- This Week in Managed Care: March 31, 2017 (ajmc.com)
Brielle Urciuoli, Welcome to This Week in Managed Care from the Managed Markets News Network.
- FDA approvals for specialty drugs to pick up in 2017 (managedhealthcareexecutive.modernmedicine.com)
The specialty drugs market is seeing increased competition and important advances in cancer and orphan drug development, including specialty generics and biosimilars...Following December’s FDA approvals of the intravenous biosimilar Lartuvo (olaratumab) for soft tissue sarcomas and the oral ovarian cancer biosimilar Rubraca (rucaparib), biosimilar and other specialty drug approvals are expected to hasten in 2017... Last year we saw a dip in...approvals but this year we are going to rebound with about 30 pending approvals...With 73 patent expirations for biologic agents by 2021, biosimilars will begin to emerge as a larger market presence in the next several years...New FDA biosimilars approvals over the next five years—including anticipated biosimilar approvals for the anti-cancer biologic agents Avastin (bevacizumab) and Herceptin (trastuzumab)—could represent a $46.2 billion market...Biologics are really acting more like competing brands, coming in at perhaps a 15% discount" compared to brand-name biologics...
- Pending approvals/patent expirations
- Recently approved specialty medications
- Specialty drug pipeline
- Senate probe keeps heat on J&J, Mylan, Depomed and others for their opioid marketing (fiercepharma.com)
Opioid makers have had no shortage of critics in recent years as the United States suffers the sting of a painful addiction epidemic. Now, a top senate Democrat is throwing the weight of her office behind efforts to dig into the industry’s marketing practices for the risky painkillers...Sen. Claire McCaskill is targeting Johnson & Johnson, Mylan, Depomed, Insys and Purdue in her investigation, which is aimed at learning whether the companies had any role in the country’s "overutilization and overprescription" of the meds...Among the documents she’s requesting are internal opioid abuse estimates, info on marketing strategies, sales quotas and contributions to patient groups...McCaskill laid out evidence that suggests drug companies sought to downplay the risks of the painkillers and positively influence physicians’ perceptions of the meds. She wrote that the allegations "show an industry apparently focused not on preventing abuse but on fostering addiction as a central component of its business model."
- New PBM programs bypass insurers to offer drug discounts directly to consumers (modernhealthcare.com)
Pharmacy benefit managers and tech startups are responding to underinsurance and the onslaught of high-deductible health plans by cutting out insurers in the quest to help patients lower their prescription drug costs...Two PBMs have launched discount programs for patients to use outside of any insurance coverage they might have. It's a notable contrast to PBMs' main business serving as third-party administrators of prescription drug coverage for insurers and employers...These efforts come as a budding industry has sprung up around helping consumers and employers rein in prescription drug costs. Startups like Blink Health and RefillWise offer pharmacy cards that provide consumers with negotiated discounts if they don't use their prescription coverage, while some insurers and pharmacy benefit managers, along with tech firm Castlight Health, are attempting to allay consumer and employers' concerns about drug costs by building apps that offer price transparency to physicians or patients.
- Pharmacy Week in Review: March 31, 2017 (pharmacytimes.com)
Brielle Urciuoli, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Ohio Limits Opioid Prescriptions to Just Seven Days (msn.com)
The Ohio governor unveiled a plan...that targets the place where experts say many opioid addictions begin — the doctor's office...Gov. John Kasich's order limits the amount of opiates primary care physicians and dentists can prescribe to no more than seven days for adults and five days for minors...In addition to the pill limits, Kasich said the new rules require doctors to provide a specific diagnosis and procedure code for every painkiller prescription they write...And Kasich warned that doctors who don't follow the rules will lose their licenses...The new limits, which have gotten the blessing of the Ohio Board of Pharmacy, the State Medical Board, and the state's dental and nursing boards, do not apply to patients who take prescription painkillers for cancer treatment or to dying patients who are already receiving hospice care...As bad as things are in Ohio, it's ever worse in West Virginia, New Hampshire and Kentucky, which have even higher drug overdose death rates, according to the federal Centers for Disease Control and Prevention...Americans get hooked on locally prescribed painkillers, lawmakers say the drug cartels have made a mint feeding their habits by smuggling Chinese-made fentanyl and other opioids into the country
- County proclaims March 30 Health Professional Recognition Day (elkodaily.com)
Elko County encourages residents to thank their health care provider...County commissioners proclaimed March 30 as Health Professional Recognition Day...Commissioner Delmo Andreozzi requested the proclamation..."Really and truly the health care professional, with the shortage that we see throughout the nation, can go anywhere they want to," he said. "They are a highly sought after resource, yet the people that we have here choose to be here and provide services. They are loyal, hardworking men and women who dedicate their lives to helping people feel better and provide excellent treatment. I think it’s really fitting that we take an opportunity to just pause and reflect for a moment about their contribution to our community, and just say thank you. Another big part of recruitment, in my mind, is retention. I think if the health care field understands that we appreciate them, I think that is a small step that goes a long way."
