Nick Basta, Editor Emeritus

It is the contention of BrightInsight, a San Jose, CA software firm, that biopharma and med-device companies seeking to develop digital health applications to wrap around their commercial products are ill-suited to the task: teams of software developers are needed to design and build the applications, including interfacing with a wide and growing variety of third-party software tools, wearable devices or monitors, all while ensuring reliable data collection and analysis, and meeting the complex strictures of (for example) FDA’s Sofware as a Medical Device (SaMD) regulations. By offering its BrightInsight Platform, a Google Cloud-based system—prebuilt with compliant reliability, privacy and interfacing capabilities, followed by easy-to-use configuration for specific medical applications—the company promises a streamlined pathway to successful digital-health resources.


Now, at this week’s international BIO meeting (San Diego, June 13-16), BrightInsight has introduced the Disease Management Solution to further tailor its platform to user needs. This solution, says Kal Patel, CEO, provides Patient App tools to communicate and engage with patients; a Healthcare Provider Interface with a clinician portal, integration with electronic health record (EHR) systems and patient-provider communication, and Analytics Dashboards to enable data scientists at biopharma and medtech companies to better understand the dynamics of drugs and devices in the real world. 

“Our clients are building regulated patient apps that support the patient care journey, including therapy administration guidance and tracking, ongoing disease monitoring, medication reminders, and communication with healthcare providers,“ he says.


Existing clients include Novo Nordisk for diabetes management, Roche for a dosing calculator for hemophila-A treatment, and CSL Behring and UCB, both for rare disease management. At Sanofi, another BrightInsight client, global leader Brad Gescheider says that “The data collected through these efforts will also help power more personalized therapies, deliver beyond-the-pill service offerings, and potentially extend the patent life of our most valuable brands.”


Patel notes that as numerous therapeutic areas become more crowded with commercialized drugs and devices, the digital health tools that the manufacturers will provide become a more crucial differentiator among those offerings. Via digital health tools, better adherence to therapy, leading to better outcomes, will result.

Articles

Configurable applications address patient and healthcare-provider interfaces, and an analytics dashboard

BrightInsight Enhances Digital Health Platform Solution

The Federal Trade Commission (FTC), which is mostly concerned with antitrust or anticompetitive activities by businesses, has unanimously okayed a “Section 6(b)” inquiry, under which the Commission is authorized “to conduct studies without a specific law enforcement purpose.” Six pharmacy benefit managers—CVS Caremark, Express Scripts, OptumRx, Humana, Prime Therapeutics and MedImpact Healthcare Systems—will have 90 days to respond to requests for records and information.

The FTC action was expected. In February, a more limited investigation was not approved but the Commission opened a request for information that resulted in 24,000 responses, according to the agency. According to an FTC news release, PBMs “often have enormous influence on which drugs are prescribed to patients, which pharmacies patients can use, and how much patients ultimately pay at the pharmacy counter. Many of these functions depend on highly complicated, opaque contractual relationships that are difficult or impossible to understand for patients and independent businesses across the prescription drug system.”

In particular, FTC will seek information on:

fees and clawbacks charged to unaffiliated pharmacies;

methods to steer patients towards PBM-owned pharmacies;

potentially unfair audits of independent pharmacies;

complicated and opaque methods to determine pharmacy reimbursement;

the prevalence of prior authorizations and other administrative restrictions;

the use of specialty drug lists and surrounding specialty drug policies;

the impact of rebates and fees from drug manufacturers on formulary design and the costs of prescription drugs to payers and patients.

For years, pharmacies and other drug purchasers have complained about PBM business practices and their dominance of commercial channels, in addition to being in competition with the specialty and mail-order pharmacies that the PBMs run themselves. Pharma manufacturers—who sit across the table from PBMs as rebates and formulary placements are discussed—are rarely outspoken about PBM practices, although they bear the brunt of the price negotiations that go on.

A decade ago there was a period of consolidation among PBMs leading to the dominance of the top three or five; in more recent years the PBMs were merged with insurance companies (Cigna owns Express Scripts, and CVS Caremark acquired insurer Aetna, while insurer Humana has expanded its PBM business) or health systems (Optum is owned by United Health).

