Free CME

Biosimilar drugs are products meant to be similar in quality, safety, and efficacy to an already licensed reference biotherapeutic product. Whereas generics are virtually identical replicas of conventional medications, biosimilars are not the same as the original product – a practically unavoidable outcome because of the considerably large molecular structure that biologics mimic. The literature suggests that learning activities focused on the evolving landscape of biosimilars, which are germane to the therapeutic area because of their potential role in cost containment. Both the FDA and medical literature independently affirm the need for clinician education on biosimilars, including:  comparative efficacy; adverse event rates and management (potential concerns have included immunogenicity); regulatory guidance on interchangeability and substitution – including prescribers retaining some degree of ability to intervene in a product’s substitution at the dispensing stage; and cost considerations.

Target Audience:

The following healthcare professionals: Rheumatologists, gastroenterologists, and primary care physicians; physician assistants, nurse practitioners, and pharmacists who practice in the aforementioned areas of specialty; and any other healthcare professionals with an interest in or who clinically encounter patients with the inflammatory disease states covered by this activity.

By the end of the session the participant will be able to:

• Describe biosimilar drugs, how they differ from generic drugs, the FDA process for their approval.
• Describe practical considerations the clinician needs when determining whether to consider when deciding whether substituting or allowing the substitution of a biosimilar medication for its reference medication, and apply them to patient case(s).
• Describe how biosimilars for inflammatory health conditions are impacting the treatment landscape with respect to number of treatment options, affordability, and safety considerations.
• Identify the currently available and emerging pharmacotherapeutic treatments for management of inflammatory health conditions and apply them to patient cases using evidence-based medicine.
• Describe strategies for helping patients understand the implications of using biosimilars.

Activity Description / Statement of Need:

In this online, self-learning activity:

Graft-versus-host disease (GvHD) is an immune-mediated response that occurs in recipients of allogenic hematopoietic cell transplantation (HCT). GvHD can be further categorized into acute and chronic cases. Maculopapular rash, follicular erythema, epidermolysis, are common manifestations of acute GvHD, in addition to liver and gastrointestinal dysfunction such as hyperbilirubinemia, nausea, and diarrhea. This activity focuses on chronic GvHD, which has more extensive multi-organ involvement including the liver, eyes, mouth, lungs, skin, genitalia, and gastrointestinal tract.

Target Audience:

The following HCPs: hematologists and oncologists; nurse practitioners, physician assistants, and pharmacists who specialize in oncology; and those who otherwise commonly care for or clinically encounter patients with GVHD.

Each year, more than 290,000 cases of breast cancer are diagnosed, making it the leading cause of cancer among females in the United States. Although earlier screening and more effective treatment options have improved outcomes among people with breast cancer, more than 43,000 people die from this type of cancer each year. Throughout the course of breast cancer management, bone health remains an important consideration. In early breast cancer, chemotherapy-induced ovarian failure and endocrine therapy can contribute to BMD loss and subsequent osteoporosis and fracture. In advanced breast cancer, about 70% of all patients will experience bone metastases, placing patients at risk for SREs. In fact, breast cancer is associated with the highest risk of SREs among all tumor types.

Maintaining bone health in patients with breast cancer requires routine monitoring and proactive management to minimize the risk of BMD loss, osteoporosis, and SREs. Guidelines therefore recommend that patients with non-metastatic breast cancer initiating aromatase inhibitors or other treatment that causes bone loss undergo dual-energy X-ray absorptiometry (DXA) scans to assess baseline BMD. Furthermore, patients at risk for osteoporosis should receive regular follow-up DXA scans to monitor for BMD loss. This represents an opportunity for ongoing education about the need for monitoring to ensure maintenance of optimal bone health.

Activity Description / Statement of Need:

In this online, self-learning activity:

Dry eye disease (DED) is a condition with a diverse group of etiologies and whose common symptoms include discomfort or pain, visual disturbance, tear film instability, and ocular surface inflammation. Compared with those without the condition, patients with DED experience higher rates of loss of work productivity, impaired of daily activities, medical visits, and sleep and mood disorders, and worse emotion well-being and overall quality of life. Although the prevalence of DED varies based on a variety of patient factors, estimates place it as high as 20% of the adult population and more than 34% in the elderly. The aggregate U.S. economic impact is estimated be over $3 billion in direct medical expenses and $55 billion in indirect expenses annually. Nonetheless, DED is both underdiagnosed and undertreated.

