Author: Peter

Takeda is going behind closed doors with its first DTC campaign for Entyvio (vedolizumab), a new biologic treatment for inflammatory bowel diseases. Bathroom doors, that is...The Japanese drugmaker uses a series of bathroom doors in its ad campaign, asking if it's "time for a different perspective." A...TV spot launched Feb. 7...has racked up $2.9 million on more than 2,000 airings...This condition is such an isolating condition and such a stressful condition. Patients are kept from doing the important things they want to be doing in their lives and as a result they miss out on a lot...In testing many different creative ideas with Crohn's and ulcerative colitis patients...the bathroom doors resonated well because patients noted it is a view they are all too familiar with...But some patients even took it to the next level in saying that the doors metaphorically represent that barrier between their disease and being able to do all of the things they want to do. Emotionally, we've touched upon the reality of their disease in a very obvious bathroom door representation, but also a representation of just barriers in general...Analysts have projected blockbuster-level sales for Entyvio by 2020...Marketing will be key to gaining share in a crowded IBD space where it's up against established...brands such as AbbVie's Humira, Amgen's Enbrel, and Johnson & Johnson's Remicade...

Imagine new medicines that effectively fight cancer, but may result in fewer side effects thanks to more accurate targeting of tumor cells. Today, PhRMA released a new video that highlights these promising new therapies called antibody drug conjugates, or ADCs...represent a continuing shift in the cancer treatment landscape toward personalized medicines that more accurately attack specific targets fueling cancer cell growth while leaving more healthy cells unharmed...You can think of them as smart bombs, basically. Precision weapons against cancer...which may provide patients the same level of benefits of standard chemotherapy without some of the side effects that often accompany such treatments...

As the pharmacy landscape shifts and evolves, pharmacists across the country continue to work toward a common and crucial goal: gaining legislative recognition as health care providers...Gaining provider status is a complex and multifaceted objective, but at its heart is the exclusion of pharmacists from the Social Security Act. Exclusion of pharmacists from the SSA prevents many state and private health care plans from compensating pharmacists for patient care services...the omission of pharmacists from the SSA also creates barriers for Medicare beneficiaries who seek to utilize these services in outpatient settings...While provider status efforts are crucial to the pharmacy profession, they’re equally important to patients...Gaining ground in the states...a number of state laws passed in 2015 have given advocates much to celebrate.

• North Dakota Governor Jack Dalrymple signed into law 4 bills that expanded the role of pharmacists in the Peace Garden State and recognized them as health care providers...
• ...Washington Governor Jay Inslee’s signing of SB 5557...The first bill in the country to require the inclusion of pharmacists in health insurance provider networks...amends the state’s Every Category of Health Care Providers law, which obliges commercial health plans to include every category of health care provider within an individual’s participating provider network.
• ...Oregon governor Kate Brown signed HB 2028 into law...bill permits pharmacists to receive reimbursement for performing clinical pharmacy services, enabling them to more fully use their skills and knowledge to treat patients.
• ...the federal arena...federal recognition remains the primary goal for many proponents of provider status...a proposed bill has given advocates hope that such a victory is well within reach...the Pharmacy and Medically Underserved Areas Enhancement Act would amend the SSA to cover pharmacists’ services under Medicare Part B, but only if these services are provided in areas of the country that the Health Resources Services Administration defines as medically underserved areas...The bill is awaiting approval...

Pharmacy students are the future of the profession and...they will be the ones most impacted by provider status...Earning legislative recognition as health care providers will ensure that the next generation of pharmacists is able to treat patients to the full extent of their knowledge and abilities...

The Nevada Board of Medical Examiners had a backlog of 525 complaints at the start of 2015. An additional 1,078 complaints were filed last year...By the end of the year, 570 complaints were pending...only 19 medical doctors and physician assistants were publicly disciplined last year...How can a board that's falling behind ever erase that backlog and fulfill its duty to discipline bad medical doctors?...Executive Director Edward Cousineau said Wednesday that the office is making headway and that the situation not as bleak as the numbers suggest...

Your medicine may come with a new side effect: financial pain. Prescription-drug spending grew 12.2% in 2014—five times as fast as the year before—according to the Centers for Medicare & Medicaid Services. And the sickest Americans bear the biggest burden. Some 43% of those in fair or poor health say it’s somewhat or very difficult to afford their medications, and 37% say they’ve skipped out on filling a prescription because of cost...What has changed? Generic drugs, long an affordable alternative to name-brand medicines, have become part of the problem. The average price of the 50 most popular generic drugs increased 373% between 2010 and 2014...One culprit is consolidation: After a decade of mergers, three big companies now control 40% of the generics market...Weaker competition means drug companies can charge your insurer more. Meanwhile, pricey new miracle drugs—like hepatitis C treatment Sovaldi are also a key factor forcing up overall medication costs...Fortunately, there are plenty of ways for you to save. By making strategic changes in the medications you take (with your doctor’s okay, of course), the places you buy them, and the insurance plan you elect, you may be able to shave 40% or more off your total prescription-drug costs this year. Here are the steps you need to take.

1. Substitute generics for name brands.
2. Combine pills—or split them.
3. Check the formulary for your insurer’s favorites.
4. Jump through your insurer’s hoops.
5. Ask your plan to make an exception.
6. Use mail-order options.
7. Use a preferred drugstore.
8. Beware of online pharmacy scams.
9. Check your insurer’s formulary lists.
10. Check for tricky deductibles.
11. Price out Medicare options.
12. Clip coupons.
13. Ask for help.

