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How HHS efforts to increase competition could hurt patients.

Lower Drug Prices Aren’t Worth Higher Health Risks

journal explores issues within pharmacy, from the impact advocacy can have in community pharmacies to staffing shortages across multiple sectors within pharmacy. This month’s issue also explored the importance of disease awareness months and how they are opportunities to maximize valued care. Check out a preview of this month’s issue here.

download the PDF of the Total Pharmacy August 2024 issue here

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In This Issue: Total Pharmacy August 2024

Combining sodium glucose co-transporter 2 inhibitors (SGLT2is) with glucagon-like peptide-1 receptor agonists (GLP-1RAs) may offer additional protection against cardiovascular and kidney disease in patients with type 2 diabetes (T2D), according to the results of a new meta-analysis published in 

 and presented at the 61st European Renal Association Congress in Stockholm, Sweden.

Separately, SGLT2is and GLP-1RAs have demonstrated cardiovascular benefits. However, little clinical literature has focused on outcomes associated with using the medicines together. Due to the growing prevalence of GLP-1RAs in the 

 and obesity landscape, accelerated by an increasing number of indications for the agent class, this is a crucial area for further study.

The SGLT2 Inhibitor Meta-analysis Cardio-Renal Trialists’ Consortium (SMART-C) is the largest assessment of outcomes for the combined therapeutic use of SGLT2is and GLP-1RAs. The study gathered data from 12 large-scale, placebo-controlled trials of SGLT2is involving 73,238 patients with diabetes. Of these, 3065 were already receiving GLP-1RAs.

Overall, SGLT2is lowered the risk of major adverse cardiovascular events by 11% and hospitalization for heart failure or cardiovascular death by 23% compared to placebo. Notably, this benefit was seen regardless of whether patients were also taking GLP-1RAs.

When used together with GLP-1RAs, SGLT2is reduced the risk of chronic kidney disease progression by 33% and slowed the annual loss of kidney function by nearly 60%.

The study found no additional safety concerns when SGLT2is were used in combination with GLP-1RAs.

Study Reveals Robust Benefits of Semaglutide in Protecting Against Kidney, CV Events in Patients With T2D

Current meta-analysis results build off positive results of the landmark FLOW trial (

). Published earlier in May, results of the international, double-blind, randomized, placebo-controlled phase 3 trial spotlighted semaglutide’s effectiveness in lowering the risk of kidney failure, decelerating worsening kidney function, and protecting against the risk of cardiovascular events and death, in patients with T2D.

“SGLT2 inhibitors have clear protective effects against heart failure and chronic kidney disease, while GLP-1 receptor agonists can reduce the risk of heart attack, stroke, and also kidney disease—as recently demonstrated in the landmark FLOW trial,” said Brendon Neuen, lead author, clinical associate professor, senior research fellow at The George Institute for Global Health, and director of kidney trials at Sydney’s Royal North Shore Hospital, in a news release.

 “Our findings support using this combination to further improve outcomes in patients with type 2 diabetes who meet guideline recommendations for both therapies.”

Elevated glucose from diabetes can damage blood vessels in the heart and kidneys, increasing the risk of 

 and kidney disease. In fact, diabetes is the most common cause of chronic kidney disease.

Moreover, estimates predicting that T2D prevalence will more than double in the next 30 years, surpassing 1 billion global cases by 2050, further strengthen the need for research into diabetes care.

 According to Neuen in an interview with 

 conducted over email, the current study offers valuable insights for developing global treatment strategies for the condition.

"These findings, which represent the largest and most comprehensive evaluation of the combined use of SGLT2i and GLP-1RA, provides the clearest evidence yet that combined use of both medicines can further reduce cardiovascular and kidney disease," said Neuen. "We anticipate that these findings will inform how people with diabetes are treated worldwide, including influencing major clinical practice guidelines.

Although current results suggest that using SGLT2is and GLP-1RAs in tandem may offer robust protection against cardiovascular and kidney disease, further research is needed to fully understand the long-term effects of the combination therapy.

