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Public Consultation on the Post-market Review of Ezetimibe. Page last updated: 23 May 2017 Public Consultation: 23 May 2017 to 6 June 2017 The Department is now inviting submissions from interested stakeholders addressing the revised draft Report to the PBAC for this Review.

Public Consultation on the Post-market Review of Ezetimibe

The public submission process will be open for two weeks. Submissions must be lodged by 5pm Tuesday, 6 June 2017. Lodgement To ensure the successful lodgement of your submission please follow these steps: Complete and attach the Ezetimibe Review Submission Cover Sheet to your submission. Revised Draft Ezetimibe Post-market Review Report to the PBAC and Revised appendix E: Public Submissions addressing Draft Ezetimibe Post-market Review Report to the Pharmaceutical Benefits Advisory Committee (PBAC): 30 January 2017 to 10 February 2017 (closed) The Call for Submissions addressing the draft review report closed on 10 February 2017.

Submissions addressing the Stakeholder Forum Outcome Statement: 23 November to 25 November 2016 (closed) Disclaimer Privacy. Making $310 million of new vital drugs available for Australian patients > Greg Hunt MP, Federal Member for Flinders. Monday, 1 May 2017 The Turnbull Government is continuing to subsidise more life-changing and life-saving drugs on the Pharmaceutical Benefits Scheme (PBS) as part of our rock solid commitment to ensuring that Australians have access to vital medicines when they need them.

Making $310 million of new vital drugs available for Australian patients > Greg Hunt MP, Federal Member for Flinders

New medicines worth $310 million have been added to the PBS today. Ivacaftor (Kalydeco®) is now available for children aged two to five years with cystic fibrosis. It’s a life-changing drug that addresses the causes of cystic fibrosis rather than just the symptoms. Without government subsidy, the treatment would cost each patient around $300,000 per year. Kalydeco has been listed on the PBS since 1 December 2014, but until now has been restricted to patients aged six years and over affected by the cystic fibrosis G551D gene mutation.

Theconversation. This week, the government announced the latest additions, amendments, and deletions from the Pharmaceutical Benefits Scheme (PBS): the program through which essential medicines are subsidised for Australian patients.

theconversation

The new medicines on the scheme are reportedly worth A$310 million. Listing on the PBS is different to a drug being approved for sale by Australia’s drug regulator, the Therapeutic Goods Administration (TGA). Once approved by the TGA, it is available to patients and hospitals at the full price. It only becomes subsidised if later listed on the PBS. Some of the notable additions to the list include drugs to treat eye infections, human immunodeficiency virus (HIV), cystic fibrosis, multiple sclerosis, cancer, and idiopathic pulmonary fibrosis – a type of scarring in the lungs. 1.

Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. 5 Ways To Stop Rising Drug Prices Now. ‘Hedge-Fund Model’ Drug Pricing Needs New Law, Senators Say - Bloomberg. A U.S.

‘Hedge-Fund Model’ Drug Pricing Needs New Law, Senators Say - Bloomberg

Senate committee is calling for the government to stop the “monopoly business model” employed by some drug companies to exorbitantly raise the price of decades-old treatments in a report that could preview legislation next year. After a yearlong investigation, the Senate Special Committee on Aging, Chairwoman Susan Collins, a Republican from Maine, and Senator Claire McCaskill, a Democrat from Missouri, said that four drugmakers they looked at act more like hedge funds than pharmaceutical companies. The drugmakers in the report include Valeant Pharmaceuticals International Inc. and Turing Pharmaceuticals AG, which have both attracted criticism for price increases on older drugs that lack competition. “The hedge-fund model of drug pricing is predatory, and immoral for the patients and taxpayers who ultimately foot the bill -- especially for generic drugs that can be made for pennies per dose,” McCaskill said in a statement. Legislation Shkreli Comments.

Theconversation. A recent Sunday Times expose of drug price rises in the NHS revealed that drug companies were exploiting a loophole that allowed them to charge up to 2,358% more for medicines through a process called “debranding”.

theconversation

Because the NHS has strict rules governing how much it will pay for branded drugs, some pharma companies were able to charge more by essentially re-categorising them. The report suggested that, among other examples, phenytoin sodium capsules, used to treat epilepsy, had gone from costing the NHS £2.3m before it was debranded to just over £50m in 2013. The finger of blame was pointed at the usual villain – the pharmaceutical industry.

But while drug companies might be to blame for finding loopholes in price-capping rules, the question we should be asking is: what does this tell us about how health is being managed in the UK? Macquarie University - Training. Introduction to health economic evaluation Introduction to health economic evaluation This course will introduce attendees to key concepts used in the economic evaluation of health care interventions and programs, and how this information can inform policy decisions.

Macquarie University - Training

Cra comparative analysis. Database Access - UNSW Library. Rogs 2017 volumee chapter10. Real-World Revolution. Part 1 of a 2 part series: Unlock valuable insights throughout the lifecycle Pharma is undergoing an ‘evidence revolution’ as real-world evidence breaks out from the confines of market access and infiltrates every part of the life of a medicine, from discovery through to late-stage commercial.

