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Peter Wehrwein has been the lead editor of Managed Healthcare Executive since February 2020.

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The IQVIA vice president and frequent speaker at pharmaceutical and managed care meetings shares some insights after he delivered the keynote talk at 2024 PBMI Annual National Conference held last week in Orlando, Florida. Long, a well-known figure in managed care circles, announced at the PBMI meeting that he is retiring in 2025.

Doug Long on the State of U.S. Healthcare, Pharmacy Deserts and "Pretty Anemic" Number of Drug Launches | PBMI 2024

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The rule places new requirements on plans, including making sure prior authorization and other utilization management tools for mental health are not stricter than those used for medical benefits.

Biden Administration Issues Final Rule for Mental Health Parity

Women with disadvantaged backgrounds may also benefit more than women with a higher socioeconomic status, study results show.

Postmenopausal Women Who Use Hormone Therapy Biologically Younger 

Kerri Tanner, Pharm.D., chief pharmacy officer of PayerAlly, discusses the dynamic pricing models of Waltz Health and Free Market Health as a way for independent specialty pharmacies to compete.

Dynamic Pricing May Help Independent Specialty Pharmacies Shut Out of Large PBM Networks | PBMI 2024

Managed Healthcare Executive provides C-suite executives at health plans and provider organizations with news, analysis, insights, and strategies to pursue value-driven solutions.

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Congress has been considering legislation that would increase transparency into pharmacy benefit management (PBM) contracts and ban certain PBM practices, such as spread pricing. 

Patrick Cooney, president of The Federal Group, a Washington, D.C., lobbying firm, said in an interview conducted at the 2024 PBMI Annual National Conference that it is "highly likely that PBM legislation will get across the finish line," partly because provisions of the current bills will save Medicare money.  

Cooney said that the Federal Trade Commission interim report on PBMs that came out in July  is "galvanizing action as well" and that the Sen. Ron Wyden, D-Oregon, chair of the Senate Finance Committee "spoke very vehemently after the report came out that he was fully committed to getting something done quickly." 

Patrick Cooney, a Washington, D.C., lobbyist, discusses the politics of Congress passing PBM legislation this year

Patrick Cooney, The Federal Group, on the PBM legislation prospects

Cooney noted that Congress will be session for about three weeks before the Nov. 5 election, but it is unlikely that will any PBM legislation will pass before the election, but that still leaves the lameduck session after the election for legislation to get through the House and the Senate and eventually on to the president's desk for signing.

Cooney, who is a consultant to Pharmacy Benefit Management Institute, spoke at session of the conference on Wednesday that focused on poiicy and politics.

Patrick Cooney, president of The Federal Group, a Washington, D.C., lobbying firm says prospects for legislation passing this year, albeit during the post-election lameduck session, are good partly because the PBM legislation would produce Medicare savings that could be put toward other uses.

Will Congress Pass PBM Legislation This Year? It Is 'Highly Likely,' Says Patrick Cooney | PBMI 2024

Billing With Intravenous and Subcutaneous Therapies

Video content above is prompted by the following:

What is the difference in the billing process with IV and subQ therapies? 

Dr Seminerio highlights the differences in billing between intravenous and subcutaneous biologics.

Clinical

Evaluating Efficacy Between Intravenous and Subcutaneous Biologics

IV vs. subQ efficacy has been studied in patients with ulcerative colitis. What did those results demonstrate, and do they impact your clinical practice?

An expert clinician expands on efficacy results seen in a study comparing intravenous and subcutaneous biologics.

 due to liver toxicity issues, Paris-based Sanofi 

 yesterday that the HERCULES phase 3 study of its investigational Bruton’s tyrosine kinase (BTK) inhibitor, tolebrutinib, met the primary endpoint of delaying time to onset of confirmed disability progression in patients with nonrelapsing secondary progressive multiple sclerosis (nrSPMS).

The HERCULES trial randomized 1,131 participants with nrSPMS to receive oral tolebrutinib or placebo daily for up to 48 months. The study defined nrSPMS as having an SPMS diagnosis with an expanded disability status scale (EDSS) score between 3.0 and 6.5 and no clinical relapses during the 24 months before enrollment. The participants must also have documented evidence of disability accumulation during the 12 months prior to enrollment.

