyalty. Given that advertisement is the most significant factor influencing customer loyalty, we conducted another survey in Kuwait to determine which advertisements influence consumer behavior, in which a total of 175 Kuwait consumers participated. The findings show consumer behavior is primarily impacted by TV advertisements and celebrity endorsements in their brand preference. The main reason for preferring Nestle products is their high product quality and advertising. Thus, Nestle is recommended to maintain its high quality and deal with celebrities for its advertisements to retain brand loyalty. Keywords: Advertising, Celebrity Endorsements, Customer Behaviour, Customer Loyalty, Product Quality, Purchase Decision.

Agent-based modeling of the word-of-mouth effect on promoting brand-name agricultural products

Agent-based modeling of the word-of-mouth effect on promoting brand-name agricultural products

Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD, 1986-2020.

Inhalers are the mainstay of treatment for asthma and chronic obstructive pulmonary disease (COPD). These products face limited generic competition in the US and remain expensive. To better understand the strategies that brand-name inhaler manufacturers have employed to preserve their market dominance, we analyzed all patents and regulatory exclusivities granted to inhalers approved by the Food and Drug Administration between 1986 and 2020. Of the sixty-two inhalers approved, fifty-three were brand-name products, and these brand-name products had a median of sixteen years of protection from generic competition. Only one inhaler contained an ingredient with a new mechanism of action. More than half of all patents were on the inhaler devices, not the active ingredients or other aspects of these drug-device combinations. Manufacturers augmented periods of brand-name market exclusivity by moving active ingredients from one inhaler device into another ("device hops"). The median time from approval of an originator product to the last-to-expire patent or regulatory exclusivity of branded follow-ons was twenty-eight years (across device hops on fourteen originator products). Regulatory and patent reform is critical to ensure that the rewards bestowed on brand-name inhaler manufacturers better reflect the added clinical benefit of new products.

Artificial sweeteners and cancer risk: Results from the NutriNet-Santé population-based cohort study.

The food industry uses artificial sweeteners in a wide range of foods and beverages as alternatives to added sugars, for which deleterious effects on several chronic diseases are now well established. The safety of these food additives is debated, with conflicting findings regarding their role in the aetiology of various diseases. In particular, their carcinogenicity has been suggested by several experimental studies, but robust epidemiological evidence is lacking. Thus, our objective was to investigate the associations between artificial sweetener intakes (total from all dietary sources, and most frequently consumed ones: aspartame [E951], acesulfame-K [E950], and sucralose [E955]) and cancer risk (overall and by site). Overall, 102,865 adults from the French population-based cohort NutriNet-Santé (2009-2021) were included (median follow-up time = 7.8 years). Dietary intakes and consumption of sweeteners were obtained by repeated 24-hour dietary records including brand names of industrial products. Associations between sweeteners and cancer incidence were assessed by Cox proportional hazards models, adjusted for age, sex, education, physical activity, smoking, body mass index, height, weight gain during follow-up, diabetes, family history of cancer, number of 24-hour dietary records, and baseline intakes of energy, alcohol, sodium, saturated fatty acids, fibre, sugar, fruit and vegetables, whole-grain foods, and dairy products. Compared to non-consumers, higher consumers of total artificial sweeteners (i.e., above the median exposure in consumers) had higher risk of overall cancer (n = 3,358 cases, hazard ratio [HR] = 1.13 [95% CI 1.03 to 1.25], P-trend = 0.002). In particular, aspartame (HR = 1.15 [95% CI 1.03 to 1.28], P = 0.002) and acesulfame-K (HR = 1.13 [95% CI 1.01 to 1.26], P = 0.007) were associated with increased cancer risk. Higher risks were also observed for breast cancer (n = 979 cases, HR = 1.22 [95% CI 1.01 to 1.48], P = 0.036, for aspartame) and obesity-related cancers (n = 2,023 cases, HR = 1.13 [95% CI 1.00 to 1.28], P = 0.036, for total artificial sweeteners, and HR = 1.15 [95% CI 1.01 to 1.32], P = 0.026, for aspartame). Limitations of this study include potential selection bias, residual confounding, and reverse causality, though sensitivity analyses were performed to address these concerns. In this large cohort study, artificial sweeteners (especially aspartame and acesulfame-K), which are used in many food and beverage brands worldwide, were associated with increased cancer risk. These findings provide important and novel insights for the ongoing re-evaluation of food additive sweeteners by the European Food Safety Authority and other health agencies globally. ClinicalTrials.gov NCT03335644.

Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling.

Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

Rabeprazole

Rabeprazole is a proton pump inhibitor that suppresses gastric acid production in the stomach. Available under different brand name products as well as in a variety of combination products, rabeprazole has several medical uses concerning the management of problems of pathological gastric acid. Rabeprazole's adverse effects tend to be mild but can be serious, including deficiencies in essential nutrients, rare incidences of liver damage, and immune-mediated reactions. As a class effect, rabeprazole can increase the risk for osteoporosis, serious infections (including Clostridium difficile infections), and kidney damage. Rabeprazole can theoretically contribute to numerous drug interactions, mediated both through its metabolic properties and its direct effect on acid in the stomach, though its potential for clinically meaningful drug interactions is low. Like other medications in the proton pump inhibitor class, rabeprazole's mechanism of action involves the irreversible inhibition of proton pumps in the stomach, which are responsible for gastric acid production. Rabeprazole has a number of chemical metabolites, though it is primarily degraded by non-enzymatic metabolism and excreted in the urine. Genetic differences in a person's drug-metabolizing enzymes may theoretically affect individual responses to rabeprazole therapy, though the clinical significance of this interaction is unlikely in comparison to other proton pump inhibitors. The purpose of this review is to provide an up-to-date monograph on rabeprazole.

The First Interchangeable Biosimilar Insulin: Insulin Glargine-yfgn.

On March 23, 2020, all insulin products were reclassified as biologics instead of drugs under the Biological Price Competition and Innovation (BPCI) Act of 2009. This allows biosimilar insulin products to be manufactured when the patent expires for the reference biologic, sometimes called the originator or brand name product. A biosimilar product may not be substituted for the reference biologic at the pharmacy counter unless the biosimilar undergoes further switch trials to earn the designation as an interchangeable biosimilar. Insulin glargine-yfgn 100 units/mL is the first biosimilar insulin to attain interchangeable status with the reference insulin glargine. In the INSTRIDE 1 and INSTRIDE 2 trials, insulin glargine-yfgn has proven noninferiority regarding blood glucose reduction and adverse effect profile versus reference insulin glargine; even in the INSTRIDE 3 trial in which treatment of diabetes was switched between insulin glargine-yfgn and reference insulin glargine throughout the trial without statistically significant changes to glucose levels or adverse effects. Insulin glargine-yfgn may be substituted at the pharmacy counter without consultation with the prescriber, in accordance with state laws. In suit with other biosimilars, insulin glargine-yfgn's list price is significantly lower than other insulin glargine products. This increases market competition leading to decreases in costs of other insulin glargine products. Many patients who could not previously afford insulin therapy may now have significantly improved access to treatment. Providers will need education to increase awareness of these new biosimilars and interchangeable biosimilar insulin products, cost benefits, and substitution allowances.

Association of Generic Competition With Price Decreases in Physician-Administered Drugs and Estimated Price Decreases for Biosimilar Competition

Price decreases of biologic and biosimilar products in Medicare Part B have been minimal, even with biosimilar competition. Medicare reimburses clinicians for biologics and biosimilars differently than for brand-name and generic drugs, which has generated greater price reductions. To characterize the nature of price competition among brand-name and generic drugs under Medicare Part B and to estimate the cost savings to the program of subjecting biologic and biosimilar therapies to a similar price competition. This cohort study analyzed all brand-name drugs and their approved generic versions as well as biologics and biosimilars that were reimbursed under Medicare Part B from quarter 1 of 2005 to quarter 2 of 2021. Two separate data sets were created: brand-name and generic drugs as well as biologics and biosimilars data sets. Brand-name products with generic versions that were introduced before 2005 were excluded, and so were vaccines. Number of generic and biosimilar competitors over time. Price change as a percentage of the brand-name drug or biologic price in the quarter before generic or biosimilar competition. Price change was modeled using a linear, fixed-effects time series regression, with the number of generic or biosimilar competitors as the main covariate. Time was expressed as the number of quarters since the first generic or biosimilar competitor entered the market. Savings were estimated by projecting the regression model of brand-name and generic drug competition to observed biologic and biosimilar competition and by applying the estimated price reduction to actual Medicare spending for those products from 2015 to 2019. Of the 988 Healthcare Common Procedure Coding System codes identified, 50 (5.0%) met the inclusion criteria for the brand-name and generic drug data set and 28 (2.8%) met the criteria for the biologic and biosimilar data set. The first generic competitor was associated with reduced drug prices by 17.0%, the second competitor with a 39.5% decrease, the third competitor with a 52.5% decrease, and the fourth and more competitors with a 70.2% decrease (price decline was measured from brand-name drug price before the first generic competitor rather than from price established with fewer competitors). If biologics and biosimilars were subject to the same Medicare reimbursement framework as brand-name and generic drugs, Medicare spending on these products was estimated to have been 26.6% lower ($1.6 billion) from 2015 to 2019. This study found minimal uptake of biosimilars and limited price reductions for biologics and biosimilars under the current Medicare Part B reimbursement policy. Adopting the bundled biosimilar reimbursement structure for biologic and biosimilar therapies may be associated with substantial savings and encourage greater biosimilar market entry.

