Health Technology Assessment (HTA) reviews are shaping the competitive landscape for innovative drugs in non-US markets. Between January 2016 and June 2018, 95 innovative medicines were approved in the US–but only 67 have launched in a major market elsewhere. Understanding which companies and products are being impacted is critical competitive intelligence for strategic planners, market access, sales and marketing professionals.
Which companies are involved? What products have made the grade and where? When could new competitive threats emerge? For answers turn to Innovative Drugs: Mapping the Pricing and Reimbursement Landscape. Comprising a detailed report and usable data set in Microsoft ExcelTM, this granular analysis exposes—at a product level—the pricing, reimbursement and status of innovative drugs in Australia, Canada, France, Germany and the UK.
Key facts about this report and data
- Products: 95 innovative products covered from abaloparatide (Radius Health), abemaciclib (Eli Lilly) and acalabrutinib (AstraZeneca) to valbenazine (Neurocrine) and venetoclax (Abbvie/Roche) and vestronidase-alfa-vjbk (Ultragenyx Pharma).
- Therapy areas: The 95 products cover 13 therapy areas, from leading areas such as oncology and anti-infectives to respiratory, musculoskeletal, gastrointestinal and neurological disorders.
- Conditions: Conditions targeted by the 95 products include cancer (various), asthma, diabetes, dry eye, Duchenne muscular dystrophy, epilepsy hepatitis C, irritable bowel syndrome, psoriasis, and Parkinson's disease.
- Companies: The products of 63 companies are covered, from Abbvie, Acadia Pharms, Achaogen and Actelion (Johnson & Johnson) to US Worldmeds, Valeant and Vertex Pharma.
- Markets: Detailed information is provided for the HTA status in Australia, Canada, France, Germany and the UK.
This report will enable you to…
- Review the pricing, reimbursement and HTA status of each product at the national level
- Profile the therapy areas that are being targeted
- Estimate likely FDA/EC approval decisions using average timeframes
- Identify products that have been approved but yet not referred for HTA assessment
- Assess the impact of emerging biotechs in the innovative drug space
- Profile the innovative therapies in key therapy areas and acute/chronic conditions
Case Study: Abbvie's Maviret (EU) Mavyret (US)
AbbVie's fixed-dose combination of 100mg of glecaprevir and 40mg of pibrentasvir is indicated for the ribarivin-free treatment of chronic hepatitis C virus (HCV) infection across all major genotypes. It is approved as Maviret in the EU and Mavyret in the US. It was approved by the US FDA on 3 August 2017 and by the European Commission (EC) on 26 July 2017. In the US, Mavyret has been competitively priced, at around $13,200 per month or $26,400 per course of treatment before discounts. This compares with $28,000 per month for Gilead's Solvaldi (sofosbuvir) and $31,500 for Harvoni (ledispavir/sofosbuir). While Mavyret was available immediately in the US, elsewhere the story differs and illustrates how variable HTAs can come to different conclusions...
- In France, the Haute Autorité de Santé issued a report for Maviret in December 2017. This gave the drug an SMR rating of Important and an ASMR of IV (minor). The drug is listed on the French public drug database and on the hospital drug list. It has an agreed price and a 100% reimbursement rate.
- In Germany, the German Institute for Quality and Efficiency in Healthcare began a review in August 2017. This reported in November 2017 and found no proof of additional clinical benefits when compared with a range of existing treatments. The G-BA confirmed this finding in its final report issued in February 2018. Maviret does have an agreed reimbursement price and is listed in the GKV database.
- In the UK, the National Institute for Health and Care Excellence issued a technology appraisal in January 2018. This recommends the drug as a treatment option for chronic hepatitis C in adults, but only if it is supplied at an agreed price.
- Maviret is approved in Canada. A Canadian Agency for Drugs and Technologies in Health common drug review was published in February 2018. This recommended use of the drug, with two conditions. First, the patient must be under the care of a physician with experience in the diagnosis and management of HCV. Second, the drug plan cost should not exceed the drug plan cost of treatment with the least-costly direct-acting antiviral agent or agents.
- Maviret is listed on the Australian Register of Therapeutic Goods, effective from September 2018. The drug is also listed on the PBS database.
What to expect
This report delivers two class-beating analysis resources
1. Analysis report
Rich in charts and tables, this detailed analysis report provides
- At a glance overview of the approved drugs, therapy areas, route of administration, company and latest sales performance.
- Pricing, reimbursement and HTA policies and practices in Canada, France, Germany and the UK
- Product level status reports providing product overview, regulatory approvals, HTA status/market launch and sales (where available)
2. Data Set
Delivered in Microsoft Excel™, all the data used to drive this report can be used for further analysis or incorporated into decision support systems. For each product the data covers:
- Generic name, brand name, developer company, condition targeted and therapy area
- US FDA/EU approval dates and number of days to approval
- HTA referral, review, decision dates and outcomes where known for Germany, Canada, France and the UK
- Sales performance, where available, in local currency and US$
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