Gilead’s freshly approved Biktarvy faces patent hurdle
Gilead Sciences’ new HIV treatment Biktarvy has been approved by the Food and Drug Administration — but its novel component is also the subject of patent infringement litigation from GSK.
Biktarvy is a triple-therapy HIV treatment that brings together bictegravir’s unboosted integrase strand transfer inhibitor with the dual nucleoside transcriptase inhibitor backbone of emtricitabine, tenofovir alafenamide — which are the two components of Gilead’s Descovy.
“Gilead is committed to improving care and simplifying therapy for people living with HIV. We continue to invest in research in next-generation treatments, including therapies that could potentially cure HIV patients,” Gilead president and CEO John Milligan said. “We are pleased to offer Biktarvy, our latest triple-therapy treatment, which brings together the potency of an integrase inhibitor with the most-prescribed dual-NRTI backbone in a once-daily single tablet regimen.”
However, now bictegravir is at the center of GSK’s lawsuit, which was filed in the U.S. District Court for the District of Delaware, as well as in Canadian Federal Court in Toronto. GSK’s majority-owned Viiv Healthcare said it is looking to prove that Biktarvy’s use of bictegravir infringes on a patent covering its dolutegravir and other compounds that use dolutegravir’s chemical scaffold. The company said it would seek financial redress.
“Intellectual property protections are critical for the life-sciences industry, allowing companies to make a return on their investment, which in turn enables research-based companies to put new funding into research and development,” GSK said. “It is this cycle which continues to result in the development of new and much-needed treatments for people living with HIV.”
NCPA survey: Independents feel hampered by DIR fees
Independent pharmacists are indicated to the National Community Pharmacists Association that it should continue to make the case for reform around direct and indirect remuneration, or DIR, fees. The Alexandria, Va.-based group recently conducted a survey of its members in which 84% said they felt DIR fees hinder their businesses.
Seventy-eight percent of independent pharmacists said that DIR fees hinder their ability to plan for their businesses’ future, with three-quarters saying the fees make their cashflow unpredictable. Pharmacists also recognized that patients feel the impact of DIR fees, too, with 69% of those surveyed saying cost-sharing levels increase as a result of the fees, raising a patient’s out-of-pocket costs. And 87% said that DIR fees push patients into the Medicare Part D coverage gap faster, which can lead to high out-of-pocket costs.
“Our members say fixing retroactive pharmacy DIR fees should be NCPA’s priority for 2018,” NCPA CEO Doug Hoey said. “The results of this recent survey will help us make the case to CMS and members of Congress that a fix is needed, and it’s needed now. … The only realistic solution is to end the retroactive nature of DIR fees — whether through S. 413 / H.R. 1038, the Improving Transparency and Accuracy in Medicare Part D Drug Spending Act, or by the Centers for Medicare & Medicaid Services flexing their regulatory muscles in a similar manner.”
NCPA attached the survey results to recent comments it sent to CMS regarding its proposed rule for 2019 Medicare Part D plans, which included a request for information on a potential proposal to include DIR fees at the point of sale.
“We commend CMS for addressing in this proposed rule troublesome practices in the Part D program and encourage the agency to implement these provisions to produce greater convenience and savings for Medicare beneficiaries and greater transparency and fairness for pharmacies,” Hoey said in January.
Pharmacy data-sharing will enable future of value-based care provision
As we look toward this New Year and at the big picture, pharmacies and providers across the healthcare spectrum continue transitioning care models from fee-for-service to value-based provision. Behind the pharmacy counter, processing the prescriptions accurately and achieving billing compliance have so far been the priority, and rightfully so. But with new demands that focus on treating the entire patient with outcomes in mind, the whole healthcare value chain is involved and at stake.
Pharmacy operations are very much part of successful patient outcomes and as such play a huge role in the clinical care continuum. Consider that the pharmacist remains the most accessible healthcare practitioner for patients, who come frequently and regularly to pick up prescriptions, ask advice about over-the-counter medications or ask general questions about overall health. Payers and pharmacy benefit managers view the pharmacist and pharmacy role as an evolving one that shoulders much more responsibility for outcomes.
According to Prescriptions for a Healthy America,” poor medication adherence results in 33 to 69 percent of medication-related hospital admissions across the U.S., at a cost of roughly $100 billion annually. At least 125,000 Americans die each year due to poor medication adherence.
This burden of adherence and general patient responsibility requires much more transparency in care. Ideally, treating the whole patient requires that all care team members have access to the important information surrounding the patient’s health — test outcomes, family history, laboratory results, and of course, medication history.
Across the entire healthcare system, providers need access to multiple datasets for knowledge sharing and open communication. Pharmacy, unfortunately, is the missing link. When a patient is admitted to a hospital or treated at a specialist, the onus is on him to report current and past medications. What if the patient is unconscious? Confused? Forgetful? Purposefully evasive?
A contributory, linking database in which pharmacists, and other providers, would willingly share important health information would translate to better patient care for the good of the entire industry. While pharmacy chains currently keep patient data within their organizations, companies within the auto insurance industry, for example, freely share claims and accident report data for the good and safety of all drivers. Surely, there are obvious concerns with sharing specific transaction information with competitors but success will be achieved when the industry has meaningful dialogue about these concerns and determines how to overcome them instead of using them as an excuse to put off data sharing efforts.
Finding the right solution for data integration is the gateway to a much-needed inevitability: a unique patient identifier, or UPI, for every single patient. The myriad benefits of a UPI include both patient safety and opioid abuse reduction and prevention. Healthcare ID fraud is a significant problem and, unfortunately, a recent trend. Pharmacies must guarantee that the person who is receiving care — and medication — is the person he says he is. Without the vigilance of a patient management tool to detect fraud on the pharmacy’s end, patients may acquire drugs from several different locations for personal use or even distribution. Across the larger healthcare spectrum, identification fraud may be executed to collect and steal payments. By contributing vital information to a database that implements widespread linking capabilities, pharmacies can reap the benefits of fraud protection while focusing on patient-centered, value-based provision of services.
While mandatory contributory state databases do exist, a broader voluntary application would yield broader results. Certainly, having an industry contributory database configured within the pharmacy’s regular workflow would mean the right data at the right time at the fingertips of pharmacists everywhere, enabling seamless automation for meeting state compliance requirements. True interoperability would enhance the prescription drug monitoring programs, or PDMPs, already in place, and make room for more comprehensive efforts.
Extensive data linking also opens up possibilities for analytics applications that help pharmacists treat patients better. For example, social determinants of health, or SDOH, — conditions in the places where people live, learn, work, and play that affect a wide range of health risks and outcomes, according to the Centers for Disease Control and Prevention, factor into outcomes. Certain socioeconomic information can help predict medication adherence and propensity for addiction. With tools that provide a broader understanding of each patient, pharmacists are presented with quick, actionable decision points that suggest the best way to intervene with the specific patient, increasing adherence and safety.
The next generation of pharmacists and practitioners have become accustomed to reaping the benefits of technology and insights in care provision. As pharmacies are held more accountable for the whole patient picture and rated on outcomes, harnessing the full potential of data sharing technology is not an “if,” but a “when” and a “how.” Pharmacy needs to be proactive in forging this path. The future of healthcare depends on it.