Channel Structure Choice for Remanufacturing under Green Consumerism

In recent decades, more and more consumers—referred to as “green consumers”—are willing to incorporate environmentally responsible decisions into their purchasing behaviors. This tendency is particularly notable in the European Union, the USA, and China. From a research perspective, while recent studies on remanufacturing have investigated optimal practices in regard to green consumerism, they have failed to address the flexibility manufacturers are afforded to outsource remanufacturing operations to third parties. In practice, some brand-name manufacturers—such as IBM, Land Rover, and Sun—do indeed outsource their remanufacturing operations. To further our understanding of the implications of differentiated structures for remanufacturing operations under green consumerism, we developed two models: one for a manufacturer undertaking remanufacturing themselves (Model M), and one for a manufacturer outsourcing it to a third-party remanufacturer (Model O). Our results indicate that, for markets with significant green consumerism, Model M tends to result in more remanufactured units and creates higher profitability for the manufacturer. However, under certain conditions, this model may also result in greater harm to the environment due to the comparative excess of manufacturers in the remanufacturing process. This implies that environmental groups and agencies should not only aim to encourage green consumerism, but should also focus their attention on the channel structures for remanufacturing.

Evaluating brand names without vowels

In recent years, a new trend has emerged where a growing number of firms have started using brand names without the vowels (e.g., Tumblr, Qzzr). However, to date research has not investigated how consumers evaluate such brand names. The current study aimed to explore the perception of vowel-less brand names among consumers. Across two studies, participants evaluated fictitious brand names of food products with and without the vowels (e.g., Ringner vs. Rngnr) on a number of attributes. Study 1 investigated the brand personality traits and Study 2 tested the fictitious brand names on traits specific to food brands (e.g., taste, healthfulness). The results of Study 1 demonstrate that brands with vowel-less (vs. voweled) names are perceived as more rugged whereas those with voweled (vs. vowel-less) brand names are perceived as more sincere, competent and sophisticated. The results of Study 2 demonstrate that food brands with vowel-less (vs. voweled) brand names are rated significantly lower in attributes of taste expectation, quality, expensiveness, willingness-to-pay, and healthfulness. Together, these findings reveal how the new trend of vowel-less brand names may influence consumers, especially in the context of food brands.

New copay rule worries patients, providers

Patients may be unpleasantly surprised by a new rule finalized by CMS in July 2020—potentially forcing them to abandon their prescriptions due to unaffordable drug costs. Sanjeev Seenath, PharmD, MBA, a managed care pharmacy specialist at State of Hawaii MedQUEST division, worries that patients will be even more concerned about their out-of-pocket expenses when they find out that the manufacturers' copay assistance programs contributions, including copay cards, are being excluded from their out-of-pocket maximums. He said this will cause a ‘trickle down’ effect, resulting in poor patient adherence to medications and negative health effects. The CMS rule allows commercial health insurers to permit these programs even when a brand name medication does not have a generic or appropriate alternative, while not requiring transparency from insurers about these programs existing, even though it will severely affect their health care spending, according to Bryan S. Walsh, JD, and Aaron S. Kesselheim, MD, JD, MPH, writing in the American Journal of Managed Care August 2021 issue. “If pharmaceutical companies are able to incentivize their brand-name drug products through their copayment assistance programs, this only fattens their pockets and adds to economic waste in the health care system, which will drive up health plan premiums and health care costs for patients,” said Seenath. Ever since drug manufacturers started offering copay assistance programs to help cover a portion or the full cost of brand-name medications, patients have been able to afford—for the most part—these medications. However, insurers, both public and private, have lost out on these manufacturer reimbursements which have, up until this point, been automatically applied to their beneficiaries' out-of-pocket maximums. With this realization in mind, insurers have put in place copay accumulator adjustment programs (CAAPs) to keep health care costs low by encouraging the use of lower-priced generic alternatives, which in turn places the financial burden on patients. “The CAAPs program makes it very unfair for patients in cases where there are no generic alternatives available for the patient or in the case where there is a generic drug available, but the brand- name drug appears to be superior due to its therapeutic equivalence,” said Seenath. When manufacturer assistance limits are met, patients will feel the high financial burden of these brand name medications. “From a CMS standpoint working for the State of Hawaii, discussions about the CAAPs are changing the landscape of how physicians are prescribing drugs because they are concerned about their patients' health and whether or not they will be able to afford brand name drugs if they aren't able to take advantage of the manufacturers' copayment assistance programs,” said Seenath. “This is inadvertently leading to more systemic issues of increased health care costs, higher hospital readmission rates here in the islands, and economic waste.” Health care providers could be more cautious about prescribing certain medications. “Clinical outcomes and the quality of care is of utmost importance,” said Seenath. “So, unless there are generic equivalents that are in the same drug class with same therapeutic equivalence and clinical benefit, then the copay adjustment accumulator program is really doing an injustice to the patient and affecting the quality of care.” To truly help patients, he said, insurance plans need to be transparent with their beneficiaries about these new rules and how it impacts their copayments in order for patients to make well-informed decisions on their health care spending.

