- This Week in Managed Care: October 13, 2017 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- What’s new on pharma’s worry list? Cybersecurity, natural disasters, and much more (fiercepharma.com)
Anyone who’s read a Securities and Exchange Commission filing in the U.S. recognizes the risk disclosure section, where biotech and pharma companies list the pitfalls of investing in their shares. Like an investor-oriented version of the risk disclosures in drug ads, they run the gamut from garden-variety competition to political unrest in farflung markets...The accounting and advisory firm BDO sifted through those statements to discover just what the top 100 life sciences companies are most worried about these days.
- Natural disasters, war, conflicts and terrorist attacks...
- The ability to maintain company infrastructure, including IT security and privacy...
- Labor concerns—including pension costs, rising healthcare costs, immigration and outsourcing...
- Litigation. Every company examined listed legal proceedings and lawsuits as risks to their operations...
- Competition and marketing challenges figured in at the top...filings, along with intellectual property protections (or loss thereof) and the success (or not) of current and future drug launches all tied for first place...
- regulation, by FDA and other authorities at the state and federal levels...
- An old-school pharmacy hand-delivers drugs to Congress, a little-known perk for the powerful (statnews.com)
Nearly every day for at least two decades pharmaceutical drugs have been brought by the carload to the Capitol — an arrangement so under the radar that even pharmacy lobbyists who regularly pitch Congress on their industry aren’t aware of it...The deliveries arrive at the secretive Office of the Attending Physician, an elaborate medical clinic where Navy doctors triage medical emergencies and provide basic health care for lawmakers who pay an annual fee of just over $600. Every one comes from Washington’s oldest community pharmacy, Grubb’s...Mike Kim...pharmacist-turned-owner of the pharmacy, said he has gotten used to knowing the most sensitive details about some of the most famous people in Washington...“At first it’s cool, and then you realize, I’m filling some drugs that are for some pretty serious health problems as well. And these are the people that are running the country,” Kim said, listing treatments for conditions like diabetes and Alzheimer’s...Kim’s tiny pharmacy — which, at its busiest, sends as many as 100 prescriptions to members in a day — is nestled among Capitol Hill’s stateliest row houses, less than four blocks from the Capitol building itself. Founded in 1867 and named for a previous owner, the pharmacy predates penicillin, the American health insurance system, and even the Lincoln Memorial.
- Drug chains tumble on reports Amazon eyeing their pie (reuters.com)
Shares of drug retailers Walgreens Boots Alliance Inc, CVS Health Corp and Rite Aid Corp tumbled on Friday after reports that Amazon.com Inc was looking to make a move into selling drugs online...Amazon is reported to be in discussions with mid-market pharmacy benefit managers and has been hiring talent to assess the drug retailing market for its entry…We are convinced that AMZN will almost certainly enter the drug distribution value chain within 2 years, evolving into a more disruptive offering over time...Amazon’s entry into pharmaceuticals has been long rumored in the media...Shares of drug retailers Walgreens closed down 5.8 percent, Rite Aid 4.9 percent and CVS Health 4.9 percent.
- Study Finds Few Medicare Limits on Prescription Opioids (ptcommunity.com)
While restrictions are increasing, a third of plans impose none...Medicare plans place few restrictions on the coverage of prescription opioids, despite federal guidelines recommending such restrictions, a new Yale study finds. The research results highlight an untapped opportunity for Medicare formularies to limit opioid prescribing... little is known about opioid coverage and restrictions under Medicare, which often serves as the standard for other insurers...Prescribing restrictions can have an impact...A prior study of a private insurer reported a 15% decrease in opioid prescribing when the insurer implemented restrictions, including prior authorization, quantity limits, and provider–patient agreements...