Pharmacy practice is always changing. Stay ahead of the curve: Sign up for our 

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1. Apperloo E, Neuen BL et al. Efficacy and safety of sodium glucose co-transporter 2 inhibitors with and without glucagon-like peptide-1 receptor agonists: A SMART-C collaborative meta-analysis of randomised controlled trials. 

. 2024. doi: 10.1016/S2213-8587(24)00183-9

2. Massaro L. Study reveals robust benefits of semaglutide in protecting against kidney, CV events in patients with T2D. 

https://www.drugtopics.com/view/study-reveals-robust-benefits-of-semaglutide-in-protecting-against-kidney-cv-events-in-patients-with-t2d

3. Combining popular diabetes drugs offers complementary heart and kidney benefits. News release. The George Institute for Global Health. July 9, 2024. Accessed July 10, 2024. 

https://www.georgeinstitute.org/media-releases/combining-popular-diabetes-drugs-offers-complementary-heart-and-kidney-benefits

4. Mayo Clinic Staff. Chronic kidney disease. Fact sheet. Accessed July 8, 2024. 

https://www.mayoclinic.org/diseases-conditions/chronic-kidney-disease/symptoms-causes/syc-20354521

5. Klein HE. Diabetes prevalence expected to double globally by 2050. 

https://www.ajmc.com/view/diabetes-prevalence-expected-to-double-globally-by-2050

When used together, sodium glucose co-transporter 2 inhibitors (SGLT2is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs) were able to lower the risk of major adverse cardiovascular events and kidney disease by 11% and 33%, respectively.

Clinical

SGLT2i, GLP-1RA Combination Therapy Offers Robust Protection Against Cardiovascular, Kidney Disease

The FDA has accepted Bayer’s New Drug Application (NDA) for elinzanetant, an investigational non-hormonal treatment for moderate-to-severe vasomotor symptoms (VMS) associated with menopause, the company announced in a release.

 The therapy is the first dual neurokinin-1 and 3 receptor antagonist in late-stage clinical development and is administered orally once daily.

“The NDA acceptance of elinzanetant by the FDA marks a significant milestone in our efforts to advance menopause care for women in the US,” said Christine Roth, executive vice president, global product strategy and commercialization, and member of the pharmaceutical leadership team at Bayer, in the same release.

 “If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency.”

The NDA application is supported by positive results from the OASIS 1, 2 and 3 phase three studies evaluating the efficacy and safety of elinzanetant versus placebo. Findings from OASIS 1 (

 and results of the phase three OASIS 3 (

) study supporting efficacy and additional long-term safety data were presented at The Menopause Society annual meeting in September 2024.

Opill Marks a New Era for Birth Control Access

OASIS 1 and 2 were randomized, double-blind, phase 3 clinical trials conducted among postmenopausal women aged 40 to 65 experiencing moderate to severe VMS. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks.

The primary endpoint included mean change in frequency and severity of moderate-to-severe VMS from baseline to weeks 4 and 12, measured by an electronic hot flash daily diary. Secondary endpoints included sleep quality and overall quality of life related to menopause.

A total of 309 and 324 participants across 184 sites in 15 countries completed OASIS 1 and 2, respectively. Although frequency and severity of VMS were comparable between the groups at baseline, elinzanetant reduced VMS frequency at weeks 4 and week 12. Elinzanetant also improved VMS severity at week 4 and week 12. Additionally, elinzanetant improved sleep disturbances and menopause-related quality of life at week 12 and its safety profile was favorable.

OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of VMS over 52 weeks. It enrolled and randomized 628 

 women between 40 and 65 years across 83 sites in 9 countries. Consistent with findings from OASIS 1 and OASIS 2, OASIS 3 showed that elinzanetant effectively reduced the frequency of moderate-to-severe VMS from baseline to week 12 compared to placebo.

