One source for the whole burst
Top-line abstract, CSR to ICH E3, manuscript, CTD Module 2 summaries and payer dossiers draw on the same verified values. A number changes once and every document shows it.
Pharma & biotech
Payers want the paper you haven't published yet.
After a readout, one locked dataset feeds the top-line abstract, the clinical study report, the manuscript, the Module 2 summaries and the payer dossier. Silogram links the numbers in all of them to the same code and commit, so a mid-sized team can move faster without the numbers drifting apart.
Most papers land after the decisions that need them.
8 months
median from an oncology results press release to the full paper, at the 20 largest oncology companies (2018–2022).7
2.1 years
median from trial completion to publication, across 165,135 trials.8
36%
of FDA cancer drug approvals in 2010–2014 had no peer-reviewed efficacy paper within 30 days of approval.15
4.2 months
median from FDA approval to US commercial payer coverage decisions for new cancer drugs.9
Abstracts and data on file only go so far.
Formulary, guideline, compendium and HTA reviews each prefer, or require, peer-reviewed evidence.
Formulary dossiers
The AMCP Format prefers studies published in peer-reviewed journals. Congress abstracts, posters and data on file are what a dossier falls back on until the paper exists.1
P&T committees
Medicare Part D guidance bases P&T decisions on scientific evidence, including peer-reviewed literature and clinical guidelines.2
NCCN Category 1
A Category 1 recommendation needs a peer-reviewed publication. Outside submissions are due 28 days before the panel's annual meeting.34
Off-label use in Medicare
Anticancer uses are medically accepted when listed in a recognized compendium or supported by peer-reviewed articles in the 26 journals CMS has named. At least one Medicare contractor asks for full articles, not abstracts.5
ICER reviews
Reviews are timed to land near approval, and a sponsor's unpublished data are redacted from the public report until they are published or presented, or 12 months pass.6
Public precedent
Daraxonrasib: a full paper 48 days after topline.
Revolution Medicines' RAS(ON) inhibitor in previously treated metastatic pancreatic cancer had a peer-reviewed paper before FDA accepted its NDA, so payers and guideline panels had published evidence from launch.121314
Topline results
RASolute 302: median overall survival 13.2 vs 6.7 months in the overall population.
ASCO plenary and NEJM
Presented and published the same day.
48 days after toplineNDA accepted
Under a Commissioner's National Priority Voucher, with real-time oncology review.
FDA approval
Approved as Rasonque, with the paper already in print.
87 days after the paper
Public precedent from company filings, PubMed and FDA reports; Revolution Medicines has no affiliation with Silogram. An ASCO plenary with a same-day NEJM paper is an exceptional best case. Silogram aims to help mid-sized teams shorten the internal drafting and checking that make up much of the usual gap.
Every document from the same locked analysis.
A shorter internal loop
Methods drafted from the code, results linked to outputs, a number audit before every review round, and your house style learned from past papers.
Dates tied to access
Link each document to the decision it supports, such as an NCCN submission, a formulary review or a joint assessment, and see the likely date and the value of a week.
How the access plan worksCode and output, ready for HTA
Every value links to the program and commit that produced it, and reproduction from code shows the outputs regenerate: what a joint assessment dossier asks for when an analysis isn't a standard method.
Sources
- 1AMCP. AMCP Format for Formulary Submissions, version 5.0 (2024).
- 2CMS. Medicare Prescription Drug Benefit Manual, chapter 6.
- 3NCCN. Development and update of the NCCN Guidelines.
- 4NCCN. Guidelines submission process FAQs (November 2024).
- 5CMS. MLN Matters MM5729; Billing and coding article A58113.
- 6ICER. ICER processes; 2023–2026 value assessment framework.
- 7Valsecchi et al. J Cancer Policy. 2025. PubMed 40268192.
- 8Cochrane. How long do clinical trials take to publish their results? (methodology review, November 2024).
- 9Haque et al. JAMA Oncol. 2023. PMC10587821.
- 10European Commission. Joint clinical assessments: factsheet.
- 11HTA Coordination Group. Guidance on the JCA dossier template for medicinal products (2024).
- 12Revolution Medicines. Form 8-K, RASolute 302 topline results (April 2026).
- 13RASolute 302 primary analysis. N Engl J Med. 2026. PubMed 42223072.
- 14CancerNetwork. report on the FDA approval of daraxonrasib (August 2026).
- 15Lammers et al. Blood Cancer J. 2017. PMC5802585.