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AMCP Formulary Dossier Builder

AMCP dossiers and unsolicited-request packets, cited and label-checked, ready before the P&T deadline

Every payer request answered with a cited, label-checked packet in days, ahead of the P&T deadline.

See one case, screen by screen ↓
demo15.3sfor the agents to build the packet for a four-ask payer request
demo14of 17dossier sections found and redlined after a new indication, a study, an extension and a price change
target2.4daysmedian from payer request received to packet sent
target87%of packets passed MLR review the first time
The problem

Why payer requests wait weeks in formulary season

Formulary season puts 14 P&T meetings into ten weeks, and each packet is due 14 days before its meeting. A new indication has just been approved, so the AMCP dossier is under revision just as plans ask for it. Every request has to be shown to be unsolicited, every ask checked against the current label, and every packet approved by medical and by regulatory and legal review before it goes out.

Most of the time goes on assembly, not judgement. Someone splits the payer’s letter into asks, checks the account was not contacted first, finds which dossier sections a new label or study touches, retypes values from forest plots and tables, presets the budget impact model to the plan’s membership and writes a cover letter. An adolescent question slipped into a packet, or a value that differs between an abstract and a figure, is exactly what MLR sends back.

estimated2–3weeksfrom payer request to packet sent, by hand
demo14P&T meetingsin the next ten weeks, each packet due 14 days before
demo14of 17dossier sections changed by one approval and three other updates
Where a payer request’s days goestimated
By hand14 days
With the solution2.1 days
  • Intake and unsolicited check2 → 0.2 d
  • Building the packet6 → 0.3 d
  • MLR review5 → 1.5 d
  • Sending and record1 → 0.1 d

Estimated median days per stage, by hand and with the solution, as shown on its dashboard.

How it works

How a payer request moves

Six specialist agents take in each request, map and read the evidence, draft, check and assemble the packet; the dossier owner decides.

What comes in
Request inPayer request or new evidence · portal, email or account director
Agents at work
Request Intake & Unsolicited Checkerpayer asks
Evidence Mapper & Change Trackernew evidence → sections
Table & Figure Readertables + curves
Then
Section Writerredline + citations
Then
Label & Claims Checkerwithin the label
Then
Packet & Deck Builderletter · dossier · model
A person decides
Dossier ownerdecides; MLR approves
What comes out
Cited dossier sections
Tailored packet sent
Payer deck
One case, step by step

One payer request, from letter to sent packet

Crestline Health Plan’s P&T Committee reviews ulcerative colitis therapies on November 12, and Veltrimab’s ulcerative colitis indication was approved on September 30. Here is what happens to their request, screen by screen, in the working solution.

  1. 01Morning

    Formulary season, on one screen

    Priya Raman · Dossier owner

    Priya opens the solution to 8 open payer requests, 3 packets due within two weeks and 14 P&T meetings ahead, four of them at accounts that have not asked for a dossier. The Veltrimab v6.0 edition stands at 7 of 17 sections done, with sign-off targeted for October 24. The P&T calendar shows every meeting by account type, from national PBMs to Medicaid.

    “Each bar is the packet window — due 14 days before the meeting.”

  2. 02Oct 6 · 16:42

    The letter, split into asks and checked as unsolicited

    Request Intake & Unsolicited Checker

    Dr. Hannah Brooks, PharmD, clinical pharmacist on Crestline’s P&T Committee, writes through the eDossier portal for a 1.4M-life plan. The agent highlights her four asks in her own words and records the unsolicited check: it came in unprompted, she decides on formulary, and the last company contact was August 14. Her request for updates for 12 months is recorded too.

    Packet due Oct 29 · 36 days to P&T.

  3. 03Next

    Each ask tested against the label

    Label & Claims Checker

    Three asks are on label: the dossier with ulcerative colitis, a budget model for the membership, and results after a failed advanced therapy — 17.9% vs 4.2% clinical remission at week 12 in VLT-301, read from the Figure 2 forest plot and confirmed by the text. The adolescent question is not: label §8.4 says safety and effectiveness in pediatric patients with ulcerative colitis have not been established. Priya hands it to Dana Okafor in Medical Information, reply due October 9.

    “This ask stays out of the packet; Medical Information answers it separately and records it.”

  4. 04Decided

    Which edition goes, and the packet built

    Priya Raman · Dossier owner

    v6.0 is under revision, so Priya chooses: send v6.0 with ulcerative colitis, since sign-off on October 24 comes before the October 29 deadline, or v5.2 now with v6.0 to follow. She picks v6.0 and presses Build packet. The agents map the asks to the dossier, preset the budget model to 1.4M members and draft the cover letter, each step shown as it runs.

