Innovative drugs: Mapping the pricing, reimbursement and HTA landscape
Widespread patient access to innovative new products is being frustrated in non-US markets by Health Technology Assessments (HTA). Between January 2016 and June 2017, 58 innovative medicines were approved and launched in the US - but what of their status elsewhere? For example, only 35 of the 58 have been approved in the EU and of these many are tied up in HTA reviews. The commercial impact cannot be underestimated: with no predictable outcome, companies cannot plan effectively or understand the competitive environment in which they will operate. Which companies are being impacted? What products have made the grade? When – and where – will new competitive threats emerge?
Delivering a detailed report and usable data set, this ground breaking analysis exposes the pricing, reimbursement and HTA review status of innovative drugs in Australia, Canada, France, Germany and the UK for a clear picture of the competitive landscape.
DISCOVER ON THIS PAGE
Pharma prides itself on being an innovative industry. It spends US$ billions on R&D and negotiates the regulatory regimes to gets its products approved. But overcoming the HTA hurdle is neither a standardised nor predictable process with commercially-acceptable pricing and reimbursement decisions far from guaranteed.
The burden of HTA assessment grows heavier as each national - or even sub-national - authority sets its own standards for evidence. Smaller companies and biotechs may not have either the finance or resources to engage. Knowing which companies are currently engaged and the impact on the products is critical competitive intelligence.
KEY FACTS ABOUT THIS REPORT AND DATA
This report delivers two competitive analysis resources!
1. Analysis report
Rich in charts and tables, this detailed analytical report provides:
Delivered in Microsoft Excel™, all the data used to drive this report can be used for further analysis or to incorporate into competitive intelligence systems. For each product the data covers:
Overview
Approved drugs
For each of the products covered
FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. FirstWord offers a range of products and services designed to help your company gain a competitive edge by making key business decisions with speed and confidence.
FirstWord Pharma PLUS is a personalised and comprehensive intelligence service delivering up-to-the-minute pharma news, insight, analysis and expert views of importance to your company’s success.
FirstWord Reports deliver timely, need-to-know intelligence about your products, your competitors and your markets. Covering biosimilars, market access, medical affairs, sales & marketing, technology and therapy areas, FirstWord Reports provide expert views and intelligence on the challenges facing pharma today.
Delivering a detailed report and usable data set, this ground breaking analysis exposes the pricing, reimbursement and HTA review status of innovative drugs in Australia, Canada, France, Germany and the UK for a clear picture of the competitive landscape.
DISCOVER ON THIS PAGE
- Why this report is important to you
- Key facts about this report and data
- This report will enable you
- The deliverables: market analysis and data set
- Table of contents
Pharma prides itself on being an innovative industry. It spends US$ billions on R&D and negotiates the regulatory regimes to gets its products approved. But overcoming the HTA hurdle is neither a standardised nor predictable process with commercially-acceptable pricing and reimbursement decisions far from guaranteed.
The burden of HTA assessment grows heavier as each national - or even sub-national - authority sets its own standards for evidence. Smaller companies and biotechs may not have either the finance or resources to engage. Knowing which companies are currently engaged and the impact on the products is critical competitive intelligence.
KEY FACTS ABOUT THIS REPORT AND DATA
- Products: 58 innovative products covered, including ixekizumab (Eli Lilly), nusinersen (Biogen), palbociclib (Pfizer), selexipag (Actelion) and sofosbuvir/velpatasir (Gilead)
- Therapy areas: The 58 products cover 13 therapy areas – mainly oncology and neurology but also respiratory, anti-infectives, musculoskeletal and gastrointestinal
- Indications: Conditions indicated for the 58 products include cancer (various), dry eye, muscular dystrophy , hepatitis C, IBS, Parkinson's disease and diabetes
- Companies: The products of 47 companies are covered including Actelion, Bristol-Myers Squibb, Eli Lilly, Genentech and Gilead
- Markets: Detailed information is provided for HTA status in Australia, Canada, France, Germany and the UK
- Review the pricing, reimbursement and HTA status of each product at the national level
- Profile the therapy areas that are being targeted by innovative drugs
- Estimate likely HTA decisions using average timeframes
- Identify products that have been approved but not referred for HTA assessment
- Assess the impact of HTA systems on smaller companies and biotechs in the innovative drug space
- Profile the emerging innovative therapies in key therapy areas
This report delivers two competitive analysis resources!
1. Analysis report
Rich in charts and tables, this detailed analytical report provides:
- At a glance overview of the approved drugs, therapy areas, routes of administration, company and latest sales performance
- Pricing, reimbursement and HTA policies and practices in Canada, France, Germany and the UK
- Product-level analysis providing overviews of regulatory approvals, HTA status/market launch and sales (including first half 2017 sales where available)
Delivered in Microsoft Excel™, all the data used to drive this report can be used for further analysis or to incorporate into competitive intelligence systems. For each product the data covers:
- Generic name, brand name, developer company, condition targeted and therapy area
- US FDA/EMA/Health Canada approval dates and days to approve
- HTA referral, review, decision dates and outcomes where known
- Sales performance, where relevant, in local currency and US$
Overview
Approved drugs
- By therapy area
- By Route of Administration
- By company
- Latest Sales Revenues by Therapy Area ($m)
- Canada
- France
- Germany
- UK
For each of the products covered
- Product overview
- Regulatory approvals
- HTA and market launch
- Sales
- Abaloparatide
- Alectinib
- Atezolizumab
- Avelumab
- Betrixaban
- Bezlotoxumab
- Brigatinib
- Brivaracetam
- Brodalumab
- Cerliponase Alfa
- Crisaborole
- Daclizumab
- Daratumumab
- Defibrotide
- Deflazacort
- Delafloxacin
- Dupilumab
- Durvalumab
- Edaravone
- Elbasvir/Grazoprevir
- Elotuzumab
- Eluxadoline
- Enasidenib
- Etelcalcetide
- Eteplirsen
- Glecaprevir/Pibrentasvir
- Guselkumab
- Ixazomib
- Ixekizumab
- Lenvatinib
- Lifitegrast Ophthalmic Solution
- Lixisenatide
- Midostaurin
- Naldemedine
- Necitumumab
- Neratinib Maleate
- Niraparib
- Nusinersen
- Obeticholic Acid
- Ocrelizumab
- Olaratumab
- Osimertinib
- Palbociclib
- Pimavanserin
- Plecanatide
- Reslizumab
- Ribociclib
- Rolapitant
- Rucaparib
- Safinamide
- Sarilumab
- Selexipag
- Sofosbuvir/Velpatasvir
- Sofosbuvir/Velpatasvir/Voxilaprevir
- Telotristat Ethyl
- Valbenazine
- Venetoclax
FirstWord is an innovative industry intelligence leader serving over 240,000 Pharma and MedTech professionals worldwide. FirstWord offers a range of products and services designed to help your company gain a competitive edge by making key business decisions with speed and confidence.
