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Drug pricing

Molly Billstein Leber
With the passing and implementation of the Biologics Price Competition and Innovation Act in 2010, biosimilars became a new classification of FDA-approved drugs. The biosimilar classification, created with a streamlined drug approval process, was intended to spur competition and reduce the cost of biological product therapies. Since the first FDA-approved biosimilar in 2015, the impact of biosimilars on the US biological product market remains to be seen. As more biosimilar products are approved and marketed, cost-savings are expected with predictions ranging from $54 billion to $250 billion by the mid-2020s...
November 2018: American Journal of Managed Care
Brian K Chen, Y Tony Yang, Charles L Bennett
Biologics and biosimilars are medicines made from living cells that treat common and serious diseases such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. They are highly targeted, efficacious, and represent an increasingly important part of physicians' armamentaria in the combat against these medical conditions. Yet they are extremely expensive, costing on average $10,000-$30,000 per year and exceed $500,000 for the most expensive biologics. The advent of biosimilar drugs, or high similar copies of biologics, was supposed to help reduce costs, but thus far the cost of treatment with biologics or biosimilars has not fallen sharply in the USA...
November 16, 2018: Drugs
Qiang Xiao, Natalie A Bécar, Nathaniel P Brown, Mason S Smith, Kimberlee L Stern, Steven R E Draper, Katherine P Thompson, Joshua L Price
Hydrocarbon stapling and PEGylation are distinct strategies for enhancing the conformational stability and/or pharmacokinetic properties of peptide and protein drugs. Here we combine these approaches by incorporating asparagine-linked O-allyl PEG oligomers at two positions within the β-sheet protein WW, followed by stapling of the PEGs via olefin metathesis. The impact of stapling two sites that are close in primary sequence is small relative to the impact of PEGylation alone and depends strongly on PEG length...
November 16, 2018: Organic & Biomolecular Chemistry
Svetlana B Tikunova, Andres Cuesta, Morgan Price, Monica X Li, Natalya Belevych, Brandon J Biesiadecki, Peter J Reiser, Peter M Hwang, Jonathan P Davis
Despite extensive efforts spanning multiple decades, the development of highly effective Ca2+ sensitizers for the heart remains an elusive goal. Existing Ca2+ sensitizers have other targets in addition to cardiac troponin (cTn), which can lead to adverse side effects, such as hypotension or arrhythmias. Thus, there is a need to design Ca2+ -sensitizing drugs with higher affinity and selectivity for cTn. Previously, we determined that many compounds based on diphenylamine (DPA) were able to bind to a cTnC-cTnI chimera with moderate affinity (Kd ∼10-120 µM)...
November 15, 2018: Journal of General Physiology
Chintan V Dave, Ajinkya Pawar, Erin R Fox, Gregory Brill, Aaron S Kesselheim
BACKGROUND: Prescription drug shortages can disrupt essential patient care and drive up drug prices. OBJECTIVE: To evaluate some predictors of shortages within a large cohort of generic drugs in the United States and to determine the association between drug shortages and changes in generic drug prices. METHODS: This was a retrospective cohort study. Outpatient prescription claims from commercial health plans between 2008 and 2014 were analyzed...
November 2018: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
James Signorovitch, Zhou Zhou, Jason Ryan, Rachel Anhorn, Anita Chawla
AIMS: Broad molecular profiling of patients with advanced non-small cell lung cancer (NSCLC) is strongly advised to optimize genomic matching with available targeted treatment options or investigational agents. Unlike conventional molecular diagnostic testing, or smaller hotspot panels, comprehensive genomic profiling (CGP) identifies genomic alterations across hundreds of clinically relevant cancer genes from a single tissue specimen. The present study sought to estimate the budget impact of increased use of CGP using a 324-gene panel (FoundationOne®) versus non-CGP (represented by a mix of conventional molecular diagnostic testing and smaller NGS hotspot panels) and the number needed to test with CGP to gain 1 life year...
November 15, 2018: Journal of Medical Economics
Stacie B Dusetzina, Michelle M Mello
No abstract text is available yet for this article.
