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If approved, clesrovimab would be the first and only FDA approved single dose immunization for infants approved in time for next year's RSV season, which lasts from October to April.

FDA Accepts Biologics License Application for Infant RSV Antibody 

Organon, the company behind Vtama, received FDA approval ahead of its scheduled date of March 12, 2025.

FDA Approved Vtama Cream for Treating Atopic Dermatitis in Adults, Children

 This latest approval is the second indication of the monoclonal antibody, Nemluvio. It was first approved in Aug. 2024 to treat patients with prurigo nodularis.

FDA Approves Nemluvio for Atopic Dermatitis 

Here’s what you missed this week on Managed Healthcare Executive.

MHE Week in Review –  Humira Dose De-escalation, 5 Drugs With Unsupported Price Increases and More

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Chief scientific officer, ADoH Scientific

Quality measures are a tool to drive healthcare toward value-based care, and in diabetes care these measures can improve diabetes management and prevent downstream conditions, such as cardiovascular disease. However, there are multiple hurdles that healthcare organizations face when implementing quality measures for diabetes care, explained Sean M. Oser, M.D., M.P.H., associate professor in the Department of Family Medicine at the University of Colorado School of Medicine, in a 

There are many differences between recommendations for quality measures and reimbursement policies for covered services from different insurers. Although Oser suggested that these all need to be streamlined, in the interim, health systems and provider organizations should have a quality improvement program or team to help understand these requirements. The team can translate the requirements down to the practice level from the health plan or health system and gather data from the electronic health record (EHR) to turn it into an actionable report.

The ability to generate reports allows providers and health systems to track measurement and performance over time to see what progress, if any, is being made. He recommends ensuring there is transparency with stakeholders so they can also follow the progress or see where improvements are lagging. “There is a ton of data that we have available now to try to improve our performance on quality measures and to target where they are not being met,” Oser said.

Advanced EHRs have the capability to generate reports and identify care gaps in real time, too. Previously, when using paper records or older EHRs, Oser would have to search through them to find the latest laboratory results to see the patient’s hemoglobin A1C level or the date of their most recent eye exam. Now, when that data is entered into the EHR, care gaps are highlighted as soon as the patient’s chart is opened during the visit.

Communication is another important aspect of filling those gaps. Patients or providers might get letters from health plans indicating that a patient who has diabetes might not be taking their statin based on claims information, but Oser doesn’t view that communication as very actionable at the practice level. What has been more successful is using care managers or nurses at the health plan to reach out to patients directly to be their personal care manager. “Actual face-to-face — or at least person to person on a telephone — communication can be a whole lot more effective than some of those letters that are received,” he said.

Another area where data has evolved for the benefit of patients with diabetes is with continuous glucose monitoring (CGM), Oser noted. “We’ve relied for a very long time on hemoglobin A1C checks, and they remain extremely useful, but they’re not always right,” he said.

CGM measures glucose levels as frequently as every minute for up to 15 minutes depending on the system, and this data provides an average glucose level. Oser noted there is a small difference between average glucose and hemoglobin A1C. In the latter, the percent of the portion of the hemoglobin molecule that has glucose attached is being measured. While this is associated with average glucose levels, “it’s not a direct correlation,” he explained.

“CGM gives us the actual average glucose, which is what we’re really looking for in the first place,” Oser said. There are many reasons why a hemoglobin A1C level may be inaccurate, such as during pregnancy, in patients with chronic kidney disease, or in patients with variants of their hemoglobin, such as in sickle cell disease.

The National Committee for Quality Assurance recently changed the name of a measure from being based on hemoglobin A1C levels to glycemic management, which allows for a measure directly derived from CGM. Higher levels are associated with diabetic retinopathy, diabetic nephropathy, chronic kidney disease and more.

Traditionally, the thought is “the lower the A1C [level], the better,” Oser said. “But as we bring glucose levels down, it stands to reason that occasionally glucose levels will drop too low, and that can be very dangerous in the short term.”

Low levels are associated with seizures and severe hypoglycemia, but CGM devices can predict low glucose before it happens and sound an alert on the device to give the patient a chance to prevent hypoglycemia. “Since an alarming amount of hypoglycemia develops without any symptoms, CGM can be a real life-changer here,” Oser said.