For its part, the Pharmaceutical Care Management Assn., the trade group of large PBMs, stated in comments to FTC that “PCMA looks forward to having a conversation about the benefits that PBMs provide consumers and hopes that this will be the beginning of a larger process designed to identify and evaluate the root causes and impacts of rising drug prices.”

Dominance of a handful of integrated firms “at the center of the US pharmaceutical system,” plus their trade practices, will be reviewed

Federal Trade Commission to Examine PBM Business Practices

For the past couple years, and as a supplement to its customer relationship-management software, Veeva has been building out Link, a “real-time customer intelligence platform” that can be used by field sales teams or marketing departments to stay close to the broad acceptance of a pharma company’s products and market position. The foundational part is Veeva Link for Key People, a digital, continuously updated form of key opinion leader management. Now, with AI and active curation of multiple data sources, Link is expanding to Key Accounts, Scientific Awareness, Medical Insights, and an enhanced internal workflow data-management service, called Link+. Only Key People is available currently; the others are expected to roll out over the coming 12 months.

As it is currently organized, Veeva Link crosses 21 therapeutic areas, from oncology (the original Link service) to psychiatry. The company touts its comprehensive coverage of social media, LinkedIn, YouTube, 200,000 local and global congresses, and 50,000 medical associations. All this across 76 countries.

Such types of data services have long been a part of pharma companies’ efforts to track the actions and sentiments of prescribers; with the growth of digital content and the ability to connect individual practitioners with their sources of information, influencers, presentations and the like—all in real time—the analytic capabilities of market researchers and sales teams becomes more powerful. In addition, the potential to connect all this digital research with the actions and findings of field sales teams, nominally through Veeva CRM, adds to that power.

Veeva pre-announced these new services as a lead-in to its annual Commercial Summit, to be held in Boston, MA on May 5.

New slices of the data will focus on key accounts, scientific awareness and medical insights

Veeva Expands Link Service Across Multiple Therapeutic Areas

 is out, from the IQVIA Institute for Human Data Science. Overall data show a double-digit increase in top-line (list price) revenue of 11.3% as well as a 13.3% increase in net revenue. A significant part of that is spending on Covid-19 vaccines and therapeutics ($29 billion), a category that was essentially nil in 2020. Separating out those expenditures, drug spending was up 5%.

Between the list prices and what payers spend lie the discounts, primarily to pharmacy benefit managers and for programs like the 340B program that discounts drug sales to certain hospitals. That discounting amounted to over $190 billion, representing an average 24% discount across all drug categories. However, there is considerable variation among drug classes: Diabetes drugs showed a weighted-average discount of 78% off list, while oncology drugs showed only a 7% discount.

Specialty pharmaceuticals now represent 55% of spending, which is actually down slightly from 2020. The crossover from traditional drug classes being the majority of spending occurred in 2018.

More broadly, IQVIA also produces a new “Health Services Utilization Index,” a measure of patient visits, procedures and new prescription starts. At the end of 2021, the Index was at 99, compared to a baseline of 100 in the first eight weeks of 2020. The Index had fallen to 66 in the second quarter of 2020 as the pandemic took hold. Overall, then, utilization rates have returned to something resembling “normal,” although IQVIA notes that there is now a significant backlog of unperformed healthcare activities. Notably, pediatric vaccinations are still running 20% lower than 2019 levels, “raising significant public health concerns about unvaccinated children” (this refers to all types of pediatric vaccinations, like those for measles or mumps, and not Covid-19 vaccines).

The report also tallies prescription activity: up 2.4% in 2021, to 6.474 billion. Average growth over the past five years has been 2.1%, but a significant dip occurred in 2020, with only 1.7% growth during the year, due to the pandemic.

Looking ahead, IQVIA predicts that market growth will return to pre-pandemic levels in 2023, with list-price growth of 2-5% CAGR during 2022-2026 and net CAGR of 1-4%. Spending on Covid-19 will drop to $4-5 billion per year after 2021. “Public pressure is likely to limit drug price increases to a greater degree than in the wider economy,” it predicts. Another significant factor is the entry of more biosimilars in the 2022-2024 period when products like ranibizumab (Lucentis), adalimumab (Humira) and ustekinumab (Stelara) will see biosimilar competition. As a category, biologics will suffer $40 billion in loss of exclusivity during 2022-2026.