  5. 0515.3 seconds later

    Four files, and nothing they did not ask for

    Packet & Deck Builder

    The cover letter answers A1–A3 one by one and lists the 14 sections changed since v5.2. The Approved Product Dossier v6.0 runs to 17 sections and 112 pages. The Excel budget impact model is preset to Crestline — year 1 $522k (+$0.031 per member per month), year 3 $1.46M (+$0.087) — with every input left editable. A 3-page §3.2B excerpt answers the subgroup question.

    “Payer deck left out. Crestline did not ask for slides, the deck stays with Sam Patel for the account meeting.”

  6. 06MLR

    Medical, then regulatory and legal review

    Omar Haddad · Lena Ortiz

    Priya sends the packet to MLR — which the solution allows only once the adolescent ask has been handed to Medical Information. Omar Haddad approves for medical review and Lena Ortiz for regulatory and legal review, both on October 7 at 09:14. The packet now reads 2 of 2 approved.

  7. 07Sent · Oct 7

    Sent through the portal, with the record filed

    Priya Raman · Dossier owner

    Priya sends the packet through the eDossier portal. The unsolicited record, the packet and both approvals are filed with REQ-2417. The rest of the packet goes now; the v6.0 dossier is released to the portal the moment it is signed.

    “Standing request: updates may go to this account until Oct 2027.”

  8. 08Behind it

    The new edition, redlined with a reason for every change

    Evidence Mapper & Change Tracker

    The UC approval touched 14 sections, the VLT-302 52-week results 4, the psoriasis 5-year extension 2 and the new list price 3. In §2.1B Product information the agents add the UC indication, 600 mg IV induction at weeks 0, 4 and 8, then 200 mg subcutaneous from week 16 and every 8 weeks after, the hepatotoxicity warning during UC induction, and the WAC from January 1, 2027. Each change shows its reason and can be reverted; unchanged text stays word for word.

    “Each change shows why — click the reason to see its source.”

  9. 09One value to decide

    Two numbers for the same endpoint, put to a person

    Table & Figure Reader

    Three values in the §3.2B evidence table come from figures, each confirmed by a table or a sentence. One is not settled: the VLT-302 abstract gives week-52 endoscopic improvement as 50.1%, while Figure 3 and Table S4 give 50.2% (136 of 271). The reader recommends Table S4 because it holds the patient counts; the dossier owner decides and the choice goes into the change log.

    No value from a figure without a confirming table or sentence.

  10. 10Last 30 days

    Turnaround, MLR and what payers decided

    Priya Raman · Dossier owner

    23 requests answered, a median of 2.4 days from received to sent, 87% passed MLR the first time and every packet before its P&T deadline. The dashboard shows what payers ask for — full dossiers 46%, budget or cost models 22% — where the days go by stage, and recent P&T decisions for accounts that received a packet.

Who it’s for

Built for everyone who touches a payer request.

The same request, seen by the five people who carry it — what their week looked like, and what it looks like now.

PR
Priya RamanUS Payer Value Communication
Dossier owner
Before
Rebuilds every packet by hand and works out from memory which sections a new label changed.
Now
Starts from checked asks and a built packet, decides the edition, and signs sections from a cited redline.
MC
Dr. Maya ChenHEOR
Model owner
Before
Presets the budget impact model for each plan and rechecks values copied from figures.
Now
Owns the model and the clinical sections; values read from figures arrive confirmed, and a conflict between sources arrives with both readings and a recommendation.
LO
Lena OrtizRegulatory & legal
MLR reviewer
Before
Reviews packets without the unsolicited evidence attached, and asks for it every time.
Now
Reviews a packet with its unsolicited record, every ask classified against the label, and approves on the request.
DO
Dana OkaforMedical Information
Unapproved-use answers
Before
Hears about off-label questions late, if at all, after they were half-answered in a packet.
Now
Receives each unapproved-use question as its own item, with the label passage behind the call and a reply date.
SP
Sam PatelNational accounts
Account director
Before
Chases status on every account’s request before the P&T meeting.
Now
Logs requests, sees each one’s stage and packet deadline, and keeps the payer deck for account meetings.
Built on the engine

6 agents. Each with one job, and hard limits.

Six specialist agents take in each request, map and read the evidence, draft, check and assemble the packet; the dossier owner decides.

Request Intake & Unsolicited Checker

Reads each payer request from the portal, email or an account director, splits it into numbered asks and records why it counts as unsolicited — channel, requester role and any company contact in the 30 days before — plus any standing request for updates.

