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.
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Why this report is important to you
- 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
This report will enable you to…
- 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
Delivering market analysis and data
- 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)
1. Data Set
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$
- By therapy area
- By Route of Administration
- By company
P&R/HTA ActivityDrug status reportsFor each of the products covered
- Latest Sales Revenues by Therapy Area ($m)
- Product overview
- Regulatory approvals
- HTA and market launch
- Cerliponase Alfa
- Lifitegrast Ophthalmic Solution
- Neratinib Maleate
- Obeticholic Acid
- Telotristat Ethyl
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