This is intended for HCPs practising in Great Britain (England, Scotland and Wales) only.
<a href="${link:{uuid:{b396cd3c-8152-48f5-ae78-06924624d39e},repository:{dam},path:{/Portal/UK/Prescribing-links/Supemtek-PI-GB-April-2023.pdf}}}" target="_blank">Supemtek®</a>▼<a href="${link:{uuid:{b396cd3c-8152-48f5-ae78-06924624d39e},repository:{dam},path:{/Portal/UK/Prescribing-links/Supemtek-PI-GB-April-2023.pdf}}}" target="_blank">Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture) Prescribing Information</a>
In October 2020, the European Centre for Disease Prevention and Control (ECDC) published the results of a systematic literature review to assess the efficacy, effectiveness and safety of enhanced inactivated flu vaccines (versus standard-dose or placebo) for the prevention of laboratory-confirmed influenza in adults ≥18 years of age.1
Only direct comparisons versus traditional vaccines were considered in the review as indirect comparisons were considered to be typically underpowered to detect differences in effect in this context.1

<h2>Methods of the ECDC systematic literature review</h2>
A systematic literature review of records published across MEDLINE, Embase, CINAHL and The Cochrane Library, up to 7 February 2020, was conducted. Randomised controlled trials and non-randomised studies of interventions were eligible for inclusion and publications were screened for relevance by two independent reviewers. Where two or more studies reported the same outcomes, results were pooled. Evidence quality was graded using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology (Figure 1).1

Figure 1: ECDC systematic review to assess the effectiveness and safety of enhanced inactivated influenza vaccines: methods.

<h2>Results of the ECDC systematic literature review for recombinant haemagglutinin vaccines1</h2>
Evidence reviewed was the two pivotal&nbsp;<a href="${link:{uuid:{1b34dd78-c3db-424c-997c-a35cbbf1e482},repository:{products},path:{/UK/supemtek}}}" target="_self">Supemtek</a>&nbsp;clinical trials versus standard-dose egg-based quadrivalent flu vaccine.

<table align="center" border="1" cellpadding="20" cellspacing="1" style="width:100%;">
 <tbody>
 <tr>
 <td style="background-color: rgb(82, 93, 163);">Protection*</td>
 <td style="background-color: rgb(82, 93, 163);">Safety profile</td>
 <td style="background-color: rgb(82, 93, 163);">Evidence†</td>
 </tr>
 <tr>
 <td>“...Studies appear to suggest that recombinant HA vaccines may offer better protection than no vaccination or standard influenza vaccines, with some possible cross-protection to drift variants”</td>
 <td>“...Findings of this review suggest that the safety profile of recombinant HA vaccines is largely similar to that of traditional influenza vaccines in terms of local and systemic effects (low-moderate certainty evidence)”</td>
 <td>“...Data related to efficacy or effectiveness for recombinant HA vaccines were limited to two efficacy randomised controlled trials”</td>
 </tr>
 </tbody>
</table>

*Versus traditional standard-dose quadrivalent influenza vaccination (QIVe) in adults ≥50 years of age.
†Trial 1 Randomised controlled trial to evaluate the protective efficacy of Supemtek (n=4,301) (45 µg of recombinant HA per strain, 180 µg of protein per dose) versus standard-dose egg-based quadrivalent influenza vaccine (QIVe) (n=4,303) (15 µg of HA per strain, 60 µg of protein per dose) during the 2014/15 influenza season. Primary endpoint: relative vaccine efficacy (rVE) against RT-PCR-confirmed, protocol-defined, influenza-like illness caused by any influenza strain starting 14 days or more after vaccination in adults aged 50+ years. The study was designed to demonstrate non-inferiority of Supemtek in terms of rVE. Trial 2: Observer-blind, randomised, active-controlled trial to evaluate immunogenicity of Supemtek (n=998) versus standard-dose QIVe (n=332) during the 2014/15 influenza season. Co-primary endpoints: non-inferiority of HA inhibition (HAI) seroconversion rates (SCRs) and post-vaccination geometric mean titre (GMT) ratios for each antigen in ambulatory, medically stable adults 18–49 years of age.2,3

<h3>Abbreviations</h3>

An ECDC systematic literature review of the efficacy, effectiveness and safety of enhanced inactivated flu vaccines.