“The detailed results of OASIS 3 are complementing the positive results of OASIS 1 and 2, addressing the question on its long-term profile and indicating the potential of elinzanetant to treat moderate to severe VMS associated with menopause,” said Christian Rommel, global head of research and development at Bayer AG’s Pharmaceuticals Division, in a separate news release.

 “We look forward to continuing our discussions with health authorities around the world regarding marketing authorizations for this compound.”

The OASIS 4 study is an expansion of the clinical phase 3 program and aims to investigate the efficacy and safety of elinzanetant in women with moderate-to-severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.

Beyond the OASIS program, Bayer is conducting NIRVANA (

), an exploratory phase 2 randomized, parallel-group treatment, double-blind study. The primary objective is to explore the efficacy of elinzanetant on sleep disturbances associated with menopause as determined by polysomnography.

Up to 80% of women experience VMS at some point during menopause, and by 2030, the global population of women in menopause is expected to reach 1.2 billion, with 47 million women entering this phase annually.

But despite the impact of menopausal symptoms on women’s health, “many go without treatment due to gaps in awareness, education, and limitation of treatment options available,” according to Roth.

 Bayer is working to close these gaps with the potential approval of elinzanetant by its Prescription Drug User Fee Act deadline of July 26, 2025.

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1. US Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant. Bayer. News release. October 9, 2024. Accessed October 10, 2024. 

https://www.bayer.com/media/en-us/us-food-and-drug-administration-fda-accepts-new-drug-application-for-elinzanetant/

2. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. 

. Published online August 22, 2024. doi:10.1001/jama.2024.14618

3. Data from phase III study OASIS 3 support efficacy and long-term safety of investigational compound elinzanetant in the treatment of moderate to severe vasomotor symptoms associated with menopause. Bayer. News release. September 10, 2024. Accessed October 10, 2024. https://www.bayer.com/en/us/news-stories/phase-iii-study-oasis-3

4. Bayer submits New Drug Application to US FDA for elinzanetant for the treatment of moderate to severe vasomotor symptoms associated with menopause. Bayer. August 1, 2024. Accesesd October 10, 2024. https://www.bayer.com/en/us/news-stories/new-drug-application-to-us-fda-for-elinzanetant

5. Lutton L. FDA accepts NDA for menopause drug, elinzanetant. 

 October 9, 2024. Accessed October 10, 2024. https://www.managedhealthcareexecutive.com/view/fda-accepts-nda-for-menopause-drug-elinzanetant

The therapy’s Prescription Drug User Fee Act date has been set for July 26, 2025.

FDA Accepts Bayer’s NDA for Elinzanetant to Treat Menopause Symptoms

1. NO PURCHASE NECESSARY. OPEN ONLY TO LEGAL RESIDENTS OF THE UNITED STATES OF AMERICA WHO ARE AT LEAST 18 YEARS OLD AT TIME OF ENTRY. Void where prohibited by law. This sweepstakes begins on October 10, 2024 at 12:01 a.m. ET and ends on November 30, 2024 at 11:59 p.m. ET (“Promotion Period”). Administrator’s computer is the official time keeping device for this Sweepstakes. Enter the Sweepstakes during the Promotion Period by: (1) complete the Salonpas survey sent to you by Drug Topics. Online entries must be received no later than 11:59 p.m. ET on November 29, 2024. Alternatively, anyone may enter the Sweepstakes by printing the words “Salonpas Sweepstakes,” along with his or her name, title, date of birth, street address, city, state, zip, and phone number on a 3.5" by 5" white index card. Mail the card to Salonpas Survey Attn: Marketing Department, 2 Commerce Drive, Cranbury, New Jersey 08512. To be considered eligible, entries must be received no later than November 29, 2024 at 11:59 p.m. ET. No methods of entry other than the methods specifically described herein will be accepted. Sponsor is not responsible for lost, late, misdirected or incomplete entries or unsuccessful attempts to enter. Incomplete entries and/or entries not received by the deadlines will not be eligible. Limit (1) one entry per person, per mailing address, per outer-mailing envelope, and per email address.
2. Winner will be selected in a random drawing from among all eligible entries received on or about November 30, 2024. Drawing will be conducted by MultiMedia Medical, LLC (“Administrator”) whose decisions are final. Drawing times are subject to change or cancellation with or without notice. Odds of dinning will depend upon the total number of eligible entries received. For winner’s name, send a separate self-addressed, stamped envelope to 2 Commerce Drive, Cranbury, NJ 08512 by November 2, 2024.

