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U.S. approved the RSVpreF vaccine for adults 60 years and older in 2023, recommending it only based on individual’s decisions with their doctors.

RSV Vaccine Highly Effective in Preventing Severe Illness in Older Adults

Predictions for this year from Perry Cohen, Pharm.D., CEO of the TPG Family of Companies and Managed Healthcare Executive editorial advisory board member.


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Pressure on Patient Assistance Programs | Predictions for 2025

Blue Shield of California new CEO Lois Quam said she will focus on the challenges that members face with accessing healthcare.

Lois Quam First Woman CEO of Blue Shield of California 

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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Duplication and other errors can turn population health into a guessing game and waste time and money.

Quality Lab Data: Why It Matters So Much

There have exceptions to their rule, such as glucagon-like peptide 1 (GLP-1) drugs and the COVID-19 vaccines. But drugs to treat cancer have been the dominant force in pharmaceutical innovation, clinical trials and drug expenditures for many years now, and nothing in Kaelyn C. Boss’ oncology drug pipeline talk yesterday at the 2024 Academy of Managed Care Pharmacy (AMCP) Nexus meeting suggested that is going to change any time soon.

Oncology represents a large portion of the drugs in development, with approximately 1,600 medicines and vaccines in the pipeline, Boss, a clinical consultant pharmacist at UMass Chan Medical School in Worcester, Massachusetts, told the AMCP Nexus audience. A large percentage of the cancer-fighting agents are treatments for rare cancers with a relatively small number of suitable patients, Boss said, while also noting that there are also a large number of agents in development for solid tumors that affect many more people, she noted.

Boss said that spending on cancer drugs worldwide is projected to increase to $409 billion by 2028. The price of novel agents is high at more than $200,000 per year on average. She said that biosimilars and generic medications may yield savings, but the money saved is no match for new agents and the trajectory of higher spending.

Boss’ encyclopedic overview of oncology drug development included drugs that the FDA has approved this year, some of which were for new indications of previously approved drugs that had been previously approved, as well those still in the wings, with FDA action expected later this year or in early 2025.

Sita Bhatt, Pharm.D., a clinical pharmacy specialist at Boston Medical Center, joined Boss in making a presentation during the oncology pipeline session. She spoke about the growing number of cell therapies for solid tumors, a group that that includes LN-145-S1 for head and neck squamous cell carcinoma (HNSCC) and melanoma; LN-145 Gen 3 for HNSCC, melanoma and NSCLC; letetresgene autoleucel for soft tissue sarcoma; ECT240 for liver cancer; ET140203 for liver cancer; and CARv3-TEAM-E for glioblastoma.

“We can see a shift towards cell therapies for solid tumors,” Bhatt said. “44% of all trials initiated in 2023 [were] for solid tumor indications . . . this is really where we're seeing the trend in the oncology pathology space right now.”

Here are the cancer drugs that Boss discussed that have been approved by the FDA this year.

Itovebi (inavolisib), a PI3K inhibitor for HER2-negative breast cancer with a PIK3CA mutation, was also approved on Oct. 10. It was studied in combination with fulvestrant and palbociclib following progression on at least one endocrine-based regimen or within 12 months of adjuvant therapy. It is also being studied in combination with fulvestrant for HR+/HER2- breast cancer and in combination with dual HER2 blockade and endocrine therapy.

Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) is a PDL-1 inhibitor that was approved on Sept. 12. for multiple indications, including nonsmall cell lung cancer (NSCLC). It is formulation of Tecentriq that will allow for subcutaneous administration. Tecentriq was orginally approved in 2016.

The combination of Lazcluze (lazertinib) and Rybrevant (amivantamab) was approved on Aug. 19 as a first-line treatment NSCLC with epidermal growth factor receptor (EGFR) mutations.

Niktimvo (axatilimab) is an anti-CSF-1R antibody approved for chronic graph versus host disease (GVHD) on Aug. 14.

Lymphir (denileukin diftitox-cxdl) is an IL2-receptor-directed cytotoxin approved on Aug. 7, for relapsed or refractory cutaneous T-cell lymphoma. The drug is a reformulated version of Ontak (denileukin diftitox), which was withdrawn due to manufacturing errors. National Comprehensive Cancer Network guidelines recommend the drug as preferred for stage 2B mycosis fungoides with generalized tumor disease and useful for some situations with other stages of mycosis fungoides with limited tumor disease.

Voranigo (vorasidenib) is an IDH1 and IDH2 inhibitor that was approved on Aug. 6 for treatment of grade 2 IDH-mutant glioma. The drug is also being studied in combination with Keytruda (pembrolizumab0 for recurrent or persistent IDH-1 astrocytomas. Of note, the cost per 40 mg tablet is $1,329 and $29,881 per 30 count bottle.

