The role of the payer in determining market access success has become significantly more prominent. Accordingly, the pharmaceutical and medical devices industries are now being challenged to demonstrate the value of their products, as well as clinical safety and efficacy.
Spectrum can assist in creating messages to reflect the desired and actual value and points of differentiation of products in development as they progress towards approval and market launch. This process helps focus clinical development plans to be aligned with the value requirements of the product and provides a road-map to the evidence base that will be required for a successful health technology appraisal.
Evidence-gathering is the first step towards successful market access. Disease area review, burden of illness and real-world evidence generation are key activities that companies look to Spectrum for assistance with.
We help meet the challenge of proving value and efficacy of medicinal products and medical devices, by incorporating Health Economics & Outcomes Research (HEOR) measures at an early stage in clinical development planning, and developing easy-to-use Budget Impact Models.
With over 50 full submissions in the UK and Ireland that have led to a positive appraisal, Spectrum offers a complete service in Health Technology Appraisal (HTA) submissions to NICE, the Scottish Medicines Consortium (SMC), the All Wales Medicines Strategy Group (AWMSG) and the National Centre for Pharmacoeconomics (NCPE). We can also help prepare for pre-submission meetings, develop responses to post-submission evaluation reports, and formulate strategies to achieve success in appeals.
A Global Value Dossier (GVD) is an essential component of a value toolkit. A well-written GVD, founded on a scientifically supportable set of value messages, communicates in a balanced manner the positive benefit-risk ratio of a product for patients and society in general. In addition, creating a GVD can be a key step in preparing an HTA submission. Learn more.
Our expertise in technical writing and economic analysis means we are well placed to help prepare informative yet succinct dossiers, using data from a wide range of sources, to support applications for reimbursement to the Drug Tariff and local formularies.
To find out more about these and other market access services from Spectrum, please call us on +44 (0)1403 320280 or contact us by email.