3. The prize (“Prize”) consists of the following: One hundred (100) $10 Starbucks gift cards to the first 100 respondents, with Approximate Retail Value (“AVR”) of $1,000. One $250 Visa Gift Card, with (“ARV”) of $250. Starbucks is a registered trademark of Starbucks Coffee Company. Visa is a registered trademark of Visa, Inc. All rights reserved. Starbucks and Visa are not participants or sponsors of this promotion.

4. The limit is one winner for the Prize. Winner will be notified by phone, email, overnight delivery or first class mail, as Sponsor shall determine. If Winner does not respond to Prize Notification as directed within five (5) days of the attempted notification date or if a Prize or Prize notification is returned as unclaimed or undeliverable, such Winner will be disqualified, Prize will be forfeited and an alternate winner will be selected. Upon disqualification, the Prize will be forfeited and no compensation will be given.

Prize is not transferable. No cash or prize substitutions, except the sponsor reserves the right to substitute prizes of equal or greater value. Acceptance of Prize constitutes permission to use that winner's name, likeness, and photo, and hometown for promotional and publicity purposes in any media now known or later developed, worldwide, at no additional compensation unless prohibited by law. All costs and expenses associated with Prize acceptance and use not specified herein as being provided such as reservation fees, taxes, insurance and other expenses incurred by accepting the Prize are the sole responsibility of the Winner. By participating and accepting a prize, winner releases and agrees to hold harmless, Hisamitsu America, Inc. A subsidiary of Hisamitsu Pharmaceutical Co., Inc. and MultiMedia Medical, LLC, their respective parent company, subsidiaries, affiliates, service agencies, sponsors and any independent contractors of any kind arising in whole or in part, directly or indirectly, from acceptance, possession, use, or misuse of the prize or the participation in this sweepstakes or any sweepstakes-related activity.

5. This sweepstakes is open only to legal residents of the United States of America who are at least 18 years old at the time of entry. Void wherever prohibited by law. All federal, state, and local laws and regulations apply. Persons in any of the following categories are not eligible to participate or win a prize: (a) persons who since January 1, 2023 were or are employees or agents of Hisamitsu America, Inc. A subsidiary of Hisamitsu Pharmaceutical Co., Inc. or MultiMedia Medical, LLC, their respective parent company, subsidiaries, affiliates, service agencies, sponsors and any independent contractors of any kind of the above organizations; (b) individuals engaged in the development, production, or distribution of materials or the implementation of the sweepstakes and (c) immediate family of, or persons living in the same household as any person in any of the preceding categories.

6. Information collected by Sponsor in connection with this Sweepstakes may be used by Sponsor and shared with third parties involved in administration of the Sweepstakes. Information collected from entrants is subject to Sponsor’s Privacy Policy available at 

. Sponsor is not responsible for any disclosure made by the other or any third party. By participating in the Sweepstakes and providing your information, Entrants hereby agree to Sponsor’s collection and usage of their personal information and acknowledge that they have read and accepted Sponsor’s Privacy Policies.

7. This promotion is in no way sponsored, endorsed or administered by, or associated with Facebook, Instagram, X.com, LinkedIn, Starbucks or Visa. You understand that you are providing your information to Sponsor and not to Facebook, Instagram, X.com, LinkedIn, Starbucks or Visa. Facebook and Instagram are registered trademarks of Meta, Inc. X.com is a registered trademark of X Corp. LinkedIn is a registered trademark of LinkedIn Corporation. Starbucks is a registered trademark of Starbucks Coffee Company. Visa is a registered trademark of Visa, Inc...