INFLUENZA

VACCINES

Enhanced Inactivated Flu Vaccines

<a href="${link:{uuid:{8cd02cf2-bd72-495f-b720-698ef8d3f0da},repository:{dam},path:{/Portal/UK/Prescribing-links/Toujeo.pdf}}}" target="_blank">Prescribing Information Toujeo (insulin glargine 300 units/mL)</a>

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There is an intense desire to participate in fasting during Ramadan, even among the people who could seek exemption1. Discover the ORION study and the 2021 IDF-DAR Practical guidance.
<h2>Summary</h2>

Download a summary of the ORION study. Real-world safety and effectiveness of Toujeo®&nbsp;in patients with Type 2 Diabetes who choose to fast during Ramadan.

Read the full publication of the ORION observational study in patients with Type 2 Diabetes who choose to fast during Ramadan.

<a href="/uk/type-2-diabetes">SEE MORE FROM SCIENCE</a>

<h3>Toujeo</h3>
Toujeo®&nbsp;is indicated as treatment of diabetes mellitus in adults,&nbsp;adolescents and children from the age of 6 years.&nbsp;&nbsp;

<h3>Patient Website</h3>
Find resources and support for your patients on Toujeo®. Help patients understand the basics of living and staying well with diabetes and how to have a positive start and experience with the medication prescribed to them.

Toujeo® (insulin glargine 300 units/mL) Prescribing Information

TYPE-2-DIABETES

DIABETES

ORION Observational Study

<h2>BRIGHT study</h2>
In this 7-minute video Dr. Alice Cheng tells you about the BRIGHT study, the head-to-head trial comparing Toujeo®&nbsp;vs insulin degludec 100 units/mL meeting the primary endpoint. She tells about the results and why they are relevant and important to her clinical practices, in helping the right patients on the right treatment.

<h3>Toujeo</h3>
Toujeo®&nbsp;is indicated as treatment of diabetes mellitus in adults,&nbsp;adolescents and children from the age of 6 years.&nbsp;

Video: BRIGHT study

<a href="${link:{uuid:{8cd02cf2-bd72-495f-b720-698ef8d3f0da},repository:{dam},path:{/Portal/UK/Prescribing-links/Toujeo.pdf}}}" target="_blank">Prescribing Information Toujeo (insulin glargine 300 units/mL)</a> <a href="${link:{uuid:{8f132346-a5c2-470d-8368-64ab56220e08},repository:{dam},path:{/Portal/UK/Prescribing-links/Lantus_GB_NI_PI.pdf}}}" target="_blank">Prescribing Information Lantus (insulin glargine 100 units/mL)</a>

<h2>Edition Junior</h2>
Download this clinical summary to read about the benefits of Toujeo®&nbsp;in children and adolescents from the age of 6 years in this randomised trial. Edition Junior was a 6 month long, open-label, double arm, parallel group, non-inferiority study in 463 children with T1DM. The aim of the study was to demonstrate non-inferiority of Toujeo®&nbsp;vs insulin glargine 100 U/mL from baseline to Week 26.

<a href="/uk/type-1-diabetes">SEE MORE FROM SCIENCE</a>

Toujeo® (insulin glargine 300 units/mL) Prescribing Information 

Lantus® (insulin glargine 100 units/mL) Prescribing Information 

TYPE-1-DIABETES

T1 Edition Junior Study

<h2>T1-Meta Analysis</h2>
Download this clinical summary to read about the benefits of Toujeo®&nbsp;in this post-hoc meta-analysis of three Edition 6 month, phase III, randomised trials. The study aimed to explore the risk of hypoglycaemia with Toujeo®&nbsp;vs insulin glargine 100U/mL in a broad pool of people with T1DM including children over the age of 6.

T1DM - Meta-Analysis

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GENERAL-TOPICS

OUT-OF-TAXONOMY

Get in Touch

<a href="${link:{uuid:{55f30477-c7e2-49c0-8cfc-16966f28d4c2},repository:{dam},path:{/Portal/UK/Prescribing-links/Praluent-PI-GB-October-2022.pdf}}}" target="_blank">Prescribing Information(GB)</a>

<a href="${link:{uuid:{9e0d6f97-2ebb-4422-92ab-569b89c7dfe0},repository:{dam},path:{/Portal/UK/Prescribing-links/Praluent-PI-NI.pdf}}}" target="_blank">Prescribing Information(NI)</a>

In patients with a prior CV event, Praluent®&nbsp;demonstrated a higher absolute risk reduction in MACE in patients with diabetes than in those with prediabetes or normoglycaemia1*
*Data from a prespecified analysis
~90% of patients in Odyssey Outcomes were on high-intensity statins and 29% of them had diabetes at baseline (99.2% of these had type 2 diabetes run in)2.
In the placebo group, the risk of MACE at median follow-up 2.8 years was approximately twice the risk in patients with diabetes than in patients with normoglycaemia (HR 2.09, 95% CI 1.78–2.46, p&lt;0.0001) or prediabetes (HR 1·90 95% CI 1·65–2·17, p&lt;0.0001)1.

