- FDA issues draft guidance on compounding at outsourcing facilities (biopharmadive.com)
The FDA released a draft version of guidance covering compounding, called "Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry," directed primarily at outsourcing facilities, addressing the use and qualification of bulk substances in compounding...The proposed rules are an extension of The Drug Quality and Security Act...which identified outsourcing facilities as its own category, separate from traditional compounders...Active pharmaceutical ingredients must be accompanied by a monograph from an appropriate governing party (if a monograph exists), must be made in a facility that has prior approval, and must come with a certificate of analysis (to prove they been characterized)...The agency proposes two specific ways to tell if a compounded drug at an outsourcing facility is safe: whether attributes of the approved drug may make it unsuitable to treat certain patients for particular conditions (including whether the compounded drug is intended to address that attribute), and second, if certain factors for each substance being proposed for use in a compounded drug product – specifically, "its physical and chemical characterization, possible or known safety issues, evidence or lack of thereof of effectiveness, and historical use" — would preclude its use by a third-party facility...The agency says the plan will "clarify and appropriately tailor the policies for traditional compounding pharmacies and the outsourcing facilities that may supply a broader market."...
- Blockchain for pharma: DHL, Imperial and Authentag embrace ledger tech (in-pharmatechnologist.com)
Three contract services firms have launched separate Blockchain-based initiatives, in a bid to increase pharmaceutical supply chain security...Blockchain – a digital ledger technology which records data in a secure, chronological way – has attracted attention in the pharmaceutical industry, as US and European serialisation deadlines approach...logistics firm DHL announced a collaboration with technology provider Accenture, to team serialization services with product verification, using a Blockchain ledger platform...The firms have created a ‘prototype simulation’ service, in order to track and trace pharmaceutical products throughout the entire supply chain...By sharing databases between multiple parties, Blockchain essentially removes the need for intermediaries who were previously required to act as trusted third parties to verify, record and coordinate transactions...Authentag announced its Blockchain-based Distributed Ledger Technology project...Our latest platforms will provide an open source architecture to allow members of the pharmaceutical community to develop their own solutions, improving the safety and security of pharmaceutical products...
- Pharmacy Week in Review: March 23, 2018 (pharmacytimes.com)
Kristi Rosa, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- 5 ways to streamline prior authorization, improve outcomes (fiercehealthcare.com)2017 AMA Prior Authorization Physician Survey (ama-assn.org)
Physicians say they face long wait times for insurers to process prior authorizations and the delays can negatively impact patient outcomes...The American Medical Association surveyed 1,000 physicians, and 64% said they wait at least one business day for insurers to decide on prior authorization. Nearly one-third (30%) said they wait at least three business days for decisions...The vast majority of physicians surveyed said that lag time can have serious consequences for patients; 92% said the prior authorization process can lead to delays in access to care, and 78% said that waiting for a decision from insurers "sometimes, often or always" causes patients to abandon certain treatments entirely...The AMA survey illustrates a critical need to help patients have access to safe, timely and affordable care, while reducing administrative burdens that take away from patient care...Six major industry groups—including America's Health Insurance Plans and the AMA—joined forces to improve the prior authorization process. The groups agreed to five steps:
1. Reduce the number of healthcare professionals subject to prior authorization requirements based on their performance, adherence to evidence-based medical practices or participation in a value-based agreement with the health insurance provider.
2. Review the services and medications that require prior authorization on a regular basis and eliminate requirements for therapies that no longer warrant them.
3. Improve communication between health insurance providers, healthcare professionals and patients to minimize delays in care and ensure clear prior authorization requirements, rationale and changes.
4. Protect the continuity of care for patients on an ongoing active treatment or a stable treatment regimen when there are changes in coverage, insurance providers or prior authorization requirements.
5. Accelerate industry adoption of national electronic standards for prior authorization and improve transparency of formulary information and coverage restrictions at the point-of-care.
- Israel to launch Big Data health project (reuters.com)
Israel will invest nearly 1 billion shekels ($287 million) in a project to make data about the state of health of its population available to researchers and private companies, Prime Minister Benjamin Netanyahu said...Almost all of Israel’s nine million citizens belong to four health maintenance organizations who keep members’ records digitally, thus comprising a huge medical database...This is a major asset and we want to make it accessible to researchers and developers in order to achieve two things: one is preventive medicine, and the second is personal medicine tailored to each individual...Nadav Davidovitch, head of the Public Health School at Ben Gurion University in southern Israel, said the country’s push to harness big data for healthcare had huge potential, but also held risks in terms of privacy and medical confidentiality...private companies would profit by using a publicly-funded database while continuing to make some medication unaffordable to many patients...mechanisms would be put in place to keep information anonymous while protecting privacy, information security and restricting access as part of the government project...Patients will be able to refuse the use of their information for research...