FirstWord Pharma PLUS is a personalised and comprehensive intelligence service delivering up-to-the-minute pharma news, insight, analysis and expert views of importance to your company’s success.
FirstWord Reports deliver timely, need-to-know intelligence about your products, your competitors and your markets. Covering biosimilars, market access, medical affairs, sales & marketing, technology and therapy areas, FirstWord Reports provide expert views and intelligence on the challenges facing pharma today.
1. EXECUTIVE SUMMARY
2. RESEARCH METHODOLOGY AND OBJECTIVES
3. OVERVIEW
3.1 Approved drugs
3.2 Sales Data
3.3 P&R/HTA Activity
4. DRUG STATUS REPORTS
4.1 Abaloparatide
4.2 Alectinib
4.3 Atezolizuma
4.4 Avelumab
4.5 Betrixaban
4.6 Bezlotoxumab
4.7 Brigatinib
4.8 Brivaracetam
4.9 Brodalumab
4.10 Cerliponase Alfa
4.11 Crisaborole
4.12 Daclizumab
4.13 Daratumumab
4.14 Defibrotide
4.15 Deflazacort
4.16 Delafloxacin
4.17 Dupilumab
4.18 Durvalumab
4.19 Edaravone
4.20 Elbasvir/Grazoprevir
4.21 Elotuzumab
4.22 Eluxadoline
4.23 Enasidenib
4.24 Etelcalcetide
4.25 Eteplirsen
4.26 Glecaprevir/Pibrentasvir
4.27 Guselkumab
4.28 Ixazomib
4.29 Ixekizumab
4.30 Lenvatinib
4.31 Lifitegrast Ophthalmic Solution
4.32 Lixisenatide
4.33 Midostaurin
4.34 Naldemedine
4.35 Necitumumab
4.36 Neratinib Maleate
4.37 Niraparib
4.38 Nusinersen
4.39 Obeticholic Acid
4.40 Ocrelizumab
4.41 Olaratumab
4.42 Osimertinib
4.43 Palbociclib
4.44 Pimavanserin
4.45 Plecanatide
4.46 Reslizumab
4.47 Ribociclib
4.48 Rolapitant
4.49 Rucaparib
4.50 Safinamide
4.51 Sarilumab
4.52 Selexipag
4.53 Sofosbuvir/Velpatasvir
4.54 Sofosbuvir/Velpatasvir/Voxilaprevir
4.55 Telotristat Ethyl
4.56 Valbenazine
4.57 Venetoclax
5. ACRONYMS USED IN THIS REPORT
2. RESEARCH METHODOLOGY AND OBJECTIVES
3. OVERVIEW
3.1 Approved drugs
3.2 Sales Data
3.3 P&R/HTA Activity
4. DRUG STATUS REPORTS
4.1 Abaloparatide
4.2 Alectinib
4.3 Atezolizuma
4.4 Avelumab
4.5 Betrixaban
4.6 Bezlotoxumab
4.7 Brigatinib
4.8 Brivaracetam
4.9 Brodalumab
4.10 Cerliponase Alfa
4.11 Crisaborole
4.12 Daclizumab
4.13 Daratumumab
4.14 Defibrotide
4.15 Deflazacort
4.16 Delafloxacin
4.17 Dupilumab
4.18 Durvalumab
4.19 Edaravone
4.20 Elbasvir/Grazoprevir
4.21 Elotuzumab
4.22 Eluxadoline
4.23 Enasidenib
4.24 Etelcalcetide
4.25 Eteplirsen
4.26 Glecaprevir/Pibrentasvir
4.27 Guselkumab
4.28 Ixazomib
4.29 Ixekizumab
4.30 Lenvatinib
4.31 Lifitegrast Ophthalmic Solution
4.32 Lixisenatide
4.33 Midostaurin
4.34 Naldemedine
4.35 Necitumumab
4.36 Neratinib Maleate
4.37 Niraparib
4.38 Nusinersen
4.39 Obeticholic Acid
4.40 Ocrelizumab
4.41 Olaratumab
4.42 Osimertinib
4.43 Palbociclib
4.44 Pimavanserin
4.45 Plecanatide
4.46 Reslizumab
4.47 Ribociclib
4.48 Rolapitant
4.49 Rucaparib
4.50 Safinamide
4.51 Sarilumab
4.52 Selexipag
4.53 Sofosbuvir/Velpatasvir
4.54 Sofosbuvir/Velpatasvir/Voxilaprevir
4.55 Telotristat Ethyl
4.56 Valbenazine
4.57 Venetoclax
5. ACRONYMS USED IN THIS REPORT