However, CGMs also have a tremendous amount of raw data. The hope is that in the future, more EHR systems will be able to manage that raw data and produce insights the way CGM systems currently do. Reports from this data can also show how much time is spent within certain ranges and how much time is spent above or below the target range. The CGM data also show how much variability there is in glucose data.

A patient with a hemoglobin A1C level of 6.7% may have a lot of really high and really low glucose readings that averaged out to look like they are meeting the glycemic target. However, the CGM will provide the extra information that shows the patient is “experiencing pretty dangerous swings in glucose,” he said.

“It’s really revolutionized the way I care for people with diabetes when I feel CGM is appropriate, which is not in every case, but I’ll use it often and get a lot more information,” Oser said.

Oser says he follows up with the data from the CGM by engaging patients about their own care. One way he does this is by focusing on the things going well. If the CGM report has multiple measures and one met its target, he starts with that. For example, if someone’s average glucose level is always high, but they have no low glucose levels, Oser will explain how that is a positive. “I try really hard to avoid using language that is judging or leading,” he said. “Focusing on CGM, I’ve found, always gives me something to start with and always something to align with a patient to be able to let them know that this takes work."

There are also quality measures related to diabetes self-management, education and support (DSMES), which engage patients. Diabetes relies heavily on patient self-management, which involves taking all of the medications as prescribed, because patients often have multiple prescriptions; being mindful of what, when and how they eat; and paying attention to movement and exercise. “Often, people with diabetes are on blood pressure medications that can be impacted by diet as well as by activity,” Oser said. “So, everything is really interrelated. There’s a large burden of self-management. So DSMES programs can really help patients directly in those ways.”

Oser also discussed how quality measures can be adapted to address social determinants of health, comorbidities, socioeconomic challenges, or cultural, racial and ethnic differences. Data show African American and Hispanic patients are likely to have higher hemoglobin A1C levels than White patients despite having the same average glucose level. "There is an important cultural, ethnic, racial difference there where CGM, for example, which is measuring the glucose levels and can calculate the actual average glucose level, can get rid of that disparity,” he said.

Since getting to the physician’s office can be a challenge for some people who can’t take time off work or travel the distance, the CGM can eliminate some of those barriers by sending the data to the office. However, there are access challenges with CGM,even though coverage for CGM has been increasing and its cost has been coming down. Oser recommends having a CGM that the practice owns and can provide to the patient for episodic use. “There are [Current Procedural Terminology] codes, billing codes, for the activities around that [so] it’s an office-based charge instead of the patient having to pay a copay for supplies and for continuous use,” Oser said. “It’s also a really useful way for practices to become more engaged with and eventually more comfortable with CGM.”

Sean M. Oser, M.D., M.P.H., an associate professor in the Department of Family Medicine at the University of Colorado School of Medicine, discussed diabetes management and quality measures in a Managed Healthcare Executive K-Cast video series.

K-Cast Written Summary. Diabetes Quality Measures Have Challenges But Also Successes

Biologics have transformed the treatment of autoimmune diseases such as rheumatoid arthritis, psoriasis, Crohn’s disease and ulcerative colitis. Jill Zouzoulas, M.D., a rheumatologist at Tryon Medical Partners in Charlotte, North Carolina, and Jennifer Seminerio, M.D., director of inflammatory bowel disease at University of Southern Florida Health in Tampa, Florida, discussed biologics and their intravenous and subcutaneous delivery methods in 

Enbrel (etanercept), the first biologic used to treat rheumatoid arthritis, was approved by the FDA in 1998. A tumor necrosis factor inhibitor, Enbrel was a leap forward in treating the inflammation of rheumatoid arthritis with more precision. “Part of what attracted me to rheumatology is that we finally had targeted therapies,” noted Zouzoulas. The outcomes for the biologics were significantly better than they were for the other treatment drugs, she said.

Seminerio said biologics were already being used as she was undergoing training. “It’s been very exciting and interesting that our knowledge on how to use them correctly has only grown.” She said her experience with biologics has been very positive. “I think that it’s been an opportunity for us to get a disease state for which we don’t have a cure under control. What I mean by that is we don’t have a way to make ulcerative colitis or Crohn’s disease end — a cure — but we can put it into remission.”

