•A QSR was carried out to define the clinical, economic, and quality of life outcomes for ESAs in patients with CKD-induced anemia or CIA.•The evidence suggests little difference in efficacy, quality ...of life, and safety outcomes among ESA types.•Cost-effectiveness and downward pressure on market price are likely to become the main factors driving the choice of agent.
Erythropoiesis-stimulating agents (ESAs) are man-made forms of erythropoietin used in the treatment of anemia. This quick-scoping review of systematic literature reviews (SLRs) was conducted to define the clinical, economic, and health-related quality of life (HRQoL) outcomes for short-acting and long-acting ESAs in patients with chronic kidney disease–induced anemia (CKD-IA) and patients with chemotherapy-induced anemia (CIA). Embase, Medline, and the Cochrane Database of Systematic Reviews were searched from their establishment until October 2017. SLRs related to the use of short-acting and long-acting ESAs in the treatment of CIA and CKD-IA were included. Forty-eight studies met the inclusion criteria. The evidence suggests little difference in efficacy, HRQoL, and safety outcomes among ESA types. Cost-effectiveness and market price are likely to become determining factors driving the choice of agent. Comparative studies and costing models accounting for the utilization of biosimilars are needed to establish which ESAs are more cost-effective.
Biosimilars have improved access to biologic medicines; however, historical thinking may jeopardize the viability of future markets.
An expert panel of eight diverse European stakeholders provided ...insights about rethinking biosimilars and cost-savings, reducing patient access inequalities, increasing inter-market equity, and improving education. The insights reported here (Part 2) follow a study that provides perspectives on leveraging the holistic benefits of biosimilars for market sustainability based on independent survey results and telephone interviews of stakeholders from diverse biosimilar markets (Part 1). Directional recommendations are provided for payers.
The panel's market maturity framework for biosimilars has three stages: 'Invest,' 'Expand' and 'Harvest.' Across market stages, re-thinking the benefits of biosimilars beyond cost-savings, considering earlier or expanded access/new indications, product innovations, and re-investment of biosimilar-generated cost-savings should be communicated to stakeholders to promote further engagement. During 'Expand' and 'Harvest' stages, development of efficient, forward-looking procurement systems and mechanisms that drive uptake and stabilize competition between manufacturers are key. Future biosimilars will target various therapy areas beyond those targeted by existing biosimilars. To ensure a healthy, accessible future market, stakeholders must align their objectives, communicate, collaborate, and coordinate via education, incentivization, and procurement, to maximize the totality of benefits.
Approved biosimilars exhibit comparable efficacy, safety, and immunogenicity to reference products. This report provides perspectives on the societal value of biosimilars within Europe and potential ...factors that have influenced market dynamics.
An independent, self-administered survey or one-on-one in-depth interview was used to collect viewpoints about the impact of biosimilar medicines within European markets. Key insights were also sought from an expert panel of European stakeholders.
Survey respondents were clinicians, pharmacists, and payers from Europe (
= 103). Perceived benefits of biosimilars included increased access to innovative medicines (73% of respondents) or biologic treatments (66%). Biosimilar competition was thought to expand access to biologics (~50% of respondents) or drug combinations (~36%) and reduce biologic access time (34%). Key drivers of biologic access after biosimilar competition included increased biologic awareness (51%) and changes to prescribing guidelines (37%) and/or treatment paradigms (28%). The expert panel developed a market maturity framework of biosimilar adoption/opportunities comprising three stages: 'Invest,' 'Expand,' and 'Harvest.' Findings were supported by published literature.
In Europe, the perceptions of well-informed survey/interview respondents are that biosimilars have improved patient outcomes via increased access to biologics and innovative biologic products, contributing to earlier and longer treatment of a broader population.
Pregabalin is an effective treatment option for many patients with neuropathic pain. Higher doses of pregabalin have been shown to be more effective in improving pain outcomes but, in practice, ...failing to appropriately increase the dose can leave patients under-treated.
This was a pooled analysis of 6 flexible-dose clinical trials of pregabalin in patients with neuropathic pain (diabetic peripheral neuropathy, peripheral herpetic neuralgia, posttraumatic pain, or postsurgical pain). Patients were divided into "dose pathway" groups based on their weekly pregabalin dose from the start of their trial to the first week of their maintenance phase. These were: 150 mg/day only; 150 to 300 mg/day; 150 to 300 to 450 mg/day; 150 to 300 to 450 to 600 mg/day; 150 to 300 to 600 mg/day; 300 to 600 mg/day. Pain outcomes assessed for each group at each new dose were proportion of 30% and 50% responders (≥30% or ≥50% reduction in mean pain score from baseline) and mean change in pain score. Percent change in mean pain score from baseline was assessed using a marginal structural model.
Seven hundred and sixty-one patients treated with flexible-dose pregabalin were included in the analysis. For each dose pathway group, there was a notably greater proportion of 30% and 50% responders and change in pain score, at each escalating dose. As assessed by the marginal structural model, higher doses of pregabalin were estimated to result in a significantly greater change in mean pain score at each week. This dose response with flexible-dose pregabalin was consistent with that previously observed with fixed-dose pregabalin.
Many patients who do not respond to lower doses of pregabalin will respond with notable improvements in pain outcomes when the dose is escalated. These data should encourage physicians treating patients with neuropathic pain to escalate pregabalin to the dose that delivers optimal analgesia and tolerable side effects.
Background
Patients with chronic pain conditions such as neuropathic pain frequently experience delays in diagnosis and treatment. Ideally, all patients should be treated in a timely manner, but in ...those patients with more established disease it is important to know that approved treatments remain effective.
Methods
This was a pooled analysis of 19 randomized placebo‐controlled trials of pregabalin for peripheral neuropathic pain conditions, including diabetic peripheral neuropathy, postherpetic neuralgia, and post‐traumatic/postsurgical pain. Patients were divided into 5 pain duration categories based on time since onset of pain (< 6 months, 6 months to < 1 year, 1 year to < 2 years, 2 years to < 5 years, and ≥ 5 years). Mean change in pain score at endpoint, vs. placebo, was assessed for each category, together with changes in Patient Global Impression of Change (PGIC) responders (“very much” or “much” improved at endpoint).
Results
The analysis included 5,783 patients (n = 3,619 pregabalin; n = 2,164 placebo). Mean baseline pain scores were similar across the pain duration categories (range 6.3 to 6.5). Pregabalin significantly improved pain score at endpoint, vs. placebo, in all patients together (treatment difference 95% confidence interval, −0.59 −0.67, −0.52, P < 0.0001) and similarly in each pain duration category (P < 0.0001 for each). There were significantly more PGIC responders with pregabalin, vs. placebo, for all patients (45.0% vs. 30.9%, P < 0.0001) and each category separately (P < 0.001 for each). There were no consistent, significant differences in treatment response between the different pain duration categories.
Conclusions
Pregabalin significantly improves pain irrespective of the length of time since onset of neuropathic pain.
The article “Systematic Review and Meta-analysis of Short-versus Long-Acting Granulocyte Colony-Stimulating Factors for Reduction of Chemotherapy-Induced Febrile Neutropenia”, written by Paul Cornes, ...Pere Gascon, Stephen Chan, Khalid Hameed, Catherine R. Mitchell, Polly Field, Mark Latymer, Luiz H. Arantes Jr was originally published electronically on the publisher’s internet portal (currently SpringerLink) on October 8, 2018 without open access.
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