8. Sponsor reserves the right, to disqualify any individual found, in its sole opinion, to be tampering with the operation of the Sweepstakes; to be acting in violation of these Official Rules; or to be acting in an unsportsmanlike manner or with the intent to disrupt the normal operation of the Sweepstakes. Any use of robotic, automatic, macro, programmed, third party or like methods to participate in the Sweepstakes will void any attempted participation affected by such methods and the disqualification of the individual utilizing the same. CAUTION AND WARNING: ANY ATTEMPT TO DELIBERATELY DAMAGE ANY WEB SITE OR UNDERMINE THE LEGITIMATE OPERATION OF THIS PROMOTION IS A VIOLATION OF CRIMINAL AND CIVIL LAWS. SHOULD SUCH AN ATTEMPT BE MADE, THE SPONSOR RESERVES THE RIGHT TO SEEK DAMAGES OR OTHER REMEDIES FROM ANY SUCH PERSON(S) RESPONSIBLE FOR THE ATTEMPT TO THE FULLEST EXTENT PERMITTED BY LAW. Sponsor reserves the right to cancel, suspend and/or modify the Promotion, or any part of it, if any fraud, technical failures or any other factor beyond Sponsor’s reasonable control impairs the integrity or proper functioning of the Sweepstakes, as determined by Sponsor in its sole discretion. In such event, Sponsor reserves the right to award the prizes at random from among the eligible entries received up to the time of the impairment. If due to a printing, production or other error, more prizes are claimed than are intended to be awarded, Prize will be awarded in a random drawing from among all verified and validated entries. In no event will more than one Prize be awarded. In the event of any conflict with any Sweepstakes details contained in these Official Rules and Sweepstakes details contained in other Sweepstakes-related materials, the details of the Sweepstakes as set forth in these Official Rules shall prevail.

9. By entering, each entrant agrees for entrant and for entrant’s heirs, executors, and administrators (a) to release and hold harmless Hisamitsu America, Inc. A subsidiary of Hisamitsu Pharmaceutical Co., Inc, MultiMedia Medical, LLC, Starbuck, Visa, Meta, Inc., X Corp., LinkedIn Corporation and their respective officers, directors, and employees (collectively, “Released Parties”) from any liability, illness, injury, death, loss, litigation, or damage that may occur, directly or indirectly, whether caused by negligence or not, from such entrant’s participation in the Sweepstakes and/or his/her acceptance, possession, use, or misuse of any prize or any portion thereof; (b) that Released Parties have neither made nor are in any manner responsible or liable for any warranty, representation or guarantee, express or implied, in fact or in law, with respect to any prize, including, without limitation, to such prize’s quality or fitness for a particular purpose; and (c) to be bound by these Official Rules and to waive any right to claim any ambiguity or error therein or in the Sweepstakes itself, and to be bound by all decisions of the Sponsor, which are binding and final. Failure to comply with these conditions may result in disqualification from the Sweepstakes at Sponsor’s sole discretion. Sponsor reserves the right to cancel, suspend and/or modify the Sweepstakes, or any part of it, if any fraud, technical failures or any other factor beyond Sponsor’s reasonable control impairs the integrity or proper functioning of the Sweepstakes, as determined by Sponsor in its sole discretion. Sponsor makes no warranties, and hereby disclaims any and all warranties, express or implied, concerning any prize furnished in connection with the Sweepstakes. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, SUCH PRIZES ARE PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND SPONSOR HEREBY DISCLAIMS ALL SUCH WARRANTIES, INCLUDING BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND/OR NON-INFRINGEMENT.

