Merck gets FDA approval for new Keytruda indication
SILVER SPRING, Md. — The Food and Drug Administration has approved a new indication for Keytruda (pembrolizumab), the drug’s manufacturer Merck announced recently. The drug is now approved as a third-line treatment for patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors test positive for a certain protein identified by an FDA-approved test.
The new indication was approved under the FDA program of accelerated approval based on tumor response rate and durability, with continued approval contingent on verification and description of benefit in future confirmatory trials, Merck said. Keytruda is an anti-programmed death receptor-1, or PD-1 therapy, which helps the immune system detect and fight tumor cells.
“Keytruda is now the first PD-1 checkpoint inhibitor approved in the United States for previously treated advanced gastric or GEJ cancer, helping to address a recognized treatment gap,” Merck Research Laboratories president Dr. Roger Perlmutter said. “This approval marks another milestone — the 10th new indication for Keytruda in just three years — which further demonstrates both our commitment to patients and the progress we have made in the fight against many cancers.”
Supermarket Wellness Watch: Data shows breadth of retailer health commitments
It’s one thing to say food retailers are boosting their commitments to health and wellness. It’s another to actually crunch the numbers and understand how this is playing out.
A recently released report does just that by quantifying the growing retailer involvement in clinics, community health partnerships, consumer education, and other areas.
That report is Food Marketing Institute’s 2017 Retailer Contributions to Health and Wellness. DSN presented a timely news story when this report was unveiled in August.
It’s worth taking a deeper dive now, because of the report’s extensive data, and to relay the perspectives of a leading retailer in health and wellness.
First, let’s look at some of the report’s key findings, based on its survey of retailers:
- The overwhelming majority of retailers — some 96% — said they are committed to expanding health and wellness programs in their stores;
- Some of the most widely practiced health-related activities include product sampling, healthy recipes, good-for-you-products, front of pack labeling on private brand products, better-for-you prepared foods, and health screenings;
- Virtually all retailers have pharmacists on staff, and almost 90% employ dietitians; and
- Three-quarters of stores report that pharmacists and dietitians are collaborating by referring customers to each other.
The findings were most illuminating when documenting extensive retailer involvement in specific initiatives, such as clinics.
“Perhaps the most tangible evidence of supermarkets becoming a key partner in health and wellness for the communities they serve is the rise of in-store clinics,” the report observed.
It found that 32% of respondents have clinics in some of their stores. All of these clinics — that’s 100%! — are staffed with nurse practitioners. Other personnel include physicians’ assistants (75%), dietitians (25%), and health coaches (12.5%). The care provided by clinics included immediate (63%) and a combination of immediate and chronic care (38%).
The report also spelled out the extent to which retailers are embracing involvement with community health partners. Some 96% of respondents have plans to work with specific community partners in the coming year. The choices of partners include local hospitals or health care networks (79%), health insurance providers (63%), allied health organizations such as AHA and ADA (63%), universities (58%), work site wellness programs (58%) and local gyms and/or professional trainers (50%).
The report also shed light on how retailers are going beyond in-store efforts to educate consumers about health. Almost all retailers — 93% — have web pages dedicated to health and wellness. The majority — 71% — publish health and wellness blogs. Sixty-two percent provide weight management programs for adults and children.
I reached out for more perspective to the retailer who chairs the FMI committee that produced this report. Natalie Menza-Crowe is director of health and wellness for Wakefern Food, the operator of ShopRite supermarkets and a retail health and wellness leader. She said the report’s findings underscore how wellness efforts now extend to virtually all retailers.
“We’re getting close to the 100% mark of retailers focused on health and wellness as a primary objective in their business models,” she said. “As you go through the report, you see that retailers vary in where they focus efforts, such as with dieticians, culinary, in-store demos, cooking classes, store tours, and other areas. But all of it works.”
She added that having dietitians partner with pharmacy is a very positive direction for the industry.
Commenting on the wide range of industry health initiatives, Menza-Crowe emphasized that choices of activities need to be determined by market needs, and even by store. “It has to be specific to the market,” she said. “Cooking classes might work better in one store, whereas one-on-one consultations may work better in another.”
The report’s data will be useful to retailers of all kinds hoping to benchmark how their activities compare with the wider industry. The upshot is that retailers are making deeper investments in wellness activities. No longer is the conversation about whether this is worthwhile. It’s about how many and which activities each retailer will focus on. That’s marks a big advancement.
