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NHS 111 and GP out-of-hours services are to be brought much closer together under a fundamental redesign of urgent care delivery throughout the National Health Service…NHS England said the new "front door" will offer patients simpler and better access to urgent care through a novel 24/7 clinical assessment, advice and treatment service via the 111 number, streamlining provision around the country… reshaping urgent care stem from NHS England’s ongoing Urgent and Emergency Care Review, and come as local health services are responding to the highest ever number of ambulance calls, A&E attendances and emergency admissions in NHS history, with even more demand expected through the coming winter months…Last winter several hospitals in England were forced to declare a ‘major incident’ and close their doors as they struggled to cope with the influx of patients, and A&E waiting times were the worst in a decade, underscoring the need for a new system.

This issue brief provides an overview of the 2016 PDP marketplace, focusing on key changes from 2015…Many will see higher premiums and deductibles…highlights include:

• beneficiaries in each region will have a choice of 26 PDPs, on average,
• average PDP premium…to increase by 13 percent…from $36.68 to $41.46 per month…largest since 2009
• More than one-third of the 11.2 million PDP enrollees who do not receive Low-Income Subsidies would pay premiums of $60 or more per month…
• Nearly 4.4 million of these enrollees not receiving the LIS face a premium increase of at least $10 per month...
• Two-thirds of all PDPs will have deductibles…a higher share than in previous years. A growing share of PDPs will impose the maximum deductible…to $360..the largest increase in the deductible since the start of the program
• Most PDPs charge coinsurance, rather than flat copayments, for non-preferred brand-name and specialty drugs, which could lead to higher out-of-pocket costs for those who use high-cost drugs.
• Nearly all PDPs use tiered pharmacy networks, with lower cost sharing in selected network pharmacies and higher cost sharing in other network pharmacies, a significant increase
• Beneficiaries receiving the LIS will have access to 7 plans for no monthly premium…fewer than in any past year.

Now that Bristol-Myers Squibb has settled its foreign bribery case with the US government, speculation has turned to which pharma company will be next…Department of Justice will being putting a bigger squeeze on companies…the department is adding to the resources devoted to investigating foreign bribery cases and is focusing on large-value, high-impact matters…Glaxo is a leading example. It paid the largest healthcare fraud settlement ever – $3 billion – to the US in 2012 to resolve criminal and civil allegations of improper marketing practices...Glaxo’s Chinese subsidiary paid nearly $500 million to China after a court found the local subsidiary guilty of bribing healthcare officials. Glaxo is likely to pay millions more to settle bribery charges as both US and UK regulators are investigating the drugmaker’s practices in China, Poland, Jordan and Lebanon.

The…practice at pharmacies and outsourcing facilities of storing sterile compounded preparations or repackaging sterile pharmaceuticals in drug-administration syringes is actually an unapproved use of these medical devices…"FDA has not cleared or approved any syringes for stand-alone use as ‘closed container systems,’"…Syringe maker Becton, Dickinson and Company…stated that it does not test the performance of its general purpose syringes as storage containers for compounded pharmaceuticals….pharmacies that want to store their own compounded or repackaged sterile preparations in general purpose syringes have two choices:

1. "Test every drug at every concentration that you use and in every size syringe that you use" or
2. rely on the results of published stability studies "if you have the exact same syringe, the exact same concentration, and the exact same drug and you…handle it and store it just like the drug in the study was stored."

Cost regulators for health technologies funded by the National Health Service in England and Wales have rejected a novel treatment for the genetic condition Duchenne Muscular Dsytrophy, seeking more data from the firm to confirm its benefit and justify its high cost...PTC Therapeutics’ Translarna (ataluren) is the first licensed treatment for DMD that addresses the loss of dystrophin, the underlying cause of the condition…NICE has recognised that the drug represents "an important development in the treatment of DMD and could potentially prolong the time before children have to use a wheelchair"…data…show that the therapy failed to achieve its main goal of significantly improving the distance achieved by patients in the standard six-minute walk test….the firm’s task of justifying the £220,256 ($340,000) per patient per year cost of the drug just got somewhat harder.

Combination products – medical products that do not fit into the traditional categories of drugs, devices, or biological products – are a growing and important category of therapeutic and diagnostic products under FDA’s regulatory authority…These products, that combine drugs, devices, and/or biological product ("constituent parts") with one another… Products in this category range from familiar products such as prefilled syringes and surgical kits to novel and innovative products, which target and enhance therapies. Examples of groundbreaking combination products include antibodies combined with drugs for targeted cancer therapy and products that mimic or replace organs, such as an artificial pancreas….we’re taking a number of steps to clarify regulatory requirements and improve our internal processes and IT systems.

• Issuing more guidance for review of combination products (e.g., our pending draft guidance document on human factors);
• Enhancing and simplifying data access and sharing for internal staff;
• Making it easier for staff to request and monitor inter-center consults;
• Updating and maintaining our internal contact directory for experts to review a combination product; and
• Improving our internal standard operating procedures for premarket reviews and compliance activities.

Department of Agriculture…said it has awarded contracts to two drug companies to manufacture doses of avian influenza vaccine for poultry, in preparation for the potential return of the fast-spreading avian influenza virus later this year…The two contracted firms - Iowa-based Harrisvaccines, and France-based Ceva Corp. - will manufacture an undisclosed number of vaccine doses…The agency's Animal and Plant Health Inspection Service has not approved the use of an avian influenza vaccine in birds, and has not made a decision whether to use such vaccines in a future outbreak..

Australia is altering its drug laws to allow for the cultivation of marijuana for medicinal and scientific purposes, removing a major hurdle to the establishment of clinical trials of the drug, the government said…Draft amendments to the Narcotics Drugs Act are being finalised to allow for the controlled cultivation of marijuana, giving patients access to "a safe, legal and sustainable supply of locally produced products for the first time,"…Australian manufacturers, researchers and patients currently have to access international supplies of legal medicinal marijuana, with cost, limited supply and export barriers making this challenging.

..majority of healthcare professionals in the UK support greater transparency on payments received from pharmaceutical companies, but some feel the move could make working with the industry more difficult…87% agreed that payments from pharma to individually named healthcare professionals should be disclosed…32% of healthcare professionals surveyed feel the disclosure of individual payments is unnecessary, while 26% believe that doing so will adversely affect medical innovation… survey results come as pharmaceutical companies gear up to unveil payments and other ‘transfers of value’ …on a publicly accessible database…the new ‘Sunshine rule’, which comes into force next year, NHS staff who fail to disclose perks received from drug companies could face being disciplined, dismissed or even sent to jail for breach of the Bribery Act.

With two dozen scheduled executions in limbo, Ohio sent a forceful letter to Washington… asserting that the state believes it can obtain a lethal-injection drug from overseas without violating any laws…stopped short of suggesting Ohio is moving forward to obtain the powerful sedative sodium thiopental…the state asked to begin discussing with federal officials about acquiring the substance legally…FDA had warned Ohio in June that importing the restricted drug could be illegal…setting up the latest roadblock that Ohio and several other states have faced in carrying out the death penalty…States have struggled to obtain lethal injection drugs since pharmaceutical companies discontinued the medications they traditionally used or put them off limits for executions…"My sense is that the Food and Drug Administration…was never designed to create an additional impediment to states trying to carry out lawful sentences,"…