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PARIOFORMA

Globally, over 60% of pharmaceutical industry growth can be attributed to specialty care brands.
These are high-priced, specialized, often biopharmaceutical molecules that have limited patient
and prescriber populations, high annual treatment costs, and restrictions on access, use, and
reimbursement.

They are dominating pipelines, and their sales are
forecasted to grow at twice the rate of traditional                              SPECIALTY PHARMACEUTICAL
products for the next five years. By 2013, global                                 SALES GROWTH, 1999-2008
revenue from specialty products will exceed $160
billion. But with such rapid growth comes unique
challenges…
   The specialty market place is very different to primary care
    markets – characterized by a tight KOL universe, small patient
    numbers, and high barriers to entry (high development cost,
    intensity of competition, threat of substitution).
   In addition, manufacturers of niche specialist products face
    unique informational and evidentiary demands to
    demonstrate comparative value.
   Of all factors contributing to product success, payer access is
    considered the most critical – therefore, the sooner Market
    Access is at the table, the more likely successful pricing and
    reimbursement strategies are to be realized.
   With the high cost of many specialty products the stakes on
    Market Access are extremely high.



                                                                      Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom
                                                                                                                     www.parioforma.com
PARIOFORMA



Case Study:
Pre-launch pricing and reimbursement strategy for an oncology product.

   Product: For use in advanced metastatic cancer.                                                        CZ – BI and CE are
                                                                                                           important and no
   Indication: Initial indication 2nd line with potential                                                   experience in
    for future launch in 1st at a higher dose.                                                              developing risk
                                                                                                           sharing strategies
   Issue: To understand how this may affect payers’                                    PL – cost per                              NL – product
                                                                                           patient is                                  needs to
    decisions when assessing the product and in                                         paramount for                            demonstrate that it
                                                                                      drugs administered                            provides more
    negotiations on price. The client wanted to gain                                    under special                               "health" than
                                                                                         therapeutic                              comparators at a
    payer insights on the future of managing price and
                                                                                                           Country
                                                                                         programmes                                reasonable cost
    access in oncology and how best to support this new
    product during its review for reimbursement,
    funding and listing.                                                                                   Insights
   Response: The Parioforma team conducted a multi-                                      PT – price                              BE – risk sharing
    country review, engaging with payers to:                                           negotiations are                            not official but
                                                                                       based on BI and                            common practice
    ◦   Establish the relative importance of the uncertainties relating to this         cost per QALY                            for all Class 1 drugs
        product and their expected impact on pricing and access;
    ◦   Evaluate the capacity of alternative access programs to mitigate                                      FI – different
        these uncertainties.                                                                               funding and pricing
                                                                                                            mechanisms for IV
Some country insights from this study are highlighted in the chart.                                          and oral drugs




                                                                                  Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom
                                                                                                                                 www.parioforma.com
PARIOFORMA


Our Services:
We specialise in qualitative & semi-quantitative directional pricing research - from broad
payer assessments for early stage assets to detailed country planning and payer engagement
for pre-launch and marketed products.

   Every buying system has multiple purchase decision makers, each with different value perceptions and influence.
   We have developed a strong network of payers and payer influencers at national, regional and local level across
    more than 40 markets worldwide.
We can help you understand:
   The approval and decision-making environment related to coverage, pricing , and reimbursement on a country-by-
    country basis (including emerging markets);
   General characteristics of healthcare delivery systems including common barriers and recommendations to
    facilitate market entry;
   Best practices for developing an access strategy;
   Methods for communicating value propositions to hospitals in individual markets.
With a network of over payer 500 specialists worldwide - our scope is global and we have the
resources and experience to tailor our services to meet your needs…
   For further information, or to discuss your Market Access requirements, contact us now on +44 (0) 207 225 3538
    or email Charles Rowlands at: charles.rowlands@parioforma.com


                                                           Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom
                                                                                                          www.parioforma.com

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Market access the challenges for niche specialist products

  • 1. PARIOFORMA Globally, over 60% of pharmaceutical industry growth can be attributed to specialty care brands. These are high-priced, specialized, often biopharmaceutical molecules that have limited patient and prescriber populations, high annual treatment costs, and restrictions on access, use, and reimbursement. They are dominating pipelines, and their sales are forecasted to grow at twice the rate of traditional SPECIALTY PHARMACEUTICAL products for the next five years. By 2013, global SALES GROWTH, 1999-2008 revenue from specialty products will exceed $160 billion. But with such rapid growth comes unique challenges…  The specialty market place is very different to primary care markets – characterized by a tight KOL universe, small patient numbers, and high barriers to entry (high development cost, intensity of competition, threat of substitution).  In addition, manufacturers of niche specialist products face unique informational and evidentiary demands to demonstrate comparative value.  Of all factors contributing to product success, payer access is considered the most critical – therefore, the sooner Market Access is at the table, the more likely successful pricing and reimbursement strategies are to be realized.  With the high cost of many specialty products the stakes on Market Access are extremely high. Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom www.parioforma.com
  • 2. PARIOFORMA Case Study: Pre-launch pricing and reimbursement strategy for an oncology product.  Product: For use in advanced metastatic cancer. CZ – BI and CE are important and no  Indication: Initial indication 2nd line with potential experience in for future launch in 1st at a higher dose. developing risk sharing strategies  Issue: To understand how this may affect payers’ PL – cost per NL – product patient is needs to decisions when assessing the product and in paramount for demonstrate that it drugs administered provides more negotiations on price. The client wanted to gain under special "health" than therapeutic comparators at a payer insights on the future of managing price and Country programmes reasonable cost access in oncology and how best to support this new product during its review for reimbursement, funding and listing. Insights  Response: The Parioforma team conducted a multi- PT – price BE – risk sharing country review, engaging with payers to: negotiations are not official but based on BI and common practice ◦ Establish the relative importance of the uncertainties relating to this cost per QALY for all Class 1 drugs product and their expected impact on pricing and access; ◦ Evaluate the capacity of alternative access programs to mitigate FI – different these uncertainties. funding and pricing mechanisms for IV Some country insights from this study are highlighted in the chart. and oral drugs Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom www.parioforma.com
  • 3. PARIOFORMA Our Services: We specialise in qualitative & semi-quantitative directional pricing research - from broad payer assessments for early stage assets to detailed country planning and payer engagement for pre-launch and marketed products.  Every buying system has multiple purchase decision makers, each with different value perceptions and influence.  We have developed a strong network of payers and payer influencers at national, regional and local level across more than 40 markets worldwide. We can help you understand:  The approval and decision-making environment related to coverage, pricing , and reimbursement on a country-by- country basis (including emerging markets);  General characteristics of healthcare delivery systems including common barriers and recommendations to facilitate market entry;  Best practices for developing an access strategy;  Methods for communicating value propositions to hospitals in individual markets. With a network of over payer 500 specialists worldwide - our scope is global and we have the resources and experience to tailor our services to meet your needs…  For further information, or to discuss your Market Access requirements, contact us now on +44 (0) 207 225 3538 or email Charles Rowlands at: charles.rowlands@parioforma.com Parioforma Ltd – 55 Princes Gate – London SW7 2PN – United Kingdom www.parioforma.com