DecisionBase

March 2013

Venous Thromboembolism (DVT and PE Treatment and Secondary Prophylaxis)

Introduction:

Therapies with Improved Safety and Delivery Profiles Are Set to Overtake Enoxaparin and Warfarin as Leading Treatments of DVT/PE

Despite the availability of efficacious drugs to treat deep vein thrombosis (DVT) and/or pulmonary embolism (PE), physicians have been limited in their treatment options, particularly with regard to long-term prophylaxis, for which warfarin has been the only available therapy until very recently. Despite warfarin’s efficacy, physicians have long desired an alternative to the agent given its high interpatient variability, its wide range of drug and food interactions, and the necessity for frequent monitoring and dose adjustment. However, the recent emergence of several novel oral anticoagulants conferring significant advantages over existing therapies is set to change the treatment of DVT and PE and will have a profound impact on a market long dominated by warfarin.

Questions Answered in This Report:

  *   Reducing the recurrence of DVT, PE, and venous thromboembolism (VTE)-related mortality are key goals in DVT/PE treatment and secondary prophylaxis. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European emergency department physicians weight specific efficacy end points and other drug attributes in their prescribing decisions for DVT/PE treatment and secondary prophylaxis?

  *   The treatment regimen of enoxaparin (Sanofi’s Lovenox, generics) plus warfarin (Bristol-Myers Squibb’s Coumadin, Eisai’s Warfarin, generics) was the 2011 major-market sales leader for DVT/PE treatment and secondary prophylaxis. What weaknesses exist in its profile that would allow emerging therapies to erode enoxaparin plus warfarin’s market share? Have emerging therapies demonstrated strengths on the attributes that surveyed emergency department physicians indicate are the most important in their prescribing decisions? Which emerging therapies will offer the clinical improvements over currently available therapies that surveyed MCO PDs seek from new therapies?

  *   The rate of mortality and the incidence of DVT and/or PE are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new therapies in the treatment and secondary prophylaxis of DVT/PE. What trade-offs across these and other clinical attributes are U.S. emergency department physicians willing to make when considering the use of emerging therapies for the treatment of DVT/PE treatment and secondary prophylaxis? Based on the trade-offs in price and performance across key drug attributes that U.S. emergency department physicians are willing to make, how does physician preference and prescribing likelihood vary across different target product profiles for DVT/PE treatment and secondary prophylaxis?

  *   By 2016, rivaroxaban will emerge as the gold-standard therapy in our Drug Comparator Model because of its superior clinical profile over the key current therapies we evaluated. On what clinical attributes is rivaroxaban most differentiated from its competitors? Which current therapies are at greatest risk of being replaced by rivaroxaban?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for DVT/PE treatment and secondary prophylaxis:

- Incidence of DVT and/or PE.

- Incidence of bleeding.

- Rate of mortality.

- Incidence of non-bleeding-related side effects.

- Dosing frequency.

- Dosage formulation.

- Price/day for six-month treatment period.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for DVT/PE treatment and secondary prophylaxis:

- Effect on incidence of DVT.

- Effect on incidence of PE.

- Incidence of treatment-related bleeding.

Physicians surveyed: 60 U.S. and 30 European emergency department physicians

Payers surveyed: 21 U.S. MCO PDs

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Enoxaparin (Sanofi’s Lovenox, generics) plus warfarin (Bristol-Myers Squibb’s Coumadin, Eisai’s Warfarin, generics)

- Unfractionated heparin (Sanofi’s Calciparine, generics) plus warfarin (Bristol-Myers Squibb’s Coumadin, Eisai’s Warfarin, generics)

- Fondaparinux (GlaxoSmithKline’s Arixtra, generics) plus warfarin (Bristol-Myers Squibb’s Coumadin, Eisai’s Warfarin, generics)

- Dalteparin (Pfizer/Eisai’s Fragmin) plus warfarin (Bristol-Myers Squibb’s Coumadin, Eisai’s Warfarin, generics)

- Tinzaparin (Leo/Celgene’s Innohep) plus warfarin (Bristol-Myers Squibb’s Coumadin, Eisai’s Warfarin, generics)

Emerging Therapies

- Rivaroxaban (Bayer/Janssen’s Xarelto)

- Injectable anticoagulant plus dabigatran etexilate (Boehringer Ingelheim’s Pradaxa)

- Apixaban (Bristol-Myers Squibb/Pfizer’s Eliquis)

- Injectable anticoagulant plus edoxaban (Daiichi Sankyo’s Lixiana)

- REG-2 (Regado Biosciences)


Search Reports

Mentioned in this report:

  • - Archemix Pharmaceuticals
  • - Bayer
  • - Boehringer Ingelheim
  • - Bristol-Myers Squibb
  • - Celgene
  • - Daiichi Sankyo
  • - Eisai
  • - GlaxoSmithKline
  • - Janssen
  • - Leo
  • - Merck
  • - Novartis
  • - Pfizer
  • - Portola Pharmaceuticals
  • - Procter & Gamble
  • - Regado Biosciences
  • - Roche
  • - Sanofi
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