HTA & Market Access
This is a specialist service distinct from an academic systematic review. An HTA review is built for a submission, not a journal. It is comparative by necessity, it often requires both a clinical and an economic review, and where there is no head-to-head trial it requires an indirect comparison. We support each of these components and assemble them into a coherent, defensible evidence package.
Every review follows the Cochrane Handbook (version 6.5, 2024), PRISMA 2020 reporting (Page et al., BMJ, 2021), and GRADE for certainty of evidence, with the methodology aligned to the reference case and expectations of the relevant assessment body.
A reimbursement submission is not a single review. It is a set of linked evidence deliverables, each with its own methodology. We produce each component to its appropriate standard and ensure they are internally consistent:
Clinical systematic literature review. The comprehensive, reproducible review of the clinical evidence for the intervention and its comparators, built to PRISMA 2020 with dual-reviewer screening, validated risk of bias assessment, and GRADE certainty ratings. This is the spine of the submission.
Economic systematic literature review. A separate, structured review of the existing cost-effectiveness, economic model, and utility evidence relevant to the indication, conducted to identify and characterize the published economic evidence that supports or contextualizes the model.
Indirect treatment comparison or network meta-analysis. When no head-to-head trial exists between the intervention and the relevant comparator, an indirect comparison is required to estimate relative effect. We assess feasibility and deliver the analysis where the evidence supports it, through our meta-analysis service.
Humanistic and burden-of-illness reviews. Where the submission requires evidence on quality of life, patient-reported outcomes, epidemiology, or disease burden, we conduct the targeted reviews that supply it.
Certainty and quality narrative. A GRADE-based assessment of the certainty of the clinical evidence, written so the submission neither overstates nor understates what the evidence supports, the calibration assessors look for.
Assessment bodies critique the evidence base before they evaluate the model. A reviewer's first question is whether the systematic literature review identified all the relevant evidence and did so reproducibly. If the search missed a relevant trial, if the comparator set is incomplete, if screening was not independent and documented, or if the risk of bias and certainty assessments are absent or misapplied, the submission is challenged at its foundation, before the economic case is even examined.
This is why a methodologically weak SLR is the most expensive shortcut in a submission. The review is the part most open to external critique, and the part hardest to repair late. Building it correctly from the protocol stage, with a search that is reproducible, a comparator set justified against the decision problem, and a synthesis calibrated to the certainty of the evidence, is what allows the rest of the submission to stand.
We build the SLR as the defensible foundation it needs to be, and we document every methodological decision so that when an assessor asks why a study was included or excluded, the answer is already on the record.
The single most consequential difference is that an HTA review is built around a decision problem, not a research question. The PICOS is defined by the reimbursement decision and the assessment body's reference case, not by what makes an interesting paper.
| Dimension | Journal Systematic Review | HTA / Market Access SLR |
|---|---|---|
| Defined by | Research question | Decision problem and assessment body reference case |
| Scope | Usually clinical only | Clinical plus economic, humanistic, and burden-of-illness |
| Comparators | As defined by authors | All relevant comparators in the decision problem; ITC where no head-to-head |
| Primary audience | Journal editor and peer reviewers | HTA assessment group and committee |
| Feeds into | A publication | An economic model and a reimbursement decision |
| Documentation | Reproducible for peers | Audit-ready; defensible to a critiquing assessment group |
| Building the evidence base for a reimbursement submission? |
|---|
Tell us the indication, the target assessment body, and which evidence components you need. A PhD methodologist will respond with a scoped proposal and a confidentiality agreement on request, or chat on WhatsApp. Request a Scoped Quote |
We build each review to the methodology expectations of the assessment body your submission targets, aligning to published methods guidance and reference cases including:
Where your submission targets a body not listed here, tell us in your enquiry. The underlying methodology is consistent across bodies; we adapt the presentation and reference case to the target. For region-specific national bodies, see our country and regulatory standards guide.
The reproducible multi-database search behind each review can also be commissioned on its own through our search strategy service.
HTA and market access reviews are scoped individually and priced per project. The cost is driven by how many evidence components the submission requires and the standard each must meet. We provide a detailed, itemized proposal after a short scoping conversation. The main drivers are:
We provide a custom quote per project. Tell us the indication, the target body, and the components you need, and we will return a scoped proposal with deliverables, timeline, and an itemized cost. A confidentiality agreement is available before you share any details. Request a Scoped Quote.
All HTA and market access engagements are covered by a mutual confidentiality agreement as standard. We do not disclose client identities, indications, submission details, or any aspect of the evidence work to third parties. An NDA is available before any project details are shared.
Our role is methodological and evidence synthesis support. Your team retains full accountability for the submission, its strategy, and its interpretation of the evidence. For our broader position, see our ethics and integrity policy. For the pharmaceutical and regulatory evidence service that complements this one, see our pharmaceutical and regulatory service.
We produce the evidence synthesis components: the clinical systematic literature review, the economic SLR, humanistic and burden-of-illness reviews, and any indirect comparison, each built to a reproducible, audit-ready standard. We do not assemble the final submission dossier or own the market access strategy; those remain with your team. We provide the defensible evidence base the submission is built on. Tell us which components you need in your enquiry.
We align to the published methods and reference cases of NICE, CADTH, PBAC, and the EU Joint Clinical Assessment under the EU HTA Regulation, among others. The core methodology is consistent across bodies; we adapt the comparator set, outcomes, and presentation to the target body. If your target is not listed, tell us in the enquiry.
Yes. Where no direct comparison exists, we assess the feasibility of an indirect treatment comparison or network meta-analysis and deliver it where the evidence supports it, through our meta-analysis service. We also advise where population-adjusted methods may be appropriate.
Yes. The clinical SLR and the economic SLR are distinct reviews with different objectives and search strategies. We conduct each to its appropriate standard and ensure they are internally consistent. You can commission the clinical review alone or both together.
Yes. A mutual confidentiality agreement is standard for HTA and market access work and can be in place before you share the indication or any project specifics.
We scope and price each project individually, driven by which components are required, the number of indications, comparator complexity, the target body's standard, and the timeline. We provide a custom, itemized quote per project after a short scoping conversation.
Submit your details through our HTA and market access enquiry form. Include the indication, the target assessment body, which evidence components you need, and your submission timeline. A PhD methodologist will respond within 2-4 business hours with a scope assessment. A confidentiality agreement is available on request before you share details.
Tell us the indication, the target assessment body, and the components you need. A PhD methodologist will respond within 2-4 business hours with a scoped proposal, timeline, and itemized cost. Confidentiality agreement available on request.
Prefer email? Send your project details to info@scribelabwriter.com