Study design:&nbsp;ODYSSEY OUTCOMES&nbsp;was a randomized, double-blind, placebo-controlled phase 3 study. Patients with a recent MI or unstable angina, and on high-intensity statin (40 or 80 mg atorvastatin or 20 or 40 mg rosuvastatin, or maximally tolerated dose of one of these agents) +/- other lipid-lowering therapy but not at predefined target LDL-C were enrolled. Patients were classified by glycaemic status at baseline (normoglycemia, prediabetes, or diabetes) defined on the basis of patient history, review of medical records, or baseline HbA1c or fasting serum glucose, and risk of new-onset diabetes among those without diabetes at baseline1,2.

PRALUENT®&nbsp;did not increase the risk of new-onset diabetes for patients with prediabetes or normoglycemia at baseline1.

DYSLIPIDEMIA

CARDIOLOGY

<a href="/uk/dyslipidaemia">SEE MORE FROM SCIENCE</a>

<h3>Praluent®</h3>
Find more information on Indication, Administration and Mechanism of Action and watch videos about Praluent®.

<h3>Patient Website</h3>
Find resources and support for your patients on Praluent®. Find useful links about how patients can manage their cholesterol.

<h2>Get in touch with the Dyslipidaemia Team</h2>

Praluent® (alirocumab) Prescribing Information (GB)

Praluent® (alirocumab) Prescribing Information (NI)

Cardiovascular outcomes for diabetes patients Praluent® (alirocumab)

<a href="${link:{uuid:{c90870f5-b8bd-4138-bee3-88766d4cee04},repository:{dam},path:{/Portal/UK/Prescribing-links/Clexane-pi.pdf}}}" target="_blank">Prescribing Information UK</a>

<h3>LMWHs, including enoxaparin, are used across a variety of indications.</h3>
LMWHs are complex to manufacture given that they are biological medicines derived from porcine heparin, taking several months (9-10 on average) to produce.
As a result, high levels of investment is needed to meet current and future quality and regulatory standards and to continue to supplying high-quality medicines on a global scale.

<h2>Market dynamics</h2>
<h3>Sanofi has observed that some procurement practices aimed at realizing short-term savings may disrupt the market balance leading to long-term market unsustainability.</h3>
In some cases, this may unintendedly disincentivise manufacturers to supply in certain markets increasing the risk of challenges in the supply chain and medicines shortages. This situation could lead to an overall increase in healthcare expenditure.
In the past demand was more predictable within the LMWH market; this led to a more sustainable market with manufacturers able to maintain continuity of supply and financial stability. Today this market has been impacted by the following issues:&nbsp;
<ul>
 <li>Increased production costs</li>
 <li>Covid-19</li>
 <li>Unsustainable prices</li>
 <li>African Swine Fever</li>
 <li>Voluntary scheme for branded medicines pricing and access (VPAS)</li>
</ul>

Furthermore, with the emergence of biosimilars alongside a continuing pattern of International Non proprietary Names (INN) prescribing, the predictability of demand in this market is becoming ever more complex.
Price-orientated procurement practices also have the potential to increase the&nbsp;availability of parallel imports&nbsp;which could destabilise the supply of LMWHs further.

<table border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
 <tr>
 <td>There is a need for more predictability of demand, particularly considering the long production time and buyer fragmentation observed in the market.</td>
 </tr>
 </tbody>
</table>

Sanofi project the global market to continue growing at approximately 5% per year between 2022-2028.*

<h3>Demand for LMWHs has been increasing over the past 10 years.</h3>

<h2>Supply resilience</h2>
<h3>In recent years, the average procurement cost of pure heparin has increased; (for Sanofi this has more than doubled over the past 5 years) with pure heparin accounting for &gt;50% of Clexane (enoxaparin) production costs.</h3>
Increased global demand for&nbsp;syringes and component parts&nbsp;has also contributed to difficult market conditions.
Currently, these difficult market conditions are exacerbated by&nbsp;global inflation&nbsp;which also increases procurement costs. At the same time, price-centric tendering practices are contributing to an unsustainable situation by commoditizing the LMWH market.
Due to the&nbsp;length of the supply chain and difficulties in accurately forecasting, the industry faces challenges in responding rapidly to changes in procurement policies and demand. Communication between industry and the NHS is essential in matching supply with demand.
Sanofi believe that if the number of suppliers in each market decrease, vulnerabilities in supply chains can become more exposed which&nbsp;increases the strain on remaining suppliers&nbsp;to deliver consistent volumes.
Investment in high-quality manufacturing supported by sustainable procurement practices can strengthen supply chain resilience.

