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Coming just a few days after the U.S. Pharmaceutical Research and Manufacturers of America called laws in India governing intellectual property "weak," a report out from the subcontinent says the Indian Pharmaceutical Alliance is making moves to assuage concerns from the U.S. Trade Representative over its IP laws...The Indian group hopes to keep the USTR from downgrading the country's status to "priority foreign country" from its current "watch list" status so it can continue to enjoy certain trade preferences...The IPA...told the USTR that collaboration between Indian and U.S companies is on the rise, that India is removing "procedural hurdles" in the industry and that it is "sharing data" with U.S. reps to bridge "the gulf" between the two countries when it comes to IP protection for drugs...India plans to clear a backlog of patent applications that has been a concern to U.S. companies and said the country would hire 500 patent and design examiners to cut the time it took to process a patent application to one year...

Eli Lilly suffered a crushing defeat in the U.K. over patents for its lung cancer blockbuster Alimta (pemetrexed) as the U.K. High Court ruled in favor of Actavis' plan to market copycat versions of the med...The High Court's decision also applies to Actavis' generics in France, Italy and Spain...The company has a separate compound patent for the drug that expires in 2017. But certain patents for Alimta expire in 2021, and the latest ruling could throw a wrench in Lilly's plans to hold on to sales...Lilly is not pleased with the High Court's decision. "We strongly disagree with the ruling by the U.K. High Court" and "we plan to seek permission to appeal this ruling,"…The company has fared better with Alimta in the U.S., though. In August, a federal court ruled in favor of Lilly and granted the company 5 more years of U.S. exclusivity for the med. The court found that generic meds proposed by Teva Pharmaceutical Industries would infringe on Lilly's method patent for Alimta in combination with vitamins, allowing Lilly to hold on to the patent until 2022...

Theranos Inc. filed a plan to U.S. regulators to fix serious deficiencies at the company’s blood-testing lab in Newark, California, as founder Elizabeth Holmes works to regain credibility for her struggling startup...The company submitted the proposed plan of correction...to the Centers for Medicare and Medicaid Services...Theranos also confirmed the filing, though it didn’t release details of the plan...CMS said in late January that Theranos’s violations of federal regulations posed "immediate jeopardy" to patients’ health and safety...Walgreens Boots Alliance Inc. and...Capital BlueCross have said they’re curtailing use of Theranos’s tests while the shortcomings identified by CMS are addressed. Theranos has hired a new lab director and said it’s working quickly to correct other problems, including personnel issues, along with the defects tied to blood testing...

The arc of history is increasingly clear: health care is shifting focus from the volume of services delivered to the value created for patients, with "value" defined as the outcomes achieved relative to the costs...But progress has been slow and halting, partly because measurement of outcomes that matter to patients, aside from survival, remains limited. And for many conditions, death is a rare outcome whose measurement fails to differentiate excellent from merely competent providers. Experience in other fields suggests that systematic outcomes measurement is the sine qua non of value improvement. It is also essential to all true value-based reimbursement models being discussed or implemented in health care. The lack of outcomes measurement has slowed down reimbursement reform and led to hesitancy among health care providers to embrace accountability for results...The International Consortium for Health Outcomes Measurement has convened groups of experts on specific conditions, together with patient representatives, to outline minimum standard outcome sets and risk factors using a structured process...ICHOM has approved or is in the final stages of approval of more than 20 sets covering about 45% of disease burden in the United States...These standards are putting providers, payers, patients, and information technology vendors on a common path for tracking what needs to be tracked, making implementation of outcomes measurement easier and more efficient.