- Trump FDA Nominee Wants Lower Drug Costs With More Generics (bloomberg.com)Trump selects Scott Gottlieb as FDA nominee (cnn.com)
President Donald Trump’s pick to head the U.S. Food and Drug Administration is among the most vigorous advocates of lowering drug costs by approving cheap generics faster, an initiative aimed directly at the profit centers of major companies...Scott Gottlieb, a former FDA deputy commissioner, would make streamlining approvals his top priority...He’s particularly focused on complex medications that combine old drugs with newer delivery devices, as well as those with unusually complicated formulations...The administration could make the changes without Congress passing a law...But it also risks angering companies that have considerable legal firepower to defend their money-makers...Getting more generics to market faster could save Americans billions of dollars a year...Absent a new law, the FDA could do much to speed approval of generics. It could devise broad guidelines for copies. And the agency could become swifter in approving drug-device combos, finding ways to allow slight differences so long as they wouldn’t confuse patients...
- President’s Pledge
- Complicated Cures
- Pricey Pens
- EpiPen Dispute
- Diversity of profession to be focus of World Pharmacists Day 2017 (fip.org)
"From research to health care: Your pharmacist is at your service" is the theme of this year’s World Pharmacists Day on 25 September, the International Pharmaceutical Federation (FIP) announced..."This theme was chosen to reflect the numerous contributions the pharmacy profession makes to health. From research and development of medicines, to educating future pharmacists and pharmaceutical scientists, and providing direct care, we do all this in the service of our patients and communities," said FIP President Dr Carmen Peña..."We want to emphasise that pharmacists are the backbone of health care in many different settings. But providing care does not begin in community or hospital pharmacies. Taking care of patients starts with recognising the health issues of populations and developing medicines, policies and education to tackle them. We pharmacists are often there at the very beginning of the process — when the first molecule that effectively treats a disease is identified," Dr Peña added...World Pharmacists Day is used by FIP’s members and others around the globe to highlight the value of the pharmacy profession and impact on improving health to authorities, other professions and the media, as well as to the general public...FIP is inviting pharmacists to support World Pharmacists Day by creating profile pictures for their social media accounts using the official FIP Twibbon or a specially designed "Your pharmacist is at your service" placard. The materials are available from today at www.fip.org/worldpharmacistsday.
- EU recommends suspending hundreds of drugs tested by Indian firm (reuters.com)
Europe's medicines regulator has recommended the suspension of more than 300 generic drug approvals and drug applications due to "unreliable" tests conducted by Indian contract research firm Micro Therapeutic Research Labs...The decision, announced by the European Medicines Agency...is the latest blow for India's drug-testing industry, which has run into a series of problems with international regulators in recent years...The inspections identified several concerns at the company’s sites regarding misrepresentation of study data and deficiencies in documentation and data handling...there is no evidence of harm or lack of effectiveness of the medicines, which include generic versions of many common prescription pharmaceuticals, including blood pressure tablets and painkillers...Drug tests carried out at Indian contract research organizations have been key in getting a huge array of generic medicines approved for sale around the world over many years…In the wake of such trial data scandals, many large drugmakers have been shifting more critical trials back to the United States and Europe over the last three years...