It's a matter of results.

CASE STUDY

Commercial Launch

Background

 

In March of 2018, D2 was commissioned to provide Trade, Distribution, and Market Access support for an international companies’ first branded product launch in the United States.  D2 was to provide guidance in gaining market access and commercialization to this newly acquired HMG-CoA reductase inhibitor for patients with primary hyperlipidemia.   The product was being launched into a highly generic dominated market with a bioequivalent competitor which was launched earlier.  

Results

 

D2 used a project management approach to help brand managers achieve the greatest pharma market access.  D2 helped the brand managers understand the market access landscape by preparing a plan that outlined the target therapeutic class.  

We were able to get the new-to-market policies for every payor and PBM so that until P&T determinations are made – patient, HCP, and field teams understood what happened on day 1 of launch. 

 

D2 helped to determine the opportunities and challenges of rebating vs patient assistance programs.   A value proposition was prepared with coverage and reporting for the top 50 accounts with commercial, Medicare, Medicaid, and VA status. 

 

Through collaboration with our customer D2 was able to utilize clinical attributes that could be strategically used to open formulary opportunities in hard to reach ADAP government programs.  About 240 thousand lives through ADAP network pharmacies across the United States gained greater access to this lipidemic drug.   

 

D2 was also able to gain access to 28 million lives by creating a strategy that removed the lipidemic drug from a PBM Exclusion list.  The PBM has followed an aggressive formulary exclusion approach since 2014.  These exclusions historically drive competition between brands to allow generics to gain preferable status.  This PBM was one of the trendsetters in using formulary exclusions and still uses drug exclusions as one of the major approaches to attain lowest net cost. 

 

D2 was able help update and broker the presentation of a strong clinical story for this lipidemic drug.  We were able to put together a strong financial “win/win” story that moved our client from being excluded in a competitive generic market to open access.  By applying our relationships and experience to this initiative we were able to move from the list within 6 months.  Once a product goes onto the Exclusion List it is extremely difficult to come off.   

David_Saunders_headandshoulders2-e149878

DAVID SAUNDERS

Vice President & Head

Managed Markets Access &

Reimbursement

david.saunders@d2rx.com

tel. +1 612 889 5359

Market Access & 

Reimbursement 

  • Payer Engagement 

  • Brand Strategy & Enhancement

  • Commercial Planning

  • MCO Account Executive Team

  • Value-Based Contracting

CASE STUDY

Commercial Launch

Background

 

D2 had been providing Trade, Distribution and 3PL navigational support for a Branded Manufacturer when they sought assistance bringing to commercialization the product that had a dominant branded and a dominant generic competitor. The product would have a unique distribution process and due the complexity of the drug delivery method, intravitreal injection, the product would be managed under the Medical or Specialty Benefit versus the Pharmacy Benefit.  

Results

 

As the Launch date was within a year, D2 created a Project Management approach that provided for expertise in the key areas of commercialization, some of which are: Pre-Launch Regulatory, Payer/Medical Advisory Panels, Market Analysis and Segmentation, Dossier and Promotional Material Development, Product Positioning and Pricing, Internal Training, Strategic National Account Deployment. 

 

By creating rolling strategies and applying decades of experience to each initiative as the launch developed, D2 was able to secure National plan adoption and reimbursement in nearly half the time typically associated with new product launches. Market share increases were soon to follow which then drove the Payers to develop favorable Coverage Policies. The product achieved VA National Formulary placement in 6 months when other similar product’s have taken up to a year. Kaiser placed the product on their formulary after several clinical presentations brokered by D2. D2 uses a 600+ point commercialization plan so no critical element is missed. This launch has been publicized as one of the top 5 biotechnology launches in U.S. history. 

 

Partial listing of D2’s Steps to Success: 

  • Payer Advisory Panels x2 

  • MAC engagement and pull-through 

  • Value Proposition Development 

  • Budget Impact model x 2 

  • VA National Formulary placement 

  • VISN and Medical Writer Engagement 

  • DoD Uniform Formulary Placement 

  • Top 50 Payers - Commercial Managed Markets Coverage and Reporting 

  • IDN Engagement  

  • Tracking Tools Development 

  • Dossier Development 

  • Strategic decision support 

  • Market research insight 

  • Business process development 

  • Commercial Launch leadership 

  • Specialty Pharmacy Product Coverage and Strategies 

  • Operational Management 

  • Market Research 

  • Contracting Strategies and Analysis 

  • Reimbursement Monitoring and “Red Flag Notification” and Resolution 

  • Account Team Leadership, Deployment, and Strategy 

  • Disease Category Management for MCO 

  • MSA Analysis and Strategy 

  • Specialty Pharmacy/Specialty Distribution support programs 

  • Government Markets 

  • Strategic Accounts- PPN, IDN, IHN, ACO, SPP, GPO, Emp. Grps 

  • Value Proposition Development and Delivery 

  • Medical Information Request Form and Process Development 

More Client Outcomes

D2 St. Louis (HQ)

400 Chesterfield Center Suite 400

Chesterfield, MO 63017

D2 Boston

100 Summit Drive

Burlington, MA 01803

  • Facebook
  • Twitter
  • LinkedIn

© 2020 D2 Pharma Consulting LLC. All Rights Reserved