Target Audience:

The following HCPs: ophthalmology and optometry; physician assistants and nurse practitioners who practice or are interested in ophthalmology; and any other healthcare professionals with an interest in or who clinically encounter patients with dry eye.

In this online, self-learning activity:

Multiple myeloma (MM) is the most common hematologic malignancy after non-Hodgkin lymphoma, with an incidence of over 34,000 and an annual mortality rate of over 12,000. MM-induced osteocyte apoptosis facilitates MM cell survival, and patients with MM are at high risk for bone disease. Osteolytic lesions are reported in up to four out of five newly diagnosed with MM, and throughout their disease course, up to 90% of patients will eventually develop bone lesions. The presence of bone lesions increases MM patient risk for skeletal-related events (SREs), such as fractures, spinal cord compression, or need for surgery or radiotherapy. Bone disease and SREs can have serious consequences in MM, leading to worsened quality-of-life and prospects for survival. Patients who experience fracture after MM diagnosis have a two-fold increased risk of death relative to those who do not experience fracture. Yet bone disease frequently goes untreated in patients with MM, suggesting that clinicians are not familiar with the serious effects of MM.

Activity Description / Statement of Need:

In this online, self-learning activity:

Narcolepsy is a neurologic disorder characterized by inappropriate regulation of the sleep-wake cycle and excessive sleepiness during waking hours. Affected individuals may fall asleep at inappropriate times, such as when talking to others, eating, or even driving. Roughly 135,000 to 200,000 people in the United States are estimated to have narcolepsy. Women and men are affected by narcolepsy equally, and most patients begin having symptoms between the ages of 7 and 25 years. The treatment of narcolepsy may be complicated and must be tailored individually after careful evaluation of the patient’s symptoms.

Target Audience:

The following HCPs: neurologists, internists, PCPs, psychiatrists; nurse practitioners, physician assistants, and pharmacists who specialize in the aforementioned areas of specialty; and those who otherwise commonly care for or clinically encounter patients with sleep disorders.

Activity Description / Statement of Need:

In this online, self-learning activity:

The term human papillomavirus encompasses a family of DNA viruses that are sexually transmittable and may cause either benign or malignant lesions. They are the leading cause of cervical cancer (CC), with approximately 90% of CC cases attributable to HPV, as well as a major contributor to anogenital and head and neck cancers, although many patients infected with HPV will never develop any related symptoms or disease. The prevalence of HPV in the U.S. is 42.5 million people, and direct medical costs attributed to it are $775 million. HPV 16 accounts for a majority or plurality of HPV-related cancers of both genital tract and head and neck.

The CDC’s Advisory Committee on Immunization Practices (ACIP) recommends HPV vaccination beginning as early as age nine for both sexes, with the schedule and number of doses dependent on age of first dose.

Target Audience:

The following HCPs: Primary care physicians and pediatricians; physician assistants, nurse practitioners, and pharmacists who practice in the aforementioned areas of specialty; and any other HCPs with an interest in or who clinically encounter patients who would benefit from HPV vaccination.

Activity Description / Statement of Need:

In this online, self-learning activity:

Biosimilar drugs are products meant to be similar in quality, safety, and efficacy to an already licensed reference biotherapeutic product. There has been remarkable growth in the number of commercially available products considered biosimilar by the FDA: over 30 FDA-approved and over 20 launched by one recent count. One therapeutic area of upcoming expansion of approvals is in ocular indications, where there is considerable active research and where available data indicate identical or near-identical rates of efficacy, safety outcomes, and immunogenicity. Biosimilars save the U.S. healthcare system $338 billion annually, a remarkable statistic for medications that are clinically interchangeable, and they are expected to continue to play a role in reducing the burden of healthcare expenditures in an era of heightened cost consciousness.

Target Audience:

The following healthcare professionals: ophthalmologists; physician assistants, nurse practitioners, and pharmacists who practice in ophthalmology; and any other healthcare professionals with an interest in or who clinically encounter patients eye disease.

Activity Description / Statement of Need:

In this online, self-learning activity:

Fibrodysplasia ossificans progressiva (FOP) is an ultra-rare genetic connective tissue disorder characterized by dysregulated chondrogenesis, with heterotopic ossification (HO) being the most typical feature. The global prevalence of FOP is estimated at 1.43 per million individuals, with a U.S. prevalence of 0.88 per million. FOP develops due to a mutation in the ACVR1 gene encoding the active receptor-like kinase (ALK2), with unique presenting symptoms including great toe malformations and the development of swelling in several areas of the body within the first decade of life.