Tecelra (afamitresgene autoleucel) is a MAGE-A4-directed genetically modified autologous T-cell immunotherapy that received accelerated approval on Aug. 2 a as treatment for unresectable or metastatic synovial sarcoma. It is one-time intravenous therapy that modifies T cells to attack cancer cells. The drug was launched with a list price of $727,000.

Augtyro (repotrectinib) is a kinase inhibitor that was granted accelerated approval on June 13 as a treatment for solid tumors with a neurotrophic tyrosine receptor kinase gene fusion that are locally advanced or metastatic, positive solid tumors. It had been previously approved in November 2023, as treatment for locally advanced or metastatic ROS1-positive NSCLC. The estimated cost per 120 count of the drug is $14,500.

Rytelo (imetelstat) is an oligonucleotide telomerase inhibitor that received approval on June 6 as a treatment for low- to intermediate-1 risk myelodysplastic syndrome (MDS) with transfusion dependent anemia. Rytelo is priced to cost approximately $385,000 a year (based on a patient weighing 70 kg), which is almost four times more than an Institute for Clinical and Economic Review assessment said it should cost based on common cost-effectiveness thresholds. 

Imdelltra (tarlatamab-dlle) received accelerated approval on May 16 as a bispecific T-cell engager for extensive stage small cell lung cancer. The estimated cost of the drug is $15,000 per 10 mg, $31,500 for cycle one and step-up dosing, and $30,000 for cycle 2 and beyond. According to NCCN recommendations, Imdelltra is preferred for small cell lung cancer as subsequent systemic therapy in chemotherapy free intervals of 6 months or less.

Ojemda (tovorafenib)accelerated approval on April 23 as a Pan-RAF kinase inhibitor for relapsed or refractory pediatric low-grade glioma with BRAF fusion or rearrangement, or BRAF V600 mutation. The estimated cost per 16, 20 or 24 count bottle is $33,916 and $8,479 per 12 mL bottle. The drug is also being studied in combination with nivolumab for the treatment of craniopharyngioma.

Anktiva (nogapendekin alfa inbakicept-pmln) received approval on April 22 as an IL-15 receptor agonist for Bacillus Calmette-Guérin-unresponsive, nonmuscle-invasive bladder cancer. The cost of induction is estimated at $214,800 and patients can receive up to two courses. For maintenance therapy at month four to 19, the estimated cost is $537,000 and an estimated $322,200 for months 25 to 27. The maximum total course for the full 27 months, including two induction courses, is estimated to be $1,288,800.

Tevimbra (tislelizumab-jsgr) is a PD-1 inhibitor, which was approved on March 13 for unresectable or metastatic esophageal squamous cell carcinoma. The NCCN recommends the drug in the second-line or subsequent therapies for category one. The cost per 10 mL (100 mg) and per dose (200 mg) is approximately $5,204 an $10,408, respectively.

Amtagvi (lifileucel) received accelerated approval on Feb. 16 for unresectable or metastatic melanoma as a tumor-derived autologous T cell immunotherapy. The drug is recommended by the NCCN as a preferred tumor-infiltrating lymphocyte therapy.

And here are the cancer drugs mentioned by Boss that are likely to be coming up for FDA approval decisions soon.

A decision on zenocutuzumab, a bispecific antibody for NRG1-positive NSCLC and NRG1-positive pancreatic cancer, is expected in the fourth quarter of 2024. It has also been given fast track designation by the FDA.

A decision on zolbetuximab, a CLDN18.2-targeted antibody for HER2-negative, CLDN18.2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma, is expected on Nov. 9.

 a CAR-T therapy for relapsed or refractory adult B-cell acute lymphoblastic leukemia, is expected on Nov.16. If the FDA approves it,obecabtegene autoleucelwould be the third CAR-T cell for this disease.

A decision on zanidatamab, a HER2-targeted bispecific antibody for previously treated, unresectable, locally advanced, or metastatic HER2-amplified biliary tract cancer, is expected on Nov. 29.

Decisions on datopotamab deruxtecan, an antibody drug conjugate for advanced nonsquamous NSCLC and metastatic HR-positive, HER2-negative breast cancer, are expected on Dec.20 and Jan. 29, 2025, respectively.

A decision on revumenib, a menin-KMT2A inhibitor for relapsed or refractory KMT2Ar acute leukemia, is expected on Dec. 26. If it gets the FDA’s OK, revumenib would be the first menin inhibitor approved. Other menin inhibitors in development are either in phase 2 (ziftomenib) or phase 1 trials (JNJ-75276617, DSP-5336, BMF-219, BN104, and balamenib.)