Q&A: Caulfield explains role of Temptime’s medication temperature monitoring tools
With specialty pharmacy marking a growing component of community pharmacies’ business, inventory monitoring — particularly for specialty medications that are meant to kept at certain temperatures — is becoming an added stressor for pharmacists. Temptime VP global customer development Christopher Caulfield spoke with Drug Store News about how the company’s temperature monitoring tools help pharmacies deliver value to patients and the healthcare system.
Drug Store News: With consumers taking greater control of their own health, how is your company helping community pharmacists use technology to better engage patients, improve the patient experience in pharmacy and/or improve communication with patients?
CHRISTOPHER CAULFIELD: Temptime spent 18 months understanding the needs and expectations of consumers, especially those managing a chronic condition. We learned that they are engaged and active in their healthcare treatment and that they desire information and assurance that the medication or therapy they are using will improve their quality of life.
In addition to consumers, Temptime has worked with pharmacists and pharmaceutical manufacturers to understand temperature monitoring requirements and how a successful communication program incorporating temperature monitoring can enhance the patient user experience, contribute to a positive impact on an outcomes-based program and reduce the number of reships to the pharmacy. Patients demand assurance from their pharmacists and healthcare providers that their medications have been stored and shipped in the proper conditions. Temptime has achieved this positive outcome via low cost, chemically based, disposable devices or with more complex data-collecting devices.
DSN: As pharmacists work to achieve provider status and continue to play a greater role in healthcare delivery, how is your company enabling community pharmacists to practice at the top of their license?
CC: Temptime understands that pharmacists are working in a dynamic environment where they are tasked with being experts in drug interactions, temperature management and logistics all in the same day. Temptime has a suite of chemical and electronic data-logging product offerings that address the various accreditation requirements and state boards of pharmacy requirements. Unique and innovative solutions make facility temperature and humidity monitoring more easily achieved while data and alarms are more effectively shared. The ease by which a pharmacy can qualify an insulated shipper using the Temptime system allows a pharmacist to focus on the patient and the medications.
DSN: Medication adherence remains one of the most cost-effective ways to lower total healthcare costs and deliver improved outcomes. How is your company helping community pharmacy solve for this big opportunity to improve health care?
CC: Temptime has been providing millions of low-cost, chemically based temperature monitoring solutions to pharmacies so that patients can immediately know if their medication has been received without exposure to potentially damaging temperatures. Identifying medication that has been delivered within the appropriate temperature range in an immediate and simple fashion allows patients to maintain their medication schedule and improve the likelihood of improved outcomes in a cost-effective manner.
DSN: How is your company helping community pharmacies drive greater efficiency in their business whether in terms of inventory management, optimizing workflow, or keeping ahead of reimbursement challenges, etc.?
CC: Temptime understands that pharmacists are taking on an ever-growing responsibility for assuring that highly valued, temperature-sensitive medications are received by the patient per the temperature requirements of the manufacturer — and in a growing number of states, the requirements of the state board of pharmacy. Temptime has worked with pharmacists, patients and manufacturers to understand the temperature monitoring requirements and how a successful program can enhance the patient use experience, contribute to a positive impact on an outcomes-based program and make a significant return on investment for the pharmacy.
DSN: As pharmacy continues to focus more broadly on outcomes and implementing more clinical services, how is your company helping pharmacy retailers better manage the vast amounts of data they need to deal with on a daily basis that comes as a part of that?
CC: Temptime is dedicated to improving global health. The company’s commitment is reflected through our dedication to understanding specific market needs and determining how we can bring innovative products to enhance those markets. Temptime has been participating on the leading edge of the pharmacy market by bringing new, patient-centric temperature monitoring solutions into the patient’s home. Temptime offers an entire range of temperature monitoring solutions from low-cost, chemically-based products to sophisticated data-driven devices equipped with low-energy Bluetooth capabilities and cloud-based data storage.
DSN: As healthcare providers look to form unique partnerships to better manage patient populations, deliver improved outcomes and better manage financial risk, how is your company helping to connect the expanded patient care team?
CC: We partner with small, medium and large national specialty pharmacies in mail-order, retail and hospitals to control escalating specialty drug costs by reducing returns and reships. Monitoring temperature-sensitive shipments can improve patient outcomes and satisfaction, protecting the integrity of the brand and maximizing value for the manufacturer and specialty pharmacy alike.
Patients and healthcare providers want the knowledge and confidence that their medications have not been adversely exposed to temperature. Manufacturers of specialty drugs want the confidence to know that patients are receiving the optimal potency to provide an optimal outcome. Payers want costs controlled and great patient outcomes.