- Specialty Pharmacy Times – Health Policy Check-Up (pharmacypodcast.com)
Dan Steiber, Editor in Chief for Specialty Pharmacy Times, speaks to True North P.S. President, Ron Lanton. What is limited distribution and its effect on specialty? What are the risks in arrangements between specialty pharmacies and manufacturers? (podcast 44:12 min)
- Pricing Power – Big pharmacies are dismantling the industry that keeps US drug costs even sort-of under control (qz.com)
When US lawmakers convened a hearing last month to discuss the pricing of prescription drugs, it was the testimony of Martin Shkreli...that garnered the headlines. But the hearing also looked at an issue that...could make drugs more expensive for far more people…The impetus was October’s announcement from Walgreens...that it was buying Rite Aid...Critics said that would create a drugstore duopoly with CVS, the market leader. They didn’t, however, look as hard at another effect of the deal, which likely will bring about the final collapse of the industry tasked with keeping prescription-drug costs under control...Buried inside Rite Aid is a bundle of pharmacy benefit managers...Walgreens says that acquiring Rite Aid’s PBMs would help it compete with arch-rival CVS, which controls a large and extremely profitable PBM called Caremark...combining pharmacies and PBMs under one roof creates a conflict of interest. It can restrict patients’ access to certain prescription drugs, and can prevent independent drugstores from competing fairly for new customers...As "competition decreases,"..."prices are going to increase. That’s what we’re finding now." If Walgreens successfully acquires Rite Aid and its PBMs, one of the industry’s last remaining constraints on drug prices will disappear.
- Bearish case for Valeant (video.cnbc.com)Five Lessons Big Pharma Should Learn From Valeant's Collapse (forbes.com)The Trouble With Female Libido Pill Is a Symptom of Valeant Woes (bloomberg.com)
Les Funtleyder, Asset Management Portfolio Manager at ESquared, gives his take on Valeant Pharmaceuticals and the pharma and health care sectors.
- When fools march in (washingtonexaminer.com)
National Institutes of Health officials just wisely rejected a petition, supported by 51 congressmen, to exercise "march-in" rights to discourage drug "price-gouging." The proposal didn't merely violate the explicit intent of a decades-old statute — the Bayh-Dole Act — it also revealed the legislators' ignorance of drug development and would have devastated medical innovation, while doing nothing to bring down drug costs...The act allows the federal government to "march in" and seize the intellectual property rights of the inventor and grant a license to "a responsible applicant or applicants" under two highly unlikely conditions...First, if the patentee and its licensee have not taken effective steps to achieve "practical application" of the subject invention — in other words, if they're just sitting on it — the government can license the patent to someone who will develop it...The second condition is met when government action is necessary to alleviate health or safety needs that are not being satisfied by the rights holder...march-in rights would not necessarily lower drug prices. March-in rights do not empower the government to control prices — they only allow the NIH to increase competition by giving additional companies the right to utilize drug patents that were directly derived from the government-funded research...Encouraging the government to seize patent rights in a non-emergency situation is a great way to discourage firms from developing and producing any new drugs...
- Myths and Hysteria Surrounding the Use of Opioids for Non-cancer Pain (pharmacytimes.com)
Jeffrey Fudin, PharmD, DAAPM, FCCP, FASHP, discusses and debunks the myths and hysteria surrounding the use of opioid therapy in treating non-cancer pain.
- How Medicare Part B ‘Value-Based Pricing’ Would Work (realclearhealth.com)Obama proposal to revamp Medicare Part B faces more opposition (statnews.com)
...Centers for Medicare & Medicaid Services spends $20 billion a year for drugs under Part B, which are those given in doctors’ offices and hospital outpatient centers. Many cancer treatments are provided that way, as are some treatments for rheumatoid arthritis, macular degeneration...Under a proposed rule, different methods would be tried in selected geographic areas over a five-year test period. Some of these experiments would begin this year, with others added in 2017...Dubbed "value-based pricing," such largely unproven ideas are the latest tactics being tried to slow growth in prescription drug spending amid rising public alarm about drug prices...The goal is to test whether alternative approaches will lead to better value...There is no perfect payment system, they all have upsides and downsides...What we don’t want to do is create a world where doctors only prescribe the cheapest stuff even if not in the interest of the patient...Here are four concepts the government is investigating:
- Cut drug reimbursements for doctors and outpatient hospital centers.
- Level payments.
- Tie payments to effectiveness.
- Cut patients’ out-of-pocket costs.
- Amgen Bests Regeneron in Patent Fight Over Cholesterol Drugs (bloomberg.com)
Amgen Inc. won a legal victory over Regeneron Pharmaceuticals Inc. in an intellectual property battle over their cholesterol-reducing drugs. Regeneron said it would appeal the decision...A federal jury...rejected Regeneron’s challenges and ruled in Amgen’s favor that two of its patents on its drug, Repatha (evolocumab), were valid...Sanofi and Regeneron said after the verdict that they plan to appeal, reiterating their position that Amgen’s patent claims are invalid. They had claimed that Amgen hasn’t fulfilled requirements to describe clearly what it had invented in a way that others could understand...Amgen...is thankful that the jury weighed the evidence carefully and recognized the validity of Amgen’s patents on Repatha...With the decision, Regeneron and Sanofi are liable for royalties...The companies may reach a settlement with Amgen...
- Nevada’s graduating medical students matched to residency programs (rgj.com)Nevada native staying local, staying rural (medicine.nevada.edu)Medical students celebrate Match Day at Las Vegas ceremony (reviewjournal.com)School of Medicine’s Class of 2016 learns residency match results (medicine.nevada.edu)
University of Nevada School of Medicine matched 64 of its graduating class with residency programs all over the country Friday morning. The reveal on where students will do residency programs was a surprise until each opened boxes listing programs...Kaleb Wartgow was one of the nearly 30,000 medical students in the U.S. matched to residency programs at hospitals around the country...But Wartgow...from the 2016 graduating class of the University of Nevada School of Medicine, is likely just one of a few absolutely sure he wants to someday practice family medicine in rural Nevada...He was one of 64 from...the...class of 2016 that found out Friday where they will spend the next few years of training. Wartgow, who grew up in Gardnerville and is a 2006 graduate of Douglas High, said he hopes to someday practice medicine in Smith Valley...
- Pharmacy Week in Review: March 18, 2016 (pharmacytimes.com)
Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- FDA warns India’s Emcure Pharma, cites repeated data fudging at plant (reuters.com)
Food and Drug Administration has warned Indian generic drugmaker Emcure Pharmaceuticals, saying it repeatedly fudged test records at its plant in western India, in another case of a pharmaceutical firm in the country facing such action...the FDA...found "significant violations" of standard manufacturing practices...The agency had already banned imports from the plant...except for some drugs...It is one of 42 drug-making factories in India that the FDA has banned in recent years as it stepped up inspections of foreign suppliers. The increased scrutiny has hit growth at Indian companies the hardest, as the country supplies nearly 40 percent of the medicines sold in the United Stares...We observed multiple examples of incomplete, inaccurate, or falsified laboratory records...The fabricated records were of tests that Emcure was required to conduct to ensure proper environmental control was maintained while aseptic filling of drug batches, so that the products wouldn't become contaminated...The company has 15 days to respond to the FDA's letter on the corrective actions it will take on the concerns raised.