Biologics can be delivered intravenously or as subcutaneous injections. Zouzoulas described the increasing availability of subcutaneous biologics as being “fantastic” for patients who are working. A lack of familiarity with self-injection and worry about pain can sometimes stir up reluctance. “In actuality,” said Zouzoulas, “once you walk the patient through that, once you train them how to use it and build the confidence, that quickly goes away and patients are just very happy that they don’t need to come in and take time away from their regular lives.” The risk of reaction is very low, Zouzoulas said, as is the chance of administering the wrong dose.

Seminerio said she has also worked to assuage patient fears of subcutaneous injection and that self-administration empowers patients, she said. “It allows them to feel like they’re still treating their disease, but they don’t have to give up key points in their life.” Seminerio said she can still recall her excitement for her patients when Stelara (ustekinumab), the first subcutaneous biologic for Crohn’s disease and ulcerative colitis, became available.

There are, though, advantages to IV infusions, noted Zouzoulas. Having patients come in regularly helps physicians and other clinicians monitor them and coordinate their care. The regularity of the visits helps patients build connections with staff and other patients, Zouzoulas said. “The nurses, especially in the infusion suite, come to know them over time, and they feel very much like they’re almost part of a community. And they tend to talk to each other and people are oftentimes scheduled on the same day so it almost in some ways is a support group for them.”

Body weight is a factor that Zouzoulas also considers. Many studies have shown that IV infusions are preferable for patients who weigh more than 100 kilograms [about 220 pounds], she said.

Seminerio said that IV formulations may be advantageous for patients for whom adherence is an issue. Clinicians and their staff can keep track of which patients come to an infusion center and receive treatment; self-administration of subcutaneous formulation is inherently more difficult to monitor. But Seminerio also stressedthe importance of patient choice.

Commercial insurers cover IV and subcutaneous therapies fairly similarly, according to Zouzoulas. Patients with traditional Medicare and Medigap coverage will have their biologic medication almost completely covered after meeting a deductible, she said. Those in a Medicare Advantage plan get 80% of the cost of an IV biologic covered, which Zouzoulas said may seem generous but “the remaining 20% is also a big number” given the price of the biologics.

Seminerio noted that the medical-pharmacy benefit divides in U.S. healthcare coverage: IV drugs are paid through the medical benefit whereas subcutaneous ones are paid through the pharmacy benefit. For clinicians working with an infusion center, billing through the medical benefit is usually a fairly streamlined process, she said, particularly for well-established drugs. Drugs paid for through the pharmacy benefit can, in contrast, be more problematic because of prior authorization and appeal processes that can take months and requirements that patients be treated with certain drugs before others. “Sometimes you just need to make sure that you’re staying on it,” she said. Specialty pharmacies step in and help with those processes, Seminerio said, although sometimes insurance companies mandate the use of specific specialty pharmacies.

Zouzoulas said staff in her office handle prior authorizations for the IV biologics because her office is buying the drug and administering it to the patient before getting reimbursed. Her office also handles prior authorizations for subcutaneous biologics, but Zouzoulas said that it is often an easy, online experience and that specialty pharmacies help with the process.

Biosimilars came into use very slowly in rheumatology, Zouzoulas said, starting with biosimilars to Remicade and Rituxan (rituximab). Over time, insurers have changed their formularies so patients often need to try one or two biosimilars before they will cover the brand-name product, said Zouzoulas. “Oftentimes patients will ask me how I pick a biosimilar. And I say, ‘I don’t. Your insurance does.’ ” Because biosimilars to IV biologics have driven down reimbursement rates, some doctors have stopped giving those drugs and have those patients go to freestanding corporate infusion suites or hospital infusion suites. In Zouzoulas’ view, biosimilars have benefited the distribution companies and pharmacy benefit managers while the out-of-pocket costs for patients have stayed the same.

Seminerio had a more positive outlook on biosimilars. She said the NOR-SWITCH study showed that patients can be safely switched from a brand-name drug to a biosimilar. If an insurer requires a switch, she says she stays matter-of-fact. “The way that I have that conversation with [the patient] is, ‘Listen, if we don’t do this, we’re going to end up with no medication. Or you’re going to end up paying a cost that may not be feasible for you. So let’s do it.’”

Zouzoulas said biologics are shifting away from IV formulations toward subcutaneous and oral ones. Drugmakers are less inclined to make an IV formulation of a biologic if they can make a subcutaneous one and are less likely to make both, she said.

