Maximizing the benefits of using biosimilars in Egypt.

BACKGROUND: Biosimilars constitute a pathway for sustainable financing of healthcare systems in the era of expensive biologics. However, such a pathway is not free of challenges. Since the biosimilars market is expanding in Egypt, there is an urgent need for a policy framework to optimize their use and diffusion in the market. We aim to characterize a national framework based on the experiences of other countries and consultation with local experts. METHODS: A narrative literature review was conducted to identify biosimilars' policy elements worldwide. A workshop was organized with experts to discuss the narrative review findings and create consensus on recommendations. RESULTS: The narrative literature review highlighted the need for biosimilar policy actions in four areas: market authorization, pricing, reimbursement, and uptake. Eighteen experts representing the Egyptian healthcare authorities attended the workshop. The most significant conclusions from the workshop included setting the price of the biosimilar at 30-40% less than its originator's price and establishing financing protocols, in which the more expensive biologics with significant price premiums should be excluded from the formulary. CONCLUSIONS: A summarized national framework policy recommendation for biosimilars was created by local experts from the main public healthcare entities in Egypt. These recommendations coincide with the international policies adopted across different countries that aim to improve patient access while sustaining health expenditure.

Clinical Outcomes After Endoscopic Endonasal Resection of Giant Pituitary Adenomas.

BACKGROUND: Giant pituitary adenomas represent a surgical challenge. We present the results of the endoscopic endonasal approach (EEA) for giant pituitary adenomas. METHODS: We retrospectively reviewed the medical records of 55 patients with giant pituitary adenomas (>4 cm in maximum diameter) who underwent surgery with an EEA between 2008 and 2016. Factors affecting the extent of resection were evaluated. RESULTS: The mean patient age was 55.5 years. Tumors were nonfunctional in all but 4 patients, including 2 with growth hormone-secreting tumors, 1 with an adrenocorticotropic hormone-secreting tumor, and 1 with prolactinoma. Gross total resection was achieved in 24 patients (44%), and near-total resection (>90%) was achieved in 26 patients (47%). A multilobular configuration (P = 0.002) and cavernous sinus invasion (P = 0.044) negatively affected the extent of resection, whereas tumor size, intraventricular, and anterior or posterior fossa extension did not. Ten patients underwent adjuvant radiotherapy. All patients with hormone-secreting adenomas required adjuvant medical and/or radiotherapy to achieve biochemical remission. Postoperative vision was improved or normalized in 32 patients (66%), stable in 15 patients (31%), and worsened in 1 patient. A new hormonal deficit occurred in 8 patients (17%), whereas recovery of an existing hormonal deficit occurred in 6 patients (20%). The mean duration of follow-up was 41 months. Tumor recurrence/progression occurred in 6 patients (11%). Complications included apoplexy of residual tumor resulting in ischemic stroke in 1 patient, postoperative cerebrospinal fluid leak in 1 patient, and permanent diabetes insipidus in 4 patients (7%). CONCLUSIONS: Surgery with the EEA is an excellent option for managing giant pituitary adenomas. It results in superior clinical outcomes to those obtained using traditional microscopic transsphenoidal and transcranial approaches as reported in the literature.

Clinical Outcome after Endoscopic Endonasal Resection of Tuberculum Sella Meningiomas.

BACKGROUND: In select cases, the endoscopic endonasal approach (EEA) has distinct advantages for resection of tuberculum sella meningiomas (TSM). OBJECTIVE: To report the extent of resection (EOR), complication rates, and outcomes in a large series of TSM treated by the EEA. METHODS: Twenty-five consecutive TSM cases treated by EEA from 2008 to 2016 were retrospectively reviewed. Patient history, imaging, volumetric EOR, complications, and outcomes are presented. RESULTS: Mean patient age was 53.9 yr, with female predominance (84%). Preoperatively, 84% of patients had vision impairment and 68% had optic canal tumor invasion. The tumor was abutting or partially encasing the anterior cerebral artery in 14 (56%) and 3 (12%) patients, respectively. The supraclinoid internal carotid artery (ICA) was partially or completely encased in 4 (16%) and 4 (16%) patients, respectively. Gross total resection (GTR) was achieved in 19/25 (76%) cases. Complete ICA encasement was the most common reason for subtotal resection. Among patients without complete ICA encasement, GTR was achieved in 19/20 (95%) patients. Optic canal invasion, tumor volume, intratumoral calcifications, and partial vascular encasement were not limiting factors for GTR. Eighty-eight percent of patients with preoperative visual impairment had improvement or normalization of vision. No patient experienced permanent visual deterioration or new permanent pituitary dysfunction. Cerebrospinal fluid leakage occurred in 2 (8%) cases. CONCLUSION: The EEA for resection of TSM provides high rates of GTR and visual improvement with a low rate of complications. Direct contact or partial encasement of the ICA and anterior cerebral artery does not limit the EOR.