"Pharmacy Joe", is the host of The Elective Rotation – A Critical Care Pharmacy Podcast. He is a Critical Care Pharmacist, Preceptor, and Board Certified Pharmacotherapy Specialist who has been in practice for over 15 years. (podcast 20:20)

In the latest government effort to penalize unfair competition among drug makers, the United Kingdom fined GlaxoSmithKline $54.5 million for illegally colluding with generic rivals to delay marketing lower-cost versions of the Paxil antidepressant...the UK Competitions and Market Authority found that between 2001 and 2004, Glaxo made payments totaling about $72 million to several generic companies. The deals were reached as part of a settlement to end patent litigation that was filed by Glaxo against the generic drug makers...Such settlements are known as pay-to-delay, since a brand-name drug company pays cash or transfers something else of value to a generic rival, which agrees to delay launching a copycat medicine. In 2001, Paxil was a blockbuster with sales in the UK exceeding $130 million...In this instance, the agreement deferred competition and potentially deprived the UK’s National Health Service of a lower-cost generic Paxil. UK authorities noted that when a generic version of Paxil eventually became available at the end of 2003, average prices fell by more than 70 percent in two years...Cracking down on these practices is essential to protect consumers, to encourage legitimate business activity that such practices stifle, and to stimulate innovation and growth...

Cardinal Health Inc. said its new medication synchronization program...offers manifold benefits for community pharmacies in terms of patient care and efficiency...MedSync Advantage enables pharmacists to coordinate a patient’s prescriptions to be picked up on the same day each month…the program not only simplifies the process for patients and caregivers who must fill multiple prescriptions, but it also improves patient medication adherence by helping to ensure they fill all scripts each month...the number of prescriptions that a patient fills each month sharpens inventory management for the pharmacy and opens up more time for the pharmacy staff to focus on interacting with patients…We believe medication synchronization is a core competency for medication therapy management expansion in the pharmacy, and we want to prepare our pharmacies to move toward a value-based pharmacy model for payment in the future...It’s a win for the patient, and it’s a win for us because it evens out our workflow and helps us operate more efficiently...The most visible thing you get from medication synchronization is your time back…

A Super Bowl commercial paid for by AstraZeneca and Daiichi Sankyo to stimulate awareness of opioid-induced constipation continues to draw controversy...days after the big game. Since Sunday, a parade of politicians, physicians and pundits have criticized the ad, linking the campaign to the opioid prescription drug addiction problem...and forcing AZ and Daiichi, which market...Movantik (naloxegol), to defend it...Vermont Governor Peter Shumlin..."In the midst of America's opiate and heroin addiction crisis the advertisement was not only poorly timed, it was a shameful attempt to exploit that crisis to boost your companies' profits."...U.S. Pain Association..."In the current health care landscape, chronic pain patients are continually forced to 'prove' their pain. They face backlash and ridicule instead of compassion and help. U.S. Pain Foundation collaborated on this ad with other organizations to spread awareness and information...The goal--for all involved on this project--was to make sure people living with OIC do not feel embarrassed or alone...Did the pharmas get their money's worth, reported at $5 million per 30 seconds this year?...so far the ad has been mentioned more than 38,000 times on social media...in the past few days, according to real-time TV tracker iSpot.tv. It also had a 50% positive Tweet rating and has been viewed more than 2 million times online...

Express Scripts Holding Co. is carefully scrutinizing prescriptions for products made by Valeant Pharmaceuticals International Inc., making sure the pharmacy manager’s rules are being followed...We are looking at every single claim for their products...They are getting extra scrutiny...Valeant last year was accused of working with a network of pharmacies to boost sales of its drugs and get them reimbursed by health insurers and pharmacy benefit managers like Express Scripts, even when there were cheaper generics available...Express Scripts reviews prescription claims to ensure that the manufacturer and pharmacies are operating in a manner consistent with its contracts and in the best interests of its clients and patients...The reviews ensure that patients and payers aren’t spending more on the products than necessary...

The Department of Justice is investigating potential fraudulent claims and billing linked to specialty creams...that claimed to treat pain symptoms...investigators have claimed many of these specialty creams have little or no medicinal value...the issue is with the alleged false claims, not the compounds themselves...It's part of a larger issue of healthcare fraud...All these people submitting claims … for drugs that have absolutely no effectiveness. Are they doing it with knowledge, and seeking reimbursement for it? It's the modern day snake oil salesman...the International Academy of Compounding Pharmacies said the creams in question "benefit people and are non-addictive."...No charges have been filed...