Brief of 14 Professors of Law as Amici Curiae in Support of the Petition for Rehearing En Banc in GlaxoSmithKline v. Teva Pharmaceuticals, Fed. Cir. No. 18-1976

In GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., the Federal Circuit considered whether labeling and marketing materials for a generic drug could induce infringement of a patent on a method of using that drug, despite the label and those materials having carved out indications relating to that method pursuant to FDA procedures and the Hatch-Waxman Act. In an original opinion from 2020 and a revised opinion in 2021, a panel of the court affirmed a jury finding of inducement. This brief calls on the full Federal Circuit to reconsider that decision en banc, for two reasons. First, the panel’s treatment of inducement opens up a direct conflict between patent law and the Hatch–Waxman Act amendments to the Federal Food, Drug, and Cosmetic Act. Those amendments, which enable abbreviated new drug applications (ANDAs), require a generic to use the same labeling as its equivalent brand-name product with only limited exceptions, as part of the carve-out procedure that deals specifically with inducement. By requiring ANDA applicants to make scattered revisions throughout their labels lest they induce infringement despite FDA approval of the label otherwise, the panel decision conflicts with this aspect of Hatch–Waxman. Importantly, the decision does not merely create dual tracks of liability that ANDA applicants must navigate; it creates a tension between the laws themselves insofar as one threatens to frustrate the other. Such a tension must be resolved in the process of statutory construction, which the panel decision failed to do. Second, the panel relies on product advertisements and government submissions that a product is “equivalent” to another to find inducement of a method-of-use patent. Such a result is problematic insofar as it denies basic comparative product information to consumers. That problem is especially concerning given that statements of product equivalence are found in a range of industries beyond generic drugs, such as biosimilars, mechanical repair parts, and information and communication technology. En banc review is necessary to reevaluate the panel’s decision insofar as it potentially creates new and unexpected avenues of patent infringement in all of these fields.

Patient and Payer Incentives to Use Patented Brand-Name Drugs vs Authorized Generic Drugs in Medicare Part D

In response to scrutiny over high drug prices, manufacturers of insulin and direct-acting antiviral agents for treating hepatitis C have recently introduced authorized generic alternatives to their patented brand-name products. These authorized generic drugs have list prices at least 50% lower than the list price of the brand-name drugs, which should result in savings to patients. However, it is unclear whether these authorized generic drugs are offered on Medicare Part D formularies because they may not provide savings to plans or Medicare. To assess Medicare Part D formulary coverage for 4 brand-name formulations of insulin and direct-acting antiviral agents and their authorized generic formulations. This cross-sectional study used Medicare Prescription Drug Plan Formulary and Pricing Information Files from quarter 3 of 2020 and Medicare Part D plan enrollment for September 2020. Four patented brand-name drugs (sofosbuvir and velpatasvir fixed-dose combination tablets [Epclusa], ledipasvir and sofosbuvir tablets [Harvoni], insulin lispro [Humalog], and insulin aspart [Novolog]) and their authorized generic formulations for all Part D stand-alone prescription drug plans (n = 959) and Medicare Advantage prescription drug plans (n = 3148) were studied. Beneficiary-weighted formulary coverage of brand-name and authorized generic products; beneficiary out-of-pocket costs; and prerebate plan, manufacturer, and Medicare spending on brand-name and authorized generic products. In quarter 3 of 2020, 97% of beneficiaries were in plans that covered brand-name drugs only or both brand-name and authorized generic drugs; approximately 3% were in plans that covered authorized generic drugs only. Observed authorized generic drug list prices were 67%, 62%, and 50% lower than list prices for Epclusa, Harvoni, and each brand-name insulin product, respectively. Medicare beneficiaries using authorized generic drugs could save $270 per year for 12 vials of Humalog and $2974 for a full course of Harvoni. Plans, however, have limited incentives to encourage authorized generic drug use because rebates for brands likely exceed savings available with authorized generic drugs, particularly for beneficiaries with spending that reaches the Medicare Part D coverage gap. The results of this cross-sectional study suggest that authorized generic drugs for insulin and direct-acting antiviral agents may lower out-of-pocket spending for patients but are unlikely to provide savings for Part D plans or Medicare. Instead, these drugs allow manufacturers to offer products at a lower list price without materially lowering net prices or profits.