<h2>Sanofi’s commitment</h2>
<h3>By supplying Clexane (enoxaparin) in more than 100 counties over a 30 year period, Sanofi has become the global leader in the supply of LMWHs.</h3>

<h4>Supplying Clexane (enoxaparin) in ~ 100 countries over 30 years</h4>

<h4>~ 70 manufacturing sites for a global supply chain</h4>

<h4>~ 20 R&amp;D sites committed to improving environmental sustainability</h4>

Sanofi also boasts a diversified global supply chain with multiple manufacturing and sourcing sites across Latin America, China and North America, and has the largest EU footprint of any LMWH manufacturer; this diversification, including local manufacturing, helps to support local economies and insulate the market from medicine shortages.&nbsp;
Furthermore, Sanofi is committed to improving environmental sustainability through improved packaging designs, reinvesting in further life cycle management and providing additional services to patients and healthcare systems.&nbsp;
<a href="https://www.sanofi.com/en/media-room/press-releases/2022/2022-03-08-13-25-40-2398922" target="_blank">Read: Sanofi recognized by S&amp;P as one of the most sustainability-committed companies - Sanofi</a>

Sanofi CEO

Paul Hudson

<h2>Case for sustainable procurement</h2>
<h3>As a leading global enoxaparin manufacturer, Sanofi has the expertise to work with authorities across the world. Sanofi is therefore approaching authorities with proposals to overcome the market and supply challenges and ensure patients' access to medicines.</h3>
Sanofi believe that the&nbsp;global LMWH&nbsp;market needs&nbsp;greater supply&nbsp;resilience&nbsp;and long-term&nbsp;sustainable&nbsp;market conditions.
Sanofi is calling for all stakeholders involved in LMWH procurement to find the most appropriate conditions and support long-term market sustainability and patient access striking a balance between fair pricing and healthcare cost optimisation

Pricing recommendations should be tailored to the local market and policy environment and should support market sustainability and patient access

National guidance on sustainable tendering practices should be recommended

Tender designs should reflect the complexities of LMWH and safeguard access to medicines

<h3>National/Regional</h3>
Sanofi asks procurement leads to consider changes to tender structures which increase the emphasis on&nbsp;non-price centric&nbsp;criteria and&nbsp;award multiple suppliers, which will benefit all stakeholders&nbsp;by increasing supply reliability and safeguarding access to these essential medicines. This is in line with the Governments Social Value Model.

<h3>Locally</h3>
Education is required for a&nbsp;greater understanding of sustainable procurement&nbsp;and local&nbsp;decisions should be communicated&nbsp;to all suppliers of LMWH.

If a locality&nbsp;chooses a single supplier, other suppliers cannot be expected to meet additional demand in the event of a shortage.&nbsp;
Alternatively, localities could consider choosing multiple suppliers and providing accurate forecasts of their demand to ensure the availability of products.

In assessing the relative benefits of multiple versus single supplier sourcing, procurement teams should look at:
<ul>
 <li>The pharmacy workforce impact of out of stock situation</li>
 <li>The shortages of tackling elective backlogs&nbsp;</li>
 <li>The green sustainability commitments of any decisions</li>
</ul>

<a href="/uk/thrombosis">SEE MORE FROM SCIENCE</a>

<h2>Get in touch with the Thrombosis Team</h2>

Clexane® (enoxaparin) Prescribing Information UK

THROMBOSIS

Social value and net zero in NHS procurement

<a href="${link:{uuid:{8cd02cf2-bd72-495f-b720-698ef8d3f0da},repository:{dam},path:{/Portal/UK/Prescribing-links/Toujeo.pdf}}}" target="_blank">Prescribing Information Toujeo (insulin glargine 300 units/mL)</a> <a href="${link:{uuid:{8f132346-a5c2-470d-8368-64ab56220e08},repository:{dam},path:{/Portal/UK/Prescribing-links/Lantus_GB_NI_PI.pdf}}}" target="_blank">Prescribing Information Lantus (insulin glargine 100 units/mL)</a>

<h2>Toujeo®&nbsp;can support your patients with T1DM</h2>
Discover the Toujeo®&nbsp;Evidence in T1DM below and get access to patient supporting tools and materials for your T1 patients who have been prescribed Toujeo®.

