TariffPath
Reimbursement Support for Part IX Medical Devices
A commercial collaboration from Med Dev Services and Real Healthcare Solutions
The rules of Part IX reimbursement are being rewritten
The Department of Health and Social Care (DHSC) Drug Tariff reform represents the most significant structural change to Part IX reimbursement in decades. For manufacturers with extensive portfolios the challenge goes beyond a tick-box exercise, for some brands commercial survival is at stake and therefore continuity of product access for community based patients.
Introduction of a revised taxonomy and product categorisation framework
Heightened evidence scrutiny under Product Evaluation Criteria
Recurrent revalidation cycles with time critical deadlines and higher evidential thresholds
Margin revision driven by the new benchmark pricing mechanism
Increased risk of delisting, restricted access, or unfavourable categorisation
Crucially, these changes are being implemented in phased waves, meaning inaction or late preparation materially increases commercial risk.
Drug Tariff Review Product Waves
01
Point of Care Testing and Hypodermic Equipment; Oral, Dental, Ear, Eye and Nasal Care
02
Wound and Skin Care
03
Gastrointestinal and Urological Care
04
Lymphoedema, Support and Therapeutics; Sexual, Reproductive and Pelvic Health; Respiratory and Airway Management
Manufacturers of the 60,000 products reimbursed under Part IX must now proactively plan for renewals, potential re-categorisation, new applications or appeals, each requiring different commercial and evidential strategies.
Wave Timeline Overview
This table details the timeline for each wave of the Drug Tariff review, outlining key dates for renewals, assessments and price updates.
Timings accurate as of March 2026 but may be subject to change
Introducing TariffPath
TariffPath is a specialist commercial support service designed to navigate Part IX reimbursed medical device portfolios through the new Drug Tariff reform process.
The service is built specifically for:
UK and international manufacturers with Part IX listings
Commercial decision-makers navigating reimbursement uncertainty
TariffPath combines regulatory insight, commercial strategy and evidence positioning to maximise the probability of successful listing and renewal.
Strategic Pathways supported by TariffPath
Creating a New Product Category
  • Strategic case development for category creation
  • Clinical and functional differentiation mapping
  • Alignment to DHSC expectations on innovation, patient benefit and system value
  • Risk assessment versus alternative categorisation routes
Outcome: Increased likelihood of fair reimbursement positioning rather than forced fit into legacy categories.
New Product Applications (Existing Categories)
  • Evidence gap identification against Product Evaluation Criteria
  • Competitive benchmarking within the category
  • Narrative positioning beyond basic technical compliance
Outcome: Stronger submissions that address both overt and implicit assessment criteria.
Renewals
(Mandatory under new system)
  • Early risk profiling to identify delisting exposure
  • Retrospective performance and quality narrative construction
  • Commercial mitigation planning if renewal conditions change
Outcome: Continuity of listing and reduced revenue disruption.
Appeals Strategy
  • Analysis of DHSC decision rationale
  • Evidence reframing and rebuttal strategy
  • Commercial impact modelling to support prioritisation
Outcome: Structured, credible appeals with a clear path to reversal.
Pricing and Performance-Based Risk Share
Every TariffPath engagement is bespoke, reflecting the complexity of each Part IX category, brand, and product variant. Pricing is therefore confirmed following an initial clarification call and agreement of a clearly defined project scope.
Given the evidence-based scoring framework applied by NHSBSA, outcomes are ultimately determined by the quality, relevance, and strength of the evidence submitted by each manufacturer. While TariffPath provides strategic direction, expert insight, and robust submission support, final decisions remain evidence-dependent.
To reflect this, TariffPath operates a shared-risk pricing model, combining:
  • a bespoke service fee covering the agreed scope of work, and
  • a success-based fee element, aligning incentives with outcome-driven results.
This approach ensures commercial transparency, shared accountability, and alignment between effort, evidence, and outcome.
Success-Based Fee Structure
Clients pay for work conducted, with success fees triggered only on positive outcomes.
All fees are subject to VAT
Structured Engagement Model
TariffPath follows a defined, transparent engagement pathway:
Phase 1: Project Scoping
Duration: 3 days |
Activities:
  • Portfolio and product review
  • Wave-specific risk mapping
  • Prequalification Criteria
  • Route-to-listing strategy definition
  • Commercial prioritisation
Outputs:
  • Agreed scope and success criteria
  • Recommended strategic pathway
Phase 2: Feasibility and GAP Analysis
Duration: 4 days |
Activities:
  • Detailed assessment against DHSC Product Evaluation Criteria:
  1. Product Performance
  1. Quality Assessment
  1. Social Value
  • Evidence gap analysis
  • Risk and mitigation planning
Outputs:
  • Feasibility report
  • Evidence GAP analysis
  • Go / no-go recommendation
Phase 3: Application or Submission Management
Duration: 5 days |
Activities:
  • Submission drafting and positioning
  • Alignment of evidence to evaluation criteria
  • Commercial narrative optimisation
  • Pre-submission readiness review
Outputs:
  • Submission-ready application
  • Supporting documentation pack
Following initial submission the TariffPath team will handle the ongoing communication with NHS BSA to address any issues raised and work collaboratively with the brand owner to secure the desired outcome of each application, renewal or appeal.
Evidence generation solutions to support your brand
Both MDS and RHS have an established network of clinical solutions partners that can quickly and cost effectively address the evidence gaps identified in the scoping and feasibility stages of our engagement.
Primary Care Research Alliance Providing direct access to over 7m patients in General Practice, Community Trusts and Hospices, the UK's largest GP-led research network
Post Market Insights Service- connecting with over 135,000 registered Health Care Professionals who can provide brand specific feedback to support your application.
Pioneer Wound Healing Centres - Pioneer are the UK’s largest expert wound healing and lymphoedema team. Working on behalf of the NHS, as well as Private Patients, they deliver world-class care with a growing reputation for clinical research.
Clinical Research Solutions Provide end-to-end clinical study solutions. From initial study design, documentation and on-site training through to practice liaison throughout delivery. CRS will also write‑up the final study to produce reimbursement‑ready evidence.
TariffPath Team
TariffPath has been created by two of the UK's market leading medical device consultancies in recognition of the need and urgency required to support manufacturers though this period of reimbursement change. We have collaborated on a number of projects and decided to pool our considerable experience and expertise in handling Drug Tariff applications to benefit our clients, providing consistency, transparency and additional capacity.
Med Dev Services (MDS)
Med Dev Services is a UK-based consultancy specialising in commercial strategy, market access and distribution support for a range of medical devices. MDS brings deep experience in Drug Tariff engagement, distributor strategy and commercial risk management.
Real Healthcare Solutions (RHS)
Real Healthcare Solutions provides specialist healthcare insight, clinical evidence interpretation and system-level understanding of NHS decision-making. RHS adds depth in evaluation criteria interpretation, social value articulation and stakeholder expectations.
James Saunders
Founder
Med Dev Services
Richard Shorney
Founder
Real Healthcare Solutions
Together, MDS and RHS have combined to deliver TariffPath a service built to navigate reimbursement reform, support market access and maintain your community reimbursement. Click the link below to start your TariffPath conversation.
Contact James