Generic drug pricing

BACKGROUND: The burden from medication costs for treating heart failure can be financially toxic for uninsured/underinsured patients and their families. Prescription discount cards, which offer cash price reductions, may decrease out-of-pocket costs for patients without prescription benefits, but the degree to which they offer financial relief remains unclear. Our objective was to assess the financial burden for uninsured/underinsured patients prescribed a drug from each of the 4 standard classes of medications for heart failure with reduced ejection fraction...

CONTEXT: Clinical endocrinology encompasses many diseases requiring long-term drug therapy. Prohibitive pricing of some endocrine drugs classified as essential by the World Health Organisation has created sub-optimal care of patients with endocrine disorders. EVIDENCE ACQUISITION: This review is based on evidence obtained from several databases and search engines including PubMed, Google and Google Scholar, reference searches, manual searching for web pages of international regulatory bodies and the authors' experience from different healthcare settings...

In this paper, the case study of ketamine as a new treatment for severe depression is used to outline the challenges of repurposing established medicines and we suggest potential solutions. The antidepressant effects of generic racemic ketamine were identified over 20 years ago, but there were insufficient incentives for commercial entities to pursue its registration, or support for non-commercial entities to fill this gap. As a result, the evaluation of generic ketamine was delayed, piecemeal, uncoordinated, and insufficient to gain approval...

BACKGROUND: Adherence and retention concerns raise questions about the effectiveness and cost-effectiveness of oral HIV pre-exposure prophylaxis (PrEP) in young men who have sex with men (YMSM). METHODS: Using an adolescent-focused simulation model, we compared annual HIV screening alone with tenofovir disoproxil fumarate/emtricitabine-based oral PrEP with every 3-month HIV screening in YMSM (aged 15-24) at increased risk of HIV. Data derived from published sources included: age-stratified HIV incidence/100 person-years (PY) on- or off-PrEP (0...

A range of treatment options are available for both mild to moderate and moderate to severe acne, and these options vary widely in their clinical uses, effectiveness, and costs. With the continued rise of dermatologic drug prices and increased cost-sharing due to high-deductible health plans, the importance of cost-effective treatment continues to grow. Failure to consider cost-effective, patient-centered care may lead to increased financial toxicity, reduced adherence, and ultimately worse outcomes and patient satisfaction...

PURPOSE/OBJECTIVE(S): In 2022, the Mark Cuban Cost Plus Drugs Company (MCCPDC) launched with the goal of offering affordable generic drugs directly to patients through a transparent pricing model. This study aims to evaluate the patient-level potential savings per prescription for patients undergoing radiation oncology treatment, regardless of insurance status. MATERIALS/METHODS: We analyzed prescription patterns of radiation oncologists in 2019 using the Medicare Part D database and selected the top 100 most frequently prescribed drugs for further analysis...

OBJECTIVE: To report out-of-pocket costs associated with Overactive Bladder (OAB) medications among Medicare beneficiaries and the uninsured. METHODS: We performed a cross-sectional analysis of the Centers for Medicare & Medicaid Services Prescription Drug Plan Formulary Data (Q1-2022). FDA-approved medications for OAB were identified. We calculated out-of-pocket costs for Medicare beneficiaries in each Part D prescription benefit phase, average retail price, total yearly costs and discounted prices through cash-pay discount coupons (GoodRx) or online pharmacies like Mark Cuban Cost Plus Drug Company (MCCPDC)...

Lenalidomide (Revlimid®) was originally approved by the Food and Drug Administration (FDA) in 2005, however, a generic version was not available until 2022. In that time, the price of lenalidomide has increased more than 20 times, and in 2021 alone, it accounted for >$5.8 billion dollars in Medicare Part D spending. This was a direct consequence of legal tactics employed by the manufacturer to thwart development of generic formulations of lenalidomide. In this report, we review the clinical development of lenalidomide, provide background on generic drug manufacturing in the United States (US), describe the steps that the manufacturer took to prevent entry of generic lenalidomide into the US market, and advocate for legislative reform of the FDA approval process and patent law protections in the US...

BACKGROUND: In September 2019, the "4 + 7" centralized procurement pilot program was expanded nationwide aiming at reducing drug prices by means of volume-based procurement and using accredited generic drugs for branded drug substitutes. Given the current uncertain effect of the policy outside pilot areas, this study was conducted to evaluate the impact of the National Volume-based Procurement policy on the use of policy-related drugs after expansion. METHOD: A single-group interrupted time series was applied using drug purchase data, covering 25 months from December 2018 to December 2020...

BACKGROUND: Photosensitivity is the response of drug or drug product to the exposure of solar, UV and visible light in the solid, semisolid, or liquid state that leads to a physical or chemical change. Exposure to light is a concern with numerous medications due to the potential for photo degradation or other chemical reactions that affect drug stability. METHODS: Out of all the registered brands in Department of Drug Administration, 9 brands of Rabeprazole tablets, 5 brands of Promethazine tablets and 5 brands of methylcobalamin tablets were selected and were subjected for testing and analysis for various quality parameters as per pharmacopoeia...