<h3>Toujeo®&nbsp;is associated with a more stable and prolonged activity profile over a full 24-hour period than insulin glargine 100 units/mL1</h3>

<h3>Toujeo®&nbsp;is associated with a flatter PK/PD profile vs insulin degludec 100 units/mL2</h3>

Toujeo®&nbsp;has a flatter, more stable activity profile – extending beyond 24 hours with a flexible dosing window (+/- 3 hours).
<ul>
 <li>PK/PD study in people with T1DM using euglycaemic-clamp technique at steady state. The results of euglycaemic clamp studies do not necessarily predict clinical outcomes in all patients.</li>
</ul>

Compared with insulin degludec, Toujeo®&nbsp;at a clinically relevant dose (0.4 units/kg/day) provides a more stable and evenly distributed PK/PD profile with less within-day fluctuation in adults with T1DM.1&nbsp;Toujeo®&nbsp;also had a&nbsp;20% lower (p=0.047)&nbsp;within-day variability&nbsp;of the smoothed GIR curve vs insulin degludec.1
<ul>
 <li>For GIR data a smoothing factor (LOESS factor 0.15) was applied. PK/PD study in people with T1DM using euglycaemic-clamo technique. The results of euglycaemic clamp studies do not necessarily predict clinical outcomes in all patients.</li>
 <li>The within-day variability of the smoother GIR curve was similiar between Toujeo®&nbsp;0.6 units/kg/day and insulin degludec 0.6 units/kg/day. Both insulins provided exposure and acctivity until 30 hours (end of clamp).</li>
</ul>

Study design:&nbsp;Becker RHA,&nbsp;et al. 2015.1
Study aim:&nbsp;to characterise the PK/PD of Toujeo®&nbsp;compared with insulin glargine 100 units/mL at steady state in people with T1DM.
Study design:&nbsp;Single-centre, randomised, double-blind, two-treatment, two-period, two sequence crossover euglycaemic clamp study.
Primary endpoint:&nbsp;GIR and INS profiles in steady state.
Treatment during the washout period was unchanged from that recieved prior to the study. For GIR and BG data a smoothing factor (LOESS factor 0.15) was applied.

Study design:&nbsp;Bailey TS,&nbsp;et al. 2018.2
Study aim:&nbsp;to compare the PK/PD properties of 0.4 and 0.6 units/kg/day Toujeo®&nbsp;with insulin degludec 100 units/mL in people with T1DM
Study design:&nbsp;Single-centre, randomised, double-blind, two-treatment, two-period, two-sequence crossover euglycaemic clamp study
Primary endpoint:&nbsp;Fluctuation (within-day variability) of the smoothed GIR curve over a 24-hour dosing period in steady state (GIR-smFL0-24)*
Treatment during the washout period was unchanged from that recieved prior to the study.&nbsp;For GIR and BG data a smoothing factor (LOESS factor 0.15) was applied.​​
​*The area of the individual smoothed GIR above and below the individual average GIR line is calculated, providing the mean amplitude of GIR fluctuations around the average GIR over 24 hours.​

The clinical implications of PK/PD data require further evaluation including CGM and larger clinical studies.&nbsp;PK/PD study in people with T1DM using euglycaemic-clamp technique at steady state.&nbsp;The results of euglycaemic clamp studies do not necessarily predict clinical outcomes in all patients.

<h2>CGM</h2>
Toujeo®&nbsp;vs Insulin Glargine 100 U/mL3

<h3>Toujeo®&nbsp;vs Insulin Glargine 100 U/mL4</h3>
Post-hoc meta-analysis of three EDITION 6-month, Phase III, randomised clinical trials
Post-hoc meta-analysis aim:&nbsp;Exploring the risk for severe hypoglycaemia with Toujeo®&nbsp;vs insulin glargine 100 units/mL in the pool of studied patients with T1DM.

Edition 4 (549 adults), Edition Junior (463 children), Edition JP 1 (243 adults).

<h3>Toujeo®&nbsp;vs other basal insulins5</h3>

A multicentre, UK, retrospective, observational study to assess the effectiveness of Toujeo®&nbsp;in treating people with Type 1 diabetes mellitus in routine clinical practice (SPARTA).
Primary endpoint:&nbsp;Change in HbA1c levels from baseline to Month 6 after Toujeo®&nbsp;initiation.

298 patients with T1DM were recruited.

Abbreviations

T1 Evidence in Adults

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