- California deals pharma a double whammy with signing of copay coupon bill (fiercepharma.com)California Takes On Drug Pricing: Real Progress Or Illusion? (healthaffairs.org)
Gov. Jerry Brown signed California's AB-265, which will limit the use of copay coupons and other discounting strategies for branded prescription drugs when a cheaper generic is available. Brown authorized that bill on the same day he signed SB-17, a separate piece of legislation which will force drugmakers to give warning of and explain price hikes...Exceptions to the copay coupon law include cases in which patients complete step therapy or receive prior authorization for the branded drug...the bills represent two significant regulatory steps on drug pricing...they are a setback for the drug industry in California. But other states could follow the model as many around the country look to take pharmaceutical prices into their own hands...PhRMA,...opposed both proposals...concerned with AB-265 because it doesn't ensure that patients who need a branded med over a generic will be able to get that drug...When patients receive short-term co-pay assistance for expensive drugs, they may be insulated from price hikes, but insurance companies, the government and employers still bear the burden of these excessive prices...these costs are eventually passed on to consumers in the form of higher premiums...
- Shire, Pfizer antitrust lawsuits could rewrite the rules for formulary contracts: report (fiercepharma.com)
Shire filed a lawsuit in a federal court against Allergan, claiming anticompetitive practices in its reimbursement contracts with payers on the eye drug Restasis. It's the latest in a series of similar cases, and the verdicts could well upturn all pharma-payer negotiations...Shire makes a rival product, Xiidra, and its fight against Allergan challenges longstanding negotiation practices that many makers of follow-on products argue are stifling competition...The verdicts in these cases could well rewrite the rules that govern how drugmakers form contracts with payers...Any verdicts in favor of the antitrust arguments could make it easier for manufacturers of biosimilars and other products entering well-established markets to steal share from the incumbents...In Shire's case, it’s arguing that Allergan improperly entered into exclusive contracts for Restasis with Medicare Part D providers. Those exclusive deals prevent makers of rival dry-eye remedies from competing for patients, the suit said...
- The little red pill being pushed on the elderly (cnn.com)
CNN investigation exposes inappropriate use of drug in nursing homes...The maker of a little red pill intended to treat a rare condition is raking in hundreds of millions of dollars a year as it aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe...Nuedexta (dextromethorphan/quinidine), is approved to treat a disorder marked by sudden and uncontrollable laughing or crying -- known as pseudobulbar affect...This condition afflicts less than 1% of all Americans, based on a calculation using the drugmaker's own figures, and it is most commonly associated with people who have multiple sclerosis or ALS (amyotrophic lateral sclerosis)...The number of pills (from 2012) rose to roughly 14 million in 2016, a jump of nearly 400% in just four years...Nuedexta's financial success...is being propelled by a sales force focused on expanding the drug's use among elderly patients suffering from dementia and Alzheimer's disease, and high-volume prescribing and advocacy efforts by doctors receiving payments from the company...
- China may relax trial requirements for new drugs, allowing foreign data (fiercebiotech.com)
China has said it will accept data from clinical trials run overseas in a bid to shorten the time it takes to approve new drugs and medical devices...It’s the latest in a string of regulatory initiatives implemented by Chinese authorities that could be a boost for international biopharma companies as well as Chinese patients, who sometimes have to wait six or seven years after launch in Western markets for drugs to be launched in China...The country’s huge and increasingly affluent population is facing an ever-growing burden of chronic diseases like cancer and diabetes, and the government has been under pressure to improve access to healthcare and new medicines...The latest wide-ranging set of proposals...recognizes that China is lagging behind other countries when it comes to approving new drugs. It’s approved 100 innovative new drugs in the last five years, around a third the number in developed markets...
- The Other Side of Opioid Limits (drugtopics.modernmedicine.com)
Proponents argue that limits reduce the risk of addiction, but are they keeping pharmacists from caring for their patients?... As the opioid crisis worsens, pharmacies, pharmaceutical manufacturers, and legislators are scrambling to help solve the problem. Recently, those efforts have focused on limiting opioid supplies. But in the effort to prevent unnecessary medications, are pain patients getting left behind?...Express Scripts and CVS Caremark recently announced a seven-day supply limit, and PhRMA...supported a seven-day limit...one-size fits all approach and will supplant providers’ clinical decision-making and the needs of patients who have legitimate need for these medications...payer limits restrict patients with legitimate pain management needs from accessing opioids. Those limitations...will force patients not at risk of abuse or misuse to work with their prescriber and pharmacist—which will cost the health-care system and “significantly” impact patients with limited resources, physical restrictions, or transportation issues...