November 14, 2018: New England Journal of Medicine
Pantea Tajik, Amir Hossein Goudarzian, Mahdi Shadnoush, Bahador Bagheri
Aim: The present study is aimed to investigate the effect of red sugar on functional constipation in children compared to figs syrup. Background: Treatment of constipation in childhood improves gastrointestinal function in the future and regular bowel habit. Red sugar is an effective ingredient in the treatment of constipation. Figs syrup is the other common natural substance used to treat constipation in children. Conducted studies on these two substances and similar herbal substances have shown their beneficial effects, but in a conducted study, it is reported that the effect of fig syrup is less than the chemical material...
2018: Gastroenterology and Hepatology From Bed to Bench
Eun-Young Bae
South Korea is the first Asian country to mandate the submission of pharmacoeconomic data for reimbursement decision making. For a new drug to be listed, it must demonstrate its value in terms of comparative effectiveness and cost effectiveness. The Health Insurance Review and Assessment Service (HIRA) judges the submitted drug's value and decides whether its coverage is appropriate on the basis of the recommendation of the Pharmaceutical Benefit Coverage Assessment Committee. Once the drug has been accepted by HIRA, the National Health Insurance Service and the sponsoring company negotiate the price and expected sales volume...
November 9, 2018: Value in Health Regional Issues
G Anil Kumar, Rakhi Dandona, Bharat B Rewari, S G Prem Kumar, Sukarma Tanwar, Marielle C Gagnier, Venkata S Vishnumolakala, Lalit Dandona
INTRODUCTION: India has scaled-up antiretroviral treatment (ART) in public sector facilities, but data to understand time trends of average cost of ART are limited. MATERIALS AND METHODS: Cost and output data were collected at all public sector ART centres in undivided Andhra Pradesh (high-HIV burden state) and Rajasthan (low-HIV burden state) in India from fiscal year 2007-2008 to 2012-2013. Average cost per patient for first-line ART, and its relation with scale of services, were assessed...
2018: PloS One
Haya I Aljohar, Hadir M Maher, Jawza Albaqami, Maha Al-Mehaizie, Rawan Orfali, Razan Orfali, Sarah Alrubia
Honey is becoming accepted as a reputable and effective therapeutic agent by practitioners of conventional medicine and by the general public. It has many biological activities and has been effectively used in the treatment of many diseases, e.g. gastrointestinal diseases, skin diseases, cancer, heart diseases, and neurological degeneration. Honey is an excellent source of energy containing mainly carbohydrates and water, as well as, small amounts of organic acids, vitamins, minerals, flavonoids, and enzymes...
November 2018: Saudi Pharmaceutical Journal: SPJ: the Official Publication of the Saudi Pharmaceutical Society
Amir Shlomai, Moshe Leshno, Daniel A Goldstein
BACKGROUND AND AIMS: Hepatocellular carcinoma (HCC) is one of the leading causes of cancer related deaths. Patients with advanced HCC are treated with sorafenib. A recent randomized controlled trial demonstrated a survival benefit for regorafenib treatment in patients with advanced HCC who had progressed on sorafenib. We aimed to evaluate the cost-effectiveness of this approach. METHODS: To evaluate the cost effectiveness of regorafenib, we used a Markov model that incorporates health outcomes, measured by life-years and quality-adjusted life-years (QALYs)...
2018: PloS One
Venkataswarup Tiriveedhi
The pricing of targeted medicines continues to be a major area of contention in healthcare economics. This issue is further complicated by redefining the role of molecular testing in precision medicine. Currently, whilst pricing of clinical laboratory diagnostics is cost-based, drug pricing is value-based. The pricing for molecular testing is under pressure to change the traditional business model, for it has a critical subsidiary role in determining the final value of targeted medicines. The market size for drugs is reduced by molecular testing when patients with the same disease are stratified based on their genetics, it is critical to determine the value of this new enhanced drug specificity to realize its full pricing potential...
November 5, 2018: Journal of Personalized Medicine
Kufreobong E Inyang, Thomas Szabo-Pardi, Emma Wentworth, Timothy A McDougal, Gregory Dussor, Michael D Burton, Theodore J Price
Metformin is a widely prescribed drug used in the treatment of type II diabetes. While the drug has many mechanisms of action, most of these converge on AMP activated protein kinase (AMPK), which metformin activates. AMPK is a multifunctional kinase that is a negative regulator of mechanistic target of rapamycin (mTOR) and mitogen activated protein kinase (MAPK) signaling. Activation of AMPK decreases the excitability of dorsal root ganglion neurons and AMPK activators are effective in reducing chronic pain in inflammatory, post-surgical and neuropathic rodent models...