Real-World Revolution

This revolution has, in part, been driven by technology – by the availability of electronic patient-level data and the ability to analyze it – and, in part, by market trends, as stakeholders clamor for ever more reliable proof of the value of new medicines. “Few people yet realize the capabilities of the new data-collection technologies and how they can impact not only clinical research but also discovery research.

They can transform the entire biomedical research enterprise, making innovation faster, more powerful and radically cheaper,” says Bernard Munos, Senior Fellow at FasterCures, an ‘action tank’ focused on speeding new therapies to market. Questions abound. The Impact of Reimbursement Policies and Practices on Healthcare Technology Innovation. Competitive Development in Pharmacologic Classes: Market Entry and the Timing of Development - DiMasi - 2016 - Clinical Pharmacology & Therapeutics. In New Survey Of Eleven Countries, US Adults Still Struggle With Access To And Affordability Of Health Care.

+ Author Affiliations ↵*Corresponding author Surveys of patients’ experiences with health care services can reveal how well a country’s health system is meeting the needs of its population.

In New Survey Of Eleven Countries, US Adults Still Struggle With Access To And Affordability Of Health Care

Using data from a 2016 survey conducted in eleven countries—Australia, Canada, France, Germany, the Netherlands, New Zealand, Norway, Sweden, Switzerland, the United Kingdom, and the United States—we found that US adults reported poor health and well-being and were the most likely to experience material hardship. The United States trailed other countries in making health care affordable and ranked poorly on providing timely access to medical care (except specialist care). In all countries, shortfalls in patient engagement and chronic care management were reported, and at least one in five adults experienced a care coordination problem.

GetSharedSiteSession?rc=4&redirect= FullReport hta20620. FullReport hta20390. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Uptake of new medicines in New Zealand: evidence of a waiting list - New Zealand Medical Journal. Worldwide, the Health Technology Assessment (HTA) Agencies responsible for pharmaceutical funding share the common goal of maximising health benefits funded, while limiting financial costs.

Uptake of new medicines in New Zealand: evidence of a waiting list - New Zealand Medical Journal

In New Zealand, this role is fulfilled by the Pharmaceutical Management Agency (PHARMAC). Established in 1993, PHARMAC was charged with the responsibility of finding new ways to manage pharmaceutical expenditure while obtaining the best health outcomes for New Zealand. As a Crown entity, PHARMAC is relatively independent of Ministerial control, and reports only according to its legislated mandate. The primary expert clinical committee that advises PHARMAC which medicines to fund, and with what priority, is the Pharmacology and Therapeutics Advisory Committee (PTAC). Box 1. Paying for costly pharmaceuticals: regulation of new drugs in Australia, England and New Zealand. The rising cost of pharmaceuticals has prompted concern globally, leading various countries to institute arrangements to control public coverage and costs generally.1 Among the longest established schemes are those in Australia, existing since 1987,2,3 and in New Zealand, since 1993.

Paying for costly pharmaceuticals: regulation of new drugs in Australia, England and New Zealand

The United Kingdom established the National Institute for Health and Clinical Excellence (NICE) in 1999. Although the processes used in these countries have been described,4-6 their decisions on whether to fund drugs with low cost-effectiveness have not been formally compared. Pharmaceutical funding criteria in the UK, Australia and NZ. Database Access - UNSW Library. Toward a treaty on safety and cost-effectiveness of pharmaceuticals and medical devices: enhancing an endangered global public good.

Database Access - UNSW Library. Database Access - UNSW Library. Measuring Access to Medicines: A Survey of Prices, Availability and Affordability in Shaanxi Province of China. Abstract Objective. Cost-Utility Analysis of Lurasidone Versus Aripiprazole in Adults with Schizophrenia. Schizophrenia is a chronic and disabling mental health condition resulting in progressive neurocognitive dysfunction, leading to alterations in perception, thoughts, mood and behaviour [1]. It has a lifetime risk of approximately 1 % and has a significant health, emotional and social impact on the patient, leading to social isolation, disability and dependence, unemployment and, in extreme cases, imprisonment and homelessness [2, 3].

The condition has a significant financial burden; in England, the total combined annual cost to society and the public sector was estimated to be £19 billion in 2010/11 [4]. The mainstay of current treatment for acute schizophrenic episodes, symptom reduction, and relapse prevention in patients with schizophrenia is antipsychotic medication [5]. Should pharma scrap per-pill pricing completely? What if, instead of cutting drug prices, the pharma industry threw out the rulebook altogether? That’s just what a European trade group is proposing, Reuters reports, in a plan that would dump per-pill or per-treatment pricing in favor of results-based payments. The “roadmap for change toward outcomes-based reward systems” sets out the benefits of hitching drug costs to real-world results.

Rather than fighting with cost-effectiveness gatekeepers over sticker prices, payment deals would be negotiated to reflect a drug’s payoffs for patients--and for payers, in instances where treatments may cost dearly up front but save even more money by preventing hospitalizations and other costly treatments down the line. The document was seen by Reuters ahead of a discussion by the European Federation of Pharmaceutical Industry Associations board next week. "This is not without risk," according to the paper, written by Efpia's director of market access Francois Bouvy (as quoted by the news service). Australian Health Review. References [1] Gabriel SE, Normand SL.