A decision on cosibelimab, a PD-L1 inhibitor, is expected on metastatic or locally advanced cutaneous squamous cell carcinoma, on Dec. 28. In December 2023, the FDA issued a complete response letter for the drug, and it was resubmitted in July 2024.

A decision on ensartinib, an ALK inhibitor for ALK-positive NSCLC, is expected on Dec. 28. The drug is also being studied for pediatric patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with ALK or ROS1 genomic alterations that are recurrent or relapsed.

A decision for the subcutaneous formulation of Opdivo (nivolumab), a PD-1 inhibitor for many oncology indications, is expected on December 29, 2024.

A decision for mirdametinib, a MEK inhibitor for neurofibromatosis type 1-associated plexiform neurofibromas, is expected in the first quarter of 2025. It has been granted orphan drug designation by the FDA and the European Commission. It is also being studied in combination with lifrafenib for advanced or refractory solid tumors.

A decision for remestemcel-L, a stem cell therapy for acute GVHD, is expected on January 7, 2024. The drug was issued two CRLs, with one due to lack of potency data and one for additional data on highest risk population.

A decision on tabelecleucel, an allogenic T-cell immunotherapy for Epstein-Barr virus-positive post-transplant lymphoproliferative disease, on Jan. 15, 2025.

A decision for the subcutaneous formulation of Rybrevant (amivantamab), a bispecific antibody for NSCLC, is expected in the second quarter of 2025.

The FDA has already made more than a dozen cancer drug approval decisions this year and more expected in the next several months and in early 2025, according to Kaelyn Boss, who gave an oncology drug pipeline talk at the 2024 AMCP Nexus meeting this week.

Clinical

Cancer’s Reign Over the Drug Development Pipeline Continues| AMCP Nexus 2024

William Shatner talked poignantly, with flashes of his trademark humor, about being diagnosed and treated for stage 4 melanoma at the annual meeting of the American Academy of Dermatology (AAD) meeting in San Diego this weekend.

It is apparently the first time that Shatner has discussed the skin cancer episode in public. He did not say when it occurred.

Shatner, who is 92, is famous for having played the role of Captain James T. Kirk in the 1960s “Star Trek” television series and subsequent movies. He has gone on to write books, star in commercials and make many public appearances like this one at the AAD meeting, which set an attendance record of nearly 20,000 dermatologists. A documentary about him titled  “You Can Call Me Bill” is scheduled to be released on March 20, two days before he turns 93. While trading on a celebrity status derived from “Star Trek,” Shatner has become almost as well known for his sense of fun, down-to-earth candor and lighthearted self-deprecation as for the Kirk role and the phrase , “Beam me up, Scotty,” a line from the television series that the Kirk character never actually said, although there are several lines that approximate it.

In a chatty, interview format with the academy president’s, Terrence A. Cronin Jr., M.D., at the meeting’s plenary session Sunday morning, Shatner joked about his short-term memory, sources of vigor and appearance. 

When Cronin asked him how he keeps going so strong, Shatner deadpanned, “I have no idea.”

As part of the same exchange, Shatner showed that comic timing and a keen sense of his audience. “Why do I look so good?” he asked rhetorically and paused. “It’s ointment!”

But the conversation took a more serious turn when Cronin asked about his recent cancer. Shatner said he was “breezing along, really looking good and feeling good” when he felt a lump near his right ear. Shatner said his family physician told him that it was caused by a blockage in the parotid gland that would go away if he massaged it.

“So I spent a month massaging and the movie “Alien” comes to mind, because I don't think people who have never had cancer, know how some cancers can grow so quickly,” he said.

Shatner said he went to another doctor. “He did what is so beautiful about being a doctor. He had artistic hands and put them on my cheek and he said, ‘We better get this out.’ It was said with such kindness and there was such gentility above the touch of this doctor on my jaw that I saw the care and love that the doctor can give the patient in that moment.”

“So,” said Shatner, his voice changing to a brisker tone, “I went and I had this thing taken out. It was a melanoma, stage 4.”

After surgery, Shatner said he was treated with immunotherapy, which had him fighting fatigue. “But here I am,” he said, before listing a number of projects he is working on. “I am really the best that I can, minus the lump in my right cheek.”

“This was an inspiring story because dermatologists recognize melanoma on a daily basis,” Cronin said in an interview after the plenary session. “The idea of early detection and treatment of melanoma and saving lives resonates with this audience. Mr. Shatner was willing to share this information with us in the hope that others would be able to recognize that early detection would save lives.”