Nominal revenue for US drug sales was up to $776 billion, reports IQVIA, but net revenue (discounting rebates) was $407 billion. Some $29 billion was spent on COVID-19 vaccines and therapeutics

Nominal Revenue for US Drug Sales Up 11.3% in 2021

 in January against several wholesalers and distributors of its HIV drugs (and others), in an alleged scheme worth an estimated $250 million, the question arose, where is the federal government in this scandal? Now a partial answer seems to be coming from a 

 that DoJ started investigating this and related instances of counterfeiting in late 2021.

The scheme that Gilead has litigated against—which was successful in at least getting suspect drugs out of circulation—involves reusing properly labeled drug bottles now containing fake product, or reselling drugs which had been previously dispensed to HIV patients. Parties involved were in ten states and Canada and were either distributors or pharmacies. Product labels designed to be in compliance with the Drug Supply Chain Security Act (DSCSA) were evidence of the diversion or reuse of drug bottles.

, these alleged counterfeiters were taking advantage of Medicaid, Medicare, or free-drug programs that provide medicine to low-income patients. In reality, of course, HIV patients need live-saving medicines regardless of their income status; moreover, there’s no saying to whom the recycled pill bottles might be sold. The DoJ investigation also involves Johnson & Johnson, ViiV Healthcare and GSK, states the 

It is a commonplace belief in the US that counterfeiting is a rare and relatively minor part of drug distribution. But the widespread availability of opioid pills intentionally designed to mimic legitimate versions, combined with incidents like the HIV medication scheme, paint a picture of opportunistic criminals taking advantage of any weaknesses to be found.

Action follows on the heels of Gilead’s court actions against a $250-million scheme

US Dept. of Justice Investigating HIV-drug Counterfeiting Ring, Says WSJ

In a second annual survey tracking the evolution of US industry compliance with the Drug Supply Chain Security Act (DSCSA), the Healthcare Distribution Alliance Research Foundation (HDA) finds some progress from last year’s survey, but still a considerable distance to anything near full compliance by November 2023, the deadline date in the 2013 law. In particular, 87.5% of manufacturer respondents are using the EPCIS 1.2 standard to communicate necessary data, and about 95% of respondents have, or plan to have, EPCIS connections with distributors. However, only a small fraction of these connections are in a “production environment” (i.e., in working order) today; dozens will need to be in place for each manufacturer before the DSCSA system becomes a reality.

Some background: EPCIS is a standard developed by the GS1 organization expressly for transmitting the barcode identifiers of individual pharmaceutical packages to trading partners; HDA considers it the “minimum … required” capability. (Industry wags have noted that EPCIS standardization is not written into DSCSA; conceivably, a manufacturer could dump a ton of barcode data on distributors and tell them to deal with it; but distributors by and large have made electronic communication via an agreed-on technology their own business rule.) When fully functional, the DSCSA compliance system will enable the tracking of individual pharma packages from manufacturer to distributor to dispenser.

The HDA survey gives some shape to how DSCSA compliance will operate in the future: as of the survey period, 26% of manufacturers plan to connect to distributors directly, while 69% will use a third party—either a 3PL or a solution provider. Few manufacturer-to-dispenser connections are planned. “Respondents noted that many dispenser customers are planning to use a portal provided by the wholesale distributor, which explains the relatively low number of direct distributor-to-dispenser connections. Rather, distributors reported that transaction data will be exchanged interoperable with manufacturers and posted to a portal that the wholesale distributor maintains on behalf of the dispenser and accessed by the dispenser,” says the report.

“EPCIS Implementation Benchmarking Survey” was conducted in Q4 by the HDA Research Foundation, and is available for free download 

https://hda.org/~/media/pdfs/center/epcis-implementation-benchmark-survey-q4-2021.ashx

) It was sponsored by AmerisourceBergen, LSPedia, TwoLabs Pharma Services, and Antares Vision Group. The latter group, with its software subsidiary RfXcel, has set up an “EPCIS Center of Excellence” which will work with HDA in future surveys.

Trading partner Interconnections via the EPCIS standard is a basic requirement