- Pharmacy Week in Review: September 16, 2016 (pharmacytimes.com)
Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- Lawmakers ask HHS to probe the Medicaid drug rebate program (statnews.com)
In the wake of the controversy over EpiPen pricing, a group of lawmakers is demanding a probe into the Medicaid Drug Rebate Program, which requires drug makers to pay rebates in exchange for having their products covered...In a letter sent...to the Inspector General at the US Department of Health and Human Services, 15 House Republicans want to know the extent to which the Centers for Medicare and Medicaid Services is properly overseeing the program and how medicines are classified. The probe should include, "but not be limited to" EpiPen...Their interest was sparked by concerns that Mylan Pharmaceuticals...may not have paid all of the rebates to which Medicaid is entitled. This is an issue for taxpayers because the states and the federal government use the rebates from drug makers to offset the cost of covering medicines...The drug maker has denied shortchanging Medicaid, but the situation remains unclear...To what extent the EpiPen episode is an isolated incident is uncertain, but the lawmakers are not the only ones who are concerned that other companies owe rebates to Medicaid...
- The pluses and minuses of drugmakers’ discount cards (hosted.ap.org)
Facing public furor for the price of its emergency allergy shot EpiPen, Mylan Pharmaceuticals quickly pointed to a familiar industry solution: copay discount cards...Copay coupons or cards have become a ubiquitous part of the pharmaceutical business, offered through websites, mobile apps and doctor's offices. Patient advocates say they can bring down out-of-pocket expenses for patients who face high copays and deductibles...But they also have a clear business purpose: steering people toward brand-name drugs when cheaper options are often available. Researchers say those higher costs ultimately drive up expenses for insurers, employers and the health system at large...A look at the pros and cons of copay discount cards:
- PRO: LOWER OUT-OF-POCKET COSTS
- CON: HIGHER-PRICED DRUGS
- PRO: PRESCRIPTIONS FILLED
- CON: SHORT-TERM SOLUTION
- ‘Extraordinary’ generics price hikes hit Medicare Part D amid big reduction overall (fiercepharma.com)
Generic drug prices in Medicare Part D decreased significantly in recent years, a new report from the U.S. Government Accountability Office says. So why the worry about price hikes? Hundreds of products saw “extraordinary price increases," that's why...For a group of 2,378 generic drugs--including those that entered or exited the market from 2010 to 2015--Medicare Part D prices fell overall by 59%...But “established generics"--the 1,441 drugs that stayed on the market the entire time--fell by just 22%. More than 300 cases of “extraordinary price increases” kept prices from falling further...Those extraordinary hikes amounted to at least 100%…The Generic Pharmaceutical Association is praising the newest GAO report. “At a time when everyone is looking for cost saving solutions, it is important to note that the GAO findings are consistent with the prevailing market trend--generic drug prices overall continue to decline year over year,”…
- The Syrian Civil War Could Spell the End of Antibiotics (newsweek.com)
...many regional health analysts…are part of a terrifying new trend: the growing number of Syrians who are immune to almost all antibiotics. The only way to treat them is to amputate their affected limbs and inject them with last-resort drugs. For those suffering from less peripheral wounds, the prognosis is even grimmer. If the infection is in the chest or brain, he will die…After five and a half years of death and destruction…the conflict escalates and conditions worsen for civilians and soldiers alike, doctors and aid workers fear antibiotic resistance could soon become deadlier than the Islamic State group…Frazzled medical professionals believe the problem is quickly getting worse, especially in besieged swathes of Syria that doctors can’t reach...In Syria, part of the problem is rooted in the country’s lax attitude toward medications. As in much of the Middle East, antibiotics have long been available without a prescription and are often seen as cure-alls with no side effects. For years, doctors doled them out for everything from headaches to common colds. Farmers in isolated areas self-medicated. Pharmacists who knew the risks prescribed them anyway, fearing their customers would go elsewhere. And with dozens of pharmaceutical factories churning out products across the country, antibiotics became available at low cost to pretty much everyone...the Syrian war still killing and maiming at a pace unmatched in recent memory, doctors and scientists say there’s only one guaranteed way to preserve one of our world’s greatest discoveries...The problem is not the mentality of the doctors; it’s the conflict...We have to treat the conflict to stop antibiotic resistance...