The reputation of the pharmaceutical industry continues to plummet. A day doesn’t go by without seeing at least one negative news story about... drug pricing...stories about how unaffordable drugs are or about how a family has gone into bankruptcy as a result of paying for a lifesaving medication...millions of dollars paid in fines by companies for the illegal detailing of drugs... Companies continue to be dogged by accusations of hiding clinical data...Direct-to-consumer ads are also a lightning rod...It’s not a happy time for the industry...The industry’s trade association, the Pharmaceutical Research and Manufacturers of America is charged with representing the industry on a host of issues, including improving its reputation...Well, PhRMA has a new leader, Mr. Stephen J. Ubl... he couldn’t have picked a more difficult time to assume the mantel of industry spokesperson. If there is one issue...it is that the pharmaceutical industry needs to be reined in, particularly with respect to drug prices. There couldn’t be a bigger bullseye on the pharmaceutical industry...Mr. Ubl has the opportunity to change the tone of the current pricing debate as well as the other issues that impact the pharmaceutical industry’s reputation...Hopefully, he can start to turn the tide and begin to bring the industry back to the esteem that it enjoyed twenty years ago.

Devices like C-PAP machines or oxygen tanks are commonplace in some households. Often, patients leave the hospital and are told they need a medical device to help them throughout the home. That's where occupational therapist Leslie Sargent comes into play. She used to visit homes to make sure the patient was safe..."When I was working in home health, a lot of them couldn't afford the equipment at that time," says Sargent...Such practices...are only going to become more common in Nevada after a medical devices tax went into effect in January 2016. Essentially a sales tax, patients are now being taxed on devices that can be used on newborns all the way to hospice patients... Doug Bennett, Chair of the Board of Bennett Medical Services...along with 35 others statewide, is circulating a petition to have voters decide on the medical devices tax in November 2016. He says they are already halfway through getting the required signatures they need to get the measure on the ballot...If it ends up on the 2016 November ballot, and passes, voters will have to approve it again in 2018.

On February 25...upon conclusion of the...criminal case...United States v. Vascular Solutions, Inc...Judge Lamberth charged the jury...The case involves allegations that...a medical device company and its president, engaged in an unlawful off-label marketing campaign. The government’s superseding indictment alleged that the defendants engaged in a criminal conspiracy to violate the Federal Food, Drug, and Cosmetic Act, and committed four counts of selling misbranded medical devices...After deliberating for one day, the jury came back with a verdict of "not guilty" on all counts for both the company and its CEO...FDA’s ability to restrict speech that is truthful and not misleading is limited...FDA has long stated that the dissemination of information about unapproved uses can be important for medical professionals, and so long as the information is distributed according to certain guidelines...promotional speech itself would not be evidence of misbranding so long as the speech was solely truthful and not misleading. This position is consistent with a growing trend among courts to find that truthful and not misleading promotional materials may be distributed by a company without violating the misbranding provisions of the FDC Act...given the growing willingness of companies to challenge FDA’s regulation of off-label promotion, their success in doing so, and court decisions indicating...an unapproved use does not violate the misbranding provisions...DOJ and FDA must carefully consider how to proceed in bringing charges of off-label promotion.

Nearly 50 students visited 31 congressional offices on Capitol Hill earlier this month as part of ASHP’s Student Advocate Training & Legislative Day. The two-day conference, also known as SSHPTakesDC, gives student pharmacists hands-on experience in how to directly affect public policy...the students made the case for provider status legislation, the Pharmacy and Medically Underserved Areas Enhancement Act (H.R.592 and S.314), by emphasizing how the pharmacy school curriculum and postgraduate residency training prepare future practitioners to be patient care providers...“I feel like we had a good impact,” said Winston Johnson, a third-year student at Palm Beach Atlantic University in West Palm Beach...Conference attendees also met with Rep. Earl “Buddy” Carter, the only pharmacist serving in Congress. Carter praised the students for their foray into advocacy and encouraged them to stay engaged in the political process. “Politics are important to our profession,” he noted...It’s so inspiring to see these ASHP student leaders in action, and it is clear after seeing their poise, passion, and professionalism during their visit to Capitol Hill that the future of the profession of pharmacy is going to be in very good hands...

...for some low-income people, having transportation to a medical facility to receive treatment has been a major obstacle. So Southwest Medical Associates, in partnership with Health Plan of Nevada and Sierra Health and Life, revisited the idea of taking medical professionals to the people..."Medicine on the Move," and it's a 45-foot state-of-the-art mobile medical center built on a custom-designed Peterbilt truck frame. It is scheduled to hit the road sometime in mid-May with the primary objective of serving Medicaid patients at homeless shelters, churches, community centers and some businesses whose employees are enrolled in Health Plan of Nevada or Sierra Health and Life medical benefit plans...The mobile medical center is equipped with seemingly everything, and in many cases, much more than what one would find in his or her own doctor's office. The radiology suite features a digital mammography unit, portable ultrasound machine, X-ray unit and four refrigerators and a freezer for storing vaccines. Patients entering the mobile facility will be able to sit in a comfortable spa-like lobby before being taken to one of two private exam rooms...The onboard staff will consist of two medical assistants, two licensed nurse practitioners and one or two providers/doctors as needed, and a radiology technician...Annual physicals, immunization shots, OB/GYN exams, lab tests, pediatric care and wellness appointments will be offered..."As a native Nevadan, I've witnessed the changes and challenges we've faced over the years with health care in Southern Nevada," McBeath (Dr. Robert McBeath) said. "And I believe that this partnership with Health Plan of Nevada and Sierra Health and Life will help us to close the gap and improve access to quality health care in our community."...