SPMS is the gradual succession of relapsing-remitting MS, which is the most common form of the disease. Someone with SPMS experiences steadily worsening MS-associated symptoms and disability. People with nrSPMS stop experiencing disease relapses but continue to have disability accumulation. This can be seen in symptoms such as balance, gait, and cognitive impairment, bowel, bladder, or sexual dysfunction, and increased fatigue. Currently, there is no approved treatment for this form of MS.

“Tolebrutinib represents an unprecedented breakthrough as a potential first-in-disease treatment option with clinically meaningful benefit in disability accumulation. Addressing disability accumulation, thought to be driven by smoldering neuroinflammation, remains the greatest unmet medical need in people with non-relapsing secondary progressive MS today,” Houman Ashrafian, M.D., Ph.D., head of research and development at Sanofi, said in a press conference.

BTK is a protein expressed in B-cells and myeloid cells, which play an integral role in MS pathology. Tolebrutinib is an oral central nervous system penetrant that is thought to modulate B-cells and microglia associated with MS disease progression. The BTK inhibitor is being evaluated for use in various forms of MS.

The GEMINI 1 and GEMINI 2 phase 3 studies evaluated the safety and efficacy of tolebrutinib versus Aubagio (teriflunomide) in patients with relapsing forms of MS. Aubagio is a pyrimidine synthesis inhibitor FDA-approved to treat relapsing forms of MS. Genzyme Corporation, a Sanofi company, manufactures the drug. The studies did not meet the primary endpoint of reducing the annualized relapse rate in up to 36 months. However, analysis of pooled data of secondary endpoint of 6-month confirmed disability worsening (CDW) demonstrated a significant delay in time to onset of CDW.

Results from the HERCULES trial, as well as those from the GEMINI 1 and 2 studies, will be presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) medical meeting in Copenhagen, Denmark, on September 20, 2024.

A positive result for Bruton’s tyrosine kinase inhibitor after the drug had been put on partial clinical hold due to concerns about liver toxicity.

Sanofi’s Tolebrutinib Meets Primary Endpoint in Phase 3 MS Trial

 has scored a major new approval, even as clinicians begin to rethink how the novel therapy will fit into the treatment strategies.

Late last month, the European Commission approved Winrevair (sotatercept) for sale in the 27 member states of the European Union, as well as Iceland, Liechtenstein, and Norway. The therapy was approved for use in combination with other PAH therapies in adult patients with functional class II-III disease. Merck noted that the approval makes the therapy the first (and only) approved PAH therapy that targets the activin signaling pathway.

"We are proud to bring this innovative treatment to more patients and remain committed to further investigating the potential of Winrevair in areas where there are unmet need in the management of PAH, said Joerg Koglin, M.D., Ph.D., the company’s head of general medicine, global clinical development, in 

The European approval came five months after the FDA approved the therapy. 

, 163 patients were treated with sotatercept in combination with standard-of-care background therapies. Compared to a 160-patient placebo group, those receiving sotatercept had significant improvement in six-minute walking distance (6MWD), along with a lower risk of death and clinical worsening.

“These findings are significant and reinforce that Winrevair, in combination with other PAH therapies, should be considered as a new standard of care for the treatment of functional class II and III adult patients,” said Marc Humbert, M.D, PhD, of the Paris-Saclay University, in the press release.

But how exactly Winrevair will fit into current clinical practice remains to be seen. Tyler Pitre, M.D., Ph.D., of the University of Toronto, noted that current international guidelines typically call for dual therapy at first in most patients being treated for PAH. That usually means pairing a phosphodiesterase 5 inhibitor (PDE5i) with an endothelin receptor agonist (ERA). However, he also noted that some patients take additional therapies.

“In both the STELLAR and PULSAR trials, approximately 60% of the participants were already on triple therapy, meaning a combination of ERA plus PDE5i, plus another agent which is typically oral prostanoid therapy,” he said. “Some of the patients in these trials were on continuous epoprostenol therapy as well.” 