- Mylan Agrees to Hand Over EpiPen Documents to Congress (fortune.com)
Mylan has been in the hot seat since reports of its extravagant price hikes for the EpiPen, a device which millions of Americans, including 1 in 13 children, rely on as a life-saving backstop, emerged last month...Now, the company has agreed to hand over documents to indignant lawmakers seeking to probe its pricing practices...Several members of Congress have been demanding more information from the generic drug giant about its pricing practices since the EpiPen scandal broke. Some, including Minnesota Sen. Amy Klobuchar, have even called for Federal Trade Commission investigations into the company...The U.S. House Committee on Oversight and Government Reform specifically asked for more detailed information about Mylan’s pricing habits, including discounts given to patients, at the end of August...That information is expected to reach lawmakers by the end of the week...
- UN panel urges wider access to medicines, but pharma slams the report (statnews.com)
United Nations...released a lengthy report that urges governments to take various steps to ensure greater access to needed medicines. And the list contains several proposals that have previously caused struggles with the pharmaceutical industry, suggesting the agency effort may be difficult to actually implement...Among the recommendations: the UN panel suggested countries should pursue compulsory licenses, which allow countries to sidestep patents and arrange for an alternative version of a medicine to become available...governments have shied away from pursuing licenses over concerns about repercussions…Consumer and patient advocacy groups largely praised the UN report. Doctors Without Borders...called it a "landmark report." But some complained that the panel did not go far enough in some ways...the UN should have "condemned trade agreements and national laws" that do not make clear that countries have the right to issue a compulsory license...The panel also said countries should require drug makers to disclose certain costs — such as R&D, production, and marketing…Another recommendation is for companies that receive public funds to publish their research findings...drug makers should make publicly available all anonymous patient data from completed and discontinued clinical trials...recommended data sharing and data access should be a condition for public grants for R&D.
- New Big Data Approach Predicts Drug Toxicity in Humans (weill.cornell.edu)
Researchers can now predict the odds of experimental drugs succeeding in clinical trials, thanks to a new data-driven approach developed by Weill Cornell Medicine scientists. The method detects toxic side effects that may disqualify drugs from human use, giving drug developers an early warning before initiating clinical trials, according to a new study...The approach upends conventional wisdom about the criteria on which to evaluate new drugs for their safety. Rather than exclusively examining molecular structure to determine viability, this new computational method combines a host of structural features and features related to how the drug binds to molecules in the body...We looked more broadly at drug molecule features that drug developers thought were unimportant in predicting drug safety in the past. Then we let the data speak for itself…The method, known as PrOCTOR, was inspired by an approach that baseball statisticians adopted to better predict which players would be successful offensively...a strategy known as "Moneyball."...Similarly, researchers developed a computational method that analyzes data from 48 different features of a drug — from molecular weight to details about its target — to determine whether it would be safe for clinical use...this approach could improve the drug discovery pipeline, save money and save lives — but only if more data on toxicity results become available. After all, only 50 percent of clinical trial results are fully reported...if we don't have data, we can't build these models...
- EpiPen, Channel Economics, and the Great PBM Rebate Debate (drugchannels.net)
For better or worse, Mylan’s EpiPen controversy has started an intriguing dialogue about my favorite subject: the economics of U.S. drug channels. Many news stories have tried to explain how a prescription drug’s list price differs from the ultimate net price paid by insurers and the government. A few brave souls have even dug into the role of such intermediaries as pharmacy benefit managers, wholesalers, and pharmacies...I highlight aspects of the EpiPen story that raise crucial questions about our healthcare system, including: Who benefits from big gross-to-net spreads in drug prices? How do benefit design and payer decisions alter channel economics? Are patients benefiting from manufacturer’s rebates to PBMs? How (if at all) should manufacturers alter their pricing strategies?...And I wonder: Will we look back on the EpiPen incident as the beginning of the end for manufacturers’ gross-to-net drug pricing models and PBMs’ traditional role in the flow of rebates?...
- Big Pharma Spends Millions to Keep Prices High for California Agencies (thestreet.com)
California's attempt to curb drug prices, Proposition 61, could cause drug companies including Merck, Pfizer and Johnson & Johnson to raise prices, according to analysts, and the companies are already taken steps to block the bill's passage…According to analyst David Larsen...the major drug companies could choose to extend the prices they offer to the Department of Veterans Affairs to the state, while offsetting the discounts by raising the prices of other drugs...drug companies could risk a domino effect of having to discount other states...manufacturers could raise the prices they offer to the VA, which was threatened in 1992 when Congress considered doing something similar on a federal level...While drug companies stand to benefit politically from opposing this bill, they likely won't see an impact on their bottom lines if Proposition 61 passes - at least at first...Prop 61 addresses such a narrow portion of the California population - state agencies and non MCO Medi-Cal, the revenue and earnings exposure for the distributors and PBMs is minimal...likely that California's legislature will realize that companies can raise prices elsewhere, and will ultimately repeal the ballot measure.