Getting the methods right: the foundation of patient-centered outcomes research. N Engl J Med 2012; 367: 787–90. | CrossRef | CAS | PubMed | [2] Oliver S, Liabo K, Stewart R, Rees R. Sixth Interim Report (Big health data: Australia's big potential) PBS and RPBS Section 85 Date of Processing and Date of Supply Data. Page last updated: 26 May 2016 These reports contain detailed information on the number of prescriptions, total cost, government and patient contributions to total cost, and the derived pharmacy mark-up for PBS and RPBS Section 85 prescriptions supplied in Australia. Totals for each of these quantities are provided by PBS item code, patient category, and month.

Reports by both date of processing and date of supply are provided. Please see the explanatory notes for details on the differences between these. These reports are updated each month, once new data is available. Discussion papers - HEDS - Sections - ScHARR. 1501. EQ 5D 5L UserGuide 2015. What is a Hidden Markov Model? Introduction. Noble Pharma Consulting. Realising the Value of Linked Data to Health Economic Analyses of Cancer Care: A Case Study of Cancer 2015. Big Data and Its Role in Health Economics and Outcomes Research: A Collection of Perspectives on Data Sources, Measurement, and Analysis.

The Limits of Cost-Effectiveness Analysis. Rwtfmanuscript. Andreas M Pleil. Rwe issue brief final. Illuminate Health Consulting. Medical Librarian Frances is a highly skilled and well-published medical librarian with over 35 years’ experience in her field including positions in a teaching hospital, the pharmaceutical industry, and medical education and publishing. Risk-Sharing Arrangements That Link Payment For Drugs To Health Outcomes Are Proving Hard To Implement. Insurers push to link cost of drugs to performance. Health insurers are pushing to link the cost of specialty medicines to how well they work to improve a patient’s condition, a bid to contain prescription drug prices after decades in which pharmaceutical companies could charge whatever the market would bear.

Novartis, Roche find 'outcome-based' drug pricing an elusive dream. International medicine pricing. PHARMAC’s job is to provide the best health outcomes from within the funding provided. We can do that, as a small country in a big market, because we can encourage competition and, ultimately, have the power to say no to pricing being offered. Increasingly, other countries are thinking they need something along these lines too. Database Access - UNSW Library. 1 s2.0 S1098301515000121 main. GetSharedSiteSession?rc=1&redirect= To view the full text, please login as a subscribed user or purchase a subscription.

Click here to view the full text on ScienceDirect. Fig. 1. WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies. Prepaccessnow. Businessspectator.com. †Introductory offers to be billed 4 weekly as per the following - Business Spectator Digital Subscription $4 per week to be billed as $16 4-weekly; Business Spectator Digital Subscription + The Weekend Australian (delivered Saturday) $4 per week to be billed as $16 4-weekly; Business Spectator Digital Subscription + 6 day paper delivery $8 per week to be billed as $32 4-weekly. 2015 IGR. Cost Recovery, Fees and charges - Frequently Asked Questions. Page last updated: 27 August 2015 What is PBS cost recovery? From 1 January 2010, Amendments to the National Health Act 1953 provide authority for the cost recovery of services provided by the Commonwealth from applicants seeking new, or changes to existing, listings of medicines, vaccines and other products or services on the PBS or NIP.

The operational processes of PBS cost recovery are prescribed by the National Health (Pharmaceuticals and Vaccines – Cost Recovery) Regulations 2009. Theconversation. Myriad Revisited – Morality and the Patent Law ~ patentology. Watermark: Intellectual Asset Management. Why TPP Threatens To Undermine One Of The Fundamental Principles Of Science. Theconversation. Database Access - UNSW Library. Arès Life Sciences. Review of Research Policy and Funding Arrangements. 823-Premium-Policy4.pdf. Improving the Legitimacy of Medicines Funding Decisions. Submissions. Intll Society For Pharmacoeconomics Research. CEA Registry Website > Home - Blog. #2 Drug Discovery Re-Invented 2015. Big Data Analytics in Pharma - How to Create a Competitive Advantage with Big Data Analytics in Pharma.

Sanofi-Sunrise. Untitled. Untitled. Untitled. Efficiency in Health - Productivity Commission. Database Access - UNSW Library. Percentage of global R&D spending 2014, by industry. 2014_global_rd_funding_forecast. Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Abstract?_returnURL= Database Access - UNSW Library. Database Access - UNSW Library. Database Access - UNSW Library. Post-Market Reviews of Pharmaceutical Benefits Scheme Subsidised Medicines. Pharmaceutical Benefits Scheme (PBS) Essential Medicines and Health Products Information Portal. Opinions - Supreme Court of the United States. New award to recognise success in science. Australian Innovation System - annual series.

5.6 Reimbursement Strategy. FA0214BDF86B488FAB31255373CD5FE1.