Annals of the American Thoracic Society, 

Pitre and colleagues analyzed studies to compare Winrevair with other approved add-on therapies for PAH. Their analysis concluded with moderate certainty that Winrevair likely reduces the risk of clinical worsening compared with add-on ERAs, inhaled prostanoids, and oral prostanoids. They also found — again with moderate certainty — that the therapy improves 6-minute walk distance compared to ERAs and oral prostanoids, though they said the improvement in those cases did not meet the level of clinically important improvement. 

Asked if any findings surprised him, Pitre said he was pleased with the breadth of the new drug's  efficacy. “As for a surprise,” he said, “I was interested to see how stably effective sotatercept was throughout comparisons and also across outcomes.”

Pitre noted that in Canada, where he lives, the Winrevair is not yet readily available. That is likely to change soon, though. Canadian regulators OKed the drug on Sept.4,  and it is now approved for use in adults in combination with standard PAH therapies.

Pitre observed that, in his and his colleagues’ meta-analysis, Winrevair was effective even when compared to dual therapy, “so there is some evidence to suggest Winrevair could be used up front as well.”

However, he also cautioned that the high-cost medication may be subject to prescribing limitations in certain jurisdictions. In Canada, Pitresaid, “I suspect they will require that patients be on at least dual or even triple therapy before we can prescribe it,” he said.

 The approval comes five months after the FDA approved Winrevair.

Winrevair Gains EU Nod, Expanding PAH Options

Although they are on opposite sides of the world, Appalachia and Sub-Saharan Africa share HIV similarities when it comes to stigma, geographic isolation and limited resource. However, their regional differences mean each area must be approached differently, according to the results of a project by the Community Education Group, an organization that provides healthcare resources to combat disease in underserved populations in Appalachia. The results were presented in July at the International AIDS 2024 Conference in Munich, Germany.

This project explored the connection between the high volume of HIV cases in Africa and Appalachia. It also explained how HIV was reduced using telemedicine and community outreach and how to maintain these successes going forward.

The Appalachian region consists of 14 states. It includes all of West Virginia and portions of Alabama, Georgia, Kentucky, North Carolina, Maryland, Mississippi, New York, Ohio, Pennsylvania, South Carolina, Tennessee and Virginia. Nearly 20% of residents in these areas live in poverty and almost 18% do not have internet access when compared with the rest of rural America, 

In Appalachia in 2022, there were 35,000 people with HIV. Five of the top 10 states with the highest HIV rates are in this region. Those states are Georgia, Mississippi, Maryland, South Carolina and North Carolina. A major contributor to HIV is these areas is injectable drugs. In Cabell County, West Virginia there was a 450% increase in cases and in Kanawha County, West Virginia there was a 110.7% increase.

In Africa in 2022, 25.6 million people were living with HIV with an estimated 20.9 million people receiving antiretroviral therapy.

The project approached each region differently and found that in Africa, telemedicine was the most effective tool to increase treatment adherence and HIV prevention. Treatment adherence improved by approximately 30% and patient follow up care improved 40% from using telemedicine.

Appalachian populations found that the deployment of community healthcare workers was the most beneficial approach because it led to a 25% increase in testing rates and a 20% increase of linkage to care within first year.

Future programs in these regions should continue to follow these pathways. In Africa, telemedicine access should be expanded to more rural areas and include features such as virtual reality consultations. In Appalachia, residents may benefit from even more community healthcare workers. Services could expand to encompass other diseases such as viral hepatitis and opioid addiction.

“The effectiveness of integrating technology and personal outreach in HIV/AIDS interventions underscores the need for continued innovation and community involvement in health strategies,” co-authors A. Toni Young and Kelli Keith, M.P.H., write in the abstract. "Future efforts should focus on expanding successful models, increasing community-led initiatives, and fostering global partnerships to address common challenges.”

Both regions experience disproportionately high HIV case numbers due to social stigmas and isolation.

Alanna Pei-Lian Sun, PharmD

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