- Feds charge 5 doctors over role in alleged Insys bribery scheme (fiercepharma.com)
The case of Insys Therapeutics has played out for several years as suspicions first cropped up in 2014 that the company aggressively marketed its powerful opioid painkiller Subsys, often for off-label uses. Now, the feds have charged five...physicians for taking bribes from the drugmaker in exchange for writing more scripts...In addition to the new complaint, authorities announced that two former Insys employees have taken guilty pleas and are cooperating with the government...doctors Gordon Freedman, Jeffrey Goldstein, Todd Schlifstein, Dialecti Voudouris and Alexandru Burducea face up to 20 years in prison for their alleged participation in the scheme...Allegations against Insys and its former management have been piling up in recent years, and in October, authorities made their way to the company's billionaire founder John Kapoor, charging him with racketeering and other felonies... Prosecutors say the company set up a "speakers bureau" to recruit doctors to write more Subsys scripts, holding "sham" speaking events... the company used the events to funnel money to doctors in exchange for more Subsys scripts, even though many of the prescriptions were outside of the drug's FDA label...
- Green Crack, Blue Dream, Gorilla Glue: The problem of pricing pot (reuters.com)
While a smoker may know the going retail price for “Strawberry Diesel” or “Buddha’s Sister”, the sector’s wholesale tier still operates much like a black market because of ongoing federal prohibition, despite legalizations in 30 U.S. states and Washington D.C...The problem spawned a different investment: The founding of New Leaf Data Services LLC, a...wholesale price data service that fields reporters to take on the steep challenge of cataloguing going rates...New Leaf now publishes weekly benchmark spot prices and forecasts on wholesale indoor-, outdoor-, and greenhouse-grown marijuana for 17 regions with legalization laws...New Leaf makes money from about 350 pot proprietors and other subscribers who buy reports and custom analytics. It has raised money from investors who want exposure to the cannabis sector without the risk of breaking federal law...New Leaf’s experience stalking prices sheds light on the murky trade of what might be the fastest-growing U.S. commodity, sold legally and illegally...prices and available products vary widely in different regions based on whether a state has both medical and recreational markets and the number of licensed dispensaries and producers...The data New Leaf collects is still fairly rough, and the marijuana market has nothing like national benchmark prices or futures contracts common to other legal commodities trades...The retail market is somewhat more transparent, and a pricing service called BDS Analytics runs an online database of more than 140,000 types of pot and pot products. BDS sells pricing and popularity data to retail shop owners...Roy Bingham...collects point-of-sale data from retailers and lists the details for products such as “Blue Dream” and “Green Crack”...When vendors come in and say they have x, y, z products, I can go back and look at whatever the going rate is for that product...
- Britain’s use of copycat biotech drugs takes off while US lags (reuters.com)
Cut-price copies of an expensive Roche biotech drug for blood cancer have taken 80 percent of the British market since launching last year, saving the healthcare system $113 million a year...The rapid adoption of two so-called biosimilar forms of rituximab from Celltrion and Novartis has been accompanied by discounts of 50 to 60 percent as the National Health Service has used tenders to bring down costs...The situation contrasts sharply with the United States, where regulators have lagged Europe in approving biosimilars while a complex system of rebates offered to insurers by original-brand drugmakers has created barriers to use...The U.S. logjam prompted Food and Drug Administration Commissioner Scott Gottlieb to complain of "rebating mischief" and a "rigged payment scheme"...
- This Week in Managed Care: March 23, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Drugmakers try rare tactic to boost sales: cutting the price by thousands (chicagotribune.com)
Drugmakers tried just about every move under the sun to nurture sales of its products -- pharmacy coupons for patients, exclusive deals with insurers, even selling a medicine's patent to a Native American tribe to shield it from a legal challenge...What's far rarer is the step two drugmakers announced...a price cut...Regeneron Pharmaceuticals Inc. and Sanofi said they would deeply discount their $14,000-a-year cholesterol treatment to $4,500 to $8,000 for some patients in order to loosen insurer restriction on the drugs, which so far have sold poorly...The announcement "will set an important precedent in the ongoing drug pricing debate here in the U.S..."This will send a ripple effect across the industry and crowded therapeutic categories will likely face additional pressure."...Sanofi and Regeneron, along with Amgen, brought their new drugs to market with the hope that their powerful effect on bad cholesterol would reduce the world's leading cause of death, and warrant the higher price...So far, they've sold far below the billion-dollar blockbuster mark...In the Praluent trial, a far narrower group of high-risk patients showed much more benefit, and Regeneron and Sanofi said the price would be offered to insurers who agree to more readily pay for the treatment in those patients...Maybe price before was for an aspiration of benefit that did not materialize...The "benefit for this population for the class of drugs seems clearer. Now for the proper pricing. And coverage."