  • Never starts a packet without an unsolicited record
  • Quotes the requester — never paraphrases an ask
  • A request through an account director waits for the requester’s own written request
Evidence Mapper & Change Tracker

Maps every source to AMCP Format 5.0 sections and, when a label, study or price memo changes, finds each section it touches and keeps the change log against the last published edition.

  • A superseded label revision is never cited
  • Every change carries its reason and source
Table & Figure Reader

Reads values from tables, forest plots, bar charts and Kaplan–Meier curves, with confidence interval, page and figure number, and checks each against the text or the source table.

  • No value from a figure without a confirming table or sentence
  • Blurred or badly scaled figures go to a person
Section Writer

Drafts each changed AMCP section with a citation on every value, keeping still-correct text word for word so the redline stays small, in plain, non-promotional language.

  • No superlatives or comparative claims beyond the evidence
  • Executive summary 5 pages, 8 at most
Label & Claims Checker

Classifies every claim and every payer ask as consistent with the label, health-care economic information on an approved indication, pre-approval information or an unapproved use, citing the label passage behind the call.

  • Unapproved uses go to Medical Information only
  • Comparisons must match the evidence
Packet & Deck Builder

Assembles the tailored packet — cover letter with what changed, the dossier, the budget model preset to the plan’s membership — and derives payer decks from the signed dossier, a section citation on every slide.

  • Nothing unrequested in a packet
  • Sends only after MLR approval
  • Every model input stays editable
Dossier owner

Decides; MLR approves. The agents propose; a named person decides.

Ask in plain words

Ask it anything, in plain words

Anyone on the team can ask about a dossier, a payer request or a source — or tell it what to change. Every answer is cited.

Which P&T meetings need the UC update first?

In order of packet deadline, Keystone Rx is due first and gets v5.2 with a note that v6.0 follows. Crestline can have v6.0 — sign-off on Oct 24 is before its Oct 29 deadline. Riverbend and St. Anselm meet in November but have not asked, so nothing goes to them.

What changed between v5.2 and v6.0?

14 of 17 sections changed, for four reasons: ulcerative colitis approved, the VLT-302 52-week results, 5-year psoriasis data and the new list price. §4.2B waits for the UC cost-effectiveness report.

Why is the adolescent question going to Medical Information?

Because it is an unapproved use. The label says the safety and effectiveness of Veltrimab in pediatric patients with ulcerative colitis have not been established. Crestline asked about it unprompted, so Medical Information answers it separately, factually and on the record — it never goes in the dossier packet.

Add a rule: hold any packet that includes material the payer did not ask for

Added and switched on. The packet builder now lists each file against the ask it answers and holds anything that answers none. It already applies to Crestline — the payer deck stays out.

Every screen

The working solution, as it ships.

13 screens from the working solution, on its sample data. Pick one to see it large.

HomeOpen payer requests, P&T meetings ahead, the edition in progress and what changed since the last one, on a ten-week P&T calendar.
Every payer requestEach request with its asks, covered lives, P&T date, packet deadline and stage — by account type, from national PBMs to Medicaid.
The requestThe payer’s letter with each ask highlighted, the unsolicited check, and the choice of which dossier edition goes.
Every ask, classifiedOn-label asks answered in the packet with citations; the unapproved-use question handed to Medical Information.
Agents at workIntake, label check, evidence mapping, the budget model preset and the cover letter, each step in view with its timing.
The packetCover letter, dossier, budget impact model and evidence excerpt — and the payer deck left out because nobody asked for it.
MLR reviewMedical review and regulatory and legal review approve the packet on the request, with date and time.
Sent and filedSent through the eDossier portal, with the unsolicited record, packet and approvals filed with the request.
The dossier redlineEvery AMCP section with its owner and status; each change since the last edition shows its reason and source.
Evidence tablesValues read from tables and figures, each confirmed — and the one value two sources disagree on, put to a person.
The evidence libraryLabels, study reports, publications, model reports and pricing memos, read to passage, table and figure, with the sections each is used in.
The dashboardRequests answered, median days to send, MLR first-time pass rate, packets on time, what payers ask for and where the time goes.
Your team’s rulesWho approves each step, and the rules the agents follow — two of them required.
Governance

Built for payer communication: unsolicited, label-checked, MLR-approved.