10. This Promotion is subject to all applicable federal, state, and local laws and regulations. Issues concerning the construction, validity, interpretation and enforceability of these Official Rules shall be governed by the laws of the State of New Jersey, without regard to any principles of conflict of laws. All disputes arising out of or connected with this Promotion will be resolved individually, and without resort to class action, exclusively by a state or federal court located in Middlesex County, New Jersey. Should there be a conflict between the laws of the State of New Jersey and any other laws, the conflict will be resolved in favor of the laws of the State of New Jersey. To the extent permitted by applicable law, all judgments or awards shall be limited to actual out-of-pocket damages (excluding attorneys’ fees) associated with participation in this Promotion and shall not include any indirect, punitive, incidental and/or consequential damages.

11. The Sponsor of this Hisamitsu America, Inc. A subsidiary of Hisamitsu Pharmaceutical Co., 11960 SAW 144th Street, Miami, FL 33186. The Administrator of this Sweepstakes is MultiMedia Medical, LLC, 2 Commerce Drive, New Jersey 08512.



Survey Sweepstakes Official Rules 2024

This year marks the 20th anniversary of American Pharmacists Month.

, “dedicated to the single thread that runs through all pharmacy professionals and the services they provide.” According to the American Pharmacists Association (APhA), there are more than 700,000 pharmacy professionals working in the US—a number inclusive of pharmacists, pharmacy technicians, and student pharmacists.

In recent years, the pharmacy profession has weathered many storms, including increasing workload, staffing shortages, drug shortages, rising drug costs, and public health crises. But through it all, pharmacists have retained their spot as one of the most trusted professions, according to research from Gallup. More than 90% of Americans live within 5 miles of a pharmacy, and pharmacists are—for some communities—the only accessible form of health care.

 will be shining the spotlight on pharmacists who are making a difference across community, health system, and specialty pharmacy.

American Pharmacists Month also includes observance days focused on other areas of pharmacy practice:

October 11 is National Student Pharmacist Day

Check back on Tuesday, October 8 for our first interview, and 

 to make sure you don’t miss a minute of our American Pharmacists Month Coverage.

American Pharmacists Month Resource Center

American Pharmacists Month. Accessed October 7, 2024. 

Brenan M, Jones JM. Ethics ratings of nearly all professions down in US. Gallup. January 22, 2024. Accessed October 7, 2024. 

https://news.gallup.com/poll/608903/ethics-ratings-nearly-professions-down.aspx

American Pharmacists Month Shines a Spotlight on Community Caregiving

It is “highly likely” that pharmacy benefit management (PBM) legislation will cross the legislative finish line this year, according to Patrick Cooney, president of The Federal Group, a Washington, DC-based lobbying firm. Cooney was interviewed during the 2024 Pharmacy Benefit Management Institute Annual National Conference by 

where he discussed the role of the Federal Trade Commission (FTC) interim report in galvanizing legislators, as well as his predictions on what provisions the potential PBM legislation might contain.

What are the chances that Congress will pass PBM legislation this year?

 I think the prospects are high. After the PBMI conference, I head back to Washington, DC. We have about a 3-week period where Congress is going to try to get a lot of different things done, [including] a number of health policy matters.

I do think PBM legislation is on the table, but I think it's unlikely something's going to happen [in] the next 3 weeks. I think more likely this is going to be legislation in a lame duck session of Congress. Postelection, Congress will come back before the new Congress sits on January 1 to finish up some of the difficult legislation; by difficult, I mean some of the things that they have to spend a lot of money on. 

The PBM legislation that we've seen in the House and the Senate saves some money under Medicare, so that savings is going to be used to bolster other areas of Medicare. That's why I think it's highly likely that PBM legislation will get across the finish line.

The other reason is that in July, we saw the FTC came out with [an interim report on its investigation into PBM practices], which highlighted some of the concerns [the agency] had with the PBM community today. I think that's galvanizing action as well.

Senator [Ron] Wyden (D-Oregon), the Senate Finance Committee chair, spoke very vehemently after the report came out and said he was fully committed to getting something done quickly.

Following the Federal Trade Commission’s interim report on PBMs, legislators are galvanized to make change happen. 

Libby Baney

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