Background: The Pilot Plan of National Centralized Volume-Based Procurement (NCVBP) was adopted to cope with the rapid increase in drug expenditures. This research aimed to quantitatively evaluate the impact of the NCVBP on antiviral medications for the hepatitis B virus. Methods: Data on nucleoside analogs (NAs) medications of hepatitis B virus monthly procurement records in the pilot cities from January 2018 to December 2019 were extracted from the China Drug Supply Information Platform (CDSIP). The impacts of the NCVBP on purchased volumes, expenditures, and pre-defined daily dose costs were evaluated by interrupted time-series (ITS) analysis using Stata 16...

BACKGROUND: Topical corticosteroids possess numerous generics and similar-strength substitutes. Affordability can impact obtaining the medication prescribed. OBJECTIVE: To determine recent trends in topical corticosteroid pricing and potential for cost saving. METHODS: A retrospective cross-sectional study analyzing all prescriptions dispensed for topical corticosteroids from January 1, 2017 through December 31, 2021, using a U.S. all-payer pharmacy-claims database and commercial coupon dataset, was performed...

Introduction: Generic pharmaceuticals account for the majority of the $359 billion US pharmaceutical market, including for cardiology drugs. Amidst a lack of price transparency and administrative inefficiencies, generic drug prices are high, causing an undue burden on patients. Methods: We identified the 50 most used generic cardiology drugs by volume per the 2020 Medicare Part D spending data. We extracted cost per dose of each drug from the Marc Cuban Cost Plus Drug Company (MCCPDC) website and estimated the aggregate cost savings if MCCPDC were employed on a national scale by calculating the difference between this cost and Medicare spending...

IMPORTANCE: Medicare Part B drug expenditures have increased in recent years. This trend is likely to persist given the increased use and availability of biologics. OBJECTIVES: To assess the extent to which Medicare Part B spending growth was associated with changes in price vs quantity, and how these trends interacted with entry of new drugs into the marketplace. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study quantified the degree of spending concentration and the association between price and use of Part B drugs among fee-for-service Medicare beneficiaries...

BACKGROUND: The HIV Prevention Trials Network (HPTN) 083/084 trials showed up to 88% increased efficacy of long-acting cabotegravir (CAB-LA) versus continuous oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). However, CAB-LA's high price limits the number of people who can be treated within fixed prevention budgets. Global human immunodeficiency virus (HIV) prevention budgets are highly limited, with TDF/FTC widely available as a low-cost generic. In randomized clinical trials, event-driven TDF/FTC has shown similar preventive efficacy to continuous TDF/FTC...

In health systems with little public funding and decentralized procurement processes, the pricing and quality of anti-cancer medicines directly affects access to effective anti-cancer therapy. Factors such as differential pricing, volume-dependent negotiation and reliance on low-priced generics without any evaluation of their quality can lead to supply and demand lags, high out-of-pocket expenditures for patients and poor treatment outcomes. While pooled procurement of medicines can help address some of these challenges, monitoring of the procurement process requires considerable administrative investment...

Considerable progress has been made in cancer drug development in recent decades. However, for people in low- and middle-income countries, including Malaysia, many of these drugs are not readily available. During the 2nd Malaysian Association for Cancer Research (MACR) International Scientific Conference, a forum discussion was held to address these challenges and explore strategies to improve access to cancer medicines in the country. This paper presents the results of the said forum discussion. A few challenges to cancer drug access were highlighted, including lengthy approval and regulatory practices, cost of medicines, and manufacturing barriers...

OBJECTIVES: To investigate trends in Medicare coverage of buprenorphine-naloxone film before and after the FDA approval of its first generic versions. STUDY DESIGN: This study used data from the Part D Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files from 2015 to 2022, which provide information on all stand-alone Medicare/Medicare Advantage Prescription Drug Plans. METHODS: We examined the percentage of plans that provided coverage of brand-name and generic buprenorphine-naloxone films with strength 8 mg/2 mg during 2015-2022...

OBJECTIVE: To review the pharmacology of bexagliflozin in addition to its safety and efficacy from available clinical trials used for its approval, as well as available clinical evidence to date. DATA SOURCES: A search of the National Institutes of Health Clinical Trials Registry (https://www.clinicaltrials.gov) and PubMed database was performed from inception through June 1, 2023. STUDY SELECTION AND DATA EXTRACTION QUANTIFICATION: The following study designs were included: meta-analyses, systematic review, clinical trial, or observational study design...

Authorized generics are approved brand-name drugs that are sold by brand-name manufacturers or licensees without brands on their labeling. Despite their prevalence in prescription drug markets in the US, little is known about trends in their launches, their timing relative to traditional generics, and the characteristics of their respective brand-name drugs. We linked Food and Drug Administration and IQVIA data to investigate newly launched authorized generics during the period 2010-19. We found 854 launches over this period, with launches peaking in 2014...