Seminerio sees problems coming from the growing number of drugs. “With more drugs, with more mechanisms of action, there becomes a greater gap in our ability to know which one to use when you’re not specifically practicing [IBD] medicine.” She said it is up to IBD specialists to educate physicians coming into the field and practitioners in the community. Seminerio said she also wants to see more head-to-head trials such as the VARSITY trial, which compared Entyvio (an IV drug) to Humira (a subcutaneous one) in patients with moderate-to-severe ulcerative colitis. Entyvio proved to be more efficacious. “I think it allowed people to see that sometimes it isn’t a matter of just IV versus [subcutaneous]. It’s the drug itself and which one is going to work better.”

Jill Zouzoulas, M.D., of  Tryon Medical Partners in Charlotte, North Carolina, and Jennifer Seminerio, M.D., of University of Southern Florida Health in Tampa, Florida, discussed the biologics and the pros and cons of the intravenous and subcutaneous delivery methods in Managed Healthcare Executive’s K-Cast video series.

K-Cast Written Summary. Key Patient Considerations for Use of Intravenous and Subcutaneous Therapies

 K-Cast video series, Zahra Mahmoudjafari, Pharm.D., MBA, discussed the epidemiology of myelofibrosis and its symptoms, treatment and management. Mahmoudjafari is the clinical pharmacy manager of the Division of Hematological Malignancies and Cellular Therapeutics at the University of Kansas Health System. Click 

Myelofibrosis is a rare and chronic bone marrow disease included in the broader category of myeloproliferative neoplasms (MPNs), Mahmoudjafari explained. The annual incidence is approximately 0.3 to 0.5 cases per 100,000 people per year, which translates into between approximately 13,000 and 18,000 individuals in the U.S. with the disease at any given time.

The other MPNs include polycythemia vera and essential thrombocythemia. Myelofibrosis has the poorest prognosis of the MPNs, said Mahmoudjafari. It is characterized by bone marrow fibrosis, which can lead to cytopenia. Myelofibrosis can progress to acute myeloid leukemia, and management and treatment of the disease is aimed at preventing that from happening, she said. Polycythemia vera is characterized by increased red blood cell production and essential thrombocythemia by excessive platelet production. Importantly, both are less likely to progress to acute myeloid leukemia.

Myelofibrosis can occur at any age, said Mahmoudjafari, but it’s most commonly diagnosed in older individuals and has a median age of diagnosis of between approximately 65 to 70 years. Men are disproportionately affected.

Many of the symptoms of myelofibrosis stem from the cytopenia it causes. Among the most common are fatigue, weight loss and night sweats. The symptoms tend to be more severe and debilitating than those experienced by patients with polycythemia vera or essential thrombocythemia. The polycythemia vera symptoms are related to blood viscosity, the essential thrombocythemia symptoms to thrombosis due to abnormal platelet function.

A large proportion of patients develop splenomegaly [an enlarged spleen], which can cause discomfort, pain, early satiety and abdominal fullness. Those can lead to complications such as portal hypertension, which can lead to ascites and varices, Mahmoudjafari said.

Fatigue, a result of ineffective hematopoiesis, can significantly impair a patient’s ability to carry out their daily tasks and reduce their quality of life, she noted. Patients can experience significant emotional and psychological effects from the fatigue and the other systemic effects, such as night sweats, and they can, in turn, lead to anxiety, depression and social isolation. Bone pain from the bone marrow fibrosis is another aspect of myelofibrosis that requires ongoing management, according to Mahmoudjafari.

One of the primary goals of treatment is to slow down any potential disease progression to acute myeloid leukemia, Mahmoudjafari said. Another is control of symptoms, which she said can be achieved with medications, blood transfusion and other supportive therapies. Complications, such as infections and bleeding, must also be managed.

The treatment of choice for high-risk patients who are not candidates for a stem cell transplant is one of the Janus kinase (JAK) inhibitors, said Mahmoudjafari. Dosing frequency is an issue when deciding among them, she said. Ruxolitinib (sold under the brand name Jakafi) is administered twice a day and needs adjustment depending on platelet counts whereas fedratinib (sold under the brand name Inrebic) is administered once a day with no additional dose adjustment for cytopenia. For patients with platelet counts less than 50,000 per microliter, pacritinib (sold under the brand name Vonjo) might be considered before the other JAK inhibitors. Mahmoudjafari said it might be best to hold off on using momelotinib (sold under the brand name Ojjaara) upfront.

