Health Technology Assessment (HTA)

A positive HTA appraisal for a pharmaceutical product is of critical importance for its reimbursement and market access.

At Tolley Health Economics we have the experience and knowledge of what is required for a successful HTA submission and our team have a successful track record across a number of therapeutic areas to all UK HTA bodies (NICE, SMC, AWMSG and NCPE). We work closely with our clients on their HTA evidence generation submissions, tailor-made to their specific needs.

Keith Tolley has extensive experience of the HTA requirements for the market access of pharmaceuticals in the UK and elsewhere. Keith was formerly an industry representative on the review board of the SMC in Scotland, and since 2005 has been a health economic assessor with the SMC. With Keith’s in-depth knowledge of the evidence needs for HTA and reimbursement and working as part of a close-knit team and network of specialist collaborators. We work extensively with economic modellers, statisticians and experienced medical writers to provide expertise on every element of the HTA and submission process.

At Tolley Health Economics we can write the whole of your submission or sections of it, and with our global network of health economists, modellers and statisticians, we can develop economic models or develop existing models to make them fit for UK purpose, and demonstrate budget impact analysis. In addition, we can provide a critique of the submission and or health economic model. Using our global collaborative network of health economists, economic modellers, and statisticians, Tolley Health Economics can offer systematic literature reviews and statistical analysis including indirect and mixed treatment comparisons (MTC). Our team also offer post-submission support and can aid your response to HTA body questions.

Submission Write-up

For the submission write-up, our clients receive a dedicated medical writer to assist with writing the clinical sections, and an experienced health economist to write the economic sections and perform budget impact analysis. Keith Tolley reviews all parts of the submission, contributes to the writing of the health economic sections and provides strategic consultancy to ensure all the key messages of the product are clearly evident. A dedicated project manager will ensure the project runs smoothly and timelines are adhered to. Our recent UK HTA submissions include:

Rienso® (Takeda)

For the treatment of iron deficiency anaemia in patients with chronic kidney disease (SMC and AWMSG)

Afinitor® (Novartis)

For the treatment of unresectable or metastatic, well- or moderately-differentiated neuroendocrine tumours of pancreatic origin (pNET) in adults with progressive disease (SMC and AWMSG)

Mepact® (Takeda)

For the treatment of high-grade resectable non-metastatic osteosarcoma in children, adolescents and young adults (NICE; STA and SMC)

Epiduo® (Galderma)

Cutaneous treatment of acne vulgaris when comedones, papules and pustules are present (SMC)


For the treatment of adults with type 2 diabetes mellitus to improve glycaemic control as monotherapy/add-on combination therapy (SMC)

Onglyza® (BMS)

For the treatment of adult patients with type 2 diabetes mellitus as add-on combination therapy with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control (SMC)

Vipidia® (Takeda)

For adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (SMC)


If you would like to receive more information on how we can help you with your HTA submission, please