The learning curve in endoscopic endonasal resection of craniopharyngiomas.

OBJECTIVE There is a paucity of literature regarding the learning curve associated with performing endoscopic endonasal cranial base surgery. The purpose of this study was to determine to what extent a learning curve might exist for endoscopic endonasal resection in cases of craniopharyngiomas. METHODS A retrospective review was performed for all endoscopic endonasal craniopharyngioma resections performed at Thomas Jefferson University from 2005 to 2015. To assess for a learning curve effect, patients were divided into an early cohort (2005-2009, n = 20) and a late cohort (2010-2015, n = 23). Preoperative demographics, clinical presentation, imaging characteristics, extent of resection, complications, tumor control, and visual and endocrine outcomes were obtained. Categorical variables and continuous variables were compared using a 2-sided Fisher's exact test and t-test, respectively. RESULTS Only the index operation performed at the authors' institution was included. There were no statistically significant differences between early and late cohorts in terms of patient age, sex, presenting symptoms, history of surgical or radiation treatment, tumor size or consistency, hypothalamic involvement, or histological subtype. The rate of gross-total resection (GTR) increased over time from 20% to 65% (p = 0.005), and the rate of subtotal resection decreased over time from 40% to 13% (p = 0.078). Major neurological complications, including new hydrocephalus, meningitis, carotid artery injury, or stroke, occurred in 6 patients (15%) (8 complications) in the early cohort compared with only 1 (4%) in the late cohort (p = 0.037). CSF leak decreased from 40% to 4% (p = 0.007). Discharge to home increased from 64% to 95% (p = 0.024). Visual improvement was high in both cohorts (88% [early cohort] and 81% [late cohort]). Rate of postoperative panhypopituitarism and permanent diabetes insipidus both increased from 50% to 91% (p = 0.005) and 32% to 78% (p = 0.004), which correlated with a significant increase in intentional stalk sacrifice in the late cohort (from 0% to 70%, p < 0.001). CONCLUSIONS High rates of near- or total resection and visual improvement can be achieved using an endoscopic endonasal approach for craniopharyngiomas. However, the authors did find evidence for a learning curve. After 20 cases, they found a significant decrease in major neurological complications and significant increases in the rates of GTR rate and discharge to home. Although there was a large decrease in the rate of postoperative CSF leak over time, this was largely attributable to the inclusion of very early cases prior to the routine use of vascularized nasoseptal flaps. There was a significant increase in new panhypopituitarism and diabetes insipidus, which is attributable to increase rates of intentional stalk sacrifice.

Endoscopic transnasal surgery for planum and tuberculum sella meningiomas: decision-making, technique and outcomes.

Tuberculum sella and planum sphenoidale meningiomas pose a management challenge given their intimate relationship to surrounding critical neurovascular structures. The development and advancement of expanded endoscopic transnasal surgery has provided a good surgical option that in well-selected cases, may provide several advantages over a transcranial route. These include early devascularization, complete dura and bone removal, elimination of brain retraction and enhanced visualization of the optic apparatus perforating vessels. The authors review the endoscopic transnasal approach to these tumors and discuss surgical decision-making and case selection, surgical technique and outcomes. We also discuss the expanding role of stereotactic radiosurgery and fractionated stereotactic radiotherapy for these challenging lesions.