November 1, 2018: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
Nigel S B Rawson
The Canadian federal government has proposed significant revisions to the way its patented medicines price regulator assesses the excessiveness of medication prices that are to take effect in 2019. The changes have the potential to decrease Canada's attractiveness as a market for innovative medicines. The objective of this analysis was to compare the number of new drugs given regulatory approval in Canada between 2002 and 2017 with the number in New Zealand and, of those approved in both countries, to compare approval dates...
November 1, 2018: Regulatory Toxicology and Pharmacology: RTP
Montu Bose, Arijita Dutta
BACKGROUND: To achieve the Sustainable Development Goals, Indian States have implemented different strategies to arrest high out-of-pocket expenditure (OOPE) and to increase equity into healthcare system. Tamil Nadu (TN) and Rajasthan have implemented free medicine scheme in all public hospitals and West Bengal (WB) has devised Fair Price Medicine Shop (FPMS) scheme, a public-private-partnership model in the state. In this background, the objectives of the paper are to - 1. Study the utilization pattern of public in-patient care facilities for the states, 2...
November 3, 2018: BMC Health Services Research
L Kandolf Sekulovic, J Guo, S Agarwala, A Hauschild, G McArthur, G Cinat, A Wainstein, C Caglevic, P Lorigan, H Gogas, M Alvarez, R Duncombe, C Lebbe, K Peris, P Rutkowski, A Stratigos, A-M Forsea, L De La Cruz Merino, M Kukushkina, R Dummer, C Hoeller, C Gorry, L Bastholt, D Herceg, B Neyns, R Vieira, P Arenberger, M Bylaite-Bucinskiene, N Babovic, M Banjin, K Putnik, V Todorovic, K Kirov, J Ocvirk, A Zhukavets, A Ymeri, I Stojkovski, C Garbe
According to data from recent studies from Europe, a large percentage of patients have restricted access to innovative medicines for metastatic melanoma. Melanoma World Society and European Association of Dermato-oncology conducted a Web-based survey on access to first-line recommended treatments for metastatic melanoma by current guidelines (National Comprehensive Center Network, European Society for Medical Oncology [ESMO] and European Organization for Research and Treatment of Cancer/European Association of Dermato-oncology/European dermatology Forum) among melanoma experts from 27 European countries, USA, China, Australia, Argentina, Brazil, Chile and Mexico from September 1st, 2017 to July 1st, 2018...
October 30, 2018: European Journal of Cancer
Daniela Moye-Holz, Rene Soria Saucedo, Jitse P van Dijk, Sijmen A Reijneveld, Hans V Hogerzeil
Background: Cancer has become the third cause of death in Mexico. Treatment for cancer is often complex and lengthy. New and better medicines enter the market at high prices, which may limit access. Like most Latin American countries, Mexico has an essential cancer medicines list that includes innovative medicines. Their accessibility and use in the public sector remains unknown. Therefore, we describe the use, as a proxy of access, of innovative and essential cancer medicines in the public sector in Mexico, by insurance institution, and by five regions between 2010 to 2016...
2018: Journal of Pharmaceutical Policy and Practice
Monica Hildegard Otto, Carla Pillarella, Claudio Jommi
The paper analyses the potential economic impact of switching drugs from prescription-only to over the counter status, using Italy as a case-study. The study assumes a societal perspective, investigating the effects of switches (and consequent delisting) on drugs spending, avoided visits by GPs (General Practitioners) and avoided time spent by patients for these visits. It overcomes the main pitfalls of previous studies, providing a rational for listing switchable products and applying both a static (no impact of switch on prices and volumes consumed) and a dynamic approach (impact on pricing policies and volumes depending on price-elasticity)...
2018: Frontiers in Pharmacology
Carlos Del Rio, Wendy S Armstrong
In no field of medicine has advocacy, including physician advocacy, been more crucial in shaping policy for delivery of care than in HIV/AIDS. Although the historic tradition is strong, there is an urgent need to re-energize advocacy efforts nationally and internationally to support programs that fund care, change policies that perpetuate stigma and discrimination, and change the public perception that the HIV/AIDS crisis is over. Established programs that require ongoing advocacy attention include the Ryan White Comprehensive AIDS Resources Emergency Act, a US program that serves as a payer of last resort for care for patients with HIV infection, and international programs like the President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund to Fight AIDS, Tuberculosis and Malaria...
September 2018: Topics in Antiviral Medicine
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