“We worry that if you don't see a dermatologist that you may have a misdiagnosis,” continued Cronin, adding that “it's not always easy or readily apparent to lay people and people who are not in dermatology, what looks like a melanoma. There can be confusion.”

Seemal R. Desai, M.D., who will take over as president of the academy at the conclusion of this meeting, noted the academy’s effort to educate the public about prevention and early detection of skin cancer, including photo protection, self-skin checks and appointments with  a board-certified dermatologist.

Shatner did not make any references to DeForest Kelley or the "Star Trek" character he played, the often-frustrated Dr. Leonard H. “Bones” McCoy. But he said he has been surprised about what he called the “politics of medicine” and the differing opinions among doctors. “There are as any opinions about what to do about whatever ails you as there are doctors,” Shatner said. 

Shatner also expressed dismay at decision-making that shifts choices to patients. “You, the ignorant patient, have got to make a decision. They would say it’s a guided decision. That’s not guided.”

Cronin told Shatner that had be been diagnosed 10 years ago, he might not be doing because immunotherapy was now the standard of care and “that innovation has changed everything" about melanoma treatment.

“No kidding,” Shatner said comically. “Well, what did they do before?” The audience laughed. “That was the cure. ‘You have melanoma. Good-bye,'"Shatner joked.

In another shift in tone, Shatner expressed amazement about the conversations physicians have with patients facing lethal diseases and mortality. “What an experience it must be for one human being … to turn to somebody and say you got five months, you'd better pack your bags. What experience to have between two people.”

The 92-year-old "Star Trek" star said the skin cancer was treated surgically and with immunotherapy. It was apparently the first time he had discussed his melanoma in public.

William Shatner Discusses Stage 4 Melanoma Diagnosis, Treatment | AAD 2024

Clinicians, patients and some experts have viewed transdermal anti-inflammatory patches as a promising way to bypass the side effects and other problems associated with oral and injectable delivery of anti-inflammatory medications.

 and meta-analysis published in November in the journal 

 may give some pause. It found that transdermal anti-inflammatory patches did not have sufficient evidence to support clinically significant impact on managing short-term and long-term musculoskeletal pain.

., from the Department of Health Professions at Manchester Metropolitan University, and researchers from the School of Pharmacy at the University of East Anglia in Norwich, United Kingdom, sought to determine the efficacy of transdermal anti-inflammatory patches in providing pain relief for acute and chronic musculoskeletal conditions. ​ They assessed whether these patches are a viable alternative to traditional oral or injectable anti-inflammatory medications, particularly regarding their effectiveness and potential reduction in adverse events. ​

Transdermal patches have a few advantages over oral medications.The patches can deliver a specific dose of the active ingredient to the site of pain. The delivery of medication avoids first pass hepatic metabolism fluctuations in drug levels and commonly associated adverse effects that are observed with oral and injectable formulations.

This analysis included 23 randomized placebo-controlled trials with 4,729 participants. All the included studies compared the effects of transdermal anti-inflammatory patches to placebo patches for various musculoskeletal conditions. The studies varied in duration, with the longest treatment period being 24 weeks and the shortest 5 days.

The meta-analysis included betamethasone, diclofenac, ibuprofen, ketoprofen and nitric oxide patches. ​ The results indicated that different medications had varying levels of efficacy, with some showing significant benefits over placebo in specific conditions.

Sanchez and the team found low-certainty evidence that these patches may provide clinically long-term pain relief for chronic conditions, although short-term benefits were not clinically significant. In addition, there were ​ no significant medium-term benefits.

The short-term pain relief was statistically significant but not clinically significant. The Cochrane Risk of Bias Tools and the GRADE approach assessed the evidence quality.

Of the drugs included in the trials for the analysis, nitric oxide patches were the most effective in relieving chronic musculoskeletal pain. Specifically, there was low-certainty evidence that nitric oxide patches had a clinically significant effect on movement pain in the long term.

The team highlighted the potential of transdermal patches to reduce adverse events associated with oral medications, such as gastrointestinal and cardiovascular issues. ​ However, local skin irritation was a common adverse event reported.

The findings suggest that clinicians and patients could consider using transdermal anti-inflammatory patches for long-term management of musculoskeletal pain, especially for patients who cannot tolerate oral medications.But the evidence is not strong, and further high-quality research is needed to confirm these results and determine the most effective types of patches and conditions they can treat.

A systematic review and meta-analysis found some supporting evidence for transdermal anti-inflammatory patches, but the results might be described as, well, patchy. 

Oleg Bess, M.D.

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