Perception of rural and urban population on generic and branded drugs

Generic medicines are identical/ clone to an innovator or product brand name. After expiration of patent terms of the innovator product, other pharmaceutical companies usually apply to the drug regulatory bodies for approval to market the generic versions of the innovator's drugs. Generic drugs in the market were sold under the non-proprietary name or brand name. Drugs and medicines form a significant portion of out of pocket (OOP) expenses in Indian households. In order to resolve this issue, Government of India launched Jan Aushadhi Scheme (JAS) to provide inexpensive generic drugs to the patients. A separate interview was conducted for the illiterate people and Google forms were forwarded through whatsapp for literates, both contain the same questions to exclude the bias. The collected data was analysed and converted to graphs/ pie charts and the collected data was documented. Our study concludes that by using the questionnaire, the total patients (n= 500) were interviewed, different ages of people were included(15 to above 50).15-30 age group 29.2%, 31-49 age group 39.8%, above 50 age group 31% were involved. Male 60.4%, Female 39.4%, literate 47.4%, illiterate 52.6%, rural 49%, urban 51% were involved. A standard survey form/data collection sheet for both rural and urban population was used. Both literates and illiterates in rural and urban population almost 49% preferred branded drugs due to brand trust, quality, efficacy, and nearly 38% purchase medications based on the availability and remaining 13% preferred generic due to various reasons like cost effectiveness, same as branded quality and effectiveness.

Limited benefit and high financial burden of drugs used to manage cancer-associated anorexia/cachexia syndrome (CACS).

55 Background: To date, drugs used for CACS have limited efficacy and may have unwanted side effects. Despite this, clinicians commonly prescribe certain drugs for CACS, adding financial burden to patients through out-of-pocket costs near or at the end of life. We sought to describe the range of costs of the multiple drugs commonly used to manage CACS. Methods: We reviewed oncology, nutrition, and supportive care guidelines (ASCO, ESMO, ESPEN, MASCC) and compiled a list of drugs recommended for CACS. We also included drugs commonly used off-label in clinical practice as identified by study authors. Using GoodRx.com, we extracted available formulations (e.g., tablet [tab] vs capsule [cap] vs oral disintegrating tablet [ODT] vs solution [sol]), and brand name vs generic products for each drug. We identified the average retail price, and the lowest price with coupons, for each formulation using the most commonly used dosage for a 2-week period (typical fill). The average retail price is the cash price for consumers without prescription drug coverage. The lowest price represents a discounted, ‘’best case’’ scenario of out-of-pocket costs for patients without prescription drug coverage. We collected data using the zip code 10065 in May 2021 to describe the range of costs of these drug formulations. Results: We included 7 drugs available in 20 formulations (Table). For a 2-week fill, the least expensive options included generic olanzapine 5 mg tab (once daily) and generic mirtazapine 15 mg tab (once daily), costing $4.50 per fill. Brand-name solutions were costly, ranging from $605.50 (megestrol acetate, Megace ES) to $1,156.30 (dronabinol, Syndros). Costs between formulations of the same drug/dosage varied widely: for olanzapine 5 mg, the lowest price varied from $4.50 [generic, tab] to $238.40 [Zyprexa zydis, brand-name, ODT]. Conclusions: We found that the costs of drugs used for CACS are highly variable, ranging from < $5 to > $1000 per fill. Overall there is limited data supporting use of drugs for managing CACS. Thus, our findings can help guide patient-clinician discussions about the risk/benefit ratio of a prescription for managing CACS, while highlighting the importance of seeking less expensive formulations when possible.[Table: see text]