When weighing whether to change a patient’s treatment from one JAK inhibitor to another, clinicians need to consider how long the patient has been on the JAK inhibitor. “Is that really lack of response or is it a loss of response either because the disease has evolved or additional mutations have occurred?” she said. Mahmoudjafari said one of the questions she is often asked is about sequencing to another JAK inhibitor after ruxolitinib. Stopping ruxolitinib can cause withdrawal systems, so that needs to be taken into consideration when transitioning from ruxolitinib to another JAK inhibitor.

Comorbidities and drug-to-drug interactions need to be considered when prescribing JAK inhibitors, Mahmoudjafari said, noting that pacritinib and momelotinib are associated with an increased risk of cardiac events.

Current recommendations are for physical examination, symptom assessments and complete blood counts, which should be done every three to six months. Bone marrow biopsies to assess changes in the bone marrow fibrosis, the bone marrow cellularity and the general morphology of the bone marrow tissue should be done on an annual or a biannual schedule.

“If we are monitoring appropriately, we are looking for a lack of improvement in our patients’ symptoms, such as splenomegaly-related discomfort, fatigue, night sweats and bone pain. We’re looking for evidence of disease progression and treatment-related adverse events,” Mahmoudjafari said. A close relationship with patients is important in the treatment of myelofibrosis, she added. “We want to make sure that we meet their treatment goals, their preferences, really ensuring that we are in alignment with their expectations,” said Mahmoudjafari.

Patients with myelofibrosis are treated for extended periods, and the drugs they are treated with have high prices. That combination means the cost burden on patients can be heavy, especially for those with high-deductible health insurance coverage. Drugs with lower wholesale acquisition cost (WAC) prices may help by evening out the out-of-pocket expenses until the deductible amount is reached, Mahmoudjafari said. A lower WAC price can also help reduce the burden of coinsurance because the coinsurance is based on the cost of the medication. She noted that some health plans have programs (called copay accumulators) that do not count the value of the manufacturer’s copay assistance program toward the deductible, which can add to the financial burden on patients.

One of the main areas of focus is combining JAK inhibitors with other agents in other classes of drugs, such as the PI3K (phosphoinositide 3-kinase) inhibitors, the mTOR (mammalian target of rapamycin) inhibitors and the BCL2 (B-cell lymphoma 2) inhibitors, Mahmoudjafari said.

Among the new agents under investigation are BET (bromodomain and extraterminal domain) inhibitors that target proteins involved in gene expression and inflammation

Researchers reported encouraging results for the combination of navitoclax, an investigational BCL2 inhibitor, and ruxolitinib, at the 2023 annual meeting of the American Society of Hematology (ASH), Mahmoudjafari said. Researchers also presented positive results for imetelstat (sold under the brand name Rytelo), a telomerase inhibitor, as a treatment for myelofibrosis at the ASH meeting, she said.

Piqray (alpelisib), a PI3K inhibitor, is being studied as a treatment for patients who have suboptimal outcomes or resistance to JAK inhibitors, Mahmoudjafari noted. And there is ongoing research into agents that can inhibit the expression of mutated CALR genes that play a causative role in myelofibrosis. “There is a lot going on in the setting of myelofibrosis, and it’s important to make sure we keep up as the treatment paradigm continues to involve,” she said.

Zahra Mahmoudjafari, Pharm.D., MBA, University of Kansas Health System, gave an overview of the epidemiology of myelofibrosis and its symptoms, treatment and management in Managed Healthcare Executive K-Cast video series.

K-Cast Written Summary. Optimizing the Management  of Myelofibrosis 

, Selina McGee, O.D., FAAO, founder and owner of BeSpoke Vision in Edmond, Oklahoma, discussed the prevalence, symptoms, diagnosis and treatment of Demodex blepharitis, an eye condition caused by the infestation of eyelid tissue by microscopic Demodex mites. McGee reviewed the treatment choices available prior to the FDA’s approval of Xdemvy (lotilaner ophthalmic solution 0.25%) last year and the advantages of this new treatment.