Unsolicited, or nothing is builtEvery request carries its unsolicited record — channel, requester role, no company contact in the 30 days before. A request that came through an account director waits for the requester’s own written request.
Unapproved uses never enter a packetThe label checker cites the label passage behind each call. Unapproved-use questions go to Medical Information, and a packet cannot go to MLR until they have been handed over.
A citation on every valueEvery answer cites the passage it rests on; click a cited number to see it. Superseded label revisions stay on file and are never cited.
Figures confirmed, conflicts to a personA value read from a figure is used only when a table or the text confirms it. When two sources disagree, both readings go to a person, and the decision is recorded in the change log.
Two MLR approvals before anything is sentMedical review and regulatory and legal review each approve the packet on the request. Dossier sections are signed with an electronic signature that records its meaning.
Every step on the recordEach agent step and each decision — an edition chosen, an ask handed over, an approval, a send — is recorded on the request’s activity trail with who and when.
Configuration

Your team’s rules, not ours

Who approves, which rules the agents follow and how packets go out are settings, not a project.

SettingDefaultChoose from
Packet deadline14 days before each P&T meetingAny number of days · drives the calendar and the clocks
Medical reviewOmar HaddadAny person on the team
Regulatory & legal reviewLena OrtizAny person on the team · keeps the unsolicited record
Budget and cost modelsDr. Maya ChenAny person on the team · §4.1B–§4.3B and every preset model
Unapproved-use questionsDana OkaforAny person on the team · answered outside the packet
Sending packetsPriya Raman, after both MLR approvalsAny person on the team
Budget model formatExcel workbook, inputs unlockedExcel workbook, inputs unlocked · Web calculator link
Rules the agents follow7 on, 2 requiredSwitch on or off · describe a new rule in plain words
Connections

Works with the systems you already run

eDossier portalrequests in and packets out
Request mailboxpayer emails, read as they arrive
Customer recordslast company contact, for the unsolicited check
Prescribing information and studieslabels, CSR synopses, publications, posters
Economic model reportsbudget impact and cost-effectiveness models
AMCP Format 5.0the section structure every dossier follows
What it changes

The difference, in numbers.

Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.

target
2.4days
median from payer request received to packet sent
By hand2–3 weeks
With agents2.4 days
target
87%
of packets passed MLR review the first time
passed MLR first time
typical
80%
less time to develop a dossier, first draft about 90% complete
By handweeks to months
With agents≈ 80% less

“demo” = seen in the working solution, on its sample products and accounts · “target” = the design goal, measured in the live solution · “estimated” = our estimate, as shown on the solution’s dashboard · Sources: AMCP Format for Formulary Submissions 5.0 (2024). People, products and accounts named on this page are characters in the working solution.

Questions

What market access teams ask us.

What is an AMCP dossier?

A formulary submission built to the AMCP Format for Formulary Submissions — executive summary, product information, clinical evidence, economic value and modelling, supporting evidence and appendices — that payers and P&T committees use to review a product. The Formulary Dossier Builder keeps those sections current with a citation on every value and builds a tailored packet when a payer asks.

How does it handle unsolicited payer requests?

The request intake agent splits each request into asks and records why it is unsolicited: the channel, the requester’s formulary role and that there was no company contact in the 30 days before. Nothing is built until that check passes, and updated dossiers go only to accounts with a standing request for a stated period.

What happens to off-label questions in a request?

The label and claims checker classifies every ask against the current prescribing information and cites the passage behind the call. An unapproved use is handed to Medical Information, answered separately and recorded; it never goes in the packet.

How does it update the dossier when a new indication is approved?

The evidence mapper finds every section the new label, study or price memo touches, and the section writer redrafts only what changed, keeping the rest word for word. Each change shows its reason and source, can be reverted, and the section is signed by its owner before the edition is published with a change appendix.

Can it read values from forest plots and Kaplan–Meier curves?

Yes. The table and figure reader reads values from tables, forest plots, bar charts and Kaplan–Meier curves, with page and figure number. It uses a value from a figure only when a table or the text confirms it, and puts any disagreement between sources to a person.

Does the budget impact model stay editable for the payer?

Yes. The packet builder presets the model to the plan’s membership and leaves every input editable in the Excel workbook the payer receives; a web calculator link is the other option in Settings.

Do people stay in control?

Yes. The dossier owner decides which edition goes and what is in the packet, section owners sign their sections, and nothing is sent until medical review and regulatory and legal review have both approved. Every agent step and every decision is on the request’s activity trail.

How long does it take to go live?

The Agentic Solution Engine builds and deploys it from your requirements — your current dossier, your evidence library, your MLR roles and a sample of past payer requests — and it goes live once every quality gate has passed. We will walk you through it on your own dossier first.

See it on
your dossiers.

We’ll run the Formulary Dossier Builder on your own dossier and a sample of past payer requests.