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Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Widespread in other industries, continuous manufacturing features what's essentially an end-to-end assembly line, through which raw materials are steadily fed and constructed into final products...It's seen as faster and more flexible than the tried-and-true system of batching that forms the foundation of pharma manufacturing. The Food and Drug Administration is eagerly encouraging its use ...on a whole, the industry remains wedded to batch production. The reasons for why are many, but foremost is a reluctance to overhaul finely tuned manufacturing networks or to introduce new risks into drug development...Doing something different like continuous was going outside the box...Using an uninterrupted production process eliminates, or significantly reduces, the "hold times" in between steps that are typical in batch manufacturing. For J&J, production of Prezista used to take about two weeks from start to finish using batch methods...through continuous manufacturing, production takes only three days...since the raw ingredients don't need to transition in and out of production for quality testing, continuous manufacturing systems can run over a longer period of time, potentially upping output...For all of the advantages of continuous manufacturing over batch production, drugmakers must weigh switching over against retooling carefully crafted production networks.

FDA...inspecting the plant of the Chinese API maker after learning its valsartan contained an impurity that is a suspected carcinogen...this was the first visit to list observations that strike at the heart of the manufacturing changes made by Zhejiang Huahai Pharmaceutical that are suspected of producing the impurity that resulted in a global recall of its valsartan...In an 11-observation, highly redacted Form 483 issued posted today, the FDA berated the management for making the process changes without thoroughly testing them...Huahai did not conduct and document a formal risk assessment for the change "to evaluate the potential impact of proposed changes on the quality of the intermediates or the final API for this critical change to your validated manufacturing process..."

The US Food and Drug Administration offered a sneak peek...into a new report on the impact of opioid use disorder (OUD) from the perspectives of about 155 patients...Preliminary results highlighted...offer insights into the impact of OUD on patients’ day-to-day lives to aid industry and FDA staff in the push for patient-focused drug development...The input can serve FDA and others in identifying specific areas of unmet needs for patients with OUD, support advice on medical product development programs and facilitate greater appropriate use of approved medications and how these are evaluated...The results highlight the impacts of OUD, a sensation called “craving,” treatment goals, as well as benefits and downsides of and the current barriers to medication-assisted treatment (MAT)...Benefits to MAT that patients reported include reducing the “euphoric rush,” as well as being able to “arrest the cravings and compulsiveness” and regain control of their life. In contrast, downsides relate to “intolerable or bothersome” side effects and the need to stay on MAT long-term. MAT also reportedly fails to address underlying issues, such as anxiety and pain...On challenges to MAT, participants cited a lack of access due to long wait times to obtain medication and strict requirements to remain in a program, among other issues. They also cited unpleasant experiences at MAT facilities, stigma, the intensity of withdrawals, addressing comorbid pain or mental health needs and a self-recognized need to come to terms with OUD.

At first glance, it seems like a logical idea: pharma companies teaching doctors' staff how to handle patients using their drugs and helping staffers with reimbursement questions. But a slew of companies are discovering that it's not so simple...In fact, it might just be against the law...Biogen, Sanofi and Gilead Sciences are under investigation by federal and state authorities for offering reimbursement services and clinical education programs, the companies have disclosed in securities filings. Additionally, Bayer, Amgen and Eli Lilly face whistleblower lawsuits over the issue...In Sanofi’s case, the U.S. Attorney’s Office...sent the company a civil investigative deman...“requesting documents and information relating to Sanofi US’s certified diabetes educator program during the period from 2007 to the present.”...Gilead....received a voluntary request from the U.S. Attorney’s Office...seeking information “related to our reimbursement support offerings, clinical education programs and interactions with specialty pharmacies for Sovaldi and Harvoni...

CVS Health and Aetna need to divest some of their Medicare Part D assets before the Department of Justice will grant approval for their proposed $69 billion mega-merger...The DOJ is expected to conclude its review of the deal once the companies have satisfied the antitrust concern...Aetna has a 9 percent market share among Part D plans while CVS Health has a 24 percent market share, with overlap in some markets...California Insurance Commissioner Dave Jones asked the DOJ to block the merger over Part D concerns, saying that reducing competition for the drug prescription plans would likely result in higher premiums.CVS has 6.1 million Part D members; UnitedHealth, 5.36 million; Humana 4.9 million; Express Scripts 2.5 million; and Aetna 2.2 million...The merger...would add a pharmacy benefit manager to one of the nation's largest health insurance companies...Approval for the vertical integration between payer and PBM has shown more success than the horizontal mergers proposed between Aetna, Humana and Anthem, Cigna. The DOJ blocked both mega bids on the basis of antitrust concerns.

Drug giants Novartis, Bayer and Roche on Friday lost a bid to stop British doctors from recommending a cheaper drug option for people with an eye disease that causes blindness, the High Court in London ruled...A drug industry group said the decision was “extraordinary” and was bad news for future regulatory cooperation between Britain and the European Union after Britain’s exit from the bloc...The companies had sought to block doctors from 12 health groups in the north of England from making Roche’s cancer therapy Avastin the preferred option for wet age-related macular degeneration, even though it is not licensed for this use...Avastin works similarly to Bayer’s Eylea and Roche’s and Novartis’s Lucentis, but those drugs were made specifically for the eye...“Treating clinicians can lawfully choose Avastin for opthalmic use on grounds of cost,” according to the ruling. It added that NICE, the UK’s drug cost effectiveness agency, had concluded that using Avastin for AMD was safe...

Health Management Associates agreed to pay more than $260 million and entered a deferred prosecution agreement to settle criminal charges for allegedly paying physicians kickbacks and defrauding Medicare, Medicaid and other federal programs...HMA, which was acquired by the for-profit hospital Community Health Systems in 2014, allegedly paid physicians in exchange for patient referrals and submitted inflated claims for emergency department facility fees to federal health insurance programs...HMA pressured emergency room physicians, including through threats of termination, to increase the number of inpatient admissions from emergency departments — even when those admissions were medically unnecessary...

CMS took the latest step in its Patients over Paperwork initiative...issuing a proposed rule that would eliminate or update a slew of regulations deemed “unnecessary, obsolete or excessively burdensome” on providers...Should the rule be finalized, the Centers for Medicare & Medicaid Services estimates that it would save providers $1.12 billion each year and eliminate millions of hours in administrative time. Through 2021, CMS projects $5.2 billion in total savings and 53 million hours of administrative burden eliminated...Much of the rule focuses on streamlining CMS’ conditions of participation and conditions for coverage, which the agency says will allow providers to operate more fluidly and efficiently without impacting patient safety and care quality. Some of the key changes the rule proposes include:

• Allowing health systems to use an integrated quality assessment and improvement platform across all their member hospitals.
• Creating a simpler process for providers to order portable X-ray machines and updating the requirements for portable X-ray technologists.
• Easing requirements for hospitals and ambulatory surgery centers for conducting physicals and collecting patient histories ahead of procedures.
• Eliminating a requirement for critical access hospitals to disclose people with a financial interest in the facility, as CMS also obtains that information outside of compliance with the conditions of participation.

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network