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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

Southern Nevada and the world watched as Las Vegas hospitals and doctors operated and cared for the wounded on Oct. 1 and subsequent days, and they’re getting high marks for their performance for handling the worst mass shooting in modern U.S. history...While 58 were killed — nearly all succumbed to their wounds at the scene of a country music concert on the Strip — more than 500 people were injured, and most passed through nine of Las Vegas’ 14 hospitals. More than 200 went to Sunrise Hospital and Medical Center, and more than 100 went to University Medical Center — the city’s two main trauma centers for handling emergency cases...The hospitals and the medical community are evaluating their performance for a wider report about lessons learned. That information will be disseminated across the country as doctors, nurses and administrators appear at panels in the coming months to share with professionals in their fields...Once hospitals complete their internal review, they will be shared with one another how they responded and what the challenges were...They will look at what they did well and how they would do something differently in the future...Las Vegas will share with the rest of the world the “best practices” it learned from the mass shooting, just like it did after the MGM Grand fire...

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars...On Dec. 4, 2017, a final round of comments from industry stakeholders who raised questions over FDA’s draft guidance, “Statistical Approaches to Evaluate Analytical Similarity,” about how to conduct analytical evaluation of similarity in biosimilars, was published...Several biopharma majors were among the commenters, including Amgen, Boehringer Ingelheim, Genentech, a Roche company, Novartis, Pfizer, Sanofi, and Shire. Other industry stakeholders include the Association for Accessible Medicines, the Biosimilars Forum, and the Biotechnology Innovation Organization...FDA introduced the draft guidance in September 2017, which specifically describes the type of information that sponsors of proposed biosimilar products should obtain regarding the structural/physicochemical and functional attributes of the reference product. In addition, the guidance describes how that information can be used in the development of an analytical similarity assessment plan for the proposed biosimilar, as well as recommends the statistical approaches for evaluating analytical similarity.

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

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Manufacturers and trading partners struggle to meet drug tracking requirements...As FDA and industry near the halfway mark in the 10-year process for establishing a national electronic drug tracking system by 2023, there’s considerable concern among pharma companies, wholesaler/distributors, and pharmacists about meeting the deadline. The process for establishing the rules and infrastructure for the track-and-trace system envisioned in the Drug Supply Chain Security Act, part of the Drug Quality and Security Act of 2013, is proving to be complex and challenging for all parties...FDA recently delayed requiring drug manufacturers to imprint unique product identifiers on individual packages by November of 2017, saying it would not enforce that policy until Nov. 27, 2018. While major pharma companies are meeting the earlier time-frame for serializing and identifying drug packages, many generic-drug makers and contract manufacturers reported confusion over who is responsible for devising the identifiers and for confirming compliance with requirements. And while manufacturers applauded gaining an additional year to fully identify individual drug packages, pharmacists and other supply chain partners raised concerns that the delay would make it even more difficult for them to comply with reporting requirements for 2018 and 2019...

The Centers for Medicare and Medicaid Services...offered further insight into how the Meaningful Measures program works...deputy director of CMS' Center for Clinical Standards and Quality, said the initiative to streamline quality reporting was launched in recognition that "there's a fine line between being helpful and being a hindrance."...CMS has heard the feedback from industry stakeholders that there are too many often-overlapping quality measures...Tracking these measures does not always lead to better outcomes for patients...there are two key problems CMS wants to solve with Meaningful Measures...The first is to focus on the highest-priority measures for quality reporting and quality improvement. The second...is to improve the agency's communications with patients, clinicians and stakeholders about what measures they should be paying most attention to...the important concepts we want every measure to be filtered through...Those are: reduce regulatory burden, improve access for rural communities, achieve cost savings, safeguard public health, track to measurable outcomes and impact and eliminate disparities...Those principals...represent the guiding framework for 18 different Meaningful Measure areas that CMS wants health systems to prioritize – they're further grouped under six thematic headings:

1. Make Care Safer by Reducing Harm Caused in the Delivery of Care
2. Strengthen Person and Family Engagement as Partners in their Care
3. Promote Effective Communication and Coordination of Care
4. Promote Effective Prevention and Treatment of Chronic Disease
5. Work with Communities to Promote Best Practices of Healthy Living
6. Make Care Affordable

Nevada health officials on Tuesday said a bill aimed at curtailing opioid overprescription will keep decision-making in the hands of physicians, not lawmakers...The provisions of Assembly Bill 474, which the Legislature passed into law this year and takes effect on New Year’s Day, were explained to about 200 physicians Tuesday evening at a forum at Las Vegas City Hall...Daniel Burkhead, a physician at the Innovative Pain Care Center in Las Vegas, said the law asks doctors to exercise caution...The law mandates that doctors conduct mental health evaluations before issuing first-time opioid prescriptions, which will be limited to 14 days. The law also mandates that doctors register with the state’s Prescription Drug Monitoring Program...“(Lawmakers) did not want to take power out of the hands of physicians,” Burkhead said. “The law wants you to think, before writing that prescription, if this patient provides a high risk of that medication being diverted or abused or misused.”

The agency and the European Commission published updated guidance to answer questions about Brexit...On Dec. 1, 2017, the European Medicines Agency and the European Commission published updated guidance for pharmaceutical companies regarding the United Kingdom’s withdrawal from the European Union. The new guidance answers additional questions about marketing applications and authorizations...New in this update is more information on batch release sites located in the UK, which must be located in the EU; the effect on herbal medicinal products; and applications for orphan drug designation. The guidance also discusses the local representatives in the UK mentioned in product information, global marketing, and the sunset clause.

Pfizer has won a first approval for OTC Viagra. Viagra Connect, the Pfizer OTC name for its blockbuster erectile dysfunction drug, has been approved for sale in the U.K...The Medicine and Healthcare products Regulatory Agency announced...that it will reclassify the 50 mg dose from prescription only to a pharmacy medicine in the U.K. Viagra Connect is expected to be available for sale in the spring of 2018. Anyone seeking to buy the drug will be required to have a discussion with a pharmacist, who will determine whether the drug is appropriate for their use...It will continue to sell branded versions of other doses of the drug in the U.K...In regard to its U.S. OTC ambitions, Pfizer said, in a statement to FiercePharma, “While we do not have information to share on specific Rx to OTC switch programs in the United States, generally we consider prescription drugs—both within the Pfizer portfolio and outside it—for potential switch to non-prescription status. Our objective is to provide consumers with significantly greater access to medicines with well-established efficacy and safety profiles without a prescription.”