McGee noted how common Demodex blepharitis is. Some research, she said, suggests that about 25 million people in the United States are affected by Demodex blepharitis. The risk increases with age. A study published in 

 in 2022 showed that 58% of patients seen at six eye clinics had Demodex blepharitis. McGee remarked that translates to nearly 6 of every 10 patients.

Blepharitis, or inflammation of the eyelid margin, has a number of causes, but the most common is an infestation of Demodex mites of eyelid tissue. The eight-legged parasites are 0.3 millimeters long, too small to be seen with the naked eye, according to the American Academy of Ophthalmology. McGee noted that people with Demodex blepharitis may have lost eyelashes or have lashes that are misdirected, and their eyelids may be red. But she said the “biggest hallmark” is itchy eyes. Moreover, the itchiness has a distinctive pattern. When McGee asks patients with Demodex blepharitis to show where the itchiness is, they tend to trace a finger across the eyelid. The gesture is “almost pathognomonic for Demodex blepharitis,” she said.

Demodex blepharitis “can really be debilitating [for patients] depending on their symptoms,” McGee said. “It can cause a lot of issues with patients being self-conscious about the way that they feel and the way that they look,” she continued. “The bottom line is these patients are really suffering day to day.”

Collarettes are a cylindrical buildup of waxy debris at the base of the eyelash. They consist of an accumulation of mite waste and other debris. “Once you see them on a patient, that’s pathognomonic for Demodex blepharitis, so the diagnosis is actually very simple,” McGee said.

McGee said they can be identified by having the patient look down and inspecting their eyelash with a slit lamp. She said her technique is to gently “tease up” the eyelid, so she has a clear view of the base of the eyelashes. McGee said slit lamp magnification typically comes at 10x (the object looks 10 times larger than it is), 16x and 25x, and she prefers 16x for viewing eyelids and eyelashes. She said eye care professionals are always pressed for time but looking for collarettes and possibly diagnosing Demodex blepharitis “doesn’t take a lot of chair time.” The belief that a diagnosis required pulling eyelashes and inspecting them has been abandoned, she said. “It was something 20 years ago we thought we had to do.”

McGee said she and other eye care professionals have traditionally treated people with Demodex blepharitis by addressing the symptoms. “We didn’t have anything that directly killed the Demodex mite, so we were simply trying to manage the patient’s symptoms,” she observed.

Clinicians have used a topical application of tea tree oil on the eyelid to treat Demodex blepharitis, McGee explained. Patients with Demodex blepharitis have also been treated with in-office procedures such as microblepharoexfoliation and with agents that contain okra extract. Microblepharoexfoliation can help reduce the waste and, thus, collarettes, said McGee, noting that collarettes are proinflammatory so they shouldn’t be left on the eyelids.

“But here’s the challenge with it,” she said. “When we do that procedure, it’s not actually treating the Demodex mite. It’s not killing the mite. While we are removing all of that waste product that is proinflammatory, their problem comes right back. Depending on the patient, depending on their mite load, they might get a benefit for two to four weeks, maybe four to six weeks. And then we’re doing another procedure and those procedures are not covered by insurance.” Each treatment costs between $75 and $150, or more, she said. The expense adds up quickly, not to mention the patient’s time to come into the office for the treatment, McGee said.

The FDA approved lotilaner ophthalmic solution 0.25%, marketed under the name Xdemvy, in July 2023. McGee stressed that is the first and only treatment for Demodex blepharitis approved by the FDA, and that approval instills confidence in the medication in her and her patients.

One of the major differences between Xdemvy and previous treatments is the treatment’s limited duration, McGee said. According to the FDA-approved package label, it should be administered as one drop in each eye twice a day for six weeks, whereas previous treatments could drag on for months or longer.

Adherence is much easier for patients with Xdemvy, said McGee. “The fact that it’s twice a day, that’s easy to incorporate into someone’s routine, morning and evening,”
she observed.

The safety and efficacy of Xdemvy was evaluated in two, six-week, multicenter randomized controlled trials, Saturn-1 and Saturn-2. A total of 833 participants were evaluated, 415 of whom were treated with Xdemvy. Efficacy was defined as a reduction to no more than two collarettes per upper eyelid in each study.

Lotilaner ophthalmic solution 0.25% drops are administered as twice daily for six weeks. Other ways of treating Demodex blepharitis manage symptoms, not the root cause, and are of indeterminate length.

Brian Sullivan, Psy.D.

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