Target Audience:

HCPs including: pediatricians, pediatric orthopedic surgeons, endocrinologists, and medical geneticists; nurse practitioners, physician assistants, and pharmacists who practice in orthopedics, orthopedic surgery, and rheumatology; and any other healthcare professionals with an interest in or who clinically encounter patients with FOP.

Activity Description / Statement of Need:

In this online, self-learning activity:

Thalassemias are a group of recessively inherited blood disorders characterized by little or no hemoglobin production and chronic anemia of varying severity. Beta-thalassemia (BT) is most commonly found in people of Mediterranean, Middle Eastern, Asian, and North African descent. Worldwide, 1.5% of people are BT carriers, with about 40,000 infants born with BT annually. About half of patients with BT are transfusion-dependent, which may significantly impact patient quality of life. BT is caused by a point mutation in the gene encoding hemoglobin subunit beta (HBB), resulting in either lower beta-globin production (termed beta-plus [B⁺]) or the prevention of all beta-globin production (termed beta-zero [B⁰]). Disease severity depends on the extent of hemoglobin β and γ chain imbalance.

Target Audience:

The following HCPs: hematologists; physician assistants, nurse practitioners, and pharmacists who practice in hematology; and any other healthcare professionals with an interest in or who may clinically encounter patients with beta-thalassemia.

Activity Description / Statement of Need:

In this online, self-learning activity:

Neonatal respiratory distress syndrome (RDS) occurs in an estimated five to seven percent of term births and up to 90% of preterm births. The risk for neonatal RDS decreases with increasing gestational age,  such that at a gestational age of 37 weeks, the risk has fallen to just three times that of a full-term infant. In addition to premature birth, risk factors for neonatal RDS include maternal gestational diabetes, male sex, multiparity, abnormal fetoplacental circulation, fetal distress, Cesarean delivery, and low birth weight. The ability for the clinician to recognize neonatal RDS is a documented practice gap, and failure to do so is associated with mortality and complications that may include respiratory failure in the short-term and chronic lung disease in the long-term.

Target Audience:

The following healthcare professionals: neonatologists; physician assistants, nurse practitioners, nurses, and pharmacists who practice in neonatology; and any other healthcare professionals with an interest in or who clinically encounter patients with neonatal RDS.  

In this online, self-learning activity:

Neonatal respiratory distress syndrome (RDS) occurs in an estimated five to seven percent of term births and up to 90% of preterm births. The risk for neonatal RDS decreases with increasing gestational age,  such that at a gestational age of 37 weeks, the risk has fallen to just three times that of a full-term infant. In addition to premature birth, risk factors for neonatal RDS include maternal gestational diabetes, male sex, multiparity, abnormal fetoplacental circulation, fetal distress, Cesarean delivery, and low birth weight. The ability for the clinician to recognize neonatal RDS is a documented practice gap, and failure to do so is associated with mortality and complications that may include respiratory failure in the short-term and chronic lung disease in the long-term.

Target Audience:

The following healthcare professionals: neonatologists; physician assistants, nurse practitioners, nurses, and pharmacists who practice in neonatology; and any other healthcare professionals with an interest in or who clinically encounter patients with neonatal RDS.  

Activity Description / Statement of Need:

In this online, self-learning activity:

Sickle cell disease (SCD) is the most common monogenic blood disorder, affecting millions of people worldwide and approximately 100,000 Americans. Although it may be found in various areas of the world, SCD predominantly affects individuals of African or Hispanic heritage. It is caused by the inheritance of b-globin alleles that code for hemoglobin S, resulting in an amino acid substitution in hemoglobin’s b chain and clinical disease. Patients with SCD have impaired circulation, and lysis of the erythrocytes contributes to a chronic inflammatory response, causing severe pain and less efficient oxygen delivery. The hallmark clinical features of SCD are hemolytic anemia and painful vaso-occlusive crises (VOCs), which may lead to emergency department visits, hospitalization, and potentially fatal complications such as acute chest syndrome, stroke, or pneumonia.

Target Audience:

The following HCPs: hematologists and primary care physicians; physician assistants, nurse practitioners, nurses, and pharmacists who specialize in the aforementioned areas of specialty; and any other HCPs with an interest in or who may clinically encounter patients with SCD.